ZINC Ref: EAS4059a LEA PROMAZINE 25MG & 50MG TAB TUK

Length: 323 mm Colours Used: PANTONE® GREEN C Width: 160 mm BLACK Depth: - Template UK & Ireland Artwork Department

PAGE 1: FRONT FACE (INSIDE OF REEL)

PROMAZINE 25 mg AND • are elderly, as it is more likely that you may Driving and using machines lens of the eye, purplish pigmentation of the 50 mg TABLETS suffer from certain of the side effects such as Promazine may cause drowsiness, dizziness, and cornea, the membrane that covers the white part drowsiness, low blood pressure, high or low cloudy or blurred vision. If you are affected by any of the eye and lines the inside of the eyelids PACKAGE LEAFLET: INFORMATION body temperature of these, DO NOT drive or operate machinery. (conjunctiva), the retina or the skin round the eyes FOR THE USER • or someone else in your family has a history of • high body temperature or low body HOW TO TAKE PROMAZINE Read all of this leaflet carefully before you start blood clots, as medicines like these have been temperature (especially in the elderly) taking this medicine. associated with formation of blood clots. • skin rash or itchiness Always take Promazine exactly as your doctor has • Keep this leaflet. You may need to read it again. Avoid exposure to direct sunlight while you are • sensitivity to light told you. You should check with your doctor or • If you have any further questions, ask your taking this medicine, as this medicine may cause • contact sensitisation (inflammation of the skin pharmacist if you are not sure. doctor or pharmacist. you to become sensitive to sunlight, particularly if or red, itchy skin rash, due to an immune • This medicine has been prescribed for you. Do you are taking high doses. The tablets should be swallowed preferably with reaction in response to a substance which has not pass it on to others. It may harm them, Taking other medicines a drink of water. The usual dose is: come into contact with the skin) even if their symptoms are the same as yours. Please tell your doctor or pharmacist if you are Adults: • suffering from infections more frequently, • If you get any side effects, talk to your doctor or taking or have recently taken any other • For psychomotor agitation which may be due to a severe reduction in the pharmacist. This includes any possible side medicines, including medicines obtained without 100-200 mg four times daily. number of white blood cells effects not listed in this leaflet. See section 4. a prescription. The Elderly: • lethargy, weakness, dizzy spells and feeling faint, pale skin, which may be due to a reduction IN THIS LEAFLET: DO NOT take Promazine with: • For agitation and restlessness • medicines to correct problems with heart rhythm 25-50 mg four times daily. in the number of red blood cells (anaemia) 1. What Promazine is and what it is used for e.g. quinidine, disopyramide, procainamide, Children: • weight gain 2. Before you take Promazine amiodarone, dofetilide, sotalol, bretylium Promazine is not recommended for use in children. • in women, production of breast milk or 3. How to take Promazine menstrual disturbance • antimalarials e.g. quinine and mefloquine If you take more Promazine than you should 4. Possible side effects • in men, impotence (inability to achieve or • antibiotics such as sparfloxacin, moxifloxacin, If you (or someone else) swallow a lot of the tablets 5. How to store Promazine maintain an erection), or breast enlargement intravenous erythromycin all together, or if you think a child has swallowed 6. Further information • in rare cases, sudden unexplained death has • certain types of (tricyclic or tetracyclic) any of the tablets, contact your nearest hospital occurred. 1 WHAT PROMAZINE IS AND WHAT IT IS antidepressants such as amitriptyline, maprotiline casualty department or your doctor immediately. USED FOR • other antipsychotics e.g. risperidone, An overdose is likely to cause drowsiness, The following have been reported at an unknown amisulpride, sertindole, haloperidol and pimozide confusion, low blood pressure, low body frequency: Promazine is one of a group of medicines called • cisapride, a medicine used in the treatment of • blood clots in the vein especially in the legs phenothiazines, which are used to treat a range of temperature, fits and coma are possible. Rarely certain gastro-intestinal disorders breathing difficulties may occur. (symptoms include swelling, pain and redness disorders including anxiety, agitation and • certain antihistamines e.g. terfenadine. in the leg), which may travel through blood disturbed behaviour. Please take this leaflet, any remaining tablets, and Talk to your doctor if you are taking any of the the container with you to the hospital or doctor so vessels to the lungs causing chest pain and Promazine is used to treat: following: that they know which tablets were consumed. difficulty in breathing. If you notice any of these • agitation and restlessness in the elderly • medicines which can affect the chemicals in your symptoms seek medical advice immediately. • short-term additional management of If you forget to take Promazine bloodstream known as electrolytes, such as: If you forget to take a tablet, take one as soon as • In elderly people with dementia, a small increase psychomotor agitation (unintentional and • diuretics e.g. furosemide in the number of deaths has been reported for purposeless motions brought on by mental you remember unless it is more than 2 hours after • antibiotics e.g. amphotericin B the missed dose; if so, ignore the missed dose and patients taking antipsychotics compared with tension; symptoms may take the form of • corticosteroids e.g. hydrocortisone those not receiving antipsychotics. restlessness, pacing, tapping fingers or feet, wait until the time of the next dose. DO NOT take • chemotherapy drugs e.g. cisplatin a double dose to make up for a forgotten dose. Reporting of side effects abruptly starting and stopping tasks, • sulphonylureas (used to treat diabetes) e.g. If you get any side effects, talk to your doctor or Stopping treatment with Promazine meaninglessly moving objects around, and more). gliclazide or glibenclamide pharmacist. This includes any possible side effects DO NOT stop taking your medicine without • antiepileptics e.g. phenytoin not listed in this leaflet. You can also report side BEFORE YOU TAKE PROMAZINE talking to your doctor first even if you feel better. 2 • blood pressure tablets effects directly via the Yellow Card Scheme at: Your medicine should only be withdrawn • calcium channel blockers e.g. amlodipine www.mhra.gov.uk/yellowcard DO NOT take Promazine if you: gradually under close supervision by your doctor. • sympathomimetics e.g. salbutamol By reporting side effects you can help provide • are allergic (hypersensitive) to promazine, any If you have any further questions on the use of other phenothiazine, or any of the other • antimuscarinics e.g. inhalations used for more information on the safety of this medicine. bronchitis such as ipratropium bromide this product, ask your doctor or pharmacist. ingredients of this medicine HOW TO STORE PROMAZINE • have phaeochromocytoma (adrenal gland • anticholinergics used to treat Parkinson’s or POSSIBLE SIDE EFFECTS tumour resulting in high blood pressure, restlessness, such as procyclidine, benzhexol, orphenadrine Keep this medicine out of the sight and reach of flushing, diarrhoea). Like all medicines, Promazine can cause side • tetrabenazine, used to treat essential tremor, children. Store the tablets below 25ºC. Keep the Promazine should not be given to patients in a effects, although not everybody gets them. chorea, tics, and related disorders container tightly closed. coma or suffering from central nervous system Stop taking the tablets and tell your doctor Do not use Promazine after the expiry date that is (CNS) depression, symptoms include decreased • ritonavir (an antiviral for HIV/AIDS) • anti-anxiety or sleeping drugs e.g. diazepam, immediately or go to the casualty department at stated on the outer packaging. The expiry date rate of breathing, decreased heart rate, and loss your nearest hospital if the following happens: refers to the last day of that month. of consciousness. temazepam, zopiclone • reboxetine (used to treat depression) • an allergic reaction causing swelling of the lips, Medicines should not be disposed of via wastewater Take special care with Promazine • lithium, (used to treat certain types of depression) face or neck leading to severe difficulty in or household waste. Ask your pharmacist how to Talk to your doctor before you start to take this • memantine, used to treat dementia breathing or severe skin rash or hives. dispose of medicines no longer required. These medicine if you: • sibutramine, used to help weight loss This is a very serious but rare side effect. You may measures will help to protect the environment. • have a history of jaundice (yellowing of the skin • cimetidine, used to treat stomach ulcer, reflux need urgent medical attention or hospitalisation. or whites of the eyes caused by liver or blood oesophagitis, Zollinger–Ellison syndrome, or Tell your doctor immediately if any of the FURTHER INFORMATION problems) other conditions where gastric acid reduction is following serious but rare effects happen: • blood dyscrasias (blood disorders which may beneficial • high body temperature, muscle rigidity, increased What Promazine Tablets contain: be characterised by fever or chills, sore throat, • antacids, used to treat indigestion and heartburn involuntary movement or tremor and altered • The active ingredient is promazine ulcers in your mouth or throat, unusual • metoclopramide, used to treat feeling or being consciousness (neuroleptic malignant syndrome) hydrochloride 25 mg or 50 mg. tiredness or weakness, unusual bleeding or sick • involuntary restless or repetitive limb • The other ingredients are lactose, maize starch, unexplained bruising) • kaolin, used to treat diarrhoea movements, shaking, inability to sit or stand still maize starch (partially pregelatinised), • have liver, kidney or heart disease • antispasmodics to treat gut spasm e.g. • jaundice (yellowing of the skin or whites of the magnesium stearate (E572), talc (E553), light • have previously had a stroke, transient ischaemic mebeverine hydrochloride eyes caused by liver or blood problems) kaolin (E559), sucrose, shellac (E904), beeswax attack (TIA, stroke that lasts only a few minutes) • medicines used for pain relief called opioid • Torsades de pointes, a life threatening irregular (E901), carnauba wax (E903), tartrazine (E102), or heart attack, have a family history of strokes, analgesics e.g. tramadol, morphine, codeine heart beat (symptoms may include recurrent titanium dioxide (E171), sodium benzoate (E211), or have other risk factors which may increase • adrenaline or noradrenaline episodes of palpitations, dizziness, fainting, povidone, acetylated monoglyceride, black iron the risk of stroke, such as high cholesterol, • alcohol. feeling sick, paleness of the skin, cold sweats, oxide (E172) and propylene glycol (E1520) uncontrolled high blood pressure, diabetes, you • The 50 mg tablets also contain sunset yellow If you are to undergo a surgical procedure that shortness of breath and chest pain) smoke or are a heavy drinker • cardiac arrest (symptoms include loss of (E110) and erythrosine (E127). • have personal or a family history of a certain requires a general anaesthetic, make sure you tell your doctor that you are taking Promazine. consciousness, breathing stops and no What Promazine Tablets look like and contents of type of heart disorder known as heartbeat or pulse can be felt. Some people may the pack: Important information about some of the “QT-prolongation” first notice that they have a racing heartbeat or • Promazine 25 mg Tablets are round biconvex ingredients of Promazine • have a history of unexplained fainting or feel dizzy or light-headed just before they faint.) yellow sugar-coated tablets coded 7Z1 on one blackouts • Patients who are intolerant to lactose should The following side effects have also been reported: side and plain on the reverse. • have any disease of the lungs, lower and upper note that Promazine contain a small amount of • nasal congestion • Promazine 50 mg Tablets are round biconvex airways, or any condition which causes lactose. If your doctor has told you that you have • dry mouth orange sugar-coated tablets coded 7Z2 on one difficulty in breathing an intolerance to some sugars, contact your • agitation, excitement side and plain on the reverse. • have Parkinson’s disease (tremor, stiffness and doctor before taking this medicinal product. • apathy (lack of feeling or emotion) • The pack sizes are 50, 100, 250 and 1,000. shuffling) • Promazine 25 mg and 50 mg tablets contain • dizziness, headache Not all pack sizes may be marketed. • have epilepsy E102 (tartrazine) and the 50 mg tablets also • fast heart rate Marketing Authorisation Holder and Manufacturer • have hypothyroidism (underactive thyroid gland) contain E110 (sunset yellow) which may cause • abdominal pain, diarrhoea, constipation • suffer from depression allergic reactions. Marketing Authorisation holder • difficulty in passing water (especially with an • have myasthenia gravis (progressive muscular Taking Promazine with food and drink TEVA UK Limited, Eastbourne, BN22 9AG. enlarged prostate) weakness) DO NOT drink alcohol whilst taking Promazine. Manufacturer • drowsiness, confusion, difficulty sleeping • have an enlarged prostate (causing difficulty in Custom Pharmaceuticals Limited, Conway Street, Pregnancy and breast-feeding • epileptic fits passing water) Hove, East Sussex, BN3 3LW, UK DO NOT take Promazine if you are pregnant, • low blood pressure • have personal or a family history of glaucoma planning to become pregnant or breast-feeding. • eye problems including blurred vision, clouding This leaflet was last revised: October 2019 (increased pressure in the eye) Ask your doctor for advice before taking any or opacity of the front part of the eye (cornea) or PL 00289/0798-9 • are taking any other neuroleptic medicines medicine. ZINC Ref: EAS4059a LEA PROMAZINE 25MG & 50MG TAB TUK

Length: 323 mm Colours Used: PANTONE® GREEN C Width: 160 mm BLACK Depth: - Template UK & Ireland Artwork Department

PAGE 2: REAR FACE (OUTSIDE OF REEL)

• are elderly, as it is more likely that you may Driving and using machines lens of the eye, purplish pigmentation of the suffer from certain of the side effects such as Promazine may cause drowsiness, dizziness, and cornea, the membrane that covers the white part drowsiness, low blood pressure, high or low cloudy or blurred vision. If you are affected by any of the eye and lines the inside of the eyelids body temperature of these, DO NOT drive or operate machinery. (conjunctiva), the retina or the skin round the eyes • or someone else in your family has a history of • high body temperature or low body HOW TO TAKE PROMAZINE Read all of this leaflet carefully before you start blood clots, as medicines like these have been 3 temperature (especially in the elderly) taking this medicine. associated with formation of blood clots. • skin rash or itchiness Always take Promazine exactly as your doctor has • Keep this leaflet. You may need to read it again. Avoid exposure to direct sunlight while you are • sensitivity to light told you. You should check with your doctor or Pharma code TBC • If you have any further questions, ask your taking this medicine, as this medicine may cause • contact sensitisation (inflammation of the skin pharmacist if you are not sure. doctor or pharmacist. you to become sensitive to sunlight, particularly if or red, itchy skin rash, due to an immune • This medicine has been prescribed for you. Do you are taking high doses. The tablets should be swallowed preferably with reaction in response to a substance which has not pass it on to others. It may harm them, Taking other medicines a drink of water. The usual dose is: come into contact with the skin) even if their symptoms are the same as yours. Please tell your doctor or pharmacist if you are Adults: • suffering from infections more frequently, • If you get any side effects, talk to your doctor or taking or have recently taken any other • For psychomotor agitation which may be due to a severe reduction in the pharmacist. This includes any possible side medicines, including medicines obtained without 100-200 mg four times daily. number of white blood cells effects not listed in this leaflet. See section 4. a prescription. The Elderly: • lethargy, weakness, dizzy spells and feeling DO NOT take Promazine with: • For agitation and restlessness faint, pale skin, which may be due to a reduction • medicines to correct problems with heart rhythm 25-50 mg four times daily. in the number of red blood cells (anaemia) 1. What Promazine is and what it is used for e.g. quinidine, disopyramide, procainamide, Children: • weight gain 2. Before you take Promazine amiodarone, dofetilide, sotalol, bretylium Promazine is not recommended for use in children. • in women, production of breast milk or 3. How to take Promazine menstrual disturbance • antimalarials e.g. quinine and mefloquine If you take more Promazine than you should 4. Possible side effects • in men, impotence (inability to achieve or • antibiotics such as sparfloxacin, moxifloxacin, If you (or someone else) swallow a lot of the tablets 5. How to store Promazine maintain an erection), or breast enlargement intravenous erythromycin all together, or if you think a child has swallowed 6. Further information • in rare cases, sudden unexplained death has • certain types of (tricyclic or tetracyclic) any of the tablets, contact your nearest hospital occurred. WHAT PROMAZINE IS AND WHAT IT IS antidepressants such as amitriptyline, maprotiline casualty department or your doctor immediately. USED FOR • other antipsychotics e.g. risperidone, An overdose is likely to cause drowsiness, The following have been reported at an unknown amisulpride, sertindole, haloperidol and pimozide confusion, low blood pressure, low body frequency: Promazine is one of a group of medicines called • cisapride, a medicine used in the treatment of • blood clots in the vein especially in the legs phenothiazines, which are used to treat a range of temperature, fits and coma are possible. Rarely certain gastro-intestinal disorders breathing difficulties may occur. (symptoms include swelling, pain and redness disorders including anxiety, agitation and • certain antihistamines e.g. terfenadine. in the leg), which may travel through blood disturbed behaviour. Please take this leaflet, any remaining tablets, and Talk to your doctor if you are taking any of the the container with you to the hospital or doctor so vessels to the lungs causing chest pain and Promazine is used to treat: following: that they know which tablets were consumed. difficulty in breathing. If you notice any of these • agitation and restlessness in the elderly • medicines which can affect the chemicals in your symptoms seek medical advice immediately. • short-term additional management of If you forget to take Promazine bloodstream known as electrolytes, such as: If you forget to take a tablet, take one as soon as • In elderly people with dementia, a small increase psychomotor agitation (unintentional and • diuretics e.g. furosemide in the number of deaths has been reported for purposeless motions brought on by mental you remember unless it is more than 2 hours after • antibiotics e.g. amphotericin B the missed dose; if so, ignore the missed dose and patients taking antipsychotics compared with tension; symptoms may take the form of • corticosteroids e.g. hydrocortisone those not receiving antipsychotics. restlessness, pacing, tapping fingers or feet, wait until the time of the next dose. DO NOT take • chemotherapy drugs e.g. cisplatin a double dose to make up for a forgotten dose. Reporting of side effects abruptly starting and stopping tasks, • sulphonylureas (used to treat diabetes) e.g. If you get any side effects, talk to your doctor or Stopping treatment with Promazine meaninglessly moving objects around, and more). gliclazide or glibenclamide pharmacist. This includes any possible side effects DO NOT stop taking your medicine without • antiepileptics e.g. phenytoin not listed in this leaflet. You can also report side BEFORE YOU TAKE PROMAZINE talking to your doctor first even if you feel better. • blood pressure tablets effects directly via the Yellow Card Scheme at: Your medicine should only be withdrawn • calcium channel blockers e.g. amlodipine www.mhra.gov.uk/yellowcard DO NOT take Promazine if you: gradually under close supervision by your doctor. • sympathomimetics e.g. salbutamol By reporting side effects you can help provide • are allergic (hypersensitive) to promazine, any If you have any further questions on the use of other phenothiazine, or any of the other • antimuscarinics e.g. inhalations used for more information on the safety of this medicine. bronchitis such as ipratropium bromide this product, ask your doctor or pharmacist. ingredients of this medicine HOW TO STORE PROMAZINE • have phaeochromocytoma (adrenal gland • anticholinergics used to treat Parkinson’s or POSSIBLE SIDE EFFECTS 5 tumour resulting in high blood pressure, restlessness, such as procyclidine, benzhexol, 4 orphenadrine Keep this medicine out of the sight and reach of flushing, diarrhoea). Like all medicines, Promazine can cause side • tetrabenazine, used to treat essential tremor, children. Store the tablets below 25ºC. Keep the Promazine should not be given to patients in a effects, although not everybody gets them. chorea, tics, and related disorders container tightly closed. coma or suffering from central nervous system Stop taking the tablets and tell your doctor Do not use Promazine after the expiry date that is (CNS) depression, symptoms include decreased • ritonavir (an antiviral for HIV/AIDS) • anti-anxiety or sleeping drugs e.g. diazepam, immediately or go to the casualty department at stated on the outer packaging. The expiry date rate of breathing, decreased heart rate, and loss your nearest hospital if the following happens: refers to the last day of that month. of consciousness. temazepam, zopiclone • reboxetine (used to treat depression) • an allergic reaction causing swelling of the lips, Medicines should not be disposed of via wastewater Take special care with Promazine • lithium, (used to treat certain types of depression) face or neck leading to severe difficulty in or household waste. Ask your pharmacist how to Talk to your doctor before you start to take this • memantine, used to treat dementia breathing or severe skin rash or hives. dispose of medicines no longer required. These medicine if you: • sibutramine, used to help weight loss This is a very serious but rare side effect. You may measures will help to protect the environment. • have a history of jaundice (yellowing of the skin • cimetidine, used to treat stomach ulcer, reflux need urgent medical attention or hospitalisation. or whites of the eyes caused by liver or blood oesophagitis, Zollinger–Ellison syndrome, or Tell your doctor immediately if any of the 6 FURTHER INFORMATION problems) other conditions where gastric acid reduction is following serious but rare effects happen: • blood dyscrasias (blood disorders which may beneficial • high body temperature, muscle rigidity, increased What Promazine Tablets contain: be characterised by fever or chills, sore throat, • antacids, used to treat indigestion and heartburn involuntary movement or tremor and altered • The active ingredient is promazine ulcers in your mouth or throat, unusual • metoclopramide, used to treat feeling or being consciousness (neuroleptic malignant syndrome) hydrochloride 25 mg or 50 mg. tiredness or weakness, unusual bleeding or sick • involuntary restless or repetitive limb • The other ingredients are lactose, maize starch, unexplained bruising) • kaolin, used to treat diarrhoea movements, shaking, inability to sit or stand still maize starch (partially pregelatinised), • have liver, kidney or heart disease • antispasmodics to treat gut spasm e.g. • jaundice (yellowing of the skin or whites of the magnesium stearate (E572), talc (E553), light • have previously had a stroke, transient ischaemic mebeverine hydrochloride eyes caused by liver or blood problems) kaolin (E559), sucrose, shellac (E904), beeswax attack (TIA, stroke that lasts only a few minutes) • medicines used for pain relief called opioid • Torsades de pointes, a life threatening irregular (E901), carnauba wax (E903), tartrazine (E102), or heart attack, have a family history of strokes, analgesics e.g. tramadol, morphine, codeine heart beat (symptoms may include recurrent titanium dioxide (E171), sodium benzoate (E211), or have other risk factors which may increase • adrenaline or noradrenaline episodes of palpitations, dizziness, fainting, povidone, acetylated monoglyceride, black iron the risk of stroke, such as high cholesterol, • alcohol. feeling sick, paleness of the skin, cold sweats, oxide (E172) and propylene glycol (E1520) uncontrolled high blood pressure, diabetes, you • The 50 mg tablets also contain sunset yellow If you are to undergo a surgical procedure that shortness of breath and chest pain) smoke or are a heavy drinker • cardiac arrest (symptoms include loss of (E110) and erythrosine (E127). • have personal or a family history of a certain requires a general anaesthetic, make sure you tell your doctor that you are taking Promazine. consciousness, breathing stops and no What Promazine Tablets look like and contents of type of heart disorder known as heartbeat or pulse can be felt. Some people may the pack: Important information about some of the “QT-prolongation” first notice that they have a racing heartbeat or • Promazine 25 mg Tablets are round biconvex ingredients of Promazine • have a history of unexplained fainting or feel dizzy or light-headed just before they faint.) yellow sugar-coated tablets coded 7Z1 on one blackouts • Patients who are intolerant to lactose should The following side effects have also been reported: side and plain on the reverse. • have any disease of the lungs, lower and upper note that Promazine contain a small amount of • nasal congestion • Promazine 50 mg Tablets are round biconvex airways, or any condition which causes lactose. If your doctor has told you that you have • dry mouth orange sugar-coated tablets coded 7Z2 on one difficulty in breathing an intolerance to some sugars, contact your • agitation, excitement side and plain on the reverse. • have Parkinson’s disease (tremor, stiffness and doctor before taking this medicinal product. • apathy (lack of feeling or emotion) • The pack sizes are 50, 100, 250 and 1,000. shuffling) • Promazine 25 mg and 50 mg tablets contain • dizziness, headache Not all pack sizes may be marketed. • have epilepsy E102 (tartrazine) and the 50 mg tablets also • fast heart rate Marketing Authorisation Holder and Manufacturer • have hypothyroidism (underactive thyroid gland) contain E110 (sunset yellow) which may cause • abdominal pain, diarrhoea, constipation • suffer from depression allergic reactions. Marketing Authorisation holder • difficulty in passing water (especially with an • have myasthenia gravis (progressive muscular Taking Promazine with food and drink TEVA UK Limited, Eastbourne, BN22 9AG. enlarged prostate) weakness) DO NOT drink alcohol whilst taking Promazine. Manufacturer • drowsiness, confusion, difficulty sleeping • have an enlarged prostate (causing difficulty in Custom Pharmaceuticals Limited, Conway Street, Pregnancy and breast-feeding • epileptic fits passing water) Hove, East Sussex, BN3 3LW, UK DO NOT take Promazine if you are pregnant, • low blood pressure • have personal or a family history of glaucoma planning to become pregnant or breast-feeding. • eye problems including blurred vision, clouding This leaflet was last revised: October 2019 (increased pressure in the eye) Ask your doctor for advice before taking any or opacity of the front part of the eye (cornea) or PL 00289/0798-9 • are taking any other neuroleptic medicines medicine. EAS4059a ZINC Ref: EAS4067a LEA PROMAZINE 25MG & 50MG TAB TUK

Length: 323 mm Colours Used: PANTONE® GREEN C Width: 160 mm BLACK Depth: - Template UK & Ireland Artwork Department

PAGE 1: FRONT FACE (INSIDE OF REEL)

PROMAZINE 25 mg AND • are elderly, as it is more likely that you may Driving and using machines lens of the eye, purplish pigmentation of the 50 mg TABLETS suffer from certain of the side effects such as Promazine may cause drowsiness, dizziness, and cornea, the membrane that covers the white part drowsiness, low blood pressure, high or low cloudy or blurred vision. If you are affected by any of the eye and lines the inside of the eyelids PACKAGE LEAFLET: INFORMATION body temperature of these, DO NOT drive or operate machinery. (conjunctiva), the retina or the skin round the eyes FOR THE USER • or someone else in your family has a history of • high body temperature or low body HOW TO TAKE PROMAZINE Read all of this leaflet carefully before you start blood clots, as medicines like these have been temperature (especially in the elderly) taking this medicine. associated with formation of blood clots. • skin rash or itchiness Always take Promazine exactly as your doctor has • Keep this leaflet. You may need to read it again. Avoid exposure to direct sunlight while you are • sensitivity to light told you. You should check with your doctor or • If you have any further questions, ask your taking this medicine, as this medicine may cause • contact sensitisation (inflammation of the skin pharmacist if you are not sure. doctor or pharmacist. you to become sensitive to sunlight, particularly if or red, itchy skin rash, due to an immune • This medicine has been prescribed for you. Do you are taking high doses. The tablets should be swallowed preferably with reaction in response to a substance which has not pass it on to others. It may harm them, Taking other medicines a drink of water. The usual dose is: come into contact with the skin) even if their symptoms are the same as yours. Please tell your doctor or pharmacist if you are Adults: • suffering from infections more frequently, • If you get any side effects, talk to your doctor or taking or have recently taken any other • For psychomotor agitation which may be due to a severe reduction in the pharmacist. This includes any possible side medicines, including medicines obtained without 100-200 mg four times daily. number of white blood cells effects not listed in this leaflet. See section 4. a prescription. The Elderly: • lethargy, weakness, dizzy spells and feeling faint, pale skin, which may be due to a reduction IN THIS LEAFLET: DO NOT take Promazine with: • For agitation and restlessness • medicines to correct problems with heart rhythm 25-50 mg four times daily. in the number of red blood cells (anaemia) 1. What Promazine is and what it is used for e.g. quinidine, disopyramide, procainamide, Children: • weight gain 2. Before you take Promazine amiodarone, dofetilide, sotalol, bretylium Promazine is not recommended for use in children. • in women, production of breast milk or 3. How to take Promazine menstrual disturbance • antimalarials e.g. quinine and mefloquine If you take more Promazine than you should 4. Possible side effects • in men, impotence (inability to achieve or • antibiotics such as sparfloxacin, moxifloxacin, If you (or someone else) swallow a lot of the tablets 5. How to store Promazine maintain an erection), or breast enlargement intravenous erythromycin all together, or if you think a child has swallowed 6. Further information • in rare cases, sudden unexplained death has • certain types of (tricyclic or tetracyclic) any of the tablets, contact your nearest hospital occurred. 1 WHAT PROMAZINE IS AND WHAT IT IS antidepressants such as amitriptyline, maprotiline casualty department or your doctor immediately. USED FOR • other antipsychotics e.g. risperidone, An overdose is likely to cause drowsiness, The following have been reported at an unknown amisulpride, sertindole, haloperidol and pimozide confusion, low blood pressure, low body frequency: Promazine is one of a group of medicines called • cisapride, a medicine used in the treatment of • blood clots in the vein especially in the legs phenothiazines, which are used to treat a range of temperature, fits and coma are possible. Rarely certain gastro-intestinal disorders breathing difficulties may occur. (symptoms include swelling, pain and redness disorders including anxiety, agitation and • certain antihistamines e.g. terfenadine. in the leg), which may travel through blood disturbed behaviour. Please take this leaflet, any remaining tablets, and Talk to your doctor if you are taking any of the the container with you to the hospital or doctor so vessels to the lungs causing chest pain and Promazine is used to treat: following: that they know which tablets were consumed. difficulty in breathing. If you notice any of these • agitation and restlessness in the elderly • medicines which can affect the chemicals in your symptoms seek medical advice immediately. • short-term additional management of If you forget to take Promazine bloodstream known as electrolytes, such as: If you forget to take a tablet, take one as soon as • In elderly people with dementia, a small increase psychomotor agitation (unintentional and • diuretics e.g. furosemide in the number of deaths has been reported for purposeless motions brought on by mental you remember unless it is more than 2 hours after • antibiotics e.g. amphotericin B the missed dose; if so, ignore the missed dose and patients taking antipsychotics compared with tension; symptoms may take the form of • corticosteroids e.g. hydrocortisone those not receiving antipsychotics. restlessness, pacing, tapping fingers or feet, wait until the time of the next dose. DO NOT take • chemotherapy drugs e.g. cisplatin a double dose to make up for a forgotten dose. Reporting of side effects abruptly starting and stopping tasks, • sulphonylureas (used to treat diabetes) e.g. If you get any side effects, talk to your doctor or Stopping treatment with Promazine meaninglessly moving objects around, and more). gliclazide or glibenclamide pharmacist. This includes any possible side effects DO NOT stop taking your medicine without • antiepileptics e.g. phenytoin not listed in this leaflet. You can also report side BEFORE YOU TAKE PROMAZINE talking to your doctor first even if you feel better. 2 • blood pressure tablets effects directly via the Yellow Card Scheme at: Your medicine should only be withdrawn • calcium channel blockers e.g. amlodipine www.mhra.gov.uk/yellowcard DO NOT take Promazine if you: gradually under close supervision by your doctor. • sympathomimetics e.g. salbutamol By reporting side effects you can help provide • are allergic (hypersensitive) to promazine, any If you have any further questions on the use of other phenothiazine, or any of the other • antimuscarinics e.g. inhalations used for more information on the safety of this medicine. bronchitis such as ipratropium bromide this product, ask your doctor or pharmacist. ingredients of this medicine HOW TO STORE PROMAZINE • have phaeochromocytoma (adrenal gland • anticholinergics used to treat Parkinson’s or POSSIBLE SIDE EFFECTS tumour resulting in high blood pressure, restlessness, such as procyclidine, benzhexol, orphenadrine Keep this medicine out of the sight and reach of flushing, diarrhoea). Like all medicines, Promazine can cause side • tetrabenazine, used to treat essential tremor, children. Store the tablets below 25ºC. Keep the Promazine should not be given to patients in a effects, although not everybody gets them. chorea, tics, and related disorders container tightly closed. coma or suffering from central nervous system Stop taking the tablets and tell your doctor Do not use Promazine after the expiry date that is (CNS) depression, symptoms include decreased • ritonavir (an antiviral for HIV/AIDS) • anti-anxiety or sleeping drugs e.g. diazepam, immediately or go to the casualty department at stated on the outer packaging. The expiry date rate of breathing, decreased heart rate, and loss your nearest hospital if the following happens: refers to the last day of that month. of consciousness. temazepam, zopiclone • reboxetine (used to treat depression) • an allergic reaction causing swelling of the lips, Medicines should not be disposed of via wastewater Take special care with Promazine • lithium, (used to treat certain types of depression) face or neck leading to severe difficulty in or household waste. Ask your pharmacist how to Talk to your doctor before you start to take this • memantine, used to treat dementia breathing or severe skin rash or hives. dispose of medicines no longer required. These medicine if you: • sibutramine, used to help weight loss This is a very serious but rare side effect. You may measures will help to protect the environment. • have a history of jaundice (yellowing of the skin • cimetidine, used to treat stomach ulcer, reflux need urgent medical attention or hospitalisation. or whites of the eyes caused by liver or blood oesophagitis, Zollinger–Ellison syndrome, or Tell your doctor immediately if any of the FURTHER INFORMATION problems) other conditions where gastric acid reduction is following serious but rare effects happen: • blood dyscrasias (blood disorders which may beneficial • high body temperature, muscle rigidity, increased What Promazine Tablets contain: be characterised by fever or chills, sore throat, • antacids, used to treat indigestion and heartburn involuntary movement or tremor and altered • The active ingredient is promazine ulcers in your mouth or throat, unusual • metoclopramide, used to treat feeling or being consciousness (neuroleptic malignant syndrome) hydrochloride 25 mg or 50 mg. tiredness or weakness, unusual bleeding or sick • involuntary restless or repetitive limb • The other ingredients are lactose, maize starch, unexplained bruising) • kaolin, used to treat diarrhoea movements, shaking, inability to sit or stand still maize starch (partially pregelatinised), • have liver, kidney or heart disease • antispasmodics to treat gut spasm e.g. • jaundice (yellowing of the skin or whites of the magnesium stearate (E572), talc (E553), light • have previously had a stroke, transient ischaemic mebeverine hydrochloride eyes caused by liver or blood problems) kaolin (E559), sucrose, shellac (E904), beeswax attack (TIA, stroke that lasts only a few minutes) • medicines used for pain relief called opioid • Torsades de pointes, a life threatening irregular (E901), carnauba wax (E903), tartrazine (E102), or heart attack, have a family history of strokes, analgesics e.g. tramadol, morphine, codeine heart beat (symptoms may include recurrent titanium dioxide (E171), sodium benzoate (E211), or have other risk factors which may increase • adrenaline or noradrenaline episodes of palpitations, dizziness, fainting, povidone, acetylated monoglyceride, black iron the risk of stroke, such as high cholesterol, • alcohol. feeling sick, paleness of the skin, cold sweats, oxide (E172) and propylene glycol (E1520) uncontrolled high blood pressure, diabetes, you • The 50 mg tablets also contain sunset yellow If you are to undergo a surgical procedure that shortness of breath and chest pain) smoke or are a heavy drinker • cardiac arrest (symptoms include loss of (E110) and erythrosine (E127). • have personal or a family history of a certain requires a general anaesthetic, make sure you tell your doctor that you are taking Promazine. consciousness, breathing stops and no What Promazine Tablets look like and contents of type of heart disorder known as heartbeat or pulse can be felt. Some people may the pack: Important information about some of the “QT-prolongation” first notice that they have a racing heartbeat or • Promazine 25 mg Tablets are round biconvex ingredients of Promazine • have a history of unexplained fainting or feel dizzy or light-headed just before they faint.) yellow sugar-coated tablets coded 7Z1 on one blackouts • Patients who are intolerant to lactose should The following side effects have also been reported: side and plain on the reverse. • have any disease of the lungs, lower and upper note that Promazine contain a small amount of • nasal congestion • Promazine 50 mg Tablets are round biconvex airways, or any condition which causes lactose. If your doctor has told you that you have • dry mouth orange sugar-coated tablets coded 7Z2 on one difficulty in breathing an intolerance to some sugars, contact your • agitation, excitement side and plain on the reverse. • have Parkinson’s disease (tremor, stiffness and doctor before taking this medicinal product. • apathy (lack of feeling or emotion) • The pack sizes are 50, 100, 250 and 1,000. shuffling) • Promazine 25 mg and 50 mg tablets contain • dizziness, headache Not all pack sizes may be marketed. • have epilepsy E102 (tartrazine) and the 50 mg tablets also • fast heart rate Marketing Authorisation Holder and Manufacturer • have hypothyroidism (underactive thyroid gland) contain E110 (sunset yellow) which may cause • abdominal pain, diarrhoea, constipation • suffer from depression allergic reactions. Marketing Authorisation holder • difficulty in passing water (especially with an • have myasthenia gravis (progressive muscular Taking Promazine with food and drink TEVA UK Limited, Eastbourne, BN22 9AG. enlarged prostate) weakness) DO NOT drink alcohol whilst taking Promazine. Manufacturer • drowsiness, confusion, difficulty sleeping • have an enlarged prostate (causing difficulty in TEVA UK Limited, Eastbourne, BN22 9AG. Pregnancy and breast-feeding • epileptic fits passing water) DO NOT take Promazine if you are pregnant, • low blood pressure This leaflet was last revised: October 2019 • have personal or a family history of glaucoma planning to become pregnant or breast-feeding. • eye problems including blurred vision, clouding PL 00289/0798-9 (increased pressure in the eye) Ask your doctor for advice before taking any or opacity of the front part of the eye (cornea) or • are taking any other neuroleptic medicines medicine. ZINC Ref: EAS4067a LEA PROMAZINE 25MG & 50MG TAB TUK

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PAGE 2: REAR FACE (OUTSIDE OF REEL)

• are elderly, as it is more likely that you may Driving and using machines lens of the eye, purplish pigmentation of the suffer from certain of the side effects such as Promazine may cause drowsiness, dizziness, and cornea, the membrane that covers the white part drowsiness, low blood pressure, high or low cloudy or blurred vision. If you are affected by any of the eye and lines the inside of the eyelids body temperature of these, DO NOT drive or operate machinery. (conjunctiva), the retina or the skin round the eyes • or someone else in your family has a history of • high body temperature or low body HOW TO TAKE PROMAZINE Read all of this leaflet carefully before you start blood clots, as medicines like these have been 3 temperature (especially in the elderly) taking this medicine. associated with formation of blood clots. • skin rash or itchiness Always take Promazine exactly as your doctor has • Keep this leaflet. You may need to read it again. Avoid exposure to direct sunlight while you are • sensitivity to light told you. You should check with your doctor or Pharma code TBC • If you have any further questions, ask your taking this medicine, as this medicine may cause • contact sensitisation (inflammation of the skin pharmacist if you are not sure. doctor or pharmacist. you to become sensitive to sunlight, particularly if or red, itchy skin rash, due to an immune • This medicine has been prescribed for you. Do you are taking high doses. The tablets should be swallowed preferably with reaction in response to a substance which has not pass it on to others. It may harm them, Taking other medicines a drink of water. The usual dose is: come into contact with the skin) even if their symptoms are the same as yours. Please tell your doctor or pharmacist if you are Adults: • suffering from infections more frequently, • If you get any side effects, talk to your doctor or taking or have recently taken any other • For psychomotor agitation which may be due to a severe reduction in the pharmacist. This includes any possible side medicines, including medicines obtained without 100-200 mg four times daily. number of white blood cells effects not listed in this leaflet. See section 4. a prescription. The Elderly: • lethargy, weakness, dizzy spells and feeling DO NOT take Promazine with: • For agitation and restlessness faint, pale skin, which may be due to a reduction • medicines to correct problems with heart rhythm 25-50 mg four times daily. in the number of red blood cells (anaemia) 1. What Promazine is and what it is used for e.g. quinidine, disopyramide, procainamide, Children: • weight gain 2. Before you take Promazine amiodarone, dofetilide, sotalol, bretylium Promazine is not recommended for use in children. • in women, production of breast milk or 3. How to take Promazine menstrual disturbance • antimalarials e.g. quinine and mefloquine If you take more Promazine than you should 4. Possible side effects • in men, impotence (inability to achieve or • antibiotics such as sparfloxacin, moxifloxacin, If you (or someone else) swallow a lot of the tablets 5. How to store Promazine maintain an erection), or breast enlargement intravenous erythromycin all together, or if you think a child has swallowed 6. Further information • in rare cases, sudden unexplained death has • certain types of (tricyclic or tetracyclic) any of the tablets, contact your nearest hospital occurred. WHAT PROMAZINE IS AND WHAT IT IS antidepressants such as amitriptyline, maprotiline casualty department or your doctor immediately. USED FOR • other antipsychotics e.g. risperidone, An overdose is likely to cause drowsiness, The following have been reported at an unknown amisulpride, sertindole, haloperidol and pimozide confusion, low blood pressure, low body frequency: Promazine is one of a group of medicines called • cisapride, a medicine used in the treatment of • blood clots in the vein especially in the legs phenothiazines, which are used to treat a range of temperature, fits and coma are possible. Rarely certain gastro-intestinal disorders breathing difficulties may occur. (symptoms include swelling, pain and redness disorders including anxiety, agitation and • certain antihistamines e.g. terfenadine. in the leg), which may travel through blood disturbed behaviour. Please take this leaflet, any remaining tablets, and Talk to your doctor if you are taking any of the the container with you to the hospital or doctor so vessels to the lungs causing chest pain and Promazine is used to treat: following: that they know which tablets were consumed. difficulty in breathing. If you notice any of these • agitation and restlessness in the elderly • medicines which can affect the chemicals in your symptoms seek medical advice immediately. • short-term additional management of If you forget to take Promazine bloodstream known as electrolytes, such as: If you forget to take a tablet, take one as soon as • In elderly people with dementia, a small increase psychomotor agitation (unintentional and • diuretics e.g. furosemide in the number of deaths has been reported for purposeless motions brought on by mental you remember unless it is more than 2 hours after • antibiotics e.g. amphotericin B the missed dose; if so, ignore the missed dose and patients taking antipsychotics compared with tension; symptoms may take the form of • corticosteroids e.g. hydrocortisone those not receiving antipsychotics. restlessness, pacing, tapping fingers or feet, wait until the time of the next dose. DO NOT take • chemotherapy drugs e.g. cisplatin a double dose to make up for a forgotten dose. Reporting of side effects abruptly starting and stopping tasks, • sulphonylureas (used to treat diabetes) e.g. If you get any side effects, talk to your doctor or Stopping treatment with Promazine meaninglessly moving objects around, and more). gliclazide or glibenclamide pharmacist. This includes any possible side effects DO NOT stop taking your medicine without • antiepileptics e.g. phenytoin not listed in this leaflet. You can also report side BEFORE YOU TAKE PROMAZINE talking to your doctor first even if you feel better. • blood pressure tablets effects directly via the Yellow Card Scheme at: Your medicine should only be withdrawn • calcium channel blockers e.g. amlodipine www.mhra.gov.uk/yellowcard DO NOT take Promazine if you: gradually under close supervision by your doctor. • sympathomimetics e.g. salbutamol By reporting side effects you can help provide • are allergic (hypersensitive) to promazine, any If you have any further questions on the use of other phenothiazine, or any of the other • antimuscarinics e.g. inhalations used for more information on the safety of this medicine. bronchitis such as ipratropium bromide this product, ask your doctor or pharmacist. ingredients of this medicine HOW TO STORE PROMAZINE • have phaeochromocytoma (adrenal gland • anticholinergics used to treat Parkinson’s or POSSIBLE SIDE EFFECTS 5 tumour resulting in high blood pressure, restlessness, such as procyclidine, benzhexol, 4 orphenadrine Keep this medicine out of the sight and reach of flushing, diarrhoea). Like all medicines, Promazine can cause side • tetrabenazine, used to treat essential tremor, children. Store the tablets below 25ºC. Keep the Promazine should not be given to patients in a effects, although not everybody gets them. chorea, tics, and related disorders container tightly closed. coma or suffering from central nervous system Stop taking the tablets and tell your doctor Do not use Promazine after the expiry date that is (CNS) depression, symptoms include decreased • ritonavir (an antiviral for HIV/AIDS) • anti-anxiety or sleeping drugs e.g. diazepam, immediately or go to the casualty department at stated on the outer packaging. The expiry date rate of breathing, decreased heart rate, and loss your nearest hospital if the following happens: refers to the last day of that month. of consciousness. temazepam, zopiclone • reboxetine (used to treat depression) • an allergic reaction causing swelling of the lips, Medicines should not be disposed of via wastewater Take special care with Promazine • lithium, (used to treat certain types of depression) face or neck leading to severe difficulty in or household waste. Ask your pharmacist how to Talk to your doctor before you start to take this • memantine, used to treat dementia breathing or severe skin rash or hives. dispose of medicines no longer required. These medicine if you: • sibutramine, used to help weight loss This is a very serious but rare side effect. You may measures will help to protect the environment. • have a history of jaundice (yellowing of the skin • cimetidine, used to treat stomach ulcer, reflux need urgent medical attention or hospitalisation. or whites of the eyes caused by liver or blood oesophagitis, Zollinger–Ellison syndrome, or Tell your doctor immediately if any of the 6 FURTHER INFORMATION problems) other conditions where gastric acid reduction is following serious but rare effects happen: • blood dyscrasias (blood disorders which may beneficial • high body temperature, muscle rigidity, increased What Promazine Tablets contain: be characterised by fever or chills, sore throat, • antacids, used to treat indigestion and heartburn involuntary movement or tremor and altered • The active ingredient is promazine ulcers in your mouth or throat, unusual • metoclopramide, used to treat feeling or being consciousness (neuroleptic malignant syndrome) hydrochloride 25 mg or 50 mg. tiredness or weakness, unusual bleeding or sick • involuntary restless or repetitive limb • The other ingredients are lactose, maize starch, unexplained bruising) • kaolin, used to treat diarrhoea movements, shaking, inability to sit or stand still maize starch (partially pregelatinised), • have liver, kidney or heart disease • antispasmodics to treat gut spasm e.g. • jaundice (yellowing of the skin or whites of the magnesium stearate (E572), talc (E553), light • have previously had a stroke, transient ischaemic mebeverine hydrochloride eyes caused by liver or blood problems) kaolin (E559), sucrose, shellac (E904), beeswax attack (TIA, stroke that lasts only a few minutes) • medicines used for pain relief called opioid • Torsades de pointes, a life threatening irregular (E901), carnauba wax (E903), tartrazine (E102), or heart attack, have a family history of strokes, analgesics e.g. tramadol, morphine, codeine heart beat (symptoms may include recurrent titanium dioxide (E171), sodium benzoate (E211), or have other risk factors which may increase • adrenaline or noradrenaline episodes of palpitations, dizziness, fainting, povidone, acetylated monoglyceride, black iron the risk of stroke, such as high cholesterol, • alcohol. feeling sick, paleness of the skin, cold sweats, oxide (E172) and propylene glycol (E1520) uncontrolled high blood pressure, diabetes, you • The 50 mg tablets also contain sunset yellow If you are to undergo a surgical procedure that shortness of breath and chest pain) smoke or are a heavy drinker • cardiac arrest (symptoms include loss of (E110) and erythrosine (E127). • have personal or a family history of a certain requires a general anaesthetic, make sure you tell your doctor that you are taking Promazine. consciousness, breathing stops and no What Promazine Tablets look like and contents of type of heart disorder known as heartbeat or pulse can be felt. Some people may the pack: Important information about some of the “QT-prolongation” first notice that they have a racing heartbeat or • Promazine 25 mg Tablets are round biconvex ingredients of Promazine • have a history of unexplained fainting or feel dizzy or light-headed just before they faint.) yellow sugar-coated tablets coded 7Z1 on one blackouts • Patients who are intolerant to lactose should The following side effects have also been reported: side and plain on the reverse. • have any disease of the lungs, lower and upper note that Promazine contain a small amount of • nasal congestion • Promazine 50 mg Tablets are round biconvex airways, or any condition which causes lactose. If your doctor has told you that you have • dry mouth orange sugar-coated tablets coded 7Z2 on one difficulty in breathing an intolerance to some sugars, contact your • agitation, excitement side and plain on the reverse. • have Parkinson’s disease (tremor, stiffness and doctor before taking this medicinal product. • apathy (lack of feeling or emotion) • The pack sizes are 50, 100, 250 and 1,000. shuffling) • Promazine 25 mg and 50 mg tablets contain • dizziness, headache Not all pack sizes may be marketed. • have epilepsy E102 (tartrazine) and the 50 mg tablets also • fast heart rate Marketing Authorisation Holder and Manufacturer • have hypothyroidism (underactive thyroid gland) contain E110 (sunset yellow) which may cause • abdominal pain, diarrhoea, constipation • suffer from depression allergic reactions. Marketing Authorisation holder • difficulty in passing water (especially with an • have myasthenia gravis (progressive muscular Taking Promazine with food and drink TEVA UK Limited, Eastbourne, BN22 9AG. enlarged prostate) weakness) DO NOT drink alcohol whilst taking Promazine. Manufacturer • drowsiness, confusion, difficulty sleeping • have an enlarged prostate (causing difficulty in TEVA UK Limited, Eastbourne, BN22 9AG. Pregnancy and breast-feeding • epileptic fits passing water) DO NOT take Promazine if you are pregnant, • low blood pressure This leaflet was last revised: October 2019 • have personal or a family history of glaucoma planning to become pregnant or breast-feeding. • eye problems including blurred vision, clouding PL 00289/0798-9 (increased pressure in the eye) Ask your doctor for advice before taking any or opacity of the front part of the eye (cornea) or • are taking any other neuroleptic medicines medicine. EAS4067a ZINC Ref: EAS4067a LEA PROMAZINE 25MG & 50MG TAB TUK

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