Eas4059a LEA PROMAZINE 25MG 50MG TAB TUK Frcust V3
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ZINC Ref: EAS4059a LEA PROMAZINE 25MG & 50MG TAB TUK <CUST Version: 3 09 October 2019 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.