Chlorphenamine PIL- 4Mg LEAF P2

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Remember, this medicine is for YOU. Do not give it to someone else, even if their symptoms are the same as yours. This medicine may harm them.

Q2186 If you forget to take a dose: P0230T If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with the regular dosing schedule. DO NOT DOUBLE THE DOSE. Please read all of this leaflet carefully before you start taking this medicine. If you have taken too many tablets: Keep the leaflet; you may need to read it again. If you have any questions or are not sure about If you think you have taken too many tablets, contact your doctor straight away or go to the anything, ask your doctor or pharmacist. nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified. In this leaflet: 4. Possible side effects 1. What Chlorphenamine Tablets are and what they are used for Like all medicines, Chlorphenamine can cause side effects, although not everybody gets them. 2. Before you take Chlorphenamine Tablets If any of the following occur STOP TAKING the tablets IMMEDIATELY and contact your doctor, as 3. How to take Chlorphenamine Tablets they may be signs of an allergic reaction to this medicine: 4. Possible side effects • skin rash, itchy or raised skin rash, peeling/blistering of the skin 5. How to store Chlorphenamine Tablets • swelling of the face, mouth or throat 6. Further information • difficulty breathing, wheezing or shortness of breath, fever 1. What Chlorphenamine Tablets are and what they are used for • increased sensitivity of the skin to the sun. The name of this medicine is Chlorphenamine. The following side effects have also been reported: This medicine is an antihistamine and is one of a group of medicines called alkylamines. It can Very common effects (may affect more than 1 in 10 people): reduce the effects of histamine and has sedative activity. • drowsiness which may cause you to fall asleep. This medicine is used to relieve the symptoms of allergic conditions, such as hay fever, Common effects (may affect up to 1 in 10 people): inflammation of the nose and upper airways, allergic reactions to medicines, nettle rash, local • dizziness itching, severe skin rash with swelling particularly of the mouth and throat, food allergies and • abnormal co-ordination insect bites. • blurred vision 2. Before you take Chlorphenamine Tablets • difficulty concentrating • nausea Do not take these tablets if: • headache • You are allergic to other antihistamines, Chlorphenamine or to any of the other tablet • dryness of the mouth ingredients (see section 6). • fatigue. • You have taken a monoamine oxidase inhibitor drug (MAOI) for depression within the last Other effects: fourteen days. • blood disorders including a reduction in the numbers of red or white blood cells (signs include Check with your doctor before taking these tablets if: pale skin, weakness, tiredness, breathlessness and can make infections more likely) • you suffer from epilepsy, raised intra-ocular pressure including glaucoma, high blood pressure • retention of urine, difficult and painful urination or heart disease, liver disease, bronchitis, asthma, an over active thyroid (thyrotoxicosis) or • irregular heartbeat have an enlarged prostate gland. • lowering in blood pressure • tightness of the chest • you have an obstruction in your intestine or have difficulty passing urine or have a rare blood • double vision disease called porphyria. • tremors, twitching, muscle weakness Taking other medicines: • depression, irritability, confusion Check with your doctor or pharmacist before taking these tablets if you are taking other • loss of appetite, vomiting, stomach pain or upset, indigestion, constipation and diarrhoea medicines, including any that you can buy without a prescription. This is especially important if • unusual excitement you are taking: • tingling, heaviness and weakness of the hands • other medicines containing an antihistamine, including products for the relief of coughs and • difficulty in sleeping, nightmares colds. • yellowing of the skin or whites of the eyes caused by liver or blood problems • ringing in the ears • medicines to treat high blood pressure such as clonidine or methyldopa. • dryness of the nose or throat, sometimes causing a cough, thickened bronchial secretions • aspirin-like medicines (salicylates), cisplatin, paromomycin, vancomycin. which may cause phlegm • central nervous system depressants (medicines which slow down the nervous system, • nervousness. possibly causing drowsiness) such as sleeping tablets, tranquillisers, antidepressants or other Children or the elderly may be more susceptible to some side effects of this medicine, such as medicines for mental problems. drowsiness, dizziness, blurred vision, lack of co-ordination, confusion, excitation, feeling faint, • anti-muscarinics such as atropine, amantadine, haloperidol, phenothiazines and restlessness or nervousness. procainamide. Reporting of side effects • anti-epileptics, especially phenytoin. If you get any side effects, talk to your doctor, pharmacist or other healthcare professional. This Other special warnings: includes any possible side effects not listed in this leaflet. You can also report side effects directly via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 Effects on driving or operating machinery: 3352 (available from 10 am to 2 pm Mondays to Fridays) or fill in a paper form available from your This medicine may cause drowsiness, dizziness, blurred vision and inco-ordination. Do not drive local pharmacy. By reporting side effects you can help provide more information on the safety of or operate machinery if the medicine has this effect on you. this medicine. Alcohol: 5. How to store Chlorphenamine Tablets Do not drink alcohol while you are taking these tablets. Alcohol will increase the drowsiness Keep this medicine in the original package. Do not store above 25°C. produced by this medicine. Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that Pregnancy and breast feeding: are out of date, return them to your pharmacist for safe disposal. Talk to your doctor before taking this medicine if you are pregnant or breast feeding, as you KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN should NOT take unless your doctor thinks it is essential. 6. Further information Important Information about an ingredient of this medicine: Contains lactose. If you have been told by your doctor that you have an intolerance to some Ingredients: sugars, contact your doctor before taking this medicine. Chlorphenamine tablets contain 4mg of the active ingredient chlorphenamine maleate. They also 3. How to take Chlorphenamine Tablets contain the following other ingredients: lactose, maize starch, magnesium stearate, pregelatinised starch, quinoline yellow lake (E104) and stearic acid. Adults and children aged 12 years and over: What the medicine looks like: The normal dose is one tablet every 4-6 hours. Do not take more than 6 tablets in 24 hours. Chlorphenamine Tablets are yellow in colour, engraved with a company logo on one side and a Elderly: breakline and B094 on the other side. Check with your doctor or pharmacist before taking this medicine as you may be more likely to get The medicine is available in pack sizes of 28, 42, 50, 56, 84, 100, 112, 250, 500 and 1000 tablets. side effects and you may need to take a lower daily dose. Not all pack sizes may be marketed. Children: Who makes this medicine and holds the Product Licence: The normal dose for children aged six to twelve years is half a tablet every 4-6 hours. Do not give The Product Licence Holder is Crescent Pharma Limited, Units 3 & 4, Quidhampton Business more than 6 half tablets in 24 hours. Units, Polhampton Lane, Overton, Hants, RG25 3ED. This medicine is not meant for children under 6 years of age. Do not give it to a child under 6 Manufactured by Surepharm Services Limited, Unit 2H, Bretby Business Park, Ashby Road East, years unless your doctor has prescribed it. Bretby, Burton Upon Trent, Staffordshire, DE15 0YZ. If this medicine has been prescribed by your doctor, he/she will decide the dose that is best for Date leaflet revised March 2013. you, the pharmacist’s label will also tell you how many tablets to take and how often. If you are not If you would like this leaflet in a different format please contact the licence holder at the above sure about anything, ask your doctor or pharmacist. (continued overleaf) address.

Base Point Size: 8.5pt DIMENSIONS: 150 X 320mm BLACK Folded size 40x150mm (If you have particular folding spac please provide) Surepharm Anne Brown Q2186 Chlorphena- mine PIL- 4mg 12/4/13 Pharma code: 128 150 x 320mm folded size 40x150mm 17/4/13 2 PATIENT INFORMATION LEAFLET P0255T CHLORPHENAMINE Tablets 4mg Please read all of this leaflet carefully before you start taking this medicine. Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, ask your doctor or pharmacist. In this leaflet: 1. What Chlorphenamine Tablets are and what they are used for 2. Before you take Chlorphenamine Tablets 3. How to take Chlorphenamine Tablets 4. Possible side effects 5. How to store Chlorphenamine Tablets 6. Further information 1. What Chlorphenamine Tablets are and what they are used for The name of this medicine is Chlorphenamine. This medicine is an antihistamine and is one of a group of medicines called alkylamines. It can reduce the effects of histamine and has sedative activity. This medicine is used to relieve the symptoms of allergic conditions, such as hay fever, inflammation of the nose and upper airways, allergic reactions to medicines, nettle rash, local itching, severe skin rash with swelling particularly of the mouth and throat, food allergies and insect bites. 2. Before you take Chlorphenamine Tablets Do not take these tablets if: • You are allergic to other antihistamines, Chlorphenamine or to any of the other tablet ingredients (see section 6). • You have taken a monoamine oxidase inhibitor drug (MAOI) for depression within the last fourteen days. Check with your doctor before taking these tablets if: • you suffer from epilepsy, raised intra-ocular pressure including glaucoma, high blood pressure or heart disease, liver disease, bronchitis, asthma, an over active thyroid (thyrotoxicosis) or have an enlarged prostate gland. • you have an obstruction in your intestine or have difficulty passing urine or have a rare blood disease called porphyria. Taking other medicines: Check with your doctor or pharmacist before taking these tablets if you are taking other medicines, including any that you can buy without a prescription. This is especially important if you are taking: • other medicines containing an antihistamine, including products for the relief of coughs and colds. • medicines to treat high blood pressure such as clonidine or methyldopa. • aspirin-like medicines (salicylates), cisplatin, paromomycin, vancomycin. • central nervous system depressants (medicines which slow down the nervous system, possibly causing drowsiness) such as sleeping tablets, tranquillisers, antidepressants or other medicines for mental problems. • anti-muscarinics such as atropine, amantadine, haloperidol, phenothiazines and procainamide. • anti-epileptics, especially phenytoin. Other special warnings: Effects on driving or operating machinery: This medicine may cause drowsiness, dizziness, blurred vision and inco-ordination. Do not drive or operate machinery if the medicine has this effect on you. Alcohol: Do not drink alcohol while you are taking these tablets. Alcohol will increase the drowsiness produced by this medicine. Pregnancy and breast feeding: Talk to your doctor before taking this medicine if you are pregnant or breast feeding, as you should NOT take unless your doctor thinks it is essential. Important Information about an ingredient of this medicine: Contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 3. How to take Chlorphenamine Tablets Adults and children aged 12 years and over: The normal dose is one tablet every 4-6 hours. Do not take more than 6 tablets in 24 hours. Elderly: Check with your doctor or pharmacist before taking this medicine as you may be more likely to get side effects and you may need to take a lower daily dose. Children: The normal dose for children aged six to twelve years is half a tablet every 4-6 hours. Do not give more than 6 half tablets in 24 hours. This medicine is not meant for children under 6 years of age. Do not give it to a child under 6 years unless your doctor has prescribed it. If this medicine has been prescribed by your doctor, he/she will decide the dose that is best for you, the pharmacist’s label will also tell you how many tablets to take and how often. If you are not sure about anything, ask your doctor or pharmacist. Remember, this medicine is for YOU. Do not give it to someone else, even if their symptoms are the same as yours. This medicine may harm them.

(continued overleaf)

Measure bar should be 150mm at 100% scale

Customer Crescent Pharma Colours Used

Description CHLORPHENAMINE 4MG Process Black

Item Code P0255T Keyline (non-printing) Profile N/A

Size 210X297MM

Min. Point Size 9pt (Main Body) 6pt (Item code)

Market UK

Language ENGLISH Warning! We cannot accept responsibility for any errors Proof By michael.casingena in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our clientʼs brief, Proof No. 2 the final responsibility must be taken by our client. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING Date 30/10/2013 FULL APPROVAL OF DESIGN AND TEXT. Pharma Artwork No. 464943/466539 Code N/A If you forget to take a dose: If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with the regular dosing schedule. DO NOT DOUBLE THE DOSE. If you have taken too many tablets: If you think you have taken too many tablets, contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified. 4. Possible side effects Like all medicines, Chlorphenamine can cause side effects, although not everybody gets them. If any of the following occur STOP TAKING the tablets IMMEDIATELY and contact your doctor, as they may be signs of an allergic reaction to this medicine: • skin rash, itchy or raised skin rash, peeling/blistering of the skin • swelling of the face, mouth or throat • difficulty breathing, wheezing or shortness of breath, fever • increased sensitivity of the skin to the sun. The following side effects have also been reported: Very common effects (may affect more than 1 in 10 people): • drowsiness which may cause you to fall asleep. Common effects (may affect up to 1 in 10 people): • dizziness • abnormal co-ordination • blurred vision • difficulty concentrating • nausea • headache • dryness of the mouth • fatigue. Other effects: • blood disorders including a reduction in the numbers of red or white blood cells (signs include pale skin, weakness, tiredness, breathlessness and can make infections more likely) • retention of urine, difficult and painful urination • irregular heartbeat • lowering in blood pressure • tightness of the chest • double vision • tremors, twitching, muscle weakness • depression, irritability, confusion • loss of appetite, vomiting, stomach pain or upset, indigestion, constipation and diarrhoea • unusual excitement • tingling, heaviness and weakness of the hands • difficulty in sleeping, nightmares • yellowing of the skin or whites of the eyes caused by liver or blood problems • ringing in the ears • dryness of the nose or throat, sometimes causing a cough, thickened bronchial secretions which may cause phlegm • nervousness. Children or the elderly may be more susceptible to some side effects of this medicine, such as drowsiness, dizziness, blurred vision, lack of co-ordination, confusion, excitation, feeling faint, restlessness or nervousness. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Chlorphenamine Tablets Keep this medicine in the original package. Do not store above 25°C. Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal. KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN 6. Further information Ingredients: Chlorphenamine tablets contain 4mg of the active ingredient chlorphenamine maleate. They also contain the following other ingredients: lactose, maize starch, magnesium stearate, pregelatinised starch, quinoline yellow lake (E104) and stearic acid. What the medicine looks like: Chlorphenamine Tablets are yellow in colour, engraved with a company logo on one side and a breakline and B094 on the other side. The medicine is available in pack sizes of 28, 42, 50, 56, 84, 100, 112, 250, 500 and 1000 tablets. Not all pack sizes may be marketed. Who makes this medicine and holds the Product Licence: Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED. Date leaflet revised October 2013. If you would like this leaflet in a different format please contact the licence holder at the above address.