CHLORPHENAMINE PIL:00400815-02 148 X 260 MM 8/20/15 12:16 PM Page 1

Patient information leaflet

CHLORPHENAMINE• 4MG TABLETS very high blood pressure • Read all of this leaflet carefully before you liver or heart disease • start taking this medicine because it contains asthma, bronchitis or bronchiectasis (chronic important information for you. inflammation of the airways that carry air to the

Always take this medicine exactly as described in lungs) this leaflet or as your doctor or pharmacist or Other medicines and Chlorphenamine nurse has told you. • Tell your doctor or pharmacist if you are taking, Keep this leaflet. You may need to read it again. • have recently taken or might take any other Ask your pharmacist if you need more medicines, especially: information or advice. • • medicine containing phenytoin for epilepsy If you get any side effects, talk to your doctor or • drugs to treat anxiety pharmacist or nurse. This includes any possible • sedatives - all drugs that have a sedative effect side effects not listed in this leaflet. are likely to increase the sedative effects of See section 4 • Chlorphenamine You must talk to a doctor if you do not feel • anticholinergic drugs (e.g. atropine and better or if you feel worse. hyoscine) may increase the action of chlorphenamine In this leaflet: • betahistine, a drug used to treat vertigo and 1. What Chlorphenamine is and what it is used for hearing disturbances. The effects may be 2. What you need to know before you take reduced if taken with Chlorphenamine Chlorphenamine • lopinavir (may increase plasma concentration 3. How to take Chlorphenamine of chlorphenamine) 4. Possible side effects 5. How to store Chlorphenamine Chlorphenamine with food, drink and alcohol 6. Contents of the pack and other information Alcohol should be avoided, as chlorphenamine may increase the sedative effects of alcohol 1. What Chlorphenamine is and what it is used for Pregnancy and breast feeding You must consult your doctor before taking This medicine contains Chlorphenamine maleate Chlorphenamine if you are pregnant, trying to which belongs to a group of medicines called become pregnant or breast feeding. antihistamines, which act to relieve the symptoms of allergies. Driving and using machines It can be used to relieve the symptoms of allergic This medicine may make you drowsy and may reactions including hayfever, raised, red itchy skin cause blurred vision and impaired movement. If (symptoms of urticaria, which is often known as affected in this way you should not drive or operate machinery. hives or nettle rash), allergic reactions to foods or medicines, insect bites, runny nose and swelling Chlorphenamine tablets contain lactose & of the face or throat due to fluid build up and sunset yellow (E110)

itching caused by chickenpox. Lactose - These tablets contain lactose. If you have been told by your doctor that you have an 2. What you need to know before you take intolerance to some sugars, contact your doctor Chlorphenamine before taking these tablets. Do NOT take Chlorphenamine if you: Sunset yellow (E110) - This colouring agent may • are allergic to Chlorphenamine or any other cause allergic reactions. antihistamines or any of the other ingredients of 3. How to take Chlorphenamine this medicine (listed in section 6). This medicine contains sunset yellow E110 and can Always take this medicine exactly as described in cause allergic type reaction, including asthma this leaflet or as your doctor or pharmacist has (allergy tends to be more common in people told you. Check with your doctor or pharmacist if who are sensitive to aspirin) you are not sure. The tablets should be swallowed • have taken monoamine oxidase inhibitor with a glass of water. (MAOI) antidepressant treatment in the past 14 Dosage days • Adults: 4mg (one tablet) every 4 to 6 hours have known brain damage or epilepsy • (maximum 24mg daily). are comatose or in pre-comatose state Children aged 6-12 years: 2mg (Equivalent to Warnings and precautions half a tablet) every 4 to 6 hours (maximum 12mg Talk to your doctor or pharmacist before taking daily). these tablets if you have: • raised pressure inside your eyes including Not recommended for children under 6 years of age. glaucoma • an enlarged prostate • Elderly: As for adults. Talk to your doctor or an overactive thyroid pharmacist before taking this medicine as you CHLORPHENAMINE PIL:00400815-02 148 X 260 MM 8/20/15 12:16 PM Page 2

may be more likely to get side effects including Reporting of side effects: confusion and you may need to take a lower dose. If you get any side effects, talk to your doctor or If you take more tablets than you should pharmacist. This includes any possible side effects If you or anyone else has taken too many tablets, not listed in this leaflet. You can also report side contact your nearest hospital casualty department effects directly via the Yellow Card Scheme at: or doctor immediately. Take any remaining tablets www.mhra.gov.uk/yellowcard. By reporting side

with you to show the doctor. effects you can help provide more information on

If you forget to take a dose the safety of this medicine. Do not take a double dose to make up for 5. How to store Chlorphenamine forgotten individual doses. If you have any further questions on the use of Keep all medicines out of the sight and reach of children this medicine, ask your doctor or pharmacist. • Do not take this medicine after the expiry date

4. Possible side effects which is stated on the label after “EXP” The expiry date refers to the last day of that month. Like all medicines, Chlorphenamine tablets can • Do not store above 25˚C. cause side effects, although not everybody gets • Keep the container tightly closed. them. • If you experience any of the following side Store in the original container. effects, stop taking the medicine and tell your Do not throw away any medicines via wastewater doctor immediately: • or household waste. Ask your pharmacist how to difficulty breathing, raised and itchy skin, throw away medicines you no longer use. These swelling of the face, lips, tongue or throat measures will help to protect the environment. (severe allergic reaction) 6. Contents of the pack and other Other side effects information *Drowsiness is the most common side effect of What Chlorphenamine tablets contain Chlorphenamine. It may cause you to fall asleep, • The active substance is Chlorphenamine. or sleepiness Each tablet contains 4mg of Chlorphenamine Other common side effects include: • maleate. feeling tired, blurred vision, dizziness • • The other ingredients are lactose Headache, inability to concentrate, lack of co- monohydrate, maize starch, magnesium ordination • stearate and the colours quinoline yellow feeling Sick (nausea), being sick, diarrhoea (E104) and sunset yellow (E110). Uncommon side effects include: See end of section 2 for further information on • sleeping difficulties, nervousness, very high lactose and sunset yellow (E110). fever, convulsions and shaking or tremors • What Chlorphenamine tablets look like and loss of appetite, heartburn, stomach pain, dry contents of the pack: mouth • • Chlorphenamine 4mg tablets are yellow, difficulty passing urine circular normal convex tablets with a break Rarer side effects include: line embossed C/4 on one face and PV on the • ringing in the ears reverse. • • other allergic reactions including skin peeling, Pack sizes for Chlorphenamine are 30, 100, itchy red skin rash, sensitivity to light 250, 500 & 1000 tablets in container packs. • Not all pack sizes may be marketed. changes in heart rate, palpitations, low blood pressure (you may feel faint), tightness of the Marketing Authorisation Holder and

chest • Manufacturer: thickening of bronchial secretions (which may Pharmvit Ltd, 177 Bilton Road, Perivale, cause a cough or phlegm) • Greenford, Middlesex UB6 7HQ. hepatitis including yellowing of the skin or Telephone: 0208 997 5444 whites of the eyes caused by liver or blood Fax: 0208 997 5433 problems • reduction in red blood cells which can make the skin pale yellow and cause weakness or To request a copy of this leaflet in large print or breathlessness and other blood dyscrasias audio format or additional copies, please • muscle weakness, twitching contact the licence holder at the address (or • depression, *irritability and *nightmares telephone, fax) above. • *excitation may occur in children • PL 04556 / 0040 P *confusion in the elderly *Children and elderly adults are more susceptible Reference: 00400815/02 to neurological anticholinergic effects and This leaflet was last revised in August 2015 paradoxical excitation (e.g. increased energy,

restlessness, nervousness).