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PACKAGE LEAFLET: INFORMATION FOR THE USER

CHLORPHENAMINE 4mg TABLETS

_Chlorphenamine Maleate_

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

•    You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet:

1.    What Chlorphenamine Tablets are and what they are used for

2.    What you need to know before you take Chlorphenamine Tablets

3.    How to take Chlorphenamine Tablets

4.    Possible side effects

5.    How to store Chlorphenamine Tablets

6.    Contents of the pack and other information

_1. What Chlorphenamine Tablets are and what they are used for_

The name of your medicine is Chlorphenamine 4mg Tablets.

The active ingredient is Chlorphenamine maleate, an antihistamine which can help to relieve the symptoms of some allergies and itchy skin rashes. It can be used to treat the itchiness, redness, swelling, tenderness and irritation that can be caused by:

•    hayfever and other allergies e.g. pet, house dust mite and mould spore allergies

•    nettle rash and hives

•    skin allergies and dermatitis

•    prickly heat and heat rash

•    reactions to food, food additives or medicines

•    insect bites and stings

•    the itchy rash of chickenpox

_2. What you need to know before you take Chlorphenamine Tablets_

Do not take Chlorphenamine Tablets if you:

•    are allergic to Chlorphenamine or any other antihistamines or any other ingredients of this medicine (listed in section 6)

•    have taken medicines for depression known as monoamine oxidase inhibitors (MAOls, for example phenelzine) within the last 14 days.

Warnings and precautions

Talk to your doctor or pharmacist before taking Chlorphenamine Tablets if you:

•    suffer from epilepsy and are taking anticonvulsant drugs such as phenytoin

•    have increased pressure in the eye (glaucoma)

•    have an enlarged prostate gland

•    have high blood pressure or are being treated for high blood pressure

•    have heart, liver or kidney disease

•    have bronchitis, asthma or bronchiectasis.

Other medicines and Chlorphenamine Tablets

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines, including medicines obtained without a prescription, particularly the following:

•    Other antihistamines, including antihistamine containing cough and cold medicines, that may make you sleepy

•    Sleeping tablets, medicines for anxiety, antidepressants

•    Phenytoin (for epilepsy)

Chlorphenamine Tablets with food and drink and alcohol

You are advised NOT to drink alcohol with this medicine.

Pregnancy and breast-feeding and fertility

Do not take Chlorphenamine Tablets if you are pregnant, planning to become pregnant, or are breast-feeding, unless directed by your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Chlorphenamine may make you feel drowsy, dizzy or have blurred vision. Make sure you are not affected before you drive or operate machinery.

Chlorphenamine Tablets contain Lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Chlorphenamine Tablets

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults and children aged 12 years and over:

Take one tablet every 4 to 6 hours as needed. Do not take more than 6 tablets in 24 hours. Children aged 6 to 12 years:

Give 1/2 tablet every 4 to 6 hours as needed. Do not give more than 6 half tablets in 24 hours. Elderly:

Talk to your doctor or pharmacist before you take this medicine as you may be more likely to get side effects including confusion and you may need to take a lower daily dose.

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•    Do not take more than the recommended dose.

•    Do not give to children under 6 years.

Method of administration

The tablets should be taken as instructed, swallowed with a glass of water.

The tablet can be divided into equal doses.

If you take more Chlorphenamine Tablets than you should

Contact your nearest hospital casualty department, or tell your doctor immediately. Take any remaining tablets and the pack with you. Do not drive if you have taken too many tablets.

If you forget to take Chlorphenamine Tablets

Take one as soon as you remember, unless it is nearly time to take the next one.

Do not take a double dose to make up for a forgotten dose.

If your symptoms persist, see your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Children and older people are more prone to side effects.

•    The most common side effect is drowsiness. This drowsiness can be helpful if symptoms are particularly troublesome at night.

Stop taking this product and consult your doctor if you experience:

•    Allergic reactions which can be severe. Signs include raised and itchy skin, swelling of the face or mouth causing difficulty breathing.

•    Liver problems including jaundice (yellowing of the skin and eyes)

•    Anaemia or unexplained bleeding or bruising.

•    Collapse

•    Difficulty passing water

The following side effects may occur:

•    Difficulty concentrating, feeling tired, dizziness, headache or blurred vision

•    Loss of appetite, indigestion, feeling or being sick, diarrhoea, tummy pain or dry mouth

•    Low blood pressure (you may feel faint) or changes in heart rhythm

•    Chest tightness or thickening of the phlegm

•    Skin peeling, itchy rash and sensitivity to the sun

•    Ringing in the ears

•    Twitching, muscular weakness and abnormal co-ordination

•    Confusion, excitability, irritability, low mood or nightmares

•    Children may become excited.

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 out of the sight and reach of children.

•    Do not store above 25⁰C. Store in the original package for blister packs. Keep the container tightly closed for containers.

•    Do not use this medicine after the expiry date which is stated on the carton or label. The expiry date refers to the last day of that month.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Chlorphenamine Tablets contain The active ingredient is 4mg of Chlorphenamine Maleate.

The other ingredients are Lactose, Potato starch, Magnesium Stearate, Quinoline yellow (E104). What Chlorphenamine Tablets look like and contents of the pack

These tablets are pale yellow, uncoated, biconvex tablets with debossed ”B” breakline ”L” on one side and ”4” on the other side.

Chlorphenamine Tablets are supplied in containers of 100, 500, 1000 and blister packs of 28, 30 and 60. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Name and address: Bristol Laboratories Ltd.,

Unit 3, Canalside, Northbridge Road,

Berkhamsted, Hertfordshire, HP4 1EG, Uinted Kingdom Telephone:    0044 (0) 1442 200922

Fax:    0044 (0) 1442 873717

e-mail:    info@bristol-labs.co.uk

Chlorphenamine 4mg Tablets; PL 17907/0349 This leaflet was last revised in April 2015

To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

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