Allergy Relief Antihistamine Tablets

Chlorphenamine maleate

Patient Information Leaflet

Read all of this leaflet carefully before you take this medicine because it contains important information you need to know.

This medicine is available without prescription, however, you still need to use this product carefully to get the best results from it. Keep this leaflet as you may need to read it again. Ask your pharmacist if you need more information or advice.

1.    What is this medicine and what is it used for?

This medicine contains:

•    chlorphenamine maleate which is an antihistamine and helps to reduce allergic conditions caused by histamines released by your body during an allergic reaction.

These tablets are used for the relief of hayfever, chronic runny nose, rashes, itching, swelling around the eyes, mouth, throat or hands, insect bites, skin and food allergies, and allergic reactions to other medicines.

2.    Is this medicine suitable for you?

Do not take this medicine if you:

•    are allergic to chlorphenamine maleate or any of the other ingredients

•    are allergic to other antihistamines

•    are pregnant or breastfeeding

•    have severe liver disease

•    are taking antidepressant drugs called monoamine oxidase inhibitors (MAOI's), or have taken them within the last 14 days -these are medicines such as phenelzine and isocarboxacid.

Please see your doctor or pharmacist before taking this medicine if you:

•    have epilepsy

•    suffer from eye problems such as glaucoma

•    have an enlarged prostate gland

•    have high blood pressure (hypertension) or cardiovascular disorder(s)

•    suffer from severe chest infections

•    suffer from asthma

•    suffer from liver problems, including alcoholic liver disease

•    have difficulty passing urine

•    have an obstruction in your intestine

•    have an overactive thyroid

•    have an intolerance to some sugars.

If you are taking any of the following medicines please see your doctor:

•    hypnotic drugs for the treatment of anxiety or sleeping disorders (insomnia), such as lorazepam, diazepam, nitrazepam or temazepam

•    medicines that contain alcohol

•    phenytoin for the treatment of epilepsy.

Other important information:

Driving and operating machinery

These tablets might cause drowsiness, dizziness, blurred vision and lack of co-ordination. If you are affected, do not drive or operate machinery.

Taking this medicine with food and drink: As with other antihistamines, the effects of alcohol may be increased. Do not drink alcohol (beer, wine, spirits etc) while taking this product. Information about some of the ingredients in this medicine:

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

Please turn over

3.    How to take this medicine

To be swallowed with a drink of water.

Adults, the elderly and children over 12

years: 1 tablet 3 or 4 times a day, as required. Do not take more than 4 tablets in any 24 hour period.

Children aged 6 to 12 years: half a tablet 3 or 4 times a day, as required. Do not give more than a total of 2 tablets in any 24 hour period.

Do not give to children under 6 years.

Do not exceed the stated dose.

If your symptoms persist or worsen, you must see a doctor or pharmacist.

If you take too many tablets by mistake, contact your doctor or pharmacist straight away.

4.    Possible side effects

Most people do not have any side effects while taking this medicine. However, if you experience any of the following side effects, or anything else unusual happens, stop taking the medicine immediately and see your doctor or pharmacist. Possible side effects are:

•    sleepiness varying from slight drowsiness to deep sleep

•    difficulty concentrating, lack of energy and lethargy

•    visual disturbances such as blurred vision

•    changes in eating habits, such as loss of appetite, indigestion, feeling sick (nausea) or being sick (vomiting), diarrhoea and lower stomach pains

•    liver problems such as hepatitis including yellowing of the skin (jaundice)

•    problems going to the toilet (inability to urinate)

•    headaches, dry mouth, dizziness

•    increased and unusual awareness of your own heart beat (palpitations), faster than normal or irregular heart beat, tighness of the chest

•    lowered blood pressure

•    thicker phlegm when you cough

•    unusual bruising or infections such as sore throats - this may be a sign of very rare changes in the blood

•    allergic reactions such as inflamed itchy skin or rashes and sensitivity to light

•    loss of co-ordination and muscular weakness, occasional muscular twitching

•    hearing problems such as ringing in the ears (tinnitus)

•    depression, irritability, sleeping disturbances such as nightmares

•    feelings of excitability in children or confusion in the elderly.

Side effects such as drowsiness, dizziness, blurred vision and loss of co-ordination are more likely in children and the elderly.

5.    How to store your medicine

Keep all medicines out of the reach and sight of children. Store below 25°C in a dry place. Do not use the tablets after the expiry date shown on the pack.

6.    What is in this medicine?

Each small pale yellow round tablet, with a break bar on one side, contains the active ingredient: chlorphenamine maleate 4 mg.

The other ingredients are: lactose, starch, magnesium stearate and the colour, quinoline yellow (E104).

This product is available in a pack size of 30 tablets.

7.    Who makes this medicine?

The Marketing Authorisation holder and manufacturer is Wrafton Laboratories Limited, Braunton, Devon, EX33 2DL, U.K.

Text Revised: March 2010.

PL 12063/0050    2722692