PACKAGE LEAFLET: INFORMATION FOR THE USER

Numark Antihistamine Tablets Chlorphenamine Maleate 4mg

Please read right through this leaflet before you start taking this medicine, referred to as Antihistamine Tablets in this leaflet. It contains important information for you.

This medicine is available without prescription; however you still need to take Antihistamine Tablets carefully to get the best results from it.

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

•    If you have any questions, or if there is anything you do not understand, ask your doctor or pharmacist.

•    You must see a doctor if your symptoms worsen or do not improve.

In this leaflet

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

2.    Before you take Antihistamine Tablets

3.    How to take Antihistamine Tablets

4.    Possible side effects

5.    How to store Antihistamine Tablets

6.    Further information

1.    What Antihistamine Tablets are and what they are used for?

Antihistamine Tablets are used to treat the symptoms of hayfever and other allergies.

The active ingredient in the tablets is chlorphenamine maleate. This is an antihistamine drug which can help relieve the symptoms of some allergies such as itchiness, redness, swelling, tenderness that can be caused by:

•    Hayfever

•    House dust mites

•    Pet allegies

•    Nettle rash and hives

•    Skin allergies

•    Reactions to food and medicines

•    Insect bites and stings

•    Swelling of the face or throat

2.    Before you take Antihistamine Tablets

Do not take these tablets if:

•    you have ever had an allergic reaction to the active ingredient (chlorphenamine maleate) or to any of the ingredients listed in section 6.

•    you have taken monoamine oxidase inhibitors (MAOIs) prescribed for depression in the last two weeks.

•    if you are taking other medicines containing other antihistamines, including products for the relief of coughs and colds

Take special care and tell your doctor or pharmacist before you take this medicine:

•    If you have very high blood pressure, heart disease, epilepsy, glaucoma, enlarged prostate, liver disease, bronchitis, asthma or bronchiectasis.

•    If you have been told by your doctor that you have an intolerance to some sugars.

Pregnancy and breast-feeding

Talk to your doctor before taking Antihistamine Tablets if you are pregnant or breast-feeding. Do not take this medicine if you are pregnant or breast-feeding unless it is approved by your doctor.

Driving and using machines

Antihistamine Tablets may cause drowsiness, dizziness and blurred vision. Do not drive or operate machinery if affected.

Taking with food and drink

Avoid drinking alcohol at the same time as taking Antihistamine Tablets as this may cause drowsiness.

Important information about some of the ingredients of Antihistamine Tablets

Antihistamine Tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars you should not take this medicine.

Taking other medicines

Before you take these tablets, make sure that you tell your pharmacist about any other medicines you might be using at the same time, particularly the following:

•    Other antihistamines, including those in cough and cold medicines, that make you sleepy

•    Sleeping tablets, medicines for anxiety, antidepressants

•    Phenytoin (for epilepsy)

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

3.    How to take Antihistamine Tablets

For oral use. Antihistamine Tablets should be taken orally with a drink of water. Each tablet can be divided into equal doses. If symptoms do not go away, talk to your pharmacist or doctor.

Do not take more tablets, or more often, than the label tells you to.

Adults and children over 12 years: One tablet every 4 to 6 hours as required.

Maximum daily dose: Six tablets (24mg) in any 24 hour period.

Elderly: The elderly are more likely to experience side effects such as confusion. You may need to take a lower daily dose e.g. a maximum of 3 tablets (12mg) in any 24 hour period (one tablet every 4 to 6 hours).

Children aged 6 to 12 years: Half a tablet every 4 to 6 hours.

Maximum daily dose: 6 half tablets (12mg) in any 24 hour period.

Children under 6 years: Not to be used

Do not give/take more than the recommended dose.

If you take more Antihistamine Tablets than you should

Contact your doctor or casualty department. Do not drive if you have taken too many tablets.

If you forget to take Antihistamine Tablets

Take the dose as soon as you remember, unless it is nearly time to take the next dose. Otherwise, wait until the next dose time and continue with your normal routine. Never take two doses together.

4.    Possible side effects

Like all medicines, Antihistamine Tablets can cause side effects, but not everyone 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 the 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 in breathing.

•    Liver problems (Symptoms could include yellowing of the skin or the whites of the eyes).

•    Anaemia (The body doesn't have enough red blood cells, or iron, hence you may feel tired with low energy levels).

•    Unexplained bleeding or bruising.

The following side effects may occur:

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

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

•    Difficulty passing water.

•    Skin peeling, itchy rash and sensitivity to the sun.

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

•    Chest tightness or thickening of the phlegm.

•    Ringing of 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 Antihistamine Tablets

Do not store above 25°C and keep the tablets in the original package in order to protect from moisture. Keep out of the sight and reach of children. Do not take them after the expiry date shown on the pack.

6. Further information

What does each tablet contain

These are small, uncoated yellow tablets, which contain 4mg of Chlorphenamine Maleate as the active ingredient. They also contain lactose monohydrate, starch, magnesium stearate and a colour, quinoline yellow (E104).

What is in the pack

Antihistamine Tablets are supplied in containers of 100, 500 and 1000 and blister packs of 28, 30 and 60.*

Who supplies these Antihistamine Tablets

Antihistamine Tablets are manufactured by Surepharm Services Ltd, Unit 2H, Bretby Business Park, Ashby Road East, Burton upon Trent DE15 0YZ, for the Marketing Authorisation holder, East Midlands Pharma Ltd., Keyworth, Nottingham NG12 5HY.

This leaflet was revised: January 2015 not all pack sizes may be marketed

PL 22958/0005