Children aged 1-2 years: Give half a spoonful (2.5 ml) twice daily (maximum daily dose is 5 ml). The minimum interval between the doses should be 4 hours.

Children under 1 year: Not recommended.

Do not take more than the recommended dose. If symptoms persist consult your doctor. Elderly: You may need to take a lower daily dose as elderly people are more likely to experience side effects including confusion. We recommend that you take no more than 12 mg in any 24 hour period.

If you take more Chlorphenamine Elixir than you should

In the event that you or someone else, have taken too much Chlorphenamine Elixir or a large overdose, contact your doctor or pharmacist for advice. It is important that you do not drive. Show the bottle to the doctor or pharmacist.

If you forget to take Chlorphenamine Elixir

If you forget to take a dose, take it as soon as you remember. If the next dose is due within 2 hours take a single dose now and skip the next.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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 face or mouth causing difficulty breathing.

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

•    Anaemia or unexplained bleeding or bruising.

•    Fatigue.

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.

•    Difficulty passing water.

•    Low blood pressure (you may feel faint), changes in heart rhythm or a pounding heart.

•    Chest tightness or thickening of 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 (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 Elixir

Keep this medicine out of the sight and reach of children.

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

Store Chlorphenamine Elixir below 25°C, protect from light.

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

6. Contents of the pack and other information

What Chlorphenamine Elixir contains

•    The active substance is chlorphenamine maleate. Each 5 ml spoonful of Chlorphenamine Elixir contains 2 mg of chlorphenamine maleate.

•    The other ingredients are maltitol solution, citric acid, sodium citrate, sodium benzoate (E211), carmellose sodium, purified water and strawberry flavour.

What Chlorphenamine Elixir looks like and contents of the pack

Chlorphenamine Elixir is a sugar free, colourless syrup in amber bottles of 150 ml. Marketing Authorisation Holder and Manufacturer

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

This leaflet was last revised in 10/2014.

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Chlorphenamine Elixir 2 mg/5 ml

Chlorphenamine Maleate Sugar free

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 of the 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 Elixir is and what it is used for

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

3.    How to take Chlorphenamine Elixir

4.    Possible side effects

5.    How to store Chlorphenamine Elixir

6.    Contents of the pack and other information

1. What Chlorphenamine Elixir is and what it is used for

Chlorphenamine maleate, is used to treat allergic symptoms of hayfever and other allergies. The active ingredient is chlorphenamine maleate, an antihistamine, that can be used to relieve the symptoms of some allergies e.g. itching skin and rashes, redness, swelling, tenderness and irritation that can be caused by:

•    hayfever and other allergies e.g. pets, dust mites and mould spores

•    nettle rash and hives

•    skin allergies and dermatitis

•    prickly heat and heat rashes

•    reactions to foods, food additives or medications

•    insect bites and stings

•    itching caused by chickenpox rash

•    rhinitis

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

Do not take Chlorphenamine Elixir

•    If you are allergic to chlorphenamine maleate, antihistamines or any other ingredients of this medicine (listed in section 6).

•    If you are taking, or have taken, any medicines known as monoamine oxidase inhibitors (MAOIs) within the last 14 days.

•    If you are taking other medicines containing antihistamines, including products for colds and coughs.

Warnings and precautions

Talk to your doctor or pharmacist before taking Chlorphenamine Elixir if you have any of the following conditions:

•    epilepsy

•    glaucoma (raised pressure within the eyeball)

•    very high blood pressure

•    heart or liver problems

•    enlarged prostate

•    breathing difficulties (including asthma and bronchitis).

Other medicines and Chlorphenamine Elixir

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially if you are taking tricyclic antidepressants (medicines used to treat depression) or atropine (medicine commonly used to manage an intestinal condition which causes spasm and pain in the intestine), phenytoin (used to treat epilepsy), anxiety or sleep medicines.

Chlorphenamine Elixir with food and drink

Do not drink alcohol whilst taking Chlorphenamine Elixir.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The safety of Chlorphenamine Elixir during pregnancy has not been established. Your doctor will decide if the benefits of taking Chlorphenamine Elixir outweigh the risks.

If you are nursing a baby, taking Chlorphenamine Elixir is not recommended, because chlorphenamine is excreted in breast milk.

Driving and using machines

If Chlorphenamine Elixir makes you feel dizzy or drowsy, causes visual disturbances and inability to perform smoothly coordinated voluntary movements, do not drive or

operate machinery whilst taking this medicine.

Chlorphenamine Elixir contains maltitol solution

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 Elixir

This medicine is for oral use.

Always take this medicine exactly 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 over 12 years: Take two 5 ml spoonfuls every 4-6 hours (maximum daily dose is 60 ml).

Children aged 6-12 years: Give one 5 ml spoonful every 4-6 hours (maximum daily dose is 30 ml).

Children aged 2-6 years: Give half a spoonful (2.5 ml) every 4-6 hours (maximum daily dose is 15 ml).

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23LL04641PW

SZ88501LL06B

Chlorphenamine Elixir 2 mg/5 ml

Chlorphenamine Maleate    Sugar Free    150 ml

For relief of hayfever, itchiness, skin allergies and allergic rhinitis.

Oral use. Read the package leaflet before use. Store below 25°C, protected from light.

Keep out of the sight and reach of children. Each 5 ml contains Chlorphenamine maleate 2 mg.

Also contains maltitol solution and E211.

Dosage instructions: Adults and children over 12 years: Two spoonfuls (10 ml) every 4 - 6 hours.

Children 6 - 12 years: One spoonful (5 ml) every 4 - 6 hours.

Children 2 - 6 years: Half a spoonful (2.5 ml) every 4 - 6 hours.

Children 1 - 2 years: Half a spoonful (2.5 ml) twice a day.

Children up to one year: not recommended.

Elderly: Talk to your doctor or pharmacist before taking this medicine as you may need to take a lower daily dose.

DO NOT EXCEED RECOMMENDED DOSES. If symptoms persist consult your doctor.

Warning: May cause drowsiness. If affected do not drive or operate I 0 chinery. Avoid alcoholic drinks.

SANDOZ

PL 04416/0368 Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR.

Base Label