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Cofsed Linctus

(pholcodine, chlorphenamine maleate, ephedrine hydrochloride)

Important information about Cofsed Linctus

•    This medicine relieves coughs and congestion.

•    It can be used by adults and children over 12 years.

Do not take....

•    If allergic to any of the ingredients. See section 6.

•    With other cough, cold or decongestant medicines.

•    Or give to children under 12 years.

Now read the rest of the leaflet before you

use this medicine. It includes other

information which might be especially

important for you.

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

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

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1.    What the medicine is for

Cofsed Linctus is an oral solution containing pholcodine which reduces the desire to cough.

It also contains ephedrine hydrochloride, a decongestant and chlorphenamine maleate which relieves nasal congestion caused by allergies. The medicine relieves dry or painful coughs in adults and children over 12 years of age and relieves congestion in the nose in colds and hay fever.

2.    Before you use this medicine

□ Do not use the medicine if you have..

• An allergy to any of the ingredients listed in section 6.

• Taken medicine for depression (monoamine oxidase inhibitors/MAOIs within the last two weeks.

• Taken other cough, cold or decongestant medicines.

• Epilepsy.

• An overactive thyroid gland.

• Glaucoma (raised pressure inside the eyeball).

• Liver disease.

• Severe kidney problems.

• Prostate trouble.

• Trouble passing urine.

• A blockage from the stomach to the small intestine.

• Heart or circulation problems, including high blood pressure, or are taking medicines to lower your blood pressure e.g. beta blockers.

• Breathing problems or shortage of breath

including chronic bronchitis.

• Phaeochromocytoma (a rare tumour of the adrenal gland).

• Or are under 12 years.

Talk to your doctor if you have..

•    Asthma • Kidney problems • Diabetes.

•    A cough for a long time or a cough which produces lots of phlegm.

•    Or you are elderly.

A Talk to your doctor or pharmacist if you are taking..

• Diuretics, which help remove fluid from the body, e.g. furosemide, hydrochlorothiazide.

• Medicines used to treat sleeplessness, anxiety, depression and schizophrenia.

• Medicines or supplements to reduce your appetite or make you more alert.

• Alcohol.

• Pain killers, e.g. morphine.

• Lopinavir (used to treat HIV).

• Phenytoin (for epilepsy).

• Muscle relaxing drugs, e.g. atropine, used for irritable bowel syndrome.

• Histamine (for some types of cancer).

• Betahistine (for vertigo).

• Caffeine.

• Theophylline (for asthma or bronchitis).

• Medicines for irregular heartbeat e.g. digoxin.

• Ergotamine or methysergide for migraine.

• Oxytocin, used to induce labour.

• Dexamethasone, a steroid used e.g. for arthritis.

• Medicines for Parkinson's Disease e.g. rasagiline, selegiline, levodopa, bromocriptine.

• Furazolidone, an antibiotic.

• Or are having surgery, as muscle relaxants used may react with this medicine.

• Or are having skin tests for allergies, as this medicine may interfere with the results.

A ant or breastfeeding..

Ask your doctor for advice before using this medicine if you are pregnant, might be pregnant or are breastfeeding. Cofsed Linctus should not be used in pregnancy unless the doctor has told you to do so.

A g and using machines..

This medicine may cause drowsiness or other side effects which could affect your ability to drive or use machinery (see section 4 for a full list of side effects). You should not drive or operate machinery until the effects have worn off.

A Important information about some of the ingredients

• This medicine contains small amounts of ethanol (alcohol), less than 100mg per 10ml dose.

• It also contains sucrose and invert sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

• It contains 7.8g of sucrose and 0.17g invert sugar per 10ml dose. This should be taken into account in people with diabetes.

• It contains parahydroxybenzoates which may cause allergic reactions (possibly delayed), and exceptionally, bronchospasm.

3. How to use this medicine

Take this medicine by mouth.

Adults and children over 12 years

Two 5ml spoonfuls (10ml) three times a day.

No more than 3 doses should be given in any 24 hours.

□ Children under 12 years

Do not give to children under 12 unless your doctor tells you to.

DO NOT EXCEED THE STATED DOSE.

If symptoms persist you should ask your doctor for advice.

A If you take too much

If you accidentally take too much, see a doctor straight away. Take the pack with you to show which medicine you have swallowed.

A If you forget a dose

Take the next dose as soon as you remember. Do not take a double dose. You can then carry on with the normal dose.

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4. Possible side effects

Like all medicines, Cofsed Linctus can have side effects, although these don't affect everyone.

Important side effects:

If you think you have any of the following side effects or symptoms, stop using this medicine immediately and see a doctor as soon as possible.

•    Allergic reactions which may cause difficulty in breathing, fever, swelling of the mouth, lips or skin, severe rashes, itching or stomach pain.

Other possible side effects are:

•    Feeling drowsy or dizzy.

•    Feeling sick or being sick.

•    Abdominal pain, diarrhoea or constipation.

•    Altered taste and smell.

•    Headache.

•    Blurred vision, dilation of the pupils, raised pressure inside the eye (glaucoma).

•    Ringing in the ears (tinnitus).

•    Anorexia.

•    Skin rashes.

•    Increased sensitivity to sunlight.

•    Dry mouth or increased amounts of saliva.

•    Thicker phlegm, or difficulty coughing up phlegm.

•    Feeling short of breath.

•    Sweating.

•    Hairs standing on end (Goose bumps).

•    Cold hands and feet.

•    Muscle trembling, feeling weak, “pins and needles” or face twitching.

•    Problems controlling movement.

•    Fits.

•    Feeling anxious, restless, irritable, excited or confused.

•    Feeling fearful, depressed or seeing things.

•    Insomnia (unable to sleep) or disturbed sleep.

•    Awareness of the heartbeat, irregular or fast heartbeat.

•    High or low blood pressure.

•    High blood sugar.

•    Blood problems (e.g. anaemia, unexplained bleeding or bruising).

•    Liver problems.

•    Problems passing urine.

If you notice these or any other side effect not included above, stop use and tell your doctor or pharmacist. They will tell you what to do.

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 following national reporting systems:

United Kingdom Yellow Card Scheme -www.mhra.gov.uk/yellowcard Malta

www.medicinesauthority.gov.mt/adrportal By reporting side effects you can help provide more information on the safety of this medicine.

5. Storing this medicine

•    Keep it out of the sight and reach of children.

•    Protect from light.

•    Do not use after the expiry date shown on the carton. The expiry date refers to the last day of that month.

•    Medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine. These measures will help to protect the environment.

6. Further information

What is in this medicine

The active ingredients per 5ml are:

pholcodine 5mg, ephedrine hydrochloride 8mg, chlorphenamine maleate 2mg.

The other ingredients are: ethanol, glycerol (E422), invert sugar, menthol, methyl parahydroxybenzoate (E218), ethyl parahydroxybenzoate (E214), propyl parahydroxybenzoate (E216), aniseed flavour, quinoline yellow (E104), sucrose and purified water.

What the medicine looks like

Cofsed Linctus is a clear, yellow liquid which smells of aniseed.

It is supplied in 100ml bottles.

Marketing authorisation holder and manufacturer

Thornton and Ross Ltd., Huddersfield,

HD7 5QH, UK.

This leaflet was last revised in March 2015

Cofsed is a trade mark of Thornton & Ross Ltd.

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