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• label-leaflet CARE_PL 00240-0099
• leaflet MAH BRAND_PL 00240-0099

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Galcodine Linctus

(Codeine phosphate)

Important information about Galcodine Linctus

•    This medicine relieves the symptoms of dry coughs in adults, including the elderly.

Do not take....

•    If you have breathing problems including bronchitis. See section 2.

•    Or give to children under 18 years old.

•    Avoid drinking alcohol while taking this medicine.

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 you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1.    What the medicine is for

Galcodine Linctus contains codeine phosphate which reduces the desire to cough.

It is used to relieve dry coughs which are without phlegm.

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.

•    Liver disease, or severe kidney problems.

•    Shallow breath or breathing difficulties.

•    A head injury or persistent headache.

•    An asthma attack.

•    Previously had a blocked bowel.

•    Previously had an addiction to medicines containing Codeine or Morphine.

•    If you know that you metabolise very rapidly codeine to morphine.

•    Previously had a bad reaction to codeine

(a known "ultra-rapid metaboliser" of codeine).

•    Or are under 18 years old.

•    If you are breastfeeding.

Talk to your doctor if you have..

•    Kidney or liver problems (a reduced dose may be recommended by your doctor).

•    A history of asthma or other breathing problems, including bronchitis.

•    Low blood pressure.

•    Irritable bowel syndrome (IBS) or other bowel problems.

•    Abdominal pain.

•    Myasthenia gravis (a disease of the muscles).

•    Underactive thyroid or adrenal gland problems (a reduced dose may be recommended by your doctor).

•    Gallstones or bile duct problems.

•    Prostate problems.

•    Problems passing urine.

•    Irregular heartbeat.

•    Fits.

•    Or you are suffering from shock.

•    Or are elderly, as elderly people can react differently to the medicine. See section 4.

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

• MAOIs (monoamine oxidase inhibitors) for

depression, selegiline for Parkinson's Disease, or the antibiotic linezolid, or you have taken them within the last two weeks.

• Any tranquillisers, antidepressants, sedatives, painkillers, general anaesthetics, sedating antihistamines or sleeping tablets.

• Any medicine for mental illness.

• Alcohol.

• Metoclopramide or domperidone for nausea and vomiting.

• Quinidine or mexiletine for irregular heartbeat. • Cimetidine for stomach ulcers.

• Sodium oxybate for sleeping disorders.

• Rifampicin for tuberculosis.

A ant or breastfeeding..

Galcodine Linctus should not be used in pregnancy unless the doctor has told you to do so.

Do not take codeine while you are breastfeeding. Codeine and morphine passes into breast milk.

Driving and using machines....

This medicine may cause drowsiness or dizziness. If you are affected do not drive or operate machinery.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

•    Do not drive while taking this medicine until you know how it affects you.

•    It is an offence to drive if this medicine affects your ability to drive.

•    However, you would not be committing an offence if:

° The medicine has been prescribed to treat a medical or dental problem and ° You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and ° It was not affecting your ability to drive safely.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

A Important information about some of the ingredients

• This medicine contains small amounts of ethanol (alcohol), less than 100mg per 5ml dose.

• It contains sodium parahydroxybenzoates and sunset yellow dye which may cause allergic reactions (possibly delayed).

3. How to use this medicine

Take this medicine by mouth.

The normal dose is given below but your doctor may prescribe a different amount for you. Always follow the instructions given by the doctor or pharmacist.

Adults

• Take one 5ml spoonful four times a day.

The elderly

• Ask your doctor for advice, a lower dose might be more suitable.

□ Children under 18 years

Do not give to children under 18 years old.

If your 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.

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 at the correct time.

4. Possible side effects

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

Important side effects

Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme and this can affect people in different ways. In some people, morphine is not produced or produced in very small quantities, and it will not provide enough pain relief. Other people are more likely to get serious side effects because a very high amount of morphine is produced. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.

Other possible side effects are:

•    Feeling or being sick.

•    Dizziness or vertigo.

•    Constipation.

•    Loss of appetite.

•    Fits.

•    Feeling unwell.

•    Muscle twitching or stiffness.

•    Difficulty in passing water.

•    Dry mouth.

•    Sweating.

•    Headache.

•    Facial flushing.

•    Fluid retention (e.g. swollen ankles and feet).

•    Abnormal heartbeat.

•    Feeling faint when standing up.

•    Slow, shallow breathing.

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•    Low body heat.

•    Hallucinations.

•    Mood changes.

•    Feeling restless or confused.

•    Pinpoint pupils or other problems with eyesight.

•    Low sexual urge.

•    Drowsiness.

•    Disturbed sleep.

•    Abdominal pain (including pain caused by inflammation of the pancreas (pancreatitis) or bile duct problems (biliary spasm)).

•    Prolonged use may worsen irritable bowel syndrome.

•    Ureteric spasm (urine tube problem causing abdominal or lower back pain).

•    Allergic reactions such as itching and a rash.

•    Prolonged use may lead to addiction, dependence and tolerance (the medicine loses its effect).

•    Elderly people may experience diarrhoea, stomach pain or a blocked bowel.

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 Yellow Card Scheme at: www.mhra.gov.uk/vellowcard. 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.

•    Do not store above 25°C.

•    Do not use after the expiry date shown on the pharmacist's label.

•    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 ingredient per 5ml is:

codeine phosphate 15mg.

The other ingredients are:

citric acid monohydrate (E330), sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215), sodium propyl parahydroxybenzoate (E217), glycerol (E422), ethanol, sunset yellow dye (E110), saccharin sodium, carmellose sodium, levomenthol, condensed milk flavour, orange flavour and purified water.

What the medicine looks like

Galcodine Linctus is a thick orange liquid which smells of menthol and orange. It is dispensed for you by the pharmacist.

Marketing authorisation holder and manufacturer

Thornton and Ross Ltd., Huddersfield,

HD7 5QH, UK.

This leaflet was revised in October 2014

Galcodine is a trade mark of Thornton & Ross Ltd.

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