Braille reads:

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FRONT FACE:

IMPORTANT: Peel this label at corner and read BEFORE use. Do not tear off, re-fix for future use.

Codeine Linctus

Codeine Phosphate Calms dry or irritating coughs

For symptomatic relief of dry or irritating coughs.

Take the solution by mouth.

Adults: Take 1 x 5ml spoonful.

The elderly: Ask your doctor for advice.

A lower dose may be more suitable.

Repeat after 4 hours if required, but not more than 4 doses in 24 hours.

Do not give to children under 18 years old.

WARNING: DO NOT EXCEED THE STATED DOSE.

If symptoms persist consult your doctor. Peel where shown for further precautions.

Active ingredient per 5ml: codeine phosphate 15mg.

Also contains amongst other ingredients: ethanol, invert sugar, sunset yellow dye (E110), sucrose 4g per 5ml, alcohol 1.8 vol%.

Peel where shown for full list of ingredients.

Do not store above 25°C. Protect from light. Keep out of the sight and reach of children.

Manufactured by the licence holder L.C.M. Ltd., Huddersfield, HD7 5QH, UK for Thornton and Ross Ltd., Huddersfield,

HD7 5QH, UK.

MA213/00301 PL 12965/0009 21486617

200ml 6 E ^

LOT, MAN & EXP Overprint area

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FRONT FACE REVERSE:

This medicine contains codeine phosphate, which

reduces the desire to cough.

1. Before you use this medicine

□ Do not use the medicine if you have....

•    An allergy to any of the ingredients listed in section 3.

•    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 into 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.

A Talk to your doctor or pharmacist 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 muscle) • 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 you are elderly, as elderly people can react differently to the medicine.

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, anaesthetics, sedating antihistamines or sleeping tablets • Any medicine for mental illness • Metoclopramide or domperidone for nausea and vomiting • Quinidine or mexiletine for irregular heartbeat • Alcohol

•    Cimetidine for stomach ulcers • Sodium oxybate for sleeping disorders • Rifampicin for tuberculosis.

APregnant or breastfeeding..

Codeine 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.

A 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.

21486617

CARRIER:

A Important ingredient information

•    This product contains 4g of sucrose per dose. To be taken into account in people with diabetes. It also contains invert syrup. 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 a small amount of ethanol (alcohol), less than 100mg per 5ml.

•    It also contains sunset yellow (E110) which may cause allergic reactions.

2. Possible side effects

Like all medicines, Codeine 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 • Drowsiness

•    Disturbed sleep • 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 • Low body heat

•    Hallucinations • Mood changes • Feeling restless or confused • Pinpoint pupils or other problems with eyesight • Abdominal pain (including pain caused by inflammation of the pancreas (pancreatitis) or bile duct problems (biliary spasm)) • Ureteric spasm (urine tube problem causing abdominal or lower back pain) • Low sexual urge • Allergic reactions such as itching and a rash • Elderly people may experience incontinence, diarrhoea, stomach pain or a blocked bowel • Prolonged use may worsen irritable bowel syndrome • Prolonged use may lead to addiction, dependence and tolerance (the medicine loses its effect).

If you notice these or any other side effects, stop use and

tell your doctor or pharmacist. They will tell you what to do.

Reporting of side effects

If you getany 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.gQv.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

3. Further information

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

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

•    Return any unused medicine to the pharmacy for disposal.

The active ingredient per 5ml is: codeine phosphate 15mg.

The other ingredients are: citric acid (E330), lemon oil terpeneless, ethanol, benzoic acid solution (E210, propylene glycol), invert syrup, quinoline yellow (E104), sunset yellow dye (E110), sucrose and purified water.

What the medicine looks like

Codeine Linctus is a yellow syrupy liquid.

It is supplied in 200ml bottles.

Text revised: April 2016    21486617

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