PRINT LAYOUT DIAGRAM

65MM X 170MM MULTIPEEL WITH 5 MM HINGE LEFT

FRONT FACE:

WARNING: DO NOT EXCEED THE STATED DOSE.

IMPORTANT: Peel this label at corner and read BEFORE use* Do *9 tear off, re-fix for future use.

LOT, MAN & EXp overprint area

Peel

^Ss^ere

^For the relief of uffprodjptive dry coughs. T'ke the solution by mouth.

Adults: Take 1 x 5ml spoonful, four times a

_day

The elderly: Ask your doctor for advice. A lower dose may be more suitable. o not give to children under 18 years old.

Codeine Phosphate Calms dry or irritating coughs

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, sunset yellow dye (E110), sodium methyl, ethyl and propyl parahydroxybenzoates (E219, E215, E217).

Peel where shown for full list of ingredients.

Do not store above 25°C.

Keep out of the sight and reach of children.

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

PL 00240/0099    23004711

PIP: 296-4633

200ml e E

\

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 metabolised' 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 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 you are elderly, as elderly people can react differently to the medicine. See section 2.

ATalk 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 • Alcohol

•    Metoclopramide or domperidone for nausea and vomiting • Quinidine, or mexiletine for irregular heartbeat • Any tranquillisers, antidepressants, sedatives, painkillers, general anaesthetics, sedating antihistamines or sleeping tablets • Any medicine for mental illness • Cimetidine for stomach ulcers • Sodium oxybate for sleeping disorders • Rifampicin for tuberculosis.

APregnant or breastfeeding..

Codeine Oral Solution Sugar Free 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.

i .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

CARRIER:

A Important ingredient information

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

•    It contains a small amount of ethanol (alcohol), less than 100mg per 5ml.

2. Possible side effects

Like all medicines, Codeine Linctus Oral Solution Sugar Free 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))

•    Prolonged use may worsen irritable bowel syndrome • 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 diarrhoea, stomach pain or a blocked bowel. 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 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.

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

What the medicine looks like

Codeine Oral Solution Sugar Free is a yellow syrupy liquid.

It is supplied in 200ml bottles.

Text revised: April 2016    23004711

Datamatrix: 23004711 VERIFIED

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