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Aspar Co-Codamol PIL N35_Victor 18/05/2015 15:35 Page 2

Patient Information Leaflet for

Co-Codamol 8mg/500mg Tablets

(Codeine Phosphate and Paracetamol)

Read this leaflet carefully before taking these tablets. It does not contain all the information about your medicine that you may need to know, so ask your doctor or pharmacist if you have any questions. This leaflet only applies to Co-Codamol tablets.

•    This medicine can only be used for the short term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone.

•    You should only take this product for a maximum of three days at a time. If you need to take it for longer than three days you should see your doctor or pharmacist for advice.

•    This medicine contains codeine which can cause addiction if you take it continuously for more than three days.

This can give you withdrawal symptoms from the medicine when you stop taking it.

•    If you take this medicine for headaches for more than three days it can make them worse.

1. What these tablets do

Co-Codamol is a type of painkiller that contains paracetamol and codeine. Co-Codamol tablets are used in adults and children over 12 years of age for the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone. For headache, migraine, toothache, period pains, rheumatic pains, muscle pains and backache.

2. Check before you take

This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it.

• If you take a painkiller for headaches for more than three days it can make them worse.

Do not take Co-Codamol tablets:

•    For pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome.

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

•    If you are breastfeeding.

•    If you are allergic to Paracetamol, to Codeine or any other similar painkillers such as dihydrocodeine, or to any of the other ingredients listed in section 6.

•    If you have liver disease or kidney failure.

•    If you have asthma or other breathing difficulties.

•    If you suffer from heart failure due to lung disease.

•    If you have recently suffered a head or brain injury.

•    If you are suffering from diarrhoea associated with colitis or due to any type of poisoning.

•    If you suffer from alcohol dependency.

Warnings and Precautions Tell your doctor if you:

•    Are pregnant or breast feeding.

•    Have kidney or liver problems or alcoholic liver disease.

•    Suffer from high blood pressure or have an irregular heartbeat (slow or rapid).

•    Have an under active thyroid gland or adrenal gland.

•    Have urinary or prostate problems.

•    Have recently had surgery on your stomach, suffer from gallstones, bowel disorders or abdominal pain or swelling.

•    Have ever suffered from convulsions or emotional problems.

•    Are suffering from any kind of shock.

•    Have a history of drug abuse.

•    Suffer from muscle weakness (myasthenia gravis).

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.

Children and adolescents

Use in children and adolescents after surgery Co-Codamol should not be used for pain relief in children and adolescents after removal of their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome.

Use in children with breathing problems Co-Codamol is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children.

Tell your doctor or pharmacist if you are

already taking any of the following medicines:

•    Metoclopramide or Domperidone (used to treat nausea and vomiting).

•    Colestyramine (used to lower cholesterol in the blood).

•    Cimetidine (to treat stomach ulcers).

•    Cisapride (to treat heartburn).

•    Quinidine or Mexiletine (to treat certain heart conditions).

•    Naloxone or Naltrexone (to treat drug overdose or abuse).

•    Chloramphenicol (to treat eye infections).

•    Hydroxyzine (an antihistamine used for itching).

•    Blood thinning medicines such as Warfarin.

•    Medicines to treat diarrhoea.

•    Diuretics or other drugs for high blood pressure.

•    Antimuscarinics (used to treat Parkinson's disease).

•    Antidepressants including those known as monoamine oxidase inhibitors, anti-anxiety drugs, sedative or hypnotic drugs.

•    Anaesthetics

•    Barbiturates (e.g.Phenobarbital)

Co-codamol tablets should not be taken by patients currently taking monoamine oxidase inhibitors (MAOI’s, e.g. moclobemide) or within two weeks of stopping treatment.

Co-codamol tablets may interfere with laboratory tests and you should inform your doctor if you have any tests scheduled.

Pregnancy, breastfeeding and fertility

Do not take Co-Codamol tablets during pregnancy or while you are breastfeeding. Codeine and Morphine passes into breast milk.

Important information about some of the ingredients

This medicine contains methyl, ethyl and propyl p-hydroxybenzoates (E218, E214 & E216) which may cause allergic reactions (possibly delayed).

3. How to take these tablets

Dosage in adults, the elderly and children aged

12 years to 18 years:

Take 1 to 2 tablets with water every 4 hours.

Do not take more than 8 tablets in 24 hours.

Children under 12 years

Not recommended due to the risk of severe

breathing problems.

When taking this medicine, it is important to

remember the following:

•    Do not take more medicine than this leaflet tells you to.

•    Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.

If you miss a dose, do not take a double dose to make up for the missed dose.

•    Do not drink alcohol or take other Paracetamol containing products whilst taking these tablets.

•    Do not take for more than 3 days. If the pain does not improve after 3 days, you must speak to your doctor or pharmacist for advice.

•    Risk of addiction: This medicine contains codeine and can cause addiction if you take it continuously for more than three days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.

4. Possible Side Effects

Some people may have side effects when taking this medicine. If you have any unwanted side-effects you should seek advice from your doctor, pharmacist or other healthcare professional.

Serious side effects

•    Itching

•    Skin rashes

•    Facial swelling

•    Convulsions

•    Breathing difficulties

If you experience any of the above symptoms after taking this medicine go to the nearest hospital IMMEDIATELY.

Other side effects

If you experience any of these or any other side effects and they get serious, contact your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard or fill in a paper form available from your local pharmacy.

How do I know if I am addicted?

If you take this medicine according to the instructions on the pack it is unlikely that you will become addicted to this medicine. However, if the following apply to you it is important that you talk to your doctor:

-    You need to take the medicine for longer periods of time.

-    You need to take more than the recommended dose.

-    When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again.

5. Storing your medicine

Keep your medicine in a safe place where children cannot see or reach it.

Do not store above 25°C. Store in a dry place. Protect from light.

Do not use this medicine after the expiry date printed on the packaging.

6. More about your medicine

The active ingredients in Co-codamol tablets are Paracetamol 500mg and Codeine Phosphate 8 mg. They are white capsule shaped tablets, broken breakline and embossed with ac 500/8 on one side. The other side is plain. The inactive ingredients are starch (maize and potato), povidone, talc, stearic acid, magnesium stearate, methyl p-hydroxybenzoate (E218), ethyl p-hydroxybenzoate (E214) and propyl p-hydroxybenzoate (E216).

PL Holder and Manufacturer:

Aspar Pharmaceuticals Ltd,

Colindale, London, NW9 0Eq.

PL 08977/0012

Available in Pharmacy packs: 12, 16, 24, 25, 30 and 32 in blister, strip or bottles.

Text Revision: May 2015.