Patient Information Leaflet

Bayer

CO-CODAMOL

8 / 500mg CAPSULES Paracetamol (500mg) and Codeine Phosphate (8mg)

Read this leaflet carefully because it contains important information for you.

Keep this leaflet, you may need to read it again.

Bayer CO-CODAMOL Capsules are a combination of codeine, which relieves pain, and paracetamol, which relieves pain and fever.

What are Bayer CO-CODAMOL CAPSULES for?

Bayer CO-CODAMOL Capsules provide strong relief from headaches (including tension headache and migraine), cold and flu symptoms including raised temperature and sore throats; muscular and rheumatic pain; back pain (including sciatica), neuralgia, period pain and dental pain.

This product contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain.

Codeine can be used in children aged 12 years and over for the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone.

When should I not take Bayer CO-CODAMOL CAPSULES?

Do not take:

•    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 are taking anything else containing paracetamol.

• If you are allergic to any of the ingredients.

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

• If you are breast-feeding

Before taking Bayer CO-CODAMOL CAPSULES:

Consult your doctor or pharmacist before taking Bayer CO-CODAMOL Capsules if you:

•    Are taking prescription medicines.

•    Are taking medicines containing codeine, metoclopramide, domperidone, colestyramine, warfarin or other coumarin anticoagulants.

•    Are taking medicines which affect the liver.

•    Have a liver or kidney condition.

Do not take for longer than directed by your prescriber. Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop taking the capsules.

Taking a painkiller for headaches too often or for too long can make them worse.

Codeine is transformed into 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 (12-18 years old)

Do not use in children and adolescents after removal of their tonsils or adenoids due to

Obstructive Sleep Apnoea Syndrome.

The product is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children.

Pregnancy and breast-feeding

Consult your doctor before taking the capsules if you are pregnant or think you may be pregnant.

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

Driving and using machines

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 may be an offence to drive when taking this medicine.

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

•    The medicine has been taken to treat a medical or dental problem and

•    You have taken it according to 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.

Details regarding a new UK driving offence, concerning driving after drugs have been taken, may be found at: www.gov.uk/drug-driving-law.

How should I take Bayer CO-CODAMOL CAPSULES?

Follow your doctor's instructions. Check the pharmacy label to see how many capsules to take and how often to take them. If you are not sure how to take them ask your pharmacist or doctor.

This medicine should not be taken for more than 3 days. If your pain does not improve after 3 days, talk to your doctor for advice.

The usual dosage is described below:

Adults and children aged 12 years and over: 1-2 capsules, repeated if necessary every 46 hours with a maximum of 8 capsules a day. Co-Codamol Capsules should not be taken by children under 12 years due to the risk of severe breathing problems.

What if I take too many Bayer CO-CODAMOL CAPSULES?

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.

Do Bayer CO-CODAMOL CAPSULES have any side effects?

Side effects are rare, but occasionally this medicine can cause constipation and hypersensitivity reactions such as skin rashes. Very rare cases of serious skin reactions have been reported. Any other unusual effects should be reported to your doctor or pharmacist. If you notice that you bruise or bleed more easily than usual or if you are more prone to infection, such as sore throats or mouth ulcers, you should speak to your doctor.

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.

How should I store Bayer CO-CODAMOL CAPSULES?

Do not store above 25°C, i.e. this medicine may be stored at room temperature. Keep out of the reach and sight of children. Do not use after the expiry date (EXP) on the carton and blister.

What do Bayer CO-CODAMOL CAPSULES contain?

Each capsule contains: Active ingredients: Paracetamol 500mg and Codeine Phosphate 8mg. Inactive ingredients: pregelatinised maize starch, colloidal silicon dioxide, magnesium stearate, titanium dioxide, gelatin, shellac, iron oxide, propylene glycol.

Available in packs of 100 capsules.

Who makes Bayer CO-CODAMOL CAPSULES?

Manufactured by Wrafton Laboratories Ltd, Wrafton, Braunton, Devon EX33 2DL, for the product licence holder: Bayer plc, Consumer Care Division, Newbury, Berkshire, RG14 1JA UK.

Leaflet last revised: April 2014.

Bayer