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Document: leaflet MAH GENERIC_PL 12762-0056 change

• leaflet MAH BRAND 2_PL 12762-0056
• leaflet MAH BRAND_PL 12762-0056
• leaflet MAH GENERIC_PL 12762-0056

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MercuryPharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Co-codamol 15mg/500mg Tablets

Codeine Phosphate/Paracetamol

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The product is known by the name above but will be referred to as Co-codamol Tablets throughout the rest of this leaflet.

In this leaflet:

1.    What Co-codamol Tablets are and what they are used for

2.    Before you take Co-codamol Tablets

3.    How to take Co-codamol Tablets

4.    Possible side effects

5.    How to store Co-codamol Tablets

6.    Further information

1. WHAT CO-CODAMOL TABLETS ARE AND WHAT THEY ARE USED FOR

Co-codamol Tablets contain paracetamol and codeine. Paracetamol is an analgesic (relieves pain) and an antipyretic (lowers raised temperatures). This product contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It can be used on its own or in combination with other pain killers.

Co-codamol Tablets are used for the relief of moderate pain. Co-codamol Tablets can be used in 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.

2. BEFORE YOU TAKE CO-CODAMOL TABLETS

Do not take with any other paracetamol-containing products. Do not take for longer than directed by your prescriber. Do not use Co-codamol Tablets for pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids as Codeine in Co-codamol Tablets may cause obstructive sleep apnoea syndrome (sleep disruption due to respiratory pauses). Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets. Taking a painkiller for headaches too often or for too long can make them worse.

Do not take Co-codamol Tablets if:

•    you know that you are allergic to paracetamol or codeine, or any of the other ingredients (refer to section 6 below)

•    you suffer from severe kidney or liver disease

•    you know that you metabolise very rapidly codeine into morphine

•    you are breast feeding

•    you suffer from asthma or any other breathing problems, for example chronic bronchitis or emphysema

•    you are taking monoamine oxidase inhibitors (MAOIs) or have been taking them within the last two weeks. MAOIs such as phenelzine or isocarboxazid are medicines used to treat depression

•    you have just had a head injury or suffer from increased pressure on the brain

•    you drink a lot of alcohol, or have done in the past

•    you have recently had an operation to your gall bladder.

Co-codamol Tablets should not be given to children under 12 years of age.

Take special care and tell your doctor or pharmacist before taking Co-codamol Tablets if:

•    you are elderly or weak

•    you have any stomach pains or other sudden problems in your abdomen (belly)

•    you have an underactive thyroid gland

•    you are prone to suffer from asthma

•    you have liver, kidney or thyroid problems, because the dose might need to be lower

•    you have problems with your adrenal glands (Addison's disease - your doctor will advise you)

•    you suffer from an enlarged prostate gland (if male) or narrowing of your urethra (tube through which urine is passed)

•    you feel you have taken Co-codamol Tablets for a long time. You may develop a dependence on Co-codamol Tablets which may be harmful.

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 should 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.

Warnings and precautions Children and adolescents

Use in children and adolescents after surgery

Codeine should not be used for pain relief in children and adolescents after removal of their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome (sleep disruption due to respiratory pauses). They may be at increased risk of severe side effects in case of morphine toxicity.

Use in children with breathing problems

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

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some medicines interact with each other and this can alter their effect. It is particularly important to tell your doctor or pharmacist if you are taking the following medicines:

•    MAOIs used to treat depression, taken within the last 14 days (refer to “do not take if” in section 2 above)

•    sedatives and sleeping tablets, e.g. temazepam and diazepam

•    medicines for irregular heart beats (mexiletine, quinine or quinidine)

•    drugs used to dry fluids in the mouth and lungs known as anticholinergics

•    medicines to treat diarrhoea or sickness (metoclopramide, domperidone)

•    medicines used to treat problems of the stomach, gall bladder, heart burn or sickness, (e.g. cimetidine, colestyramine)

•    other strong painkillers called opioids

•    medicines which prevent blood clotting (anticoagulants such as warfarin).

Co-codamol Tablets can interfere with some laboratory tests used for determining some diseases.

Co-codamol Tablets must not be taken with any other medicines containing paracetamol or codeine. Some products which can be bought without a prescription may contain paracetamol or codeine, so always check the labels for ingredients.

Taking Co-codamol Tablets with food and drink

Do not drink alcohol whilst taking Co-codamol Tablets. Swallow the tablets with a glass of water. Do not bite or chew the tablets.