PACKAGE LEAFLET: INFORMATION FOR THE USER

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Co-codamol 30/500 mg Tablets

Codeine phosphate and 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Co-codamol is and what it is used for

2.    Before you take Co-codamol

3.    How to take Co-codamol

4.    Possible side effects

5.    How to store Co-codamol

6.    Further information

A SANDOZ

What Co-codamol is and what it is used for

The name of your medicine is Co-codamol 30/500 mg Tablets.

The active ingredients in Co-codamol are paracetamol and codeine phosphate. 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 such as paracetamol.

Paracetamol is also an antipyretic which means that it helps to reduce fever and lower your temperature.

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

2 Before you take Co-codamol

Do not take Co-codamol:

•    If you are allergic (hypersensitive) to paracetamol, codeine or any of the other ingredients in Co-codamol Tablets.

•    If you drink excessive amounts of alcohol.

•    If you have severe asthma, breathing problems or if you are having an asthma attack.

•    If you have recently had a head injury or have increased pressure within your head (raised intracranial pressure).

•    If you have recently had surgery on your bile duct.

•    If you are under 12 years of age.

•    If you are taking a monoamine-oxidase inhibitor (MAOI) or have taken a MAOI within the last 14 days. These medicines are usually used to treat depression and include tranylcypromine, phenelzine or isocarboxazide

•    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 the answer to any of these questions is YES, tell your doctor or pharmacist before taking Co-codamol tablets.

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.

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.

Take special care with Co-codamol

Before taking this medicine, you need to know the following:

•    This product contains paracetamol.

•    Do not take with any other paracetamol containing products.

•    If your symptoms last for more than 3 days talk to your doctor.

•    Do not take Co-codamol for longer than directed by your doctor. Taking codeine regularly for a long time can lead to addiction.

•    Taking a painkiller for headaches for too long may make them worse.

Talk to your doctor or pharmacist before taking Co-codamol if:

•    You are pregnant or breast-feeding (see ‘Pregnancy and breast-feeding’ below).

•    You have asthma.

•    You have serious problems with your liver or kidneys.

•    You are elderly, as you may need a lower dose.

•    You are being treated with depressants (medicines used to treat anxiety).

•    You have an enlarged prostate.

•    You have an inflamed bowel or obstructive bowel disorder.

•    You have an under active thyroid.

•    You have Addison’s disease.

Warnings and precautions

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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines you have bought yourself without a prescription.

In particular you should tell your doctor if you are taking any of the following:

•    Barbiturates (to help you sleep or treat epilepsy).

•    Anticonvulsants (to treat epilepsy).

•    Antidepressants (tricyclics or MAOIs).

•    Antipsychotics (to help mood disorders).

•    Anxiolytics (to help with anxiety).

•    Hypnotics (to help you sleep).

•    Chloramphenicol (an antibiotic).

•    Colestyramine (used to lower cholesterol).

•    Cisapride, metoclopramide or domperidone (used to help stop nausea and vomiting)

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•    Anticoagulants (medicines used to thin the blood, such as warfarin).

•    Ciprofloxacin (an antibiotic).

•    Cimetidine (for stomach ulcers).

•    Ritonavir (used to treat HIV infection).

Taking Co-codamol with food and drink

Do not drink alcohol while you are taking Co-codamol. Alcohol may increase the sedative effects of Co-codamol and make you very sleepy. It can also increase the risk of some side effects.

Pregnancy and breast-feeding

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

If you are pregnant or breast-feeding you should talk to your doctor or pharmacist before taking any medicine.

Driving and using machines

Codeine may cause dizziness or drowsiness in some people. Do not drive or use any tools or machines if you are affected in this way and do not drink alcohol, as this will make these effects worse. Other medicines may also increase these effects.

3 How to take Co-codamol

medicine and talk to your doctor immediately if you notice any of the following symptoms:

•    You bruise more easily, have bleeding gums or bleed for longer after cutting yourself or you feel tired or look pale.

•    You seem to be getting more infections than usual or you develop ulcers in your mouth or throat.

•    You have a severe abdominal pain (in the upper middle or upper left part of the belly) usually accompanied by sickness, diarrhoea or fever.

•    You have an allergic reaction. The signs of an allergic reaction may include: a rash, difficulty breathing or swallowing, swelling of your lips, face, throat or tongue.

Other more common side effects that some people notice when taking Co-codamol are listed below:

•    Constipation

•    Nausea

•    Drowsiness

•    Confusion and

•    Vomiting

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.

Always take Co-codamol tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is described below.

These tablets are for oral administration. They should be swallowed with a glass of water.

Dosage instructions

Children aged 12 years of above should take two tablets every four hours, as needed. Do not take more than eight tablets in 24 hours.

Elderly: Your doctor may have reduced the dose for you. If this is the case follow your doctor’s instructions.

Co-codamol should not be taken by children below the age of 12 years, due to the risk of severe breathing problems.

Do not take more tablets than your doctor has prescribed for you.

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

If you take more Co-codamol than you should

Always take the medicine as recommended by your doctor. If you take too much medicine, tell your doctor immediately or go to your local hospital emergency department, even if you feel well. This is because there is a delayed risk of serious liver damage.

If you forget to take Co-codamol

Take your usual dose as soon as you remember, provided it is at least 4 hours since your last dose.

Never take a double dose to make up for a missed dose.

If you stop taking Co-codamol

Do not stop taking these tablets immediately, it could make you feel restless or irritable. Talk to your doctor about reducing your dose gradually.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

5 How to store Co-codamol

Keep out of the reach and sight of children.

Do not use Co-codamol tablets after the expiry date which is stated on the carton or blister.

The expiry date refers to the last day of that month.

Talk to your pharmacist before taking these tablets if they are chipped or broken.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

6 Further information

What Co-codamol contains

The active ingredients in Co-codamol Tablets are paracetamol, 500 mg and codeine phosphate, 30 mg.

The other ingredients are starch, sodium starch glycollate, magnesium stearate, povidone (K-30), colloidal silicon dioxide, talc, sodium lauryl sulphate, glycerol and purified water.

What Co-codamol looks like and contents of the pack

Co-codamol Tablets are white to off-white capsule shaped tablets with a central break-line on one face.

They are available in packs of 60 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

This leaflet was last revised in 09/2013.

4 Possible side effects

Like all medicines, Co-codamol can cause side effects, although not everybody gets them. Tell your doctor if you think your medicine is making you feel unwell.

It is very unlikely that you will experience the following side effects. However, you should stop taking this

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