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

-    Keep this leaflet. You may need to read it again.

-    Ifyou have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you. Do not pass it onto others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects get 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 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

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

The active ingredients in Co-codamol are paracetamol and codeine phosphate. This product contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. Codeine can be used 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 shortterm relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone. These tablets are usually used for relief of severe pain such as muscular and rheumatic pain, headache, migraine, neuralgia, toothache and period pains.

2. BEFORE YOU TAKE CO-CODAMOL TABLETS

Do not take Co-codamol Tablets if:

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

•    You drink excessive amounts of alcohol.

•    You have severe asthma, bronchitis, breathing problems or ifyou are having an asthma attack.

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

•    You are under 12 years of age.

•    You are suffering from severe diarrhoea.

•    You have been told you have liver disease.

•    You are at risk of a blocked intestine.

•    You are in a coma.

•    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

•    Ifyou know that you metabolise very rapidly codeine into morphine

•    Ifyou are breastfeeding

Take special care with Co-codamol Tablets

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 for longer than directed by your prescribes

•    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.

Talk to your doctor or pharmacist before taking Co-codamol

Tablets if:

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

•    You are taking or have taken within the last two weeks, monoamine oxidase inhibitors (MAOIs) such as moclobemide or phenelzine used in the treatment of depression.

•    You have asthma, bronchitis or emphysema. You should not take codeine ifyou are having an acute asthma attack.

•    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 suffer from biliary tract disorders such as gallstones.

•    You are very run down.

•    You suffer from convulsions (fits).

•    You are a poor metaboliser of codeine.

•    You have had a drug addiction.

•    You have Addison's disease.

•    You have a poorly functioning adrenal gland.

•    You have difficulty passing water.

•    You have low blood pressure or shock.

•    You have weak muscles (myasthenia gravis).

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. Ifyou 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.

Caution should be exercised when taking paracetamol prior to (less than 72 hours before) or at the same time as intravenous busulfan.

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.

Taking other medicines

Please tell your doctor or pharmacist ifyou 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 ifyou are taking any of the following:

•    Antidepressants such as phenelzine, dosulepin (Tricyclic and MAOIs), chlorpromazine (phenothiazines).

•    Anxiolytics (to help with anxiety).

•    Antipsychotics (to help mood disorders).

•    Hypnotics such as diazepam, nitrazepam and temazepam (to help you sleep).

•    Cholestyramine (used to lower cholesterol).

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

•    Anaesthetics, particularly general anaesthetics (used in surgery to numb pain).

•    Antihistamines such as benadryl (used to treat allergies e.g. hayfever).

•    Sodium oxybate (used to treat narcolepsy).

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

•    Antidiarrhoeal agents such as loperamide or kaolin.

•    Muscle relaxants such as atropine.

•    Cimetidine (used to treat stomach ulcers and indigestion).

•    Anti-arrhythmic agents such as flecainide, quinidine and mexiletine.

•    Intravenous busulfan (used in chemotherapy to treat cancer).

Taking Co-codamol Tablets with food and drink

Do not drink alcohol while you are taking Co-codamol Tablets. 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

Ifyou are pregnant or breast-feeding you should talkto your doctor or pharmacist before taking any medicine. Do not take codeine while you are breastfeeding. Codeine and morphine passes into breast milk.

Driving and using machines

Codeine may cause drowsiness or changes in vision, including blurred or double vision in some people. Do not drive or use any tools or machines ifyou are affected in this way and do not drink alcohol, as this will make these effects worse. Other medicines may also increase these effects.

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:

o The medicine has been prescribed to treat a medical or dental problem and

o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

o It was not affecting your ability to drive safely Talkto your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

3. HOW TO TAKE CO-CODAMOL TABLETS

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

Adults and children over 12 years: Take one to two tablets every four hours. 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.

Children under 12 years: Co-codamol tablets 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. The dose should be reduced in patients with liver problems.

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 Tablets than you should

Always take the medicine as recommended by your doctor. Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

If you forget to take Co-codamol Tablets

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 Tablets

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.

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

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

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

•    Constipation

•    Nausea (feeling sick)

•    Vertigo (a feeling of dizziness or'spinning')

•    Dizziness

•    Drowsiness

•    Confusion

•    Vomiting (being sick)

•    Pain or difficulty in passing urine

•    Dry mouth

•    Sweating

•    Facial flushing

•    Slower or faster heart rate

•    Palpitations (feeling your heartbeat)

•    Feeling faint on standing up

•    Low body temperature

•    Difficulty breathing

•    Stomach cramps

•    Increased or decreased frequency of passing urine

•    Restlessness

•    Mood changes including depression, sadness and euphoria

•    Hallucinations (seeing or hearing things that are not there)

•    Pinpoint pupils

•    Blurred vision

•    Double vision or other changes in vision

•    Pressure on the brain

•    Kidney damage

•    Blood disorders (such as thrombocytopenia (reduction in blood platelets, which increases risk of bleeding or bruising), neutropenia and leucopenia (reduction in white blood cells, which may make infection more likely) and pancytopenia (severe reduction in blood cells which can cause weakness, bruising or make infections more likely)

•    Low sex drive

•    Hyperglycaemia (abnormally high levels of glucose in the blood)

•    Pancreatitis (inflammation of the pancreas)

•    Feeling tired

•    Feeling unwell

•    Hypothermia

•    Biliary spasms (causing a pain in the right side of your abdomen, particularly after eating a meal)

•    Fever

•    Enlarged spleen or swollen/enlarged lymph nodes

•    Anorexia

•    Uncontrolled muscle movements

•    Muscle rigidity

•    Weak erection in men

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.

If you have to take these tablets for a long time it is possible that you could become dependent on them and have withdrawal symptoms when you stop. This can also happen to babies born to mothers who have been given co-codamol during pregnancy.

Prolonged use of a painkiller for headaches can make them worse. Regular prolonged use of codeine is known to lead to addiction and tolerance.

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.m hra.gov.u k/yel lowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE CO-CODAMOL TABLETS

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 inner container or if the tablets show signs of 'going off'such as discoloration.

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

Do not store above 25°C. Store in the original container.

Remember this medicine is for you only. Never give it to anyone else. It may harm them, even if their symptoms are the same as yours.

Unless your doctor tells you to, do not keep tablets that you no longer need. Give them back to your pharmacist.

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 Tablets contain

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

The other ingredients are pregelatinised maize starch, magnesium stearate and povidone K30.

What Co-codamol Tablets look like and contents of the pack

Co-codamol Tablets are white, circular tablets marked CCD 30 on one face and CP on the reverse.

They are available in packs of 28,30,56,60,84,90 and 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Wockhardt UK Limited, Ash Road North, Wrexham, LL13 9UF, UK. Manufacturer

CP Pharmaceuticals Limited, Ash Road North, Wrexham, LL13 9UF, UK. Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800198 5000 (UK Only). Please be ready to give the following information:

Product name	Reference number
Co-codamol 30mg/500mg Tablets	29831/0047

This leaflet was last revised in August 2014

107070/1    fwOCKHARDT

India Version Artwork

Neutral code not required on the leaflet artworks

Package leaflet: Information for the user Co-codamol 30mg/500mg Tablets Codeine phosphate and paracetamol

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

-    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 onto others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects get 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 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

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

The active ingredients in Co-codamol are paracetamol and codeine phosphate. This product contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. Codeine can be used 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 pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone. These tablets are usually used for relief of severe pain such as muscular and rheumatic pain, headache, migraine, neuralgia, toothache and period pains.

2. BEFORE YOU TAKE CO-CODAMOL TABLETS

Do not take Co-codamol Tablets if:

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

•    You drink excessive amounts of alcohol.

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

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

•    You are under 12 years of age.

•    You are suffering from severe diarrhoea.

•    You have been told you have liver disease.

•    You are at risk of a blocked intestine.

•    You are in a coma.

•    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

Take special care with Co-codamol Tablets

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 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 the tablets.

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

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

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

•    You are taking or have taken within the last two weeks, monoamine oxidase inhibitors (MAOIs) such as moclobemide or phenelzine used in the treatment of depression.

•    You have asthma, bronchitis or emphysema. You should not take codeine if you are having an acute asthma attack.

•    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 suffer from biliary tract disorders such as gallstones.

•    You are very run down.

•    You suffer from convulsions (fits).

•    You are a poor metaboliser of codeine.

•    You have had a drug addiction.

•    You have Addison's disease.

•    You have a poorly functioning adrenal gland.

•    You have difficulty passing water.

•    You have low blood pressure or shock.

•    You have weak muscles (myasthenia gravis).

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.

Caution should be exercised when taking paracetamol prior to (less than 72 hours before) or at the same time as intravenous busulfan.

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.

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:

•    Antidepressants such as phenelzine, dosulepin (Tricyclic and MAOIs), chlorpromazine (phenothiazines).

•    Anxiolytics (to help with anxiety).

•    Antipsychotics (to help mood disorders).

•    Hypnotics such as diazepam, nitrazepam and temazepam (to help you sleep).

•    Cholestyramine (used to lower cholesterol).

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

•    Anaesthetics, particularly general anaesthetics (used in surgery to numb pain).

•    Antihistamines such as benadryl (used to treat allergies e.g. hayfever).

•    Sodium oxybate (used to treat narcolepsy).

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

•    Antidiarrhoeal agents such as loperamide or kaolin.

•    Muscle relaxants such as atropine.

•    Cimetidine (used to treat stomach ulcers and indigestion).

•    Anti-arrhythmic agents such as flecainide, quinidine and mexiletine.

•    Intravenous busulfan (used in chemotherapy to treat cancer).

Taking Co-codamol Tablets with food and drink

Do not drink alcohol while you are taking Co-codamol Tablets. 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

If you are pregnant or breast-feeding you should talk to your doctor or pharmacist before taking any medicine. Do not take codeine while you are breastfeeding. Codeine and morphine passes into breast milk. Driving and using machines

Codeine may cause drowsiness or changes in vision, including blurred or double vision 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.

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.

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