MAH: Custom Healthcare Ltd. Conway Street, Hove, BN3 3LW PL 33446/0001

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BRAILLE READS:

BRAILLE SPECIFICATION: MARBURG MEDIUM

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ealthcare ltd

ARK 006

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Co-codamol 8/500 mg Capsules

Codeine Phosphate, Paracetamol

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.

2. Before you take Co-codamol

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

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

Co-codamol is a combination of two pain killing drugs, Paracetamol and Codeine Phosphate. It is used to relieve the symptoms of influenza and feverish colds including a raised temperature. It is also used for the relief of mild to moderate pain caused by headaches, sore throats, period pains, migraine, toothache, neuralgia, muscular and rheumatic pains.

Do not take Co-codamol if you:

•    Are allergic (hypersensitive) to Paracetamol, Codeine Phosphate or other medicines known as opioids, e.g. Morphine, or any of the other ingredients of Co-codamol (see section 6. Further Information)

•    Have asthma or suffer from breathing difficulties which may be due to disease or brought on by taking other painkilling drugs such as morphine, fentanyl or pethidine

•    Have diarrhoea caused by poisoning or have pseudomembranous colitis which causes severe bloody diarrhoea.

Take special care

You should talk to your doctor or pharmacist before you take Co-codamol if any of

the following apply to you:

•    You have kidney or liver problems

•    You drink excessively, are alcoholic or suffer from non cirrhotic alcoholic liver disease

•    You are suffering from, or have been treated in the past for, head injuries or pressure inside your head

•    You have an under-active thyroid gland (hypothyroidism) which can cause tiredness or weight gain

•    You have Addison's disease which can lead to weight loss, low blood pressure and bronzing of the skin

•    You have phaeochromocytoma (a tumour near a kidney causing high blood pressure)

•    You have an enlarged prostate gland which causes difficulty passing urine in men

•    You have inflammatory bowel disease e.g. Crohn's disease or ulcerative colitis

•    You have recently had surgery on your digestive system or urinary tract

•    You have gall bladder disease or gallstones

•    You suffer from a disease called myasthenia gravis

•    You have experienced convulsions

•    You have low blood pressure or are in shock

•    You have suffered from drug dependence or abuse, or mental illness.

-    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.

Taking other medicines

Before taking Co-codamol, you should tell your doctor or pharmacist about all medicines you are taking or plan to take, including those obtained without prescription.

Whilst taking Co-codamol you should not take any other medicines which contain Paracetamol. This includes some painkillers, cough and cold remedies and a wide range of other medicines available from shops and pharmacies.

You should not take Co-codamol if you are taking or have taken any medicines for depression of the type known as Monoamine Oxidase Inhibitors (MAOIs) such as Phenylzine, Tranylcypromine or Isocarboxazide within the last two weeks.

If you are taking any of the following drugs, you should talk to your doctor before you first start taking Co-codamol as your doctor may need to alter the dosage of your medication:

•    Cimetidine (used to treat stomach ulcers)

•    Cyclizine, Metaclopramide or Domperidone (used to prevent nausea or vomiting)

•    Colestyramine (used to treat high cholesterol in the blood)

•    Ciprofloxacin (an antibacterial medicine)

•    Mexiletine (use to treat an irregular heartbeat)

•    Cisapride (used to treat gastro-oesophageal reflux disease)

•    Selegiline (used to treat Parkinson's disease)

•    Hydroxyzine (an antihistamine, also used to treat anxiety)

•    Oral contraceptives ("the pill")

•    Warfarin and other medicines to thin the blood

•    Anticholinergic medicines e.g. Atropine, which affect the central nervous system

•    Any sedative or tranquiliser medicines, including phenothiazines e.g. Chlorpromazine, barbiturates e.g. Phenobarbital, and tricyclic antidepressants e.g. Amitriptyline

•    Anaesthetics

•    Medicines to treat high blood pressure such as Guanethidine or diuretics ("water tablets") e.g. Furosemide

•    Medicines known as opioid antagonists e.g. Buprenorphine, Naltrexone, Naloxone

•    Muscle relaxants

•    Medicines for diarrhoea.

Taking Co-codamol with food and drink

•    Do not drink alcohol whilst taking Co-codamol.

•    If you have a poor diet with a low intake of protein your risk of serious paracetamol poisoning when taking Co-codamol may be increased.

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Packaging

Supplier

Artwork Date 09/12/2011 TEXT SIZES

Smallest Text    8 pt

Line Spacing    8.75 pt

Logo Type    7 pt

Artwork Approval Signature Box

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Proofreader

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Site Packaging

Bar prints 100mm @ 100%

Pregnancy and Breastfeeding

•    Taking Co-codamol is not recommended during pregnancy, unless advised by your doctor.

•    Usually it is safe to take Co-codamol Capsules while breast feeding as the level of codeine in breast milk is too low to cause your baby any problems. However, some women who are at increased risk of developing side effects at any dose may have higher levels of codeine in their breast milk. If any of the following side effects develop in you or your baby stop taking this medicine and seek immediate medical advice; feeling sick, vomiting, constipation, decreased or lack of appetite, feeling tired or sleeping for longer than normal, and shallow or slow breathing.

Driving and using machines

Co-codamol may cause dizziness or blurred vision, or impair your ability to think clearly. Do not drive or use machinery if affected in this way.

3. How to take Co-codamol

Always take Co-codamol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. You can swallow your capsules with or without food. Most people take the capsules with a drink of water. Adults and Children over 12 years of age:

• 1 or 2 capsules to be taken every 4 hours as required.

Do not exceed the stated dose:

-    Do not take more frequently than - every 4 hours

-    Do not take more than 2 capsules at a time

-    Do not take more than 8 capsules in 24 hours.

If you think you have taken too many capsules go to your doctor or nearest casualty department, taking your medicine with you.

Contains Paracetamol. Do not take with any other Paracetamol containing products. 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.

4. Possible Side Effects

Like all medicines Co-codamol may occasionally cause side effects in some patients.

Stop taking the medicine and see a doctor or go to a hospital straight away if you develop a rash, start to itch, get short of breath or wheezy, develop swelling of the mouth, throat, face or eyes, have increased sweating, a red or flushed face. This may mean you are having an allergic reaction to Co-codamol.

Below is a list of other side effects which have occurred whilst taking Co-codamol:

•    Drowsiness, reduced mental alertness

•    Nausea, vomiting, constipation

•    Heartburn, abdominal pain or bloating

•    Loss of appetite, dry mouth

•    Liver and kidney problems

•    Pancreatitis (inflammation of the pancreas which causes severe pain in the abdomen and back)

•    Vertigo, lightheadedness, dizziness or fainting

•    Confusion, mood changes, restlessness, excitation

•    Difficulty sleeping, nightmares

•    Tolerance (your medicine has less effect)

•    Raised pressure in the skull which causes headache and eye problems

•    Blurred or double vision, very small pupils of the eyes

•    Slow or irregular heartbeat, inflammation of the heart muscle

•    Tiredness, sweating

•    Feeling unwell, trembling, hypothermia

•    Pain and difficulty in urinating

•    Fits

•    Hallucinations

•    Mental depression

•    Unexplained bruising and bleeding, sore throat and fever. This could because of a blood problem which may require diagnosis by a blood test.

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Important side effects you should know about Co-codamol:

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

•    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.

If you experience these or any other side effects, stop taking the capsules and talk to your doctor.

5. Storing your medicine

Keep your capsules out of the reach and sight of children. Do not store above 25 °C.

Keep them in the pack in which they were supplied so they do not get mixed up with other medicines.

Return any unused capsules to your pharmacist. Do not use after the expiry date printed on the label.

6. Further Information

The active substances in these capsules are Codeine Phosphate 8 mg and Paracetamol 500 mg.

The other ingredients are Light Kaolin and Magnesium Stearate.

The capsule shells contain Gelatin and the colourant, Erythrosine.

The capsule ink contains Shellac and Black Iron Oxide E172.

Co-codamol 8/500 mg Capsules are pink, translucent, hard gelatine capsules, printed CO COD 8.

They are available in packs of 32 and 100 capsules.

Remember, this medicine is for you. Do not share it with anyone else. It may not suit them.

The MA holder and Manufacturer is:

Custom Healthcare Limited Conway Street, Hove East Sussex, BN3 3LW

This leaflet was last revised in November 2011.

Co-codamol 8/500 mg Capsules* •

4

Codeine and para'etimol.

100 Capsules.

• •

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Custom

Healthcare Ltd.

Capsule contents: codeine phosphate 8 mg &

,.paracetamol 500 ma. . .

• • • •

Contains paracetamol. Do not take with any other paracetamol- ’ontrnrg products. Immediate medical advice should be sought in the event of an overdose, even if you feel well.

• •

• • • •

For oral use.

Take as directed by your doctor.

If symptoms persist consult your doctor.

Do not take for longer than directed by your prescriber as taking codeine regularly for a long time can lead to addiction.

For further information, please see the attached leaflet.

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Regulatory.

Market Affiliate

ARK Pharma Graphics Ltd

Crown House Business Centre Home Gardens, Dartford, Kent DA1 1DZ

Tel +44(0)1322 424656

V2.05.2008