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PACKAGE LEAFLET: INFORMATION FOR THE USER

¹ Co-Codamol Effervescent Tablets 8/500mg

I (codeine phosphate and paracetamol)

.__J

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    This medicine can only be used to relieve ' acute moderate pain including headache,

I migraine, toothache, rheumatic, muscular and period pains

•    You should only take this product for a

I maximum of three days at a time. If you need to take it for longer than three days you should see your doctor or pharmacist for advice

•    This medicine contains codeine which can

I cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it

•    If you take a painkiller for headaches for more than three days it can make them worse

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

•    Ask your pharmacist if you need more information or advice

•    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section

I 4.

•    You must talk to doctor if you do not feel better | or if you feel worse after 3 days.

What is in this leaflet:

1.    What Co-Codamol Effervescent Tablets are i and what they are used for

2.    What you need to know before you take Co-I Codamol Effervescent Tablets

3.    How to take Co-Codamol Effervescent Tablets

4.    Possible side effects

5.    How to store Co-Codamol Effervescent Tablets

6.    Contents of the pack and other information

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

Co-Codamol Effervescent Tablets contain the active ingredients paracetamol and codeine.

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.

his product contains codeine. Codeine belongs to group of medicines called opioid analgesics hich act to relieve pain. This medicine also contains paracetamol. Co-Codamol Effervescent Tablets can be used alone or in combination with other pain killers except other medicines which contain paracetamol.

Co-Codamol Effervescent Tablets are used for the short term treatment of acute moderate pain including headache, migraine, neuralgia, toothache, rheumatic, muscular and period pains, when other painkillers have not worked.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-CODAMOL EFFERVESCENT TABLETS

This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it.

f you take a painkiller for headaches for more than three days it can make them worse.

Do not take Co-Codamol Effervescent Tablets:

•    If you are allergic (hypersensitive) to paracetamol, codeine or any of the other ingredients in this medicine

•    If you suffer from liver or kidney problems including alcoholic liver disease

•    If you suffer or have suffered from alcoholism

•    If you suffer from breathlessness (acute respiratory depression)

•    If you have raised intracranial pressure or have I a head injury

•    Do not take anything else containing paracetamol while taking this medicine

•    For pain relief in children and adolescents (0-

I 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.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before

taking Co-Codamol Effervescent Tablets if you:

•    Are on a restricted sodium diet (see section on Important information about some of the ingredients in this medicine)

•    Have phenylketonuria (see section on Important information about some of the ingredients in your medicine)

•    Have low blood pressure

•    Have an under active thyroid gland (hypothyroidism)

•    Suffer from any disorders that are characterised by seizures

•    Have asthma

•    Have an enlarged prostate gland.

Taking codeine regularly for a long period of time can lead to addiction which may lead you to feel irritable and restless when you stop taking the tablets.

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.

Other medicines and Co-Codamol Effervescent Tablets

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

This is particularly important if you are taking any of the following:

•    Alcohol

•    Barbiturates, Anxiolytics and Hypnotics which can be used to treat sleeping disorders

•    Anticonvulsants used to treat epilepsy

•    Mono-amine oxidase inhibitors (MAOIs) and tricyclic antidepressants used to treat depression

•    Chloramphenicol used to treat eye infections

•    Colestyramine used to treat high cholesterol

•    Metoclopramide and domperidone used to treat nausea and sickness

•    Warfarin and other coumarins used to stop the blood clotting

•    Antipsychotics used to treat mental illness

•    Ciprofloxacin used to treat bacterial infections

•    Cisapride and cimetidine used to treat some stomach disorders

•    Ritonavir used in the treatment of HIV.

Pregnancy and breast-feeding

These tablets are not recommended for use during pregnancy or breast-feeding. Codeine and morphine passes into breast milk. If you are pregnant, think you might be pregnant or want to breast-feed you should talk to your doctor before using these 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.

Driving and using machines

These tablets contain codeine which can cause drowsiness. If this occurs you should not drive or operate machinery until you feel better.

Important information about some of the ingredients in these tablets Aspartame: These tablets contain aspartame which is a source of phenylalanine. This may be harmful for people with phenylketonuria.

Sodium: Each Co-Codamol Effervescent Tablet contains 438mg of sodium. If you are on a restricted sodium diet this should be taken into consideration. Talk to your doctor or pharmacist before taking these tablets.

3. HOW TO TAKE CO-CODAMOL EFFERVESCENT TABLETS

Always take Co-Codamol Effervescent Tablets exactly as your doctor has told you. If you are not sure you should check with your doctor or pharmacist before taking.

These tablets must be dissolved in half a glass of water. The tablets dissolve more quickly in warm water or if stirred.

Adults:

One or two tablets to be taken every 4 to 6 hours if necessary.

,DO NOT take more than 2 tablets at any one time. DO NOT exceed 8 tablets in any 24 hour period. DO NOT take more medicine than what is stated.

If you do not get better, talk to your doctor.

Children aged 12 years and above:

Children aged 12 years and above should take one or two tablets every 6 hours, as needed.

DO NOT take more than 8 tablets in 24 hours.

Do NOT TAKE FOR MORE THAN 3 DAYS. If you

need to use this medicine for more than three days you must speak to your doctor or pharmacist.

If you suffer from liver or kidney disease this dose may be different. Your pharmacist will advise you how many tablets to take.

This medicine should not be given to children 12 years of age and under due to the risk of severe breathing problems.

If symptoms persist for more than 3 days you must consult a doctor.

Possible withdrawal effects when stopping treatment

This medicine contains codeine and can cause addiction if you take it continuously for more than three days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.

If you take more Co-Codamol Effervescent Tablets than you should

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. You should take any remaining tablets and the pack with you.

If you forget to take a dose

If you forget to take your medicine, take the missed dose as soon as you remember unless your next dose is due within 2 hours. If this is the case take one dose when you remember and skip the next dose. Never take two doses together.

Then continue to take your tablets at the correct times. If you have trouble remembering when to take your tablets talk to your doctor or pharmacist.

Tell your doctor or pharmacist if any | of the following side effects gets serious or lasts longer than a few    I

days:

• Constipation    i

•    Feeling sick (nausea), being sick (vomiting)

•    Drowsiness, confusion

•    You get infections or bruise more easily than usual. This could be because of a blood problem (such as agranulocytosis, neutropenia or thrombocytopenia).

Other side effects, particularly if large doses are taken include:

•    Breathlessness

•    Dizziness when standing up

•    Difficulty passing water

•    Dry mouth

•    Sweating

•    Headache

•    Facial flushing

•    Vertigo

•    Slow or fast heart rate, palpitations

•    Hypothermia

•    Seeing and hearing things which are not there (Hallucinations)

•    Depression and mood changes

•    Dependence

•    Constriction of pupils

•    Decreased sex drive or potency

•    Skin rash and itching.

How do I know if I am addicted?

If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:

•    You need to take the medicine for longer periods of time

•    You need to take more than the recommended dose

•    When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again.

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: http://www.mhra.gov.uk/yellowcard

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

5. HOW TO STORE CO-CODAMOL EFFERVESCENT TABLETS

Do not store above 25°C. Store in the original package in order to protect from moisture.

Do not use Co-Codamol Effervescent Tablets after the expiry date stated on the pack. The expiry date refers to the last day of that month.

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

Keep out of the sight and reach of children.

4. POSSIBLE SIDE EFFECTS

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Important side-effects you should know about Co-Codamol Effervescent Tablets:

•    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 tablets.

Stop taking Co-Codamol Effervescent Tablets and see a doctor or go to a hospital straight away if:

•    You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). This may mean you are having an allergic reaction to Co-Codamol Effervescent

| Tablets.

Talk to your doctor straight away if you notice the following serious side effect:

•    Severe stomach pain, which may reach through to your back. This could be a sign of inflammation of the pancreas (pancreatitis). This is a very rare side effect.

Very rare cases of serious skin reactions have been reported.

What Co-Codamol Effervescent Tablets contain

Co-Codamol Effervescent Tablets contain 8mg of codeine phosphate and 500mg of paracetamol.

The other ingredients are sodium bicarbonate, anhydrous citric acid, anhydrous sodium carbonate, povidone, simethicone, polysorbate 80, sodium saccharin and aspartame.

What Co-Codamol Effervescent Tablets look like and contents of the pack

Co-Codamol Effervescent Tablets are white, round bevelled edged tablets.

Co-Codamol Effervescent Tablets are available in packs of 10,12,16, 24, 30, 36, 50, 56,100 and 112 tablets.

MARKETING AUTHORISATION HOLDER:

Ennogen Pharma Limited

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

MANUFACTURER:

Lagap Pharmaceuticals Ltd

Woolmer Way, Bordon, Hampshire, GU35 9QE

This leaflet was last revised in December 2015