Document: leaflet MAH GENERIC_PL 36390-0050 change

• leaflet MAH GENERIC_PL 20417-0064
• leaflet MAH GENERIC_PL 36390-0050

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PATIENT INFORMATION LEAFLET

PARACETAMOL, CODEINE & CAFFEINE 500mg/8mg/30mg SOLUBLE TABLETS

The name of this medicine is Paracetamol, Codeine & Caffeine 500mg/8mg/30mg Soluble Tablets, which will be referred to as Paracetamol, Codeine & Caffeine Tablets throughout

this leaflet.

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 for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone.

•    You should only take this product for a 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 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 this medicine for headaches for more than three days it can make them worse.

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

•    If you have further questions, please ask your doctor or your 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.

Paracetamol, Codeine & Caffeine Tablets contain the active ingredients paracetamol 500 mg, codeine phosphate hemihydrate 8 mg and caffeine 30 mg.

Paracetamol, Codeine & Caffeine 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.

They contain paracetamol and codeine, which are both pain-relieving drugs. 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 also helps to reduce temperature when you have a fever. Codeine has some cough suppressant action. Caffeine is a stimulant which acts to enhance the pain-relieving.

They are used to relieve migraine, headache, dental pain, period pain, backache, rheumatic pain, strains and sprains, and sciatica.

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.

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

Do not take Paracetamol, Codeine & Caffeine Tablets if you:

•    are allergic (hypersensitive) to paracetamol, codeine, caffeine, other opioid painkillers or

any of the other ingredients in the tablets (these are listed in Section 6, Content of the pack and other information).

•    are taking or have recently taken any other paracetamol or codeine containing products.

•    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

•    know that you metabolise very rapidly codeine into morphine

•    are breastfeeding

Take special care with Paracetamol, Codeine & Caffeine Tablets WARNINGS AND PRECAUTIONS

Please see your doctor before you take Paracetamol, Codeine & Caffeine Tablets if you:

•    have severe liver or kidney disease, including alcoholic liver disease.

•    have bowel problems including blockage of the bowel.

•    have had an operation to remove your gall bladder.

If your headaches become persistent, see your doctor.

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.

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 obtained without a prescription. Certain medicines can interfere with the effectiveness of each other. It is particularly important to tell your doctor or pharmacist before taking this medicine if you are also on:

•    metoclopramide or domperidone (for sickness or stomach problems)

•    colestyramine (used to treat high cholesterol)

•    monoamine oxidase inhibitors (MAOIs) (used to treat depression)

•    blood thinning medicines (anti coagulants) such as warfarin and you need to take a painkiller on a daily basis over a long period. However, you can take occasional doses of Paracetamol, Codeine & Caffeine Tablets.

It may still be alright for you to take Paracetamol, Codeine & Caffeine Tablets and your doctor will be able to decide what is suitable for you.

Taking your medicine with food and drink

Paracetamol, Codeine & Caffeine Tablets should be dissolved in at least half a glass of water and can be taken with or without a meal.

You should avoid drinking too much coffee or tea when taking these tablets.

Pregnancy and breast-feeding

Please see your doctor before you take this medicine if you are pregnant or likely to become pregnant. Do not take codeine while you are breastfeeding. Codeine and morphine passes into breast milk.

Ask your doctor or pharmacist for advice before taking any medicines.

Driving and using machinery

The tablets may make you feel dizzy or drowsy. If affected do not drive or operate machinery.

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

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.”

Important information about some of the ingredients of Paracetamol, Codeine & Caffeine Tablets

Each of these tablets contains about 403.24 mg of sodium and may interfere if you are on a low sodium diet.

This product also contains aspartame (a source of phenylalanine), which should not be given to anyone with phenylketonuria.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Do not exceed the recommended doses.

Dosage

-Adults over 18 years: Two tablets dissolved in water every 4 hours as needed.

-Children aged 12 years to 18 years: Two tablets dissolved in water every 6 hours as needed.

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

Paracetamol, codeine and caffeine tablets should not be taken by children below the age of 12 years, due to the risk of severe breathing problems.

Method of Administration

For oral administration only. These tablets should be dissolved in at least half a glass of water before taking them. Stir before use. The solution should be drunk immediately after preparation. These tablets are meant to be dissolved first so don’t try to swallow them whole.

If symptoms persist consult your doctor.

If you take more Paracetamol, Codeine & Caffeine Tablets than you should

If you have accidentally taken more than the recommended dose, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you.

The most common symptoms of overdose are nausea (feeling sick), vomiting (being sick) and stomach pain. You may also notice a rapid heartbeat.

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. An overdose of paracetamol can cause serious liver damage, which may not show any signs for a day or two, by which time treatment may not be successful.

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 have any further questions about this product ask your doctor or pharmacist.

Some people may have side effects when taking this medicine. If you have any unwanted side effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.yellowcard.gov.uk; alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday - Friday) or fill in a paper form available from your local pharmacy.

If you get any of the following symptoms after taking these tablets, you should contact your doctor immediately:

•    any sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.

•    an acute allergic reaction (anaphylaxis) or swelling of the skin

•    severe abdominal pain, nausea and vomiting if you have recently had your gall bladder removed

•    unexplained bruising or bleeding

•    nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin

The following side effects have also been reported:

•    constipation

Very rare cases of serious skin reactions have been reported.

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

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.

Do not store your tablets above 30°C. Store in the original package.

Do not take this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.

Keep all medicines out of the reach and sight of children.

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

What Paracetamol, Codeine & Caffeine Tablets contain:

The active ingredients are paracetamol, codeine phosphate hemihydrate and caffeine.

Each tablet contains paracetamol 500 mg, codeine phosphate hemihydrate 8 mg and caffeine 30 mg.

The other ingredients are anhydrous citric acid, povidone, sodium hydrogen carbonate, sodium saccharin, anhydrous sodium carbonate, simeticone, polysorbate 80 and aspartame (E951).

What Paracetamol, Codeine & Caffeine Tablets look like and the contents of the pack:

Paracetamol, Codeine & Caffeine Tablets are white, circular, flat bevelled soluble tablets, which are plain on both sides.

Your medicine is available in blister packs of 16, 24 or 32 tablets.

Marketing Authorisation Holder and Manufacturer:

The Product Licence holder is Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher,

Surrey, KT10 9NW.

Cipla (EU) Limited, 20 Balderton Street, London W1K 6TL,United Kingdom

Cipla Europe NV , Uitbreidingstraat 80, 2600 Antwerp, Belgium

This information is available in alternative formats upon request.

This leaflet was last revised in 09/2016