Patient leaflet - PARACETAMOL CODEINE AND CAFFEINE 500 MG / 8 MG / 30 MG SOLUBLE TABLETS
Package leaflets: Information for the user
Paracetamol/Codeine/Caffeine
The name of this medicine is Paracetamol/Codeine/Caffeine 500 mg/8 mg/30 mg 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.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
What is in this leaflet:
1. What Paracetamol, Codeine & Caffeine Tablets are and what they are used for
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 shortterm relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone.
This medicine contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It also contains paracetamol, another analgesic to relieve pain
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.
You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
Do not take Paracetamol, Codeine & Caffeine Tablets if you:
Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol, Codeine & Caffeine Tablets if you:
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
Other medicines and Paracetamol, Codeine & Caffeine Tablets
Paracetamol, Codeine & Caffeine Tablets 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 this medicine.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take codeine while you are breast-feeding. Codeine and morphine passes into breast milk.
Driving and using machines
Paracetamol, Codeine & Caffeine Tablets contain sodium and aspartame
| 3. How to take Paracetamol, Codeine & Caffeine Tablets
Always take this medicine exactly as described in this leaflet or 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: One to two tablets dissolved in water every 4 to 6 hours as needed up to a maximum of 8 tablets daily.
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-Children aged 16 years to 18 years: One to two tablets dissolved in water every 6 hours as needed up to a maximum of 8 tablets daily.
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-Children aged 12 years to 15 years: One tablet dissolved in water every 6 hours as needed up to a maximum of 4 tablets daily.
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– Avoid too much caffeine in drinks like coffee and tea. High caffeine intake can cause difficulty sleeping, shaking and an uncomfortable feeling in the chest.
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.
Possible withdrawal effect
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 on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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.
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, dry mouth, nausea and vomiting if you have recently had your gall bladder removed
- unexplained bruising or bleeding
- nausea, upset stomach, sudden weight loss, loss of appetite and yellowing of the eyes and skin
- nervousness, dizziness, irritability, drowsiness or restlessness
- breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen and aspirin
- Severe reduction in number of white blood cells which makes infections more likely (agranulocytosis)
- Skin rash or peeling or mouth ulcers, itching or sweating
The following side effects have also been reported:
- constipation
Very rare cases of serious skin reactions have been reported.
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 website:or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How do I know if I am addicted?
| 5. How to store Paracetamol, Codeine & Caffeine tablets
Store below 30°C. Store in the original package.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Keep this medicine out of the sight and reach of children.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required. These measures will help to protect the environment.
6. contents of the pack and other information— 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.
What paracetamol, codeine & caffeine tablets look like and the contents of the pack:
Paracetamol, codeine & caffeine tablets are white to off-white coloured circular flat bevelled 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 and manufacturer is Cipla (EU) Limited, Dixcart house, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, United Kingdom
This information is available in alternative formats upon request.
This leaflet was last revised in 06/2020