Paracetamol And Codeine Tablets
PACKAGE LEAFLET - INFORMATION FOR THE USER PARACETAMOL & CODEINE TABLETS
Codeine Phosphate and Paracetamol
FI
L_J Important things you should know about Paracetamol & Codeine Tablets
• This medicine can only be used for the short term treatment of acute moderate pain where other pain killers have not worked
• You should only take this product for a maximum of 3 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 3 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 3 days it can make them worse
Read all of this leaflet carefully before you start taking this medicine because It contains Important Information for you.
Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or pharmacist. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Paracetamol & Codeine is and what it is used for
2. What you need to know before you take Paracetamol & Codeine
3. How to take Paracetamol & Codeine
4. Possible side effects
5. How to store Paracetamol & Codeine
6. Contents of the pack and other information
The name of your medicine is Paracetamol & Codeine Tablets (called Paracetamol & Codeine throughout this leaflet). Paracetamol & Codeine contains codeine phosphate and paracetamol. It is an analgesic (painkiller) and is for the short term treatment of acute moderate pain such as headaches, migraine, toothache, neuralgia, period pain and rheumatic pains when other painkillers have not worked. Wait at least 4 hours after you last took other painkillers before taking this medicine.
0» This medicine contains codeine which can cause addiction If you take It for more than 3 days at a time. This can give you withdrawal symptoms from the medicine when you stop taking It • If you take a painkiller for headaches for more than 3 days It can make them worse
Do not take Paracetamol & Codeine and tell your doctor If:
• You are allergic (hypersensitive) to codeine, paracetamol or any of the other ingredients in your medicine (listed in Section 6)
Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of the legs, arms, face, throat or tongue • The person going to take the tablets is under 12 years of age. Paracetamol & Codeine must not be given to children under 12 years of age • You are breastfeeding
Do not take Paracetamol & Codeine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Paracetamol & Codeine.
Take special care and check with your doctor before taking Paracetamol & Codeine if:
• You have severe kidney or liver problems • You have a liver problem caused by alcohol
If you are not sure if the above applies to you, talk to your doctor or pharmacist before taking this medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal products. This is because Paracetamol & Codeine and other medicines can affect the way each other works
While taking Paracetamol & Codeine you should not take any other medicines which contain paracetamol.
This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines available from your doctor and more widely in shops.
Tell your doctor if you are taking any of the following medicines:
• Medicines used to thin the blood such as warfarin
• Metoclopramide or dompei idone - used to stop you feeling sick (nausea) or being sick (vomiting)
• Colestyramine - for lowering blood cholesterol levels
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Paracetamol & Codeine.
Pregnancy and breastfeeding
Talk to your doctor before taking these tablets if:
• You are pregnant, think you may be pregnant or plan to get pregnant • You are in the last three months of pregnancy or in labour
You should not take this medicine if you are breastfeeding. This is because the codeine in your breast milk may affect your baby.
Always take Paracetamol & Codeine exactly as instructed on the leaflet. You should check with your doctor or pharmacist if you are not sure.
Adults and children over 12
• Do not take more than the recommended dose
• Do not take for more than 3 days. If you need to use this medicine for more than 3 days you must speak to your doctor or pharmacist
• Swallow the tablets whole with a drink of water
• The usual dose of Paracetamol & Codeine is 2 tablets, taken together
• Wait at least 4 hours before taking another dose
• Do not take more than 8 tablets in any 24-hour period
Children: Paracetamol & Codeine should not be given to children under 12 years of age.
If you take more Paracetamol & Codeine than you should
• 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
• Remember to take any remaining tablets and the pack with you. This is so the doctor knows what you have taken If you have forgotten to take Paracetamol & Codeine
If you forget to take a dose at the light time, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take two doses at or near the same time. Remember to leave at least 4 hours between doses.
If you stop taking Paracetamol & Codeine
This medicine contains codeine and can cause addiction if you take it for more than 3 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.
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.mhra.gov.uk/yellowcard; 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.
The following side effects may happen:
Stop taking Paracetamol & Codeine 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 Paracetamol & Codeine
Talk to your doctor straight away if you notice any of the following serious side effects:
• Severe stomach pain, which may reach through to your back. This could be a sign of inflammation of the pancreas (pancreatitis). This is a veiy rare side effect
• Yellowing of your skin or eyes and your urine becomes darker in colour. This could be a liver problem, such as jaundice or hepatitis
• A severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body or you develop skin blisters. You may also feel generally unwell, have a fever, chills and aching muscles.
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:
• Constipation, feeling sick (nausea), being sick (vomiting)
• Dizziness, light-headedness, drowsiness, confusion
• Difficulty in passing water
• You get infections or bruise more easily than usual. This could be because of a blood problem.
• Becoming addicted to codeine
n
t_U How do I know if I am addicted?
If you take this 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
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date shown on the pack. The expiiy date refers to the last day of that month.
Store your medicine in the original packaging in order to protect from moisture. Do not store above 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Paracetamol & Codeine Tablets contain:
• The active substances are codeine phosphate and paracetamol. Each tablet contains 8mg of codeine phosphate and 500mg of paracetamol.
• The other ingredients are maize starch, povidone, potassium sorbate, microciystalline cellulose, stearic acid, magnesium stearate, talc, pregelatinised starch and purified water.
What Paracetamol & Codeine Tablets look like and contents of the pack:
• Flat white tablets, marked S/4 on one side. They come in cartons of 32 tablets.
The Marketing Authorisation Holder and Manufacturer is: Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK.
This leaflet was updated in September 2012.