Co-Codamol 30/500mg Tablets
Sandoz Ltd
Co-codamol 30/500 mg Tablets
PL 04416/0378
Patient Information Leaflet
06/08/15
PACKAGE LEAFLET: INFORMATION FOR THE USER Co-Codamol 30/500mg Tablets Codeine phosphate and Paracetamol
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Co-codamol is and what it is used for
2. What you need to know before you take Co-codamol
3. How to take Co-codamol
4. Possible side effects
5. How to store Co-codamol
6. Further information
1. WHAT CO-CODAMOL IS AND WHAT IT IS USED FOR
The name of your medicine is Co-codamol 30/500mg Tablets.
The active ingredients in Co-codamol are paracetamol and codeine phosphate. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. Paracetamol is also an antipyretic which means that it helps to reduce fever and lower your temperature.
Codeine can be used in children over 12 years of age for the short-term relief of moderate to severe pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-CODAMOL
Do not take Co-codamol:
• If you are allergic (hypersensitive) to paracetamol, codeine or any of the other ingredients in Co-codamol Tablets.
• If you drink excessive amounts of alcohol.
• If you have severe asthma, breathing problems or if you are having an asthma attack.
• If you have recently had a head injury or have increased pressure within your head (raised intracranial pressure).
• If you have recently had surgery on your bile duct.
• If you are under 12 years old.
• If you are taking a monoamine-oxidase inhibitor (MAOI) or have taken a MAOI within the last 14 days. These medicines are usually used to treat depression and include tranylcypromine, phenelzine or isocarboxazide.
• 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.
• If you know that you metabolise very rapidly codeine into morphine.
• If you are breastfeeding.
If the answer to any of these questions is YES, tell your doctor or pharmacist before
taking Co-codamol 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.
Take special care with Co-codamol
Before taking this medicine, you need to know the following:
• Contains paracetamol.
• Do not take anything else containing paracetamol while taking this medicine.
• Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.
• Do not take Co-codamol for longer than directed by your doctor. Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets.
• 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.
Talk to your doctor or pharmacist before taking Co-codamol if:
• You are pregnant or breast-feeding (see ‘Pregnancy and breast-feeding’ below).
• You have asthma.
• You have serious problems with your liver or kidneys.
• You are elderly, as you may need a lower dose.
• You are being treated with depressants (medicines used to treat anxiety).
• You have an enlarged prostate.
• You have an inflamed bowel or obstructive bowel disorder.
• You have an under active thyroid.
• You have Addison’s disease.
Warnings and precautions
Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces the effects of codeine and relieves pain. 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines you have bought yourself without a prescription.
In particular you should tell your doctor if you are taking any of the following:
• Barbiturates (to help you sleep or treat epilepsy).
• Anticonvulsants (to treat epilepsy).
• Antidepressants (tricyclics or MAOIs).
• Antipsychotics (to help mood disorders).
• Anxiolytics (to help with anxiety).
• Hypnotics (to help you sleep).
• Chloramphenicol (an antibiotic).
• Colestyramine (used to lower cholesterol).
• Cisapride, metoclopramide or domperidone (used to help stop nausea and vomiting)
• Anticoagulants (medicines used to thin the blood, such as warfarin).
• Ciprofloxacin (an antibiotic).
• Cimetidine (for stomach ulcers).
• Ritonavir (used to treat HIV infection).
Taking Co-codamol with food and drink
Swallow your tablets with a glass of water.Alcohol can increase the risk of some paracetamol and codeine related side effects.
Pregnancy and breast-feeding
Do not take Co-codamol while you are breastfeeding. Codeine and morphine passes into breast milk
If you are pregnant or breast-feeding you should talk to your doctor or pharmacist before taking any medicine.
Driving and using machines
Codeine may cause dizziness or drowsiness in some people. Other medicines and alcohol may increase these effects.
Sandoz Ltd
Co-codamol 30/500 mg Tablets
3. HOW TO TAKE CO-CODAMOL
Always take Co-codamol tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is described below.
These tablets are for oral administration. They should be swallowed with a glass of water.
Dosage instructions
Children aged 12 years of above should take two tablets every four hours, as needed.
Do not take more than eight tablets in 24 hours.
Elderly: Your doctor may have reduced the dose for you. If this is the case follow your doctor's instructions.
Co-codamol should not be taken by children below the age of 12 years, due to the risk of severe breathing problems
Do not take more tablets than your doctor has prescribed for you.
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 take more Co-codamol than you should
Always take the medicine as recommended by you doctor. If you take too much medicine, tell your doctor immediately or go to your local hospital emergency department, even if you feel well. This is because there is a delayed risk of serious liver damage.
If you forget to take Co-codamol
Take your usual dose as soon as you remember, provided it is at least 4 hours since your last dose. Never take a double dose to make up for a missed dose.
If you stop taking Co-codamol
Do not stop taking these tablets immediately, it could make you feel restless or irritable. Talk to your doctor about reducing your dose gradually.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Co-codamol can cause side effects, although not everybody gets them. Tell your doctor if you think your medicine is making you feel unwell.
It is very unlikely that you will experience the following side effects. However, you should stop taking this medicine and talk to your doctor immediately if you notice any of the following symptoms:
• You bruise more easily, have bleeding gums or bleed for longer after cutting yourself or you feel tired or look pale.
• You seem to be getting more infections than usual or you develop ulcers in your mouth or throat.
• You have a severe abdominal pain (in the upper middle or upper left part of the belly) usually accompanied by sickness, diarrhoea or fever.
Other more common side effects that some people notice when taking Co-codamol are listed below.
Allergic (hypersensitivity) reactions such as skin rash may occur occasionally. Constipation, nausea, drowsiness, confusion and vomiting have also been reported.
Taking a painkiller for headaches for too long may make them worse.
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 (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
Keep out of the reach and sight of children.
Do not use Co-codamol tablets after the expiry date which is stated on the carton or blister.
The expiry date refers to the last day of that month.
Talk to your pharmacist before taking these tablets if they are chipped or broken. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION What Co-codamol contains
The active ingredients in Co-codamol Tablets are paracetamol, 500mg and codeine phosphate, 30mg
The other ingredients are starch, sodium starch glycollate, magnesium stearate, povidone (K-30), colloidal silicon dioxide, talc, sodium lauryl sulphate and purified water.
What Co-codamol looks like and contents of the pack
Co-codamol Tablets are white to off-white capsule shaped tablets with a central breakline on one face.
They are available in packs of 60 and 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sandoz Limited, Frimley Business Park, frimley, Camberley, Surrey, GU16, 7SR This leaflet was last revised in 08/2015.
N018: Art 31 PRAC recommendation - not
suitable in under 12 years + RFI
PIL.0378.009.1d JV