Patient leaflet - Co-codamol 8 mg / 500 mg capsules hard

1. WHAT CO-CODAMOL IS AND WHAT IT IS USED FOR

The name of your medicine is Co-codamol 8mg/500mg Capsules (called co-codamol throughout this leaflet). It is used for the short term relief of most painful conditions such as headache including migraine, toothache, neuralgia, period pain, pain caused by rheumatism and arthritis and to relieve the symptoms of colds, flu and sore throats.

Co-codamol contains two different medicines called codeine and paracetamol. Codeine belongs to a class of medicines called opioid analgesics which are pain relievers. Opioids can cause addiction and you should not take this medicine for more than 3 days. Wait at least 4 hours after you last took other painkillers before taking this medicine.

Co-codamol 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.

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

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 a painkiller for headaches for more than 3 days it can make them worse

Warnings and precautions

Do not take co-codamol 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 capsules is under 12 years of age. Co-codamol must not be given to children under 12 years of age - You are under 18 years of age and have had your tonsils or adenoids removed due to obstructive sleep apnoea syndrome - You know that you metabolise very rapidly codeine into morphine
You are breastfeeding or planning to breastfeed

Do not take co-codamol if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking co-codamol. Take special care and check with your doctor before taking co-codamol if:

You have severe kidney or liver problems
You are taking a benzodiazepine
You suffer from seizures

Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces the effects of codeine and relieves pain and symptoms of cold. 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.

Children and adolescents

Use in children and adolescents after surgery

Co-codamol 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

Co-codamol is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children. Co-codamol is not recommended in adolescents over 12 years of age with breathing problems for the treatment of colds. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.

Other medicines and co-codamol

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 medicines. This is because co-codamol can affect the way some other medicines work. Also, some other medicines can affect the way co-codamol works.

While taking co-codamol 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. Concomitant use of co-codamol and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor does prescribe co-codamol together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms. Tell your doctor if you are taking any of the following medicines:

Benzodiazepines – for treating anxiety
Medicines used to thin the blood such as warfarin
Metoclopramide or domperidone - 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 co-codamol.

Pregnancy and breast-feeding

Do not take co-codamol and speak to your doctor if you are pregnant or think you might be pregnant. If you use co-codamol during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Do not take co-codamol while you are breastfeeding. Codeine and morphine passes into breast milk.

Driving and using machines

Co-codamol can affect your ability to drive as it may make you sleepy or dizzy.

Do not drive whilst 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:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
- 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 whilst taking this medicine.

3. HOW TO TAKE CO-CODAMOL

Always take co-codamol exactly as instructed on the leaflet. Check with your doctor or pharmacist if you are not sure.

Do not take more than the recommended dose.
Do not take for more than 3 days
Swallow the capsules whole with a drink of water.

Adults: 2 capsules every 4 to 6 hours when necessary up to a maximum of 8 capsules in 24 hours.

Use in children aged 16 to 18 years: 1 to 2 capsules every 6 hours when necessary up to a maximum of 8 capsules in 24 hours. Use in children aged 12 to 15 years: 1 capsule every 6 hours when necessary to a maximum of 4 capsules in 24 hours. 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. Co-codamol should not be given to children under 12 years of age due to the risk of severe breathing problems.

If you take more co-codamol 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. Remember to take any remaining capsules and the pack with you. This is so the doctor knows what you have taken. If you forget to take co-codamol

If you forget to take a dose at the right time, take it as soon as you remember. However do not take a double dose to make up for a forgotten dose. Remember to leave at least 4 hours between doses.

If you stop taking co-codamol

This medicine contains codeine and can cause addiction if you take it continuously 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.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine: Stop taking co-codamol 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
You get serious skin reactions. Very rare cases have been reported
You have a fit (seizure).
You have difficulty breathing and you feel dizzy.

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 very rare side effect

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), dry mouth
Dizziness, light-headedness, drowsiness, confusion
Feeling overly happy (euphoria)
A feeling of unease or dissatisfaction
Excessive constriction (shrinking) of the pupil of your eye
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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow card Scheme at: www.mhra.gov.uk/yellowcard 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?

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 this medicine you feel very unwell but you feel better if you start taking the medicine again

5. HOW TO STORE CO-CODAMOL

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 expiry date refers to the last day of that month.

Store below 30°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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Co-codamol 8mg/500mg Capsules contain

The active substances are codeine phosphate hemihydrate and paracetamol. Each capsule contains 8mg of codeine phosphate hemihydrate and 500mg of paracetamol.
The other ingredients are silica colloidal anhydrous, starch pregelatinised, magnesium stearate, hard gelatin capsule, iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), and edible printing ink which contains Shellac (E904) and iron oxide red (E172).

What Co-codamol 8mg/500mg Capsules look like and contents of the pack

Size ‘0’ hard gelatin capsules of opaque cream coloured body and opaque red coloured cap with ‘S175’ imprinted in red ink on body. They come in cartons of 32 capsules.

The Marketing Authorisation Holder is: Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, UK.

This leaflet was last updated in April 2021

Controlled drug	Yes, Schedule 5 of the Misuse of Drugs Regulations? Controlled drugs are medicines that UK law controls more strictly because they can be misused or cause dependence. The Misuse of Drugs Regulations 2001 divide them into 5 schedules: schedule 1 has the strictest rules, schedule 5 the lightest. Schedule 5 has the lightest rules: low-strength preparations, for example of codeine or morphine, with a low risk of misuse. A prescription for it is valid for 6 months, as for other medicines. Never give it to anyone else.
Active substances	Codeine phosphate, Paracetamol
Strength	8 mg / 500 mg
Pharmaceutical form	Oral capsule Size ‘0’ hard gelatin capsules of opaque cream coloured body and opaque red coloured cap with ‘S175’ imprinted in red ink on body.
How is it taken	Oral
Excipients	Silica colloidal anhydrous, Starch pregelatinised, Magnesium stearate, Hard gelatin capsule, Iron oxide red (E172), Titanium dioxide (E171), Iron oxide yellow (E172), Shellac (E904)
Is it available?	No, all its packs are listed as discontinued (NHS Dictionary of Medicines and Devices – not a record of current supplies)
Shelf life	3 years
Storage	Store below 30°C.
Drug group (ATC)	Paracetamol combinations excl. Psycholeptics N Nervous system drugs N02 Analgesics N02A Opioid analgesics N02AJ Opioids in combination with non-opioid analgesics N02AJ06 codeine and paracetamol
Marketing authorisation	PL 17780/0813 (first authorised 3 August 2026)
Marketing authorisation holder	Zentiva Pharma UK Limited
Codes	BNF 04070100

Co-codamol 8 mg / 500 mg capsules hard – patient leaflet, side effects, dosage