This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

• This medicine can only be used for the short term treatment of acute moderate pain such as headache, migraine, rheumatic pain, muscular pain, backache, neuralgia, toothache and period pain that is not relieved by aspirin, ibuprofen or paracetamol alone
• You should only take this product for a maximum of 3 days at a time. If you need to take it for longer than 3 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
• Keep this leaflet, you may need to read it again
• Ask your pharmacist if you need more information or advice

• 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 allergic to any of the ingredients
• If you have severe liver problems
• If you are pregnant, unless your doctor tells you to
• If you are breastfeeding (see “Other important information”)

• If you have severe kidney problems
• If you have other liver problems (including a disease caused by drinking alcohol)
• If you are taking monoamine oxidase inhibitors (for depression), or have taken them in the last 14 days

Do not drink alcohol (wine, beers, spirits) whilst taking this medicine. Alcohol increases the risk of side effects occurring and may make you feel more drowsy.

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.

Breastfeeding: Do not take codeine while you are breastfeeding. Codeine and morphine passes into breast milk.

Driving and using machines: This medicine can affect your ability to drive or use machines as it may make you feel sleepy or dizzy.

• Do not drive or used machines while taking this medicine until you are sure you are not affected
• 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 while taking this medicine.

Important information about some of the ingredients in this medicine: The colour ponceau 4R (E124) in this medicine may cause allergic reactions.

This medicine contains less than 1 mmol sodium (23mg) per capsule, that is to say essentially ‘sodium-free’.

This medicine contains paracetamol.

Do not take anything else containing paracetamol while taking this medicine.

Before you take these capsules, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

• Domperidone or metoclopramide for feeling sick or being sick (may increase the pain relief effect of paracetamol)
• Colestyramine for reducing blood fat levels (may reduce the pain relief effect of paracetamol)
• Warfarin or other blood thinners - if you take warfarin you can take occasional amounts of this medicine, but talk to your doctor first before you take it on a regular basis
• Medicines for epilepsy
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (high anion gap metabolic acidosis) that must have urgent treatment and which may occur particularly in case of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

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.

• Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)
• Very rare cases of serious skin reactions have been reported. This may include peeling, blistering and lesions of the skin.

• Constipation, feeling sick
• Drowsiness or dizziness – do not drive or use machines if you feel drowsy or dizzy
• Confusion, restlessness, changes in mood, hallucinations, headaches
• Other allergic reactions (e.g. skin rash)
• Unusual bruising, or infections such as sore throats - this may be a sign of very rare changes in the blood

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

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 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.

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 amount
• When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again