Co-Codamol Cipla 8/500mg Soluble Tablets contain 500 mg paracetamol and 8 mg codeine phosphate hemihydrate per tablet. They are used for the short term relief of acute moderate pain that is not relieved by paracetamol, ibuprofen or aspirin alone.

Co-Codamol 8/500 can be used for muscular and rheumatic pain, headache, migraine, neuralgia, toothache, period pain, aches and pains. Codeine is an opioid analgesic and paracetamol is an analgesic; together they act to relieve pain.

These effervescent tablets are dissolved in water before taking, providing a practical alternative for people who prefer not to swallow tablets whole. They are intended for adults and children aged 12 years and over, with age-specific dosing instructions.

This medicine should only be used for a maximum of 3 days. Codeine can cause dependence and addiction if taken continuously for longer than recommended. A pharmacist can provide advice if you are unsure how to use this medicine safely.

Patient Information Leaflet

Main ingredients: Paracetamol 500 mg and codeine phosphate hemihydrate 8 mg per tablet. Excipients: sodium hydrogen carbonate, citric acid, sodium carbonate, povidone, simeticone, sodium saccharin, aspartame (E951), polysorbate 80.

Co-Codamol 8/500 is for the short term treatment of acute moderate pain that has not been relieved by paracetamol, ibuprofen or aspirin alone.

Adults over 18 years: Dissolve 1 to 2 tablets in water every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children aged 16 to 18 years: Dissolve 1 to 2 tablets in water every 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children aged 12 to 15 years: Dissolve 1 tablet in water every 6 hours as needed. Do not take more than 4 tablets in 24 hours.

Children under 12 years: Do not give Co-Codamol 8/500 because of the risk of severe breathing problems.

Do not use for more than 3 days. If the pain does not improve after 3 days, speak to a doctor or pharmacist.

For oral use only. Dissolve the required dose in at least half a glass of water, stir well and drink the solution. Do not swallow the effervescent tablets whole. The medicine can be taken with or without food.

If you forget a dose, take the next dose when you remember and then continue as directed. Do not take a double dose to make up for a forgotten dose.

Do not take more than the recommended amount and do not take any other medicine containing paracetamol at the same time.

If you take too much Co-Codamol, seek medical attention immediately even if you feel well, because excessive paracetamol can cause delayed, serious liver damage.

Do not take Co-Codamol 8/500 if you:

• Are allergic to paracetamol, codeine or any of the other ingredients.
• Have alcohol dependence.
• Have difficulty breathing or another chronic lung condition.
• Are having an asthma attack.
• Have bowel problems.
• Have raised pressure inside the skull or a head injury.
• Know that your body converts codeine into morphine very rapidly.
• Are breastfeeding.
• Are under 12 years of age.
• Are under 18 and require pain relief following removal of the tonsils or adenoids for obstructive sleep apnoea.

Codeine can cause dependence and addiction. Only use this medicine for a maximum of 3 days. Using codeine for longer, or taking more than the recommended dose, increases the risk of dependence, overdose and other serious harm.

Speak to a doctor or pharmacist before taking this medicine if you have liver or kidney problems, myasthenia gravis, breathing problems, or other medical conditions that may make you more sensitive to opioid medicines.

Stop taking the medicine and seek immediate medical advice if you develop slow or shallow breathing, severe sleepiness, confusion, very small pupils, sickness, constipation or loss of appetite, as these may indicate excessive conversion of codeine to morphine.

Contact a doctor if you develop breathing pauses during sleep, waking because of shortness of breath, difficulty staying asleep or excessive daytime drowsiness.

Do not take other medicines containing paracetamol while using Co-Codamol.

Tell your doctor or pharmacist about other medicines you use. Important interactions may occur with MAO inhibitors, medicines that cause drowsiness, benzodiazepines, sedatives, sleeping medicines, some antidepressants and antipsychotics, gabapentin, pregabalin, metoclopramide, domperidone, colestyramine, anticoagulants such as warfarin and flucloxacillin.

Pregnancy: If you are pregnant, think you may be pregnant or are planning a baby, ask a doctor or pharmacist for advice before taking this medicine. The leaflet states that your doctor should advise you about taking it during pregnancy.

Breastfeeding: Do not take codeine while breastfeeding because codeine and morphine pass into breast milk.

This medicine may cause dizziness or drowsiness. Do not drive or operate machinery until you know how it affects you, and do not drive if your ability to drive safely is impaired.

Each tablet contains 438 mg sodium, equivalent to 21.9% of the recommended maximum daily dietary intake of sodium for an adult. Each tablet also contains 5 mg aspartame, a source of phenylalanine, which may be harmful if you have phenylketonuria.

Seek medical advice if you develop severe upper abdominal pain that may spread to the back, particularly with nausea, vomiting or fever.

Overdose requires immediate medical attention even if you feel well, because serious liver damage can be delayed.

Do not take Co-Codamol 8/500 if you:

• Are allergic to paracetamol, codeine or any of the other ingredients.
• Have alcohol dependence.
• Have difficulty breathing or another chronic lung condition.
• Are having an asthma attack.
• Have bowel problems.
• Have raised pressure inside the skull or a head injury.
• Know that your body converts codeine into morphine very rapidly.
• Are breastfeeding.
• Are under 12 years of age.
• Are under 18 and require pain relief following removal of the tonsils or adenoids for obstructive sleep apnoea.

Codeine can cause dependence and addiction. Only use this medicine for a maximum of 3 days. Using codeine for longer, or taking more than the recommended dose, increases the risk of dependence, overdose and other serious harm.

Speak to a doctor or pharmacist before taking this medicine if you have liver or kidney problems, myasthenia gravis, breathing problems, or other medical conditions that may make you more sensitive to opioid medicines.

Stop taking the medicine and seek immediate medical advice if you develop slow or shallow breathing, severe sleepiness, confusion, very small pupils, sickness, constipation or loss of appetite, as these may indicate excessive conversion of codeine to morphine.

Contact a doctor if you develop breathing pauses during sleep, waking because of shortness of breath, difficulty staying asleep or excessive daytime drowsiness.

Do not take other medicines containing paracetamol while using Co-Codamol.

Tell your doctor or pharmacist about other medicines you use. Important interactions may occur with MAO inhibitors, medicines that cause drowsiness, benzodiazepines, sedatives, sleeping medicines, some antidepressants and antipsychotics, gabapentin, pregabalin, metoclopramide, domperidone, colestyramine, anticoagulants such as warfarin and flucloxacillin.

Pregnancy: If you are pregnant, think you may be pregnant or are planning a baby, ask a doctor or pharmacist for advice before taking this medicine. The leaflet states that your doctor should advise you about taking it during pregnancy.

Breastfeeding: Do not take codeine while breastfeeding because codeine and morphine pass into breast milk.

This medicine may cause dizziness or drowsiness. Do not drive or operate machinery until you know how it affects you, and do not drive if your ability to drive safely is impaired.

Each tablet contains 438 mg sodium, equivalent to 21.9% of the recommended maximum daily dietary intake of sodium for an adult. Each tablet also contains 5 mg aspartame, a source of phenylalanine, which may be harmful if you have phenylketonuria.

Seek medical advice if you develop severe upper abdominal pain that may spread to the back, particularly with nausea, vomiting or fever.

Overdose requires immediate medical attention even if you feel well, because serious liver damage can be delayed.