Mybucod 10 mg/200 mg/350 mg Film-Coated Tablets

MYBUCOD contains codeine which belongs to a group of medicines called opioid analgesics. Analgesics help to relieve pain. MYBUCOD contains ibuprofen which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs help in reducing swelling. MYBUCOD contains paracetamol which belongs to a group of medicines called non-opioid analgesics, which help to relieve pain. MYBUCOD is indicated for the relief of mild to moderate pain or fever of inflammatory origin for a maximum treatment period of 5 days.

Do not take MYBUCOD:

• if you are hypersensitive (allergic) to codeine, ibuprofen or paracetamol or any of the other ingredients of MYBUCOD (listed in section 6).
• if you have difficulty breathing or breathing problems, acute asthma, uncontrolled asthma, head injuries or increased pressure inside the skull.
• if you have heart failure or heart disease.
• if you have ingested large quantities of alcohol (acute alcoholism).
• if you are taking a medicine classified as a monoamine oxidase inhibitor (MAOI), or within 14 days of stopping such treatment.
• if you have diarrhoea associated with pseudomembranous colitis.
• if you have liver or kidney problems.
• if you have had a history of stomach (gastrointestinal) perforation, ulceration or bleeding in the stomach or small intestine (duodenum) (PUBs) related to previous use of medicines for pain and inflammation such as non-steroidal anti-inflammatory medicines (NSAIDs).
• if you have or have had an ulcer, bleed or perforation in the stomach.
• if you are allergic to aspirin or other non-steroidal anti-inflammatory medicines.
• during an asthma attack, while you are having difficulty breathing or if you have heart failure secondary to chronic lung disease.
• if you have painless growths on the inside of your nose (nasal polyps), associated with aspirin-induced bronchospasm.
• if you have bleeding disorders.
• if you are taking coumarin anticoagulants (blood-thinning medicine) like warfarin (also see Other medicines and MYBUCOD).
• if you are pregnant, do not use NSAIDs, including MYBUCOD in the third trimester or later in your pregnancy because these medicines may cause problems in your unborn baby.
• if you are breastfeeding or in the third trimester of your pregnancy.
• if you just had an operation on the biliary tract.
• if you are a paediatric patient (aged below 18 years) and you are undergoing a procedure to remove your tonsils or adenoids for obstructive sleep apnoea syndrome.
• if you are an ultra-rapid metaboliser of CYP2D6, you should not take MYBUCOD. Even small doses of codeine can lead to increased formation of the active metabolite morphine resulting in clinical signs of morphine intoxication (see If you take more MYBUCOD than you should).
• if you have chronic constipation.
• if you are under the age of 12.

Do not share medicines prescribed for you with any other person. Always take MYBUCOD exactly as described in this leaflet or as your doctor or pharmacist or nurse have told you. Check with your doctor or pharmacist or nurse if you are not sure.

Adults (over the age of 12 years)

The usual dose of MYBUCOD is one to two tablets every four hours. Do not take more than 6 tablets in a 24-hour period. Consult your healthcare provider if you require further treatment after 5 days. MYBUCOD is not recommended for children 12 years of age and younger. Start with the lowest effective dose for the shortest possible time. Exceeding the prescribed dose, together with prolonged and continuous use of MYBUCOD, may lead to dependency and addiction. DO NOT EXCEED THE RECOMMENDED DOSAGE.

MYBUCOD can have side effects. Not all side effects reported for MYBUCOD are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MYBUCOD, please consult your healthcare provider for advice.

If any of the following happens, stop taking MYBUCOD and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting,
• blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), erythema multiforme, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS), Acute Generalised Exanthematous Pustulosis (AGEP), Drug induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE). These are all very serious side effects. If you have them, you may have had a serious reaction to MYBUCOD. You may need urgent medical attention or hospitalisation.

Store all medicines out of reach of children. Store at or below 25 °C in airtight containers. Protect from light. Keep in original packaging until required for use. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).