Almus Ibuprofen & Codeine 200mg/12.8mg 24 Tablets contain ibuprofen 200 mg and codeine phosphate hemihydrate 12.8 mg in each film-coated tablet.

They are used for the short-term relief of acute moderate pain that is not relieved by paracetamol, ibuprofen or aspirin alone, including rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain and period pain.

Ibuprofen is a non-steroidal anti-inflammatory medicine that helps reduce pain and inflammation. Codeine is an opioid painkiller that acts to relieve pain.

The tablets are suitable for adults and children aged 12 years and over. The usual dose is one or two tablets when required, with at least 4 hours between doses and a maximum of six tablets in 24 hours.

Do not take this medicine for more than 3 days. Codeine can cause dependence and addiction if used for longer than recommended.

This is a pharmacy medicine. A pharmacist can provide advice about its appropriate use where required.

Patient Information Leaflet

Main ingredients: Ibuprofen 200 mg and codeine phosphate hemihydrate 12.8 mg per film-coated tablet. Excipients: microcrystalline cellulose, hypromellose, sodium starch glycolate, pregelatinised maize starch, titanium dioxide (E171), talc.

Almus Ibuprofen & Codeine 200mg/12.8mg Tablets are used for the short-term relief of acute moderate pain that has not been relieved by paracetamol, ibuprofen or aspirin alone, including rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain and period pain.

Adults, the elderly and children aged 12 years and over: Swallow one or two tablets with water, up to three times a day as required.

Leave at least 4 hours between doses.

Do not take more than six tablets in any 24-hour period. This is equivalent to a maximum of 1200 mg ibuprofen and 76.8 mg codeine phosphate hemihydrate in 24 hours.

Children under 12 years: Do not give this medicine to children under 12 years because of the risk of severe breathing problems associated with codeine.

Use the lowest effective dose for the shortest time necessary to relieve symptoms.

Do not take this medicine for more than 3 days. If effective pain relief is not achieved, symptoms persist or worsen, or new symptoms develop, speak to a doctor or pharmacist.

If you have an infection and symptoms such as pain or fever persist or worsen, consult a doctor without delay because ibuprofen can mask signs of infection.

If more than the recommended dose is taken, or if a child takes this medicine accidentally, contact a doctor or the nearest hospital immediately for advice. Symptoms of overdose can include nausea, stomach pain, vomiting, headache, ringing in the ears, confusion, drowsiness, chest pain, palpitations, loss of consciousness, convulsions and breathing problems.

Do not take Almus Ibuprofen & Codeine 200mg/12.8mg Tablets if you:

• Have or have previously had two or more episodes of a stomach ulcer, perforation or bleeding.
• Have previously had gastrointestinal bleeding or perforation while taking an NSAID.
• Are allergic to ibuprofen, codeine or any of the other ingredients, or have previously had asthma, swelling, a rash or another allergic reaction after taking aspirin, ibuprofen or a similar medicine.
• Have severe liver, kidney or heart problems.
• Have breathing difficulties, including respiratory depression, or raised pressure inside the skull.
• Have chronic constipation.
• Are taking another NSAID painkiller or aspirin at a daily dose above 75 mg.
• Are taking a monoamine oxidase inhibitor (MAOI), or have taken one within the last 14 days.
• Are in the last 3 months of pregnancy.
• Are breastfeeding.
• Are under 12 years of age.
• Know that you metabolise codeine into morphine very rapidly.
• Are aged under 18 years and require pain relief following removal of the tonsils or adenoids for obstructive sleep apnoea.

This medicine contains codeine, which can cause dependence and addiction. Do not use it for longer than 3 days. Taking higher doses or using it for longer than recommended increases the risk of serious harm, including stomach or intestinal damage, kidney problems, very low potassium levels, dependence and potentially life-threatening overdose.

Speak to a doctor or pharmacist before taking this medicine if you have or have previously had asthma; kidney, heart, liver or bowel problems; high or low blood pressure; a head injury; a thyroid disorder; systemic lupus erythematosus; ulcerative colitis or Crohn's disease; cardiovascular disease; prostate problems; Addison's disease; gallstones; myasthenia gravis; or if you are dehydrated.

Children and adolescents aged 12 to 18 years who are dehydrated may be at increased risk of kidney problems.

This medicine can mask symptoms of infection, including pain and fever. If symptoms of an infection persist or worsen, consult a doctor without delay.

Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome and acute generalised exanthematous pustulosis have been reported. Stop taking the medicine and seek immediate medical attention if you develop a severe or widespread rash, blistering or peeling skin, ulcers affecting the mouth, throat, nose, eyes or genitals, or a rash accompanied by fever.

Codeine can cause breathing problems. Stop taking the medicine and seek immediate medical advice if you develop slow or shallow breathing, confusion, marked sleepiness, very small pupils, nausea or vomiting, constipation or loss of appetite.

Tell your doctor or pharmacist about other medicines you are taking. Important interactions include anticoagulants such as warfarin, medicines for high blood pressure, diuretics, antidepressants including MAOIs and SSRIs, sedatives and benzodiazepines, gabapentin or pregabalin, corticosteroids, lithium, methotrexate, ciclosporin, tacrolimus, quinolone antibiotics and other medicines that can cause drowsiness or affect breathing.

Do not drink alcohol while taking this medicine. Alcohol can increase drowsiness and the effects of codeine.

Pregnancy: Do not take this medicine during the last 3 months of pregnancy. During the first 6 months, it should only be used if absolutely necessary and advised by a doctor. If it is required during this period, the lowest dose should be used for the shortest possible time. Use for more than a few days from 20 weeks of pregnancy may affect the baby's kidneys or a blood vessel in the baby's heart.

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

This medicine may cause sleepiness, dizziness or drowsiness. Do not drive or use machinery until you are sure you are not affected.

Stop taking the medicine and seek immediate medical help if you develop signs of gastrointestinal bleeding, such as black or bloody stools or vomiting blood; severe breathing difficulties; swelling of the face, tongue or throat; severe skin reactions; chest pain associated with an allergic reaction; symptoms of meningitis such as a stiff neck, severe headache, fever or confusion; or symptoms of serious kidney problems.

Seek medical advice if you develop severe upper abdominal pain that may spread to the back with nausea, vomiting or fever, as this may indicate inflammation of the pancreas or biliary tract.

If more than the recommended dose is taken, contact a doctor or the nearest hospital immediately.