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Patient Information leaflet MANDAFEN 600mg (Ibuprofen)

Read all of this leaflet carefully because it contains important information for you.

Keep this leaflet. You may need to read it again.

Ask your doctor or pharmacist if you need more information or advice.

1. WHAT MANDAFEN TABLETS ARE AND WHAT THEY ARE USED FOR

Mandafen tablets contain ibuprofen which belongs to a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs).

Mandafen 600mg tablets are used to treat mild to moderate pain including period pains, headache, migraine and toothache; pain after operations; rheumatoid arthritis (including juvenile arthritis or Still’s disease) and other muscle or bone disorders.

2. BEFORE YOU TAKE MANDAFEN TABLETS Do NOT take Mandafen tablets if:

•you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of this medicine (listed in section 6)

• you have a history of allergy to aspirin, ibuprofen or NSAIDs, which includes attacks of asthma, swelling of the nose and throat, skin rash or runny nose •you have an active or history of recurrent peptic ulcers (more than two)

•you have a history of stomach bleeding or perforation related to the use of NSAIDs

•    you have an increased tendency for bleeding

•    you have severe heart, kidney or liver failure •you are in the last 3 months of pregnancy.

Talk to your doctor or pharmacist before you take this medicine if:

•you have systemic lupus erythematous (SLE) or connective tissue disease •you have heart, kidney or liver problems

•    you have a history of heart failure or high blood pressure

•    you have asthma or have a history of asthma

•    you have a history of stomach or bowel disorders (e.g. ulcerative colitis, Crohn’s disease)

•    you are in the first 6 months of pregnancy or are trying to become pregnant

•    Mandafen 600mg tablets may make it more

difficult to become pregnant. Tell your doctor if you have problems becoming pregnant •you are breast-feeding.

Warning: Medicines such as Mandafen 600mg tablets may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

If you have heart problems, previous stroke or think you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

Taking other medicines

Talk to your doctor or pharmacist before you take

Mandafen if you are taking, or have recently

taken, any of the following:

•    medicines for high blood pressure or heart failure, such as diuretics (water tablets)

•    medicines for thinning the blood (anticoagulants e.g. warfarin)

•    medicines for depression such as SSRIs or lithium

•    corticosteroids

•    certain antibiotics (quinolones e.g. ciprofloxacin)

•    other NSAIDs, aspirin or other painkillers

•    methotrexate (used to treat some cancers, psoriasis or arthritis)

•    ciclosporin and tacrolimus (used to prevent

rejection of organ transplants)

•    mifepristone (used to induce abortion)

•    zidovudine (used to treat viral infection) •aminoglycosides (a type of antibiotic) •colestyramine (used to lower cholesterol)

•    medicines known as sulfonylureas (used to treat diabetes)

•    voriconazole or fluconazole (anti-fungal medicines)

•    Ginkgo biloba (a herbal medicine).

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast feeding Use in pregnancy or breast feeding should be avoided and only used on advice of your doctor. Ibuprofen should not be used in the last 3 months of pregnancy.

Driving and using machines

Side effects such as dizziness, drowsiness, tiredness and visual disturbances are possible after taking NSAIDs. If affected, you should not drive or operate machinery.

Important information about some of the ingredients of this medicine

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE MANDAFEN TABLETS

Your doctor has carefully chosen the correct dosage for you. Always follow your doctor’s instructions and those on the pharmacy label. Ask your doctor or pharmacist if you are not sure.

The tablets should be swallowed whole with a glass of water or milk, with or after food. Do not chew, suck, crush or break the tablets to avoid mouth discomfort and throat irritation.

The usual doses are given below:

Adults: initially 2 to 3 tablets daily in divided doses; increased if necessary to a maximum of 4 tablets daily. A maintenance dose of 1 to 2 tablets daily may be adequate.

Elderly:    lose should be considered and the

patient should be monitored for gastro-intestinal bleeding for 4 weeks after starting the tablets. Children: 20mg per kg body weight daily, in divided doses. For juvenile rheumatoid arthritis, up

to 40mg per kg daily, in divided doses.

Children under 30kg must not receive more than 500mg per day even in divided doses.

Ibuprofen 600mg Tablets should NOT be taken by children weighing less than 7 kg.

•    Always use the lowest dose for the shortest time necessary to relieve your symptoms.

•    If symptoms persist or worsen consult your doctor.

If you or anyone else takes too many labials

Contact your doctor immediately or go to your nearest hospital casualty department. Please take this leaflet, any remaining tablets and the container with you.

If you forget to take a tablet take one as soon as you remember, unless it is nearly time to take the next dose. Do not take a double dose to make up

for a forgotten dose and do not take more than the maximum dose per day.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Mandafen can cause side effects, although not everybody gets them.

Side effects will be minimised by using the lowest dose for the shortest time necessary to control your symptoms. The incidence of gastro-intestinal side effects may be greater in the elderly.

STOP TAKING the tablets and seek immediate medical help if you experience any of the following:

• Stomach irritation or bleeding with any of the following symptoms:

-    pass blood in your faeces (stools/motions)

-    pass black tarry stools

-    vomit any blood or dark particles that look like coffee grounds.

•    Allergic reactions with any of the following symptoms:

-    asthma, worsening of asthma, wheezing or difficulty breathing; skin rashes or itching; swelling of the lips, tongue or face; fast heart rate, low blood pressure, collapse.

•    Severe skin reaction with blistering and peeling.

STOP TAKING the tablets and tell your doctor if

you experience:

•    Indigestion or heartburn

•    Stomach pains or other abnormal stomach symptoms.

Medicines such as Mandafen 600mg may be

associated with a small increased risk of heart

attack (“myocardial infarction”) or stroke.

Other side effects:

•    nausea, vomiting, diarrhoea, flatulence, constipation

•    inflammation of the pancreas causing severe stomach and back pain

•    blood disorders (symptoms may include unusual bleeding or bruising, sore throat, fever, exhaustion or anaemia)

•    liver problems such as hepatitis and jaundice (yellowing of the skin or whites of the eyes)

•    kidney problems and swelling caused by fluid retention, very rarely kidney failure

•    high blood pressure and heart failure

•    headache, visual disturbances or blurring, ringing in the ears, impaired hearing

•    depression, confusion, hallucination, anxiety

•    rhinitis (blocked, runny nose)

•    numbness or tingling of the hands or feet

•    vertigo, dizziness, tiredness, drowsiness, malaise, insomnia

•    sensitivity of the skin to the sun

•    single cases of aseptic meningitis have been reported

•    worsening of symptoms of colitis or Crohn's disease.

Reporting of side effects

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.

By reporting side effects you can help provide more

information on the safety of this medicine.

5.    HOW TO STORE MANDAFEN TABLETS

Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use after the expiry date printed on the pack.

6.    FURTHER INFORMATION

What Mandafen 600mg tablets contain:

•    The active ingredient in each tablet is ibuprofen 600mg.

•    The other ingredients are maize starch, cellulose microcrystalline, sodium starch glycollate (type A), povidone, alginic acid, silica colloidal anhydrous, magnesium stearate, croscarmellose sodium, sodium lauryl sulphate.

• The tablet coating contains lactose monohydrate, hypromellose, titanium dioxide (E171), Macrogol 4000 and erythrosine lake (E127).

What Mandafen 600mg tablets look like and contents of the pack:

They are pink, oval shaped, film-coated tablets with “M” and “A” either side of a break line on one side and “600” on the other.

They are available in plastic containers of 7, 12, 14, 16, 24, 28, 32, 48, 50, 56, 60, 72, 84, 96, 100, 250 and 500 tablets.

Marketing Authorisation Holder and Manufacturer:

M & A Pharmachem Ltd, Bolton BL5 2AL, UK.

Date of last revision: July 2013 PL 04077/0173