Do not take these capsules if you:

• are allergic to ibuprofen or any of the other ingredients of this product, aspirin or other related painkillers (see end of section 2 and section 6)
• have had a worsening of asthma, allergic rash or itchy, runny nose when taking similar medicines
• have (or have had) two or more episodes of a stomach ulcer, perforation or bleeding
• ever had stomach bleeding or a perforation due to NSAIDs
• are already taking other drugs that belong to the NSAIDs group
• are taking aspirin at doses of above 75 mg daily
• are in the last 3 months of pregnancy
• suffer from severe heart, liver or kidney disease.

Warnings and precautions

Please see your doctor or pharmacist before taking this medicine if you:

• have an infection – please see heading “Infections” below.
• are elderly, as you may be more likely to suffer from side effects
• have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems
• are allergic to any other painkiller
• suffer from systemic lupus erythematosus (a chronic rheumatic disease)
• suffer from an allergy
• suffer from inflammation of the intestines (ulcerative colitis, Crohn’s disease)
• are on low-dose aspirin (up to 75 mg daily)
• are a smoker
• are in the first 6 months of pregnancy
• are 12-18 years old and have not been drinking fluids or have lost fluids due to continuous vomiting or diarrhoea, as there is a risk of kidney damage.

If symptoms persist or worsen, consult your doctor.

Infections: Flarin 200mg Soft Capsules may hide signs of infections such as fever and pain. It is therefore possible that Flarin 200mg Soft Capsules may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.

Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking Flarin 200 mg Soft Capsules if you:

• have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”).
• have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.

Skin reactions: Serious skin reactions have been reported in association with ibuprofen treatment. You should stop taking Flarin 200 mg Soft Capsules and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4.

Very rare reports of potentially life threating skin rashes (Stevens Johnson Syndrome, toxic epidermal necrolysis) have been reported with the use of ibuprofen. Patients are at a higher risk of such reactions during the first month of therapy. STOP TAKING Flarin and seek medical assistance from your doctor or pharmacist if you notice a skin rash, lesions or any other signs of allergic reaction (see Section 4).

Other medicines and Flarin 200 mg Soft Capsules

Flarin 200 mg Soft Capsules may affect or be affected by some other medicines. For example:

• any other painkillers (or other NSAIDs)
• corticosteroids (anti-inflammatory) which can increase the risk of side effects in the stomach including bleeding
• serotonin reuptake inhibitors and lithium (for treatment of depression – bipolar disease and mania)
• cardiac glycosides (treatment of heart failure and cardiac arrhythmia)
• methotrexate (anti-cancer and psoriasis)
• zidovudine (HIV/AIDS infection)
• cyclosporine (prevent rejection after organ transplant)
• mifepristone (emergency contraceptive). Do not take this medicine for 8-12 days after mifepristone administration as it can reduce its effect.
• tacrolimus (prevent rejection after organ transplant, treatment of skin diseases)
• quinolone (antibiotics)
• medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan).

Some other medicines may also affect or be affected by the treatment of Flarin 200 mg Soft Capsules. You should therefore always seek the advice of your doctor or pharmacist before you use Flarin 200 mg Soft Capsules with other medicines.

Pregnancy and breast-feeding

Ask your doctor or pharmacist before taking this medicine if you are in the first 6 months of pregnancy. DO NOT TAKE the capsules if you are in the last 3 months of pregnancy.

Ask your doctor or pharmacist for advice before taking any medicine if you are breast-feeding.

Female fertility

Flarin 200 mg Soft Capsules belong to a group of medicines which may impair fertility in women. This effect is reversible on stopping the medicine. It is unlikely that Flarin 200 mg Soft Capsules used occasionally, will affect your chances of becoming pregnant, however, tell your doctor before taking this medicine if you have problems becoming pregnant.

Driving and using machines

Flarin 200 mg Soft Capsules are unlikely to cause any effect on your ability to drive or use machines.

Important information about some of the ingredients of Flarin 200 mg Soft Capsules.

• Contains sorbitol. If you have an intolerance to some sugars, contact your doctor before taking this product.
• Brilliant blue (E133) and Allura Red (E129) may cause allergic reactions.