Ibuprofen 400mg - Pain & Fever - Viatris Advice - 12 film-coated tablets

Description

This medicine contains a non-steroidal anti-inflammatory drug: ibuprofen. It is indicated for adults and children over 30 kg (approximately 11-12 years of age) for the short-term treatment of fever and/or pain such as headaches, flu-like symptoms, toothache, muscle aches and painful periods.

It is indicated in adults, after at least one medical consultation, for the treatment of mild to moderate migraine attacks, with or without aura.

Directions for use

Painful and/or feverish conditions

FOR ADULTS AND CHILDREN WEIGHING 30 kg OR MORE (approximately 11-12 years old). The usual dosage is 1 tablet (400 mg) per dose, to be repeated if necessary after 6 hours. In all cases, do not exceed 3 tablets per day (i.e. 1200 mg per day). The 400 mg tablet is reserved for more intense pain or fever, or pain or fever that is not relieved by a 200 mg ibuprofen tablet. Regular doses help prevent peaks in fever or pain. They should be spaced at least 6 hours apart. Elderly patients are at increased risk of adverse effects, so use the lowest possible dose for the shortest time necessary to relieve symptoms. Do not exceed the recommended doses or duration of treatment (3 days for fever or migraine, 5 days for pain). The maximum dosage is 3 tablets per day (1200 mg).

In the event of a migraine attack

FOR ADULTS ONLY. 1 tablet of 400 mg as soon as possible after the onset of the attack. If a patient does not feel relief after the first dose, a second dose should not be taken during the same attack. However, the attack can be treated with another treatment that is not a non-steroidal anti-inflammatory drug or aspirin. If the pain returns, a second dose may be taken provided that there is an 8-hour interval between the two doses.

Contraindications

Do not take Ibuprofen Viaris Conseil 400 mg film-coated tablets:

· if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6); · if you have a history of allergies or asthma triggered by taking this medicine or a related medicine, including other nonsteroidal anti-inflammatory drugs, acetylsalicylic acid (aspirin), rhinitis, swelling, or hives; · if you are pregnant, from the beginning of the 6th month of pregnancy (beyond 24 weeks of amenorrhea); · if you have a history of gastrointestinal bleeding or ulcers related to previous NSAID treatment; · if you have an active or recurring stomach or intestinal ulcer or bleeding; · if you have gastrointestinal bleeding, cerebral bleeding or other bleeding in progress; · if you have severe liver disease; · if you have severe kidney disease; · if you have severe heart disease; · if you have systemic lupus erythematosus.

Composition

The active ingredient is: ibuprofen.................................................................................................................. 400.00 mg as ibuprofen lysinate............................................................................................. 684.00 mg per film-coated tablet.

The other ingredients are:

- Core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone type A, crospovidone type B, povidone K30, magnesium stearate, talc.

- Film-coating: OPADRY II white 85F18422 [hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc].

- Printing ink: OPACODE black S-1-17823 [shellac, isopropyl alcohol, black iron oxide (E172), anhydrous chlorobutanol, propylene glycol, ammonium hydroxide].