ratioDolor® forte Ibuprofen 400 mg film-coated tablets, 20 ST

ratioDolor® forte Ibuprofen 400 mg film-coated tablets are an over-the-counter medicine containing the active ingredient ibuprofen. The tablets are intended for use to relieve pain such as headaches, toothache, muscle pain, etc.

ratioDolor forte Ibuprofen 400 mg is a pain-relieving and fever-reducing medicine (a non-steroidal anti-inflammatory drug, also known as a non-steroidal anti-rheumatic drug [NSAID]).

ratioDolor forte Ibuprofen 400 mg is used for the short-term symptomatic treatment of:

• Mild to moderate pain such as headaches, toothache, period pain, and fever and pain associated with the common cold
• Acute migraine headaches with or without aura

ratioDolor forte Ibuprofen 400 mg is indicated for children weighing 20 kg or more (aged 6 years and over), adolescents and adults.

Dosage form

Film-coated tablets

Directions for use

• Adults – Initial dose: Take 200 mg or 400 mg of ibuprofen (½ or 1 tablet of ratioDolor forte Ibuprofen 400 mg). If necessary, take a further 200 mg or 400 mg of ibuprofen (½ or 1 tablet), but do not exceed a total dose of 1200 mg of ibuprofen (3 tablets) within 24 hours. The interval between doses should be at least 6 hours.
• Children weighing 20 kg or more (aged 6 years and over) and adolescents ratioDolor forte Ibuprofen 400 mg must only be used in children weighing at least 20 kg. The maximum total daily dose of ibuprofen is 30 mg per kg body weight, divided into 3 to 4 individual doses. The interval between doses should be at least 6 hours. Do not exceed the recommended maximum daily dose.
• Duration of use: For short-term use only. The lowest effective dose should be used for the shortest possible time necessary to control the symptoms. If adults need to take ratioDolor forte Ibuprofen 400 mg for more than 3 days to treat migraine headaches or fever, or for more than 4 days to treat pain, or if symptoms worsen, they should consult a doctor. If this medicine needs to be used in children and adolescents for more than 3 days, or if symptoms worsen, a doctor should be consulted.
• Method of administration: For oral use. Swallow the film-coated tablets with water. For patients with a sensitive stomach, it is recommended that ratioDolor forte Ibuprofen 400 mg be taken with meals. The tablet can be divided into equal doses.

The following dosage guidelines apply to ratioDolor forte Ibuprofen 400 mg for children and adolescents:

• Body weight – 20–29 kg – Single dose mg ibuprofen (tablets): 200 mg (½ tablet); Maximum daily dose mg ibuprofen (tablets): 600 mg (1 ½ tablets).
• Body weight – 30–39 kg – Single dose mg ibuprofen (tablets): 200 mg (½ tablet); Maximum daily dose mg ibuprofen (tablets): 800 mg (2 tablets).
• Body weight – 40 kg and above – Single dose mg ibuprofen (tablets): 200–400 mg (½–1 tablet); Maximum daily dose mg ibuprofen (tablets): 1200 mg (3 tablets).

Notes: Must only be given to children under 12 years of age on medical prescription. Please speak to your doctor or pharmacist if you feel that the effect of ratioDolor forte Ibuprofen 400 mg is too strong or too weak.

Ingredients

• The active ingredient is ibuprofen-dl-lysine. Each film-coated tablet contains 400 mg of ibuprofen (as ibuprofen-dl-lysine (1:1)).
• The other ingredients are: Tablet core Microcrystalline cellulose, croscarmellose sodium, talc, highly dispersed anhydrous silica; magnesium stearate. Film coating Hypromellose, macrogol 6000, glycerol 85%.