MYLAN, Brufenlik 400 mg 20 MYLAN

“Composition
Active ingredients
Each sachet (10 ml) contains 400 mg of ibuprofen.
Excipients
Glycerol Liquid maltitol E965 Xanthan gum Citric acid Sodium citrate Sodium benzoate E211 Sodium saccharin Purified water Sodium chloride Hypromellose Strawberry flavor containing benzyl alcohol Thaumatin E957

Directions
Brufenlik 400 mg is indicated for the short-term symptomatic treatment of mild to moderate pain and/or fever in adults and children over 6 years of age (> 20 kg).

Method of administration and dosage
Therapy should be initiated with the minimum effective dose, which can then be adjusted depending on the therapeutic response and possible side effects.

Dosage
Adults and adolescents over 12 years (≥ 40 kg): The dose of ibuprofen depends on the patient’s age and body weight. The maximum single daily dose for adults and adolescents should not exceed 400 mg ibuprofen. A dose greater than 400 mg at a time does not provide a better analgesic effect. The total dose should not exceed 1200 mg ibuprofen within 24 hours. The initial dose is 200 mg or 400 mg ibuprofen. If necessary, additional doses can be taken by 1 or 2 sachets (from 200 mg to 400 mg ibuprofen) up to 3-4 times a day at intervals of 4-6 hours. If children and adolescents need to take this medicine for more than 3 days or if symptoms worsen, a doctor should be consulted.
Body weight 400 mg oral suspension in sachets Frequency Maximum daily dose
? 40 kg (adolescents, adults and elderly) 1 sachet (400 mg) Up to 3-4 times daily depending on a single dose of 1200 mg ibuprofen
Paediatric population Children aged 6-12 years (20-39 kg): the maximum total daily dose of ibuprofen is 30 mg per kg of body weight, divided into 3-4 doses at intervals of 6-8 hours. The maximum recommended daily dose should not be exceeded.
Age/Body Weight Frequency Maximum Daily Dose
6-7 years (20-30 kg) Up to 3 times daily 30 mg per kg of body weight
8-12 years (> 30 kg) Up to 4 times daily 30 mg per kg of body weight
Brufenlik is not indicated for children under 6 years of age.
Elderly: No special dosage adjustment is required unless renal or hepatic function is impaired; in this case, the dosage should be assessed individually. In this group, attention should be paid to the dosage.
Impaired renal function: in patients with mild to moderate renal impairment, no dose reduction is required (for patients with severe renal impairment, see section Contraindications ).
Liver failure: in patients with mild to moderate hepatic impairment, no dose reduction is required (for patients with severe hepatic impairment, see section Contraindications ).
Method of administration
For oral use. Before use, mix the contents of the sachet thoroughly by pressing the top and bottom of the sachet several times with your fingers. The contents of the sachet must not be divided into several doses; the entire contents of the sachet must be used. For a faster onset of effect, the dose can be taken on an empty stomach. Patients with increased stomach sensitivity are advised to take ibuprofen with food.

Contraindications
Hypersensitivity to the active substance or to any of the listed excipients. In patients who have experienced asthma, urticaria or allergic reactions after taking acetylsalicylic acid or other NSAIDs;
Severe heart failure (NYHA class IV).
Severe liver failure
Severe renal failure (glomerular filtration rate less than 30 ml/min).
Disorders associated with increased bleeding tendency or active bleeding.
History of gastrointestinal bleeding or perforation related to previous NSAID therapy.
Presence or history of ulcerative colitis, Crohn’s disease, recurrent peptic ulcer disease or gastrointestinal bleeding (defined as two or more separate episodes of confirmed ulceration or bleeding).
During the last trimester of pregnancy.”

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