Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ibuprofen
Geltec Private Limited
M01AE01
ibuprofen
400mg
capsules soft
(20/2x10/) in blister
OTC
Registered
2020-11-20
_Confidential _ _ _ _Module 1 _ SUMMARY OF PRODUCT CHARACTERISTICS IBUPROFEN SOFT GELATIN CAPSULES 400 MG 1. NAME OF THE MEDICINAL PRODUCT: Brufen ® Rapid, ibuprofen capsules 400 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Capsules 400 mg: Each Soft Gelatin Capsule Contains: Ibuprofen Ph. Eur. Excipients q.s. Please refer point no. 6.1 for detail list of inactive ingredients 3. PHARMACEUTICAL FORM: Capsules 400 mg: The drug product is a Pale yellow colored, 14 minims, oval shaped, transparent soft gelatin capsules with clear fill material, printed with # in white colour ink. 4. CLINICAL PARTICULARS: 4.1 THERAPEUTIC INDICATIONS: Adults, elderly, and children over 12 years of age: Brufen ® Rapid 400 mg, capsules, is indicated for short-term symptomatic treatment of non-severe forms of arthritis, rheumatic pain, back and muscle pain, neuralgia, migraine, headache, toothache, dysmenorrhea, flu symptoms and colds. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION: For oral administration and short-term use only. The capsules should be taken with water. _Adults, elderly, children and adolescents from 12 to 18 years:_ Adverse reactions when taking the drug can be reduced by using the minimum effective dose for the shortest period necessary to relieve symptoms (see section "precautions"). If a child or teenager needs to take this medicine for more than 3 days or symptoms worsen. The doctor should be consulted. _Children and adolescents aged 12 to 18 years: _ 1-2 capsules, but no more than 3 capsules per day as needed. _Adults: _ 1 capsule, but no more than 3 capsules per day as needed. The capsules should be taken with water. It is necessary to observe an interval of at least 4 hours between doses of the drug. Do _Confidential _ _ _ _Module 1 _ not take more than 3 capsules within 24 hours. 4.3 CONTRAINDICATIONS: Hypersensitivity to ibuprofen or any of the constituents in the product. Ibuprofen is contra-indicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angiodema or Прочитать полный документ