Caffetin Rapid tablets film-coated

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

ibuprofen (ibuprofen lysine)

متاح من:

Alkaloid AD Skopje

ATC رمز:

M01AE01

INN (الاسم الدولي):

ibuprofen (ibuprofen lysine)

جرعة:

400mg

الشكل الصيدلاني:

tablets film-coated

الوحدات في الحزمة:

(10/1x10/) in blister, (20/2x20/) in blister

نوع الوصفة الطبية :

OTC

الوضع إذن:

Registered

تاريخ الترخيص:

2021-04-16

خصائص المنتج

Caffetin
®
Rapid 400 mg film-coated tablets
Summary of Product Characteristics
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Caffetin
®
Rapid 400 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg ibuprofen (equivalent to 684
mg ibuprofen lysine).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
•
Film-coated tablets
Oblong, biconvex, white to creamy film-coated tablets with break-mark
on one side. The
break mark is only to facilitate breaking for ease of swallowing and
not to divide into equal
doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Caffetin Rapid is indicated for the short term symptomatic treatment
of mild to moderate pain
such as headache, migraine, neuralgia, dental pain, dysmenorrhea,
muscular pain, back pain,
rheumatic pain, fever and symptoms associated with the common cold and
influenza.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For short-term use only.
Posology
The lowest effective dose should be used for the shortest duration
necessary to relieve
symptoms (see section 4.4).
_Adults, the elderly and adolescents between 12 and 18 years _
The recommended single dose is 1 tablet with water, up to three times
a day as required.
The interval between two doses should not be shorter than 4 hours.
No more than 3 tablets (1200 mg ibuprofen) should be taken in any 24
hour period.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest
duration necessary to control symptoms (see section 4.4).
Caffetin
®
Rapid 400 mg film-coated tablets
Summary of Product Characteristics
2
If symptoms worsen or if they persist after 3 days, the patient must
not continue treatment
without consulting a doctor.
_Paediatric population_
Not intended for children under 12-years old.
Method of administration
For oral use.
It is recommended that patients with gastric disorders take the
tablets with food.
4.3
CONTRAINDICATIONS
-
Hypersensitivity to ibuprofen or to any of the excipie