TALVOSILEN FORTE

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

ΠΑΡΑΚΕΤΑΜΌΛΗ, ΚΩΔΕΐΝΗ ΦΩΣΦΟΡΙΚΌ ΆΛΑΣ

Διαθέσιμο από:

MULTI-PHARM CO LTD

Φαρμακολογική κατηγορία (ATC):

N02BE71

INN (Διεθνής Όνομα):

PARACETAMOL, CODEINE PHOSPHATE

Φαρμακοτεχνική μορφή:

CAPSULE,HARD

Σύνθεση:

0000103902 - PARACETAMOL - 500 MG; 0000052288 - CODEINE PHOSPHATE - 30 MG

Οδός χορήγησης:

ORAL USE

Τρόπος διάθεσης:

Με Ιατρική Συνταγή

Θεραπευτική περιοχή:

PARACETAMOL, COMBINATIONS WITH PSYCHOLEPTICS

Περίληψη προϊόντος:

01 - PACK WITH 20 CAPS IN BLISTER(S) - 20 - CAPSULE - 890044501 - Εγκεκριμένο

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
PROFESSIONAL INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
TALVOSILEN FORTE
® CAPSULES
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances: paracetamol, codeine phosphate hemihydrate.
Each hard capsule contains 500 mg of paracetamol and 30 mg of codeine
phosphate hemihydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard Capsules
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Talvosilen forte capsules is indicated in patients older than 12 years
of age for
the treatment of moderate to severe pain which is not considered to be
relieved
by other analgesics such as paracetamol or ibuprofen (alone).
4.2 POSOLOGY, METHOD AND DURATION OF ADMINISTRATION
POSOLOGY
Dosage schedule (single and daily doses): Children over 12 years of
age,
adolescents and adults should take 1-2 capsules up to 4 times daily,
if
necessary. The interval between doses should be 6 to 8 hours.
The dose of paracetamol depends on the patient’s body weight and age
(as a
rule 10 to 15 mg/kg body weight as a single dose). The total daily
dose of
paracetamol in the fixed drug combination should not exceed 60 mg/kg
body
weight.
Page 1 of 14
Thus, with regard to the codeine component in the fixed drug
combination, the
maximum daily dose is 240 mg of codeine phosphate hemihydrate
(equivalent to
8 hard capsules.
The particular dosage interval depends on the symptoms and on the
maximum
daily dose. It should be at least six hours.
BODY WEIGHT (AGE)
SINGLE DOSE
(EQUIVALENT TO
PARACETAMOL AND
CODEINE PHOSPHATE
HEMIHYDRATE)
MAXIMUM DAILY DOSE (24
HR)
(EQUIVALENT TO
PARACETAMOL AND CODEINE
PHOSPHATE HEMIHYDRATE)
From 43 kg
(children 12 years of
age or older,
adolescents and
adults)
1 - 2 hard capsules
(equivalent to 500 - 1,000
mg of paracetamol and
30 - 60 mg of codeine
phosphate hemihydrate)
Up to 8 hard capsules
(equivalent to up to 4,000
mg of paracetamol and up
to 240 mg of codeine
phosphate hemihydrate))
The maximum daily dose indicated in this table (per 24 hours) should
nev