TALVOSILEN TABLETS

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

ΚΩΔΕΐΝΗ ΦΩΣΦΟΡΙΚΌ ΆΛΑΣ, ΠΑΡΑΚΕΤΑΜΌΛΗ

Διαθέσιμο από:

MULTI-PHARM CO LTD

Φαρμακολογική κατηγορία (ATC):

N02BE71

INN (Διεθνής Όνομα):

CODEINE PHOSPHATE, PARACETAMOL

Φαρμακοτεχνική μορφή:

TABLETS

Σύνθεση:

0000052288 - CODEINE PHOSPHATE - 20 MG; 0000103902 - PARACETAMOL - 500 MG

Οδός χορήγησης:

ORAL USE

Τρόπος διάθεσης:

Με Ιατρική Συνταγή

Θεραπευτική περιοχή:

PARACETAMOL, COMBINATIONS WITH PSYCHOLEPTICS

Περίληψη προϊόντος:

01 - PACK WITH 20 TABS IN BLISTER(S) - 20 - TABLET - 880056401 - Εγκεκριμένο

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
PROFESSIONAL INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
TALVOSILEN TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances: paracetamol, codeine phosphate hemihydrate.
Each Tablet contains 500 mg of paracetamol and 20 mg of codeine
phosphate
hemihydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Talvosilen Tablets 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 Talvosilen Tablets 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.
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
Talvosilen Tablet).
Page 1 of 14
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 or 2 tablets
(equivalent to 500 - 1,000
mg of paracetamol and
20 - 40 mg of codeine
phosphate hemihydrate)
Up to 8 tablets
(equivalent to up to 4,000
mg of paracetamol and up
to 160 mg of codeine
phosphate hemihydrate)
The maximum daily dose indicated in this table (per 24 hours) should
never be
exceeded.
METHOD AND DURAT