KALOBA TABLETS

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Bahan aktif:

PELARGONIUM SIDOIDES ROOTS (1: 8- 10) (EPS® 7630) DRIED LIQUID EXTRACT; EXTRACTING AGENT : ETHANOL 11% (W/W)

Tersedia dari:

DR.SAMUELOV IMPORTING & MARKETING LTD, ISRAEL

Kode ATC:

R05FB01

Bentuk farmasi:

FILM COATED TABLETS

Komposisi:

PELARGONIUM SIDOIDES ROOTS (1: 8- 10) (EPS® 7630) DRIED LIQUID EXTRACT; EXTRACTING AGENT : ETHANOL 11% (W/W) 20 MG

Rute administrasi :

PER OS

Jenis Resep:

Not required

Diproduksi oleh:

DR. WILLMAR SCHWABE GMBH &CO. KG, GERMANY

Area terapi:

COUGH SUPPRESSANTS AND MUCOLYTICS

Indikasi Terapi:

- Symptomatic treatment of acute bronchitis.- Traditional herbal medicinal product for use in the common cold.

Tanggal Otorisasi:

2023-04-30

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
KALOBA TABLETS® FILM-COATED TABLETS
For adults, adolescents and children over the age of 6 years
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains:
Dried liquid extract of Pelargonium sidoides roots (1: 8- 10) (EPs®
7630) 20 mg
Extraction agent: ethanol 11 % (w/w)
For full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
-Symptomatic treatment of acute bronchitis
- Traditional herbal medicinal product for use in the common cold
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and adolescents over 12 years: 1 film-coated tablet 3 times
daily
Children aged 6-12 years:
1 film-coated tablet twice daily
Tablets are taken with some liquid (preferably a glass of water) in
the morning, midday
and evening. Tablets are not to be taken in a lying position.
After symptoms subside, it is recommended to continue the treatment
for several days
in order to prevent a relapse. The duration of treatment should not
exceed 3 weeks.
4.3.
CONTRA-INDICATIONS
Kaloba® tablets are not to be used in cases of hypersensitivity to
one of the components
of the pharmaceutical. Kaloba® tablets are not to be taken in cases
of severe hepatic
diseases as no sufficient experience is available in this respect.
4.4.
SPECIALS WARNINGS AND PRECAUTIONS FOR USE
A doctor is to be consulted immediately if the condition does not
improve within one
week, in cases of fever lasting for several days or in cases of
shortness of breath or
bloody sputum.
Cases of liver damage and hepatitis have been reported in connection
with the use of
medicinal products containing Pelargonium. Patients should be told to
discontinue
treatment with Kaloba® tablets immediately and to consult a doctor if
signs indicating
liver function disorders occur.
Kaloba® tablets are not to be used in children under the age of 6
years.
Patients with rare hereditary galactose intolerance, lactase
deficiency or glucose-