SIRAN 200 MG EFFERVESCENT TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ACETYLCYSTEINE

Available from:

MEGAPHARM LTD

ATC code:

R05CB01

Pharmaceutical form:

TABLETS EFFERVESCENT

Composition:

ACETYLCYSTEINE 200 MG

Administration route:

PER OS

Prescription type:

Not required

Manufactured by:

TEMMLER PHARMA GNBH, GERMANY

Therapeutic group:

ACETYLCYSTEINE

Therapeutic area:

ACETYLCYSTEINE

Therapeutic indications:

Mucolytic in respiratory tract disorders where reduction of sputum viscosity is required.

Authorization date:

2023-08-31

Patient Information leaflet

SIRPIL 082016 P.1 MegaPharm Ltd.
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) 1986
THIS MEDICINE IS TO BE SUPPLIED WITHOUT PHYSICIAN’S PRESCRIPTION
SIRAN 200MG
EFFERVESCENT TABLETS
(NO SUGAR ADDED, NO COLOURING AGENTS, LEMON FLAVOUR) _ _
_ _
COMPOSITION :
ACTIVE INGREDIENT:
Each tablet contains
Acetylcysteine 200 mg
_ _
This medicine contains:_ _
Sodium 146.5 mg
Aspartame 10 mg
For Inactive ingredients and their quantity in each tablet – see
section 'Additional information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains essential information
about this medicine. If you have any further questions, refer to the
physician or the pharmacist.
This medicine is supplied without physician's prescription. The
medicine is intended for adults and children above the
age of two years, under this age refer to the physician. The medicine
should be used in a proper manner. For more
information consult a pharmacist. Refer to the physician if the signs
of the illness (symptoms) get worse or do not
improve after 4-5 days.
WHAT IS THIS MEDICINE INTENDED FOR?
Mucolytic in respiratory tract disorders where reduction of sputum
viscosity is required.
THERAPEUTIC GROUP: sputum viscosity reducer (mucolytics).
BEFORE USING THIS MEDICINE
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
•
In very rare cases, severe skin reactions associated with
acetylcysteine treatment may develop, such as
Stevens-Johnson Syndrome and Lyell Syndrome. If you have noticed any
changes in the skin and/or
mucous tissue, contact a physician immediately and stop using SIRAN.
•
If you suffer from asthma, or if you suffer or had previously suffered
from gastric ulcer or intestinal ulcer,
consult a physician prior to use.
•
Patients with histamine intolerance should exercise extreme caution
and consult a physician prior to initiating
treatment. Avoid prolonged treatment in these patients since SIRAN
affects histamine metabolism, which
may cause symptoms of intolerance (such

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SIRAN 200 MG EFFERVESCENT TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Siran 200 mg effervescent tablet contains 200 mg acetylcysteine.
Each effervescent tablet contains aspartame and sodium hydrogen
carbonate.
For a full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Effervescent tablet
White, round tablet with a breaking notch on one side.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mucolytic in respiratory tract disorders where reduction of sputum
viscosity is required.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
If not prescribed otherwise, the following dosage is recommended for
Siran 200 mg effervescent tablets:
Adults and juveniles aged 14 and above: 1 effervescent tablet 2 - 3
times a day (corresponding to 400 -
600 mg acetylcysteine per day).
Children and juveniles from 6 - 14 years of age, 1 effervescent tablet
twice a day (corresponding to 400 mg
acetylcysteine per day).
Children from 2 - 5 years of age, ½ effervescent tablet 2 - 3 times a
day (corresponding to 200 - 300 mg
acetylcysteine per day).
Nature and overall duration of the application
Do not take Siran 200 mg effervescent tablets without medical advice
for longer than 4 - 5 days.
Siran 200 mg effervescent tablets are taken dissolved in a glass of
water after meals.
4.3
CONTRAINDICATIONS
Siran 200 mg effervescent tablets may not be administered in the event
of hypersensitivity against
acetylcysteine or one of the other ingredients.
Siran 200 mg effervescent tablets may not be used for children under
the age of 2 due to the high content of
the active substance.
1
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Very rarely, the occurrence of severe skin reactions such as
Stevens-Johnson syndrome and Lyell syn-
drome has been reported in close connection with the application of
acetylcysteine.
If new changes to the skin and the mucous membranes occur, medical
advice should be obtained without
delay and the