SINUFED TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PSEUDOEPHEDRINE HYDROCHLORIDE

Available from:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD

ATC code:

R01BA02

Pharmaceutical form:

TABLETS

Composition:

PSEUDOEPHEDRINE HYDROCHLORIDE 60 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL

Therapeutic group:

PSEUDOEPHEDRINE

Therapeutic area:

PSEUDOEPHEDRINE

Therapeutic indications:

Symptomatic treatment of nasal congestion, to relieve eustachian tube congestion.

Authorization date:

2023-01-31

Patient Information leaflet

101258012
0417
G
PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
SINUFED
10 TABLETS/SYRUP
SINUFED TABLETS:
Pseudoephedrine hydrochloride 60 mg
SINUFED SYRUP:
Each 5 ml contains:
Pseudoephedrine hydrochloride 30 mg
For inactive ingredients in the preparation –
see section 6 “Further Information”.
READ THIS PACKAGE INSERT CAREFULLY IN ITS
ENTIRETY BEFORE USING THE MEDICINE. This
leaflet contains concise information about
the medicine. If you have further questions,
refer to the doctor or pharmacist.
You must use the medicine in the correct
manner. Consult the pharmacist if you need
further information. Consult the doctor if
signs of the illness (symptoms) worsen or
if they do not improve after 7 days.
For children below 12 years of age, it is
recommended that the medicine be taken
in the syrup form. The syrup dosage form
is not intended for infants under one year
of age. For children over one year and
under 6 years of age, a doctor should be
consulted.
1. WHAT IS THE MEDICINE INTENDED
FOR?
The medicine is intended for symptomatic
treatment of nasal congestion in cases of
acute rhinitis and relief of eustachian tube
congestion due to ear infection.
THERAPEUTIC GROUP Alpha-agonist.
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF:
•
you are sensitive to the active ingredient
or to any of the other ingredients the
medicine contains (see section 6)
.
• Do not use in infants under one year
of age.
• you are pregnant or breastfeeding.
• you are being treated concomitantly
with medicines from the monoamine
oxidase inhibitors (MAOI) group (for
treatment of depression), or within 14
days of stopping treatment with this
group of medicines.
• you suffer from heart diseases such
as: ischemic heart disease, occlusive
vascular disease or hypertension.
• you have diabetes.
• you suffer from severe kidney function
impairment.
• you have a phaeochromocytoma (a
rare tumor of the adrenal glands).
• you have an overactive thyroid gland.
• you have glauco