PROFITEN TABLETS

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

KETOTIFEN AS FUMARATE

متاح من:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ATC رمز:

R06AX17

الشكل الصيدلاني:

TABLETS

تركيب:

KETOTIFEN AS FUMARATE 1 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

المجموعة العلاجية:

KETOTIFEN

المجال العلاجي:

KETOTIFEN

الخصائص العلاجية:

Prophylactic treatment of bronchial asthma. Symptomatic treatment of allergic conditions such as rhinitis, hay fever, bronchitis and urticaria.

تاريخ الترخيص:

2022-08-31

نشرة المعلومات

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a
doctor’s prescription only.
PROFITEN TABLETS
EACH TABLET CONTAINS:
KETOTIFEN (AS FUMARATE) 1 MG
PROFITEN SYRUP
EACH TEASPOON (5 ML) OF SYRUP CONTAINS:
KETOTIFEN (AS FUMARATE) 1 MG
Inactive and allergenic ingredients in the
preparation - see section 6 in the leaflet.
READ THIS LEAFLET 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.
This medicine has been prescribed to
treat you. Do not pass it on to others. It
may harm them even if it seems to you
that their medical condition is similar.
The tablets are not intended for children
under the age of 3. The syrup is not
intended for children under 6 months
of age.
1. WHAT IS THE MEDICINE
INTENDED FOR?
As a prophylactic treatment of bronchial
asthma. For symptomatic treatment of
allergic conditions such as: bronchitis,
rhinitis, hay fever, and skin rash )urticaria(.
THERAPEUTIC GROUP: Other antihistamines
for systemic treatment.
2. BEFORE
USING
THE
MEDICINE DO NOT USE THE MEDICINE IF:
∙ You are sensitive )allergic( to the
active ingredient or to any of the
additional ingredients contained in
the medicine )see section 6 for a list
of inactive ingredients(.
∙ You
are
being
concomitantly
treated with oral anti-diabetic
preparations. SPECIAL WARNINGS REGARDING USE OF
PROFITEN:
Since this medicine is intended for
asthma prophylaxis, it is not effective in
cases of acute asthma attacks. In such
cases, use other preparations.
When you start treatment with Profiten, do
not stop taking anti-asthma preparations
you are currently using )especially
preparations containing corticosteroids(
without the doctor’s permission. BEFORE TREATMENT WITH PROFITEN, TELL
THE DOCTOR IF:
∙ You are pregnant, planning to become
pregnant or are breastfeeding.
∙ You are suffering from epilepsy.
∙ You are suffering from a hereditary

خصائص المنتج

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Profiten Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg Ketotifen (as fumarate).
For the full list of excipients and information on excipients with
known effect, see section
4.4 and section 6.1.
3
PHARMACEUTICAL FORM
Clear to slightly yellow scored tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylactic treatment of bronchial asthma.
Symptomatic treatment of allergic conditions including bronchitis,
rhinitis, hay fever and urticaria.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults
1mg twice daily with food. If necessary the dose may be increased to
2mg twice daily.
Children
From 3 years of age: 1 mg twice daily with food.
For patients for whom a tablet form may no be suitable, an alternative
dosage form should be
considered.
Use in the elderly
No evidence exists that elderly patients require different dosages or
show different side-effects from
younger patients.
Patients known to be easily sedated should be given 0.5 -1 mg at night
for the first few days.
4.3
CONTRAINDICATIONS
o
Hypersensitivity to ketotifen or any of the excipients listed in
section 6.1.
o
Epilepsy
o
Patients being treated with oral antidiabetic agent
o
Breastfeeding
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
2
If intercurrent infection occurs, Profiten treatment must be
supplemented by specific antimicrobial
therapy.
Convulsions have been reported very rarely during Profiten therapy. As
Profiten may lower the
seizure threshold it should be used with caution in patients with a
history of epilepsy.
Thrombocytopenia may occur in patients taking Profiten at the same
time as oral antidiabetic
drugs (biguanides). The simultaneous administration of these drugs
should therefore be avoided
(see section 4.3).
In case of reduced attention, possibly due to the sedating effect of
Profiten, the dose should be
reduced.
Excipients with known effect:
Profiten Tablets contains Lactose. Patients with rare hereditary
problems of galactose intolera