PERMIXON 160 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

LIPIDOSTEROLIC EXTRACT OF SERENOA REPENS

متاح من:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

الشكل الصيدلاني:

CAPSULES

تركيب:

LIPIDOSTEROLIC EXTRACT OF SERENOA REPENS 160 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

PIERRE FABRE MEDICAMENT, FRANCE

الخصائص العلاجية:

Treatment of moderate micturation troubles related to benign hypertrophy of prostate in adult men.

تاريخ الترخيص:

2013-12-31

نشرة المعلومات

PATIENT PACKAGE
INSERT ACCORDING TO
PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
This medicine can be dispensed
with a doctor’s prescription only
PERMIXON
® 160 MG
CAPSULES
COMPOSITION:
ACTIVE INGREDIENT AND ITS QUANTITY –
EACH CAPSULE CONTAINS:
Lipidosterolic Extract of Serenoa
Repens 160 mg
Inactive ingredients and allergens
in the medicine: see section 6.
READ THE LEAFLET CAREFULLY IN
ITS ENTIRETY BEFORE USING THE
MEDICINE. This leaflet contains
concise information about the
medicine. If you have any further
questions, ask your doctor or
pharmacist.
This
medicine
has
been
prescribed for your treatment. Do
not pass it on to others. It might
harm them, even if you think that
their medical condition is similar.
1. WHAT IS THE MEDICINE
INTENDED FOR?
Treatment of moderate micturition
troubles
related
to
benign
hypertrophy of prostate in adult men.
THERAPEUTIC GROUP: a medicinal
product that is used for the
treatment of benign hypertrophy
of the prostate.
2. BEFORE
USING
THE
MEDICINE
DO NOT USE THE MEDICINE IF:
•
You are hypersensitive )allergic(
to
the
active
ingredient
Lipidosterolic
Extract
of
Serenoa Repens or to any of
the other ingredients contained
in the medicine )see section 6(.
SPECIAL WARNINGS REGARDING THE
USE OF THIS MEDICINE
•
Taking the medicine on an empty
stomach may cause nausea.
• While using the medicine it
is necessary to monitor your
prostate
regularly
by
your
doctor. Under no circumstances
may Permixon replace surgery,
if surgery is necessary.
DRUG INTERACTIONS
IF YOU ARE TAKING, OR HAVE RECENTLY
TAKEN OTHER MEDICINES, INCLUDING
NON-PRESCRIPTION DRUGS AND
NUTRITION SUPPLEMENTS, TELL THE
DOCTOR OR PHARMACIST.
USE OF THIS MEDICINE AND FOOD
Take this medicine with meals.
PREGNANCY, BREASTFEEDING AND
FERTILITY
This medicinal product is not
intended for use in women.
3.
HOW TO USE THIS MEDICINE
Always
use
according
to
the
doctor’s instructions. Check with the
doctor or pharmacist if you are not
sure about the dosage or manner of
treatment with the medicine.
The
dosage
and
manner

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
PERMIXON
_®_
160 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lipidosterolic Extract of Serenoa Repens 160mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Capsule
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of moderate micturition troubles related to benign
hypertrophy of
prostate in adult men.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
2 capsules a day, at mealtimes,should be taken with a glass of water.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In accordance with the routine monitoring of benign prostatic
hypertrophy, the patient must be
under ongoing medical supervision during treatment_._
Taking this medicinal product on empty stomach may cause nausea.
4.5 INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
The results of in vitro studies showed the lack of inhibition
potential of the Lipido-
sterolic Extract of Serenoa Repens.
4.6 FERTILITY, PREGNANCY AND BREASTFEEDING
Not applicable, as this medicinal product is not indicated in women.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Effects on the ability to drive and use machines have not been
studied.
4.8 UNDESIRABLE EFFECTS
The following table shows the undesirable effects observed in 7
clinical studies on
3,595 patients in total, 2,127 of which were taking Permixon, for
which the
assessment of causality was not “excluded”.
The undesirable effects are presented according to the MedDRA system
organ class
and listed below as very common (
≥
1/10), common (
≥
1/100 , < 1/10), uncommon
(
≥
1/1,000 , < 1/100), rare (
≥
1/10,000, < 1/1,000), very rare (< 1/10,000) and
unknown (cannot be estimated on the basis of available data).
The analysis showed no rare, very rare or very common undesirable
effect. Thus,
these frequencies are not represented in the table.
COMMON >=1% TO 10% UNCOMMON >=0.1% TO 1% UNK