SALAGEN

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

PILOCARPINE HYDROCHLORIDE

متاح من:

MEGAPHARM LTD

ATC رمز:

N07AX01

الشكل الصيدلاني:

TABLETS

تركيب:

PILOCARPINE HYDROCHLORIDE 5 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

EISAI INC., USA

المجموعة العلاجية:

PILOCARPINE

المجال العلاجي:

PILOCARPINE

الخصائص العلاجية:

For the treatment of symptoms of xerostomia and salivary gland hypofunction caused by radiotherapy for cancer of the head and neck. Sjogren detected by biopsy.

تاريخ الترخيص:

2017-06-30

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986
This medicine is dispensed with a physician’s prescription only
SALAGEN
TABLETS
ACTIVE INGREDIENT:
Each tablet contains pilocarpine hydrochloride 5.0 mg.
For a list of inactive and allergenic ingredients in the preparation,
see section
6 “Additional information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have any
further questions, consult your physician or pharmacist.
This medicine has been prescribed for your treatment. Do not pass it
on to
others. It may harm them even if it seems to you that their medical
condition
is similar.
1. WHAT IS THIS MEDICINE INTENDED FOR?
• For the treatment of symptoms of xerostomia and salivary gland
hypofunction
caused by radiotherapy for cancer of the head and neck.
• Sjogren detected by biopsy.
THERAPEUTIC GROUP: Parasympathomimetics
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
• You are allergic to the active ingredient, pilocarpine
hydrochloride, or to
any of the additional ingredients that the medicine contains )see
section
6 “Additional information”(.
• You are under the age of 18.
• You have untreated asthma.
• You have untreated heart or kidney disease.
• You have a chronic disease that is being treated with medicines
that act
like SALAGEN.
• You have an inflammation of the iris of the eye )iritis(.
SPECIAL WARNINGS REGARDING THE USE OF SALAGEN:
BEFORE YOU TAKE SALAGEN, TELL YOUR PHYSICIAN IF YOU SUFFER FROM:
• impaired lung function )e.g., asthma, chronic bronchitis and/or
chronic
obstructive pulmonary disease(.
• heart disease )e.g., heart failure, arrhythmias(.
• gallbladder problems )e.g. gallstones(.
• stomach problems )e.g., gastric ulcers(.
• impaired liver function.
• nervous system problems or mental disorders.
• impaired kidney function )e.g., renal insufficiency or kidney
stones(.
• eye disorders )e.g., narrow-angle g

خصائص المنتج

1. NAME OF THE MEDICINAL PRODUCT
Salagen
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg of pilocarpine hydrochloride.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

The treatment of symptoms of dry mouth from xerostomia and salivary
gland hypofunction
caused by radiotherapy for cancer of the head and neck.

The treatment of symptoms of dry mouth in patients
with Sjogren's Syndrome detected by
biopsy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Regardless of the indication, the starting dose in patients with
moderate hepatic impairment should be
5 mg twice daily, followed by adjustment based on therapeutic response
and tolerability. Patients with
mild hepatic insufficiency do not require dosage reductions. The use
of pilocarpine in patients with
severe hepatic insufficiency is not recommended. If needed, refer to
the Hepatic Insufficiency
subsection of the Precautions section of this label for definitions of
mild, moderate and severe hepatic
impairment.
Head & Neck Cancer Patients: The recommended initial dose of Salagen
Tablets is 5 mg taken three
times a day. Dosage should be titrated according to therapeutic
response and tolerance. The usual
dosage range is up to 15-30 mg per day. (Not to exceed 10 mg per
dose.) Although early improvement
may be realized, at least 12 weeks of uninterrupted therapy with
Salagen Tablets may be necessary to
assess whether a beneficial response will be achieved. The incidence
of the most common adverse
events increases with dose. The lowest dose that is tolerated and
effective should be used for
maintenance.
Sjogren's Syndrome Patients: The recommended dose of Salagen Tablets
is 5 mg taken four times a
day. Efficacy was established by 6 weeks of use.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Salagen is contraindicated in patients with clinically significant,
uncontrolled cardior