SILDAZEN

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

SILDENAFIL AS CITRATE

متاح من:

TARO INTERNATIONAL LTD, ISRAEL

ATC رمز:

G04BE03

الشكل الصيدلاني:

SUSPENSION FOR ORAL SPRAY

تركيب:

SILDENAFIL AS CITRATE 25 MG / 1 ML

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

Required

المصنعة من قبل:

FARMALIDER S.A., SPAIN

المجال العلاجي:

SILDENAFIL

الخصائص العلاجية:

Sildazen is indicated in the treatment for adult men with erectile dysfunction.

تاريخ الترخيص:

2022-10-19

نشرة المعلومات

1
Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) - 1986
This medicine is dispensed with a doctor's prescription only
Sildazen
12.5 mg/actuation, oral suspension
Active ingredient
1 ml of suspension contains 25 mg sildenafil (as citrate)
Inactive ingredients and allergens: see section 2 under ‘Important
information about some of
this medicine’s ingredients’, and section 6 ‘Additional
information'.
Read the entire leaflet carefully before you start using this
medicine. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
1.
What is this medicine intended for?
Sildazen is intended for treatment of erectile dysfunction in adult
men (impotence).
This happens when a man cannot get, or keep a firm erection suitable
for satisfactory sexual
activity.
Therapeutic group: phosphodiesterase type 5 inhibitor (PDE5).
Sildazen works by dilating the blood vessels in your penis, allowing
blood to flow into it when
you are sexually stimulated. Sildazen will only help you to get an
erection if you are sexually
stimulated.
2.
Before using this medicine
Do not use this medicine if:
-
You are sensitive (allergic) to sildenafil or to any of the other
ingredients in this
medicine (see section 6).
-
You are taking medicines called nitrates, as the combination may lead
to a dangerous
fall in your blood pressure. Tell your doctor if you are taking any of
these medicines,
which are often given for relief of angina pectoris (chest pain).
-
You are using any of the medicines known as nitric oxide donors such
as amyl nitrite
(“poppers”), such as certain medicines for treatment of angina
pectoris (chest pain),
as the combination may lead to a dangerous fall in your blood
pressure.
-
You are taking riociguat. This medicine is used to treat pulmonary
arterial
hyper

خصائص المنتج

1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Sildazen
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre of suspension contains sildenafil citrate equivalent
to 25 mg of sildenafil (35.1 mg
as sildenafil citrate).
Each actuation delivers 0.5 mL of suspension which contains 12.5 mg of
sildenafil.
Excipient with known effect:
Each millilitre of suspension contains 1 mg of sodium benzoate (E211).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
White to off-white suspension, free of foreign substances with mint
odour.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Sildazen is indicated in adult men with erectile dysfunction.
In order for Sildazen to be effective, sexual stimulation is required.
4.2 Posology and method of administration
Posology
_Use in adults _
The recommended dose is 2 mL (4 actuations), equivalent to 50 mg of
sildenafil taken as
needed, approximately one hour before sexual activity. Based on
efficacy and tolerability, the
dose may be increased to 4 mL (8 actuations), equivalent to 100 mg, or
decreased to 1 mL
(2 actuations), equivalent to 25 mg of sildenafil. The maximum
recommended dose is 4 mL
(8 actuations), equivalent to 100 mg of sildenafil. The maximum
recommended dosing
frequency is once per day. If Sildazen is taken with food, the onset
of its pharmacological activity
may be delayed compared to the fasted state (see section 5.2).
Number of actuations
Quantity of suspension
delivered
Quantity of sildenafil
2
1 mL
25 mg
4
2 mL
50 mg
8
4 mL
100 mg
Each actuation delivers 0.5 mL of product which contains 12.5 mg of
sildenafil.
Special populations
_Elderly_
_ _
Dosage adjustments are not required in elderly patients (patients aged
65 years or older).
Page 2 of 17
_Renal impairment _
The dosage recommendations described under “Use in adults” are
applicable to patients with
mild to moderate renal impairment (creatinine clearance = 30-80
mL/min).
Since sildenafil clearance is reduced in patients with severe renal
impairment (