REVATIO

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

SILDENAFIL AS CITRATE

متاح من:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC رمز:

G04BE03

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

SILDENAFIL AS CITRATE 20 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

FAREVA AMBOISE, FRANCE

المجموعة العلاجية:

SILDENAFIL

المجال العلاجي:

SILDENAFIL

الخصائص العلاجية:

For adults > 18 years: Treatment of primary pulmonary hypertension (PPH) pulmonary hypertension (PH) associated with connective tissue disease (CTD) or PH following surgical repair at least 5 years previously of atrial septal defect (ASD) ventricular septal defect (VSD) patent ductus arteriosus (PDA) or aorto-pulmonary window.

تاريخ الترخيص:

2021-10-31

نشرة المعلومات

Revatio PIL CC 270422 English
2022-0075062
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
REVATIO
®
20 MG
FILM-COATED TABLETS
Each film-coated tablet contains SILDENAFIL (AS CITRATE) 20 MG
Inactive ingredients and allergens: See section 2 under “Important
information about some of this medicine’s
ingredients” and section 6 “Further information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE 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. This medicine is
intended for adults over 18 years old.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
This medicine is intended for treating pulmonary hypertension in
patients over 18 years old.
THERAPEUTIC GROUP:
Inhibitors of the enzyme phosphodiesterase 5 (PDE5).
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 containing nitrates, or nitric oxide donors
such as amyl nitrate.
These medicines are usually given for relief of chest pain (angina
pectoris). Revatio can
cause a serious increase in the effects of these medicines.
•
you are taking riociguat, a medicine used to treat pulmonary
hypertension (which can be
secondary to blood clots). Because PDE5 inhibitors such as Revatio
have been shown
to increase the hypotensive effect of this medicine. If you are taking
riociguat or are not
sure about it tell your doctor.
•
you have recently had a stroke, a heart attack or if you have severe
liver disease or very
low blood pressure (<90/50 mmHg).
•
you are taking medicine to treat fungal infections such as
ketoconazole or itraconazole
or medicines containing ri

خصائص المنتج

Revatio LPD CC 150822
1
2021-0072830
REVATIO
®
1.
NAME OF THE MEDICINAL PRODUCT
Revatio
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg of sildenafil (as citrate).
Excipients with known effect:
lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated Tablet.
White to off white, round, biconvex film-coated tablets marked
“Pfizer” on one side and “RVT 20”on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For
adults
>
18
years:
Treatment
of
primary
pulmonary
hypertension
(PPH)
pulmonary hypertension
(PH)
associated with connective tissue disease (CTD) or PH following
surgical repair at least 5 years previously of atrial
septal defect (ASD) ventricular septal defect (VSD) patent ductus
arteriosus (PDA) or aorto-pulmonary window.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should only be initiated and monitored by a physician
experienced in the treatment of pulmonary arterial
hypertension. In case of clinical deterioration in spite of Revatio
treatment, alternative therapies should be
considered.
Posology
Adults
The recommended dose is 20 mg three times a day (TID). Physicians
should advise patients who forget to take
Revatio to take a dose as soon as possible and then continue with the
normal dose. Patients should not take a double
dose to compensate for the missed dose.
Patients using other medicinal products
In general, any dose adjustment should be administered only after a
careful benefit-risk assessment. A downward
dose adjustment to 20 mg twice daily should be considered when
sildenafil is co-administered to patients already
receiving CYP3A4 inhibitors like erythromycin or saquinavir. A
downward dose adjustment to 20 mg once daily is
recommended in case of co-administration with more potent CYP3A4
inhibitors clarithromycin, telithromycin and
nefazodone. For the use of sildenafil with the most potent
CYP3A4 inhibitors, see section 4.3
.
Dose adjustments for
sildenafil may be required when co-administered with C