NORVASC 5 MG TABLETS
البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
نشرة المعلومات
(PIL)
01-03-2023
خصائص المنتج
(SPC)
30-08-2022
تقرير التقييم الجمهور
(PAR)
17-08-2016
العنصر النشط:
AMLODIPINE AS BESYLATE
متاح من:
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
ATC رمز:
C08CA01
الشكل الصيدلاني:
TABLETS
تركيب:
AMLODIPINE AS BESYLATE 5 MG
طريقة التعاطي:
PER OS
نوع الوصفة الطبية :
Required
المصنعة من قبل:
PFIZER INC, USA
المجموعة العلاجية:
AMLODIPINE
المجال العلاجي:
AMLODIPINE
الخصائص العلاجية:
Mild to moderate hypertension. Vasospastic angina ( Prinzmetal's or variant angina). Chronic stable angina.
تاريخ الترخيص:
2023-11-30
نشرة المعلومات
Norvasc PIL CC 180123
2
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
NORVASC
®
5 MG
NORVASC
®
10 MG
TABLETS
EACH TABLET CONTAINS:
AMLODIPINE (AS BESYLATE) 5 MG, 10 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. Consult your doctor or pharmacist if
you have any further
questions.
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?
•
treating hypertension
•
treating chronic stable angina pectoris
•
treating vasospastic angina pectoris (called Prinzmetal angina)
THERAPEUTIC GROUP:
calcium channel blockers (dihydropyridines).
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
other ingredients in this
medicine (see section 6) or other calcium channel blockers. This
sensitivity may be
experienced as itching, reddening of the skin, or difficulty in
breathing.
•
You have severe low blood pressure (hypotension).
•
You have a narrowing of the aortic heart valve (aortic stenosis) or
cardiogenic shock (a
condition where your heart is unable to supply enough blood to the
body).
•
You have heart failure after a heart attack.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE STARTING TREATMENT WITH NORVASC TELL YOUR DOCTOR IF YOU HAVE OR
HAVE EVER HAD ANY OF
THE FOLLOWING CONDITIONS:
•
a recent heart attack
•
heart failure
•
severe increase in blood pressure (hypertensive crisis)
•
liver disease
•
you are elderly and need a dose increase
CHILDREN AND ADOLESCENTS
There is no information regarding the safety and effectiven
اقرأ الوثيقة كاملة
خصائص المنتج
Norvasc LPD CC 270722
Pfleet 2022-0078743
1 NORVASC
® 5 MG TABLETS
NORVASC
® 10 MG TABLETS
1. NAME OF THE MEDICINAL PRODUCT
Norvasc
®
5mg Tablets
Norvasc
®
10mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains amlodipine (as besylate) equivalent to 5 or 10mg
amlodipine.
Excipients: For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Norvasc 5mg tablets: White to off-white, emerald-shaped tablets
engraved "AML-5" and breaker score on one
side and Pfizer logo on the other side or blank on the other side.
Norvasc 10mg tablets: White to off-white, emerald-shaped tablets
engraved "AML-10" on one side and Pfizer
logo on the other side or blank on the other side.
The 5 mg tablet can be divided into equal halves.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1. Treatment of mild to moderate Hypertension. It may be used alone or
in combination with other
antihypertensive agents.
2. Treatment of chronic stable Angina. Norvasc may be used alone or in
combination with other antianginal
agents.
3. Treatment of confirmed or suspected vasospastic Angina
(Prinzmetal’s or variant Angina). Norvasc may be
used as monotherapy or in combination with other antianginal drugs.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults
For both hypertension and angina, the usual initial dose is 5 mg once
daily which may be increased to a
maximum dose of 10 mg depending on the individual patient's response.
In hypertensive patients, Norvasc has been used as monotherapy or in
combination with a thiazide diuretic, alpha
blocker, beta blocker, or an angiotensin converting enzyme inhibitor.
For angina, Norvasc may be used as
monotherapy or in combination with other antianginal medicinal
products.
Norvasc LPD CC 270722
Pfleet 2022-0078743
2
No dose adjustment of Norvasc is required upon concomitant
administration of thiazide diuretics, beta blockers,
and angiotensin-converting enzyme inhibitors.
Dosage should be adjusted according to each patient’s need. In
general, titration should pro
اقرأ الوثيقة كاملة
