NORVASC TABLETS 5 mg

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Viatris Healthcare (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO 5 mg AMLODIPINE

Authorization status:

Registered

Authorization date:

1993-02-11

Patient Information leaflet

Viatris Healthcare (Pty) Ltd
Page 1 of 8
Norvasc Tablets 5 mg and 10 mg
Final Approved Patient Information Leaflet – 19 February 2024
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S3
NORVASC
® TABLETS 5 MG
NORVASC
® TABLETS 10 MG
AMLODIPINE BESYLATE
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING NORVASC
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care provider.
•
NORVASC has been prescribed for you personally and you should not
share your medicine with other
people. It may harm them, even if their symptoms are the same as
yours.
WHAT IS IN THIS LEAFLET
1. What NORVASC is and what it is used for
2. What you need to know before you take NORVASC
3. How to take NORVASC
4. Possible side effects
5. How to store NORVASC
6. Contents of the pack and other information
1. WHAT NORVASC IS AND WHAT IT IS USED FOR
NORVASC belongs to a group of medicines called calcium antagonists.
NORVASC is used to treat high blood pressure (hypertension) and a type
of chest pain called angina, a
rare form of which is Prinzmetal’s or variant angina. NORVASC is
also used to reduce the risk of fatal and
non-fatal heart disease or stroke.
NORVASC can be used alone or with other medicines to treat these
conditions.
Viatris Healthcare (Pty) Ltd
Page 2 of 8
Norvasc Tablets 5 mg and 10 mg
Final Approved Patient Information Leaflet – 19 February 2024
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORVASC
DO NOT TAKE NORVASC:
•
If you are hypersensitive (allergic) to amlodipine or any of the other
ingredients of NORVASC (listed in
section 6).
•
If you have had an allergic reaction to other medicines of this type.
•
In combination with grapefruit juice.
•
If you have severe low blood pressure (hypotension).
•
If you have cardiogenic shock (a condition where your heart is unable
to supply enough blood to the
body).
•
If you have narrowing of the aortic heart valve (aortic stenosis) or
cardiogenic shock (a conditi

Summary of Product characteristics

Viatris Healthcare (Pty) Ltd
Page 1 of 14
Norvasc Tablets 5 mg and 10 mg
Final Approved Professional Information – 19 February 2024
SCHEDULING STATUS: S3
1. NAME OF THE MEDICINE
NORVASC
® TABLETS 5 MG
NORVASC
® TABLETS 10 MG
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each NORVASC 5 mg tablet contains amlodipine besylate equivalent to 5
mg active amlodipine base.
Each NORVASC 10 mg tablet contains amlodipine besylate equivalent to
10 mg active amlodipine base.
Sugar free.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
TABLETS
NORVASC 5 mg: White, emerald shaped tablets marked PFIZER on one side
and AML-5 on the other.
NORVASC 10 mg: White, emerald shaped tablets marked PFIZER on one side
and AML-10 on the other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
HYPERTENSION
NORVASC is indicated for the treatment of mild to moderate
hypertension. NORVASC may be combined
with other antihypertensive medicines.
CORONARY ARTERY DISEASE (CAD)
_Angina pectoris _
NORVASC is indicated for the treatment of angina pectoris.
_Chronic stable angina _
NORVASC is indicated for the first line treatment of myocardial
ischaemia, whether due to fixed obstruction
Viatris Healthcare (Pty) Ltd
Page 2 of 14
Norvasc Tablets 5 mg and 10 mg
Final Approved Professional Information – 19 February 2024
(stable
angina)
and/or
vasospasm/vasoconstriction
(Prinzmetal's
or
variant
angina)
of
coronary
vasculature. NORVASC may be used alone, as monotherapy, or in
combination with other antianginal
medicines.
_Coronary artery disease _
NORVASC is indicated to reduce the risk of coronary revascularisation
and the need for hospitalisation
due to angina in patients with coronary artery disease.
NORVASC is also indicated to reduce the risk of fatal coronary heart
disease and non-fatal myocardial
infarction, and to reduce the risk of stroke.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Hypertension and angina pectoris _
The initial dose is 5 mg NORVASC once daily, which may be increased to
a maximum dose of 10 mg
d