NOVABE #N/A

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Novagen Pharma (Pty) Ltd

Dosage:

Not Indicated

Pharmaceutical form:

#N/A

Composition:

None

Authorization status:

Registered

Patient Information leaflet

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SCHEDULING STATUS: S4
NOVABE, 10 MG TABLETS
EZETIMIBE
CONTAINS SUGAR
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING NOVABE
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other healthcare provider.
•
NOVABE 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 NOVABE is and what it is used for
2. What you need to know before you take NOVABE
3. How to take NOVABE
4. Possible side effects
5. How to store NOVABE
6. Contents of the pack and other information
1. WHAT NOVABE IS AND WHAT IT IS USED FOR
NOVABE contains the active substance ezetimibe 10 mg per tablet and
belongs to a group of medicines called
serum-cholesterol reducers.
NOVABE is a medicine used to lower increased cholesterol levels.
NOVABE lowers total cholesterol, as well as
LDL or “bad” cholesterol.
NOVABE works by reducing the cholesterol absorbed from your digestive
tract.
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NOVABE adds to the cholesterol-lowering effect of statins, a group of
medicines that reduce the cholesterol your
body makes by itself.
NOVABE is used in conjunction with diet, either alone, or with another
cholesterol lowering medicine (statin).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NOVABE
DO NOT TAKE NOVABE:
•
if you are hypersensitive (allergic) to ezetimibe or to any other
ingredients of NOVABE
•
if you are pregnant or breastfeeding
•
if you have moderate or severe liver problems
•
if you are a child below the age of 10 years
Do not take NOVABE together with a statin if you have active liver
disease or unexplained persistent elevations
in liver enzymes.
WARNINGS AND PRECAUTIONS
Tell your doctor or healthcare professional before taking NOVABE:
Take special care with NOVABE:
•
if you are taking NOVABE with a statin, please refer to the Patient
Information Leaflet for that particular
medicine
•
if you are

Summary of Product characteristics

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SCHEDULING STATUS:
S4
1. NAME OF THE MEDICINE
NOVABE (10 mg tablets)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg ezetimibe.
_Excipient with known effect: _
NOVABE contains sugar, lactose monohydrate 62 mg per tablet.
_ _
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablets.
White to off-white, uncoated, capsule shaped, bevelled edge tablets
debossed with “E Z” on one side and “10” on
the other side. The size is 8,1 mm x 4,1 mm.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PRIMARY HYPERCHOLESTEROLAEMIA:
NOVABE administered with an HMG-CoA reductase inhibitor (statin) or
alone, is indicated as adjunctive therapy
to diet for the reduction of elevated total cholesterol (total-C) and
low-density lipoprotein cholesterol (LDL-C), in
patients with primary (heterozygous familial and non-familial)
hypercholesterolaemia.
HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA (HOFH)
NOVABE administered with a statin is indicated for the reduction of
elevated total-C and LDL-C levels in patients
with HoFH.
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4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The patient should be on an appropriate lipid-lowering diet and weight
loss programme where indicated and should
continue on this diet during treatment with NOVABE.
The recommended dose of NOVABE is 10 mg once daily, used alone, with a
statin, or with fenofibrate.
ELDERLY PATIENTS
No dosage adjustment is required for elderly patients (see
section 5.2).
PAEDIATRIC PATIENTS
Children 10 years of age or older: No dosage adjustment is required
(see
section 5.2).
Children under 10 years of age: No clinical data on safety and
efficacy are available; therefore, treatment with
NOVABE is contraindicated.
HEPATIC IMPAIRMENT
No dosage adjustment is required in patients with mild hepatic
insufficiency (Child Pugh A). Treatment with
NOVABE is contraindicated in patients with moderate (Child Pugh B) or
severe (Child Pugh C) liver dysfunction
due to unknown effects (see section 4.3 and 5.2).
CO-ADMINISTRATION WITH BI