CANURETIC Tablets

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Austell Pharmaceuticals (Pty) Ltd

Dosage:

Not Indicated

Pharmaceutical form:

Tablets

Composition:

Each tablet contains CANDESARTAN CILEXETIL 16,0 mg and HYDROCHLOROTHIAZIDE 12,5 mg

Authorization status:

Registered

Authorization date:

2022-04-08

Patient Information leaflet

Austell Pharmaceuticals (Pty) Ltd, 49/7.1.3/0054, CANURETIC, 16/12,5
mg, Tablets
2023.02.02 (v4) Page 1 of 12
APPROVED PATIENT INFORMATION LEAFLET FOR MEDICINES FOR HUMAN USE:
CANURETIC
SCHEDULING STATUS: S3
CANURETIC
EACH TABLET CONTAINS 16 MG CANDESARTAN CILEXETIL AND
12,5 MG HYDROCHLOROTHIAZIDE
CONTAINS SUGAR (LACTOSE MONOHYDRATE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING CANURETIC.
•
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.
•
CANURETIC 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.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What CANURETIC is and what it is used for
2. What you need to know before you take CANURETIC
3. How to take CANURETIC
4. Possible side effects
5. How to store CANURETIC
6. Contents of the pack and other information
1. WHAT CANURETIC IS AND WHAT IT IS USED FOR
Austell Pharmaceuticals (Pty) Ltd, 49/7.1.3/0054, CANURETIC, 16/12,5
mg, Tablets
2023.02.02 (v4) Page 2 of 12
CANURETIC is used for treating high blood pressure (hypertension) in
adult patients. It contains two
active ingredients: candesartan cilexetil and hydrochlorothiazide.
These work together to lower your
blood pressure.
•
Candesartan cilexetil belongs to a group of medicines called
angiotensin II receptor antagonists. It makes your blood vessels relax
and widen. This helps
to lower your blood pressure.
•
Hydrochlorothiazide belongs to a group of medicines called diuretics
(water tablets). It helps
your body to get rid of water and salts like sodium in your urine.
This helps to lower your
blood pressure.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CANURETIC
DO NOT TAKE CANURETIC:
•
If you are allergic (hypersensitive) to candesartan cilexetil or
h

Summary of Product characteristics

Austell Pharmaceuticals (Pty) Ltd, 49/7.1.3/0054, CANURETIC, 16/12,5
mg, Tablets
2023.02.02 (v4) Page 1 of 22
APPROVED PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE:
CANURETIC
SCHEDULING STATUS
S3
1. NAME OF THE MEDICINE
CANURETIC
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
CANURETIC:
Each tablet contains 16 mg candesartan cilexetil and
12,5 mg hydrochlorothiazide.
Contains sugar (lactose monohydrate):
182,1 mg lactose monohydrate per tablet
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
CANURETIC tablets are white, elliptic biconvex tablets, marked _CH_
and _16_ on the same face; and are
scored on both faces.
Thickness: 4.3 ± 0.2 mm
Length: 12.0 ± 0.2 mm
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Austell Pharmaceuticals (Pty) Ltd, 49/7.1.3/0054, CANURETIC, 16/12,5
mg, Tablets
2023.02.02 (v4) Page 2 of 22
CANURETIC is indicated for essential hypertension in patients
stabilised on the individual
components given at the same dosages.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
CANURETIC should be taken once daily and may be taken with or without
food.
Most of the antihypertensive effect is usually attained within 4 weeks
of initiation of treatment.
_ _
SPECIAL POPULATIONS
_ELDERLY PATIENTS _
No special dosage recommendations.
_ _
_PATIENTS WITH IMPAIRED RENAL FUNCTION _
CANURETIC should not be used in patients with moderate to severe renal
impairment (creatinine
clearance ≤ 60 mL / min / 1,73 m
2
BSA).
_PATIENTS WITH IMPAIRED HEPATIC FUNCTION _
CANURETIC should not be used in patients with moderate to severe
hepatic impairment and / or
cholestasis.
PAEDIATRIC POPULATION
The safety and efficacy of CANURETIC has not been established in
children.
METHOD OF ADMINISTRATION
CANURETIC should be taken once daily and may be taken with or without
food.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to irbesartan, hydrochlorothiazide or to any of the
excipients listed in sec