Cardimyl 5mg/12.5mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE

Available from:

Jenson Pharmaceutical Services Limited

ATC code:

C07BB07

INN (International Name):

HYDROCHLOROTHIAZIDE 12.5 mg BISOPROLOL FUMARATE 5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

HYDROCHLOROTHIAZIDE 12.5 mg BISOPROLOL FUMARATE 5 mg

Prescription type:

POM

Therapeutic area:

BETA BLOCKING AGENTS

Authorization status:

Withdrawn

Authorization date:

2012-03-28

Patient Information leaflet

PAGE 1 OF 7 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

CARDIMYL 5 MG/12.5 MG FILM-COATED TABLETS 
CARDIMYL 10 MG/25 MG FILM-COATED TABLETS 
Bisoprolol fumarate 
Hydrochlorothiazide 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU. 
- 
Keep this leaflet. You may need to read it again. 
- 
If you have any further questions, ask your doctor
or pharmacist. 
- 
This medicine has been prescribed for you only.  Do not pass it
on to others.  It may harm them, 
even if their signs of illness 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. 

WHAT IS IN THIS LEAFLET:  
1. 
What Cardimyl is and what it is used for 
2. 
What you need to know before you take Cardimyl 
3. 
How to take Cardimyl 
4. 
Possible side effects 
5. 
How to store Cardimyl 
6. 
Contents of the pack and other information 

1. 
WHAT CARDIMYL IS AND WHAT IT IS USED FOR 

The active substances are bisoprolol and hydrochlorothiazide: 
Bisoprolol belongs to the family of medicines called beta-blockers
and it is used to decrease blood 
pressure. 
Hydrochlorothiazide belongs to the family of medicines called
thiazide diuretics (also known as 
“water tablets”). This product helps to lower blood pressure
by increasing the elimination of urine. 

This medicine is recommended in the treatment of high blood pressure
in patients whose blood 
pressure is not sufficiently controlled by bisoprolol
or hydrochlorothiazide alone.

2. 
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARDIMYL

DO NOT TAKE CARDIMYL IF YOU 
- 
are allergic to bisoprolol, hydrochlorothiazide, other thiazides,
sulphonamides (substances 
chemically related to hydrochlorothiazide) or any of the other
ingredients of this medicine 
(listed in section 6) 
- 
suffer from acute weakness of the heart muscle

Summary of Product characteristics

PAGE 1 OF 12 

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

CARDIMYL  5 MG/12.5 MG FILM-COATED TABLET 
CARDIMYL 10 MG/25 MG FILM-COATED TABLET

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each 5 mg/12.5 mg film-coated tablet contains:  
5 mg bisoprolol fumarate 
12.5 mg hydrochlorothiazide 

Each 10 mg/25 mg film-coated tablet contains:  
10 mg bisoprolol fumarate 
25 mg hydrochlorothiazide 

Excipient with known effect: 
Each tablet contains: 
29.3 mg lactose (anhydrous) 

For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Film-coated tablet. Diameter: 7.6 mm. 

Cardimyl 5 mg/12.5 mg film-coated tablet 
A pinkish grey, film coated, round, biconvex tablet debossed with
‘BH4’ over ‘M’ on one side and breakline 
on the other side of the tablet. 

5/12.5 mg only: The score line is only to facilitate breaking for
ease of swallowing and not to divide into 
equal doses. 

Cardimyl 10 mg/25 mg film-coated tablet 
A reddish grey, film coated, round, biconvex tablet debossed with
‘BH5’ over ‘M’ on one side and breakline 
on the other side of the tablet. 

10/25 mg only: The tablet can be divided into equal doses. 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Essential hypertension. 
The fixed-dose combination of bisoprolol fumarate/hydrochlorothiazide
5 mg/12.5 mg or bisoprolol 
fumarate/hydrochlorothiazide 10 mg/25 mg is indicated in
patients whose blood pressure cannot be 
adequately controlled using bisoprolol or hydrochlorothiazide
alone. 

Cardimyl is indicated in adults only. 
PAGE 2 OF 12 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Posology 

Individual dose titration with each single component is recommended.
If clinically appropriate, a direct 
switch from monotherapy to the fixed combination may be taken into
consideration. 

The usual dose is 5 mg bisoprolol and 1