Cobisomyl 5mg/12.5mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

hydrochlorothiazide 12.5 mg, bisoprolol fumarate 5 mg

Available from:

Jenson Pharmaceutical Services Limited

ATC code:

C07BB07

INN (International Name):

hydrochlorothiazide, bisoprolol fumarate

Pharmaceutical form:

film-coated tablet

Authorization status:

Authorised

Authorization date:

2012-03-28

Patient Information leaflet

PAGE 1 OF 8 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

COBISOMYL 5 MG/12.5 MG FILM-COATED TABLETS 
COBISOMYL 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 Cobisomyl is and what it is used for 
2. 
What you need to know before you take Cobisomyl 
3. 
How to take Cobisomyl 
4. 
Possible side effects 
5. 
How to store Cobisomyl 
6. 
Contents of the pack and other information 

1. 
WHAT COBISOMYL 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 COBISOMYL

DO NOT TAKE COBISOMYL IF YOU 
-

are allergic to bisoprolol, hydrochlorothiazide, other thia

Summary of Product characteristics

PAGE 1 OF 12 

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

COBISOMYL 5 MG/12.5 MG FILM-COATED TABLET 
COBISOMYL 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. 

Cobisomyl 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. 

Cobisomyl 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. 

Cobisomyl 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