Telmisartan Jubilant 20mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TELMISARTAN

Available from:

Jubilant Pharmaceuticals nv Axxes Business Park, Guldensporenpark 22 – Block C, 9820 Merelbeke, Belgium

ATC code:

C09CA07

INN (International Name):

TELMISARTAN 20 mg

Pharmaceutical form:

TABLET

Composition:

TELMISARTAN 20 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Withdrawn

Authorization date:

2013-10-08

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 

TELMISARTAN JUBILANT 20 MG TABLETS 
TELMISARTAN JUBILANT 40 MG TABLETS 
TELMISARTAN JUBILANT 80 MG TABLETS 
_ _ 
Telmisartan 

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 Telmisartan Jubilant is and what it is used for 
2. 
What you need to know before you take Telmisartan Jubilant 
3. 
How to take Telmisartan Jubilant 
4. 
Possible side effects 
5. 
How to store Telmisartan Jubilant 
6. 
Contents of the pack and other information 

1. 
WHAT TELMISARTAN JUBILANT IS AND WHAT IT IS USED FOR 

Telmisartan Jubilant belongs to a class of medicines known as
angiotensin II receptor antagonists. 
Angiotensin II is a substance produced in your body which causes your
blood vessels to narrow, 
thus increasing your blood pressure. Telmisartan Jubilant blocks the
effect of angiotensin II so that 
the blood vessels relax, and your blood pressure is lowered. 

TELMISARTAN JUBILANT IS USED TO treat essential hypertension (high
blood pressure) in adults. 
‘Essential’ means that the high blood pressure is not caused by
any other condition. 

High blood pressure, if not treated, can damage blood vessels in
several organs, which could lead 
sometimes to heart attack, heart or kidney failure, stroke, or
blindness. There are usually no 
symptoms of high blood pressure before damage occurs. Thus it is
important to regularly measure 
blood pressure to verify if it is within the normal range. 
�

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Telmisartan Jubilant 20 mg tablets 
Telmisartan Jubilant 40 mg tablets 
Telmisartan Jubilant 80 mg tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

20 mg tablets 
Each tablet contains 20 mg telmisartan.  
Excipients with known effect: Each tablet contains 85 mg of mannitol
(E421) 

40 mg tablets 
Each tablet contains 40 mg telmisartan.  
Excipients with known effect: Each tablet contains 170 mg of mannital
(E421) 

80 mg tablets 
Each tablet contains 80 mg telmisartan.  
Excipients with known effect: Each tablet contains 339 mg of mannitol
(E421) 

For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Tablet. 

20 mg tablets are white to off-white, round, flat face, beveled edge
tablets, approximately 7.16 mm 
in diameter and approximately 2.60 mm thick, debossed with “B” on
one side and plain on the other 
side. 
40 mg tablets are white to off white, capsule shaped tablets,
approximately 12.15 mm in length, 
approximately 3.75 mm thick and approximately 6.10 mm in width,
debossed with “H” on one side 
and plain on other side.  
80 mg tablets are white to off white, oval shaped tablets,
approximately 16.40 mm in length, 
approximately 4.70 mm thick and approximately 8.10 mm width, debossed
with “D” on one side 
and plain on other side. 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Hypertension 
Treatment of essential hypertension in adults. 

Page 1 of 13 

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 

Posology 

_Treatment of essential hypertension _
The usually effective dose is 40 mg once daily. Some patients may
already benefit at a daily dose of 
20 mg. In cases where the target blood pressure is not achieved, the
dose of telmisartan can be 
increased to a maximum of 80 mg once daily. Alternatively,
telmisartan may be used in 
combination with thiazide-type diuretics