Bosentan Dr. Reddy’s 62.5mg Film-Coated Tablets

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

bosentan

Available from:

Dr. Reddy’s Laboratories (UK) Ltd.

ATC code:

C02KX01

INN (International Name):

bosentan

Dosage:

62.5mg

Pharmaceutical form:

Film-coated tablet

Administration route:

oral use

Units in package:

Pack sizes: 14, 56 or 112 tablets

Prescription type:

POM prescription only medicine

Manufactured by:

Dr. Reddy’s Laboratories (UK) Ltd.

Therapeutic group:

other antihypertensives

Therapeutic indications:

Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III. Efficacy has been shown in: • Primary (idiopathic and heritable) pulmonary arterial hypertension • Pulmonary arterial hypertension secondary to scleroderma without significant interstitial pulmonary disease • Pulmonary arterial hypertension associated with congenital systemic-topulmonary shunts and Eisenmenger’s physiology

Authorization status:

authorized

Authorization date:

2015-03-02

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 

BOSENTAN 62.5 MG, 125 MG FILM-COATED TABLETS _ _
Bosentan 

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. See 
section 4. 

WHAT IS IN THIS LEAFLET 
1.  WHAT BOSENTAN IS AND WHAT IT IS USED FOR 
2.  WHAT YOU NEED TO KNOW BEFORE YOU TAKE BOSENTAN 
3.  HOW TO TAKE BOSENTAN 
4.  POSSIBLE SIDE EFFECTS 
5.  HOW TO STORE BOSENTAN 
6.  CONTENTS OF THE PACK AND OTHER INFORMATION 

1.  
WHAT BOSENTAN IS AND WHAT IT IS USED FOR 

Bosentan tablets contain bosentan, which blocks a naturally 
occurring hormone called endothelin-1 (ET-1), which causes 
blood vessels to narrow. Bosentan therefore causes blood 
vessels to expand and belongs to the class of
medicines called 
‘endothelin receptor antagonists’. 

Bosentan is used to treat:  


PULMONARY ARTERIAL HYPERTENSION (PAH): PAH is a disease 
of severe narrowing of the blood vessels in the lungs 
resulting in high blood pressure in the blood vessels (the 
pulmonary arteries) that carry blood from the heart to the 
lungs. This pressure reduces the amount of oxygen that can 
get into the blood in the lungs, making physical activity more 
difficult. Bosentan widens the pulmonary arteries, making it 
easier for the heart to pump blood through them.
This lowers 
the blood p

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Bosentan Dr. Reddy’s 62.5 mg Film-Coated Tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each film-coated tablet contains 62.5 mg bosentan (as monohydrate).

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Film-coated tablet  

Light orange, film-coated, round biconvex tablets (diameter 6 mm),
debossed with 
“62.5” on one side and plain on the other side. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
Treatment of pulmonary arterial hypertension (PAH) to improve
exercise capacity 
and symptoms in patients with WHO functional
class III. Efficacy has been shown in:  
•

Primary (idiopathic and heritable) pulmonary arterial hypertension

•

Pulmonary arterial hypertension secondary to scleroderma
without significant 
interstitial pulmonary disease  
•

Pulmonary arterial hypertension associated with
congenital systemic-to-
pulmonary shunts and Eisenmenger’s physiology  

Some improvements have also been shown in patients with
pulmonary arterial 
hypertension WHO functional class II (see section 5.1).  

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Method of administration  
Tablets are to be taken orally morning and evening, with or
without food. The film-
coated tablets are to be swallowed with water.  

Posology  
Pulmonary arterial hypertension  
Treatment should only be initiated and monitored by a physician
experienced in the 
treatment of pulmonary arterial hypertension. 

_Adults _ 
In adult patients, Bosentan treatment should be initiated at
a dose of 62.5 mg twice 
daily for 4 weeks and then increased to the maintenance dose of
125 mg twice daily. 
The same recommendations apply to re-introduction
of Bosentan after treatment 
interruption (see section 4.4).  

_Paediatric population _ 
In c