Fosinopril + Hydrochlorothiazide Aurobindo 20mg + 12.5mg, Tablets

Country: মাল্টা

ভাষা: ইংরেজি

সূত্র: Medicines Authority

সক্রিয় উপাদান:

FOSINOPRIL SODIUM, HYDROCHLOROTHIAZIDE

থেকে পাওয়া:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

এটিসি কোড:

C09BA09

INN (International Name):

FOSINOPRIL SODIUM 20 mg HYDROCHLOROTHIAZIDE 12.5 mg

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

FOSINOPRIL SODIUM 20 mg HYDROCHLOROTHIAZIDE 12.5 mg

প্রেসক্রিপশন টাইপ:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

2013-11-27

তথ্য লিফলেট

Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE USER
FOSINOPRIL + HYDROCHLOROTHIAZIDE AUROBINDO 20 MG + 12.5 MG TABLETS
fosinopril sodium + 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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Fosinopril + Hydrochlorothiazide Aurobindo is and what it is used
for
2.
What you need to know before you take Fosinopril + Hydrochlorothiazide
Aurobindo
3.
How to take use Fosinopril + Hydrochlorothiazide Aurobindo
4.
Possible side effects
5.
How to store Fosinopril + Hydrochlorothiazide Aurobindo
6.
Contents of the pack and other information
1.
WHAT FOSINOPRIL + HYDROCHLOROTHIAZIDE AUROBINDO IS AND WHAT IT IS USED
FOR
Fosinopril + Hydrochlorothiazide Aurobindo contains two active
substances, fosinopril (and
hydrochlorothiazide.
Fosinopril belongs to a group of medicines known as angiotensin ACE
inhibitors.
Fosinopril belongs to the group of medicines called antihypertensives
(which are used to lower blood
pressure) and is an angiotensin converting enzyme inhibitors (ACE
inhibitors).
Hydrochlorothiazide belongs to a group of medicines known as thiazide
diuretics and is an
antihypertensive (lowers blood pressure).
Fosinopril + Hydrochlorothiazide Aurobindo is used in the treatment of
high blood pressure when
treatment with fosinopril alone is not effective.
It may also be used to replace separate tablets containing 20 mg of
fosinopril and 12.5 mg of
hydrochlorothiazide
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOSINOPRIL + HYDROCHLOROTHIAZIDE
AUROBINDO
DO NOT TAKE FOSINOPRIL + HYDROCHLOROTHI

পণ্য বৈশিষ্ট্য

Page 1 of 23
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fosinopril + Hydrochlorothiazide Aurobindo 20 mg + 12.5 mg, Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of fosinopril sodium and 12.5 mg of
hydrochlorothiazide.
Excipient(s) with known effect:
Each tablet contains 238,776 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Peach colored, round, biconvex, uncoated tablets debossed with ‘C
85’ on one side and deep score line on
the other side. The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Fosinopril + Hydrochlorothiazide Aurobindo is indicated for the
treatment of essential hypertension in
patients who have inadequately responded to the treatment with
fosinopril as monotherapy.
The fixed dose may also replace the combination of 20 mg fosinopril
and 12.5 mg hydrochlorothiazide in
patients who have been stabilised on the individual active substances
given in the same proportions as
separate medications.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
Dosage has to be individualized (see sections 4.3, 4.4, 4.5 and 5.1).
The fixed dose combination is not suitable for initial therapy.
Individual dose titration with the components is recommended. When
clinically appropriate, direct change
from monotherapy to the fixed combination may be considered.
Adults: The usual dose is one tablet once daily.
Special populations:
Renal impairment: In patients with renal impairment (creatinine
clearance > 30 mL/min and < 80 ml/min)
dose adjustment should be carried out with special care and individual
dose titration with the
monocomponents is recommended, prior to using the fixed combination.
Fosinopril + Hydrochlorothiazide
Page 2 of 23
Aurobindo is contra-indicated in patients with severe renal impairment
(creatinine clearance <30 ml/min)
(see sections 4.3 and 4.4).
Hepatic impairment: No initial dose adjustment is necessary in
pa