Ramipril/Hydrochlorothiazide TAD 2.5 mg/12.5 mg tablets

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

RAMIPRIL, HYDROCHLOROTHIAZIDE

Dostopno od:

TAD Pharma GmbH Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany

Koda artikla:

C09BA05

INN (mednarodno ime):

RAMIPRIL 2.5 mg HYDROCHLOROTHIAZIDE 12.5 mg

Farmacevtska oblika:

TABLET

Sestava:

RAMIPRIL 2.5 mg HYDROCHLOROTHIAZIDE 12.5 mg

Tip zastaranja:

POM

Terapevtsko območje:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Status dovoljenje:

Authorised

Datum dovoljenje:

2016-04-18

Navodilo za uporabo

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RAMIPRIL/HYDROCHLOROTHIAZIDE TAD 2.5 MG/12.5 MG TABLETS
RAMIPRIL/HYDROCHLOROTHIAZIDE TAD 5 MG/25 MG TABLETS
ramipril/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 Ramipril/Hydrochlorothiazide TAD is and what it is used for
2.
What you need to know before you take Ramipril/Hydrochlorothiazide TAD
3.
How to take Ramipril/Hydrochlorothiazide TAD
4.
Possible side effects
5.
How to store Ramipril/Hydrochlorothiazide TAD
6.
Contents of the pack and other information
1.
WHAT RAMIPRIL/HYDROCHLOROTHIAZIDE TAD IS AND WHAT IT IS USED FOR
Ramipril/Hydrochlorothiazide TAD is a combination of two medicines
called ramipril and
hydrochlorothiazide.
Ramipril belongs to a group of medicines called “ACE inhibitors”
(Angiotensin Converting Enzyme
Inhibitors). It works by:
-
Decreasing your body’s production of substances that raise your
blood pressure.
-
Making your blood vessels relax and widen.
-
Making it easier for your heart to pump blood around your body.
Hydrochlorothiazide belongs to a group of medicines called “thiazide
diuretics” or water tablets. It
works by increasing the amount of water (urine) you produce. This
lowers your blood pressure.
Ramipril/Hydrochlorothiazide TAD is used to treat high blood pressure.
The two active substances
work together to lower your blood pressure. They are used together
when treatment with just one did
not work.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAMIPRIL/HYDROCHLOROTHIAZIDE TAD

Lastnosti izdelka

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ramipril/Hydrochlorothiazide TAD 2.5 mg/12.5 mg tablets
Ramipril/Hydrochlorothiazide TAD 5 mg/25 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Ramipril/Hydrochlorothiazide TAD 2.5 mg/12.5 mg tablets _
Each tablet contains 2.5 mg ramipril and 12.5 mg hydrochlorothiazide.
_Ramipril/Hydrochlorothiazide TAD 5 mg/25 mg tablets _
Each tablet contains 5 mg ramipril and 25 mg hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
2.5 mg/12.5 mg tablets: white to off-white, round tablets, with
bevelled edges and engraved with C on
one side. Tablet diameter: 5.5 mm.
5 mg/25 mg tablets: white to off-white, round tablets, with bevelled
edges, scored on one side and
engraved with S on other side of tablet. Tablet diameter: 7.5 mm.The
tablet can be divided into equal
doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypertension.
This fixed dose combination is indicated in patients whose blood
pressure is not adequately controlled
with ramipril alone or hydrochlorothiazide alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The dose should be individualised according to the patient profile
(see section 4.4) and blood pressure
control. The administration of the fixed combination of ramipril and
hydrochlorothiazide is usually
recommended after dosage titration with one of the individual
components.
Ramipril/Hydrochlorothiazide TAD should be started at the lowest
available dosage. If necessary, the
dose can be progressively increased to achieve target blood pressure;
the maximum permitted doses
are 10 mg of ramipril and 25 mg of hydrochlorothiazide daily.
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_Special populations _
_Diuretic-treated patients _
In patients concurrently treated with diuretics, as hypotension may
occur following initiation of the
treatment, caution is recommended. Consideration must be given to
reducing the diuretic dose or
discontinuing the diuretic before starting t