Ramipril/Hydroklortiazid Ebb 5 mg/25 mg Tablett

Krajina: Švédsko

Jazyk: švédčina

Zdroj: Läkemedelsverket (Medical Products Agency)

Aktívna zložka:

hydroklortiazid; ramipril

Dostupné z:

Ebb Medical AB

ATC kód:

C09BA05

INN (Medzinárodný Name):

hydrochlorothiazide; ramipril

Dávkovanie:

5 mg/25 mg

Forma lieku:

Tablett

Zloženie:

ramipril 5 mg Aktiv substans; hydroklortiazid 25 mg Aktiv substans

Typ predpisu:

Receptbelagt

Prehľad produktov:

Förpacknings: Blister, 100 tabletter

Stav Autorizácia:

Avregistrerad

Dátum Autorizácia:

2017-09-13

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RAMIPRIL/HYDROKLORTIAZID HEXAL 2.5 MG/12.5 MG TABLETS
RAMIPRIL/HYDROKLORTIAZID HEXAL 5 MG/25 MG TABLETS
ramipril and 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 [nationally completed name] is and what it is used for
2.
What you need to know before you take [nationally completed name]
3.
How to take [nationally completed name]
4.
Possible side effects
5.
How to store [nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] 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.
[Nationally completed name] 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 [NATIONALLY COMPLETED NAME]
DO NOT TAKE
[nationally completed name]
:
•

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ramipril/Hydroklortiazid HEXAL 2.5 mg/12.5 mg tablets
Ramipril/Hydroklortiazid HEXAL 5 mg/25 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg of ramipril and 12.5mg of
hydrochlorothiazide.
Each tablet contains 5 mg of ramipril and 25 mg of
hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
[Nationally approved name] 2.5 mg/12.5 mg
_: _
White, oblong, biplane with facet, both sides with
breaking notch. Embossment one-sided 'R 15'
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
[Nationally approved name] 5 mg/25 mg: White, oblong, biplane with
facet, both sides with breaking
notch. Embossment one-sided 'R 30'
The score line is only to facilitate breaking for ease of swallowing
and not to divide 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
It is recommended that [nationally completed name] is taken once
daily, at the same time of the day,
usually in the morning.
[Nationally completed name] can be taken before, with or after meals,
because food intake does not
modify its bioavailability (see section 5.2).
[Nationally completed name] has to be swallowed with liquid. It must
not be chewed or crushed.
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 dose titration with one of the individual
components.
[Nationally completed name] should be started at the lowest available
dose. If necessary, the dose can
be progressively increased to achieve target blood pressure; the
maximum permitted d