Ramizek Combi capsules hard

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ramipril, amlodipine (amlodipine besilate)

Available from:

Adamed Pharma S.A.

ATC code:

C09BB07

INN (International Name):

ramipril, amlodipine (amlodipine besilate)

Dosage:

5mg+ 5mg, (30/5x6/) in blister

Pharmaceutical form:

capsules hard

Units in package:

5mg+5mg, (30/5x6/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-06-14

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RAMIZEK COMBI, 5 MG + 5 MG, CAPSULE, HARD
RAMIZEK COMBI, 10 MG + 5 MG, CAPSULE, HARD
RAMIZEK COMBI, 10 MG + 10 MG, CAPSULE, HARD
Ramipril + Amlodipine
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 Ramizek Combi is and what it is used for
2.
What you need to know before you take Ramizek Combi
3.
How to take Ramizek Combi
4.
Possible side effects
5.
How to store Ramizek Combi
6.
Contents of the pack and other information
1.
WHAT RAMIZEK COMBI IS AND WHAT IT IS USED FOR
Ramizek Combi contains two active substances: ramipril and amlodipine.
Ramipril belongs to a group of
medicines called ACE inhibitors (Angiotensin Converting Enzyme
inhibitors). Amlodipine belongs to a
group of medicines called calcium antagonists.
Ramipril works by:
•
Decreasing your body’s production of substances that could raise
your blood pressure
•
Making your blood vessels relax and widen
•
Making it easier for your heart to pump blood around your body
Amlodipine works by:
•
Relaxing and widening blood vessels, so that blood passes through them
more easily.
Ramizek Combi is used to treat hypertension (high blood pressure), in
patients whose blood pressure is
adequately controlled with amlodipine and ramipril given concurrently
at the same dose level as in Ramizek
Combi, but as a separate medicines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAMIZEK COMBI
DO NOT TAKE RAMIZEK COMBI:
-
if you are allergic to ramipril, amlodipine (active substances), other
ACE inhibitor med

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ramizek Combi, 5 mg
_+ _
5 mg, capsule, hard
Ramizek Combi, 10 mg + 5 mg, capsule, hard
Ramizek Combi, 10 mg + 10 mg, capsule, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ramizek Combi, 5 mg
_ + _
5 mg, capsule, hard: each capsule contains 5 mg ramipril and
amlodipine besilate
equivalent to 5 mg amlodipine.
Ramizek Combi, 10 mg
_ + _
5 mg, capsule, hard: each capsule contains 10 mg ramipril and
amlodipine besilate
equivalent to5 mg amlodipine.
Ramizek Combi, 10 mg
_ + _
10 mg, capsule, hard: each capsule contains 10 mg ramipril and
amlodipine
besilate equivalent to 10 mg amlodipine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
Ramizek Combi, 5 mg + 5 mg, capsule, hard: hard gelatin capsules, size
no.1, cap: opaque pink colour, body:
opaque white colour. Content of capsules: white or almost white
powder.
Ramizek Combi, 10 mg + 5 mg, capsule, hard: hard gelatin capsules,
size no.1, cap: opaque dark pink colour,
body: opaque white colour. Content of capsules: white or almost white
powder.
Ramizek Combi, 10 mg + 10 mg, capsule, hard: hard gelatin capsules,
size no.1, cap: opaque brown colour,
body: opaque white colour. Content of capsules: white or almost white
powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypertension in adults
_._
Ramizek Combi is indicated as substitution therapy of patients with
blood pressure adequately controlled
with ramipril and amlodipine given concurrently at the same dose
level.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Ramizek Combi should not be used for initiating treatment of
hypertension. The doses of each component
should be individualised according to the patient profile and blood
pressure control.
If a dose change is required, the dosing regimen should be
individually determined using the individual
components of ramipril and amlodipine first, and once established, it
could be changed to Ramizek Combi.
The recommended dose is one c