Ramipril/amlodipine Krka 10mg/5mg hard capsules

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Ramipril; Amlodipine

Dostupno od:

KRKA, d.d., Novo mesto

ATC koda:

C09BB; C09BB07

INN (International ime):

Ramipril; Amlodipine

Doziranje:

10mg/5 milligram(s)

Farmaceutski oblik:

Capsule, hard

Tip recepta:

Product subject to prescription which may be renewed (B)

Područje terapije:

ACE inhibitors and calcium channel blockers; ramipril and amlodipine

Status autorizacije:

Not marketed

Datum autorizacije:

2017-05-05

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RAMIPRIL/AMLODIPINE KRKA 5 MG/5 MG HARD CAPSULES
RAMIPRIL/AMLODIPINE KRKA 5 MG/10 MG HARD CAPSULES
RAMIPRIL/AMLODIPINE KRKA 10 MG/5 MG HARD CAPSULES
RAMIPRIL/AMLODIPINE KRKA 10 MG/10 MG HARD CAPSULES
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 Ramipril/amlodipine Krka is and what it is used for
2.
What you need to know before you take Ramipril/amlodipine Krka
3.
How to take Ramipril/amlodipine Krka
4.
Possible side effects
5.
How to store Ramipril/amlodipine Krka
6.
Contents of the pack and other information
1.
WHAT RAMIPRIL/AMLODIPINE KRKA IS AND WHAT IT IS USED FOR
Ramipril/amlodipine Krka contains two active substances called
ramipril and amlodipine . Ramipril
belongs to a group of medicines called ACE inhibitors (Angiotensin
Converting Enzyme inhibitors),
while amlodipine belongs to a group of medicines called calcium
channel blockers
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.
Ramipril/amlodipine Krka can be used to treat high blood pressure
(hypertension) in patients who are
adequately controlled with the individual products given concurrently
at the same doses level as in the
combination, but as separate tablets.
2.
WHAT YOU NEED TO KNOW BEFORE Y

Svojstava lijeka

Health Products Regulatory Authority
13 February 2020
CRN009GV8
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ramipril/amlodipine Krka 10mg/5mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 10 mg ramipril and 5 mg amlodipine (as
amlodipine besilate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard (capsule)
The body of capsule is white to almost white colour with imprinted
gray to black mark 1005. The cap of the capsule is orange
brown colour. The content of the capsule is white to almost white
powder with possible crystals. Capsule size No. 0.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ramipril/amlodipine Krka is indicated for treatment of hypertension as
substitution therapy in patients adequately controlled
with the individual products given concurrently at the same dose level
as in the combination, but as separate tablets.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Recommended daily dose is one capsule of the given strength.
Fixed-dose combination is not suitable for initial therapy.
Before switching to Ramipril/amlodipine Krka patients should be
controlled on stable doses of the monocomponents taken at
the same time. The dose of Ramipril/amlodipine Krka should be based on
the doses of the individual components of the
combination at the time of switching.
If the change of the dosage is needed, it should be carried out by
individual titration of the free combination's ingredients.
_Special populations_
_Diuretic-treated patients_
In diuretic-treated patients caution is recommended, as in these
patients fluid and/or salt depletion may occur. Renal function
and serum potassium level should be monitored.
_Patients with renal impairment_
To find the optimal starting dose and maintenance dose of patients
with renal impairment, the patients should be individually
titrated using the individual components of amlodipine and ramipril.
Renal function and serum potassium levels should be monitored