Nifedi-Denk 20 Retard tablets prolonged-release

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

nifedipine

Available from:

Denk Pharma GmbH & Co. KG

ATC code:

C08CA05

INN (International Name):

nifedipine

Dosage:

20mg

Pharmaceutical form:

tablets prolonged-release

Units in package:

(100/10x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-09-19

Patient Information leaflet

_Nifedi-Denk 20 Retard_
Prolonged-release tablet – oral use
Calcium antagonist
Active substance: nifedipine
Package leaflet: Information for the patient
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 pharma
-
cist. This includes any possible side effects not listed in
this leaflet. See section 4.
What is in this leaflet
1.
WHAT NIFEDI-DENK 20 RETARD IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE NIFEDI-DENK 20 RETARD
3.
HOW TO TAKE NIFEDI-DENK 20 RETARD
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE NIFEDI-DENK 20 RETARD
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Nifedi-Denk 20 Retard is and what it
is_ _used for
Nifedi-Denk 20 Retard contains the active substance nifedipine.
Nifedi-Denk 20 Retard_ _ is used in the treatment of cardiac
complaints, which are associated with insufficient oxygen
supply to the heart muscle (angina pectoris), and in the
treatment of hypertension.
Nifedi-Denk 20 Retard_ _is used in:
•
complaints (e.g. pain or tightness in the chest) in condi
-
tions with an inadequate supply of oxygen to the heart
muscle during exertion: chronic stable angina pectoris
(effort angina)
•
vasospastic angina pectoris (Prinzmetal’s angina, variant
angina)
•
non-organ-related high blood pressure (essential hyper
-
tension).
2.
What you need to know before you take
Nifedi-Denk 20 Retard
Do not take Nifedi-Denk 20 Retard
•
if you are allergic to nifedipine or any of the other ingredi-
ents of this medicine (listed in section 6)
•
if you have had a cardiogenic shock
•
if you have heart valve stenosis (aortic stenosis)
•
if you suffer from complaints at rest (e.g. pa

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Nifedi-Denk 20 Retard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: nifedipine
Each prolonged-release tablet contains 20 mg nifedipine.
Excipient with known effect: Each prolonged-release tablet contains
36.2 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet
Oblong, greyish-red film-coated tablets with score line on both sides.
The score line is not intended for
breaking the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Chronic stable angina pectoris (effort angina)
-
Vasospastic angina pectoris (Prinzmetal’s angina, variant angina)
-
Essential hypertension
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment should as far as possible be administered individually on
the basis of the severity of the
condition and the patient's response.
The target dose should be reached gradually, depending on the medical
condition concerned.
Patients with severe cerebrovascular disorders should be treated with
low doses.
Patients with high blood pressure suffering from severe
cerebrovascular disease and patients expecting
an excessive response to nifedipine due to low body weight or due to
multiple treatment with other
antihypertensives should be treated with nifedipine 10 mg
prolonged-release tablets. Patients whose
side effects to the nifedipine treatment would seem to make a more
subtle adjustment of the dosage
level desirable should also have the dose of nifedipine 10 mg
prolonged-release tablets adapted
individually.
If not prescribed otherwise, the recommended dose for adults is:
Chronic stable angina pectoris
1 prolonged-release tablet (nifedipine 20 mg) twice daily.
2
If necessary the dose may be increased gradually to 2 x 40 mg of
nifedipine.
Vasospastic angina pectoris (Prinzmetal’s angina, variant angina)
1 prolonged-release tablet (nifedipine 20 mg) twice daily.
If necessary the dose may be increased gradually to 2 x 40 mg of
nifedi