NIF-TEN 50mg/20mg Capsules

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Atenolol; Nifedipine

제공처:

AstraZeneca AB

ATC 코드:

C07FB; C07FB03

INN (국제 이름):

Atenolol; Nifedipine

복용량:

50 mg/20 milligram(s)

약제 형태:

Capsule, hard

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

Beta blocking agents, selective, and other antihypertensives; atenolol and other antihypertensives

승인 상태:

Not marketed

승인 날짜:

1998-09-29

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NIF-TEN

50 MG / 20 MG CAPSULES
atenolol / nifedipine
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 NIF-TEN is and what it is used for
2.
What you need to know before you take NIF-TEN
3.
How to take NIF-TEN
4.
Possible side effects
5.
How to store NIF-TEN
6.
Contents of the pack and other information
1.
WHAT NIF-TEN IS AND WHAT IT IS USED FOR
NIF-TEN contains the active substances atenolol and nifedipine. Each
of these works in a
different way.

Atenolol belongs to a group of medicines called beta-blockers. It
works by making your
heart beat more slowly and with less force. This helps to prevent
chest pain.

Nifedipine belongs to a group of medicines called dihydropyridines.
Dihydropyridines are
a type of calcium channel blocker. They work by making your blood
vessels widen. This
helps to prevent chest pain and lowers your blood pressure.
NIF-TEN is used to treat high blood pressure (hypertension) or to
prevent chest pain (angina).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NIF-TEN
DO NOT TAKE NIF-TEN:

If you are allergic to atenolol or nifedipine, or any of the other
ingredients of this
medicine (listed in section 6).

IF YOU ARE HAVING AN ANGINA ATTACK (SUDDEN CHEST PAIN). NIF-TEN cannot
treat an
angina attack, but it can help you get fewer attacks if you take it
regularly.

If you are allergic to other dihydropyridines such as amlodipine or
felodipine.

If you have any of the following heart problems:
-
heart failure w

제품 특성 요약

Health Products Regulatory Authority
22 September 2020
CRN009VSH
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NIF-TEN 50mg/20mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg atenolol and 20 mg nifedipine.
Excipient with known effect:
Each capsule contains 10mg of lactose monohydrate (see section 4.4)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsules, hard.
Reddish brown capsules containing atenolol and a slow release
formulation of nifedipine.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NIF-TEN is indicated for:
i) Management of Hypertension
ii) Management of Angina pectoris
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS
_Hypertension:_
One capsule daily. NIF-TEN is recommended for use in hypertensive
patients where monotherapy may prove inadequate. If
necessary, the dosage may be increased to one capsule twice daily.
_ _
_Angina_
One capsule twice daily. NIF-TEN is recommended for use in angina
patients where monotherapy may prove inadequate.
Where additional efficacy is necessary, prophylactic nitrate therapy
or additional nifedipine may be of benefit.
ELDERLY
Dosage should not exceed one capsule daily in hypertension, or one
capsule twice daily in angina.
PAEDIATRIC POPULATION
The safety and efficacy of NIF-TEN has not yet been established. No
data are available. Therefore it is not recommended for
use in children.
RENAL IMPAIRMENT
NIF-TEN should not be used in patients with marked renal impairment
(see section 4.3).
METHOD OF ADMINISTRATION
For administration by the oral route.
4.3 CONTRAINDICATIONS
NIF-TEN should not be used in patients with any of the following:
Health Products Regulatory Authority
22 September 2020
CRN009VSH
Page 2 of 11

Hypersensitivity to either active substance or to any of the
excipients listed in section 6.1.

Bradycardia.

Cardiogenic shock.

Hypotension;

Metabolic acidosis.

Severe peripheral arterial circulatory disturbances.

Second- or third