NIF-TEN

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

ATENOLOL ; NIFEDIPINE

Disponible depuis:

AstraZeneca UK Limited

Code ATC:

C07FB03

DCI (Dénomination commune internationale):

ATENOLOL ; NIFEDIPINE

Dosage:

50/20 Milligram

forme pharmaceutique:

Capsules Hard

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

atenolol and other antihypertensives

Statut de autorisation:

Marketed

Date de l'autorisation:

1988-09-29

Notice 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 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 which is not under control
(this usually makes you breathless and
causes your ankles or legs to swell)

Résumé des caractéristiques du produit

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.
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