NIFEDILONG 60

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

NIFEDIPINE

Tilgjengelig fra:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

ATC-kode:

C08CA05

Legemiddelform:

TABLETS PROLONGED RELEASE

Sammensetning:

NIFEDIPINE 60 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

VALPHARMA S.P.A., REPUBLIC OF SAN MARINO

Terapeutisk gruppe:

NIFEDIPINE

Terapeutisk område:

NIFEDIPINE

Indikasjoner:

Chronic stable angina, hypertension.

Autorisasjon dato:

2017-12-31

Informasjon til brukeren

PATIENT LEAFLET IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed with a doctor’s
prescription only
NIFEDILONG 30 MG PROLONGED RELEASE
TABLETS.
NIFEDILONG 60 MG PROLONGED RELEASE
TABLETS.
Each prolonged release tablet of Nifedilong 30 mg
contains: Nifedipine 30 mg
Each prolonged release tablet of Nifedilong 60 mg
contains: Nifedipine 60 mg
Inactive ingredients in the medicine – see section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE
MEDICINE. This leaflet contains concise information
about the medicine. If you have any other questions,
refer to the doctor or the pharmacist.
This medicine has been prescribed for treatment
of your illness. Do not pass it on to others. It may
harm them even if it seems to you that their medical
condition is similar. This medicine is not intended for
children and adolescents under the age of 18.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for treatment of
chronic and stable angina, and for treatment of
hypertension.
THERAPEUTIC CLASS: Calcium channel blockers.
2. BEFORE USING THE MEDICINE:
DO NOT USE THIS MEDICINE IF:
You had a heart attack in the past month.
You previously collapsed due to a cardiac
problem )cardiogenic shock(, resulting in
symptoms of respiratory arrest, pallor, dry
mouth and cold sweat.
You had esophageal obstruction.
You had surgery for removal of the colon
)colectomy( and formation of a pouch from a
loop of the small intestine, which is attached
to the stomach wall and can be emptied by
the patient )Kock Pouch(, Stoma.
Your blood pressure keeps rising despite
treatment with the medicine )malignant
hypertension(.
Sensitivity to one of the medicine’s
ingredients )specified in section 6( is known,
or to a similar medicine that belongs to the
dihydropyridine group.
There is hypersensitivity to Nifedipine.
Do not use the medicine for treatment of acute
angina or an unstable angina.
You are suffering from liver diseases.
You are suffering from aortic stenosis.
You are suffering from i

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nifedilong 30 mg prolonged-release tablets
Nifedilong 60 mg prolonged-release tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 30 or 60 mg nifedipine,
respectively.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged-release film-coated tablet.
Round biconvex tablets with a pale red colour.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the treatment of chronic stable angina and hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
_Adults:_
Dosage must be adjusted according to each patient's needs. Therapy for
either
hypertension or angina should be initiated with 30 or 60 mg once
daily.
_Nifedilong Prolonged Release tablets_ should be swallowed whole and
should
not be bitten or divided. In general, titration should proceed over at
7-14 day
period so that the physician can fully assess the response to each
dose level
and monitor blood pressure before proceeding to higher doses. Since
steady-
state plasma levels are achieved on the second day of dosing, if
symptoms so
warrant, titration may proceed more rapidly provided the patient is
assessed
frequently. Titration to doses above 120 mg are not recommended.
_A_
_ _
_Switch over from Nifedipine capsules to Nifedilong_
Angina patients controlled on Nifedipine capsules alone or in
combination with
other antianginal medications may be safely switched to Nifedilong
Prolonged
Release tablets at the nearest, equivalent total daily dose (e.g. 1
Nifedipine
capsule of 10 mg t.i.d. up to q.i.d. may be changed to 30 mg once
daily of
Nifedilong Prolonged Release tablet). Subsequent titration to higher
doses
may be necessary and should be initiated as clinically warranted.
Experience
with doses greater than 90 mg in patients with angina is limited.
Therefore,
doses greater than 90 mg should be used with caution and only when
clinically
warranted.
No "rebound effect" has been observed upon discontinuation of
Nifedilong