LOPRESOR DIVITABS 200 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

METOPROLOL TARTRATE

Available from:

NOVARTIS ISRAEL LTD

ATC code:

C07AB02

Pharmaceutical form:

TABLETS SLOW RELEASE

Composition:

METOPROLOL TARTRATE 200 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

NOVARTIS SAGLIK, GIDA VE TARIM URUNLERI SAN.VE TIC. A.S., TURKEY

Therapeutic group:

METOPROLOL

Therapeutic area:

METOPROLOL

Therapeutic indications:

Hypertension, angina pectoris, arrhythmia, prophylaxis of migrain, prophylaxis of reinfarction.

Authorization date:

2015-02-28

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
LOPRESOR
® DIVITABS 200 MG
SLOW-RELEASE FILM-COATED TABLETS
THE ACTIVE INGREDIENT:
Each tablet contains: Metoprolol tartrate 200 mg
INACTIVE INGREDIENTS: See section 6 “Further information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE. This leaflet contains concise information about the
medicine. If you have further questions, refer to the doctor or
pharmacist. Keep this leaflet. You may need to read it again.
This medicine has been prescribed for the treatment of your
ailment. Do not pass it on to others. It may harm them, even if
it seems to you that their ailment is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the treatment of hypertension,
angina pectoris and irregular heart rate, for the prevention
of migraine and for the prevention of recurrent myocardial
infarction.
Lopresor Divitabs dilates the blood vessels, thereby reducing
the blood pressure.
THERAPEUTIC GROUP: Beta receptor blockers.
2. BEFORE USING THE MEDICINE
X
DO NOT USE THE MEDICINE IF:
- you are sensitive (allergic) to metoprolol or to any of the
additional ingredients contained in the medicine (see
section 6 “Further information”) or to any other medicine
of the beta receptor blockers group.
Some of the symptoms of an allergic reaction can include
rash, itching or hives; swelling of the face, lips, tongue
or other parts of the body; breathlessness, wheezing or
breathing problems.
- you have one of the following medical conditions:
∘
asthma, wheezing, difficulty breathing or other severe
lung problems, or if you had these problems in the past.
∘
very slow heart rate, lower than 45-50 beats per minute.
∘ low blood pressure.
∘ severe blood vessel disorder that causes poor circulation
in the limbs (arms and legs).
∘ a rare tumor of the adrenal gland (pheochromocytoma)
that is not being treated with other medicines.
∘

Summary of Product characteristics

LOP API 01APR20
New Zealand Data Sheet Jan 2020
1 PRODUCT NAME
LOPRESOR
®
DIVITABS 200 MG
(METOPROLOL TARTRATE)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is
Di-[(±)-1-(isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol]
L(+)-tartrate (metoprolol tartrate).
Metoprolol is an aryloxypropanolamine derivative.
For a full list of excipients, see Section 6.1 List of excipients.
3 PHAMACEUTICAL FORM
LOPRESOR
® DIVITABS 200 MG
Divitabs slow-release film coated tablets of 200 mg
Pale yellow, capsule-shaped, film-coated tablets with biconvex surface
and a deep score on
both sides.
Imprints: “CG/CG” on one side and “CDC/CDC” on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension, angina pectoris, arrhythmia, prophylaxis of migraine,
prophylaxis of
reinfarction.
_4.2 DOSAGE AND METHOD OF ADMINISTRATION _
The tablets should be swallowed unchewed with a glass of water.
The tablets may be divided in two, if needed.
The dosage should be adapted to the requirements of the individual
patient. The following
dosage recommendations may be taken as a guide:
ARRHYTHMIAS
100 to 300 mg daily, given in one to three divided doses.
HYPERTENSION
The daily oral dose is 100 to 200 mg.
1 of the Divitabs early in the morning; if necessary, another
antihypertensive can be
prescribed in addition. In mild hypertension, ½ of one of the
Divitabs taken early in the
morning may suffice.
ANGINA PECTORIS
The daily oral dose is 100 to 200 mg; if necessary, the daily dose can
be increased to 400
mg.
LOP API 01APR20
New Zealand Data Sheet Jan 2020
½ or 1 of the Divitabs early in the morning; if necessary, this dose
can be repeated in the
evening.
MYOCARDIAL INFARCTION
Maintenance treatment:
The oral maintenance dose is 200 mg daily. The treatment should be
continued for at least 3
months.
The 200 mg of slow-release preparations (Divitabs) should be taken
once daily in the
morning.
The recommended dosage can be reduced depending on the hemodynamic
status of the
patient.
PREVENTION OF MIGRAINE
T