MONONIT 20

Israel - English - Ministry of Health

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Active ingredient:
ISOSORBIDE MONONITRATE 20 MG
Available from:
PERRIGO ISRAEL PHARMACEUTICALS LTD
ATC code:
C01DA14
Pharmaceutical form:
TABLETS
Administration route:
PER OS
Manufactured by:
PERRIGO ISRAEL PHARMACEUTICALS LTD
Therapeutic group:
ISOSORBIDE MONONITRATE
Therapeutic indications:
Prophylactic treatment of angina pectoris. Treatment of Congestive Heart Failure.
Authorization number:
069312532500
Authorization date:
2010-10-01

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

25-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

25-01-2021

drugs for the treatment of migraines of the ergot group (in large

dosages), noradrenaline.

Side effects: In addition to the desired effect of the medicine, adverse

reactions may occur during the course of taking this medicine, for

example: nausea/vomiting, headache (see below), dizziness - especially

when rising from a lying to a standing position (see "Warnings"), fast

heartbeat, flushing of face and neck, weakness. These side effects

usually disappear within a short time following the period of adaptation

to the medicine. However, if they persist and/or are bothersome,

consult your doctor.

Side effects that require special attention:

Skin rash or irritation,

dryness of the mouth, persistent headache (see below), blurred vision

(rare): stop the treatment and refer to the doctor.

Side effects resulting from overdosage: Bluish-coloured lips, fingernails

or palms of the hands, pressure in head.

In the event that you experience side effects not mentioned in this

leaflet, or if there is a change in your general health, consult your

doctor immediately.

Dosage: According to doctor's instructions only.

Do not exceed the recommended dosage.

This medicine is not usually intended for children and infants.

Directions for use: Do not chew! Swallow the medicine with a large

amount of water after meals. The tablets can be halved but not

crushed.

How can you contribute to the success of the treatment?

Complete the full course of treatment as instructed by the doctor.

Even if there is an improvement in your health, do not discontinue

use of this medicine before consulting your doctor; and even then

this should be done gradually.

During treatment with this medicine, especially at the beginning, you

may suffer from headaches which accompany the action of this

medicine; this may be overcome by taking aspirin or similar pain

reliever. You should try to continue treatment in spite of the pain. If

the pain persists or worsens, consult your doctor about continuation

of treatment.

Avoid poisoning! This medicine and all other medicines, must be

stored in a safe place out of the reach of children and/or infants, to

avoid poisoning. If you have taken an overdose, or if a child has

accidentally swallowed the medicine, proceed immediately to a hospital

emergency room and bring the package of the medicine with you.

Do not induce vomiting unless explicitly instructed to do so by a

doctor! This medicine has been prescribed for the treatment of your

ailment; in another patient it may cause harm.

Do not give this

medicine to your relatives, neighbours or acquaintances.

Do not take medicines in the dark! Check the label and the dose each

time you take your medicine. Wear glasses if you need them.

Storage: In a cool and dry place, below 25

Even if kept in their original container and stored as recommended,

medicines may be kept for a limited period only. Please note the

expiry date of the medicine! In case of doubt, consult the pharmacist

who dispensed the medicine to you.

Do not store different medications in the same package.

License number: 6931.25325, 5138.25326

Manufacturer: Perrigo Israel Pharmaceuticals Ltd., Yeruham.

PATIENT PACKAGE INSERT IN ACCORDANCE WITH

THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986

The dispensing of this medicine requires a doctor's prescription

Read this package insert carefully in its entirety

before using this medicine

The format of this leaflet was determined by the Ministry of Health

and its content was checked and approved by it in January 2006

MONONIT 20

MONONIT 40

Tablets

Tablets

Composition:

Each tablet contains:

Each tablet contains:

Isosorbide 5 mononitrate 20 mg

Isosorbide 5 mononitrate 40 mg

Each tablet also contains:

Each tablet also contains:

Lactose 151.7 mg

Lactose 303.4 mg

Inactive ingredients:

Lactose monohydrate, talcum, colloidal silicon

dioxide, potato starch, microcrystalline cellulose, aluminium stearate.

Therapeutic group: Nitrates.

Therapeutic activity: Prophylactic treatment of angina pectoris and

treatment of cardiac failure.

When should the preparation not be used?

Do not use this medicine if you are sensitive to any of its ingredients

or to other medications of the nitrates group.

Do not use this medicine in cases of myocardial infarction, severe

hypotension, anaemia or cerebral accident.

This preparation is not intended for the relief of an acute attack of

angina pectoris.

Do not use concomitantly with medicines of the PDE5 inhibitor

group (medicines for the treatment of erectile dysfunction) such as

Viagra, Cialis and Levitra in light of the severe side effects that may

occur (such as fainting, myocardial infarction). If you have taken

Viagra, you must not take Mononit within the next 48 hours. If you

are in doubt, contact your family physician or cardiologist.

Do not take this medicine without consulting a doctor before

starting treatment in the following cases:

If you are pregnant or if you are breastfeeding.

If you are suffering, or have suffered in the past, from impaired function

of the eyes (e.g. glaucoma), the liver, the kidney/urinary tract, the

digestive system (e.g. ulcer), the thyroid gland, from orthostatic

hypotension, cerebral hemorrhage or damage, low body temperature.

If you are sensitive to lactose.

How will this medicine affect your daily life?

Do not drink wine or

alcoholic beverages while under treatment with this medicine.

Warnings: Avoid sudden changes from a lying/sitting position to a

standing position, in order to avoid dizziness and in extreme cases

fainting. It is also recommended to avoid standing for many hours,

over-exertion or exposure to the sun.

Drug interactions: If you are taking another drug concomitantly or

if you have just finished treatment with another medicine, inform the

attending doctor in order to prevent hazards or lack of efficacy arising

from drug interactions. This is especially important for medicines

belonging to the following groups: cough and cold preparations,

antiasthmatic preparations, antihypertensives and heart medications,

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