מלודיל 25

ישראל - עברית - Ministry of Health

קנה את זה

עלון מידע עלון מידע (PIL)

23-11-2020

מרכיב פעיל:
MAPROTILINE HYDROCHLORIDE
זמין מ:
UNIPHARM LTD, ISRAEL
קוד ATC:
N06AA21
טופס פרצבטיות:
טבליה
הרכב:
MAPROTILINE HYDROCHLORIDE 25 MG
מסלול נתינה (של תרופות):
פומי
סוג מרשם:
מרשם נדרש
תוצרת:
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL
קבוצה תרפויטית:
MAPROTILINE
איזור תרפויטי:
MAPROTILINE
סממני תרפויטית:
Treatment of depressive states and anxiety states associated with depression.
מספר אישור:
032 57 22655 00
תאריך אישור:
2013-07-31

מסמכים בשפות אחרות

עלון מידע עלון מידע - אנגלית

17-08-2016

עלון מידע עלון מידע - ערבית

23-11-2020

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Maprotiline HCl 25 mg †∫‰ÏÈÎÓ†≤μ†ÏÈ„ÂÏÓ†Ï˘†‰Ùˆӆ‰ÈϷˆÏÎ

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∫ÌÈÏÈÚÙ†È˙Ï·†ÌȯÓÂÁ

Lactose, maize starch, pregelatinized starch, talc, tricalcium

phosphate, magnesium stearate, Opadry.

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118608010 1212D

PATIENT PACKAGE INSERT IN ACCORDANCE WITH

THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986

MELODIL

Film-coated Tablets

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

Composition:

EachMelodil 25film-coated tablet contains:

Maprotiline HCl 25 mg

Also contains lactose 24 mg.

EachMelodil 50film-coated tablet contains:

Maprotiline HCl 50 mg

Also contains lactose 29 mg.

Inactive ingredients: Lactose, maize starch, pregelatinized starch,

talc, tricalcium phosphate, magnesium stearate, Opadry.

Therapeutic activity:Treatment of depressive states and anxiety

states associated with depression.

When should the preparation not be used?

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

or to other tricyclic antidepressants.

Do not use this medicine concomitantly with monoamine oxidase

inhibitor (MAOI) antidepressants or within 14 days after

discontinuation of such treatment.

Do not take this medicine without consulting a doctor before

starting treatment:

If you are pregnant or breastfeeding.If you are suffering, or have

suffered in the past, from impaired function of the respiratory system

(e.g.asthma), the heart and/or vascular system, the eyes (e.g.

glaucoma), the liver, the kidneys/urinary tract, the digestive system

(e.g.ulcer), the thyroid gland, the blood system (e.g.coagulation

disorder), the nervous system, from prostate gland enlargement,

from alcoholism, from epilepsy.

If you are receiving electroconvulsive therapy (ECT).

How will this medicine affect your daily life?

Use of this medicine may impair alertness and therefore caution

should be exercised when engaging in activities such as driving

a car, operating dangerous machinery and in any other activity

which requires alertness.Children should be cautioned against

engaging in activities such as bicycle riding, playing near roads

and the like.

Donotdrinkwine or other alcoholic beverages while under treatment

with this medicine.

This medicine may cause a special sensitivity when the patient is

exposed to the sun;therefore, avoid exposure to the sun and take

appropriate precautions (long clothes, a hat, protective creams,

etc.).

Warnings:Patients and their family members are advised to observe

changes, such as:worsening of depression, suicidal thoughts,

aggressiveness, etc.If such changes occur - refer to the doctor

immediately.Extreme caution should be exercised in following this

recommendation in young patients 18-24 years of age.In children,

adolescents and young adults below 24 years of age who took

antidepressants, an increase was observed in side effects such as

suicide attempts, suicidal thoughts and hostility.Nevertheless, your

doctor can prescribe this medicine, if he thinks it will benefit you.

If your doctor prescribed this medicine to you and you are interested

in discussing it with him, consult the doctor again.You must report

to the doctor if some of the aboveside effects appear or get worse.

If you are sensitive to any type of food or medicine, inform your

doctor before commencing treatment with this medicine.

in patients sensitive to lactose.

If you are about to undergo surgery (including dental) or any

procedure involving anesthesia, inform the anesthesiologist that

you are taking this medicine.

Drug interactions:If you are taking another drug concomitantly or

if you havejust 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:drugs affecting the

central nervous system (e.g.sedatives, hypnotics, drugs for

parkinsonism, epilepsy, antiallergics, surgical anesthetics and narcotic

analgesics), antihypertensives, cough and cold preparations,

barbiturates, quinidine or procainamide (for the heart), thyroid

preparations, anticholinergic medicines or medicines with

anticholinergic effect (e.g.antispasmodics), cimetidine (for ulcer),

phenytoin (anticonvulsant), alcohol, clonidine (for hypertension and

migraine), sulphiram (Antabuse for withdrawal).

Do not use this medicine concomitantly or within 14 days after

discontinuation of treatment with MAOI antidepressants.

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

adverse reactions may occur during the course of taking this

medicine, for example:dryness of the mouth, diarrhea, blurring of

vision, nausea, drowsiness, headache, dizziness, weakness,

unpleasant taste, weight gain.If the abovesymptoms continue

and/or are bothersome, refer to your doctor.

Side effects that requirespecial attention: Skin rash or irritation,

high fever, difficulty swallowing, tremor, constipation, intestinal

obstruction, sore throat, hallucinations, eyepain, difficulty speaking,

difficulty moving, difficulty urinating:stop treatment and refer to your

doctor.

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:Dosage is according to doctor’s instructions only.

Do not exceed the recommended dosage.

This medicine is to be taken at specific time intervals as determined

bythe attending doctor.If you forget to take this medicine at the

specified time, take the dose as soon as you remember, but never

take a double dose to compensate for a missed one!

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

small amount of water.This medicine can be taken with food.

How can you contribute to the success of the treatment?

Complete the full course of treatment as instructed byyour doctor.

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

discontinue use of this medicine, without consulting your doctor and

even then, only in a gradual manner.

Avoidpoisoning!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 havetaken 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.Donotinducevomiting unless explicitly instructed to do

so bya 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.

Donottakemedicinesinthedark! Check the label and the dose

eachtime you take your medicines.Wear glasses if you need them.

Storage:Store in a cool and dry place.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:

Melodil 25: 325722655 Melodil 50:324722654

Manufacturer:Trima Ltd., Kibbutz Maabarot,

for Unipharm Ltd., P.O.Box 21429,Tel Aviv.

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