היסטפד סירופ

ישראל - עברית - Ministry of Health

קנה את זה

עלון מידע עלון מידע (PIL)

24-11-2020

מרכיב פעיל:
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLRIDE
זמין מ:
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD
קוד ATC:
R06AX07
טופס פרצבטיות:
סירופ
הרכב:
PSEUDOEPHEDRINE HYDROCHLORIDE 30 MG / 5 ML; TRIPROLIDINE HYDROCHLRIDE 1.25 MG / 5 ML
מסלול נתינה (של תרופות):
פומי
סוג מרשם:
אין צורך במרשם
תוצרת:
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL
קבוצה תרפויטית:
TRIPROLIDINE
איזור תרפויטי:
TRIPROLIDINE
סממני תרפויטית:
For the symptomatic relief of congestion such as rhinitis and associated allergic conditions.
מספר אישור:
107 14 21824 00
תאריך אישור:
2012-08-31

מסמכים בשפות אחרות

עלון מידע עלון מידע - אנגלית

17-08-2016

עלון מידע עלון מידע - ערבית

24-11-2020

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ƉÊȯ‡†‰˙‡·†˙Â¢†˙ÂÙ¯˙†ÔÒÁ‡Ï†Ôȇ

∫‰Ù¯˙‰†ÌÂ˘È¯†’ÒÓ ††∫˙ÂÈÙÁÓ†„ÙËÒȉ ∞≤∑†π¥†≤±∏≤μ†∞∞

†∫Ù¯ÈÒ†„ÙËÒȉ ±∞∑†±¥†≤±∏≤¥†∞∞

¯˘Â‡Â†˜„·†ÂÎÂ˙†˙‡ȯ·‰†„¯˘Ó†È¢Ú†Ú·˜†‰Ê†ÔÂÏÚ†ËÓ¯ÂÙ

Æ„È≠ÏÚ

Triprolidine HCl 1.25 mg

Pseudoephedrine HCl 30.0 mg

ÌÈÁ˜Â¯‰†˙Â˜˙†ÈÙφÔίˆÏ†ÔÂÏÚ

±π∏∂†≠†Â¢Ó˘˙‰†®ÌÈ¯È˘Î˙©

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∫·Î¯‰

∫˙ÂÈÙÁÓ†„ÙËÒȉ

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∫Ù¯ÈÒ†„ÙËÒȉ

∫‰ÏÈÎÓ†®Ï¢Ó†μ©†˙ÈÙΆÏÎ

ÆÔ¯˙†‚¢Ó†≤Æμ†≠†Ê¯ÎÂ̯҆‚†≥†ÌÈÏÈÎӆϢӆμ†ÏÎ

∫ÌÈÏÈÚÙ†È˙Ï·‰†ÌÈ·ÈίӉ

Sucrose, talc, dicalcium hydrogen phosphate, ††††††††∫˙ÂÈÙÁÓ†„ÙËÒȉ

microcrystalline cellulose, maize starch, povidone, magnesium

stearate, colloidal silicon dioxide, Opalux ASF 2833, cellulose

acetate phthalate, pregelatinized starch.

Purified water, strawberry flavour, methyl †††††††††††††∫Ù¯ÈÒ†„ÙËÒȉ

hydroxybenzoate, saccharine sodium, citric acid anhydrous, sucrose,

propyl hydroxybenzoate sodium, glycerol.

∫˙ÈËÈÂÙ¯˙†‰ˆÂ·˜

‚ÂÒÓ†ÔÈÓËÒȉÈË‡†‡Â‰†≠ Triprolidine

ÆËÒÈ‚‡†‰Ùχ†‡Â‰†≠† Pseudoephedrine

∫‰ÈÂÂ˙‰

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Ɖ˘†ÏȂφ˙Á˙Ó†˙˜ÂÈ˙·†˘Ó˙˘‰Ï†Ôȇ†Æ MAOI ≠‰†˙ÁȘÏ

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˙¯ȉʆ·ÈÈÁÓ†ÔΆÏÚ†˙Â¯ÈÚ·†Ì‚ÙφÏÂÏÚ†Âʆ‰Ù¯˙·†˘ÂÓÈ˘‰

˙·ÈÈÁÓ‰†˙ÂÏÈÚÙ†Ïη†˙ÂÎÂÒÓ†˙ÂÂÎÓ†˙ÏÚÙ‰·†¨·Î¯·†‰‚ȉ·

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ƉӄΆ˘È·Î‰†˙·¯˜·†ÌȘÁ˘ÓÓ

ƉÙ¯˙·†ÏÂÙÈˉ†˙Ù˜˙·†ÌÈÙȯÁ†˙‡˜˘Ó†Â‡†˙ÂÈȆ˙Â˙˘Ï†Ôȇ

Ɖȇ¯‰†˘ÂˢËφ̯‚φÏÂÏÚ†Âʆ‰Ù¯˙·†˘ÂÓÈ˘‰† ∫˙¯‰Ê‡

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ƉÙ¯˙‰†˙ÏÈË†ÈÙφ‡Ù¯φÍÎ≠ÏÚ†ÚȄ‰φÍÈÏÚ

ÆʯÎÂÒ†ÌÈÏÈÎÓ†ÌÈ¯È˘Î˙‰

̇†Â‡†¨˙ÙÒÂ†‰Ù¯˙†˙ØÏËÂ†Íȉ†Ì‡ †∫˙ÂÈ˙Ù¯˙†ÔÈ·†˙·‚˙

ÏÙËÓ‰†‡Ù¯φÁ„φÍÈÏÚ†¨˙¯Á‡†‰Ù¯˙·†ÏÂÙȈ‰˙Ú†‰Ê†˙¯Ó‚

Æ˙ÂÈ˙Ù¯˙†ÔÈ·†˙·‚˙Ó†ÌÈÚ·Â‰†˙ÂÏÈÚÈ≠ȇ†Â‡†ÌÈÂÎÈÒ†ÚÂÓφȄΠ0111D

¥∞≤≥∞†˙¯·ÚÓ

ÌÈÈχ¯˘È†‰‡ÂÙ¯†È¯ˆÂ˙

Triprolidine HCl 2.5 mg

Pseudoephedrine HCl 60.0 mg

PATIENT PACKAGE INSERT IN ACCORDANCE WITH

THEPHARMACISTS'REGULATIONS(PREPARATIONS)-1986

HISTAFED

Dragee/Syrup

Read this package insert carefully in its entirety before using this

medicine

Composition:

Histafed dragee: Each dragee contains:

Triprolidine HCl 2.5 mg

Pseudoephedrine HCl 60.0 mg

Each dragee contains 37.7 mg sucrose.

Histafed syrup: Each teaspoon (5 ml) contains:

Triprolidine HCl 1.25 mg

Pseudoephedrine HCl 30.0 mg

Each 5 ml contains 3 g sucrose and 2.5 mg sodium.

Inactive ingredients:

Histafed dragee: Sucrose, talc, dicalcium hydrogen phosphate,

microcrystalline cellulose, maize starch, povidone, magnesium stearate,

colloidal silicon dioxide, OpaluxASF 2833, cellulose acetate phthalate,

pregelatinized starch.

Histafed syrup: Purified water, strawberry flavour, methyl

hydroxybenzoate, saccharine sodium, citric acid anhydrous, sucrose,

propyl hydroxybenzoate sodium, glycerol.

Therapeutic group:Triprolidine is an H 1 -antihistamine.

Pseudoephedrine is an alpha-agonist.

Indication:For the symptomatic relief of nasal congestion in case of

rhinitis and associated allergic conditions.

When should the preparation not be used?

Do not use this medicine if you are breastfeeding.

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

Not to be used in patients with severe hypertension, problems with

coronary arteries and/or urinary retention.Not to be used during an

asthmatic attack.Histafed should not be administered concurrently

with MAOI preparations or within 14 days from the end of the

treatment with MAOI preparations.Do not use this medicine in infants

under one year of age.

Do not take this medicine without consulting a doctor before

starting treatment:

If you are pregnant.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 (including hypertension),

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

system (e.g. ulcer), the thyroid gland, the prostate gland, urinary

retention, diabetes.If in addition to a cough you suffer from high fever,

continuing headaches, dizziness or skin rash.

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 alcoholic beverages while under treatment with

this medicine.

Warnings:Use of this medicine may cause blurring of vision.

Do not use this medicine frequently, or for a long period, without

consulting a doctor.If you are sensitive to any type of food or medicine,

inform your doctor before commencing treatment with this medicine.

The preparations contain sucrose.

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: drugs affecting the central nervous

system (e.g. sedatives, hypnotics, drugs for parkinsonism, epilepsy,

drugs for treatment of allergies, surgical anesthetics and narcotic

(e.g. beta blockers), anticholinergic drugs, cough and cold medicines,

appetite suppressants (e.g. amphetamines). Do not use concomitantly

and within 14 days from the end of the treatment with MAOI preparations

(for depression).

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, skin rash, blurring of vision, nausea,

drowsiness, feeling of raised temperature, stomach ache, dizziness,

tiredness, irritability (especially with children), restlessness, sleeping

disturbances.

Side effects that requirespecial attention: High fever, skin rash, sore

throat, continuous headaches, shortness of breath, difficulties in

breathing, irregular heartbeat, hallucinations, convulsions (rare): stop

taking this medicine and approach your physician. Urinary retention

(rare): stop treatment and approach the doctor immediately. 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.

Adverse reactions and drug interactions in children and infants:

Parents must inform the attending doctor about any side effects, as

well as any additional medicine being taken by the child. See above

for details of side effects and drug interactions.

Dosage:Recommended dosage unless otherwise prescribed by your

doctor:

Adults and children over 12 years of age:

10 ml or 1 dragee every 4-6 hours, up to 4 times daily.

Children from 6 to 12 years of age:

5 ml every 6-8 hours, up to 4 times daily.

The use in children from 1-6 years of age is according to physician’s

prescription only.

Do not exceed the recommended dosage or the recommended duration

of treatment.

This medicine is not intended for administration to infants under

one year of age.

If there is no improvement in your condition within 7 days, refer to your

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!

Attention:Take care to measure the syrup dose using a special

measuring cup or measuring spoon.

Directions for use:Dragee:Do not chew! Swallow with a little amount

of water.

Take the medicine with meals or with milk to reduce stomach upset.

In order to minimize sleeping problems, the last daily dose should be

taken a few hours before bedtime.

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 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.

Donotinducevomiting unless explicitly instructed to do so by a doctor!

Donottakemedicinesinthedark! Check the label and the doseeach

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

Storage:Store in a cool and dark 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:Histafed dragee:027 94 21825 00

Histafed syrup: 107 14 21824 00

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

and its content was checked and approved by it.

Manufacturer and License holder:

103218010 Maabarot 40230

Israel Pharmaceutical Products

Maabarot Ltd. 0111D

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