HISTAMINE-CARE

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0111B

107358090

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†‚ÂÒÓ†ÔÈÓËÒȉÈË‡†≠†

Triprolidine

ÆËÒÈ‚‡†‡Ùχ†≠†

Pseudoephedrine

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MAOI

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MAOI

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Ì„†ıÁφ˙„¯Â‰Ï†˙ÂÙ¯˙†¨Ô‡ÎÈ„†„‚†˙ÂÙ¯˙†¨®ÌÈÈ˘¯†ÌÈ·‡Î

„‚†˙ÂÙ¯˙†¨˙ÂÈ‚¯ÈÏÂÎ≠ÈË‡†˙ÂÙ¯˙†¨®‡˙È·†ÈÓÒÂÁ†∫Ô‚Ω†·ÏÏÂ

Triprolidine HCl

1.25 mg

Pseudoephedrine HCl

30.0 mg

Purified water, strawberry flavour,

methyl hydroxybenzoate, saccharine sodium, citric acid

anhydrous, sucrose, propyl hydroxybenzoate sodium, glycerol.

PATIENT PACKAGE INSERT IN ACCORDANCE WITH

THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986

HISTAMINE-CARE

Syrup

Read this package insert carefully in its entirety before using this medicine

Composition: Each teaspoonful (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:

Purified water, strawberry flavour, methyl

hydroxybenzoate, saccharine sodium, citric acid anhydrous,

sucrose, propyl hydroxybenzoate sodium, glycerol.

Therapeutic group:

Triprolidine - H

antihistamine.

Pseudoephedrine - alpha agonist.

Indication:

For the symtomatic 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.

Do not use this medicine if you suffer from severe

hypertension, problems with coronary arteries or urinary

retention. Do not use during an asthmatic attack.

Do not use Histamine Care concurrently with MAOI

preparations, until 14 days passed since discontinuation 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 a cough is accompanied by high fever, persisting 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.

Do not drink wine 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 preparation contains 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

anaesthetics and narcotic analgesics), antidepressants,

antihypertensives and heart medications (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 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, 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 require special attention:

High fever, rash,

sore throat, continuous headaches, shortness of breath,

difficulties in breathing, irregular heartbeat, hallucinations,

convulsions (rare): stop taking this medicine and approach

your doctor. 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 every 4-6 hours up to 4 times a day.

Children of 6-12 years of age:

5 ml every 6-8 hours up to 4

times a day. The use in children from 1-6 years of age is

according to physician’s prescription only.

Do not exceed the recommended dosage. Do not exceed the

recommended dose or duration of treatment.

This medicine is not intended for administration to infants

under 1 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 dose using a measuring cup or

measuring spoon.

Directions for use:

Take the medicine with meals or with milk to reduce stomach

upset. In order to minimise sleeping problems, the last daily

dose should be taken a few hours before bedtime.

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!

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: 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: 135.57.31475.00

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:

107358090

0111B

Maabarot 40230

Israel Pharmaceutical Products

Maabarot Ltd.