Histafed syrup

Active Ingredients

Each 5 ml contains:

• Triprolidine HCl 1.25mg
• Pseudoephedrine hydrochloride 30mg

Indications

Therapeutic group:

Triprolidine is an H1-antihistamine.

Pseudoephedrine is an alpha-agonist.

Therapeutic activity:

Histafed syrup is intended for the symptomatic relief of nasal congestion in case of rhinitis and associated allergic conditions.

Instructions

The usual acceptable dosage is:

Adults and children above 12 years of age:

10 ml every 4-6 hours. Do not exceed the dosage of 4 doses (40 ml) in 24 hours.

Children 6-12 years of age:

5 ml every 6-8 hours. Do not exceed the dosage of 4 doses (20 ml) in 24 hours.

Children from one year to 6 years of age:

Dosage will be determined according to the doctor’s instruction.

This medicine is not intended for administration to infants under one year of age.

With liquid medications, you must use a measuring cup, syringe or dropper meant for measuring the correct amount of medicine. Do not use a household spoon to measure the amount of the medicine. Household spoons differ in size and you may not get the correct amount of medicine.

In order to minimize insomnia, the last daily dose should be taken a few hours before bedtime.

Consult the doctor if signs of the illness (symptoms) worsen or if they do not improve after 7 days.

Do not exceed the recommended dose.

If you forget to take your medication on time, take the dose as soon as you remember; but if it is almost time for the next dose, skip the forgotten dose and take the next dose at the usual time. Never take a double dose!

Use this medicine within 6 months of first opening the bottle.

Warnings

Do not use Histafed syrup if you are sensitive to the active ingredients or to any of the other ingredients that this medicine contains.

Do not use this medicine in infants under one year of age.

This medication is not intended for infants under one year of age and is not recommended for children under 6 years of age. Children from 1-6 years of ages should be given this medication by prescription only.

Do not use this medicine if you are pregnant and/or breastfeeding.

Do not use this medicine if you are being treated concomitantly with medicines from the monoamine oxidase inhibitors (MAOI) group (for treatment of depression), or within 14 days of stopping treatment with this group of medicines.

Do not use Histafed syrup if you are experiencing an asthmatic attack.

Do not use this medicine if you suffer from heart diseases such as: ischemic heart disease, Coronary artery disease, occlusive vascular disease or hypertension.

Do not use this medicine if you suffer from diabetes.

Do not use this medicine if you suffer from severe kidney function impairment.

Do not use this medicine if you suffer from a phaeochromocytoma (a rare tumor of the adrenal glands).

Do not use this medicine if you suffer from an overactive thyroid gland.

Do not use this medicine if you suffer from glaucoma.

Do not use this medicine if you suffer from an enlarged prostate gland and/or urinary retention.

Do not use this medicine if you are taking other medicines to treat congestion including nasal sprays.

The use of this medicine may cause blurring of vision.

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

Avoid drinking alcoholic beverages and/or using other drugs which cause drowsiness (such as sedatives) while taking Histafed, as the effect of alcohol and/or sedatives may be intensified by the use of Histafed syrup.

Histafed syrup contains pseudoephedrine. Before starting to use any additional medication (prescription or over the counter medication), check the list of ingredients to find out if the new medicine contains pseudoephedrine. If it does, or if you are not sure, consult your doctor or pharmacist.

Do not start a new diet while taking Histafed syrup, and avoid taking appetite suppressants without consulting a doctor.

If you are experiencing sleeping difficulties while using Histafed syrup consult your doctor or pharmacist regarding the best time to take the medication.

Caution is advised when the medication is administered to elderly people, as they may be more sensitive to the medication’s effects.

Beware of the possible evolvement of excitability when Histafed syrup is being administered to children.

Do not use this medicine without consulting a doctor before beginning treatment if:

• You suffer or have suffered from impaired function of the respiratory system (such as asthma), heart, liver, kidney / urinary tract, gastrointestinal tract (such as stomach ulcers, obstruction of the stomach or intestine), seizures, sleep related breathing difficulties, sleeping difficulties, breathing problems (such as asthma, emphysema, chronic bronchitis), Porphyria (blood disease)
• The cough is accompanied by high fever, persistent headaches, dizziness or rash
• You are about to undergo surgery, due to a possible reaction with anesthetics

If you are taking or have recently taken other medicines, including nonprescription medications and nutritional supplements, inform your doctor or pharmacist. In particular inform the doctor or the pharmacist if you are taking:

• Medicines affecting the central nervous system (e.g. sedatives, hypnotics, drugs for epilepsy, drugs for treatment of allergies, surgical anesthetics and narcotic analgesics)
• Medicines for treatment of depression (e.g., monoamine oxidase inhibitors MAOI)
• Antihypertensive and heart medications (e.g. beta blockers, diuretics)
• Anticholinergic drugs
• Other sympathomimetics medicines to treat cough and cold (e.g. to reduce congestion)
• Appetite suppressants (e.g. amphetamines)
• Medicines that stimulate the nervous system (e.g., medicines used to treat narcolepsy or medicines used to treat attention deficit disorder ADD)
• Antipsychotics medicines
• Digoxin, Quinidine
• Medicines to treat Parkinson’s disease (selegiline and rasagiline)
• Medicines to treat migraine (ergot alkaloids)
• Antacids (kaolin and aluminium hydroxide)
• Apraclonidine (medicine for glaucoma)
• Oxitocin

Do not drink wine or any other alcoholic beverages while using the medicine.

If you are pregnant or breastfeeding, do not use this product. If you become pregnant while using Histafed surup, consult your doctor immediately.

Use of this medicine may impair alertness and therefore caution should be exercised when driving a car, operating dangerous machinery and in any other activity which requires alertness. Children should be cautioned against bicycle riding, playing near roads and the like.

The syrup preparations contain sucrose. If you are known to suffer from any kind of sugar intolerance, consult your doctor prior to using the medication.

Please do not consider this information as an alternative to consulting your physician or pharmacist.

For further information on instructions for use, risks and side effects, please read the patient package insert and consult your doctor or pharmacist.
Read the patient package insert carefully before starting to take any medication.