Histafed tablets

Active Ingredients

Each film coated tablet contains:

• Triprolidine HCI 2.5mg
• Pseudoephedrine hydrochloride 60mg

Indications

Therapeutic group:

Triprolidine is an H1-antihistamine.

Pseudoephedrine is an alpha-agonist.

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

Instructions

Swallow the tablet with a small amount of water. Do not crush, halve or chew the tablet.

The usual acceptable dosage of Histafed tablets is:

Adults and children over 12 years of age:

One tablet every 4-6 hours. Do not take more than 4 tablets within 24 hours.

Children below 12 years of age:

The medicine should be taken in the syrup dosage form.

Do not exceed the recommended dose.

Refer to the doctor if the signs of the illness (symptoms) get worse or do not improve after 7 days.

Histafed may be taken with or without food. If stomach upset occurs, take with food or milk.

If you are experiencing sleeping difficulties while using Histafed consult your doctor or pharmacist regarding the best time to take the medication. In order to minimize insomnia, the last daily dose should be taken a few hours before bedtime.

Warnings

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

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 the Histafed tablets 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.

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

Histafed 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, and avoid taking appetite suppressants without consulting a doctor.

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

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

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.
• you are sensitive to any type of food or medicine.

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.

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.

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.