Clemastinum Hasco

Package Leaflet: Information for the Patient

CLEMASTINUM HASCO

1 mg/10 ml, syrup

Clemastinum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Clemastinum HASCO and what is it used for
• 2. Important information before taking Clemastinum HASCO
• 3. How to take Clemastinum HASCO
• 4. Possible side effects
• 5. How to store Clemastinum HASCO
• 6. Contents of the pack and other information

1. What is Clemastinum HASCO and what is it used for

Clemastinum HASCO, syrup contains clemastine, an antihistamine that counteracts the action of histamine, one of the substances involved in allergic reactions in the body. As a result of its antihistamine action, clemastine alleviates the symptoms of allergic rhinitis (sneezing, runny nose, tearing) and skin allergies (hives, swelling, itching). This medicine is intended for use in relieving the symptoms of:

• skin allergies (such as contact dermatitis, hives, itching) and skin symptoms of angioedema (Quincke's edema);
• allergic rhinitis, such as runny nose, sneezing, tearing.

If there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Clemastinum HASCO

When not to take Clemastinum HASCO:

• if the patient is allergic to clemastine or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to other compounds with a similar chemical structure to clemastine (such as diphenhydramine, chlorpheniramine),
• in patients who are also taking monoamine oxidase inhibitors (MAOIs), see "Clemastinum HASCO and other medicines",
• in children under one year of age.

Warnings and precautions

Before starting treatment with Clemastinum HASCO, syrup, the patient should discuss it with their doctor, pharmacist, or nurse.
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Caution should be exercised:

• in patients with increased intraocular pressure or narrow-angle glaucoma,
• in patients with pyloric stenosis,
• in patients with gastric ulcer that impairs the passage of food,
• in patients with prostatic hyperplasia or urinary retention,
• in patients with hyperthyroidism,
• in patients with asthma,
• in patients with cardiovascular diseases and hypertension,
• in patients with porphyria, as clemastine may exacerbate the symptoms of this disease,
• in elderly patients due to the increased risk of side effects (such as dizziness, excessive sedation, and hypotension).

The patient should consult a doctor, even if the above warnings apply to past situations.
The patient should avoid taking clemastine with medicines that depress the activity of the central nervous system (see "Clemastinum HASCO and other medicines").
The patient should stop taking clemastine a few days (at least 3 days) before undergoing allergy tests.

Clemastinum HASCO and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Concomitant use of clemastine and medicines that depress the central nervous system (such as sedatives, hypnotics, anxiolytics, and some psychotropic medicines) enhances its sedative effect. Therefore, the patient should avoid taking clemastine with such medicines.
Concomitant use of clemastine with anticholinergic medicines may enhance their effects.
Medicines from the group of monoamine oxidase inhibitors (used in the treatment of depression) prolong and enhance the action of clemastine, so concomitant use of these medicines is contraindicated, see "When not to take Clemastinum HASCO".

Clemastinum HASCO with food, drink, and alcohol

The patient should not drink alcohol while taking clemastine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Clemastine crosses the placenta, and there is a lack of data to fully assess the safety of the medicine in pregnant women. Clemastine may be used during pregnancy only on the advice of a doctor and only when absolutely necessary.
Clemastine should not be used in breastfeeding women, as it passes into breast milk.

Driving and operating machinery

The medicine may cause drowsiness, which reduces psychophysical fitness, the ability to drive vehicles, and operate machinery. Therefore, the patient should not drive or operate machinery while taking clemastine.

Clemastinum HASCO contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate

The medicine may cause allergic reactions (possible late reaction).
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Clemastinum HASCO contains maltitol (E 965)

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. The medicine may have a slight laxative effect.
Caloric value: 2.3 kcal/g maltitol.

Clemastinum HASCO contains propylene glycol (E 1520)

The medicine contains approximately 369 mg of propylene glycol in each 10 ml of syrup.

Clemastinum HASCO contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 10 ml of syrup, which means the medicine is considered "sodium-free".

3. How to take Clemastinum HASCO

This medicine should always be taken as directed by a doctor or pharmacist. In case of doubts, the patient should consult a doctor or pharmacist.
Oral administration.
A measuring cup is included with the packaging to measure 2.5 ml, 5 ml, or 10 ml of syrup.

Children from 1 to 3 years of age:

2.5 ml to 5 ml of syrup (i.e., 0.25 mg to 0.5 mg of clemastine) twice a day, in the morning and evening.

Children from 3 to 6 years of age:

5 ml of syrup (i.e., 0.5 mg of clemastine) twice a day, in the morning and evening.

Children from 6 to 12 years of age:

5 ml to 10 ml of syrup (i.e., 0.5 mg to 1 mg of clemastine) twice a day, in the morning and evening.

Children over 12 years of age and adults:

10 ml of syrup (i.e., 1 mg of clemastine) twice a day, in the morning and evening.
The maximum dose for adults is up to 60 ml of syrup (i.e., up to 6 mg of clemastine) per day.

Taking a higher dose of Clemastinum HASCO than recommended

In case of taking a higher dose of the medicine than recommended, the patient should consult a doctor or pharmacist.
The most common symptoms of clemastine overdose in children are: excitement, hallucinations, clumsiness, and coordination disorders, muscle tremors, high fever, convulsions, cyanosis, and excessive reactivity leading to deepening depression.
The following may also occur: dryness of the mucous membranes, dilated pupils, facial flushing, increased body temperature. In adults, drowsiness and even coma are more common.
Both in children and adults, coma and cardiovascular collapse may occur.
Procedure in case of overdose
If the patient is conscious, they should induce vomiting as soon as possible after the overdose, and then take activated charcoal. To reduce fever, cold compresses should be applied. There are no specific antidotes; if necessary, symptomatic treatment is used.

Missing a dose of Clemastinum HASCO

The patient should not take a double dose to make up for a missed dose.
In case of any further doubts about taking this medicine, the patient should consult a doctor, pharmacist, or nurse.
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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Nervous system disorders
The most common are: excessive sedation, drowsiness, headaches, and dizziness, coordination disorders. The following may also occur: disorientation, anxiety, excessive excitement, fatigue, tremors, insomnia, blurred vision, double vision, tinnitus, convulsions, concentration disorders.
Gastrointestinal disorders
The most common are: stomach pain, nausea, constipation, diarrhea, vomiting. Loss of appetite may also occur.
Respiratory, thoracic, and mediastinal disorders
The most common is an increase in the density of secretions in the airways. The following may also occur: a feeling of chest tightness, wheezing, dryness of the mucous membranes of the mouth, nose, and throat, a feeling of a blocked nose.
Cardiac and vascular disorders
Hypotension, palpitations, accelerated heart rate, extra beats.
Skin and subcutaneous tissue disorders
Hives, rash, and itching.
Blood and lymphatic system disorders
Changes in blood count (decreased white blood cell count, significant decrease or absence of granulocytes in the blood, decreased platelet count, and hemolytic anemia).
Renal and urinary disorders
Difficulty urinating, urinary retention.
General disorders and administration site conditions
Excessive sweating, chills, hypersensitivity to light.
Reporting side effects
If any side effects occur, including those not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Clemastinum HASCO

The medicine should be stored out of sight and reach of children.
Store in the original packaging, at a temperature not exceeding 25°C.
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Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Clemastinum HASCO contains

• The active substance is clemastine. 10 ml of syrup contains 1 mg of clemastine in the form of clemastine fumarate.
• The other ingredients (excipients) are: liquid maltitol (E 965), propylene glycol (E 1520), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate, sodium saccharin dihydrate, dipotassium phosphate, sodium dihydrogen phosphate dihydrate, raspberry flavor (contains propylene glycol (E 1520)), purified water.

What Clemastinum HASCO looks like and contents of the pack

The medicine is a colorless syrup, clear or slightly opalescent.
One bottle contains 100 ml of syrup. A measuring cup or dosing spoon is included with the packaging.

Marketing authorization holder and manufacturer

PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Information about the medicine

tel.: (22) 742 00 22
e-mail: [email protected]

Date of last revision of the leaflet:

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