Clemastinum Hasco

Leaflet included in the packaging: patient information

CLEMASTINUM HASCO

1 mg, tablets
Clemastinum
You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to you for a specific reason. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned 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 undesirable effects
• 5. How to store Clemastinum HASCO
• 6. Contents of the packaging and other information

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

Clemastinum HASCO, tablets contain clemastine, an antihistamine that counteracts the effects 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, angioedema, itching).
This medicine is intended for use in alleviating 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 you are allergic to clemastine or any of the other ingredients of this medicine (listed in section 6),
• if you are 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 to take Clemastinum HASCO, you should discuss it with your doctor, pharmacist, or nurse.
In patients with:

• narrow-angle glaucoma or with a narrow pupil,
• urinary retention,
• peptic ulcer that interferes with the passage of food,
• prostate enlargement or urethral stricture,
• hyperthyroidism,
• asthma,
• cardiovascular diseases and hypertension,
• porphyria, as clemastine may exacerbate the symptoms of this disease,
• elderly patients, due to the increased risk of undesirable effects (such as dizziness, excessive sedation, and hypotension).

You should consult a doctor, even if the above warnings refer to situations that have occurred in the past.
You should avoid taking clemastine at the same time as medicines that depress the activity of the central nervous system (see "Clemastinum HASCO and other medicines").
You should stop taking clemastine a few days (at least 3 days) before performing allergy tests.

Clemastinum HASCO and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Concomitant use of clemastine and medicines that depress the central nervous system (such as sedatives, hypnotics, antihistamines, and some psychotropic medicines) enhances its sedative effect on the central nervous system. Therefore, you should avoid taking clemastine at the same time as 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, and therefore concomitant use of these medicines is contraindicated, see "When not to take Clemastinum HASCO".

Clemastinum HASCO with food, drink, and alcohol

You should not drink alcohol while taking clemastine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, you should consult your doctor or pharmacist before taking this medicine.
Clemastine passes through the placenta, and there is no data that allows for a full assessment of the safety of the use 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 using machines

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

Clemastinum HASCO contains lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Clemastinum HASCO

This medicine should always be taken according to the doctor's or pharmacist's recommendations.
In case of any doubts, you should consult a doctor or pharmacist.
Oral administration.
In adults, 1 tablet (i.e., 1 mg of clemastine) is given twice a day, in the morning and evening.
The maximum dose for adults is up to 6 tablets (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, you should consult a doctor or pharmacist.
There have been reports of adult poisoning caused by an overdose of clemastine, with symptoms of depression or stimulation of the central nervous system, most often depression of the central nervous system, manifested by drowsiness, and even coma. Cardiac arrest may occur.
The following may also occur: hallucinations, stimulation, incoordination, and disturbances of movement, tremors, high fever, dryness of the mucous membranes of the mouth, dilation of the pupils, flushing of the face, convulsions, cyanosis, and excessive reactivity leading to deepening depression.
Procedure after overdose
If the patient is conscious, vomiting should be induced shortly after the overdose, and then activated charcoal should be given. To reduce fever, cold compresses should be applied. There are no specific antidotes, and if necessary, symptomatic treatment is used.

Missing a dose of Clemastinum HASCO

You should not take a double dose to make up for a missed dose.
In case of any further doubts related to the use of this medicine, you should consult a doctor, pharmacist, or nurse.

4. Possible undesirable effects

Like all medicines, this medicine can cause undesirable effects, although not everybody gets them.
The following undesirable effects may occur:
Nervous system disorders
Most often: excessive sedation, drowsiness, headaches, and dizziness. The following may also occur: disorientation, anxiety, excessive stimulation, feeling of fatigue, tremors, insomnia, blurred vision, double vision, tinnitus, convulsions, and concentration disorders.
Gastrointestinal disorders
Most often: stomach pain, nausea, constipation, diarrhea, vomiting. Loss of appetite may also occur.
Respiratory, thoracic, and mediastinal disorders
Most often: increased density of respiratory secretions. The following may also occur: feeling of pressure in the chest, wheezing, dryness of the mucous membranes of the mouth, nose, and throat, feeling of a blocked nose.
Cardiovascular 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 (decrease in white blood cell count, significant decrease in or absence of granulocytes in the blood, decrease in platelet count, and hemolytic anemia).
Renal and urinary disorders
Difficulty urinating, urinary retention.
General disorders
Excessive sweating, chills, increased sensitivity to light.
Reporting undesirable effects
If any undesirable effects occur, including any undesirable effects not mentioned in the leaflet, you should inform your doctor, pharmacist, or nurse.
Undesirable effects can be reported directly to the Department for Monitoring of Undesirable Effects of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
tel.: 22 49 21 301, fax: 22 49 21 309,
e-mail: ndl@urpl.gov.pl.
Undesirable effects can also be reported to the marketing authorization holder.
Thanks to the reporting of undesirable effects, more information can be collected on the safety of the use of the medicine.

5. How to store Clemastinum HASCO

Store in a temperature below 25°C.
Store in the original packaging.
The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers.
You should ask your pharmacist how to dispose of medicines that are no longer needed.
This will help protect the environment.

6. Contents of the packaging and other information

What Clemastinum HASCO contains

• The active substance of the medicine is clemastine. 1 tablet contains 1 mg of clemastine in the form of clemastine fumarate
• The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, Povidone K 30, sodium carboxymethylcellulose (Type A), magnesium stearate, anhydrous colloidal silica.

What Clemastinum HASCO looks like and what the packaging contains

The medicine is in the form of white tablets with a uniform surface.
One packaging contains 7, 15, or 30 tablets.

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: informacjaoleku@hasco-lek.pl

Date of the last update of the leaflet:

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