Clemastinum hasco
Poland
Table of Contents
Patient Information Leaflet Included in the Packaging
CLEMASTINUM HASCO
1 mg, tablets
Clemastine
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
- Keep this leaflet for future reference.
- If you have any doubts or questions, consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
- If the patient experiences any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Contents of the Leaflet:
- What is Clemastinum HASCO and what is it used for
- Important information before taking Clemastinum HASCO
- How to take Clemastinum HASCO
- Possible side effects
- How to store Clemastinum HASCO
- Contents of the package and other information
1. What is Clemastinum HASCO and what is it used for
Clemastinum HASCO tablets contain clemastine, a drug which inhibits the action of histamine—one of the substances involved in allergic reactions in the body. Due to its antihistamine effect, clemastine relieves symptoms of allergic rhinitis (sneezing, watery nasal discharge, tearing) and skin allergies (urticaria, swelling, itching). This medicine is intended for alleviating symptoms of:
- Skin allergies (such as contact dermatitis, urticaria, itching) and skin manifestations of angioedema (Quincke's edema);
- Allergic rhinitis, such as watery nasal discharge, sneezing, and tearing.
If there is no improvement or if the patient feels worse, consult a doctor.
2. Information before using Clemastinum HASCO
When not to use Clemastinum HASCO:
- if you are allergic to clemastine or to any of the other ingredients of this medicine (listed in section 6),
- if you are allergic to other compounds with a chemical structure similar to clemastine (e.g. diphenhydramine, chlorpheniramine),
- in patients currently taking medicines belonging to the group of so-called monoamine oxidase inhibitors (MAO inhibitors), see "Clemastinum HASCO and other medicines",
- in children under one year of age.
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Warnings and precautions
Before starting treatment with Clemastinum HASCO tablets, you should discuss this with your doctor,
pharmacist, or nurse.
- in patients with increased intraocular pressure or narrow-angle glaucoma,
- in patients with pyloric stenosis,
- in patients with peptic ulcer causing impaired passage of food through the gastrointestinal tract,
- in patients with benign prostatic hyperplasia or urinary bladder neck obstruction,
- in patients with hyperthyroidism,
- in patients with bronchial asthma,
- in patients with cardiovascular diseases and arterial hypertension,
- in patients with porphyria, because clemastine may exacerbate symptoms of this disease,
- in elderly patients due to increased risk of adverse effects (e.g. dizziness, excessive sedation, and lowering of blood pressure).
You should consult your doctor, even if the above warnings refer to conditions
occurring in the past.
You should avoid using clemastine concurrently with medicines that depress the central nervous system (see "Clemastinum HASCO and other medicines").
You should discontinue clemastine for several days (at least 3 days) before undergoing allergy testing.
Clemastinum HASCO and other medicines
You must tell your doctor or pharmacist about all 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 (e.g. sedatives, hypnotics, opioids, some psychotropic medicines) may enhance the depressant effect of clemastine on the central nervous system. Therefore, concomitant use of clemastine with such medicines should be avoided.
Concomitant use of clemastine with anticholinergic medicines may enhance their effects.
Medicines belonging to the group of monoamine oxidase inhibitors (used in the treatment of depression) prolong and intensify the effect of clemastine; therefore, concomitant use of these medicines is contraindicated, see "When not to use Clemastinum HASCO".
Clemastinum HASCO, food, drink, and alcohol
Do not drink alcohol while taking clemastine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Clemastine crosses the placenta; there are insufficient data to fully assess the safety of using this medicine in pregnant women. Clemastine may be used during pregnancy only on medical advice and only in cases of clear necessity.
Clemastine should not be used in breastfeeding women, as it passes into breast milk.
Driving and operating machinery
This medicine may cause drowsiness, which may impair psycho-physical performance, ability to drive, and operate machinery. Therefore, during treatment with clemastine, you should not drive or operate machinery.
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Clemastinum HASCO contains lactose monohydrate
If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking this medicine.
3. How to use Clemastinum Hasco
This medicine should always be used according to the instructions given by your doctor or pharmacist. In case of doubts,
you should consult your doctor or pharmacist.
Oral administration.
In adults, the dose is 1 tablet (i.e. 1 mg of clemastine) twice daily, 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 more than the recommended dose of Clemastinum Hasco
If more than the recommended dose is taken, you should consult your doctor or pharmacist.
Cases of poisoning in adults due to clemastine overdose have been reported, presenting with symptoms of central nervous system depression or stimulation, most commonly leading to central nervous system depression manifested as drowsiness or even coma. Cardiovascular collapse may occur.
Other possible symptoms include: hallucinations, agitation, disinhibition, motor coordination disturbances, muscle tremors, high fever, dryness of the oral mucosa, pupil dilation, facial flushing, convulsions, cyanosis, and excessive excitability progressing into deepening depression.
Management in case of overdose
If the patient is conscious, vomiting should be induced shortly after the overdose, followed by administration of activated charcoal. Cold compresses should be used to reduce fever. There is no specific antidote; symptomatic treatment should be administered if necessary.
Missed dose of Clemastinum Hasco
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor, pharmacist, or nurse.
4. Possible adverse reactions
Like all medicines, this medicine may cause adverse reactions, although they do not occur in everyone.
The following adverse effects may occur:
Nervous system disorders
Most commonly occurring: excessive sedation, drowsiness, headache and dizziness, disturbances in motor coordination.
Also possible: disorientation, anxiety, excessive excitation, feeling of fatigue, tremors, insomnia, blurred vision, double vision, tinnitus, convulsions, difficulty concentrating.
Gastrointestinal disorders
Most commonly occurring: stomach pain, nausea, constipation, diarrhoea, vomiting. Loss of appetite may also occur.
Respiratory, thoracic and mediastinal disorders
Most commonly occurring: increased viscosity of respiratory tract secretions. Also possible: chest tightness, wheezing, dryness of the mucous membranes of the mouth, nose and throat, sensation of nasal congestion.
Cardiac and vascular disorders
Hypotension, palpitations, tachycardia, extrasystoles.
Skin and subcutaneous tissue disorders
Urticaria, rash and itching.
Blood and lymphatic system disorders
Changes in blood picture (reduction in white blood cell count, marked decrease or absence of granulocytes in blood, reduced platelet count, and haemolytic anaemia).
Renal and urinary disorders
Difficulty in urination, urinary retention.
General disorders
Excessive sweating, chills, photosensitivity.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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: [email protected].
Adverse reactions may also be reported to the responsible entity.
Reporting adverse reactions helps to gather more information on the safety of using the medicine.
5. How to store Clemastinum Hasco
Store below 25°C. Keep in the original packaging.
The medicine should be stored out of sight and out of 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 stated month.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.
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6. Contents of the pack and other information
What Clemastinum HASCO contains
- The active substance is clemastine. Each 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 carboxymethyl starch (Type A), magnesium stearate, colloidal anhydrous silica.
What Clemastinum HASCO looks like and contents of the pack
The medicinal product is in the form of white tablets with a uniform surface.
One pack contains 7, 15 or 30 tablets.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information on the medicinal product
tel.: 22 742 00 22
e-mail: [email protected]
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