Clemastinum Hasco

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Clemastinum Hasco

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Overview of Clemastinum Hasco

Clemastinum Hasco is a synthetic pharmaceutical product containing the active substance Clemastine, designed to counteract the body's reaction to allergens. It is officially classified as a first-generation antihistamine and an H₁-receptor antagonist.


Quick Facts: Clemastinum Hasco

Property Description
Active ingredient Clemastine (Clemastine fumarate salt)
Form Syrup (oral solution) and tablets
Pharmacological class First-generation H₁-receptor antagonist
Common use Systemic relief from allergic manifestations
Origin Synthetic

Clemastinum Hasco: Identity and Classification

Clemastinum Hasco is a specific medicinal preparation based on the active ingredient Clemastine (specifically, Clemastine fumarate salt), and is manufactured by Hasco-Lek S.A. It is a chemically synthetic, single active ingredient product. The World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) system places Clemastine within the R06AA group (aminoalkyl ethers), underscoring its established classification as a first-generation antihistamine.

This classification is relevant as the H₁-receptor antagonist action of Clemastine is recognized for providing effective relief from acute allergy symptoms.

What is the General Purpose of This Type of Medicine?

The general purpose of this type of medicine is to provide systemic relief from the symptoms associated with allergic reactions by blocking a key chemical mediator. The core mechanism is characterized by its role in stabilizing the body's response to allergens. This medicine can diminish the intensity of symptoms like irritation and itching (pruritus) that occur during an allergic reaction.

The product is formulated for administration via the oral route, being available both as a liquid syrup and as solid tablets. This distinction, particularly the availability of the liquid syrup, makes it an option for patients who may struggle with swallowing tablets or require more precise dose adjustments, thereby expanding its accessibility for various patient groups.

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What side effects are possible with Clemastinum Hasco?

Possible side effects and safety information

The regulatory safety profile of Clemastine, the active component in Clemastinum Hasco, is characterized primarily by its effects on the Central Nervous System (CNS). The official labeling identifies transient drowsiness and sedation as the most common adverse reactions, a characteristic frequently observed with first-generation antihistamines. In addition to these common CNS effects, which may include dizziness, fatigue, and disturbed coordination, the official documentation lists potential effects across several body systems.


System-Organ Classes and Adverse Events

The officially documented adverse reactions are grouped into several categories, including Gastrointestinal Disorders (such as dry mouth, epigastric distress, nausea, and constipation), Cardiac Disorders (including palpitation and tachycardia), and Vascular Disorders (notably hypotension). Other systems affected may include the Respiratory System (thickening of bronchial secretions) and the Dermatological System (drug rash, photosensitivity).

Serious Adverse Reactions and Population-Specific Safety

Although rare, the regulatory profile includes documentation of serious adverse reactions, such as convulsions/seizures, anaphylactic shock, and certain hematologic effects (e.g., agranulocytosis).

Specific safety considerations are defined for certain populations. Older adults (60 years and older) are noted as being more susceptible to certain effects, including dizziness, sedation, and hypotension. Conversely, children may experience a paradoxical reaction of CNS excitement or stimulation. Use of the medicine is contraindicated in nursing mothers and in neonates/premature infants due to potential risks to the infant.

Official labeling also places safety-related restrictions concerning pre-existing conditions, advising that the medicine is contraindicated in individuals with lower respiratory tract disease and requires considerable caution in those with conditions like narrow-angle glaucoma, symptomatic prostatic hypertrophy, and cardiovascular disease. These classifications establish the factual basis for understanding the medicine's limitations and documented risks.

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Overdose and Emergency Response

Overdose and When to Seek Help

Overdose of Clemastine fumarate, the active ingredient in Clemastinum Hasco, can result in a range of manifestations documented in official regulatory labeling. The symptom profile may include paradoxical central nervous system (CNS) effects, varying from periods of CNS stimulation (such as excitement, hallucinations, tremors, and ataxia) to profound CNS depression (such as drowsiness or coma). Anticholinergic signs, including a flushed face, dry mouth, and fixed dilated pupils, are also documented as part of the toxicity profile.

Severe and Life-Threatening Outcomes

Official information highlights the risk of serious complications, including convulsions (seizures), hyperthermia, hypotension (low blood pressure), and the risk of cardiorespiratory arrest. Children are noted to be more susceptible to the initial stimulation syndrome, while the elderly are more prone to pronounced sedation and hypotension.

Mandatory Emergency Action

The official guidance strictly mandates that emergency medical attention must be sought immediately if an overdose is suspected or has occurred. Urgent medical help is specifically required if the affected individual has collapsed, experienced a seizure, has trouble breathing, or cannot be awakened. Treatment described in regulatory labeling is symptomatic and supportive, often involving procedures such as gastric emptying and managing critical symptoms with documented medical agents.

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Therapeutic Uses of Clemastinum Hasco

Quick Facts

  • Therapeutic Domain: Temporary relief of symptoms associated with allergic conditions.
  • Key Uses: Management of allergic rhinitis (hay fever) and certain allergic skin manifestations.
  • Alleviates Symptoms Such As: Sneezing, watery eyes, runny nose, and itching of the nose, throat, or skin.

What Clemastinum Hasco Treats: Main Uses and Benefits

Clemastinum Hasco is a medication used to help manage symptoms associated with various allergic conditions. Its primary function is to offer temporary relief from manifestations that arise due to the body's reaction to allergens.

The medication is indicated for use in relieving the symptoms of allergic rhinitis, a condition commonly known as hay fever. This includes addressing symptoms such as frequent sneezing, excessive watery discharge from the nose (rhinorrhea), and tearing or itching of the eyes and nose.

Furthermore, Clemastinum Hasco is used for the management of mild, uncomplicated allergic skin conditions. Specifically, it may be used to help reduce symptoms related to urticaria (hives), contact dermatitis, and pruritus (itching) associated with these manifestations. It also provides relief for certain skin symptoms of angioedema (swelling). The active component is recognized for its role in providing symptom relief in allergic disorders.

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Eligibility and Restrictions for Use

Who Can and Cannot Use Clemastinum Hasco?

The eligibility for using Clemastinum Hasco (Clemastine fumarate) is strictly defined by regulatory criteria, with absolute restrictions applying to several patient groups.

Contraindicated Populations

Use of the medicine is contraindicated and must be avoided for the following groups, as stated in official labeling:

  • Individuals with known hypersensitivity to clemastine fumarate or chemically similar antihistamines.
  • Newborns and premature infants.
  • Nursing mothers.
  • Patients currently receiving Monoamine Oxidase Inhibitor (MAOI) therapy.
  • For the treatment of lower respiratory tract symptoms, including asthma.

Age-Related Eligibility

Age Group Eligibility Status (Regulatory Context)
Adults and Children geq 12 years Use is established
Children 6–11 years (Syrup) Use is established (for oral solution/syrup)
Children < 6 years (Syrup) Safety and efficacy not established
Children < 12 years (Tablet) Safety and efficacy not established
Elderly Patients (geq 60 years) Use requires caution

Conditional Use Restrictions

Regulatory documents mandate considerable caution in patients with pre-existing conditions, including narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, and bladder neck obstruction. Use during pregnancy is permitted only if clearly needed due to inadequate human experience.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Clemastinum Hasco (Clemastine) is defined by its activity as a first-generation antihistamine, establishing restrictions across medicinal products and diagnostic procedures as documented in official regulatory sources.

Formal Interaction Restrictions

Interaction Classification Interacting Agent Official Restriction and Outcome
Contraindicated Combination Monoamine Oxidase Inhibitors (MAOIs) Co-administration is formally prohibited. MAOIs prolong and intensify the anticholinergic (drying) effects of Clemastine.
Pharmacodynamic Interaction Alcohol (Ethanol) Leads to additive Central Nervous System (CNS) depression, increasing the risk of drowsiness and dizziness.
Pharmacodynamic Interaction Other CNS Depressants Co-administration with sedatives, hypnotics, tranquilizers, or barbiturates may cause enhanced CNS depression.
Timing-Based Restriction Antigen or Histamine Skin Tests The medicine must be discontinued for at least 3 days prior to testing to prevent suppression of the diagnostic response.

Population-Specific Interaction Notes

The risk associated with the primary pharmacodynamic interactions is notably higher in certain groups. Regulatory documents state that the manifestation of effects like dizziness and sedation is increased in elderly patients (approximately 60 years or older) taking antihistamines.

This structure reflects the established regulatory guidance regarding the use of Clemastine with other substances.

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Mechanism of Action

H1 Receptor Blockade: Dampening Histamine Signaling

Clemastinum Hasco's primary mechanism is competitive antagonism of the H1 histamine receptor. This action blocks the effect of histamine, a key physiological mediator, on the cells, thereby suppressing the molecular cascade that initiates specific physiological responses including increased capillary permeability and smooth muscle contraction.


Modulation of Central Histaminergic Pathways

The drug is highly lipophilic and readily crosses the blood-brain barrier, allowing it to act on H1 receptors in the central nervous system (CNS). This central H1 receptor blockade interferes with histamine's role as a wakefulness-promoting neurotransmitter, which results in the inhibition of signaling associated with central arousal.


Secondary Muscarinic Cholinergic Receptor Antagonism

Clemastinum Hasco exhibits a secondary anticholinergic action by also blocking certain muscarinic cholinergic receptors. This mechanistic domain influences pathways that regulate glandular secretions and muscle tone, leading to altered physiological control over glandular secretion and smooth muscle contractility.

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Dosage and Administration Information

How Clemastinum Hasco is Used

Clemastinum Hasco (clemastine) is administered via the oral route, available in both tablet and syrup (oral solution) forms.


Standard Dosage and Frequency

Patient Group Standard Initial Dose Typical Frequency Maximum Daily Dose
Adults (12 years and older) 1 mg clemastine base Twice Daily (BID) Up to 6 mg clemastine base
Children (6 to 11 years) 0.5 mg to 1 mg clemastine base Twice Daily (BID) 3 mg clemastine base

Dosage is generally twice daily on a divided schedule, though frequency may be increased up to three times daily, not to exceed the established maximum limits. The medication may be taken with or without food as timing in relation to meals is flexible.


Specific Administration and Adjustment Rules

  1. Syrup Measurement: For the liquid oral solution, the dose must be accurately measured using a calibrated dosing device (such as a cup or spoon) to ensure the correct volume is administered.
  2. Pediatric and Hepatic Use: Dosing for children aged 6 to 11 years is scaled by age and is generally administered via the syrup form. Dosage reduction may be warranted for patients with hepatic impairment, as clemastine is metabolized in the liver.
  3. Missed Dose: If a dose is missed, it should be skipped if it is almost time for the next scheduled dose, and the patient should continue the regular dosing schedule. A double dose should not be taken to compensate for the missed one.
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Recent Clinical Evidence

Evidence for Use in Allergic Rhinitis (Hay Fever)

The research foundation to evaluate its use in allergic rhinitis, commonly known as hay fever, primarily consists of short-term, randomized controlled trials (RCTs). These studies typically explored how symptoms change over defined time intervals, often in comparison with a placebo or other types of allergy medicines. Researchers tracked changes in patient-reported severity for symptoms such as frequent sneezing, a runny nose (rhinorrhea), and itching or watering of the eyes and nose, which served as the primary outcomes. Regulatory reviews describe this evidence base as High in terms of consistency and volume, reflecting the long history of clinical evaluation for this established use.

However, the evidence structure for short-term symptom changes includes certain limitations. Long-term effects are not fully established, and the evidence base is characterized by a lack of extensive data concerning sustained outcomes beyond a few weeks. The research primarily applies to adults and children, but data for groups like older adults or patients with complex comorbidities remain limited.

Evidence for Use in Allergic Skin Manifestations

Clemastine was also studied for its use in conditions characterized by fluctuating or episodic manifestations, such as hives (urticaria) and the generalized itching (pruritus) associated with allergic skin conditions. The evidence supporting this use is derived from a structure of older clinical trials, as well as systematic literature reviews that often group Clemastine with other first-generation antihistamines.

Research examined outcomes related to physical discomfort, such as measuring the change in the visible severity of hives or monitoring patient-reported outcomes describing perceived discomfort from itching. The research is limited by a lack of recent, large-scale RCTs, and comparative evidence is lacking in some areas, reflecting the Moderate classification of this evidence.

Key Studies & References

  1. CLEMASTINE FUMARATE tablet - DailyMed (US National Library of Medicine/NIH)
  2. Clemastine: MedlinePlus Drug Information (NIH)
  3. R06AA04 - ATCDDD - ATC/DDD Index (WHO Collaborating Centre for Drug Statistics Methodology)
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Frequently Asked Questions (FAQ)

Common questions about Clemastinum Hasco (FAQ)


Q: How quickly does Clemastinum Hasco usually start working for allergy symptoms?

Pharmacokinetic studies described in regulatory documents indicate that the maximum effect of this medication on reducing allergic responses, such as wheal and flare suppression, is typically observed approximately 5 to 7 hours following an oral dose.


Q: What is the typical duration of action for Clemastinum Hasco?

Official information states that the antihistaminic effect of Clemastinum Hasco usually lasts for about 10 to 12 hours. In some individuals, the effects may persist for up to 24 hours.


Q: Is Clemastinum Hasco the same type of medication as Allegra or Zyrtec?

No. Clemastinum Hasco is classified as a first-generation H₁-receptor antagonist. Medications like Allegra (fexofenadine) and Zyrtec (cetirizine) are classified as second-generation antihistamines. This classification describes differences in chemical structure and the potential for crossing the blood-brain barrier.


Q: What types of medications are known to increase the sedative effects of Clemastinum Hasco?

Regulatory labeling warns that combining Clemastinum Hasco with alcohol or other Central Nervous System (CNS) depressants can intensify effects like drowsiness and dizziness. CNS depressants include medications such as sedatives, tranquilizers, hypnotics, and barbiturates.


Q: Does Clemastinum Hasco affect the results of allergy skin tests?

Yes, official safety information specifies that Clemastinum Hasco can suppress the diagnostic response to antigen or histamine skin tests. Regulatory sources advise discontinuing the medication before such testing is performed.


Q: How long before an allergy test should I stop taking Clemastinum Hasco?

According to official regulatory guidance, the medicine should be stopped for a period of at least three days prior to undergoing an antigen or histamine skin test.


Q: Can I take Clemastinum Hasco if I have a history of glaucoma?

Official guidelines recommend considerable caution when the medication is used by individuals with certain pre-existing eye conditions, specifically narrow-angle glaucoma. This precaution is due to the medicine's secondary anticholinergic properties, which can influence eye pressure.


Q: What should I know about using Clemastinum Hasco if I have prostate issues?

Regulatory documents state that considerable caution is required for individuals who have conditions such as symptomatic prostatic hypertrophy (enlarged prostate) or bladder neck obstruction. This is a safety consideration related to the medication’s anticholinergic action.


Q: What happens if I take Clemastinum Hasco with anxiety medication?

If the anxiety medication is classified as a Central Nervous System (CNS) depressant, taking it with Clemastinum Hasco can lead to an additive pharmacological effect. This interaction may result in enhanced sedation, dizziness, and decreased coordination.


Q: What's the difference in use between the tablet and syrup form of Clemastinum Hasco?

The oral solution (syrup) is the established form for dosing children aged 6 to 11 years, as documented in regulatory materials. The syrup allows for more accurate and scaled administration in these younger age groups, while both forms are generally indicated for adult use.


Q: What kind of scientific research is available about Clemastinum Hasco?

The evidence base used for regulatory review includes short-term randomized controlled trials (RCTs) that focus on symptom relief for allergic rhinitis and certain skin conditions. Studies also examine pharmacokinetics, which describes how the body processes the medication over time.


Q: Is there any evidence about the effectiveness of Clemastinum Hasco in chronic conditions?

Official evaluations of the available evidence state that the medication has been primarily studied in short-term settings. Consequently, comprehensive data concerning sustained long-term outcomes for chronic conditions are not fully established in formal regulatory review.


Q: Can I use Clemastinum Hasco for a persistent cough?

The medicine is indicated for relief of symptoms associated with allergies, such as sneezing and a runny nose. Official labeling states that antihistamines should generally not be used for treating symptoms related to the lower respiratory tract, including asthma.


Q: Is Clemastinum Hasco effective for pet allergies?

Official indications for Clemastinum Hasco state that it is used for the relief of symptoms associated with allergic rhinitis. Allergic rhinitis is a condition that may be caused by various environmental triggers, including allergens from pets.


Q: Does taking Clemastinum Hasco affect my blood pressure?

The official safety profile includes documentation of potential cardiovascular adverse effects. These rare potential reactions include hypotension (low blood pressure) and tachycardia (increased heart rate).


Q: Is Clemastinum Hasco used for conditions other than allergies?

Regulatory documents list the indications for this medication as the relief of symptoms associated with allergic rhinitis (e.g., sneezing, runny nose) and mild allergic skin manifestations (e.g., hives, itching).


Q: Can Clemastinum Hasco be taken on an empty stomach?

Official administration instructions state that the medication may be taken with or without food. The timing of the dose in relation to meals is considered flexible.


Q: What does the 'Hasco' part of the drug name refer to?

The name 'Hasco' refers to the company, Hasco-Lek S.A., which is the manufacturer and marketing authorization holder for this specific pharmaceutical product.


Q: Can Clemastinum Hasco be used to treat cold symptoms?

Regulatory documents indicate that the medication may be used for the temporary relief of specific allergy-like symptoms, such as rhinorrhea (runny nose) or sneezing, that may also be associated with the common cold.


Q: Are there studies on the long-term safety of Clemastinum Hasco?

The evidence base for this medicine consists primarily of short-term studies focusing on immediate effects. Comprehensive data concerning sustained long-term safety profiles, particularly beyond a few weeks of use, are not fully established in the formal regulatory review.

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How should Clemastinum Hasco be stored and disposed of?

How to Store and Dispose of Clemastinum Hasco?

Official Storage Requirements

Clemastinum must be stored at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F). The product must be kept in its original, tightly closed container and protected from excess heat, moisture, and direct sunlight. The liquid forms (syrup) must not be frozen.

Child Safety and Disposal

Official labeling mandates that the medicine must always be kept out of the sight and reach of children. Do not use the product after its expiration date. Disposal of unused or expired Clemastinum must be carried out according to local, state, and federal regulations; the medication must not be flushed down a toilet or poured into a drain.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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