Циннаризин Софарма

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Циннаризин Софарма

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Overview of Циннаризин Софарма

Property Description
Active ingredient Cinnarizine (INN)
Form Tablets (for oral use)
Pharmacological class H1-receptor Antihistamine and Calcium Channel Blocker
Common use Vestibular (balance) disorders
Origin Synthetic

Identity and Composition: Defining Циннаризин Софарма

Циннаризин Софарма is a single-ingredient, synthetic medicinal product administered orally in tablet form. Its sole active ingredient is the chemical substance Cinnarizine (INN), which belongs to the class of piperazine derivatives. Being a synthetic compound, it is manufactured to consistently provide its targeted pharmacological actions. This medicine’s identity is specifically associated with the manufacturer, Sopharma, and is readily available in many markets as a recognized preparation for balance support.

Pharmacological Classification and Function

Cinnarizine is categorized primarily as an antivertigo preparation. Pharmacologically, the substance has a dual role, classified both as a first-generation H1-receptor antihistamine and, critically, a non-selective calcium channel blocker (CCB). This CCB property allows it to influence the vascular system by reducing the flow of calcium ions into the smooth muscle cells of blood vessel walls. Its efficacy is clinically recognized for managing symptoms related to vestibular dysfunction, highlighting its specific anti-motion and anti-vertigo profile.

General Therapeutic Role and Core Benefit

Owing to its action as a labyrinthine sedative and microcirculatory agent, the overall purpose of Cinnarizine is to stabilize the sensory apparatus responsible for balance. This formulation is often used in scenarios where motion or internal disturbance leads to feelings of disequilibrium. By damping the hyper-responsiveness of the vestibular system and supporting microcirculation, the medicine provides the core benefit of helping to manage sensations of generalized dizziness, unsteadiness, or the spinning feeling of vertigo, thereby promoting a more stable sensory experience.

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What side effects are possible with Циннаризин Софарма?

Possible Side Effects and Safety Information

The safety profile of Циннаризин Софарма is defined by common, generally mild reactions, and more serious, though rare, neurological effects, particularly with prolonged use.


Adverse Reactions Summary

Classification Adverse Reactions
Common (Affects < 1 in 10) Drowsiness or sedation, weight gain, gastrointestinal upset (nausea, indigestion, stomach pain).
Less Common/Rare Headaches, dry mouth, increased perspiration, skin reactions (rash, itchy bumps), or jaundice (yellowing of skin/eyes).
Serious/Clinically Significant Extrapyramidal symptoms (movement disorders like tremors, muscle stiffness, or slow/jerky movements), which are more likely with long-term use, especially in the elderly. Signs of a serious allergic reaction/hypersensitivity.

Contraindications and Safety Restrictions

Циннаризин Софарма must not be used in individuals with:

  • Known hypersensitivity to cinnarizine or any component of the formulation.
  • Porphyria (a rare inherited blood disorder).
  • Severe liver disease.

Caution is required in patients with:

  • Parkinson's disease, as symptoms may be aggravated or movement disorders may be induced.
  • Glaucoma or epilepsy.
  • Renal or hepatic insufficiency.

Due to the risk of drowsiness, concurrent use with alcohol or other Central Nervous System (CNS) depressants is discouraged as it increases the sedative effect. Patients should avoid driving or operating heavy machinery until they know how the medication affects them. Safety during pregnancy and lactation has not been established, and use is generally advised against unless essential and justified by therapeutic benefit.

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Overdose and Emergency Response

Overdose and When to Seek Help

The overdose profile for Cinnarizine is defined exclusively by official government regulatory documents, with reported ingestions ranging from 90 mg to 2,250 mg. Documented clinical manifestations primarily affect the central nervous system, involving a spectrum of alterations in consciousness, ranging from somnolence to stupor and coma. Other noted signs include vomiting, generalized muscle weakness (hypotonia), and extrapyramidal symptoms.

Regulatory statements confirm that deaths have been reported following single and multi-drug overdoses. Serious neurological risks include the development of seizures, particularly in young children. For this population, official guidance mandates that pediatric patients be observed in a health care facility for potential complications.

Immediate medical action is required when overdose is suspected. Individuals must seek immediate medical attention and contact emergency services if a very fast, irregular, or pounding heartbeat (palpitations) occurs. Treatment is limited to symptomatic and supportive care, as regulatory labeling confirms that no specific antidote is known. Decontamination procedures, such as the administration of activated charcoal, are only considered when presentation occurs within one hour of ingesting a dose exceeding 15 mg/kg.

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Therapeutic Uses of Циннаризин Софарма

What Циннаризин Софарма treats: main uses and benefits

This medicine is used across several key therapeutic domains, primarily addressing conditions associated with symptoms that interfere with daily functioning by affecting the inner ear's balance system.

It helps manage symptom clusters of dizziness, vertigo, and unsteadiness, as well as tinnitus (ringing in the ears). It also plays a role in managing manifestations of poor peripheral circulation in the limbs and is used when short-term symptomatic assistance is needed to prevent and relieve motion sickness.

By offering supportive relief, this medication provides support that helps ease the overall symptom burden.

“It supports the patient during difficult episodes by easing distress and provides supportive relief when symptoms interfere with routine activities.”

Quick Fact: Focus on Balance and Auditory Symptoms

This medicine assists with maintaining functional stability and contributes to improved day-to-day comfort during symptomatic periods, especially when symptoms become more noticeable.

Regulatory References

  1. UK Medicines and Healthcare products Regulatory Agency (MHRA) assessment
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Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Циннаризин Софарма — Official Regulatory Information

The official eligibility profile for Cinnarizine is defined by specific prohibitions and conditional use warnings detailed in governmental regulatory documents.

Eligibility Scope Status according to Regulatory Documents
Populations for whom use is allowed Adults and adolescents (typically over 12 years) are permitted under standard labeled conditions. Children aged 5 to 12 years may use the medicine at a restricted, lower dose.
Populations for whom use is contraindicated Patients with known hypersensitivity to cinnarizine or its excipients, as well as those diagnosed with Porphyria. In some regions, use is contraindicated in severe hepatic disease and severe renal impairment [1.1, 1.4, 2.4].
Age-related eligibility rules Use is not recommended or contraindicated in children under 5 years of age [2.4]. Older adults require special caution due to increased susceptibility to central nervous system effects [1.2].
Condition-specific eligibility rules Patients with Parkinson's disease must only be given the medicine if the clinical advantages are determined to outweigh the possible risk of aggravating the disease [1.7]. Caution is also advised in patients with mild to moderate hepatic or renal insufficiency [2.4].
Pregnancy and lactation eligibility Use during pregnancy and lactation is generally not advisable as safety in human pregnancy is not established, and data on excretion into breast milk is lacking [2.4, 2.5].

Connection to the overall eligibility profile

Regulatory documents define who can and cannot use the medicine based on a structure of absolute prohibitions (contraindications) and mandatory conditional use warnings. Eligibility is restricted for age (children under 5) and physiological states (pregnancy, lactation) due to insufficient established human safety data, alongside specific limitations for patients with pre-existing neurological and metabolic conditions as defined in the official prescribing information.

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What should I know about interactions with other medicines?

The official interaction profile for Cinnarizine is defined by documented pharmacodynamic risks and procedural timing constraints as stated in authoritative regulatory sources. This information focuses strictly on additive effects and administration separation requirements.


Pharmacodynamic Interactions and Restrictions

Co-administration with other medicines classified as Central Nervous System (CNS) Depressants may lead to the potentiation of sedative effects. This interaction pattern is also documented for Tricyclic Antidepressants, resulting in an additive effect on sedation. Due to the risk of enhancing these effects, the consumption of alcohol must be strictly avoided. This is formally stated in the regulatory documentation to manage the risk of additive central nervous system effects.


Timing-Based Constraints

A mandatory procedural constraint exists due to the drug’s antihistamine properties. Because Cinnarizine may prevent an otherwise positive reaction to dermal reactivity indicators, its use must be suspended up to four days prior to undergoing skin allergy testing. This temporal separation is a required constraint to ensure the accuracy of the diagnostic procedure.

No specific interactions related to drug exposure modification (e.g., altered AUC or clearance) or population-dependent interaction risks are formally documented in the regulatory interaction sections. The regulatory framework establishes that this medicine's interaction structure is based on additive sedative effects with certain substance classes, requiring avoidance of alcohol, and a clear temporal separation rule for diagnostic testing.

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Mechanism of Action

How Циннаризин Софарма Works


Modulating Vascular Contraction via Calcium Channels

Циннаризин primarily operates as a non-competitive calcium channel blocker, mainly targeting the smooth muscle cells of blood vessels. This action inhibits the influx of calcium ions ( Ca^2+) necessary for sustained muscle contraction. By dampening this core signaling mechanism, the drug modulates vascular smooth muscle contraction, resulting in vasodilation (vessel widening). This mechanistic consequence is associated with altered microcirculatory dynamics and perfusion in peripheral and cerebral vascular beds.


Suppressing Vestibular Signaling Pathways

The drug also acts as an H1-receptor antagonist, particularly within the vestibular system of the inner ear. By blocking these histamine receptors, Циннаризин interferes with the neural transmission of balance and motion signals to the CNS. This action results in suppression of histamine-mediated neural activity in the vestibular nuclei. The consequence is a mechanistic dampening of signal transduction in the balance pathways.


Modifying Hemorheology and Blood Properties

A secondary mechanism involves influencing hemorheology, or the flow properties of the blood. Циннаризин is associated with increasing the flexibility (deformability) of erythrocytes (red blood cells). This alteration in hemorheological properties reduces flow resistance and modifies microcirculatory dynamics.

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Dosage and Administration Information

The medicine is available in tablet form and is intended for oral administration. Specific, structured dosing schedules are based on the required usage pattern and patient group.

Official Dosing and Frequency

Usage Scenario Adult Standard Dose Frequency Pattern
Vestibular Disorders 25 mg (one tablet) Three times daily (TID)
Motion Sickness Prophylaxis 25 mg (one tablet) Initial dose taken 30 minutes to 2 hours before travel, then repeated every 6 to 8 hours during the journey

The total 24-hour dose for any approved indication should not exceed 225 mg.

Administration Context and Population Rules

Timing in relation to meals: the tablet should preferably be taken after meals or with a snack to minimize gastric irritation. The tablets may be swallowed whole with water, chewed, or sucked, depending on patient preference.

Age-group administration rules involve dose adjustments for the pediatric population. Children between the ages of 5 and 12 years use half the adult dose when the medicine is administered for either motion sickness or vestibular symptoms. Furthermore, a specific condition requires that administration be avoided in the four days preceding diagnostic dermal reactivity testing due to potential interference with test results.

Standard protocols establish a structured approach to administration, distinguishing between the continuous daily pattern necessary for maintenance and the event-specific, intermittent regimen required for travel prophylaxis.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Циннаризин Софарма

This section provides an overview of the types of clinical research and studies that have been conducted on Cinnarizine-containing products. This information is intended to describe the structure of the existing evidence, focusing only on what researchers investigated and reported, and does not offer medical advice, dosing instructions, or treatment recommendations.

1. Evidence for use in Vertigo (Vestibular Disorders)

Cinnarizine has been studied for its use in vertigo, a condition characterized by fluctuating or episodic manifestations of dizziness and spinning. Research examined the outcomes associated with Cinnarizine-containing regimens, including formulations that combine it with other medicines, in the context of these episodes.

The studies primarily involved short-term randomized controlled trials (RCTs) and systematic reviews, which were evaluated in adult populations experiencing various forms of vertigo. Researchers focused on outcomes related to physical discomfort and outcomes reflecting daily functioning by using patient-reported symptom scales, such as the Mean Vertigo Score (MVS). Studies report how symptoms evolved in the observed populations over these short treatment periods. Findings often compare these patterns to those seen with an inactive control (placebo) or other comparator treatments. The follow-up durations were limited in many of these studies, and the persistence or durability of reported outcomes over extended time is less characterized.

2. Evidence for use in Meniere's Disease (Ménière-like Symptoms)

Research on Cinnarizine for Meniere's disease or similar symptom complexes is primarily based on smaller comparative clinical studies. Studies explored the reported frequency of vertigo attacks and the intensity of associated symptoms in patients with this condition involving periods of heightened symptoms. These findings describe group patterns observed in the studies regarding symptom activity. The evidence quality varies across studies. There is a lower number of recent, large-scale controlled trials focusing specifically on Cinnarizine monotherapy for this condition.

3. Evidence in Special Populations and Uncertainties

Data for certain groups remain insufficient. Research has explored Cinnarizine use in the elderly population; however, dedicated subgroup findings are often limited in published reviews. Studies observing Cinnarizine specifically in pediatric populations are generally limited. Furthermore, the overall evidence quality varies across studies, and sample sizes were modest in many of the individual trials, which can impact the certainty of the findings. Long-term effects are not fully established regarding sustained use. Research is ongoing, but existing studies often provide limited insight into individual responses, as findings describe group patterns, not personal outcomes.

Key Studies & References

  1. Efficacy of cinnarizine/dimenhydrinate compared to betahistine in the Management of Adults with Peripheral Vestibular Disorder: A Systematic Review of Randomized Controlled Trials
  2. Betahistine or cinnarizine with or without dimenhydrinate for Mé- nière's disease/syndrome and symptoms of vestibular vertigo and/or tinnitus (HTA Report for the Swiss Federal Office of Public Health)
  3. Australian Public Assessment Report for Cinnarizine / Dimenhydrinate (Regulatory document, used for indications and study scope)
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Frequently Asked Questions (FAQ)

Common questions about Циннаризин Софарма (FAQ)


Q: Is Циннаризин Софарма an anti-allergy medication or something else?

Official regulatory documents classify Cinnarizine as having two main actions: it is an H1-receptor antihistamine and a calcium channel blocker. While the antihistamine property is the same found in some allergy medicines, its primary role is defined as helping to stabilize the sensory apparatus responsible for balance, making it an anti-vertigo preparation.


Q: Is it necessary to take Циннаризин Софарма with a meal?

Official patient information states that the medicine should preferably be taken after meals or with a snack. This administration timing is advised to help minimize the potential for stomach or gastric irritation that can sometimes occur.


Q: Can this medication be used safely for long-term treatment, such as over several months?

Official safety information notes that use for extended periods increases the likelihood of experiencing certain movement disorders, known as extrapyramidal symptoms. This risk is particularly noted in older adults. For this reason, the duration of treatment is an aspect that is determined by a healthcare professional.


Q: Can people with pre-existing liver conditions use Циннаризин Софарма?

According to the official product information, the medicine is generally advised against for individuals with severe liver disease. For patients with mild to moderate liver impairment (hepatic insufficiency), special caution is noted in the official prescribing information.


Q: What type of research has been conducted on the use of Циннаризин Софарма in children?

Regulatory documents indicate that research focusing specifically on pediatric populations is generally limited. Despite this, official dosage instructions exist for children between 5 and 12 years of age when the medicine is used for specific conditions like motion sickness or vestibular symptoms.


Q: Is there a specific age limit for who can or cannot use Циннаризин Софарма?

Yes, official eligibility guidelines state that the medicine is generally not recommended or is contraindicated for children younger than 5 years of age. Special reduced dosage rules are provided for children between 5 and 12 years.


Q: Is there any connection between Циннаризин Софарма and feeling depressed or anxious?

The official safety profile for the medication reports depression as a less common or rare undesirable effect, especially in older patients. However, the safety information generally does not establish a specific connection between the medicine and feelings of anxiety.


Q: What is the difference in effect between Циннаризин Софарма and Betahistine?

Cinnarizine acts as an H1-receptor antagonist and a calcium channel blocker, influencing both blood vessels and the inner ear balance system. Other treatments like Betahistine, which is often used as a comparator in studies, act as a selective H3-receptor antagonist. Official documents note that a reduction in Cinnarizine's effectiveness is documented when the two substances are used in combination.


Q: How quickly should I expect to feel the effect of Циннаризин Софарма after taking it?

Regulatory pharmacokinetic data indicates that the highest concentration of the medicine in the blood, known as peak plasma concentration, typically occurs between 2 to 4 hours after the medicine is taken by mouth.


Q: What happens if I forget to take a dose of Циннаризин Софарма?

Patient information generally describes the guideline for a missed dose as taking it as soon as it is remembered. However, patients are explicitly advised that taking a double dose to make up for a missed one is not recommended.


Q: Is Циннаризин Софарма considered to be habit-forming?

Official regulatory classification and pharmaceutical databases generally do not indicate that Cinnarizine is classified as a controlled substance, is habit-forming, or has a potential for dependence.


Q: Is the dizziness or lightheadedness from the medication permanent?

The common side effects of dizziness and sleepiness are typically not permanent and often lessen or disappear within a few days of starting treatment. More serious movement-related side effects that may occur with long-term use are generally described as being reversible.


Q: Is Циннаризин Софарма available without a prescription?

The regulatory classification of the substance permits its availability over-the-counter in many global markets, particularly for conditions like motion sickness. However, this access status can vary significantly depending on the country and local regulations.


Q: What are the known differences between Циннаризин and Cinnarizine?

The names Циннаризин and Cinnarizine refer to the exact same active pharmaceutical ingredient. Cinnarizine is the internationally recognized nonproprietary name (INN); Циннаризин is simply the spelling of that name using the Cyrillic alphabet.


Q: What is the typical time frame for the duration of one dose's effect?

Pharmacokinetic data indicates the medicine's half-life, which is the time it takes for half of the drug to be eliminated from the body, is typically between 3 to 6 hours. When used for travel prophylaxis (motion sickness prevention), official instructions advise repeating the dose every 6 to 8 hours during the journey.


Q: Does Циннаризин Софарма contain lactose or other common allergens?

The tablet formulation typically contains various inactive ingredients, or excipients, such as lactose monohydrate and sucrose. Patients with known sensitivities or allergies to these ingredients are advised to refer to the full list of excipients in the official product leaflet.


Q: Is a headache a commonly reported side effect when starting Циннаризин Софарма?

Headache is listed in official documents as a less common or rare side effect. Common adverse reactions are reported to include drowsiness, sedation, and gastrointestinal upset, especially when beginning treatment.


Q: Is Циннаризин Софарма approved for use in all countries globally?

Official pharmaceutical databases indicate that Cinnarizine is approved and marketed by many national authorization agencies worldwide. However, it is not centrally authorized by major bodies such as the US FDA or the European Medicines Agency (EMA) for use as a single-ingredient therapy.

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How should Циннаризин Софарма be stored and disposed of?

How to Store and Dispose of Циннаризин Софарма?

Official regulatory documents define specific conditions for the storage and disposal of Cinnarizine Sopharma tablets to maintain stability and ensure safety.


Storage Requirements

  • Temperature and Light: The medicine must be stored at a temperature below 30 C and protected from light.
  • Child Safety: In line with all pharmaceutical labeling, the product must be kept out of the sight and reach of children.

Disposal Instructions

  • Mandatory Procedure: Unused or expired tablets must not be thrown away with regular household waste or disposed of via wastewater.
  • Guidance: Patients should consult a pharmacist to learn how to discard the medicine properly, following local requirements for pharmaceutical waste.

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

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