Cinnarizin Actavis

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Overview of Cinnarizin Actavis

Property Description
Active ingredient Cinnarizine
Form Tablet
Pharmacological class Selective calcium channel blocker, Histamine mathrmH1 receptor antagonist
Common use Anti-vertigo and anti-motion sickness agent
Origin Synthetic diphenylmethylpiperazine derivative

What Type of Medicine is Cinnarizin Actavis?

Cinnarizin Actavis is a brand-name medicinal product containing the single active ingredient Cinnarizine, a synthetic chemical compound. Pharmacologically, Cinnarizine is classified as both a selective calcium channel blocker and a Histamine mathrmH1 receptor antagonist. This dual classification directs its function toward the regulation of circulation and balance. The active substance, which is a synthetic diphenylmethylpiperazine derivative, is supplied as a single-ingredient product in tablet form for oral administration, designed for systemic delivery within the body.

Understanding the General Purpose of Cinnarizine

The general purpose of Cinnarizine is to support equilibrium and microcirculatory integrity, leading to its international classification as an antivertigo preparation. This classification stems from its two primary physiological actions. First, Cinnarizine promotes vasodilation by selectively inhibiting calcium ion entry into vascular smooth muscle cells, which enhances cerebral and peripheral circulation.

Second, it acts to reduce the excitability of the vestibular apparatus—the balance-controlling organ in the inner ear. Cinnarizine is used for addressing symptoms related to balance disorders, such as chronic sensations of dizziness and vertigo. This action defines its role in the general relief of dizziness, spinning sensations (vertigo), and the symptoms resulting from compromised balance.

Regulatory References

  1. Domperidone-containing medicines referral (includes cinnarizine combination)
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What side effects are possible with Cinnarizin Actavis?

Possible side effects and safety information

Cinnarizine's official safety profile is classified according to the frequency and physiological system affected, based on regulatory documentation from health authorities.


Frequency-Classified Adverse Reactions

The most commonly documented adverse reactions predominantly affect the nervous system, while other effects are classified as uncommon or rare in regulatory labeling:

  • Common (affecting 1 to 10 users in 100): Somnolence (drowsiness/sleepiness), Headache.
  • Uncommon (affecting 1 to 10 users in 1,000): Dyskinesia (involuntary movements), Dry mouth, Weight increase, Fatigue/Tiredness.

System-Organ Classes and Serious Reactions

Adverse effects are documented across several organ classes, including Nervous System Disorders, Gastrointestinal Disorders, and Immune System Disorders. Regulatory information notes rare but clinically significant adverse reactions, such as cholestatic jaundice, extrapyramidal symptoms (e.g., tremor, rigidity), and the potential for Systemic Lupus Erythematosus (SLE)-like symptoms.


Population and Exposure-Related Safety Notes

The medicine's safety profile includes specific considerations regarding the duration of use and certain populations. Sedation is noted as being more likely to occur at the start of treatment. The risk of developing extrapyramidal symptoms is associated with long-term use, particularly in older adults. Furthermore, the regulatory label notes the potential for the medicine to worsen Parkinson's disease in affected patients.


Safety Restrictions

Official prescribing information documents contraindications regarding known hypersensitivity to Cinnarizine or its components. The label also notes that using this medicine with Central Nervous System (CNS) depressants may lead to an increased risk of sedation.

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Overdose and Emergency Response

Overdose and when to seek help

Overdosage of Cinnarizine (the active substance in Cinnarizin Actavis) may result in severe manifestations affecting the central nervous system (CNS) and cardiovascular system. The officially documented spectrum of CNS effects ranges from alterations in consciousness, including somnolence and stupor, to excitability, seizures, and coma.

Other regulator-listed clinical signs of overdose include vomiting, decreased muscle tone (hypotonia), and tachycardia (accelerated heart rate). Severe outcomes documented in regulatory labeling include the potential for cardiovascular collapse, respiratory distress, and rare instances of death.

Symptoms are described as being more pronounced in young children, with a heightened risk of severe neurological complications, specifically seizures.

Required Emergency Actions

Anyone with suspected Cinnarizine overdosage must seek immediate medical attention. Management for this scenario is entirely symptomatic and supportive treatment within a healthcare setting, as no specific antidote is known.

Procedures such as gastric lavage or the administration of activated charcoal may be considered by medical professionals to reduce absorption. Due to the severity of potential CNS effects, especially in the pediatric population, continuous observation in a health care facility is a regulatory requirement for suspected overdosage.

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Therapeutic Uses of Cinnarizin Actavis

What Cinnarizin Actavis treats: main uses and benefits

Cinnarizin Actavis is indicated for the management of symptoms associated with specific conditions affecting balance and movement. The therapeutic focus is on providing relief from associated symptoms, particularly dizziness, nausea, and vomiting.

The medicine is utilized to assist in the management of manifestations associated with: travel sickness (kineticosis), symptoms of Ménière's disease (such as vertigo, tinnitus, and nausea), and other forms of dizziness (vertigo) originating from the inner ear. Use is common for short-term situations like motion sickness prevention or as a component of a longer-term strategy for inner ear balance issues.

Many patients find that using this medicine supports their ability to engage in activities, including travel, by assisting in the mitigation of motion sickness symptoms.

“It is used to assist in the management of inner-ear-related discomfort.”

Quick Fact: Supports the management of symptoms associated with Dizziness and Nausea


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Eligibility and Restrictions for Use

Who can and cannot use Cinnarizin Actavis?

The eligibility for using Cinnarizin Actavis (Cinnarizine) is determined by official regulatory documentation, focusing on age, pre-existing conditions, and physiological status.

Contraindicated Populations (Must Not Use)

This medicine is formally contraindicated for use in:

  • Patients with known hypersensitivity to cinnarizine or any excipients.
  • Individuals diagnosed with Porphyria.
  • Patients with rare hereditary metabolic issues, such as Lapp lactase deficiency or glucose-galactose malabsorption, due to excipient content in some formulations.

Age and Condition-Based Restrictions

Population Group Official Eligibility Status
Adults and Elderly Use is generally approved; caution is advised in the elderly due to susceptibility to extrapyramidal symptoms.
Children under 5 years Not recommended for use.
Pregnant Women Not advisable to administer; safety has not been established.
Nursing Mothers Use is not recommended.
Parkinson's Disease Conditional use only; should be given only if benefits outweigh the risk of aggravating the condition.
Severe Organ Impairment Contraindicated in severe hepatic or renal impairment in some regulatory documents; use with care in mild-to-moderate insufficiency.

Eligibility criteria should always be confirmed with a healthcare professional based on the specific product label.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Pharmacodynamic Interaction Risks

Official regulatory information emphasizes pharmacodynamic potentiation with several substance categories. Co-administration with Central Nervous System (CNS) depressants, including alcohol, may result in an additive sedative effect. The official labeling advises that alcoholic drink should be avoided for this reason. A similar potentiation of sedative effects is documented for co-use with tricyclic antidepressants. Other antimuscarinic drugs may also exert an additive anticholinergic action when taken concomitantly.

Metabolic Pathway and Diagnostic Constraints

Cinnarizine is subject to extensive hepatic metabolism primarily involving the CYP2D6 enzyme, a documented pharmacokinetic pathway that establishes a basis for potential metabolic interactions. Due to its antihistamine activity, Cinnarizine may prevent a positive reaction to dermal reactivity indicators; regulatory documents require the medicine be stopped at least 4 days prior to allergy skin testing. Furthermore, its anti-nausea effects may mask the warning signs of damage caused by ototoxic drugs, such as aminoglycoside antibiotics.

Population-Specific Caution

The medicine's regulatory profile notes that use should be approached with caution in patients with Parkinson's disease due to the possible risk of aggravating the condition. Caution is also advised for use in patients with hepatic or renal insufficiency.

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Mechanism of Action

Modulating Sensory Cell Excitability (Calcium Channel Blockade)

Cinnarizine primarily modulates calcium ion (Ca^2+) flux by blocking specific voltage-gated calcium channels in the sensory hair cells of the vestibular system. This mechanism limits Ca^2+ influx, which is crucial for stabilizing the cell membrane potential and modulating afferent signal transmission originating from the inner ear to the central nervous system (CNS).

Antagonism of Central Neurotransmitter Pathways

The molecule also acts centrally as a direct antagonist on multiple key neurotransmitter receptors, including Histamine H1 receptors and Dopamine D2 receptors. This antagonism interferes with the binding of endogenous signaling molecules, thereby modulating signal transduction within the central pathways that process motion information and coordinate the brainstem’s autonomic responses.

Regulation of Localized Vascular Tone

Additionally, the calcium channel blockade alters smooth muscle tone in blood vessel walls. This vasorelaxation affects vascular resistance, which can modulate microcirculation in the inner ear and associated CNS areas. The combined action of modulating vestibular signal transduction, antagonizing central receptors, and regulating localized vascular tone comprises the full pharmacodynamic profile of the compound.

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Dosage and Administration Information

Cinnarizine Actavis is administered exclusively via the oral route as a tablet. The administration protocol is determined by the specific context of use, which dictates the appropriate dosage and frequency. Administration is directed to be taken preferably after meals to minimize the potential for gastric irritation. Depending on the specific product formulation, the tablets may be chewed, sucked, or swallowed whole with water.

For the maintenance of chronic balance disorders, such as vertigo, the standard adult regimen is typically 25 mg taken in divided doses three times daily. When used for motion sickness prophylaxis, an initial dose of 25 mg is generally taken approximately 30 minutes to two hours before the start of the journey. This initial dose may be followed by subsequent maintenance doses of 25 mg repeated every six to eight hours throughout the duration of the travel, as needed.

All adult regimens are subject to a strict upper limit: the total daily dosage of Cinnarizine should not exceed 225 mg. For pediatric patients aged 5 to 12 years, the usage protocol calls for the administration of approximately half the adult dose for both motion sickness and balance issues. The duration of use is flexible, ranging from short-term intermittent use for acute travel to a longer-term maintenance pattern for several months. A minimum time interval of at least 8 hours must be maintained between subsequent doses.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Cinnarizin Actavis

The evidence for Cinnarizin Actavis was studied for its use in specific conditions through various types of clinical research. Research provides context but not individual predictions about whether a person will have a similar outcome. Findings describe group patterns, and research does not determine whether an individual will respond similarly.


Evidence for Use in Vertigo and Vestibular Disorders

Research exploring Cinnarizin Actavis for conditions characterized by functional imbalance, such as vertigo and vestibular disorders, primarily included short-term Randomized Controlled Trials (RCTs) and systematic reviews that pool the data from these trials. These studies were generally applied in populations of adult patients, including those with diagnoses like Menière's disease.

Researchers examined outcomes related to functional imbalance, specifically measuring changes in the intensity of symptoms like dizziness, unsteadiness, and rotary sensations. They also monitored changes in the frequency of vertigo attacks and measured physical performance during balance tests. Studies also monitored the overall reporting of events and the rate of patient withdrawal during the trial periods. Studies report how symptoms evolved in the observed populations over defined, limited time intervals. Some trials described patterns observed in which changes in measured vertigo symptom scores were reported in the study groups. However, findings across individual studies have sometimes varied, coinciding with the different specific populations or comparators used in research exploring short-term symptom changes.


Long-Term Studies and Durability of Response

Research exploring extended use beyond a few months is limited, and information on the durability of any reported short-term effects is not well characterized. Long-term effects are not fully established, and there is limited information for long-term outcomes, particularly regarding how outcomes related to functional imbalance might change over a year or more.


Evidence in Special Patient Populations

Older Adults (Geriatric Populations)

Cinnarizin Actavis was evaluated in studies that included older adults. These analyses helped contextualize how the measured outcomes might compare between younger and older adult populations. However, data for certain groups remain insufficient, particularly for patients with multiple, complex comorbidities. Research highlights that some of the results apply only to the populations studied in the research.

Pediatric Populations

Research exploring the use of Cinnarizin Actavis in children is limited. The evidence contributes to understanding symptom patterns, but there are few data available for pediatric populations across all approved indications. Therefore, subgroup findings are uncertain due to a lack of dedicated studies.


What is Still Uncertain About Cinnarizin Actavis

The available evidence landscape highlights several areas where more research is needed. Comparative evidence is lacking for Cinnarizin Actavis against some other antivertigo and anti-motion sickness treatments. Furthermore, evidence quality varies across studies, and the sample sizes were modest in some original trials, meaning the findings may not be generalizable to all patients. Overall, research provides insight into short-term changes, but there is limited information for long-term outcomes.

Key Studies & References

  1. Fixed Combination of Cinnarizine and Dimenhydrinate Versus Betahistine Dimesylate in the Treatment of Meniere's Disease: A Randomized Clinical Study
  2. Cinnarizine 15mg Tablets - Summary of Product Characteristics (SmPC) - (emc)
  3. Public Assessment Report National Procedure Cinnarizine 15mg Tablets (MHRA)
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Frequently Asked Questions (FAQ)

Common questions about Cinnarizin Actavis (FAQ)


Q: Can Cinnarizin Actavis affect the ability to drive or operate machinery?

Official labeling notes that the medicine may cause drowsiness or sleepiness (somnolence), particularly when treatment is first started. If this side effect occurs, regulatory documents state that activities requiring full mental alertness, such as driving or operating machinery, should be avoided.


Q: Can Cinnarizin Actavis be used for anxiety or sleep issues?

According to regulatory documents, the approved uses for this medicine are primarily for anti-vertigo and anti-motion sickness actions. Official information does not list the primary treatment of anxiety or general sleep issues as clinical indications for Cinnarizin Actavis.


Q: Are there any known genetic factors that affect how Cinnarizin Actavis works?

Official regulatory information indicates that this medicine is metabolized in the body by the CYP2D6 enzyme. This specific metabolic pathway is known to be subject to genetic variability (polymorphism). This means inherited factors can influence how the medicine works or how quickly it is processed in different individuals.


Q: Is Cinnarizin Actavis related to any other common allergy medicines?

Yes, regulatory information classifies Cinnarizine as a Histamine mathrmH1 receptor antagonist. This pharmacological category includes many common over-the-counter and prescription allergy medicines that share a similar action profile.


Q: What is the typical time frame to see improvement when taking Cinnarizin Actavis for vertigo?

Official product information indicates that the medicine typically works gradually within the body. It may take up to four hours after taking a dose to reach its full intended effect on symptoms of vertigo or dizziness.


Q: Can Cinnarizin Actavis be taken with standard pain relievers?

Regulatory documents suggest that caution is required when using Cinnarizin Actavis alongside certain pain relievers, specifically noting drugs like Ibuprofen and Naproxen. It is stated that co-administration may pose potential interaction risks, and consultation with a healthcare professional is noted.


Q: If I miss a dose of Cinnarizin Actavis, what does the official information suggest?

Official patient information contains guidance on handling a missed dose to ensure patient safety and maintain efficacy. This guidance is detailed in the official patient leaflet and should be reviewed for administration protocols.


Q: Are there any common vision changes associated with Cinnarizin Actavis?

Regulatory information does not classify common vision changes as a frequent side effect. However, official warnings caution against use in patients with conditions like glaucoma. Unusual changes, such as yellowing of the eyes or persistent visual disturbance, are noted to require the attention of a healthcare professional.


Q: Can Cinnarizin Actavis be taken safely with vitamins or herbal supplements?

Official guidance notes that consultation with a healthcare professional is relevant regarding the co-administration of the medicine with herbal remedies and supplements. Regulatory bodies acknowledge that potential interactions with these non-standard treatments may not be fully tested or established.


Q: How soon after stopping Cinnarizin Actavis do the side effects typically fade?

Information concerning the resolution of side effects is complex and varies depending on the specific effect. Clinical data regarding some severe side effects, such as drug-induced movement disorders, indicate that symptoms can take weeks, months, or potentially over a year to fully resolve after the medicine is stopped.


Q: Why is Cinnarizin Actavis sometimes used for Tinnitus?

The medicine is officially noted for use in controlling symptoms related to specific vestibular disorders. This includes Tinnitus (ringing in the ears) in certain contexts, alongside the more common uses for vertigo and Ménière's disease symptoms.


Q: Are skin reactions like rash or itching listed as a possible side effect of Cinnarizin Actavis?

Regulatory information notes that severe skin reactions, such as a rash or persistent itching, can be signs of a serious allergic reaction to the medicine. Official guidance notes that any such serious skin reaction represents a medical emergency.


Q: Can Cinnarizin Actavis cause temporary changes in mood?

Official labeling lists 'Depressed mood' as a potential side effect of Cinnarizin Actavis. Due to this association, regulatory information also includes a caution for use in patients with active or past instances of depression.


Q: What are the risks associated with Cinnarizin Actavis in patients with epilepsy?

Official information advises that caution should be exercised when using the medicine in patients with epilepsy. This is due to the potential for the medicine to have disease interactions in individuals with epilepsy or other similar mental disorders.

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How should Cinnarizin Actavis be stored and disposed of?

Storage and Disposal: Official Regulatory Information

The storage and handling of Cinnarizine tablets must comply strictly with the conditions defined in the regulatory documentation.

Item Labeled Regulatory Requirement
Maximum Temperature Limit Do not store above 30 C
Protection Requirement Protect from light
Child Safety Mandate Keep out of the reach and sight of children
Labeled Shelf Life Typically 3 years (valid until expiry date if stored correctly)

The official storage conditions are designed to maintain product stability and require a controlled room temperature, not exceeding 30 C. The integrity of the packaging must be maintained to ensure the product is protected from light until use. When the medicine is no longer needed, all unused or expired product must be disposed of in accordance with local requirements for pharmaceutical waste.

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

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