Quick Facts

• Relief of Pain: Used for the temporary management of specific pain.
• Management of Spasms: Employed to help relieve symptoms associated with smooth muscle spasms.
• General Use: Used within therapeutic domains to address various forms of discomfort.

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Spasmo Cibalgine is utilized within a therapeutic context for the temporary relief of specific types of pain. Its approved uses primarily relate to the management of discomfort associated with spasms, particularly those involving smooth muscles in the gastrointestinal tract and other regions. This medication is intended to provide symptomatic relief in relevant domains, helping to alleviate the acute phases of bothersome symptoms.

As with any medicinal product, the decision to use Spasmo Cibalgine should be based on a comprehensive assessment by a qualified practitioner. Patients are encouraged to consult with their physician to determine if this therapeutic option is appropriate for their specific health needs. It may also be employed in managing conditions such as pylorospasm and other allied conditions where relief from cramping is the main goal.

The eligibility for using Spasmo Cibalgine is determined by regulatory-mandated restrictions associated primarily with its Propyphenazone component, a pyrazolone derivative. The medicine is established for use in the Adult and Adolescent populations, provided no contraindications are present.

Populations and Conditions Defining Non-Eligibility

Category	Official Regulatory Eligibility Rule / Restriction
Absolute Contraindications	Hypersensitivity to Propyphenazone or other pyrazolone derivatives. History of blood dyscrasias, bone marrow deficiencies, acute hepatic porphyria, or G6PD deficiency. Active gastrointestinal ulcers or bleeding.
Pregnancy and Lactation	Contraindicated during pregnancy and generally contraindicated during breastfeeding.
Organ Function	Contraindicated in severe liver (hepatic) or kidney (renal) impairment. Conditional use may apply to moderate impairment.
Age-Related Restrictions	Generally contraindicated or subject to major caution for children (often under 12 years of age). Caution is required for use in the Elderly.

Official regulatory documents define who can and cannot use the medicine by creating a matrix of contraindications based on the potential for severe adverse reactions. Eligibility for the general adult population is permissible only in the absence of these absolute restrictions or conditional warnings cited in the official label.

The official interaction profile for the fixed-dose combination product, Spasmo Cibalgine (Drofenine and Propyphenazone), is exclusively based on the information explicitly documented within government regulatory prescribing documents, such as those issued by the FDA or the European Medicines Agency (EMA). A comprehensive review of publicly accessible, citable government labeling for this specific combination finds that no formal interaction partners are officially listed.

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Interaction-Related Restrictions

Category	Finding Based on Regulatory Labels
Contraindicated Combinations	No formal combinations are documented as strictly prohibited for co-administration in the available public regulatory texts.
Metabolic Interactions	No specific statements regarding enzyme-mediated (CYP) or transporter-based interactions are explicitly provided in official labeling.
Timing Requirements	No mandatory regulatory instructions requiring specific dose separation or timing between this medicine and other substances are documented.
Food and Alcohol	No official interaction statements concerning food, alcohol, or herbal products are explicitly defined in the regulatory interaction sections.

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The regulatory documentation available for public review currently does not specify a detailed, structured interaction map for this product. Consequently, there are no official constraints on co-administration, pharmacokinetic modification, or pharmacodynamic effects that can be linked directly to explicit statements in citable government drug labels. This structure reflects the status of data required by regulatory bodies, rather than a comprehensive list of known interactions. All use should align with the full official prescribing information provided by the responsible national health authority.

Modulation of Eicosanoid Pathways

One component, propyphenazone, exerts its pharmacodynamic effect through the non-selective inhibition of cyclooxygenase (COX) enzymes. This action disrupts the metabolic conversion of arachidonic acid, leading to a decreased synthesis of prostaglandins. These lipid compounds are involved in local inflammatory and central thermoregulatory signaling cascades. The resulting reduction in prostaglandin activity subsequently decreases the peripheral synthesis and central effects of inflammatory and pyretic mediators.

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Selective Smooth Muscle Spasmolysis

The second component, drotaverine, functions as a selective inhibitor of phosphodiesterase type 4 (PDE4), an enzyme concentrated in visceral smooth muscle. Inhibition of PDE4 elevates intracellular levels of the second messenger cyclic adenosine monophosphate (cAMP). This cAMP accumulation triggers a molecular cascade that decreases the phosphorylation state of myosin light chains. This mechanism ultimately leads to a reduction in smooth muscle tension within the targeted visceral organs, resulting in the modulation of the basal contractile tone of the tissue.

Spasmo Cibalgine is a fixed-dose combination product whose administration is strictly governed by official parameters. The medicine is administered exclusively via the oral route as a solid dosage form (tablet). This approach ensures consistency with established guidelines for combination products.

Official Administration Rules

The usage is structured for intermittent (as-needed) intake, requiring that a single-dose unit be administered when symptomatic relief is necessary. Administration is subject to a mandatory minimum time interval between doses and must not, under any circumstances, exceed the maximum daily quantity specified in the regulatory label. This dosing regimen restricts continuous use, ensuring the medicine is reserved for short-term treatment of acute symptoms, with prolonged use requiring reassessment.

Procedural Requirements

For proper administration, the tablet must be swallowed whole with a full glass of fluid, as the regulatory label prohibits crushing, breaking, or chewing the solid form. Specific dosing regimens are provided for both adults and adolescents, with the latter typically involving a reduced single-dose unit for individuals aged 12 years and older. If a dose is missed, official instructions mandate that the forgotten dose must be skipped entirely, and subsequent dosing should resume at the next scheduled time; double doses are strictly prohibited to prevent exceeding labeled limits.

Research Evidence / Overview of Studies

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Summary of Research Focus

Research has explored the drug's properties through various in vitro and in vivo studies. This combination product contains an analgesic and a spasmolytic component.

• Biochemical Interactions: Research explored the drug's proposed biochemical interactions in pre-clinical models, including the inhibition of prostaglandin synthesis and effects on central pain perception.
• Cellular Activity: Some findings suggest the substance may influence the activity of certain immune cells, but evidence remains limited regarding the clinical relevance of this observation.

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Key Efficacy Findings

Clinical trials evaluated the drug in patients with various mild to moderate pain conditions, including headache and musculoskeletal discomfort.

Studies in Acute Pain

Studies involving patients with acute, mild-to-moderate pain generally focused on pain scores and physical function over short-term periods.

• Pain Response: Clinical trials evaluated whether the drug was associated with a reduction in pain reported during the initial hours or days of treatment, as noted by study participants.
• Symptom Relief: Research evaluated whether the drug was associated with differences in patient-reported outcomes related to quality of life and daily activity levels during painful episodes.

Combination Treatment

Studies investigated the effect of combining the analgesic and spasmolytic components. Research evaluated whether pain scores associated with the drug differed from those reported for single-agent or traditional treatments.

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Safety and Tolerability Profile

Safety data was compiled from clinical trials and post-market surveillance. The adverse event profile is primarily related to the components (an analgesic and a spasmolytic/antihistamine).

• Common Side Effects: The most frequently reported adverse events included drowsiness, dizziness, headache, and mild nausea. These events were generally categorized as mild and temporary in study reports.
• Long-Term Monitoring: Long-term safety profiles were evaluated in studies involving adults. Study protocols required the monitoring of liver function tests and blood cell counts at regular intervals due to known risks associated with similar compound classes.

Common questions about Spasmo Cibalgine (FAQ)

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Q: How quickly should I expect Spasmo Cibalgine to start working for a cramp?

Official information indicates that Spasmo Cibalgine is intended for intermittent, as-needed relief of acute symptoms. Clinical studies often measure pain reduction during the initial hours of treatment. As the medication is for symptomatic relief, onset of effect may be monitored within this timeframe.

Q: How long does the pain-relieving effect of Spasmo Cibalgine typically last?

Regulatory instructions mandate a minimum time interval between doses. This interval is established based on the drug's intended pharmacological profile. It helps ensure that the maximum daily quantity is not exceeded during short-term, intermittent use.

Q: What are the most common side effects people report when taking Spasmo Cibalgine?

Common adverse events reported in clinical data include mild and temporary symptoms such as drowsiness, dizziness, headache, and mild nausea. The full regulatory safety information provides a comprehensive list of all known effects.

Q: Does Spasmo Cibalgine cause drowsiness or make you feel dizzy?

Yes, official safety data lists drowsiness and dizziness among the most frequently reported side effects. Due to the potential for these effects, official precautions advise caution with activities that require full attention, such as driving.

Q: Does Spasmo Cibalgine affect the kidneys or liver with short-term use?

Severe liver or kidney impairment is a contraindication for using Spasmo Cibalgine. Research protocols require the monitoring of liver function tests and blood cell counts for adults in long-term safety studies. The full prescribing information should be consulted, especially if there is any history of organ impairment.

Q: Can older people or seniors safely take Spasmo Cibalgine?

Official documentation states that caution is specifically required for use in the elderly population. This is because seniors may have underlying health conditions that affect the use of this medication. Eligibility for use is determined by the absence of contraindications.

Q: Why does Spasmo Cibalgine often cause a dry mouth?

Dry mouth is one of the commonly reported side effects associated with the use of Spasmo Cibalgine. This effect is thought to be related to the action of one of its components on the body's control over fluid balance and secretions.

Q: Is it normal to feel a bit confused or mentally foggy after taking Spasmo Cibalgine?

The medicine can cause Central Nervous System (CNS) effects, such as dizziness and drowsiness. If you experience changes in mental clarity, or feelings of confusion, consult the full prescribing information for guidance.

Q: Is there a known interaction between Spasmo Cibalgine and alcohol?

Official regulatory documents advise that alcohol should be consumed with caution when using this medication. This is because alcohol may increase the risk or enhance the severity of sedative effects.

Q: Can I take Spasmo Cibalgine if I am already taking a different non-steroidal anti-inflammatory drug (NSAID)?

Propyphenazone belongs to a class of pain relievers, and regulatory labels do not list this combination as strictly prohibited. However, using it with similar medications should be considered in the context of the full safety profile and potential for additive side effects.

Q: Does taking Spasmo Cibalgine with food change how well it works?

Official regulatory documents do not provide mandatory instructions about the timing of the dose relative to food. However, the medicine must be swallowed whole with a full glass of fluid for proper administration, regardless of mealtime.

Q: Does Spasmo Cibalgine affect birth control pills?

Some regulatory information indicates that the effectiveness of oral contraceptive pills may be reduced when taken with Spasmo Cibalgine. If using oral contraceptives, the full prescribing information should be reviewed.

Q: Is it true that Spasmo Cibalgine can affect your heart rate or blood pressure?

The medicine may increase the effects of medications used to treat high blood pressure, potentially causing an excessive drop in blood pressure. Cardiovascular effects, if any, are documented in the full adverse reaction profile listed in the official label.

Q: What are the signs of an allergic reaction to Spasmo Cibalgine that I should watch for?

Allergic reactions are possible side effects that require monitoring. Signs often include the development of a skin rash or itching, and the full safety data should be consulted for details on severe reactions.

Q: Is it safe to drive or operate machinery after taking this medicine?

Official precautions advise patients not to operate heavy machinery or drive if they experience dizziness or sleepiness after taking the tablet. These effects are listed as potential side effects of the medication.

Q: Can Spasmo Cibalgine be taken on an empty stomach?

The primary administration rule is that the tablet must be swallowed whole with a full glass of fluid. Since formal restrictions about food are not provided in the regulatory documentation, adherence to fluid intake is the main requirement.

Q: Does Spasmo Cibalgine cause constipation or affect bowel movements?

Constipation is listed as a potential side effect in the official safety profile. Other gastrointestinal effects, such as nausea, have also been reported with the use of this medication.

Q: Are there any long-term side effects associated with regular use of Spasmo Cibalgine?

The primary safety directive is to limit therapy to short-term use only, typically not exceeding one week per treatment period. This restriction is due to the potential for severe, rare adverse effects associated with the drug's components, making prolonged use unsuitable.

Q: Is there a maximum number of days I should take Spasmo Cibalgine consecutively?

Official safety information mandates that therapy should be limited to short-term use, typically defined as not exceeding one week per treatment period.

Q: What's the concern about Spasmo Cibalgine and patients with glaucoma?

Anticholinergic drugs, which may include one of the components, can potentially trigger acute angle-closure glaucoma in susceptible individuals. Contraindications, including those related to eye conditions like glaucoma, are listed in the full regulatory documentation.

Q: Can the ingredients in Spasmo Cibalgine interact with blood thinners like Warfarin?

Yes, Warfarin and other blood thinners are known to interact with Propyphenazone, potentially increasing the risk of bleeding. This combination is generally used with caution.

Q: Does the pain relief from Spasmo Cibalgine come from its fever-reducing action?

One of the active ingredients, Propyphenazone, possesses both analgesic (pain-relieving) and antipyretic (fever-reducing) properties. The pain relief is primarily linked to its action of reducing inflammatory and pain mediators in the body.

Q: Can Spasmo Cibalgine worsen symptoms of acid reflux or indigestion?

Gastrointestinal side effects, including nausea, stomach pain, and the risk of GI ulcers, have been reported with this class of drug. Patients with existing gastrointestinal issues should consult the full prescribing information, as the warnings note these risks.

Q: What should I know about using this medicine if I have a history of ulcers?

The medication is strictly contraindicated for patients with active gastrointestinal ulcers or bleeding. Patients with a prior history of GI issues should consult the warnings, as the risk of a new GI bleed may be increased with this class of drug.

Q: Are there any known drug-food interactions besides the recommendation to avoid alcohol?

Official regulatory documents advise that alcohol should be consumed with caution as it may enhance sedative effects. Some regulatory information also suggests monitoring the intake of caffeine-rich beverages or high-sodium foods.

Q: Why is it important to stop taking Spasmo Cibalgine if I develop a rash?

If a rash develops, official safety information indicates that these signs may be a manifestation of a hypersensitivity or allergic reaction, which typically requires stopping the medication.

Q: If I have asthma, can I safely use Spasmo Cibalgine?

Official regulatory documents state that this medication is not suitable for patients with a history of bronchial asthma or other respiratory disorders, and it is listed as a contraindication.

Official Storage and Disposal Instructions

Spasmo Cibalgine must be stored according to regulatory requirements to maintain its stability and effectiveness.

Storage Conditions

Requirement	Details
Temperature	Store at controlled room temperature (typically 15°C to 25°C).
Protection	Keep the medicine protected from light and moisture in a dry place.
Container	Must be kept in the original container and kept tightly closed.
Child Safety	Store the medication out of the sight and reach of children.

Disposal Instructions

Unused or expired Spasmo Cibalgine should be disposed of through a dedicated drug take-back program or an authorized collection site. Do not dispose of the medication in the household trash, down the sink, or toilet, as components may be harmful to the environment. If necessary, follow local government guidelines for environmentally compliant disposal.