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Paramolan C

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Paramolan C

Paramolan C_PL

Method of action: Analgesic, Antipyretic, Cough And Cold Preparations, Immunostimulants, Reducing Fragility And Permeability Of Blood Vessels, Stimulating Metabolic Processes

Treatment option: Arthralgia, Pain, Headache, Toothache, Migraine, Rhinorrhea, Neuralgia, Edema, Rhinitis

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Paramolan C

Property Description
Active Ingredients Acetaminophen, Sodium Ascorbate (Vitamin C)
Form Tablet, Effervescent tablet
Pharmacological Class Analgesic, Antipyretic, Vitamin Supplement
Common Use Symptomatic relief of pain and fever
Type Fixed-dose combination product (FDC)

Defining Paramolan C: Fixed-Dose Combination and Classification

Paramolan C is a non-opioid, fixed-dose combination (FDC) preparation classified broadly as an analgesic, an antipyretic, and a vitamin supplement. This compound is engineered to provide symptomatic relief through the pharmacological actions of its core components. The core analgesic component, Acetaminophen (Paracetamol), is used for its properties in reducing pain and fever. Its dual-component nature places it distinctly within the category of supportive compound analgesics.

Composition and Origin: Acetaminophen with Sodium Ascorbate

The active composition of Paramolan C pairs Acetaminophen, a synthetic derivative, with Sodium Ascorbate, an essential nutrient derivative. The primary component for symptom relief is Acetaminophen, while Sodium Ascorbate is the readily available, water-soluble form of Vitamin C. This specific salt form is often preferred for preparations intended for oral administration, particularly the effervescent tablet form, which provides for rapid dissolution.

The inclusion of the antioxidant component incorporates the role of Vitamin C in supporting the body's normal metabolic processes and contributing to immune function. This composition reflects an integrated approach to care.

General Therapeutic Purpose of the Combination

The general therapeutic purpose of Paramolan C is to secure prompt symptomatic relief from acute pain and fever while providing physiological support. The product leverages the action of Acetaminophen to mitigate acute discomfort and normalize an elevated body temperature. A typical, neutral use scenario involves managing the transient aches and elevated temperature associated with the common cold. The integrated antioxidant component contributes to the body's general resilience, offering a broader supportive benefit than an analgesic alone.

What side effects are possible with Paramolan C?

Possible side effects and safety information

The official safety profile for Paramolan C, an analgesic and antipyretic combination product, details the risks primarily associated with its core component, Acetaminophen (Paracetamol). Regulatory documents classify adverse reactions based on frequency and affected physiological systems.

Adverse Reaction Classifications

Side effects are grouped into categories such as Rare (1/10,000 to <1/1,000), Very Rare (<1/10,000), and Not Known, where frequency cannot be estimated from available data. Affected system-organ classes include Hepatobiliary Disorders, Skin and Subcutaneous Tissue Disorders, Blood and Lymphatic System Disorders, and Immune System Disorders.

Serious Documented Risks and Safety Constraints

The most significant and serious adverse reaction documented in official labeling is severe liver damage (hepatotoxicity), especially when the product is used in chronic, high-dose exposure or when dosage limits are exceeded. Very rare but serious reactions include severe skin reactions (such as Stevens-Johnson syndrome) and anaphylactic shock.

Safety constraints and cautions are explicitly defined in regulatory documents for specific populations. The medicine is often contraindicated in individuals with severe hepatic impairment or severe active liver disease. Furthermore, official notes indicate a greater risk of toxicity for patients with chronic alcohol consumption or conditions that lead to glutathione depletion.

Long-term use patterns, defined as greater than three months, are officially associated with risks such as the development or worsening of analgesic overuse headache. The sodium content of effervescent formulations must also be taken into account for individuals on sodium-restricted diets.

Overdose and Emergency Response

The official regulatory documents define the Paramolan C overdose profile through the risk of severe, time-critical toxicity primarily from its Acetaminophen component. Initial manifestations of overdose are often nonspecific (such as nausea, vomiting, pallor, or loss of appetite) or may be absent altogether, which requires heightened caution. Regulatory guidance mandates seeking immediate medical attention or advice in the event of a suspected overdose, even if the individual feels well. This required action is due to the potential for delayed, life-threatening liver damage (hepatic failure) progressing to complications like encephalopathy, acute renal failure, and death.

Hospital management involves supportive care and immediate assessment, including the measurement of plasma acetaminophen concentration. The official antidote, N-acetylcysteine (NAC), is specified for managing this toxicity, with maximal protective benefit documented when administered within the critical 0 to 8 hours post-ingestion. Monitoring protocols require serial liver function tests and Prothrombin Time (PT/INR) to track the progression of hepatic injury. Specific populations face an increased hazard of severe overdose, including those with pre-existing non-cirrhotic alcoholic liver disease or severe hepatic/renal impairment.

Therapeutic Uses of Paramolan C

What Paramolan C Treats: Main Uses and Benefits

This combination product is commonly used to provide symptomatic relief from the pain and fever that frequently accompany flu-like syndromes and the common cold. The active component is utilized across domains where short-term symptom management is appropriate. It addresses symptom clusters involving elevated body temperature and associated discomforts, including headache and body malaise.

The medication is commonly used to help with various sources of mild to moderate acute pain, including tension headaches, acute toothache, and episodic pains, such as menstrual period pain. Using Paramolan C is used to assist with these acute, distressing manifestations and contributes to easing the overall symptom load during periods of sudden symptom intensification.

In addition to addressing pain and fever symptoms, the inclusion of Vitamin C (Sodium Ascorbate) offers a supportive benefit. This component is relevant in contexts where additional physiological support and general resilience are needed during acute, symptom-driven clinical presentations.

“This formulation is applied in situations where symptoms create noticeable interference with daily stability, assisting with easing the overall symptom load during difficult episodes.”

Quick Fact: Relief for Acute Symptom Clusters

Regulatory References

  1. NIH MedlinePlus overview of Acetaminophen

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Paramolan C — Official Regulatory Information

This section outlines the eligibility criteria for Paramolan C, strictly based on governmental regulatory documents.

Populations for whom use is Contraindicated

Use of Paramolan C is prohibited for individuals with:

  • Known hypersensitivity or allergy to paracetamol (acetaminophen) or any other component of the medicine.
  • Severe liver disease or severe hepatic impairment (including severe active liver disease).
  • Severe kidney failure or severe renal insufficiency (creatinine clearance below 10 ml/min in some documents).
  • Hepatic porphyria or porphyria.

Restricted or Not Recommended Populations

Use requires special consideration and a consultation with a healthcare professional in the following cases:

  • Condition-specific: Patients with non-cirrhotic alcoholic liver disease, mild to moderate hepatic impairment (including Gilbert's syndrome), glucose-6-phosphate dehydrogenase (G6PD) deficiency, haemolytic anaemia, glutathione deficiency, or dehydration. The risk of overdose is greater in those with non-cirrhotic alcoholic liver disease.
  • Pregnancy and Lactation: Use is not recommended for pregnant or breastfeeding women. If use is clinically necessary during pregnancy, it should be at the lowest effective dose for the shortest duration.
  • Age-related: The medicine is generally recommended for adults and adolescents over 12 years (or over 40 kg), though this is dosage form dependent. The medicine is not recommended for children below certain age/weight limits (e.g., under 12 years) as the dosage strength may be unsuitable.

Eligibility-Related Restrictions

Patients must not take any other products containing paracetamol (acetaminophen) concurrently with Paramolan C due to the high risk of severe liver damage from overdose.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes officially documented interactions for Paramolan C, which contains paracetamol and ascorbic acid (vitamin C), based on authoritative government regulatory information.

Interaction Restrictions

  • Other Paracetamol-Containing Products: Concomitant use with any other medicine containing paracetamol (acetaminophen) is strongly restricted due to the significant risk of accidental overdose and potential toxicity.

Documented Pharmacokinetic and Pharmacodynamic Interactions

Interacting Substance/Class Regulatory Statement and Impact
Oral Anticoagulants (e.g., Warfarin) Regular daily use of paracetamol with warfarin is documented to increase the risk of bleeding. Clinical monitoring, such as of the International Normalized Ratio (INR), may be necessary.
Enzyme-Inducing Medicines (e.g., specific treatments for epilepsy or tuberculosis) Caution is advised upon co-administration, as these drugs may increase the potential for liver toxicity following an overdose of paracetamol.
Medicines that alter gastric emptying (e.g., Metoclopramide, Cholestyramine) These may affect the rate and extent of paracetamol absorption. Consult official labeling for specific guidance on spacing the administration of these agents.
Ascorbic Acid (Vitamin C, at high doses) The ascorbic acid component, especially at high doses, is officially noted for its potential to increase paracetamol plasma levels.

Interaction Context

Official regulatory documents define the product's interaction structure by highlighting the potential for elevated toxicity when combined with other paracetamol sources and emphasizing the need for monitoring when co-administered with anticoagulants. These statements provide the essential constraints for use, ensuring the established safety requirements for the product are maintained during co-administration with other medicines.

Mechanism of Action

Paramolan C exerts its effects through two distinct pharmacodynamic mechanisms. The Paracetamol component acts primarily within the Central Nervous System (CNS). It is metabolized into the active molecule AM404, which functions by modulating TRPV1 receptors and interfering with endocannabinoid reuptake, thereby influencing descending pain signaling pathways to reduce nerve signal transmission. Separately, Paracetamol targets Cyclooxygenase (COX) enzyme activity in the hypothalamus, inhibiting the production of Prostaglandin E2 (PGE2). This molecular action causes a shift in the hypothalamic temperature set point, which initiates peripheral heat dissipation mechanisms. The second component, Ascorbic Acid (Vitamin C), acts as a systemic, water-soluble antioxidant, scavenging free radicals and maintaining cellular redox balance. This mechanism assists in sustaining cellular redox potential under conditions of heightened metabolic activity.

Dosage and Administration Information

How to Use Paramolan C: Administration Guidelines

Paramolan C is a fixed-dose combination product containing Acetaminophen (Paracetamol) and Sodium Ascorbate (Vitamin C) that is designed strictly for oral administration. The medicine is administered as an effervescent tablet, which mandates dissolution in a full glass of water before being consumed immediately. This preparation requirement ensures the correct oral solution is formed.

Dosing and Frequency Protocol

Adult dosing follows established ceilings. The usual single dose for the analgesic component is 500 mg to 1000 mg. Administration is limited by a strict 4-hour minimum interval between doses, with the maximum single dose set at 1000 mg. The maximum total daily dose of Acetaminophen must not exceed 4000 mg (4 g) in a 24-hour period, a rule that applies to all sources of the analgesic component.

Administration Conditions and Constraints

Use of Paramolan C is generally limited to short-term periods, typically not exceeding 10 days for pain or 3 days for fever without medical re-evaluation. Due to the nature of the Vitamin C component, it is advised that the medicine should be avoided late in the evening.

The effervescent form contains Sodium (content varies by formulation), which must be considered for patients following a sodium-restricted diet. Furthermore, special consideration is given to patients with impaired organ function: individuals with severe renal or hepatic impairment require the dosing interval to be prolonged to 6 or 8 hours to accommodate reduced clearance.

Recent Clinical Evidence

The research base for Paramolan C, a fixed-dose combination product, is structured around the clinical evaluation of its core components, primarily the analgesic (Acetaminophen). Randomized Controlled Trials (RCTs) and systematic reviews were used in research exploring how symptoms change over time and were conducted on adults and adolescents experiencing outcomes related to physical discomfort, such as headache and fever. These studies monitored outcomes like changes in pain intensity scores and elevated body temperature, forming a well-characterized evidence base for acute relief.

The product was also evaluated in research exploring outcomes related to general well-being due to the Sodium Ascorbate (Vitamin C) component. Research on this aspect often involved Systematic Reviews investigating vitamin supplementation in conditions involving periods of heightened symptoms, such as those associated with the common cold. Findings in this area were mixed across different studies. Some research describes patterns of observed changes in cold duration or symptom scores, while other studies report how symptoms evolved with minimal difference.

Crucially, comparative evidence is lacking in trials designed to isolate the specific contribution of the FDC beyond the core analgesic component alone. The research is consistently short-term, meaning long-term effects are not fully established, and there is limited information available for patients who use the product repeatedly. Furthermore, data for certain groups remain insufficient, with limited FDC-specific evidence for populations such as children or older adults with complex health needs. The overall body of evidence primarily contributes to the broader evidence landscape for short-term, acute symptom management.

Key Studies & References Efficacy and safety of ibuprofen and acetaminophen in children and adults: a meta-analysis and qualitative review

Frequently Asked Questions (FAQ)

Common questions about Paramolan C (FAQ)

Q: Can I drink alcohol while taking Paramolan C?

Official product information strongly warns against consuming alcohol while taking this medicine. The paracetamol component of Paramolan C can increase the risk of serious liver damage when combined with alcohol. Regulatory warnings indicate that avoiding alcohol is generally necessary during treatment.

Q: Does Paramolan C need to be kept refrigerated?

No, Paramolan C does not need to be refrigerated. Regulatory documents state that the medicine should be stored in its original packaging, protected from light and moisture, typically below 25 C (or room temperature). Referencing the official leaflet for specific storage conditions is recommended.

Q: Will Paramolan C make me sleepy?

Regulatory documents indicate a low potential for central nervous system effects, such as mild drowsiness or dizziness, as a possible side effect. While uncommon, these effects may require caution when performing tasks that demand full mental alertness.

Q: Can Paramolan C be used during pregnancy?

The official product information advises that Paramolan C should only be used during pregnancy if a medical professional determines it is absolutely necessary. This recommendation is due to the need to assess the overall risk-benefit balance, particularly concerning the component vitamin C which may cross the placenta. Consultation with a healthcare professional is necessary before using this medicine during pregnancy.

How should Paramolan C be stored and disposed of?

The official storage and disposal requirements for Paramolan C are mandatory conditions necessary to maintain product quality and public safety.

Storage Conditions

The medicine must be stored in its original package and kept out of the sight and reach of children.

  • Temperature: Store below 25 C or at room temperature (20 C to 25 C), as excess heat must be avoided.
  • Handling: The container or tube must be kept tightly closed to protect the effervescent product from moisture and light.
  • Stability: The medicine must not be used after the expiry date shown on the package.

Disposal Instructions

  • Environmental Protection: Expired or unused Paramolan C must not be thrown away via wastewater or household waste.
  • Procedure: Patients must ask a pharmacist how to dispose of the medicine, ensuring it is discarded in accordance with local pharmaceutical waste requirements.

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

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