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Paracetamol STADA

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Paracetamol STADA

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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.

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Overview of Paracetamol STADA

Quick Facts Description
Active ingredient Paracetamol (Acetaminophen)
Common Forms Tablet, Capsule, Oral Solution, Suppository
Pharmacological class Analgesic and Antipyretic
General purpose Symptomatic relief of pain and fever
Origin Synthetic

1. What is Paracetamol STADA? (Definition and Classification)

Paracetamol STADA is a medicine used primarily for relieving pain and reducing fever, belonging to the pharmacological class of analgesics and antipyretics. The product contains the single active ingredient, Paracetamol (INN/Acetaminophen). The name 'STADA' identifies the product as a specific formulation manufactured by the STADA Arzneimittel AG group, a company known for producing quality generic medicines. Paracetamol is synthetic in origin and is recognized as an essential medicine globally. This status confirms its wide-ranging importance and utility for basic healthcare needs.


2. Composition and Forms: What is Paracetamol Made Of?

The therapeutic effect of this medicine is driven solely by the Paracetamol molecule, which is available in various forms for different routes of administration. The STADA formulation typically focuses on delivering a quality generic version, but the core active ingredient remains consistent. The efficacy of the drug in its various forms against acute pain is supported by clinical evidence. This supports the effectiveness of Paracetamol tablets and other forms in treating sudden-onset pain. The medicine is available in common dosage forms such as tablets, capsules, and liquid solutions, facilitating both oral and rectal administration.


3. Primary Purpose: What Does Paracetamol Generally Help With?

The primary purpose of taking Paracetamol is to provide general, symptomatic relief from mild to moderate pain and to bring down a high body temperature (fever). For example, it is commonly used to help patients manage discomfort associated with headaches or muscle soreness. Its action is clinically recognized for its capacity to offer rapid symptomatic relief without the significant anti-inflammatory or gastric irritation effects often seen with NSAIDs. By targeting the pain and temperature control centers, it reliably addresses these two discomforts.

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What side effects are possible with Paracetamol STADA?

Possible side effects and safety information

The safety profile of Paracetamol STADA is defined by the classifications established in official regulatory documents, such as the Summary of Product Characteristics (SmPC) and FDA Prescribing Information. The primary safety concern is the potential for hepatotoxicity (liver damage), which is strongly dependent on the total amount administered. Risk of severe hepatic injury is explicitly linked to acute overdose or prolonged use exceeding the maximum recommended daily dose. The medicine is formally contraindicated in individuals with severe hepatic impairment.

Adverse reactions listed in regulatory documents are often categorized by frequency, with many serious events being classified as Rare (1 in 1,000 to 1 in 10,000 users) or Very Rare (less than 1 in 10,000 users). These serious adverse reactions, highlighted across official sources, primarily involve:

  • Hepatobiliary Disorders: Risk of severe hepatic failure or necrosis.
  • Immune System Disorders: Including Anaphylactic shock and various hypersensitivity reactions.
  • Skin and Subcutaneous Tissue Disorders: Including very rare reports of Severe Cutaneous Adverse Reactions (SCARs), such as Stevens-Johnson Syndrome (SJS).
  • Blood and Lymphatic System Disorders: Rare reports of blood cell count abnormalities like agranulocytosis and thrombocytopenia.

Safety notes specify caution for use in patients with chronic alcohol abuse, chronic malnutrition, and severe renal impairment. Regulatory guidelines underscore the critical safety restriction against the simultaneous use of Paracetamol STADA with any other medicine containing Paracetamol to prevent accidental overdose and subsequent liver damage.

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Overdose and Emergency Response

Overdose Manifestations and Required Actions

Official regulatory documentation emphasizes the time-critical nature of Paracetamol overdose management. Early manifestations are often non-specific and may include anorexia, nausea, vomiting, malaise, and diaphoresis (sweating). Crucially, the absence of these initial symptoms does not preclude severe toxicity.

The most serious outcome defined in official labeling is the progression to hepatic necrosis and subsequent hepatic failure, which can advance to metabolic acidosis, coagulation disorders, coma, and death. Patients who are chronic alcohol users or have underlying hepatic impairment are specifically noted in regulatory documents as being at increased risk for severe hepatic injury.

When Immediate Medical Help Is Required

Regulatory bodies universally mandate that individuals must seek immediate medical attention or contact emergency medical services following any suspected overdose, irrespective of whether the person is currently feeling well. The effectiveness of the specific antidote, N-acetylcysteine (NAC), is highly time-dependent, underscoring the urgency of this action. Management protocols require urgent hospital monitoring, including plasma Paracetamol concentration measurement and continuous assessment of hepatic function through liver enzyme and prothrombin time monitoring.

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Therapeutic Uses of Paracetamol STADA

What Paracetamol STADA Treats: Main Uses and Benefits

Paracetamol STADA is commonly used to provide targeted, short-term support for the symptomatic relief of acute symptoms, focusing on the two key therapeutic domains of pain and fever. Its core use is aligned with the analgesic and antipyretic properties of its active ingredient, which is commonly utilized for mild to moderate discomfort.

The active substance is widely used to provide support for acute discomfort, and its use is relevant in clinical contexts involving heightened symptoms. The core therapeutic benefit is to support the patient during difficult episodes by easing distress, helping patients maintain a sense of stability when symptoms are more noticeable. The medicine is commonly used to help with symptom clusters such as episodic headaches, acute toothache, muscle soreness, and symptoms linked to sprains or fever associated with colds and influenza.

“Provides support that helps ease the overall symptom burden during periods when symptoms create noticeable physiological strain.”

The medication is relevant in contexts where short-term symptomatic assistance is needed, supports the patient during difficult episodes by easing distress and contributes to improved day-to-day comfort.

Quick Fact Relief for Symptom
Pain Intensity Mild to moderate discomfort
Symptom Type Aches, headaches, fever
Context Short-term, acute episodes

Therapeutic Application: The substance is utilized for treating both pain and fever, often for mild to moderate discomfort.


Out of Scope Note: This information describes only the drug’s intended therapeutic uses and symptomatic benefits. It does not cover how to use, dosage instructions, mechanism of action, side effects, or safety warnings.

Regulatory References

  1. NIH StatPearls overview on Acetaminophen
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Eligibility and Restrictions for Use

Official Eligibility Profile

Regulatory documents establish eligibility for Paracetamol STADA based on a patient’s health status and age, defining groups that are strictly prohibited from use and those who require conditional use.

Classification Population/Condition
Absolute Contraindication Patients with known hypersensitivity to Paracetamol or product excipients.
Absolute Contraindication Patients with severe hepatic impairment or severe active liver disease.

Eligibility is conditional for several groups. Caution is advised for patients with mild-to-moderate hepatic insufficiency, non-cirrhotic alcoholic liver disease, or those with severe renal impairment (Creatinine;Clearance le 30;mL/min), as official guidance mandates a review of use or dose interval adjustment. Individuals at risk of glutathione depletion (e.g., chronic alcoholism, malnutrition) also fall under conditional use.

Age Group Eligibility Status (Regulatory)
Adults and Adolescents Generally Eligible for standard use.
Paediatric Population Use is restricted by formulation; certain strengths are not recommended for children below specific age/weight limits.
Pregnancy Conditional use only if clinically needed, restricted to the lowest effective dose for the shortest duration.
Breastfeeding Generally compatible with use at therapeutic doses.
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What should I know about interactions with other medicines?

The official regulatory profile for Paracetamol identifies several categories of interaction, primarily related to drug clearance, plasma exposure, and specific pharmacodynamic effects.

Interaction-Related Restrictions

The most significant restriction is the contraindication against combining Paracetamol STADA with any other medicinal product containing paracetamol (acetaminophen). This prohibition is documented to mitigate the risk of accidental overdose, which may lead to severe liver damage.

Documented Pharmacokinetic Interactions

Category Interacting Substances Official Interaction Pattern/Outcome
Clearance Reduction Probenecid Reduces the removal of Paracetamol, which may significantly increase its concentration in the plasma.
Enzyme Inducers Rifampicin, Carbamazepine, Phenobarbital, Alcohol, St. John’s Wort May accelerate Paracetamol's metabolism, increasing the formation of potentially toxic metabolites and elevating the risk of liver damage.
Absorption Rate Metoclopramide, Domperidone Accelerate the absorption rate of Paracetamol.
Timing Separation Cholestyramine Reduces Paracetamol absorption; administration must be separated by at least one hour.

Pharmacodynamic and Specific Interactions

Prolonged, regular daily use of Paracetamol may enhance the anticoagulant effect of Warfarin and other Coumarins, which is officially associated with an increased risk of bleeding. Concurrent chronic use with Zidovudine is associated with an enhanced incidence of neutropenia. Furthermore, Paracetamol co-administered with Flucloxacillin has been linked to high anion gap metabolic acidosis in patients with specific underlying risk factors, such as sepsis or malnutrition.

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Mechanism of Action

Paracetamol STADA (acetaminophen) readily crosses the blood-brain barrier, localizing its primary actions within the central nervous system (CNS). Its mechanism of action involves multiple molecular pathways.

Molecular and Intracellular Pathways

One primary action is the inhibition of cyclooxygenase (COX) enzymes, particularly the COX-1 variant and COX-2, in the CNS. The drug acts as a reducing co-substrate at the peroxidase site of these enzymes, preventing the formation of a critical tyrosyl radical necessary for their cyclooxygenase activity. This action modulates the central synthesis of prostaglandin E2 (PGE2), a key mediator in thermoregulation and nociception.

Additionally, paracetamol is metabolized to N-(4-hydroxyphenyl)arachidonoylamide (AM404). AM404 acts as an agonist on cannabinoid receptor type 1 (CB1) and the transient receptor potential vanilloid-1 (TRPV1) channel. Activation of these receptors contributes to central descending inhibitory serotonergic pathway potentiation.

System-Level Physiological Consequences

Modulation of PGE2 synthesis in the hypothalamus results in a decrease of the thermoregulatory set-point in the CNS, leading to a system-level increase in heat dissipation. The combined central actions on COX, CB1, TRPV1, and the descending serotonergic system result in the modulation of nociceptive signal transmission along the spinal cord and supraspinal structures.

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Dosage and Administration Information

The use of Paracetamol is governed by standardized protocols defining administration routes, dose limits, and frequency. The medicine is permitted for administration via the oral route (tablets, capsules, solutions), rectal route (suppositories), and as an intravenous (IV) infusion, with the latter reserved for supervised clinical settings.

Usage follows a fixed intermittent regimen structured by two primary constraints. For adults, the standard single administration typically ranges from 500 mg to 1000 mg (1 g). This is coupled with a mandatory minimum time interval of four to six hours between any two administrations. Crucially, an absolute maximum daily dose of 4000 mg (4 g) must not be exceeded from the cumulative use of all Paracetamol-containing products within a 24-hour period.

Administration procedures are formalized for specific forms: oral forms can be taken independently of meals, while effervescent tablets require complete dissolution in water before ingestion. The protocol also requires modifications for specific populations. Dosing for children is based on body weight (e.g., 10-15 mg/kg per dose), and patients with renal or hepatic impairment must adhere to a reduced maximum daily limit or a prolonged dosing interval (e.g., 6 or 8 hours). Overall use is restricted to short-term symptomatic support.

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Recent Clinical Evidence

Evidence for use in Mild to Moderate Pain

Research examined outcomes related to physical discomfort through Randomized Controlled Trials (RCTs) and systematic reviews, focusing on acute episodes in adults and adolescents. Outcomes measured included changes in pain severity and the use of supplemental pain relief. Studies report how symptoms evolved over short timeframes. However, the quality of the evidence varies across conditions, and the database is described as insufficient or of low quality for many common pain conditions examined.


Evidence for use in Fever Reduction (Antipyresis)

Paracetamol was studied for how the substance was observed in patients presenting with fever, examining outcomes related to systemic imbalance. Research utilized RCTs and systematic reviews relevant to short-term symptom patterns. Data categorized as High quality for short-term changes in body temperature has been reported by systematic reviews. However, the evidence is limited regarding the substance's properties when applied to certain specific patient groups, such as critically ill individuals.


Extended Research, Populations, and Uncertainty

The overall evidence base focuses on short-term changes, with follow-up durations limited to a single day or less. Long-term effects are not fully established, and there is limited information for outcomes over extended periods. Research has explored the substance in specific groups, including children and older adults. However, subgroup findings are often uncertain due to modest sample sizes, and a major gap remains the lack of robust, high-quality data for many chronic or sustained painful conditions.

Key Studies & References

  1. Acetaminophen: Drug Information (StatPearls)
  2. Paracetamol for fever in children (Cochrane Review)
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Frequently Asked Questions (FAQ)

Common questions about Paracetamol STADA (FAQ)


Q: Is it possible for Paracetamol STADA to cause stomach issues?

A: Regulatory documents indicate that Paracetamol is generally tolerated and does not typically cause the significant gastric irritation generally associated with certain other types of pain relievers. While the medicine is usually well-tolerated, official product information often lists gastrointestinal side effects, such as nausea or vomiting, as uncommon or rare in frequency.


Q: What are the most commonly reported side effects listed in official documents for Paracetamol STADA?

A: Official regulatory summaries categorize adverse effects by their frequency of occurrence, such as Common, Uncommon, or Rare. The rare and very rare categories include serious events like liver failure or certain blood disorders. The most frequent effects are detailed within the appropriate frequency tables found in the full product documentation.


Q: What foods or supplements are noted in official sources as interacting with Paracetamol STADA?

A: Official product information indicates that the product can typically be taken independently of regular meals. However, caution is advised regarding alcohol consumption, which may increase the risk of liver toxicity. Certain herbal supplements, such as St. John’s Wort, are also noted as having potential interactions that can affect how the body processes the medicine.


Q: Is there a maximum number of days Paracetamol STADA is typically described as being suitable for use?

A: Official patient information often describes a recommended maximum duration for use without medical review. For adults, the product is generally stated as being suitable for use for no more than 3 days for fever relief or 5 days for pain relief. This guidance is consistent with the medicine’s classification for short-term symptomatic support.


Q: What happens if Paracetamol STADA is taken at the same time as cold medicine?

A: The official restrictions strictly prohibit combining Paracetamol STADA (contraindication) with any other medicinal product that contains paracetamol. This is a critical prohibition intended to prevent accidental overdose and subsequent severe liver damage, as many cold and flu remedies contain this active ingredient.


Q: Is Paracetamol STADA mentioned in official documents as suitable for period pain?

A: Yes, official indications confirm that the medicine is indicated for the symptomatic relief of pain, which includes discomfort associated with dysmenorrhea, or period pain. It is classified under the general use for treating mild to moderate pain.


Q: Is the onset of action different for the various formulations (e.g., tablets vs. effervescent)?

A: Regulatory documents describe that the speed at which the active ingredient is absorbed can vary by formulation. Soluble or effervescent tablets may achieve maximum concentration in the blood more quickly than standard film-coated tablets, which can influence how fast the pain-relieving effect begins.


Q: What types of allergic reactions are noted in the safety data for Paracetamol STADA?

A: Reported allergic reactions listed in official documents include common hypersensitivity issues such as skin rash or hives. It also notes the rare but severe reactions, including life-threatening skin disorders and anaphylactic shock.


Q: What research themes are commonly studied regarding paracetamol use in pain management?

A: Studies examined outcomes related to physical discomfort primarily involve assessing changes in pain intensity over short timeframes. Key research themes include evaluating patient global assessments of efficacy and observing the necessity for using supplemental pain relief medication.


Q: Why is paracetamol generally recommended as a first-line treatment for certain types of pain?

A: The classification of paracetamol as a preferred initial option for certain types of pain and fever is based on its established efficacy profile for mild-to-moderate pain and fever. This position is also related to a generally lower potential for causing gastric irritation, according to its regulatory profile, compared to non-steroidal anti-inflammatory drugs (NSAIDs).


Q: Is there a specific age cut-off described for using Paracetamol STADA without medical guidance?

A: Regulatory documents define product restrictions based on age or body weight, often specifying a minimum threshold for use. For instance, the product is generally not recommended for use below a specific minimum age or weight without seeking professional guidance.


Q: Does Paracetamol STADA have a different strength than other paracetamol products?

A: Product documentation confirms that Paracetamol STADA is available in different authorized strengths, such as 500 mg tablets and 1000 mg versions. This availability helps ensure compliance with the different single dose amounts approved for both adults and children.


Q: Can Paracetamol STADA be taken if I am already taking an antibiotic?

A: Regulatory guidance notes specific interactions with certain types of anti-infective agents. These interactions can affect how the body processes the medicine. Official guidance generally recommends review of the product documentation for specific anti-infective agent names.


Q: How quickly should I expect Paracetamol STADA to start working?

A: According to the official product information and pharmacokinetic summaries, the initial onset of the pain-relieving effect is typically observed within 15 to 30 minutes following oral administration.


Q: How long does the effect of Paracetamol STADA typically last?

A: The duration of the medicine's pain-relieving effect is generally described in official summaries as lasting approximately 4 to 6 hours.


Q: Can a person with high blood pressure use Paracetamol STADA?

A: Official regulatory documents do not list high blood pressure (hypertension) as a condition that requires an absolute contraindication or special caution for the use of Paracetamol STADA.


Q: Is it possible to become dependent on Paracetamol STADA?

A: Official regulatory data notes that the active ingredient, paracetamol (acetaminophen), is not associated with abuse potential. The product is not classified as having the capacity to cause physical dependence.


Q: What is the purpose of the inactive ingredients listed in Paracetamol STADA?

A: Inactive ingredients (excipients) are added to the formulation to serve specific non-therapeutic functions. These functions include helping to bind the tablet together, adding flavoring or coloring, or controlling the speed at which the active ingredient is dissolved and released in the body.


Q: Does Paracetamol STADA interact with birth control pills?

A: Official regulatory texts do not typically list an interaction with oral contraceptives. This lack of listing indicates that a clinically significant interaction is not officially recognized in the product summaries.


Q: What is the standard regulatory classification of Paracetamol STADA (e.g., OTC or prescription)?

A: In many regions, Paracetamol products in standard strengths are classified by government drug databases as generally available Over-The-Counter (OTC). This means the product can typically be purchased without a prescription, subject to local quantity restrictions.


Q: Why are there different strengths of paracetamol available from STADA?

A: The availability of different strengths is described as a factor in ensuring compliance with approved regulatory dosing requirements. This includes meeting the weight-based dosing necessary for children and providing the varying single dose amounts approved for adults.


Q: Does the time of day matter when taking Paracetamol STADA?

A: Official dosing instructions place the primary emphasis on strict adherence to the minimum time interval that must pass between individual doses and the absolute maximum daily limit. The documentation does not require the medicine to be taken at a specific time of day.


Q: Can Paracetamol STADA be used to help with sleep?

A: Regulatory indications define the product’s approved purpose solely as the symptomatic relief of pain and fever. Sleep aid or sedative effects are not listed as an approved use or property of the medicine.


Q: What precautions are described for patients with asthma taking Paracetamol STADA?

A: While asthma is not an absolute contraindication, official documents describe an association that may warrant caution for paracetamol use in patients who have a known history of severe reactions to aspirin or other NSAIDs due to the potential for cross-sensitivity in some individuals.


Q: What are the signs described in official documents that indicate Paracetamol STADA is not appropriate for someone?

A: Regulatory documents describe key signs of severe adverse events that signal that use should be stopped. These include the development of a sudden severe rash or swelling (hypersensitivity) or yellowing of the skin or eyes (jaundice), which may indicate liver involvement.


Q: Does Paracetamol STADA affect the results of any common medical tests?

A: Official regulatory sources note that paracetamol may interfere with the results of certain laboratory tests. Specifically, the substance has been shown to potentially affect assays used to measure uric acid and blood glucose levels.


Q: What information is available about how Paracetamol STADA is broken down by the body?

A: Official pharmacokinetic summaries describe that the active ingredient is primarily processed (metabolized) in the liver. It is subsequently removed from the body through the kidneys, with a described elimination half-life typically ranging from 1 to 3 hours.

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How should Paracetamol STADA be stored and disposed of?

Storage and Disposal Requirements for Paracetamol STADA

Paracetamol STADA must be stored and disposed of according to regulatory requirements to maintain its stability and ensure environmental safety.


Official Storage Conditions

Scope Item Requirement
Temperature Store the product below 25 C.
Protection Protect from moisture and keep in the original package.

Safety and Disposal

Scope Item Requirement
Child Safety Keep this medicine out of the sight and reach of children.
Disposal Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to properly discard unused or expired product.

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

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