STOPAIN — Professional Drug Commentary
1. Disclaimer
This information is provided for educational and general medical-information purposes only. It is not a substitute for the official package leaflet, prescribing information, or individualized advice from a qualified physician or pharmacist. Medication suitability, dose, duration of treatment, and monitoring requirements can vary according to age, medical history, organ function, pregnancy status, and concomitant medicines.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. Readers are responsible for independently verifying the information before relying on it.
2. Summary
Stopain is an oral analgesic and antipyretic combination containing propyphenazone, paracetamol (acetaminophen), and caffeine. Egyptian market listings currently identify Stopain 20 tablets/caplets manufactured by EVA Pharma, while published pharmaceutical literature specifically documents the Stopain formulation as propyphenazone 150 mg + paracetamol 300 mg + caffeine 50 mg per tablet. ([DwaPrices][1])
The combination is intended for symptomatic relief of pain and fever, including headache, migraine-type headache, toothache, musculoskeletal pain and painful conditions associated with colds. It does not treat the underlying infectious cause of a cold or other disease.
3. Brand Name
Stopain®
The currently indexed Egyptian market presentation is Stopain 20 tablets/film-coated caplets, associated with EVA Pharma. ([DwaPrices][1])
4. Category
Therapeutic category: Analgesic and antipyretic combination.
ATC classification: Propyphenazone combinations excluding psycholeptics, N02BB54. ([Vademecum][2])
It is a non-opioid analgesic combination and is not an antibiotic.
5. Active Ingredient
Each documented Stopain tablet contains:
- Propyphenazone — 150 mg
- Paracetamol (Acetaminophen) — 300 mg
- Caffeine — 50 mg
The 150/300/50 mg composition is supported by pharmaceutical literature analyzing genuine Stopain tablets manufactured by EVA Pharma, as well as Egyptian drug-reference material. ([PubMed Central (PMC)][3])
6. Pharmaceutical Form & Strength
Dosage form: Oral tablet/caplet; current market imagery identifies the presentation as film-coated caplets.
Strength per caplet:
Propyphenazone 150 mg + Paracetamol 300 mg + Caffeine 50 mg. ([PubMed Central (PMC)][3])
The currently indexed Egyptian presentation is a 20-caplet pack. Older Egyptian product information also documented packs of 10 and 200, but these should not be assumed to be current retail presentations without checking the actual market pack. ([Vezeeta][4])
7. Manufacturer & Marketing Authorization Holder
Manufacturer: EVA Pharma for Pharmaceuticals & Medical Appliances, Egypt. Egyptian pharmaceutical references and current Egyptian market listings identify EVA Pharma as the manufacturer. ([DrugPamphlet][5])
Marketing Authorization Holder: EVA Pharma is the company associated with the Egyptian product in the accessible market records. A separate current marketing-authorization holder could not be independently established from an openly accessible, current Egyptian regulatory product record; therefore, no different MAH is asserted here.
8. Mechanism of Action
Paracetamol produces analgesic and antipyretic effects primarily through central mechanisms involving inhibition of prostaglandin synthesis; its exact mechanism is not completely established. It acts centrally on the hypothalamic temperature-regulating system to reduce fever. ([Medicines.org.uk][6])
Propyphenazone is a pyrazolone analgesic and antipyretic. Its pharmacological effects are associated with inhibition of pain- and inflammation-related pathways, although its complete mechanism is not as precisely characterized as that of many modern analgesics. It has also been associated with clinically important hypersensitivity and blood-cell adverse reactions. ([PubMed][7])
Caffeine is a methylxanthine CNS stimulant that acts mainly through antagonism of adenosine receptors. When combined with simple analgesics, caffeine can enhance analgesic efficacy in some pain conditions and may improve the overall analgesic response. ([Medicines.org.uk][6])
9. Spectrum of Activity
Stopain has analgesic and antipyretic activity. It is intended to relieve symptoms such as headache, migraine, toothache, musculoskeletal pain and fever.
It has no antimicrobial spectrum; therefore, it does not eradicate bacteria, viruses or other infectious organisms. The benefit in a common cold is symptomatic relief rather than treatment of the viral infection itself.
10. Pharmacokinetics
The pharmacokinetic profile of the complete Stopain combination is not as extensively characterized in publicly accessible current sources as the individual components.
For propyphenazone, published human pharmacokinetic data show rapid absorption after oral administration, with maximum plasma concentrations reported approximately 30 minutes after a 220-mg oral dose in volunteers. It undergoes substantial metabolism, principally involving demethylation, with urinary metabolites including glucuronide derivatives. ([PubMed Central (PMC)][8])
Paracetamol is rapidly absorbed after oral administration and is extensively metabolized in the liver, predominantly by conjugation; a small fraction is converted to a reactive metabolite that is normally detoxified by glutathione. Overdose can overwhelm these pathways and cause severe hepatic injury. ([U.S. Food and Drug Administration][9])
Caffeine is rapidly absorbed and is metabolized primarily in the liver. Its pharmacological activity contributes to the stimulant effects of the combination.
Because the pharmacokinetics of each component can be affected by age, hepatic function, renal function, interacting drugs, and repeated dosing, the dosing instructions supplied with the current product should be followed.11. Indications
Stopain is used for symptomatic relief of pain and fever, including conditions such as:
- Headache and migraine-type headache
- Toothache and dental pain
- Backache and musculoskeletal or muscle pain
- Rheumatic pain
- Pain associated with common cold/flu-like illnesses and fever
- Other short-term painful conditions for which an analgesic-antipyretic combination is appropriate
Published Egyptian product information lists headache/migraine, dental pain, musculoskeletal/rheumatic pain, cold-associated symptoms and postoperative pain among its uses. ([DrugPamphlet][5])
The treatment of moderate pain is also consistent with the ATC/product information classification for propyphenazone combinations. ([Vademecum][2])
12. Administration
Route: Oral.
The historically documented Egyptian Stopain leaflet specifies for adults: 1–2 caplets every 6 hours, with a maximum of 8 caplets in 24 hours. ([DrugPamphlet][5])
However, because an independently accessible, current Egyptian regulatory leaflet was not located online, the leaflet supplied with the current pack should take precedence over older reproduced dosage information.
At the documented strength, eight caplets would contain 2,400 mg paracetamol, 1,200 mg propyphenazone and 400 mg caffeine. The maximum of eight caplets must not be interpreted as permission to combine Stopain with additional paracetamol-containing products. Excessive total paracetamol exposure can cause severe liver injury. ([U.S. Food and Drug Administration][9])
13. Method of Preparation
No special preparation or reconstitution is required.
The medicine is supplied as a ready-to-use oral caplet/tablet. It should be swallowed with water according to the accompanying product instructions. It is not intended to be dissolved, injected, or otherwise prepared for another route of administration.
14. Contraindications
Stopain should not be used in patients with:
- Known hypersensitivity to propyphenazone, paracetamol, caffeine, or another ingredient of the product.
- Acute hepatic porphyria, because propyphenazone is considered unsuitable in this condition. ([DrugPamphlet][5])
- A previous serious hypersensitivity reaction to pyrazolone/pyrazolidine analgesics should prompt particular caution and medical assessment because cross-reactivity can occur among some members of this chemical group. ([PubMed Central (PMC)][10])
The contraindications printed on the current pack/official leaflet should always be checked before use.
15. Warnings & Precautions
Liver: Because Stopain contains paracetamol, excessive dosing or simultaneous use of other paracetamol-containing medicines can cause severe liver injury. Particular caution is warranted in patients with liver disease or significant alcohol exposure. ([U.S. Food and Drug Administration][9])
Kidney: Use with caution in patients with impaired renal function; medical assessment may be appropriate where impairment is significant.
Blood disorders: Propyphenazone belongs to the pyrazolone group, for which rare but potentially serious blood-cell abnormalities, including neutropenia/agranulocytosis, have been reported. A documented case report specifically implicated propyphenazone in drug-induced neutropenia. ([PubMed][11])
Allergy: Serious immediate hypersensitivity reactions to propyphenazone have been documented. Patients developing facial swelling, difficulty breathing, widespread rash, or other severe allergic symptoms require urgent medical attention. ([PubMed][7])
Caffeine: Excessive additional caffeine from coffee, tea, energy drinks or other medicines may increase nervousness, insomnia, tremor or palpitations.
Duration: Stopain should not be used repeatedly or for prolonged periods without medical supervision, particularly because of the propyphenazone component and the risks associated with cumulative paracetamol exposure.
16. Drug Interactions
Clinically relevant interactions include:
Other paracetamol-containing medicines: Do not combine indiscriminately with other products containing paracetamol/acetaminophen, including many cold and flu preparations, because of the risk of cumulative overdose. ([U.S. Food and Drug Administration][9])
Enzyme-inducing medicines: Phenobarbital, phenytoin, carbamazepine, rifampicin and other enzyme-inducing medicines can increase the risk of paracetamol-related liver toxicity, particularly with repeated use. ([Medicines.org.uk][12])
Warfarin and related anticoagulants: Repeated regular use of paracetamol may enhance the anticoagulant effect and increase bleeding risk, particularly with prolonged use. ([Medicines.org.uk][12])
Chloramphenicol: Paracetamol may increase chloramphenicol concentrations. ([Medicines.org.uk][12])
Zidovudine: Regular concomitant paracetamol use may increase the risk of neutropenia. ([Medicines.org.uk][12])
Metoclopramide or domperidone: These drugs can increase the rate of paracetamol absorption; concomitant use is not necessarily prohibited, but should follow medical advice where clinically relevant. ([Medicines.org.uk][12])
Alcohol: Excessive alcohol intake increases concern regarding paracetamol-associated liver toxicity. ([U.S. Food and Drug Administration][9])
Additional caffeine: Large amounts of caffeine from beverages or other medicines may add to caffeine-related adverse effects.
Because interaction data for the three-drug combination are less complete than for paracetamol alone, the full medication and supplement list should be reviewed by a pharmacist or physician.
17. Side Effects
Potential adverse effects include:
Common or dose-related caffeine effects: nervousness, restlessness, insomnia, tremor, headache, gastrointestinal discomfort or palpitations, particularly with additional caffeine.
Paracetamol-related: adverse effects are uncommon at recommended doses, but serious allergic reactions and severe liver injury can occur, especially with overdose. Rare serious skin reactions have also been reported. ([U.S. Food and Drug Administration][9])
Propyphenazone-related: allergic/hypersensitivity reactions and, rarely, clinically significant blood-cell disorders such as leukopenia, neutropenia or agranulocytosis. ([PubMed][13])
The older Stopain information specifically warned that white-blood-cell abnormalities can rarely occur with pyrazolone derivatives and advised discontinuation and medical evaluation if a reduction in white-cell count develops. ([DrugPamphlet][5])
18. Use in Special Populations
Children: The adult dosage should not automatically be applied to children. The current pack/official pediatric dosing information should be checked before administration to a child. Because this is a multi-ingredient product, pediatric dosing requires particular caution.
Older adults: Use with greater caution when there is reduced liver or kidney function, polypharmacy, increased sensitivity to caffeine, or other comorbidities.
Pregnancy: The safety of the specific propyphenazone-containing combination cannot be inferred simply from the established use of paracetamol alone during pregnancy. The combination should therefore be used in pregnancy only after appropriate medical assessment. Animal research involving propyphenazone-containing analgesic combinations has raised developmental concerns, although animal findings do not by themselves establish human risk. ([PubMed][14])
Breastfeeding: Do not assume that the safety profile of paracetamol alone applies to the complete Stopain combination. Use during breastfeeding should be discussed with a healthcare professional.
Hepatic impairment: Extra caution is required because paracetamol is extensively metabolized by the liver. ([U.S. Food and Drug Administration][9])
Renal impairment: Medical advice is recommended before repeated use in significant renal impairment.
19. Storage Conditions
The historically documented Egyptian Stopain information specifies:
Store below 30°C.
Keep the medicine in its original packaging and out of the reach of children. ([DrugPamphlet][5])
The storage instructions printed on the current package should be followed if they differ.
20. Additional Sections
Important overdose precaution: The most important practical safety issue is avoiding unintentional duplication of paracetamol/acetaminophen through other painkillers or cold/flu medicines. The FDA specifically advises checking all products for acetaminophen and never exceeding the labeled total daily amount. ([U.S. Food and Drug Administration][9])
When to seek urgent medical attention: Severe allergic symptoms, difficulty breathing, extensive skin reactions, signs of serious liver injury, or suspected overdose warrant urgent medical evaluation. Paracetamol overdose may cause serious liver damage even before severe symptoms become obvious. ([U.S. Food and Drug Administration][9])
Current Egyptian presentation: Current indexed Egyptian pharmacy information identifies Stopain 20 tablets from EVA Pharma, and current packaging imagery identifies the product as 20 film-coated caplets. ([DwaPrices][1])
21. Frequently Asked Questions (FAQ)
What is Stopain used for?
It is an analgesic and antipyretic combination used for symptomatic relief of headache, migraine-type headache, toothache, musculoskeletal pain and other painful or febrile conditions. ([DrugPamphlet][5])
What are the active ingredients in Stopain?
The documented Stopain formulation contains propyphenazone 150 mg, paracetamol 300 mg and caffeine 50 mg per caplet. ([PubMed Central (PMC)][3])
Is Stopain an antibiotic?
No. It is an analgesic/antipyretic combination and does not treat bacterial or viral infections.
Can Stopain be taken with another paracetamol medicine?
It should not be combined casually with another paracetamol-containing product because the total dose can become excessive and potentially hepatotoxic. ([U.S. Food and Drug Administration][9])
What is the adult dose?
The historically documented Stopain leaflet states 1–2 caplets every 6 hours, maximum 8 caplets in 24 hours. Because current online regulatory documentation is not readily accessible, the dosage printed in the leaflet supplied with the current package should be treated as authoritative. ([DrugPamphlet][5])
Does Stopain contain caffeine?
Yes. Each documented caplet contains 50 mg of caffeine. Additional coffee, energy drinks, or other caffeine-containing medicines may increase caffeine-related adverse effects. ([PubMed Central (PMC)][3])
Can Stopain be used during pregnancy or breastfeeding?
The safety of the complete propyphenazone/paracetamol/caffeine combination should not be equated with the safety profile of paracetamol alone. Medical advice should be obtained before use.
Is Stopain suitable for long-term treatment?
It should not be used for prolonged or repeated treatment without medical supervision because of potential blood-related reactions associated with propyphenazone and the cumulative hepatic risks associated with excessive paracetamol exposure.
What should I do if too much Stopain has been taken?
Seek urgent medical advice, particularly because of the paracetamol component. Do not wait for symptoms of liver injury to appear. ([U.S. Food and Drug Administration][9])
22. References
- EVA Pharma / Egyptian Stopain product information reproduced in Egyptian drug-reference material: formulation, indications, adult dosing, warnings and storage. ([DrugPamphlet][5])
- Current Egyptian market listing — Stopain 20 tab: product name, active ingredients, manufacturer and current 20-tablet presentation. ([DwaPrices][1])
- Published pharmaceutical analysis of Stopain tablets manufactured by EVA Pharma: confirms 50 mg caffeine + 150 mg propyphenazone + 300 mg paracetamol per tablet. ([PubMed Central (PMC)][3])
- British Journal of Clinical Pharmacology: pharmacokinetics and metabolism of propyphenazone and related pyrazolones. ([PubMed Central (PMC)][8])
- Electronic Medicines Compendium (eMC) — Paracetamol/Caffeine SmPC: mechanisms, indications, dosage principles and relevant interactions. ([Medicines.org.uk][6])
- U.S. Food and Drug Administration (FDA) — Acetaminophen safety information: maximum exposure principles, overdose and liver-injury warnings. ([U.S. Food and Drug Administration][9])
- NHS — Paracetamol for adults: practical safety information, duplicate-paracetamol warning and important interactions. ([nhs.uk][15])
- PubMed literature on propyphenazone-associated hematological reactions and hypersensitivity. ([PubMed][11])
- WHO/WAO-related evidence concerning pyrazolone hypersensitivity and cross-reactivity. ([PubMed Central (PMC)][10])
- EVA Pharma official corporate information: confirms EVA Pharma as an Egyptian pharmaceutical manufacturer and its current corporate identity. ([EVA Pharma][16])
Current-market note: The currently indexed Egyptian product is Stopain 20 tablets/film-coated caplets, EVA Pharma, containing the documented combination of propyphenazone + paracetamol + caffeine. Because publicly accessible sources do not provide a clearly current, official Egyptian regulatory leaflet with every clinical detail, the leaflet enclosed with the current pack remains the primary source for the exact current dosage, contraindications, and storage instructions. ([DwaPrices][1])