Flustop™ Tablets
1. Disclaimer
This information is provided for educational and reference purposes only and is not a substitute for the advice, diagnosis, or treatment provided by a qualified physician or pharmacist. Medication should be used according to the current package leaflet, approved local product information, and professional medical advice.
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
Flustop™ is a multi-ingredient oral tablet marketed in Egypt for the temporary symptomatic relief of common cold and influenza-like upper-respiratory symptoms. Current Egyptian-market sources identify the product as containing paracetamol, pseudoephedrine, chlorpheniramine, and caffeine and list GlaxoSmithKline (GSK) as the producer.
The combination provides analgesic/antipyretic, nasal decongestant, antihistamine, and caffeine-adjuvant effects. It is intended to relieve symptoms rather than eradicate the viral or other underlying cause of a respiratory infection.
3. Brand Name
Flustop™ Tablets
Pack size commonly listed in Egypt: 20 tablets.
4. Category
Therapeutic category: Common cold and influenza symptomatic preparations / analgesic–decongestant–antihistamine combination.
5. Active Ingredient
Current Egyptian-market sources identify the four active ingredients as:
- Paracetamol (acetaminophen) — 400 mg
- Pseudoephedrine hydrochloride — 60 mg
- Chlorpheniramine maleate — 3 mg
- Caffeine anhydrous — 32 mg
These strengths are supported by current product listings and are consistent with published Egyptian product information for Flustop. Because a current Flustop manufacturer leaflet with the complete formulation was not publicly retrievable, the current pack/leaflet should remain the definitive source for the exact marketed formulation.
6. Pharmaceutical Form & Strength
Dosage form: Oral tablets.
Strength: One tablet contains the four active ingredients listed above.
Pack: 20 tablets are currently listed for the Egyptian product.
7. Manufacturer & Marketing Authorization Holder
Manufacturer / local GSK operation: GlaxoSmithKline S.A.E. (GSK Egypt) is identified in Egyptian medicine listings as the producer of Flustop. GSK currently maintains an Egyptian operation and manufacturing facilities.
Marketing Authorization Holder: A current publicly accessible Flustop-specific regulatory record identifying a separate legal MAH could not be independently verified. Therefore, no separate MAH is stated here beyond the documented GSK Egypt entity.
8. Mechanism of Action
Flustop combines four pharmacological actions:
Paracetamol: Provides analgesic and antipyretic effects through central mechanisms; it is used to reduce pain and fever.
Pseudoephedrine: A sympathomimetic nasal decongestant that reduces nasal mucosal congestion primarily through vasoconstrictive activity. Current labeling recognizes its usefulness for temporary nasal congestion associated with the common cold and upper-respiratory allergies.
Chlorpheniramine: A first-generation H1-antihistamine that reduces histamine-mediated symptoms such as sneezing and rhinorrhea. It can also produce drowsiness and anticholinergic effects.
Caffeine: A CNS stimulant that can act as an analgesic adjuvant. Evidence indicates that caffeine can modestly enhance the analgesic effect of common analgesics such as paracetamol.
9. Spectrum of Activity
Flustop does not have an antibacterial or antiviral spectrum of activity. It is a symptomatic treatment for upper-respiratory symptoms such as nasal congestion, rhinorrhea/sneezing, headache, fever, and minor body aches.
It should not be described as treating or eliminating influenza viruses or other respiratory pathogens.
10. Pharmacokinetics
The available sources do not provide a validated, product-specific pharmacokinetic profile for the complete Flustop combination.
For the individual components:
- Pseudoephedrine is rapidly absorbed after oral administration. Its mean elimination half-life is generally about 4–6 hours, although urinary pH can substantially affect elimination. Most of the dose is eliminated through the kidneys, much of it unchanged.
- Chlorpheniramine is orally absorbed with substantial first-pass metabolism. Published human studies report a relatively long elimination half-life, commonly around 20–28 hours, with considerable inter-individual variation.
- Paracetamol is rapidly absorbed after oral administration and is predominantly metabolized in the liver by conjugation pathways; its adult elimination half-life is generally around 2–3 hours.
- Caffeine is rapidly absorbed and predominantly metabolized hepatically, principally through CYP1A2; its adult half-life is generally several hours.
The overall duration of effect of the combination depends on the individual components and patient-specific factors.
11. Indications
Flustop may be used for temporary relief of multiple symptoms associated with the common cold and similar upper-respiratory illnesses, particularly:
- Nasal congestion
- Runny nose and sneezing
- Headache
- Fever
- Minor aches and pains associated with a cold
Current Egyptian-market descriptions specifically associate the product with colds, nasal discharge/congestion, and headache.
It does not cure the underlying viral infection.
12. Administration
For the Egyptian product, a current market listing reports 1 tablet three times daily for cold symptoms.
Because a current manufacturer-issued Flustop dosing leaflet was not publicly retrievable, the current package leaflet and healthcare-professional instructions should take precedence if they differ.
The tablet should be swallowed with water. Do not exceed the recommended dose.
Particular care is required with other cold/flu preparations because several may also contain paracetamol, pseudoephedrine, or other sympathomimetics.
13. Method of Preparation
No preparation is required. Flustop is supplied as a finished oral tablet and is intended to be swallowed with water.
Do not crush, split, or modify the tablet unless the current product instructions specifically permit it.
14. Contraindications
Flustop should not be used in patients with:
- Known hypersensitivity to any component of the product.
- Current treatment with a monoamine oxidase inhibitor (MAOI) or during the 14-day/2-week period after stopping an MAOI, because of the risk of serious sympathomimetic interaction.
- Conditions in which the pseudoephedrine component is medically unsuitable, particularly significant cardiovascular disease or uncontrolled/severe hypertension, unless specifically assessed and advised by a healthcare professional. Current pseudoephedrine labeling requires medical advice in patients with heart disease or hypertension.
Patients with narrow-angle glaucoma or urinary retention/prostatic obstruction also require particular caution because of the sympathomimetic and anticholinergic effects of the components.
15. Warnings & Precautions
Use with medical or pharmacist advice in patients with:
- Hypertension or cardiovascular disease
- Hyperthyroidism
- Diabetes mellitus
- Glaucoma or increased intraocular pressure
- Difficulty urinating or prostatic enlargement
- Renal impairment
- Hepatic impairment
Pseudoephedrine may cause nervousness, insomnia, dizziness, palpitations, or increases in blood pressure in susceptible individuals.
Chlorpheniramine may cause drowsiness and impaired alertness. Alcohol, sedatives, and tranquilizers may increase this effect; caution is required with driving or operating machinery.
Do not exceed the recommended dose. Paracetamol overdose can cause severe liver injury, and the total amount of acetaminophen/paracetamol from all medicines combined must be considered. FDA guidance states that the total adult/≥12-year amount should not exceed 4,000 mg in 24 hours unless a healthcare professional gives different instructions.
16. Drug Interactions
Important potential interactions include:
- MAO inhibitors: Contraindicated during treatment and for 2 weeks after discontinuation because of potentially dangerous sympathomimetic effects.
- Other sympathomimetics/decongestants: May increase cardiovascular and stimulant adverse effects.
- Antihypertensive medicines: Pseudoephedrine may interfere with the effect of some blood-pressure-lowering drugs.
- Tricyclic antidepressants and certain other medicines: May increase sympathomimetic effects and require professional review.
- Sedatives, tranquilizers, alcohol, and other CNS depressants: May increase chlorpheniramine-related drowsiness and impairment.
- Other paracetamol-containing medicines: Can result in unintentional paracetamol overdose.
Patients should inform their doctor or pharmacist of all prescription, non-prescription, and herbal medicines they are using.
17. Side Effects
Possible adverse effects include:
Common or clinically relevant effects
- Drowsiness or reduced alertness
- Dizziness
- Nervousness or restlessness
- Difficulty sleeping
- Dry mouth
- Difficulty urinating
- Palpitations or other cardiovascular symptoms
- Gastrointestinal discomfort
Chlorpheniramine is particularly associated with drowsiness, while pseudoephedrine can cause stimulant/sympathomimetic effects such as nervousness, dizziness, and insomnia.
Serious symptoms such as marked palpitations, severe headache, significant blood-pressure elevation, severe allergic reaction, confusion, seizures, or suspected overdose require prompt medical assessment.
18. Use in Special Populations
Children: Available Egyptian dosing information for Flustop is for patients over 12 years. The dose should not be extrapolated to younger children. Combination cold medicines require particular caution in pediatric patients.
Elderly: Older adults may be more susceptible to antihistamine-related sedation, confusion, anticholinergic effects, and urinary difficulties. Conservative use and professional review are appropriate.
Pregnancy: Because the combination contains pseudoephedrine and a first-generation antihistamine, use during pregnancy should be based on an individual medical assessment rather than routine self-treatment. Pseudoephedrine is generally not recommended during pregnancy by the NHS.
Breastfeeding: Pseudoephedrine can enter breast milk in small amounts and may reduce milk production; chlorpheniramine may also cause infant effects or reduce milk supply with larger or prolonged exposure, particularly when combined with a sympathomimetic. Professional advice is recommended before use.
Renal/Hepatic impairment: Medical advice is appropriate because pseudoephedrine is substantially renally eliminated and paracetamol is primarily metabolized in the liver.
19. Storage Conditions
Keep the tablets in their original packaging, tightly closed and protected from excessive heat and moisture. Keep out of reach of children.
The exact storage temperature should be taken from the current Flustop package/leaflet if specified; a product-specific current temperature requirement could not be independently verified from publicly accessible manufacturer information.
20. Additional Sections
Overdose & Key Safety Point
The most important overdose concern in this combination is paracetamol-associated hepatotoxicity, together with potentially serious cardiovascular and central nervous system effects from excessive sympathomimetic/antihistamine exposure.
In paracetamol overdose, specific antidotal treatment may be required. N-acetylcysteine is the preferred antidote; methionine may be used as an alternative in selected circumstances.
Do not combine Flustop with another medicine containing paracetamol without calculating the total daily amount. Suspected overdose requires urgent medical evaluation even if the patient initially feels well.
Important Product-Limitations Note
Current Egyptian sources support the continued listing of Flustop 20 tablets containing the four active ingredients and identifying GSK as producer; however, a current publicly accessible manufacturer-issued Flustop product monograph containing every prescribing detail was not found. Therefore, product-specific details such as the current legal MAH and exact storage instructions should be confirmed against the latest package/official local leaflet.
21. Frequently Asked Questions (FAQ)
Does Flustop cure influenza or the common cold?
No. It is intended to relieve symptoms such as pain, fever, nasal congestion, runny nose, and sneezing; it does not eradicate the underlying viral infection.
Can Flustop be taken with another cold or flu medicine?
Not automatically. Many cold/flu products contain paracetamol, pseudoephedrine, or other decongestants. Combining them can lead to excessive doses or additive adverse effects.
Can I drive after taking Flustop?
Use caution. Chlorpheniramine can cause drowsiness and impaired alertness. Do not drive or operate machinery if you feel sleepy, dizzy, or impaired.
Can Flustop be used during pregnancy or breastfeeding?
Pregnancy and breastfeeding require professional assessment, particularly because of pseudoephedrine. Pseudoephedrine may reduce breast-milk production and is generally not preferred during pregnancy.
Should the recommended dose be increased if symptoms are severe?
No. Increasing the dose does not make the medicine predictably more effective and may substantially increase toxicity risk, particularly from paracetamol and pseudoephedrine.
22. References
- GSK Egypt. Egypt country information, current GSK operations, manufacturing facilities, and healthcare-professional contact information.
- GSKPro Egypt. Current GSK Egypt healthcare-professional portal and product-safety information.
- Egyptian medicine market listings for Flustop 20 Tablets. Current listings confirming the product name, pack size, four active ingredients, and GSK producer.
- Rosheta Egypt / regional medicine listing. Product composition reported as paracetamol 400 mg, pseudoephedrine 60 mg, chlorpheniramine maleate 3 mg, and caffeine 32 mg.
- DailyMed — Pseudoephedrine HCl. Current labeling regarding indications, MAOI interaction, cardiovascular precautions, and adverse effects.
- DailyMed — Chlorpheniramine maleate. Current warnings concerning drowsiness, alcohol, sedatives, glaucoma, and urinary difficulty.
- FDA — Acetaminophen. Current safety information and maximum total daily adult dose.
- LactMed — Chlorpheniramine and Pseudoephedrine. Current breastfeeding safety information and effects on milk production.
- Huang SM, et al. Pharmacokinetics of chlorpheniramine after intravenous and oral administration in normal adults. European Journal of Clinical Pharmacology.
- Renner B, et al. Caffeine accelerates absorption and enhances the analgesic effect of acetaminophen. Journal of Clinical Pharmacology.
- Cochrane Review. Caffeine as an analgesic adjuvant for acute pain in adults.