Registered Rwanda · Rwanda FDA

GACET 500

Paracetmol Effervescent Granules

Rwanda FDA-HMP-MA-2115 Effervescent Granules 500 MG

What it does

Paracetamol is a common pain reliever and fever reducer.

Commonly used for: pain relief (analgesia), fever reduction (antipyretic)

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
Rwanda FDA-HMP-MA-2115
Registration date
18/10/2024
Expiry date
17/10/2029
Status
Registered
Active ingredient
Paracetmol Effervescent Granules
Dosage form
Effervescent Granules
Strength
500 MG
Pack size
10 sachets
Therapeutic class
-
Manufacturer / MAH
Bliss Gvs Pharma
Applicant / LTR
BLISS GVS PHARMA LTD
Country of origin
India
Manufacturer location
102, Hyde Park, Saki Vihar Rd, Ganesh Nagar, Marol, Andheri East, Mumbai, Maharashtra 400072, India

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:03 · updated 2026-09-21 02:30:19

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About this medicine

Paracetamol is a common pain reliever and fever reducer.

What it treats

  • pain relief (analgesia)
  • fever reduction (antipyretic)

How it works

Paracetamol works by blocking pain signals in the brain and reducing fever.

Who it's for

It is suitable for adults and children who need relief from mild to moderate pain or fever.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: paracetmol

Paracetamol, also known as acetaminophen, is a widely used analgesic and antipyretic medication. It is commonly employed in the management of mild to moderate pain and to reduce fever. Paracetamol is favored for its safety profile and is often the first-line treatment for many conditions due to its low incidence of side effects compared to non-steroidal anti-inflammatory drugs (NSAIDs).

Indications

  • Mild to moderate pain relief
  • Fever reduction
  • Headaches
  • Muscle aches
  • Arthritis pain
  • Back pain
  • Toothaches
  • Cold and flu symptoms

Dosage

Children: Refer to specific dosing guidelines in professional texts as per individual patient needs and clinical context.

Adults: Refer to specific dosing guidelines in professional texts as per individual patient needs and clinical context.

Mechanism of action

Paracetamol's exact mechanism of action is not fully understood. However, it is believed to inhibit the cyclooxygenase (COX) enzymes, particularly COX-2, in the brain. This action leads to a decrease in the synthesis of prostaglandins, which are mediators of pain and fever. Additionally, paracetamol may enhance the effects of endogenous cannabinoid system and influence serotonergic pathways, contributing to its analgesic effects.

Pharmacodynamics

Paracetamol exhibits analgesic properties by elevating the pain threshold through its action on the central nervous system. It has antipyretic effects by acting on the hypothalamic heat-regulating center, leading to peripheral vasodilation and increased sweating, which helps lower body temperature. Unlike NSAIDs, paracetamol has minimal anti-inflammatory effects.

Pharmacokinetics

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract, with peak plasma concentrations occurring within 30 to 60 minutes after oral administration. It is metabolized primarily in the liver through conjugation with glucuronic acid and sulfate. A small fraction is metabolized via the cytochrome P450 pathway to a reactive metabolite that can lead to hepatotoxicity in overdose situations. The elimination half-life is typically 1 to 4 hours, and it is excreted mainly as non-toxic metabolites in urine.

Contra-indications

  • Severe hepatic impairment
  • Active liver disease
  • Hypersensitivity to paracetamol or any excipients

Adverse effects

  • Nausea
  • Vomiting
  • Rash
  • Allergic reactions
  • Hepatotoxicity
  • Renal impairment

Interactions

  • Alcohol may increase the risk of hepatotoxicity
  • Warfarin may have increased anticoagulant effects with chronic use of paracetamol
  • Rifampicin may increase the metabolism of paracetamol, reducing its effectiveness

Precautions

  • Use with caution in patients with liver disease
  • Caution in patients with renal impairment
  • Avoid exceeding the recommended dose to prevent hepatotoxicity
  • Monitor liver function in long-term use

Pregnancy

Paracetamol is generally considered safe for use during pregnancy when taken at recommended doses.

Breast-feeding

Paracetamol is excreted in breast milk in small amounts, generally considered safe for use while breastfeeding.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Tablets
  • Oral suspension
  • Effervescent tablets
  • Suppositories

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.