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PAINGAY CAPSULES SOLID (Hard gelatin capsule Diclofenac 100mg)

diclofenal

FDA/SD.255-123461 diclofenal 100mg

What it does

Diclofenac is a medication used to relieve pain and reduce inflammation.

Commonly used for: pain relief (analgesia), inflammation (swelling and redness), osteoarthritis, rheumatoid arthritis …

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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.
FDA/SD.255-123461
Registration date
2025-12-30
Expiry date
2030-12-31
Status
Valid
Active ingredient
diclofenal
Dosage form
diclofenal
Strength
100mg
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Umedical Laboratories
Applicant / LTR
Shalom Phamal Ltd Ghana
Country of origin
INDIA
Manufacturer location
9WFH+HC9, Phase 2, GIDC, Vapi, Chharwada, Gujarat 396195, India

Source: Food and Drugs Authority · fetched 2026-04-18 08:48:12 · updated 2026-10-20 04:00:03

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

About this medicine

Diclofenac is a medication used to relieve pain and reduce inflammation.

What it treats

  • pain relief (analgesia)
  • inflammation (swelling and redness)
  • osteoarthritis
  • rheumatoid arthritis
  • gout

How it works

Diclofenac works by blocking certain chemicals in the body that cause pain and inflammation.

Who it's for

Diclofenac is suitable for adults and children over a certain age, as determined by a healthcare provider.

Cautions

  • • May cause stomach issues, such as ulcers or bleeding
  • • Use with caution if you have heart or kidney problems
  • • Not recommended during pregnancy without medical advice

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

Clinical monograph: diclofenal

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that is commonly used to relieve pain, reduce inflammation, and lower fever. It belongs to the phenylacetic acid derivative class of NSAIDs and is widely used for various conditions including arthritis, acute pain, and postoperative pain.

Indications

  • Rheumatoid arthritis
  • Osteoarthritis
  • Ankylosing spondylitis
  • Acute musculoskeletal pain
  • Postoperative pain
  • Dysmenorrhea
  • Migraine attacks

Dosage

Children: Refer to the BNF for Children for appropriate dosing in paediatric populations.

Adults: Refer to the specific product information for dosing recommendations, as it varies based on the formulation and indication.

Mechanism of action

Diclofenac works by inhibiting the activity of cyclooxygenase (COX) enzymes, particularly COX-1 and COX-2, which play a crucial role in the conversion of arachidonic acid to prostaglandins. Prostaglandins are mediators of inflammation and pain. By reducing their synthesis, diclofenac alleviates pain and inflammation.

Pharmacodynamics

The pharmacodynamic effects of diclofenac include analgesia, anti-inflammatory effects, and antipyretic actions. The onset of analgesic effect typically occurs within 30 minutes to 1 hour after administration, with peak effects occurring within 2 to 4 hours.

Pharmacokinetics

Diclofenac is rapidly absorbed from the gastrointestinal tract after oral administration. It has a high bioavailability of approximately 50% due to first-pass metabolism in the liver. The drug is highly protein-bound, primarily to albumin, and has a half-life of about 1 to 2 hours. Diclofenac undergoes hepatic metabolism primarily via cytochrome P450 enzymes, with metabolites excreted in urine.

Contra-indications

  • Active gastrointestinal bleeding
  • Severe heart failure
  • Severe renal impairment
  • History of hypersensitivity to diclofenac or other NSAIDs
  • Pregnancy (particularly in the third trimester)

Adverse effects

  • Gastrointestinal discomfort or bleeding
  • Nausea
  • Vomiting
  • Headache
  • Dizziness
  • Rash
  • Elevated liver enzymes
  • Renal impairment

Interactions

  • Increased risk of bleeding with anticoagulants (e.g., warfarin)
  • Increased effects of antihypertensive medications when used with NSAIDs
  • Potential for increased nephrotoxicity when used with other nephrotoxic drugs (e.g., aminoglycosides)
  • May reduce the effectiveness of diuretics

Precautions

  • Use with caution in patients with pre-existing cardiovascular disease
  • Monitor renal function in long-term use
  • Avoid use in patients with a history of peptic ulcer disease
  • Consider potential for cross-reactivity in patients with aspirin allergy

Pregnancy

Use is not recommended, especially during the third trimester due to potential risks to the fetus.

Breast-feeding

Diclofenac is excreted in breast milk; caution is advised when administering to nursing mothers.

Storage

Store at room temperature, away from light and moisture. Keep out of reach of children.

Formulations

  • Oral tablets
  • Topical gel
  • Injection

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