International reference: 1 US FDA recall for this ingredient

Failed Dissolution Specifications: Low dissolution results were obtained during stability testing (mefanamic)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Zambia.

Registered Zambia · ZAMRA

Pause MF Tablets

Mefanamic Acid 250.000 mg,Tranexamic Acid 500.000 mg

ZAMRA-HM-23-45 Film Coated Tablets 250.000 mg,500.000 mg

What it does

Mefanamic acid is a pain reliever that helps reduce inflammation and relieve pain.

Commonly used for: menstrual pain (dysmenorrhea), mild to moderate pain, inflammation

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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.
ZAMRA-HM-23-45
Registration date
2023-05-30
Expiry date
2028-05-29
Status
Registered/Compliant
Active ingredient
Mefanamic Acid 250.000 mg,Tranexamic Acid 500.000 mg
Dosage form
Film Coated Tablets
Strength
250.000 mg,500.000 mg
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Emcure Pharmaceuticals
Country of origin
India
Manufacturer location
Plot No. P-1 & P-2, IT-BT Park, Phase-II, D.C, M.I, Hinjawadi, Pune, Man, Maharashtra 411057, India

Source: Zambia Medicines Regulatory Authority · fetched 2026-03-12 00:01:41 · updated 2026-09-24 03:33:18

Disclaimer: This information is sourced from Zambia Medicines Regulatory Authority (Zambia). Always consult a qualified healthcare professional before using any medication.

About mefanamic

Mefanamic acid is a pain reliever that helps reduce inflammation and relieve pain.

What it treats

  • menstrual pain (dysmenorrhea)
  • mild to moderate pain
  • inflammation

How it works

It works by blocking substances in the body that cause pain and inflammation.

Who it's for

It's for adults and children over the age of 12 who need relief from pain.

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

About tranexamic

Tranexamic acid is a medicine that helps reduce excessive bleeding.

What it treats

  • heavy menstrual bleeding (menorrhagia)
  • bleeding after surgery
  • bleeding disorders

How it works

It helps the blood to clot more effectively, which reduces bleeding.

Who it's for

This medicine is for people who experience heavy bleeding due to various medical conditions.

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

Clinical monograph: mefanamic

Mefanamic acid is a non-steroidal anti-inflammatory drug (NSAID) used primarily for the treatment of mild to moderate pain and for the relief of dysmenorrhea. It exhibits analgesic, anti-inflammatory, and antipyretic properties, making it useful in various clinical settings. Mefanamic acid is often used when other NSAIDs are not suitable or when patients are specifically seeking a medication with its profile.

Indications

  • Mild to moderate pain
  • Dysmenorrhea
  • Osteoarthritis
  • Rheumatoid arthritis

Dosage

Children: Refer to the BNF for Children for specific dosing guidelines.

Adults: Refer to the BNF for specific dosing guidelines.

Mechanism of action

Mefanamic acid works by inhibiting the enzyme cyclooxygenase (COX), which is responsible for the conversion of arachidonic acid to prostaglandins. By blocking COX enzymes, mefanamic acid reduces the synthesis of prostaglandins, thereby decreasing inflammation, pain, and fever. It primarily inhibits COX-1 and COX-2, which leads to a reduction in the inflammatory response in tissues.

Pharmacodynamics

The pharmacodynamic effects of mefanamic acid include its ability to decrease pain perception and reduce inflammation. It achieves this through the inhibition of prostaglandin synthesis, which plays a crucial role in mediating pain and inflammatory processes. Mefanamic acid is particularly effective in alleviating menstrual pain due to its pronounced effect on prostaglandin levels related to uterine contractions.

Pharmacokinetics

Mefanamic acid is well absorbed from the gastrointestinal tract, with peak plasma concentrations typically occurring within 2 to 4 hours after oral administration. It has a bioavailability of approximately 90%. The drug is extensively metabolized in the liver, with a half-life ranging from 2 to 4 hours. It is primarily excreted in the urine as metabolites, with less than 1% of the dose being excreted unchanged. The pharmacokinetics can be influenced by factors such as age, liver function, and concurrent medications.

Contra-indications

  • Active peptic ulceration
  • History of gastrointestinal bleeding
  • Severe renal impairment
  • Hypersensitivity to mefanamic acid or any of its components
  • Pregnancy, particularly during the third trimester

Adverse effects

  • Gastrointestinal disturbances (nausea, vomiting, diarrhea)
  • Dizziness
  • Headache
  • Rash or allergic reactions
  • Increased risk of cardiovascular events with long-term use
  • Hepatic dysfunction

Interactions

  • May enhance the effects of anticoagulants such as warfarin
  • May reduce the effect of antihypertensive drugs
  • Concurrent use with other NSAIDs may increase the risk of gastrointestinal side effects
  • Caution with renal excretion drugs due to potential renal impairment

Precautions

  • Use with caution in patients with a history of asthma or allergic reactions
  • Monitor renal function in long-term therapy
  • Evaluate cardiovascular risk factors before initiation
  • Avoid use in dehydration or hypovolemia

Pregnancy

Mefanamic acid is not recommended during pregnancy, especially in the third trimester due to potential effects on the fetal cardiovascular system and possible increase in bleeding risk during delivery.

Breast-feeding

Mefenamic acid is excreted in breast milk; caution is advised when administered to nursing mothers.

Storage

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

Formulations

  • Capsules
  • Tablets
  • Oral suspension

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

Clinical monograph: tranexamic

Tranexamic acid is a synthetic derivative of the amino acid lysine, primarily used as an antifibrinolytic agent. It works by inhibiting the activation of plasminogen to plasmin, which reduces the breakdown of fibrin and stabilizes blood clots, making it effective in conditions where bleeding is a concern. It is commonly used in surgeries, trauma, and certain bleeding disorders.

Indications

  • Heavy menstrual bleeding (menorrhagia)
  • Surgical procedures to reduce blood loss
  • Trauma-related bleeding
  • Hereditary angioedema
  • Dental procedures in patients with bleeding disorders

Dosage

Children: Refer to the BNF for Children for specific dosing guidelines based on age, weight, and indication.

Adults: Refer to the BNF for specific dosing guidelines based on indication and patient condition.

Mechanism of action

Tranexamic acid competitively inhibits the lysine binding sites on plasminogen, preventing its conversion to plasmin. This inhibition decreases fibrinolysis, leading to increased clot stability and reduced bleeding.

Pharmacodynamics

The primary pharmacodynamic effect of tranexamic acid is its ability to reduce bleeding by stabilizing fibrin clots. The drug exhibits a dose-dependent effect on clotting, with higher doses leading to a more pronounced antifibrinolytic effect. Tranexamic acid does not significantly affect platelet function or coagulation factors.

Pharmacokinetics

Tranexamic acid is rapidly absorbed after oral administration, with peak plasma concentrations occurring within 1 to 3 hours. It has a bioavailability of approximately 30% to 50%. The drug is primarily excreted unchanged in the urine, with a half-life of approximately 2 hours. It does not undergo significant metabolism in the liver, which is beneficial in patients with hepatic impairment.

Contra-indications

  • Active venous thromboembolism
  • History of thromboembolic disorders
  • Severe renal impairment
  • Hypersensitivity to tranexamic acid or any excipients

Adverse effects

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Dizziness
  • Headache
  • Visual disturbances
  • Thrombosis
  • Hypotension
  • Allergic reactions

Interactions

  • Anticoagulants (increased risk of thrombosis)
  • Hormonal contraceptives (increased risk of thrombosis)
  • Fibrinolytics (increased risk of bleeding)

Precautions

  • Monitor for signs of thrombosis during treatment
  • Use with caution in patients with a history of seizures
  • Caution in patients with renal impairment
  • Assess the risk of bleeding before use

Pregnancy

Tranexamic acid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Tranexamic acid is excreted in breast milk; caution should be exercised when administered to nursing mothers.

Storage

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

Formulations

  • Tablets
  • Injection solution

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

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.