Flamifast 50 mg 30 tablets

Flamifast Diclofenac Potassium 50 mg 30 Orally Disintegrating Tablets

Composition:

Each tablet contains 50 mg of diclofenac potassium as the active ingredient.

Description:

Flamifast is a fast-acting oral formulation of diclofenac potassium, designed to be taken for the acute treatment of migraine attacks with or without aura in adults. The orally disintegrating tablets dissolve quickly in the mouth without the need for water, offering convenience during migraine episodes.

Indications for Use:

-Flamifast is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older).

-It is not intended for the prophylactic therapy of migraine.

-The safety and effectiveness of diclofenac potassium for cluster headaches have not been established.

Dosage and Administration:

For acute treatment of migraine, take one orally disintegrating tablet (50 mg) at the onset of a migraine attack.

Do not use liquids other than water to swallow the tablet.

It is recommended to take the tablet on an empty stomach for optimal effectiveness.

Use the lowest effective dose for the shortest duration necessary to manage symptoms. The safety and effectiveness of a second dose have not been established.

Flamifast is not interchangeable with other diclofenac formulations.

Contraindications:

-Flamifast is contraindicated in the following conditions:

-Known hypersensitivity to diclofenac or any of the components of the drug.

-History of asthma, urticaria, or other allergic reactions after taking aspirin or other NSAIDs.

-In the peri-operative period following coronary artery bypass graft (CABG) surgery.

Warnings and Precautions:

-Cardiovascular Thrombotic Events: Diclofenac increases the risk of serious cardiovascular events, including myocardial infarction and stroke, which can be fatal. This risk may increase with prolonged use and is higher in patients with existing cardiovascular conditions.

-Hepatotoxicity: There may be liver enzyme elevations, and severe liver reactions, including liver failure, have been reported.

-Renal Toxicity: Prolonged use of NSAIDs can lead to kidney damage, especially in patients with pre-existing renal disease.

-Hypertension: Diclofenac may cause or worsen hypertension.

-Gastrointestinal Risks: NSAIDs can cause gastrointestinal bleeding, ulcers, and perforations.

Pregnancy and Lactation:

Pregnancy: Flamifast should be avoided starting at 30 weeks of gestation due to the risk of premature closure of the fetal ductus arteriosus.

Lactation: It is not known whether diclofenac is excreted in human milk. Caution should be exercised when administering Flamifast to nursing mothers.

Side Effects:

Common Side Effects: Nausea, dizziness.

Serious Side Effects: Cardiovascular thrombotic events, gastrointestinal bleeding, liver toxicity, renal toxicity, anaphylactic reactions, skin reactions such as Stevens-Johnson Syndrome.

Less Common Effects: Edema, hypertension, headache, rash, pruritus, tinnitus.

Storage Conditions:

Store in a cool, dry place at room temperature (15°C to 30°C). Keep out of the reach of children.

Packaging:

 a carton box containing 30 orally disintegrating tablets.