FLUTAMIDE TABLETS 250 MG

1. COMPOSITION

Each tablet contains:

Flutamide 250 mg
Excipients: q.s.
Colour: As approved.

2. PHARMACEUTICAL FORM

Tablets

3. THERAPEUTIC CLASS

Non-Steroidal Antiandrogen / Androgen Receptor Antagonist

4. INDICATIONS

Flutamide is indicated, in combination with medical or surgical castration, for the treatment of advanced prostate cancer.

It may be used to reduce the effects of androgens in patients with advanced disease as directed by an oncologist or urologist.

5. CONTRAINDICATIONS

Hypersensitivity to flutamide or any component of the formulation.
Significant hepatic impairment or active liver disease.
Use with caution in patients with a history of liver disease.

Flutamide may cause serious hepatic injury. Liver function should be assessed before treatment and monitored regularly during therapy.

6. DRUG INTERACTIONS

Flutamide may interact with:

Warfarin and other anticoagulants
Other medicines that may affect liver function
Medicines extensively metabolized by hepatic enzymes

Patients should inform their physician about all prescription, non-prescription, and herbal medicines being taken.

7. ADMINISTRATION

For oral use only.

The usual adult dose is 250 mg three times daily, approximately every 8 hours, or as directed by the physician.

The tablets may be taken with or without food and should be taken at evenly spaced intervals.

Regular monitoring of liver function tests is essential, particularly during the first months of treatment.

Patients should immediately report symptoms such as loss of appetite, persistent nausea or vomiting, abdominal pain, dark urine, jaundice, or unusual fatigue.

8. STORAGE

Store below 25°C, protected from moisture and excessive heat.

Keep the container tightly closed and out of reach of children.

Do not use after the expiry date stated on the package.

Market : international export

Private Label : Available

Registration Support : Available

Regulatory documents : Available on request