Dosage form and active ingredients:

Each film coted circle tablet contains 25 mg of Tetrabenazine.

Indications and Usage:

TETROGER® is a medicine that is used to treat the involuntary movements (chorea) of Huntington’s disease. TETROGER® does not cure the cause of the involuntary movements, and it does not treat other symptoms such as problems with thinking or emotions.

Drug Dosage in adults for Huntington

• Treatment with Tetroger should only be initiated by physicians.
• Initial Dose: 12.5 mg orally per day once in the morning; increase to 12.5 mg orally twice a day after one week.
• Maximum Single Dose: 25 mg
• Do not take another dose until you talk to your doctor.
• If your doctor thinks you need to take more than 50 mg of TETROGER® each day, you will need to have a blood test to see if a higher dose is right for you.
• It is not known whether TETROGER® is safe and effective in children.

Important side effects:

• Sleepiness (sedation) :do not drive a car or operate dangerous machinery until you know how TETROGER® affects you. Alcohol and other drugs may increase sleepiness caused by TETROGER®.
• Trouble sleeping, Depression, Tiredness (fatigue), Anxiety, Restlessness, Agitation and Nausea.

Contraindications:

• Hypersensitivity
• Hepatic impairment
• Patients who are actively suicidal, or who have untreated or inadequately treated depression

Storage condition:

• Store bellow 30 degree centigrade and keep away from direct light, moist and frizzing.
• Keep out of reach of children.
• Don’t use expired TETROGER®.

Nature and contents of container

10 Tablets are packaged in each opaque blister cards and each package contains 30 tablets.

Marketing authorization holder

Hogerdaroo danesh Pharmaceutical CO.

Shahid Beheshti Uni. Technology Incubators

Tehran, Iran.   postal code: 1983969411

Manufacturing and packing at:

Kishmedipharm pharmaceutical company