FASIGYN (Fasigyn) 500mg – 100 tablet

Tinidazole Information

What is this drug used for?

• It is used to treat infections.

Possible side effects

Tinidazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Bad taste in your mouth.
• Upset stomach.

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• A burning, numbness, or tingling feeling that is not normal.
• Seizures.
• Vaginal itching or discharge.

Storage and Stability

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light.

Adverse Reactions

1% to 10%:

Central nervous system: Fatigue (≤2%), malaise (≤2%), dizziness (≤1%), headache (≤1%)

Dermatologic: Body odor (vaginal: >2%)

Endocrine & metabolic: Hypermenorrhea (>2%)

Gastrointestinal: Dysgeusia (bitter taste, metallic taste: 4% to 6%), nausea (3% to 5%), anorexia (2% to 3%), decreased appetite (>2%), flatulence (>2%), dyspepsia (≤2%), abdominal cramps (≤2%), epigastric distress (≤2%), vomiting (1% to 2%), constipation (≤1%)

Genitourinary: Vulvovaginal candidiasis (5%), dysuria (>2%), pelvic pain (>2%), urine abnormality (>2%), vulvovaginal disease (discomfort) (>2%)

Neuromuscular & skeletal: Weakness (1% to 2%)

Renal: Urinary tract infection (>2%)

Respiratory: Upper respiratory tract infection (>2%)

Frequency not defined:

Cardiovascular: Flushing, palpitations

Central nervous system: Ataxia, burning sensation, drowsiness, insomnia, peripheral neuropathy (transient; includes numbness and paresthesia), seizure, vertigo

Dermatologic: Diaphoresis, pruritus, skin rash, urticaria

Endocrine & metabolic: Increased thirst

Gastrointestinal: Abdominal pain, diarrhea, oral candidiasis, salivation, stomatitis, tongue discoloration, xerostomia

Genitourinary: Dark urine, vaginal discharge

Hematologic & oncologic: Leukopenia (transient), neutropenia (transient)

Hepatic: Increased serum transaminases

Hypersensitivity: Angioedema

Infection: Candidiasis (overgrowth)

Neuromuscular & skeletal: Arthralgia, arthritis, myalgia

Miscellaneous: Fever

<1%, postmarketing, and/or case reports: Bronchospasm, coma, confusion, depression, dyspnea, erythema multiforme, hairy tongue, hypersensitivity reaction (acute, severe), pharyngitis, Stevens-Johnson syndrome, thrombocytopenia (reversible)