IROVEL-H (AVALIDE)150 12.5MG – 50 tablet

Irbesartan and Hydrochlorothiazide Information

What is this drug used for?

• It is used to treat high blood pressure.
• It may be given to you for other reasons. Talk with the doctor.

Possible side effects

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

• Dizziness.
• Feeling tired or weak.

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.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
• Chest pain.
• Swelling.
• Any skin change.
• This drug can cause certain eye problems. If left untreated, this can lead to lasting eyesight loss. If eye problems happen, signs like change in eyesight or eye pain most often happen within hours to weeks of starting this drug. Call your doctor right away if you have these signs.

Medication Safety Issues

Storage and Stability

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Adverse Reactions

Reactions/percentages reported with combination product; also see individual agents.

1% to 10%:

Cardiovascular: Edema (3%), chest pain (2%), decreased blood pressure (excessive reduction in patients with uncomplicated hypertension: 1%), tachycardia (1%)

Central nervous system: Dizziness (8%; orthostatic: 1%), fatigue (6%)

Endocrine: Hypokalemia (≤8%)

Gastrointestinal: Nausea and vomiting (3%), dyspepsia (≤3%), heartburn (≤3%), abdominal pain (2%)

Genitourinary: Difficulty in micturition (2%)

Neuromuscular & skeletal: Musculoskeletal pain (6%)

Renal: Increased blood urea nitrogen (2%), increased serum creatinine (1%)

Miscellaneous: Flu-like symptoms (3%)

<1%, postmarketing, and/or case reports: Angioedema, hepatitis, hyperkalemia, tinnitus, urticaria