Olmesafe-HT 20/12.5 Tablet: Each film coated tablet contains Olmesartan Medoxomil BP 20 mg and Hydrochlorothiazide BP 12.5 mg.

BP

Angiotensin Receptor Blockers & diuretics

Treatment of essential hypertension. Olmesafe-HT is indicated in adult patients whose blood pressure is not adequately controlled on Olmesartan Medoxomil monotherapy.

Hypersensitivity to the active substances, to any of the excipients or to other sulfonamide-derived substances, severe renal impairment (creatinine clearance < 30 mL/min), refractory hypokalemia, hypercalcemia, hyponatremia and symptomatic hyperuricemia, severe hepatic impairment, cholestasis and biliary obstructive disorders.

Adults: Olmesafe HT is not for use as initial therapy, but in patients whose blood pressure is not adequately controlled by Olmesartan Medoxomil alone. Olmesafe-HT is administered once daily, with or without food.

Elderly (age 65 years or older): In elderly patients the same dosage of the combination is recommended as for adults.

Renal impairment: When Olmesartan Medoxomil and Hydrochlorothiazide is used in patients with mild to moderate renal impairment (creatinine clearance of 30-60 ml/min) periodic monitoring of renal function is advised.

Hepatic impairment: Olmesartan Medoxomil and Hydrochlorothiazide should be used with caution in patients with mild to moderate hepatic impairment. In patients with moderate hepatic impairment, an initial dose of 10 mg Olmesartan Medoxomil once daily is recommended and the maximum dose should not exceed 20 mg once daily.

The most commonly reported adverse reactions during treatment with Olmesartan Medoxomil and Hydrochlorothiazide are headache, dizziness and fatigue. Other common side effects are chest pain, fatigue, influenza-like symptoms, peripheral oedema. Hydrochlorothiazide may cause volume depletion which may lead to electrolyte imbalance.

Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of Olmesartan Medoxomil and Hydrochlorothiazide.

Use of Olmesartan Medoxomil and Hydrochlorothiazide and lithium in combination is not recommended. NSAIDs (i.e. acetylsalicylic acid (> 3 g/day), COX-2 inhibitors and non-selective NSAIDs) may reduce the antihypertensive effect of thiazide diuretics and angiotensin-II antagonists. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of angiotensin-II antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter.

Olmesafe-HT 20/12.5 Tablet: Each box contains 3x10’s tablets in alu-alu blister.

The safety and efficacy of Olmesartan Medoxomil and Hydrochlorothiazide in children and adolescents below 18 years has not been established. No data are available.

Given the effects of the individual components in this combination product on pregnancy, the use of Olmesartan Medoxomil and Hydrochlorothiazide is not recommended during the first trimester of pregnancy. The use of Olmesartan Medoxomil and Hydrochlorothiazide is contraindicated during the 2nd and 3rd trimester of pregnancy. Because no information is available regarding the use of Olmesartan Medoxomil and Hydrochlorothiazide during breast feeding, it is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant. Hydrochlorothiazide is excreted in human milk in small amounts. Thiazides in high doses causing intense diuresis can inhibit the milk production. The use of Olmesartan Medoxomil and Hydrochlorothiazide during breast feeding is not recommended. If Olmesartan Medoxomil and Hydrochlorothiazide is used during breast feeding, doses should be kept as low as possible.

Store in a cool and dry place, protected from light at 25 oC temperature. Keep all medicine out of the reach of children.