Eprosartan Tablets

Eprosartan contains the active substance eprosartan. Eprosartan belongs to a group of medicines known as "angiotensin II receptor inhibitors" and blocks the action of a substance called "angiotensin II". This substance causes the blood vessels to narrow, making it difficult for blood to pass through them, leading to increased blood pressure. By blocking this substance, the blood vessels relax and blood pressure decreases.

Eprosartan is an orally active, synthetic, non-tetrazole, non-biphenyl receptor blocker for angiotensin II.

Angiotensin II plays a very important role in the pathophysiology of hypertension. Angiotensin II selectively binds to the AT1 receptor in numerous tissues (eg, vascular smooth muscle, adrenal, kidney, and heart) and has important biological effects, such as vasoconstriction, sodium retention, and aldosterone release.

Eprosartan antagonized the effect of angiotensin II on blood pressure, renal blood flow, and aldosterone secretion in healthy volunteers. In hypertensive patients, similar control of blood pressure is achieved when eprosartan is administered as a single dose or in two doses. Blood pressure control is maintained uniformly and constantly for 24 hours. Suspension of eprosartan treatment does not cause a rapid increase in rebound blood pressure.

Eprosartan was evaluated in patients with mild or moderate hypertension (PAD 95 95 mm Hg and <115 mm Hg in a sitting position) and patients with severe hypertension (PAD 115 115 mm Hg and 125 125 mm Hg in a sitting position).

Eprosartan belongs to a group of medicines known as angiotensin II inhibitors. This medication is used to treat high blood pressure. Each coated tablet contains 600 mg eprosartan (as mesylate dihydrate). The other ingredients are lactose monohydrate, microcrystalline cellulose, gluten-free pregelatinized corn starch, crospovidone, magnesium stearate, hypromellose, titanium dioxide (E 171), macrogol 400, and polysorbate 80.

Always use this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist again.

The usual eprosartan dosage is one tablet a day, taken in the morning. Swallow the tablet with water. Try to take the tablets at the same time each day. It is important to continue taking the tablets until your doctor tells you to.

Use in children and adolescents

Children and adolescents should not take Eprosartan Pensa.

If you take more Eprosartan Actavis than you should:

If you accidentally take too many tablets, or if a child swallows a tablet, consult your doctor or go to the hospital emergency department.

If you forget to take a dose of Eprosartan Pensa

If you have forgotten to take a dose, take the next dose as soon as you remember, and continue your treatment as before. If you forget to take a dose one day, simply take the dose the next day at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Eprosartan Pensa

Do not stop taking Eprosartan Pensa yourself. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:

Allergic reactions (may affect less than 1 in 100 people)

If you experience an allergic reaction, stop taking the medicine, and see a doctor immediately. Signs may include the following:

• skin reactions such as a rash or hives with swelling (hives)
• swelling of the lips, face, throat, or tongue
• difficulty breathing
• swelling of the face or skin and mucous membrane (angioedema)
• Other possible side effects of Eprosartan Mylan Pharmaceuticals include the following:

The following section details the known eprosartan side effect and their respective frequency.

Very common (may affect more than 1 in 10 people)

• headache

Common (may affect up to 1 in 10 people)

• dizziness
• rash or itching (pruritus)
• nausea, vomiting, diarrhea
• weakness (asthenia)
• stuffy nose (rhinitis)

Uncommon (may affect up to 1 in 100 people)

• low blood pressure, including low blood pressure on rising. You may feel dizzy

Unknown frequency (cannot be estimated from the available data)

• kidney problems, including kidney failure
• joint pain (arthralgia)

Warnings and precautions

Liver disorders

In the case of mild or moderate hepatic impairment, eprosartan should be used with caution due to the limited experience available in this patient population.

Kidney disorders

In case of moderate or severe renal insufficiency (creatinine clearance <60 ml/min), the daily dose should not exceed 600 mg. Caution is recommended in patients with creatinine clearance <30 ml/min or in patients on dialysis.

Patients dependent on the renin-angiotensin-aldosterone system

Some patients whose kidney function depends on the continued inherent activity of the renin-angiotensin-aldosterone system (eg, patients with severe heart failure [NYHA classification: class IV], bilateral renal artery stenosis, or artery stenosis renal in a single kidney), have a certain risk of developing oliguria and/or progressive azotemia, and rarely acute renal failure, during treatment with an angiotensin-converting enzyme (ACE) inhibitor. Patients treated concomitantly with a diuretic are more likely to experience these events. There is insufficient therapeutic experience with angiotensin II receptor antagonists, such as eprosartan, to determine whether there is a similar risk of developing impaired renal function in these susceptible patients. In patients with renal insufficiency, renal function should be evaluated before starting treatment with eprosartan and periodically after starting treatment. If worsening renal function is observed during treatment, eprosartan should be re-evaluated.

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