Areta. 10 mg. 30 tablets

Areta. 10 mg. 30 tablets
€ 12.00
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Each tablet contains 10 mg lerkanidipinov hydrochloride as lerkanidipinov hydrochloride hemihydrate. This is equivalent to 9.4 mg of lercanidipine.
Each tablet contains 36.55 mg lactose monohydrate.

Areta. 10 mg. 30 tablets

 
 
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg lerkanidipinov hydrochloride as lerkanidipinov hydrochloride hemihydrate. This is equivalent to 9.4 mg of lercanidipine.
Each tablet contains 36.55 mg lactose monohydrate.

PHARMACEUTICAL FORM
Aretha 10 mg film-coated tablets
Yellow, round, biconvex, film-coated scored tablets.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

CLINICAL DATA
INDICATION:
Aretha is indicated for the treatment of mild to moderate essential hypertension.

DOSAGE AND METHOD OF ADMINISTRATION
Method of administration:
Oral administration.
The tablets should be swallowed with a sufficient amount of liquid / naprimen glass of water /
The recommended dose is 10 mg orally once daily, at least 15 minutes before eating / preferably before breakfast /. Depending on the individual response of the patient, the dose can be increased to 20 mg.

Use in the elderly
Although according to pharmacokinetic data and clinical experience do not need dose adjustment when initiating therapy in elderly patients need special attention.

Use in children
Aretha is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.

Administration to patients with impaired renal or hepatic function.
Caution should be used when initiating therapy in patients with mild to moderate renal and hepatic function. Although the usual recommended dose can be tolerated by these patients, an increase in dose to 20 mg daily should be done carefully. The antihypertensive effect may be enhanced in patients with hepatic impairment and consequently an adjustment of the dose.
Aretha is not recommended for use in patients with severe hepatic impairment or in patients with severe renal impairment.


CONTRAINDICATIONS:
- Hypersensitivity to the active substance, to any dihydropyridine or to any of the excipients
- Pregnancy and lactation
- Women of childbearing potential unless effective contraception is used
- Outflow of the left ventricle
- Untreated congestive heart failure
- Unstable angina pectoris
- Severe renal or hepatic impairment
- Within one month after myocardial infarction
- Concomitant use of:
= Strong inhibitors of CYP 3A4
= Cyclosporin
= Grapefruit Juice

Pregnancy and lactation
Data for lercanidipine showed no evidence of teratogenic effects in rats and rabbits and reproduction in rats is not affected. However, due to lack of clinical experience with lercanidipine in pregnancy and lactation and for teratogenic effects of other dihydropyridines in animals Aretha should not be used during pregnancy or in women of childbearing potential unless effective contraception is used. Due to the high lipophilicity of lercanidipine may be expected excreted in human milk. Therefore should not be administered to nursing women.

EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES
Clinical experience shows that it is unlikely to break lercanidipine patient's ability to drive and use machines. However, caution is required because sometimes may occur dizziness, asthenia, fatigue and rarely somnolence.

SIDE EFFECTS

Side effects occur in about 1.8% of treated patients.
The most common adverse events were headache, dizziness, peripheral edema, tachycardia, palpitations, flushing, each of which occurs in less than 1% of patients.
Investigations
Lercanidipine did not affect blood sugar or serum lipid levels.

Cardiac disorders:
Uncommon: tachycardia, palpitations
Rare: angina pectoris
Some dihydropyridines may lead to precordial pain or angina pectoris.
Very rare in patients with pre-existing angina pectoris may increase the frequency, duration or severity of these attacks. May be isolated cases of myocardial inforkt.

Nervous system disorder:
Uncommon: headache, dizziness
Rare: somnolence

Gastrointestinal disorders:
Rare: nausea, despepsiya, diarrhea, abdominal pain, vomiting

Renal and urinary disorders:
Rare: popiuriya

Skin and subcutaneous tissue disorders
Rare: rash

Musculo-skeletal and connective tissue disorders:
Rare: myalgia

Vascular disorders:
Uncommon: Flushing
Very rare: syncope

General disorders and administration site conditions:
Uncommon: peripheral edema
Rare: asthenia, fatigue

Spontaneously reported during post-marketing studies have reported the following side effects:

Investigations
Very rare: reversible increases in serum levels of hepatic transaminases

Gastrointestinal Disorders
Very rare: gingival hypertrophy

Renal and urinary disorders:
Very rare: frequent urination

Vascular disorders:
Very rare: hypotension

General disorders and administration site conditions:
Very rare: chest pain.

LIST OF OTHER INGREDIENTS:
Lactose monohydrate, pregelatinized maize starch, croscarmellose sodium, hypromellose, silica colloidal anhydrous, magnesium stearate

Aretha 10 mg tablets: film coating, hypromellose, macrogol 8000, titanium dioxide, talc, iron oxide yellow.
 
 
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