Aretha table. 10 mg

Aretha table. 10 mg
€ 18.00
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Each tablet contains 10 mg lerkanidipinov hydrochloride in the form of hydrochloride hemihydrate lerkanidipinov. This is equivalent to 9.4 mg lercanidipine.
Each tablet contains 36.55 mg of lactose monohydrate.

Aretha table. 10 mg
 

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 10 mg lerkanidipinov hydrochloride in the form of hydrochloride hemihydrate lerkanidipinov. This is equivalent to 9.4 mg lercanidipine.
Each tablet contains 36.55 mg of 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 ADMINISTRATION

 
Method of application:
Oral.
Tablets should be swallowed with some liquid / naprimen glass of water /
The recommended dose is 10 mg orally once a day at least 15 minutes before eating / preferably before breakfast /. Depending on individual patient response, the dose may be increased to 20 mg.
 
Use in the elderly
 
Although according to the 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 when initiating therapy in patients with mild to moderate renal or hepatic function. Although the usual recommended dose may be tolerated by these patients, increasing the dose to 20 mg daily must be approached with caution. 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
 Obstruction of left ventricular outlet
 Untreated congestive heart failure
 Unstable angina pectoris
Severe renal or hepatic impairment
Up to one month after myocardial infarction
 
 Concomitant use of:
  Strong inhibitors of CYP 3A4
Cyclosporine
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 in animals other dihydropyridines, 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 radiation in breast milk. Therefore, it should not be administered to nursing women

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

 
Clinical experience has shown that lercanidipine is unlikely to affect the patient's ability to drive and use machines. However, caution is required because sometimes occur dizziness, asthenia, fatigue and rarely somnolence.

SIDE EFFECTS

 
Adverse reactions occurring in approximately 1.8% of treated patients.
The most common side effects are 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, palpitation
Rare: Angina pectoris
Some dihydropyridines may lead to precordial pain or angina pectoris.
Very rare: In patients with pre-existing angina pectoris may experience increased frequency, duration or severity of these attacks. It 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
 
From spontaneous reports from post-marketing studies have reported the following side effects:
 
Investigations
 
Very rare: reversible increases in serum levels of liver transaminases
 
Gastrointestinal Disorders
 
Very rare: gingival hypertrophy
 
Renal and urinary disorders:
 
Very rare: urination
Vascular disorders:
Very rare: hypotension
 
General disorders and administration site conditions:
 
Very rare: chest pain.
 

LIST OF OTHER INGREDIENTS:

 
Lactose monohydrate, pregelatinized corn starch, croscarmellose sodium, hypromellose, silica colloidal anhydrous, magnesium stearate
Aretha 10 mg tablets: film-coated finish, hypromellose, macrogol 8000, titanium dioxide, talc, iron oxide yellow.
€ 18.00
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