Felodip p / o prolonged-release tablets 10mg, No. 30

• Arterial hypertension

• Stable angina (including Prinzmetal's angina)

The drug is best taken orally in the morning, before meals or after a light breakfast.
Film-coated tablets must not be bitten, divided or crushed.
Arterial hypertension
Adults (including the elderly): The
dosage is always determined individually. Therapy begins with a dose of 5 mg once a day. If necessary, the dosage can be increased; the usual maintenance dose is 5-10 mg once a day. To determine the individual dose, it is best to use tablets containing 2.5 mg of felodipine. In the elderly or patients with impaired liver function, the recommended starting dosage is 2.5 mg once a day.
Stable angina
Adults:
The dosage is always determined individually. Treatment begins with a dose of 5 mg once a day, if necessary, you can increase the dose to 10 mg once a day. The maximum daily dose is 20 mg once a day.
FELODIP can be used in combination with beta-blockers, angiotensin-converting enzyme (ACE) inhibitors or diuretics. Combination therapy usually enhances the antihypertensive effect of the drug. It is necessary to beware of the development of arterial hypotension. In patients with severely impaired liver function, the therapeutic dose should be reduced. In patients with impaired renal function, the pharmacokinetics of the drug does not significantly change.

Active substance:

felodipine - 10 mg;

Excipients :

Lactose monohydrate, microcrystalline cellulose, hypromellose, povidone, propyl gallate, magnesium stearate, colloidal anhydrous silicon, iron oxide yellow, iron oxide red, titanium dioxide, talc, propylene glycol.

• Hypersensitivity to felodipine and other dihydropyridine derivatives

• Unstable angina

• Acute myocardial infarction and within one month after myocardial infarction

• Cardiogenic shock

• Clinically significant aortic stenosis

• Pregnancy and lactation

• Heart failure in the stage of decompensation

• Severe arterial hypotension

• Age under 18 years of age (efficacy and safety have not been established)

With caution: hepatic and / or renal failure.

Trade name of the drug : FELODIP

International non-proprietary name : Felodipine

Dosage form : tablets of prolonged action, film-coated

Composition :
1 tablet of prolonged action, coated, contains:
Active substance :
FELODIP 2.5 mg
Contains active substance felodipine 2.5 mg.
FELODIP 5 mg The
active substance felodipine 5 mg is contained .
FELODIP 10 mg The
active substance Felodipine 10 mg is contained .
Excipients : Lactose monohydrate, microcrystalline cellulose, hypromellose, povidone, propyl gallate, magnesium stearate, colloidal anhydrous silicon, iron oxide yellow, iron oxide red, titanium dioxide, talc, propylene glycol.

Description :
FELODIP 2.5 mg : round, coated, lentil-shaped tablet, yellow, odorless, designated by the code 2.5.
FELODIP 5 mg : round, lentil-shaped film- coated tablet, light pink, odorless, denoted by code 5.
FELODIP 10 mg : rounded, lentil-shaped film- coated tablet, red-brown, odorless, denoted by code 10.

Pharmacotherapeutic group : blocker of 'slow' calcium channels.

Pharmacological properties

Pharmacodynamics
FELODIP belongs to the blockers of 'slow' calcium channels of the dihydropyridine series. It has a hypotensive, antianginal effect. Reduces blood pressure (BP) by reducing peripheral vascular resistance. It has a dose-dependent anti-ischemic effect. Reduces the size of myocardial infarction, protects against complications of reperfusion. Has practically no negative inotropic effect, has a minimal effect on the cardiac conduction system.

Pharmacokinetics
Absorption and distribution
Delayed release of felodipine from coated tablets leads to an extension of the absorption phase of the drug and ensures a uniform concentration of felodipine in blood plasma for 24 hours. Felodipine is almost completely absorbed in the gastrointestinal tract. The bioavailability of the drug does not depend on the dose within the therapeutic interval and is approximately 15%. 99% of felodipine binds to blood plasma proteins, primarily albumin.
Metabolism and excretion
Felodipine is completely metabolized in the liver, and all of its metabolites are inactive. The half-life of felodipine is 25 hours. With prolonged use, cumulation of felodipine does not occur.
Pharmacokinetics in special patient groups
In elderly patients and in cases of impaired liver function, the concentration of felodipine in the blood plasma is higher than in young patients. Pharmacokinetic parameters of felodipine do not change in patients with impaired renal function, including during hemodialysis. About 70% of the dose taken is excreted in the urine, and the rest in the feces in the form of metabolites. Less than 0.5% of the dose is excreted unchanged in the urine. Felodipine crosses the blood-brain barrier into the placenta and is excreted in breast milk.

Indications for use

• Arterial hypertension

• Stable angina (including Prinzmetal's angina)

Contraindications

• Hypersensitivity to felodipine and other dihydropyridine derivatives

• Unstable angina

• Acute myocardial infarction and within one month after myocardial infarction

• Cardiogenic shock

• Clinically significant aortic stenosis

• Pregnancy and lactation

• Heart failure in the stage of decompensation

• Severe arterial hypotension

• Age under 18 years of age (efficacy and safety have not been established)

With caution: hepatic and / or renal failure.

Method of administration and dosage
The drug is best taken orally in the morning, before meals or after a light breakfast.
Film-coated tablets must not be bitten, divided or crushed.
Arterial hypertension
Adults (including the elderly): The
dosage is always determined individually. Therapy begins with a dose of 5 mg once a day. If necessary, the dosage can be increased; the usual maintenance dose is 5-10 mg once a day. To determine the individual dose, it is best to use tablets containing 2.5 mg of felodipine. In the elderly or patients with impaired liver function, the recommended starting dosage is 2.5 mg once a day.
Stable angina
Adults:
The dosage is always determined individually. Treatment begins with a dose of 5 mg once a day, if necessary, you can increase the dose to 10 mg once a day. The maximum daily dose is 20 mg once a day.
FELODIP can be used in combination with beta-blockers, angiotensin-converting enzyme (ACE) inhibitors or diuretics. Combination therapy usually enhances the antihypertensive effect of the drug. It is necessary to beware of the development of arterial hypotension. In patients with severely impaired liver function, the therapeutic dose should be reduced. In patients with impaired renal function, the pharmacokinetics of the drug does not significantly change.

Side effects
As with other slow calcium channel blockers, the drug may cause facial flushing, headache, palpitations, dizziness and fatigue. These reactions are reversible and most often appear at the beginning of treatment or with an increase in the dose of the drug. Also, depending on the dose, peripheral edema may appear, which is a consequence of precapillary vasodilation. Patients with gum disease or periodontitis may experience mild swelling of the gums. This can be prevented by maintaining good oral hygiene.
In some cases:
From the skin : rarely - urticaria and itching. In isolated cases, photosensitization reactions;
From the musculoskeletal system: in isolated cases - arthralgia, myalgia; From the side of the central and peripheral nervous system: headache, dizziness. In rare cases, paresthesia;
From the side of the digestive tract : rarely - nausea, gingival hyperplasia; increased activity of 'liver' enzymes.
From the side of the cardiovascular system : rarely tachycardia, palpitations, peripheral edema;
others : rarely fatigue, in isolated cases - hypersensitivity reactions, for example, angioedema.

Overdose
Symptoms: marked decrease in blood pressure, bradycardia. Treatment: symptomatic therapy is performed. With a pronounced decrease in blood pressure, the patient should be given a horizontal position, his legs should be raised. With the development of bradycardia, intravenous administration of atropine in a dose of 0.5-1 mg is indicated. If this is not enough, it is necessary to increase the blood plasma volume by infusion of a solution of dextrose (glucose), sodium chloride or dextran. Symptomatic drugs with a predominant effect on alpha-adrenergic receptors are prescribed if the above measures are ineffective.

Interaction with other medicinal products
Felodipine increases the concentration of digoxin in the blood plasma, however, no change in the dosage of felodipine is required.
Inhibitors of cytochrome P 450 (for example, cimetidine, erythromycin, intraconazole, ketoconazole) slow down the metabolism of felodipine in the liver, increasing the concentration of the drug in the blood plasma.
Microsomal enzyme inducers (phenytoin, carbazepine, rifampicin, barbiturates) reduce the concentration of felodipine in blood plasma.
Non-steroidal anti-inflammatory drugs do not weaken the hypotensive effect of felodipine.
The high degree of binding of felodipine to proteins does not affect the binding of the free fraction of other drugs (for example, warfarin). Do not use FELODIP simultaneously with grapefruit juice due to the flavonoid in it, which increases the bioavailability of felodipine. Beta-blockers, verapamil, tricyclic antidepressants and diuretics enhance the hypotensive effect of FELODIP.

SPECIAL INSTRUCTIONS
The drug FELODIP, as well as other vasodilators, can in rare cases cause significant arterial hypotension, which in a number of predisposed patients can lead to the development of myocardial ischemia. Currently, there is no data on the feasibility of using the drug as a secondary prevention of myocardial infarction. FELODIP is effective and well tolerated by patients regardless of gender and age, as well as by patients with concomitant diseases such as bronchial asthma and other lung diseases; impaired renal function; diabetes; gout; hyperlipidemia; Raynaud's syndrome, and also after lung transplantation. FELODIP has no effect on blood glucose concentration and lipid profile. Influence on the ability to drive vehicles and control mechanisms: patients,in whom weakness, dizziness is observed during treatment with felodipine, you should refuse to drive vehicles and work that requires increased attention and concentration.

Release form
Tablets of prolonged action, coated, 2.5 each; 5 and 10 mg.
10 tablets in blister A1-PVC / PVDC / PE. 3 or 10 blisters are placed in a cardboard box along with instructions for use.

Storage
conditions Keep out of reach of children.

Storage conditions
At temperatures from 10 ? C to 25 ? C in a dark place.

Shelf life is
4 years.
Do not use after the date printed on the package

Terms of dispensing from pharmacies
Prescription.