Fokusin capsules with modified release 0,4 mg, No. 90

Treatment of functional symptoms in benign prostatic hyperplasia.

The drug is prescribed at 400 mcg (1 capsule) per day.
The capsules are taken after the first meal with plenty of water. It is not recommended to chew the capsule.

Active ingredient: Tamsulosin hydrochloride 0.4 mg
Excipients: 30% dispersion of methacrylic acid-ethacrylate copolymer (1: 1), microcrystalline cellulose, dibutylsebakat, polysorbate 80, colloidal silicon dioxide, talc.
Capsule shell : azorubin, dye Patent blue V, gelatin.

Hypersensitivity to the components of the drug.
With care: chronic renal failure (decrease in creatinine clearance below 10 ml / min), arterial hypotension (including orthostatic), severe hepatic failure.

Trade name of the drug: FokusinЃ

International non-proprietary name:

Tamsulosin

Dosage form:

modified release capsules

COMPOSITION
Active ingredient: Tamsulosin hydrochloride 0.4 mg
Excipients: 30% dispersion of methacrylic acid-ethacrylate copolymer (1: 1), microcrystalline cellulose, dibutylsebacate, polysorbate 80, colloidal silicon dioxide, talc.
Capsule shell : azorubin, dye Patent blue V, gelatin.

DESCRIPTION
Hard gelatin capsules No. 1. Body and lid: dark blue, transparent.
Capsule content: almost white micropellets.

PHARMACOTHERAPEUTIC GROUP: alpha 1-adrenergic blocker

ATX code: G04CA02

PHARMACHOLOGIC EFFECT

Pharmacodynamics
Tamsulosin selectively and competitively blocks postsynaptic a1A-adrenergic receptors located in the smooth muscles of the prostate gland, bladder neck and prostatic urethra, as well as a1D-adrenergic receptors, mainly located in the body of the bladder. This leads to a decrease in the tone of the smooth muscles of the prostate gland, bladder neck and prostatic urethra and an improvement in detrusor function. This reduces the symptoms of obstruction and irritation associated with benign prostatic hyperplasia. As a rule, the therapeutic effect develops 2 weeks after the start of taking the drug, although in some patients, a decrease in the severity of symptoms is noted after taking the first dose.
The ability of tamsulosin to act on a1A-adrenergic receptors is 20 times higher than its ability to interact with a1B-adrenergic receptors, which are located in the smooth muscles of blood vessels. Due to this high selectivity, the drug does not cause any clinically significant decrease in systemic blood pressure (BP) in both hypertensive patients and patients with normal baseline blood pressure.

Pharmacokinetics
Absorption
After oral administration, tamsulosin is rapidly and almost completely absorbed from the gastrointestinal tract. The bioavailability of the drug is about 100%. After a single oral dose of the drug in 400 mg C max of the active substance in plasma obtained 6 hours.
Distribution
In the equilibrium state (after 5 days course doses) Cmax values (the active substance in blood plasma by 60-70% higher than the Cmax after a single dose . drug binding to plasma proteins - 99% Tamsulosin has a slight volume of distribution (about 0.2 l / kg)..
Metabolism
Tamsulosin does not undergo the 'first pass' effect and is slowly biotransformed in the liver with the formation of pharmacologically active metabolites that retain high selectivity for ?1A-adrenergic receptors. Most of the active substance is present in the blood unchanged.
Excretion
Tamsulosin is excreted by the kidneys, 9% of the dose is excreted unchanged.
T1 / 2 of tamsulosin with a single dose - 10 hours, after multiple doses - 13 hours, the final half-life is 22 hours.

INDICATIONS FOR USE
Treatment of functional symptoms in benign prostatic hyperplasia.

CONTRAINDICATIONS
Hypersensitivity to the components of the drug.
With care: chronic renal failure (decrease in creatinine clearance below 10 ml / min), arterial hypotension (including orthostatic), severe hepatic failure.

DOSAGE AND METHOD OF APPLICATION
The drug is prescribed at 400 mcg (1 capsule) per day.
The capsules are taken after the first meal with plenty of water. It is not recommended to chew the capsule.

SIDE EFFECTS
Rarely - headache, dizziness, asthenia, sleep disturbance (drowsiness or insomnia), retrograde ejaculation, decreased libido, back pain, rhinitis, nausea, vomiting, constipation or diarrhea.
In isolated cases, orthostatic hypotension, tachycardia, palpitations, chest pain.
In extremely rare cases - hypersensitivity reactions (skin rash, itching, angioedema).

OVERDOSE
There were no cases of acute drug overdose.
Symptoms: Theoretically, acute hypotension is possible.
Treatment: carry out cardiotropic therapy. If symptoms persist, volume replacement solutions or vasoconstrictors should be administered. To prevent further absorption of tamsulosin, gastric lavage, activated charcoal or an osmotic laxative may be used.

INTERACTION WITH OTHER DRUGS
Cimetidine increases plasma concentration, furosemide - decreases (no significant clinical significance). Diclofenac and indirect anticoagulants slightly increase the rate of elimination of tamsulosin.
The simultaneous use of tamsulosin with other alpha1-blockers can lead to a pronounced increase in the hypotensive effect.

SPECIAL INSTRUCTIONS
Tamsulosin should be used with caution in patients with a predisposition to orthostatic hypotension. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should be seated or laid down.
Before starting to use the drug, it is necessary to verify the diagnosis.
During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions.

FORM OF RELEASE
10 capsules in a blister made of PVC / PVDC / AI. 3, 9 or 10 blisters are placed in a cardboard box along with instructions for use.

STORAGE CONDITIONS
Does not require special storage conditions. Keep out of the reach of children.

SHELF LIFE
2 years.
Do not use after the date indicated on the package.

TERMS OF RELEASE FROM PHARMACIES
By prescription.