Tamsulosin-Vertex, 0.4 mg capsules 30 pcs

Urinary disorders, Prostate Hyperplasia

Symptoms of lower urinary tract involvement due to benign prostatic hyperplasia (BPH).

Active ingredient

Composition

Active ingredient:

tamsulosin hydrochloride pellets 0.15% – 267 mg,

containing tamsulosin hydrochloride – 0.4 mg

Pellet excipients:

sucrose – 143.36 mg,

starch – 95.58 mg,

ethylcellulose – 3.74 mg,

p> hypromellose – 2.56 mg,

povidone K-30 – 1.5 mg,

copovidone (plasdon S-630) – 2.54 mg,

hypromellose phthalate – 10.4 mg,

cetyl alcohol – 1.0 mg,

diethyl phthalate – 0.35 mg,

Talc – 5.47 mg

The composition of the gelatin capsule:

Gelatin – 62.306465 mg

Caps Dyes:

Brilliant Black – 0.0065 mg

Patent Blue – 0.00715 mg

Quinoline Yellow – 0.00871 mg

/p>

Iron oxide yellow – 0.071175 mg

Titanium dioxide – 1.3 mg

Base Dyes:

Titanium dioxide – 1.3 mg

How to take, the dosage

One capsule daily after breakfast or first meal.

The capsule should be swallowed without biting and with a glass of water while standing or sitting (but not lying down).

The capsule must not be crushed as this may interfere with the release of the long acting active ingredient.

Interaction

In concomitant use with atenolol, enalapril, nifedipine and theophylline no interactions have been observed. When concomitant administration with cimetidine plasma concentration of tamsulosin increases, with furosemide decreases, but remains within normal limits.

Tamsulosin has been found not to interact with amitriptyline, salbutamol, glibenclamide and finasteride in invitro studies of liver microsomal fractions (representing the enzyme metabolism system associated with cytochrome P-450). Administration of diclofenac and warfarin may increase the excretion of tamsulosin.

Concomitant use with other α1A-adrenoreceptor antagonists may contribute to lower blood pressure.

Contraindications

Hypersensitivity to tamsulosin (including the development of angioedema due to the drug) or to any excipient.

A history of orthostatic hypotension (history of orthostatic hypotension).

Severe hepatic insufficiency.

Tamsulosin is intended to be taken only by men.

Side effects

Pupil constriction, known as IRIS, may occur during cataract extraction while taking tamsulosin. The adverse events, classified by organ and system, are listed below in descending order of frequency: frequent ( >1/100 < 1/10), infrequent ( >1/1000 < 1/100), rare ( >1/10,000 < 1/1000), very rare ( < 1/10,000).

Cardiac disorders. Infrequent: tachycardia.

Nervous system disorders. Frequent: dizziness. Infrequent: headache. Rare: fainting.

Vascular system disorders. Infrequent: orthostatic hypotension.

Disorders of the respiratory system and mediastinum. Infrequent: rhinitis.

Gastrointestinal disorders. Infrequent: constipation, diarrhea, nausea, vomiting.

Skin and subcutaneous tissue disorders. Infrequent: rash, itching, urticaria. Rare: angioedema.

Reproductive system and mammary glands. Infrequent: violation of ejaculation. Rare: priapism.

General disorders and complications by site of administration. Infrequent:asthenia.

Overdose

There are no reported cases of overdose. However, in theory, in an overdose, a sharp decrease in blood pressure is possible, in which case therapy aimed at maintaining cardiovascular function is necessary.

If the patient is laid down, the blood pressure and heart rate may normalize. If there is no effect, substances that increase circulating blood volume and, if necessary, vasoconstrictors should be administered. Renal function should be monitored and general restorative measures used. Dialysis is ineffective in such cases, since tamsulosin is very well absorbed with plasma proteins.

If a very large dose of the drug is taken, the stomach may be flushed and activated charcoal and an osmotic laxative prescribed.

Similarities