Tamsulosin-Vertex, 0.4 mg capsules 30 pcs

Urinary disorders, Prostate Hyperplasia

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

Indications

Symptoms of damage to the lower urinary tract caused by benign prostatic hyperplasia (BHP).

Active ingredient

Tamsulosin

Composition

Active substance:

tamsulosin hydrochloride pellets 0.15% – 267 mg,

containing tamsulosin hydrochloride – 0.4 mg

Pellet auxiliary substances:

Sucrose – 143.36 mg,

starch – 95.58 mg,

ethylcellulose – 3.74 mg,

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

Composition of gelatin capsule:

Gelatin – 62.306465 mg

Cover Dyes:

Diamond Black – 0.0065 mg

Blue patent – 0.00715 mg

Quinoline yellow – 0.00871 mg

Iron oxide yellow – 0.071175 mg

Titanium dioxide – 1.3 mg

Base Dyes:

Titanium dioxide – 1.3 mg

Contraindications

Hypersensitivity to tamsulosin (including the development of angioedema caused by taking the drug) or to any excipient.

History of orthostatic hypotension (presence of orthostatic hypotension in the past).

Severe liver failure.

Tamsulosin is intended for use by men only.

Side Effects

During cataract removal, while taking tamsulosin, the pupil may become narrowed, known as iris constriction syndrome (IRIS). Adverse events classified by organs and systems are listed below in descending order of frequency: frequent (>1/100 1/1000 1/10000 <1/1000), very rare (<1/10000).

Cardiac disorders. Uncommon: tachycardia.

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

Disorders of the vascular system. Uncommon: orthostatic hypotension.

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

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

Disorders of the skin and subcutaneous tissue. Uncommon: rash, itching, urticaria. Rare: angioedema.

Reproductive system and mammary glands. Uncommon: ejaculation disorder. Rare: priapism.

General disorders and complications at the injection site. Uncommon: asthenia.

Interaction

When taken simultaneously with atenolol, enalapril, nifedipine and theophylline, no interactions were observed. When taken simultaneously with cimetidine, the concentration of tamsulosin in plasma increases, with furosemide it decreases, but remains within normal levels.

It was established that tamsulosin in in vitro studies of liver microsomal fractions (representing the metabolic system of enzymes associated with cytochrome P-450) does not interact with amitriptyline, salbutamol, glibenclamide and finasteride. Taking diclofenac and warfarin may increase the elimination of tamsulosin.

Concomitant use with other α1A-adrenergic receptor antagonists may help lower blood pressure.

Overdose

There are no reports of cases of overdose. However, theoretically, with 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, blood pressure and heart rate may return to normal. If there is no effect, substances that increase the volume of circulating blood and, if necessary, vasoconstrictors should be administered. Kidney function should be monitored and general restorative measures should be used. Dialysis in such cases is ineffective, since tamsulosin is very well absorbed from plasma proteins.

If a very large dose of the drug is taken, you can lavage the stomach and prescribe activated charcoal and an osmotic laxative.

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 30 ºС.

Shelf life

3 years

Manufacturer

Vertex, Russia