Floxin capsules 0.4 mg 30

Floxin capsules 0.4 mg 30

Product Code: 12415
Availability: In Stock

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active substance: 1 capsule contains 0.4 mg tamsulosin hydrochloride


granule core: microcrystalline cellulose, methacrylate copolymer (type a) dispersion 30% (containing Polysorbate 80 and sodium lauryl sulfate), triethyl citrate, talc

shell granules methacrylate copolymer (type A) dispersion 30% (containing Polysorbate 80 and sodium lauryl sulfate), triethyl citrate, talc

capsules (body composition): iron oxide red (E172), titanium dioxide (E 171), iron oxide yellow (E172), gelatin;

capsules (cap composition): Indigo-FD & C blue No. 2 (E 132), iron oxide black (E172), titanium dioxide (E 171), iron oxide yellow (E172), gelatin;

capsules (ink composition): shellac, iron oxide black (E172), propylene glycol, ammonium hydroxide.


Dosage form

Capsule, hard modified-release.


drug description

Agents used in benign prostatic hyperplasia. Antagonists of ?-adrenergic receptors. ATC code G04C A02.


Treatment of functional disorders of the lower urinary tract in benign prostatic hyperplasia (BPH).


hypersensitivity Reactions, including angioedema quince, to tamsulosin hydrochloride or to any of the excipients; orthostatic hypotension expressed hepatic insufficiency.

Method of application and doses

the recommended dose of 1 capsule daily after Breakfast. The capsule should be swallowed whole with milk or water (about 150 ml), standing or sitting. Capsule you can't chew, because it will interfere with the modified release of the active ingredient.

Side effects

The The The The The The The
From the nervous system
of the heart
on the vascular side
orthostatic hypotension
from the respiratory system, chest and mediastinal organs
From the digestive tract
Constipation, diarrhea, nausea, vomiting
in the skin and subcutaneous adipose tissue
Rash, itch, urticaria
Stevens - Johnson Syndrome
on the part of the genitals and mammary glands
retrograde ejaculation
common disorders

& nbsp;

in patients treated with tamsulosin during operations for cataract and glaucoma have also been cases of the development of the syndrome of narrow pupils, known as intraoperative iris syndrome atonic (ISAR) (see Section "Peculiarities of use").

in addition to the adverse effects of tamsulosin above, there has been a history of atrial fibrillation, arrhythmia, tachycardia and shortness of breath. Since these phenomena were described in spontaneous messages received during the post-registration period, it is impossible to establish with full confidence their frequency and communication with tamsulosin.


acute overdose of tamsulosin hydrochloride at a dose of 5 mg was Reported. the patient had acute arterial hypotension (systolic blood pressure - 70 mm Hg). St.), Vomiting and diarrhea, for which he was given infusion therapy, and on the same day he was discharged from hospital.

in the case of acute hypotension, which occurred after an overdose, measures should be taken to support blood circulation. To normalize blood pressure and heart rate of the patient should be placed in a horizontal position. If this measure does not help, it is recommended to use plasma substitutes and, if necessary, vasoconstrictors. Kidney function should be monitored and maintenance therapy should be carried out. The benefits of hemodialysis are unlikely, since tamsulosin is largely associated with proteins blood plasma.

measures aimed at preventing suction, such as vomiting, will help. With a significant overdose, it is necessary to flush the stomach, as well as take activated charcoal and an osmotic laxative agent, such as sodium sulfate. 

pregnancy and lactation

the Preparation is used only by men.



the Drug is prescribed to adults.

application Features

During surgery for cataracts and glaucoma in some patients receiving or previously taking tamsulosin, was observed "intraoperative iris syndrome atonic (ISAR)", the variant syndrome of narrow pupils. ISAR may increase procedural complications during the operation. Patients preparing for surgery for cataracts and glaucoma are not recommended to start tamsulosin therapy.

in some cases, tamsulosin should be discontinued 1-2 weeks prior to cataract and glaucoma surgery, but the expediency of discontinuation as well as duration of withdrawal prior to surgery has not yet been fully established.

to avoid ISAR, which may occur during cataract and glaucoma surgery, surgeons and ophthalmologists should find out during the preoperative evaluation whether the patient did not use tamsulosin before surgery or whether he continues to use this drug.

As with other blockers of the ?1-adrenergic receptors, tamsulosin can cause in some patients, lowering blood pressure, in rare cases, leads to fainting. At the first signs of orthostatic hypotension (dizziness, weakness), the patient must sit down or lie down until the symptoms disappear.

treatment with tamsulosin should be preceded by examination of the patient in order to exclude any other disease occurring with complaints similar to those in benign prostatic hyperplasia. Treatment should be preceded by rectal finger prostate examination and measurement of prostate specific antigen (PSA) levels, which are repeated regularly during treatment.

in severe renal failure (creatinine clearance


Ability to influence the reaction rate when driving motor transport or operating other mechanisms

study of the effect of tamsulosin on the ability to drive vehicles or work with other mechanisms has not been conducted. However, patients should be aware that as a result of the use of this drug may occur dizziness, fainting.

Interaction with other medicinal products and other forms of interaction.

the study of tamsulosin interaction with other drugs was conducted only in adults.

with the simultaneous use of tamsulosin hydrochloride with atenolol, enalapril or theophylline drug interaction was not noted. Concomitant use with cimetidine increases, and with furosemide reduces the concentration of tamsulosin in plasma, but since these levels remain within normal limits, in a special correction of tamsulosin dose is not necessary.

in studiesin vitrodiazepam, propranolol, trichloromethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not affect the free fraction of tamsulosin in human blood plasma. Likewise, tamsulosin does not change the level of the free fractions of diazepam, propanolol, trichlormethiazide and chlormadinone in human blood plasma.

in studiesin vitroon the microsomal fraction of the liver (which facilitates the study of the enzyme system of cytochrome p 450, which takes part in the metabolism of drugs) at the level of hepatic metabolism has not been confirmed nor the interaction with amitriptyline, salbutamol, glibenclamide and finasteride. However, diclofenac and warfarin may increase the elimination rate of tamsulosin.

the Simultaneous application of tamsulosin with other ?1adrenergic receptors may enhance hypotensive effect.

while the use of paroxetine, a strong inhibitor CYP 2D6, grow withmaxand AUC tamsulosin 1,3 and 1,6 times respectively, but this increase is not considered clinically significant. Simultaneous use with strong inhibitors of CYP ZA4 can increase the effect of tamsulosin. At simultaneous application with ketoconazole (a known strong inhibitor of CYP ZA4) is induced by the increase in Cmaxand AUC of tamsulosin with a factor of 2.8 and 2.2, respectively. Tamsulosin hydrochloride should not be administered in combination with strong SURZA4 inhibitors in patients with phenotype, which is characterized by a low level of CYP2D6 metabolism.


Pharmacological properties


Tamsulosin selectively and effectively binds to postsynaptic ?1A -adrenoreceptors, in particular, adrenoreceptors of subtypes ?1Aand ?1D.this leads to a decrease in the tone of the smooth muscles of the prostate gland, the urethra.

Tamsulosin increases the maximum volumetric rate of urination. By relaxing the smooth muscles of the prostate and urinary tract, it reduces obstruction of the urinary tract and thus facilitates urination. It also improves reservoir function, which is often disturbed due to bladder instability. The effectiveness of tamsulosin tank function and urination function are preserved in the case of its long-term use. Thus, it significantly reduces the need for surgery or catheterization. Blockers of the ?1-adrenergic receptors can reduce blood pressure by reducing peripheral vascular resistance. There was no clinically significant decrease in arterial pressure in tamsulosin studies.



.Tamsulosin is absorbed in the intestine almost completely. In the case of tamsulosin immediately after meals, its absorption decreases. To tamsulosin all the time absorbed about the same extent, it must be used at the same time. The pharmacokinetic parameters of tamsulosin vary in direct proportion to the dose. After a one-time reception on a full stomach tamsulosin reaches a maximum concentration in blood plasma through 6:00; in equilibrium, occurs on the 5th day of treatment, the value of Cmaxabout two-thirds higher than the value of Cmaxafter taking a single dose.

Distribution.in humans, tamsulosin is associated with blood plasma proteins at 99%. The volume of distribution is insignificant (about 0.2 l/kg).

Metabolism.the first time tamsulosin passes through the liver, it is metabolized only in a small amount. In General, its metabolism is slow. In the blood plasma of tamsulosin is present mainly in the form of unchanged active substance. Tamsulosin is metabolized in the liver. According to studies on animals, and tamsulosin is not an inducer of isoenzymes of cytochrome. None of the metabolites of tamsulosin has a higher activity than the original compound.

Output.Tamsulosin and its metabolites are excreted primarily in the urine; approximately 9% of the dose is excreted in the form of unchanged active substance. After a single application of tamsulosin on the full stomach, its half-life is about 10: 00, and after reaching an equilibrium state - about 13 hours.

Basic physical and chemical properties

hard gelatin capsule with orange body and lid olive green. At the apex of the body and cover caused by a single black line. The cap is printed in black ink code "TSL 0.4". The capsule is filled with granules of white or almost white.


shelf Life

3 years. Do not use after the expiry date. 

no Special storage conditions are required. Store in the original package.



10 capsules in blister, 3 blisters in a cardboard box.


Category vacation

According to the recipe.


The Applicant

Menarini International Opera Houses Luxembourg S. A.

Location.1, Avenue de La Gare, L-1611 Luxembourg, Luxembourg.


Menarini International Operations Luxembourg SA

Location, 1, Avenue de la Gare, L-1611, Luxembourg.



production" in bulk", serial control:

Rottendorf Pharma GmbH, Germany.

Location.Osterfelder Strasse 51-61, 59320 Ennigerloh, Germany.

 The "in bulk" manufacture, batch control: Rottendorf Pharma GmbH, Germany

Location. Ostenfelder Strasse 51-61, 59320 Ennigerloh, Germany

"in bulk" Production, packaging, series inspection:

Tamar A. V. E. Anthoussa Plant, Greece

Location.Anthoussa Avenue 7, Anthoussa Attiki, 153 44, Greece.

The" in bulk " manufacture, packing, batch control:Famar AVE Anthoussa Plant, GreeceLocation.Anthoussa Avenue 7, Anthoussa Attiki, 153 44, Greece.

Hispania of Sinton, S. L., Spain.

Location.test Site Industrial Les Salines, Carrer Castello, 1, 08830 Sant Boi where Llobregat (Barcelona), Spain.

Synthon Hispania SL, Spain

Location.Poligono Industrial Les Salines, Carrer Castello 1, 08830 Sant Boi de Llobregat (Barcelona), Spain.

Packaging, inspection and production:

Menarini - Von Heyden GmbH, Germany.

Location.Leipziger Strasse 7-13, 01097 Dresden, Germany.

Packing, batch control, batch release:Menarini-Von Heyden GmbH, Germany

Location.Leipzig Strasse 7-13, 01097 Dresden, Germany

& nbsp;


Flosin capsules 0.4 mg No. 30 is a complex drug that reduces the tone of the smooth muscle layer in the prostate gland, as well as in the urinary tract. Tamsulosin is the main active ingredient of the drug. The component selectively blocks adrenoreceptors, which helps to reduce tone in smooth muscles.


the Drug is prescribed in the treatment of:

  • prostatic Hyperplasia (benign).
  • The
  • of the Lower urinary tract.

as a result of taking the drug improves urine outflow, relieves spasms from the smooth muscles of the urinary canal and prostate gland. In addition, the patency of the urinary tract is restored. The composition of the drug include: hydrochloride tamsulosin, microcrystalline cellulose, ethylacrylate, red iron oxide and Indigo Carmine. The therapeutic effect of the remedy occurs after the first use of the tablet after 6 hours.

Dosage and mode of use

the Drug is designed for oral administration. Men are advised to use 1 capsule once a day. Medication is advisable to drink after the first eating, do not chew.the Medicine is not intended to treat women, children and adolescents.

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