Tamsulosin (Tablets, Capsules) Instructions for Use

Instructions
Dosage forms

ATC Code

G04CA02 (Tamsulosin)

Active Substance

Tamsulosin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug used for urination disorders associated with benign prostatic hyperplasia. Alpha₁-adrenergic blocker

Pharmacotherapeutic Group

Drugs used in urology. Drugs for the treatment of benign prostatic hyperplasia. Alpha-adrenergic blockers.

Pharmacological Action

Alpha₁-adrenergic receptor blocker; an agent for the symptomatic treatment of benign prostatic hyperplasia.

It selectively blocks postsynaptic alpha_1A-adrenergic receptors of the smooth muscles of the prostate gland, bladder neck, and prostatic part of the urethra. As a result, the tone of the smooth muscles of these structures decreases, facilitating urine outflow. Simultaneously, the symptoms of obstruction and irritation associated with benign prostatic hyperplasia are reduced. The therapeutic effect appears approximately 2 weeks after the start of treatment.

Tamsulosin has a significantly lower ability to block alpha_1B-adrenergic receptors of vascular smooth muscles, therefore its effect on systemic blood pressure is insignificant.

Pharmacokinetics

After oral administration, Tamsulosin is rapidly and almost completely absorbed from the gastrointestinal tract. After a single oral dose of 400 mcg, the C_max of the active substance in plasma is reached after 6 hours.

Plasma protein binding is 99%. The V_d is insignificant and amounts to 0.2 l/kg.

Tamsulosin is slowly metabolized in the liver to form pharmacologically active metabolites that retain high selectivity for alpha_1A-adrenergic receptors. Most of the active substance is present in the blood unchanged.

The T_1/2 of tamsulosin after a single dose is 10 hours, the terminal T_1/2 is 22 hours. It is excreted by the kidneys, 9% unchanged.

Indications

Treatment of dysuric disorders in benign prostatic hyperplasia.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
N40	Hyperplasia of prostate
R30.0	Dysuria

ICD-11 code	Indication
GA90	Hyperplasia of prostate
MF50.7	Dysuria

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Take one 400 mcg tablet or capsuleonce daily.

Administer the dose at the same time each day, approximately 30 minutes after the same meal.

Swallow the tablet or capsule whole; do not crush, chew, or open.

The therapeutic effect typically appears after 2 to 4 weeks of continuous treatment.

Do not exceed the recommended daily dose of 400 mcg.

If a dose is missed, take it as soon as remembered on the same day. If a full day has passed, skip the missed dose and continue the regular schedule; do not double the dose.

No dosage adjustment is required for patients with mild to moderate renal impairment.

This medication is contraindicated in patients with severe hepatic insufficiency.

Inform your surgeon and ophthalmologist about tamsulosin use prior to any surgery, especially for cataract or glaucoma.

Adverse Reactions

From the cardiovascular system palpitations, atrial fibrillation, arrhythmia, tachycardia, dyspnea, orthostatic hypotension.

From the central nervous system headache, dizziness, syncope.

From the digestive system: constipation, diarrhea, nausea, vomiting.

From the skin and subcutaneous tissues: skin rash, skin itching, urticaria, angioedema, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis.

From the reproductive system ejaculation disorders, priapism.

Other rhinitis, asthenia. Cases of intraoperative floppy iris syndrome (IFIS) during cataract and glaucoma surgery in patients taking Tamsulosin have been reported.

Contraindications

Hypersensitivity to tamsulosin; orthostatic hypotension (including history), severe hepatic insufficiency; children and adolescents under 18 years of age.

With caution severe renal failure (creatinine clearance less than 10 ml/min); arterial hypotension.

Use in Pregnancy and Lactation

Not applicable.

Use in Hepatic Impairment

Contraindicated in severe hepatic insufficiency.

Use in Renal Impairment

Should be used with caution in severe renal failure (creatinine clearance < 10 ml/min).

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

Before starting therapy with tamsulosin, the patient should be examined for the presence of other diseases that may cause the same symptoms as benign prostatic hyperplasia. Before starting treatment and regularly during therapy, a digital rectal examination and, if required, determination of prostate-specific antigen should be performed. In patients with impaired renal function, no dosage adjustment is required.

There have been reports of cases of prolonged erection and priapism during therapy with alpha₁-adrenergic blockers. If an erection persists for more than 4 hours, immediate medical attention should be sought. If therapy for priapism is not carried out immediately, it can lead to damage to the penile tissues and irreversible loss of potency.

In some patients taking or having previously taken Tamsulosin, during surgical interventions for cataract or glaucoma, the development of intraoperative floppy iris syndrome (IFIS) is possible, which can lead to complications during surgery or in the postoperative period. It is not recommended to start tamsulosin therapy in patients who are scheduled for cataract or glaucoma surgery. During the preoperative examination of patients, the surgeon and ophthalmologist should take into account whether the patient is taking or has taken Tamsulosin. This is necessary to prepare for the possible development of intraoperative floppy iris syndrome during surgery.

Effect on the ability to drive vehicles and mechanisms

During the use of tamsulosin, patients should exercise caution when driving vehicles and mechanisms, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

With simultaneous use of tamsulosin with cimetidine, some increase in the concentration of tamsulosin in blood plasma was noted, and with furosemide – a decrease in concentration; with other alpha₁-adrenergic blockers – a pronounced enhancement of the hypotensive effect is possible.

Diclofenac and indirect anticoagulants somewhat increase the elimination rate of tamsulosin.

Diazepam, propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not change the free fraction of tamsulosin in human plasma in vitro. In turn, Tamsulosin also does not change the free fractions of diazepam, propranolol, trichlormethiazide and chlormadinone.

In vitro studies, no interaction at the level of hepatic metabolism with amitriptyline, salbutamol, glibenclamide and finasteride was found.

Other alpha₁-adrenergic blockers, acetylcholinesterase inhibitors, alprostadil, anesthetics, diuretics, levodopa, antidepressants, beta-adrenergic blockers, slow calcium channel blockers, muscle relaxants, nitrates and ethanol may increase the severity of the hypotensive effect.

Concomitant administration of tamsulosin with potent inhibitors of the CYP3A4 isoenzyme may lead to an increase in the concentration of tamsulosin. Concomitant administration with ketoconazole led to an increase in the AUC and C_max of tamsulosin by 2.8 and 2.2 times, respectively.

Tamsulosin should not be used in combination with potent CYP3A4 inhibitors in patients with impaired metabolism of the CYP2D6 isoenzyme. Tamsulosin should be used with caution in combination with potent and moderate CYP3A4 inhibitors.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Tamsulosin [Jivdhara Pharma, Private Limited (India)]
Modified-release capsules 0.4 mg: 10, 30, 60, or 90 pcs.

Marketing Authorization Holder

Jivdhara Pharma, Private Limited (India)

Manufactured By

Rozlex Pharm LLC (Russia)

NPC Scan Biotek, LLC (Russia)

Dosage Form

Tamsulosin

Modified-release capsules 0.4 mg: 10, 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Modified-release capsules hard gelatin, size No. 2, with a transparent colorless body and a transparent yellow cap; the contents of the capsules are spherical granules (pellets) of white or almost white color.

	1 caps.
Tamsulosin substance-pellets	300 mg,
Equivalent to tamsulosin hydrochloride content	0.4 mg

Excipients : hypromellose – 1.91 mg, dibutyl phthalate – 0.21 mg, starch – 54.9 mg, macrogol (polyethylene glycol) – 6.21 mg, methacrylic acid and ethyl acrylate copolymer (1:1) – 62.06 mg, sodium lauryl sulfate – 0.2 mg, sucrose – 164.8 mg, talc -7.54 mg, ethylcellulose – 1.77 mg.

Pellet shell composition: magnesium stearate – 1.5 mg, talc – 1.5 mg.
Cap cap composition gelatin – up to 100%, purified water – 14.5%, quinoline yellow dye (E104) – 0.25%.
Capsule body composition gelatin – up to 100%, purified water – 14.5%.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (9) – cardboard packs.

Tamsulosin [Aspectus Pharma LLC (Russia)]
Enteric-coated extended-release capsules 0.4 mg: 10, 15, 30, 60, or 90 pcs.

Marketing Authorization Holder

Aspectus Pharma LLC (Russia)

Manufactured By

Synthon Hispania, S.L. (Spain)

Packaging and Quality Control Release

ASPECTUS PHARMA, LLC (Russia)

Dosage Form

Tamsulosin

Enteric-coated extended-release capsules 0.4 mg: 10, 15, 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated extended-release capsules hard gelatin No. 2EL, with an orange body and a grey-green cap; capsule contents: pellets from white to almost white.

	1 caps.
Tamsulosin hydrochloride	0.4 mg

Excipients : microcrystalline cellulose (type 101) – 96.574 mg, methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion – 5.77 mg (contains polysorbate 80 – 2.8%, sodium lauryl sulfate – 0.7%), triethyl citrate – 0.577 mg, talc – 5.77 mg.

Pellet shell: methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion – 7.274 mg (contains polysorbate 80 – 2.8%, sodium lauryl sulfate – 0.7%), talc – 2.909 mg, triethyl citrate – 0.726 mg.
Capsule body : iron oxide red dye (E172) – 0.0239 mg, titanium dioxide (E171) – 0.53 mg, iron oxide yellow dye (E172) – 0.258 mg, gelatin – 38.938 mg.
Capsule cap : indigo carmine FD&C Blue 2 (E132) – 0.00152 mg, iron oxide black dye (E172) – 0.0107 mg, titanium dioxide (E171) – 0.356 mg, iron oxide yellow dye (E172) – 0.114 mg, gelatin – 23.268 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
15 pcs. – contour cell packs (1) – cardboard packs.
15 pcs. – contour cell packs (2) – cardboard packs.
15 pcs. – contour cell packs (4) – cardboard packs.
15 pcs. – contour cell packs (6) – cardboard packs.
30 pcs. – polyethylene jars (1) – cardboard packs.
60 pcs. – polyethylene jars (1) – cardboard packs.
90 pcs. – polyethylene jars (1) – cardboard packs.

Tamsulosin [Atoll LLC (Russia)]
Extended-release capsules 0.4 mg: 7, 10, 14, 20, 21, 30, 35, 42, 50, 60, 63, 70, 90, or 100 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Tamsulosin

Extended-release capsules 0.4 mg: 7, 10, 14, 20, 21, 30, 35, 42, 50, 60, 63, 70, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

Extended-release capsules hard gelatin No. 2; capsule body light grey, cap light yellow with a light brown tint, opaque; capsule contents – pellets of white or almost white color.

	1 caps.
Tamsulosin hydrochloride (as 0.2% pellets)	200 mg,
Equivalent to tamsulosin hydrochloride content	0.4 mg

Excipients : sugar spheres (sucrose – 99%, hypromellose – 1%) – 190 mg, methacrylic acid and methacrylate copolymer [1:1] (methacrylic acid copolymer) – 4.8 mg, ethylcellulose – 4 mg, macrogol (polyethylene glycol) – 0.8 mg.

Capsule body composition: iron oxide black dye – 0.05%, titanium dioxide – 2%; gelatin – up to 100%;
Capsule cap composition: iron oxide yellow dye – 0.1%, titanium dioxide – 2%; gelatin – up to 100%.

7 pcs. – contour cell packs (1) – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (5) – cardboard packs.
7 pcs. – contour cell packs (6) – cardboard packs.
7 pcs. – contour cell packs (9) – cardboard packs.
7 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.

Tamsulosin [N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)]
Enteric-coated extended-release capsules 400 mcg: 10, 20, 30, 50, 60, 90, or 100 pcs.

Marketing Authorization Holder

N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)

Manufactured By

YUGPHARM, LLC (Russia)

Dosage Form

Tamsulosin

Enteric-coated extended-release capsules 400 mcg: 10, 20, 30, 50, 60, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated extended-release capsules hard gelatin No. 2, with a light orange body and an olive green cap; the cap and capsule body are marked in the upper part with a black stripe; the inscription “TSL 0.4” is printed on the capsule cap in black ink; capsule contents – pellets from white to almost white.

	1 caps.
Tamsulosin hydrochloride	400 mcg

Excipients : microcrystalline cellulose – 276.9 mg, methacrylic acid and ethyl acrylate copolymer (1:1) – 16.5 mg*, triethyl citrate – 1.65 mg, talc – 16.5 mg, purified water – 12.48 mg.

Pellet shell composition methacrylic acid and ethyl acrylate copolymer (1:1)* – 21.63 mg, talc – 8.65 mg, triethyl citrate – 2.16 mg, purified water*** – q.s.

* It is a 30% aqueous dispersion containing as emulsifiers the excipients polysorbate-80 (≈ 2.8%) and sodium lauryl sulfate (≈ 0.7%).

** Partially removed during the drying of the granules until a loss on drying value of 2-4% is reached.

*** Removed during the coating process.

Capsule shell composition iron oxide red dye – 0.0239 mg (0.06%), titanium dioxide – 0.53 mg (1.3333%), iron oxide yellow dye – 0.258 mg (0.65%), gelatin – 38.938 mg (up to 100%).
Capsule cap composition: indigo carmine – 0.00152 mg (0.0064%), iron oxide black dye – 0.0107 mg (0.045%), titanium dioxide – 0.356 mg (1.5%), iron oxide yellow dye – 0.114 mg (0.48%), gelatin – 23.268 mg (up to 100%).
Ink composition for marking pharmaceutical glaze (45% shellac solution (20% esterified) in ethanol)* – 59.420%, iron oxide black dye – 24.650%, n-butyl alcohol* – 24.650%, purified water* – 3.249%, propylene glycol – 1.3 mg, ethanol* – 1.08%, isopropanol* – 0.55%, ammonium hydroxide 28%** – 0.001%.

* It is a volatile component and does not remain on the capsule.

** Used to regulate the pH of the medium.

10 pcs. – PVC/PE/PVDC blisters (1) – cardboard packs.
10 pcs. – PVC/PE/PVDC blisters (2) – cardboard packs.
10 pcs. – PVC/PE/PVDC blisters (3) – cardboard packs.
10 pcs. – PVC/PE/PVDC blisters (4) – cardboard packs.
10 pcs. – PVC/PE/PVDC blisters (5) – cardboard packs.
10 pcs. – PVC/PE/PVDC blisters (6) – cardboard packs.
10 pcs. – PVC/PE/PVDC blisters (9) – cardboard packs.
10 pcs. – PVC/PE/PVDC blisters (10) – cardboard packs.

Tamsulosin [Pranapharm, LLC (Russia)]
Extended-release capsules 0.4 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.

Marketing Authorization Holder

Pranapharm, LLC (Russia)

Dosage Form

Tamsulosin

Extended-release capsules 0.4 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

Extended-release capsules are hard gelatin, size No. 0, with a transparent colorless body and an opaque green cap; the capsule contents are white or almost white spherical pellets.

	1 caps.*
Tamsulosin hydrochloride	0.4 mg

* pellet-substance, 0.133% – 300.3 mg.

Excipients: core (75% sucrose and 25% starch) – 220 mg: hypromellose E5 – 1.9132 mg, sodium lauryl sulfate – 0.2 mg, dibutyl phthalate – 0.2088 mg, talc – 7.5358 mg; coating: macrogol 6000 – 6.2058 mg, ethylcellulose – 1.7748 mg, methacrylic acid and ethyl acrylate copolymer [1:1] [30% dispersion] – 62.0585 mg.

Capsule body composition: gelatin – 100%.
Capsule cap composition: titanium dioxide -1%, iron oxide yellow – 0.7%, indigo carmine – 0.15%, gelatin – up to 100%.

Tamsulosin [Pharmfirma Sotex, CJSC (Russia)]
Enteric-coated prolonged-release capsules 0.4 mg: 10, 30 or 100 pcs.

Marketing Authorization Holder

Pharmfirma Sotex, CJSC (Russia)

Manufactured By

Synthon Hispania, S.L. (Spain)

Packaging and Quality Control Release

Pharmfirma Sotex, CJSC (Russia)

Dosage Form

Tamsulosin

Enteric-coated prolonged-release capsules 0.4 mg: 10, 30 or 100 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated prolonged-release capsules are hard gelatin, with an orange body and a grey-green cap; the capsule contents are round pellets of white or almost white color.

	1 caps.
Tamsulosin hydrochloride*	0.4 mg

* calculated as the anhydrous substance

Excipients: microcrystalline cellulose PH101 (MCC-101), Eudragit^® L30 D-55 [methacrylic acid and ethyl acrylate copolymer [1:1] dispersion 30%, polysorbate 80, sodium lauryl sulfate], talc, triethyl acetate.

Capsule body: gelatin, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172).
Capsule cap: gelatin, titanium dioxide (E171), iron oxide yellow (E172), iron oxide black (E172), indigo carmine (E132).

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (10) – cardboard packs.

Tamsulosin Canon [Canonpharma Production, CJS (Russia)]
Prolonged-release film-coated tablets 0.4 mg: 10 or 30 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Manufactured By

Canonpharma Production, CJS (Russia)

Dosage Form

Tamsulosin Canon

Prolonged-release film-coated tablets 0.4 mg: 10 or 30 pcs.

Dosage Form, Packaging, and Composition

Prolonged-release film-coated tablets are yellow, round, biconvex; on the cross-section – a core of almost white color.

	1 tab.
Tamsulosin hydrochloride	0.4 mg

Excipients: hypromellose – 75 mg, colloidal silicon dioxide – 1.2 mg, lactose monohydrate – 12 mg, magnesium stearate – 2.4 mg, microcrystalline cellulose – 149 mg.

Film coating Opadry II yellow – 7 mg, including: [polyvinyl alcohol – 2.8 mg, macrogol (polyethylene glycol) – 1.414 mg, talc – 1.036 mg, titanium dioxide – 1.645 mg, iron oxide yellow dye – 0.105 mg].

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.

Tamsulosin Canon [Canonpharma Production, CJS (Russia)]
Enteric-coated extended-release capsules 0.4 mg: 10, 30, 60, or 90 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Form

Tamsulosin Canon

Enteric-coated extended-release capsules 0.4 mg: 10, 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated extended-release capsules are hard gelatin No. 2, with a yellow body and a yellow cap; the capsule contents are white or almost white spherical granules.

	1 caps.
Tamsulosin pellet-substance 0.133%	300 mg
Equivalent to tamsulosin hydrochloride content	0.4 mg

Excipients of the pellet-substance: hypromellose E5 (hydroxypropyl methylcellulose) – 1.9132 mg, dibutyl phthalate – 0.2088 mg, starch – 55 mg, macrogol 6000 (polyethylene glycol 6000) – 6.2058 mg, methacrylic acid and ethyl acrylate copolymer [1:1] – 62.0585 mg, sodium lauryl sulfate – 0.2 mg, sucrose – 165 mg, talc – 7.5358 mg, ethylcellulose – 1.7748 mg, magnesium stearate – 1.5 mg, talc – 1.5 mg.

Hard gelatin capsule No.2:
Body gelatin – 37.3478 mg, iron oxide yellow – 0.3811 mg, titanium dioxide – 0.3811 mg;
Cap gelatin – 22.4322 mg, iron oxide yellow – 0.2289 mg, titanium dioxide – 0.2289 mg.

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.
15 pcs. – contour cell blisters (2) – cardboard packs.
15 pcs. – contour cell blisters (4) – cardboard packs.
15 pcs. – contour cell blisters (6) – cardboard packs.

Tamsulosin Renewal [Obnovlenie Pfc, JSC (Russia)]
Enteric-coated extended-release capsules 0.4 mg: 30 or 90 pcs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Tamsulosin Renewal

Enteric-coated extended-release capsules 0.4 mg: 30 or 90 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated extended-release capsules are hard, gelatin No.2, with a brownish-orange body and a greenish-brown cap; the capsule contents are spherical pellets of white or almost white color.

	1 caps.
Tamsulosin, pellet-substance 0.2%	200 mg
Equivalent to tamsulosin hydrochloride content	0.4 mg

Excipients of the pellets: “inert” pellets (sucrose 79.83% + starch 20% + povidone 0.17%), hypromellose, talc, colloidal silicon dioxide, polysorbate; excipients for the coating – hypromellose, ethylcellulose, methacrylic acid and ethyl acrylate copolymer (1:1), triethyl citrate.
Hard gelatin capsules:
Body: titanium dioxide (E171), iron oxide yellow dye (E172), iron oxide red dye (E172), gelatin;
Cap: titanium dioxide (E171), iron oxide yellow dye (E172), iron oxide red dye (E172), indigo carmine (E132), gelatin.

10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.

Tamsulosin Velpharm [Velpharm, LLC (Russia)]
Extended-release capsules 0.4 mg: 10 or 30 pcs.

Marketing Authorization Holder

Velpharm, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

Velpharm-M, LLC (Russia)

Dosage Form

Tamsulosin Velpharm

Extended-release capsules 0.4 mg: 10 or 30 pcs.

Dosage Form, Packaging, and Composition

Extended-release capsules are gelatin, size No.2, with a white body, light green cap; the capsule contents are white or almost white spherical pellets.

	1 caps.
Tamsulosin hydrochloride pellets 0.15%	267 mg,
Equivalent to tamsulosin hydrochloride content	0.4 mg

Excipients: sucrose – 143.36 mg, starch – 95.58 mg, ethylcellulose – 3.74 mg, hypromellose – 2.56 mg, povidone K30 – 1.5 mg, copovidone (Plasdone S-630) – 2.54 mg, hypromellose phthalate – 10.4 mg, cetyl alcohol – 1 mg, diethyl phthalate – 0.35 mg, talc – 5.47 mg.

Composition of the gelatin capsule gelatin – 62.306465 mg; cap dyes: brilliant black – 0.0065 mg, patent blue – 0.00715 mg, quinoline yellow – 0.00871 mg, iron oxide yellow – 0.071175 mg, titanium dioxide – 1.3 mg; body (base) dye: titanium dioxide – 1.3 mg.

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (7) – cardboard packs.
10 pcs. – contour cell blisters (8) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.
10 pcs. – contour cell blisters (10) – cardboard packs.
20 pcs. – contour cell blisters (1) – cardboard packs.
20 pcs. – contour cell blisters (2) – cardboard packs.
20 pcs. – contour cell blisters (3) – cardboard packs.
20 pcs. – contour cell blisters (4) – cardboard packs.
20 pcs. – contour cell blisters (5) – cardboard packs.
20 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
70 pcs. – polymer jars (1) – cardboard packs.
80 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.
120 pcs. – polymer jars (1) – cardboard packs.

Tamsulosin-Binergia [Binergia JSC (Russia)]
Enteric-coated extended-release capsules 0.4 mg: 10, 30, 60, 90, or 100 pcs.

Marketing Authorization Holder

Binergia JSC (Russia)

Manufactured By

PharmVILAR NPO, LLC (Russia)

Dosage Form

Tamsulosin-Binergia

Enteric-coated extended-release capsules 0.4 mg: 10, 30, 60, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated extended-release capsules are hard gelatin, size No.2, with a white body and a white cap; the capsule contents are spherical pellets of white or almost white color.

	1 caps.
Tamsulosin pellet-substance	200 mg,
Equivalent to tamsulosin hydrochloride content	0.4 mg

Excipients: sugar pellets (sucrose, corn starch, povidone K30), hypromellose, talc, colloidal silicon dioxide, polysorbate 80.

Composition of the pellet coating: hypromellose, ethylcellulose, methacrylic acid and ethyl acrylate copolymer (1:1), triethyl citrate.
Composition of the hard gelatin capsule (body and cap) titanium dioxide (E171), gelatin.

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.
10 pcs. – contour cell blisters (10) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Tamsulosin-Edvansd [Advanced Pharma, LLC (Russia)]
Extended-release capsules 0.4 mg: 10, 30, 60, or 90 pcs.

Marketing Authorization Holder

Advanced Pharma, LLC (Russia)

Dosage Form

Tamsulosin-Edvansd

Extended-release capsules 0.4 mg: 10, 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Extended-release capsules are hard, gelatin, No. 2, with a transparent colorless body and a transparent yellow cap; the capsule contents are white or almost white spherical granules (pellets).

	1 caps.
Tamsulosin pellet-substance	300 mg
Equivalent to tamsulosin hydrochloride content	0.4 mg

Excipients: hypromellose E5 (hydroxymethylcellulose) – 1.91 mg, dibutyl phthalate – 0.21 mg, starch – 55 mg, macrogol 6000 – 6.21 mg, methacrylic acid and ethyl acrylate copolymer (1:1) – 62.06 mg, sodium lauryl sulfate – 0.2 mg, sucrose – 165 mg, talc – 7.54 mg, ethylcellulose – 1.77 mg, magnesium stearate – 1.5 mg, talc – 1.5 mg.

Hard gelatin capsule No. 2:
Body gelatin (up to 100%), purified water (14.5%);
Cap gelatin (up to 100%), purified water (14.5%), quinoline yellow dye (E104) (0.1%), sunset yellow FCF dye (E110) (0.024%).

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (9) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
90 pcs. – jars (1) – cardboard packs.

Tamsulosin-OBL [Aliym, JSC (Russia)]
Modified-release capsules 0.4 mg: 10, 14, 15, 20, 28, 30, 40, 42, 45, 60, 84, 90, or 120 pcs.

Marketing Authorization Holder

Aliym, JSC (Russia)

Dosage Form

Tamsulosin-OBL

Modified-release capsules 0.4 mg: 10, 14, 15, 20, 28, 30, 40, 42, 45, 60, 84, 90, or 120 pcs.

Dosage Form, Packaging, and Composition

Modified-release capsules are hard gelatin, size No.2, with a transparent colorless body and a transparent pink cap; the capsule contents are spherical pellets of white or almost white color.

	1 caps.
Tamsulosin hydrochloride (in the form of pellets)	0.4 mg

Excipients: “inert” pellets (sucrose, corn starch, povidone), hypromellose, talc, colloidal silicon dioxide (aerosil), polysorbate 80.

Coating composition hypromellose, ethylcellulose, methacrylic acid and ethyl acrylate copolymer (1:1), triethyl citrate.
Composition of hard gelatin capsules[body: gelatin; cap: azorubine dye, gelatin].

Tamsulosin-Roslex [Scan Biotech LLC (India)]
Modified-release capsules 0.4 mg: 10, 30, 60, or 90 pcs.

Marketing Authorization Holder

Scan Biotech LLC (India)

Manufactured By

Rozlex Pharm LLC (Russia)

Dosage Form

Tamsulosin-Rozlex

Modified-release capsules 0.4 mg: 10, 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Modified-release capsules hard gelatin, size No. 2, with a transparent colorless body and a transparent yellow cap; the capsule contents are white or almost white spherical granules (pellets).

	1 caps.
Tamsulosin substance-pellets	300 mg,
Equivalent to tamsulosin hydrochloride content	0.4 mg

Excipients: hypromellose – 1.91 mg, dibutyl phthalate – 0.21 mg, starch 54.9 mg, macrogol (polyethylene glycol) – 6.21 mg, methacrylic acid and ethyl acrylate copolymer [1:1] – 62.06 mg, sodium lauryl sulfate 0.2 mg, sucrose – 164.8 mg, talc -7.54 mg, ethylcellulose – 1.77 mg.

Pellet coating composition: magnesium stearate – 1.5 mg, talc – 1.5 mg.
Capsule cap composition gelatin – up to 100%, purified water – 14.5%, quinoline yellow dye (E 104) – 0.25%.
Capsule body composition gelatin – up to 100%, purified water – 14.5%.

10 pcs. – PVC/aluminum foil blisters (1) – cardboard packs.
10 pcs. – PVC/aluminum foil blisters (3) – cardboard packs.
10 pcs. – PVC/aluminum foil blisters (6) – cardboard packs.
10 pcs. – PVC/aluminum foil blisters (9) – cardboard packs.
15 pcs. – PVC/aluminum foil blisters (2) – cardboard packs.
15 pcs. – PVC/aluminum foil blisters (4) – cardboard packs.
15 pcs. – PVC/aluminum foil blisters (6) – cardboard packs.
10 pcs. – high-density polyethylene jars (1) – cardboard packs.
30 pcs. – high-density polyethylene jars (1) – cardboard packs.
60 pcs. – high-density polyethylene jars (1) – cardboard packs.
90 pcs. – high-density polyethylene jars (1) – cardboard packs.

Tamsulosin-SZ [Severnaya Zvezda NAO (Russia)]
Prolonged-release film-coated tablets 0.4 mg

Marketing Authorization Holder

Severnaya Zvezda NAO (Russia)

Dosage Form

Tamsulosin-SZ

Prolonged-release film-coated tablets 0.4 mg

Dosage Form, Packaging, and Composition

Prolonged-release film-coated tablets

Tamsulosin

0.4 mg

30 pcs. – jars – cardboard packs (30 pcs.) – By prescription
30 pcs. – contour cell blisters – cardboard packs (30 pcs.) – By prescription
30 pcs. – contour cell blisters (2 pcs.) – cardboard packs (60 pcs.) – By prescription
30 pcs. – contour cell blisters (3 pcs.) – cardboard packs (90 pcs.) – By prescription
30 pcs. – bottles – cardboard packs (30 pcs.) – By prescription

Tamsulosin-Teva [Pliva Hrvatska, d.o.o. (Croatia)]
Modified-release capsules 400 mcg: 10 or 30 pcs.

Marketing Authorization Holder

Pliva Hrvatska, d.o.o. (Croatia)

Manufactured By

FAMAR S.A. (Greece)

Dosage Form

Tamsulosin-Teva

Modified-release capsules 400 mcg: 10 or 30 pcs.

Dosage Form, Packaging, and Composition

Modified-release capsules hard gelatin, with an orange body and a green cap, with a black ring on both ends of the capsule, with a black inscription “TSL 0.4” on the capsule; the capsule contents are white or almost white pellets.

	1 caps.
Tamsulosin hydrochloride	400 mcg,
Equivalent to tamsulosin content	367 mcg

Excipients: pellet core – microcrystalline cellulose (101) 276.9 mg, methacrylic acid and ethyl acrylate copolymer (1:1) 16.5 mg, triethyl citrate 1.65 mg, talc 16.5 mg, water (removed during manufacturing) 276.9 mg, sodium hydroxide/hydrochloric acid q.s.; pellet coating – methacrylic acid and ethyl acrylate copolymer (1:1) 21.63 mg, talc 8.65 mg, triethyl citrate 2.16 mg, water (removed during manufacturing) q.s.

Capsule body composition iron oxide red 23.9 mcg, titanium dioxide 530 mcg, iron oxide yellow 258 mcg, gelatin 38.938 mg.
Capsule cap composition indigo carmine (FD&C Blue 2) 1.52 mcg, iron oxide black 10.7 mcg, titanium dioxide 356 mcg, iron oxide yellow 114 mcg, gelatin 23.268 mg.
Printing ink composition for the capsule Glaze lacquer 47.5% 59.42%, propylene glycol 1.3%, iron oxide black 24.65%.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.

Tamsulosin-Teva [Teva Pharmaceutical Industries, Ltd. (Israel)]
Extended-release tablets, film-coated, 0.4 mg: 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 pcs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Dosage Form

Tamsulosin-Teva

Extended-release tablets, film-coated, 0.4 mg: 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 pcs.

Dosage Form, Packaging, and Composition

Extended-release film-coated tablets yellow, oval, biconvex, with an engraving “T04” on one side; on cross-section – a core from white to almost white.

	1 tab.
Tamsulosin hydrochloride	0.4 mg

Excipients: microcrystalline cellulose – 47 mg, macrogol – 200 mg, colloidal silicon dioxide – 1.3 mg, magnesium stearate – 1.3 mg.

Film coating composition Opadry yellow 03F32784 (hypromellose 6cP – 5.2152 mg, titanium dioxide – 1.03425 mg, macrogol-8000 – 0.9768 mg, iron oxide yellow – 0.273 mg, iron oxide red – 0.00075 mg).

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (9) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.
10 pcs. – blisters (20) – cardboard packs.
7 pcs. – blisters (2) – cardboard packs.
7 pcs. – blisters (4) – cardboard packs.
7 pcs. – blisters (8) – cardboard packs.

Tamsulosin-Vertex [Vertex, JSC (Russia)]
Extended-release capsules 400 mcg: 10, 20, 30, 60, or 90 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Tamsulosin-Vertex

Extended-release capsules 400 mcg: 10, 20, 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Extended-release capsules hard gelatin, green, size No. 3; the capsule contents are white or almost white pellets.

	1 caps.
Tamsulosin hydrochloride	400 mcg

Excipients: sucrose – 99%, hypromellose – 1% (sugar spheres – 190 mg), methacrylic acid copolymer – 4.8 mg, ethylcellulose – 4 mg, polyethylene glycol – 0.8 mg.

Capsule shell composition titanium dioxide – 1%, iron oxide yellow (iron oxide) – 0.27%, patent blue dye – 0.015%, gelatin – up to 100%.

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
15 pcs. – contour cell blisters (2) – cardboard packs.
15 pcs. – contour cell blisters (4) – cardboard packs.
15 pcs. – contour cell blisters (6) – cardboard packs.
20 pcs. – contour cell blisters (3) – cardboard packs.
30 pcs. – polyethylene jars (1) – cardboard packs.
60 pcs. – polyethylene jars (1) – cardboard packs.
90 pcs. – polyethylene jars (1) – cardboard packs.

Tamsulosin-Vertex [Vertex, JSC (Russia)]
Prolonged-release film-coated tablets 0.4 mg: 30, 60, or 90 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Tamsulosin-Vertex

Prolonged-release film-coated tablets 0.4 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Prolonged-release film-coated tablets yellow, round, biconvex; on cross-section – a core from white to almost white.

	1 tab.
Tamsulosin hydrochloride	0.4 mg

Excipients: microcrystalline cellulose, hypromellose 2208, colloidal hydrophobic silicon dioxide, magnesium stearate.

Film coating composition (hypromellose 2910, talc, titanium dioxide, macrogol 4000 (polyethylene glycol 4000), iron yellow dye) or (dry mix for film coating, containing hypromellose 2910, talc, titanium dioxide, macrogol 4000 (polyethylene glycol 4000), iron oxide yellow).

10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.
15 pcs. – contour cell blisters (2) – cardboard packs.
15 pcs. – contour cell blisters (4) – cardboard packs.
15 pcs. – contour cell blisters (6) – cardboard packs.
20 pcs. – contour cell blisters (3) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
90 pcs. – jars (1) – cardboard packs.

Medixlife (Author)

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