Description
Trade name:
Tamsulin Plus
Compound:
Each tablet contains:
solifenacin succinate 6 mg
tamsulosin hydrochloride 0.4 mg
Auxiliary components:
Hypromellose, carboner, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, lactose monohydrate.
Properties:
A combination medicinal product containing two active substances, solifenacin and tamsulosin. These active substances have independent and complementary mechanisms of action in the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia, in the presence of filling symptoms.
Solifenacin is a selective competitive inhibitor of bladder muscarinic receptors, primarily the M3 subtype, with low or no affinity for other receptors, enzymes and ion channels.
Tamsulosin is an alpha1-adrenergic blocker. It is a selective competitive blocker of postsynaptic alpha1-adrenergic receptors, especially 1A and 1D subtypes, responsible for relaxation of the smooth muscles of the lower urinary tract.
Indications:
Treatment of moderate to severe filling (irritative) symptoms (urinary urgency, urinary frequency) and voiding (obstructive) symptoms associated with benign prostatic hyperplasia in men.
Method of administration and dosage:
The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a specific drug with the indications for use and dosage regimen.
On average, one tablet is taken per day.
The maximum daily dose is 1 (6 mg/0.4 mg) tablet of Tamsulin Plus.
Contraindications:
Hypersensitivity to the active substances or any of the excipients; – hemodialysis; severe liver failure; severe renal failure or moderate liver failure during concomitant treatment with strong inhibitors of the CYP3A4 isoenzyme, such as ketoconazole; severe gastrointestinal diseases (including toxic megacolon); myasthenia; angle-closure glaucoma; orthostatic hypotension; children under 18 years of age.
With caution:
Severe renal impairment; risk of urinary retention; gastrointestinal obstructive diseases; risk of gastrointestinal hypomotility; hiatal hernia, gastroesophageal reflux and patients taking concomitant medications that may cause or aggravate esophagitis (eg, bisphosphonates); autonomic neuropathy; the presence of risk factors such as long QT syndrome and hypokalemia (prolongation of the QT interval and torsades de pointes have been observed).
Precautions:
As with other alpha1-adrenergic blockers, in some cases, tamsulosin treatment may cause a decrease in blood pressure, which in rare cases may lead to fainting. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down and remain in this position until the symptoms disappear.
Side effects:
From the side of metabolism: decreased appetite, hyperkalemia.
From the nervous system: dizziness, drowsiness, dysgeusia, headache, fainting, hallucinations, psychosis, delirium.
From the organ of vision: blurred vision, intraoperative instability of the iris, dry eyes, glaucoma.
From the skin: itching, dry skin, Quincke’s edema, erythema multiforme, exfoliative dermatitis.
From the cardiovascular system: palpitations, pirouette-type tachycardia, prolongation of the QT interval, atrial fibrillation, arrhythmia, tachycardia, orthostatic hypotension.
From the respiratory system: rhinitis, shortness of breath, dry nose, dysphonia.
From the digestive system: dry mouth, dyspepsia, constipation, nausea, abdominal pain, GERD, diarrhea, dry throat, vomiting, colonic obstruction, coprostasis, intestinal obstruction, abdominal discomfort, liver dysfunction, increased activity of “liver” enzymes.
From the musculoskeletal system: muscle weakness.
From the reproductive system: ejaculation disorders, priapism.
From the urinary system: urinary tract infections, cystitis, urinary retention, difficulty urinating, renal failure.
Other: anaphylactic reaction
Storage method:
In a cool, dry place at a temperature not exceeding 30 degrees.