UROMEN 0.4 мг Капсулы с модифицированным высвобождением

UROMEN 0.4 mg
Modified-release hard capsules
Tamsulosin

PHARMACOTHERAPEUTIC CATEGORY
UROMENis a drug with alpha-adrenergic receptor blocking activity that reduces muscle tension
in the prostate and urethra, facilitating urination.

THERAPEUTIC INDICATIONS
Symptoms of the lower urinary tract associated with benign prostatic hyperplasia.

CONTRAINDICATIONS
Hypersensitivity to the active ingredient (tamsulosin), including drug-induced angioedema or to
any of the excipients. Severe hepatic insufficiency.
Previous episodes of orthostatic hypotension.

PRECAUTIONS FOR USE
As with other alpha-blockers, during treatment with UROMEN, a reduction in blood pressure may occur
in particular cases, and therefore, rarely, syncope may occur. At the first
signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down until
the symptoms disappear.
With chronic use of the product, periodic medical check-ups are advisable.
Before starting therapy, the patient should be evaluated to exclude the presence of other
conditions that may cause the same symptoms as benign prostatic hyperplasia. Rectal exploration and, if
necessary, the determination of prostate-specific antigen (PSA) should be
performed before starting treatment and subsequently at regular intervals.
Treatment of patients with severe renal impairment (creatinine clearance less than 10
ml/min) should be considered with caution as these subjects have not been studied.

INTERACTIONS
Interaction studies have only been conducted in adults. No interactions were observed when
tamsulosin hydrochloride was taken concurrently with atenolol, enalapril, or theophylline.
Concomitant use of cimetidine results in increased levels of tamsulosin in plasma
while furosemide lowers them; however, the levels of plasma concentrations of tamsulosin
are within the therapeutic range and therefore no dose adjustment is necessary.

InvitroDiazepam, propranolol, trichlorothiazide, chlormadinone, amitriptyline, diclofenac,
glibenclamide, simvastatin and warfarin do not modify the free fraction of tamsulosin in human
blood. Tamsulosin does not modify the free fraction of diazepam, propanolol, trichlorothiazide and
chlormadinone.
However, diclofenac and warfarin may increase the elimination rate of tamsulosin.
Concomitant administration of tamsulosin hydrochloride and strong CYP3A4 inhibitors (such as
ketoconazole) may lead to increased exposure to tamsulosin hydrochloride.
Concomitant use of other alpha1-adrenoceptor antagonists may determine hypotensive effects.

Inform your doctor or pharmacist if you have recently taken any other medicines, including

those available without a prescription.

SPECIAL WARNINGS
During cataract surgery, some patients, previously treated with or currently treated with drugs
containing tamsulosin, have developed IFIS ‘Intraoperative Floppy Iris Syndrome’ known as flag iris.
The appearance of this syndrome may increase surgical complications during and after surgery. Therefore, it is
recommended not to start treatment with tamsulosin hydrochloride in patients awaiting cataract surgery.
Anecdotal experiences have shown that discontinuation of treatment with tamsulosin
hydrochloride 1 or 2 weeks before surgery may be helpful. However, the benefit of discontinuation and the
necessary interruption period have not yet been established.
IFIS has also been found in patients who had discontinued tamsulosin for a longer period
before cataract surgery. In the pre-operative evaluation phase, the doctor must investigate
whether the patient destined for surgery is or has been treated with tamsulosin in order to
ensure appropriate measures for managing IFIS during surgery.

Driving and operating machinery
There is no data to highlight the influence of UROMEN on the ability to drive and operate
machinery. However, it is important to know that dizziness may occur in some cases.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
One capsule a day to be taken after breakfast or after the first meal of the day.
The capsule must be swallowed whole and must not be crushed or chewed as this
could interfere with the controlled release of the active ingredient.

OVERDOSE
No cases of overdose have been reported. However, theoretically, in case of overdose
acute hypotension may occur, which therefore requires prompt action at the cardiovascular level.
Blood pressure and heart rate can be returned to normal by making
the patient lie down. If this is not sufficient, plasma expanders and, if necessary,
vasoconstrictor drugs can be administered. In addition to general supportive measures, the
renal function should be monitored.
Dialysis is of little use as tamsulosin binds strongly to plasma proteins.
Some measures such as emesis can be taken to prevent absorption.
In case of ingestion of considerable doses, gastric lavage and activated charcoal and an osmotic laxative, such as sodium sulfate, can be administered.

In case of accidental ingestion of an excessive dose of UROMEN, immediately warn the

doctor or go to the nearest hospital.

What to do if you forget to take one or more doses
If the patient has forgotten to take the daily dose, it can be taken
later in the day. If a day of treatment has been skipped, it is advisable to continue therapy as usual,
according to the medical prescription.

If you have any doubts about the use of UROMEN, consult your doctor or pharmacist.

UNDESIRABLE EFFECTS
Like all medicines, UROMEN can cause side effects, although not everyone experiences them.
The following side effects have been reported with the use of UROMEN:

Common(≥1%, <10%)

• Nervous system disorders: dizziness (1.3%)
• Reproductive system disorders: ejaculation disorders. Uncommon(≥0.1%, <1%)
• Nervous system disorders: headache
• Cardiac disorders: palpitations
• Vascular disorders: postural hypotension
• Respiratory, thoracic and mediastinal disorders: rhinitis
• Gastrointestinal disorders: diarrhea, nausea, vomiting, constipation
• Skin and subcutaneous tissue disorders: skin rash, itching, urticaria
• Systemic disorders and conditions related to the site of administration: asthenia

Rare(≥0.01%, <0.1%)

• Nervous system disorders: syncope
• Skin and subcutaneous tissue disorders: angioedema

Very rare(<0.01%)

• Reproductive system and breast disorders: priapism
• Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome

Frequency not known:

• Gastrointestinal disorders: dry mouth.

During cataract surgery, cases of IFIS “Intraoperative Floppy Iris Syndrome” known as “flag iris” associated with tamsulosin treatment have been reported (See
“Special warnings”).
Post-marketing experience: in addition to the adverse effects listed above, cases of atrial fibrillation, arrhythmia, tachycardia and dyspnea have been reported in association with the use of tamsulosin. Since these events reported spontaneously come from post-marketing experience
worldwide, their frequency and the role of tamsulosin cannot be determined
certainly.

If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

SHELF LIFE AND STORAGE
Check the expiry date indicated on the packaging.
The expiry date refers to the product in intact packaging, stored correctly.
Store at a temperature not exceeding 25 °C.
Caution: do not use the medicine after the expiry date indicated on the packaging.
DO NOT USE IN CASE OF CLEAR SIGNS OF DETERIORATION.

Medicines should not be disposed of via wastewater or household waste. Ask your

pharmacist how to dispose of medicines you no longer use. This will help protect

the environment.

KEEP THE MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN
COMPOSITION
One capsule contains:
Active ingredient: tamsulosin hydrochloride 0.4 mg;
Excipients: sodium alginate; methylacrylic acid - ethyl acrylate copolymer (1:1); Glycerol dibehenate;
maltodextrin; sodium lauryl sulfate; macrogol; polysorbate 80; sodium hydroxide; simethicone; colloidal anhydrous silica;
Capsule: gelatin; purified water; red iron oxide (E 172); titanium dioxide (E 171); yellow iron oxide (E 172).

PHARMACEUTICAL FORM AND CONTENT
Modified-release hard capsule – Box of 20 capsules in blisters

AIC HOLDER
Farmitalia s.r.l. - Viale Alcide De Gasperi 165/B – 95127 Catania

MANUFACTURER AND FINAL CONTROLLER
Special Product’s Line S.p.A. –Via Fratta Rotonda Vado Largo 1 – 03012 Anagni (FR)

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