UROMEN

UROMEN 0.4 mg
Modified-release hard capsules
Tamsulosin

PHARMACOTHERAPEUTIC CATEGORY
UROMEN is a drug with alpha-adrenergic receptor-blocking activity that reduces muscular tension in the prostate and urethra, thereby facilitating urination.

THERAPEUTIC INDICATIONS
Lower urinary tract symptoms associated with benign prostatic hyperplasia.

CONTRAINDICATIONS
Hypersensitivity to the active substance (tamsulosin), including drug-induced angioedema, or to any of the excipients. Severe hepatic impairment.
History of orthostatic hypotension.

PRECAUTIONS FOR USE
As with other alpha-blockers, treatment with UROMEN may in rare cases lead to a reduction in blood pressure, potentially resulting in syncope. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down until symptoms resolve.
Regular medical monitoring is advisable during long-term use.
Before initiating therapy, patients should be evaluated to exclude other conditions that may cause symptoms similar to those of benign prostatic hyperplasia. Digital rectal examination and, if necessary, measurement of prostate-specific antigen (PSA) should be performed before starting treatment and at regular intervals thereafter.
Caution is recommended when treating patients with severe renal impairment (creatinine clearance below 10 ml/min), as these patients have not been studied.

INTERACTIONS
Interaction studies have only been conducted in adults. No interactions were observed when tamsulosin hydrochloride was co-administered with atenolol, enalapril, or theophylline.
Concomitant use of cimetidine increases plasma levels of tamsulosin, while furosemide decreases them; however, plasma concentrations of tamsulosin remain within the therapeutic range, and therefore dosage adjustment is not required.
In vitro, diazepam, propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin, and warfarin do not alter the free fraction of tamsulosin in human blood. Tamsulosin does not modify the free fraction of diazepam, propranolol, trichlormethiazide, or chlormadinone.
However, diclofenac and warfarin may increase the elimination rate of tamsulosin.
Concomitant administration of tamsulosin hydrochloride and strong CYP3A4 inhibitors (e.g., ketoconazole) may lead to increased exposure to tamsulosin hydrochloride.
Concomitant use of other alpha1-adrenergic receptor antagonists may enhance hypotensive effects.
Inform your doctor or pharmacist if you have recently taken any other medicines, including those
not requiring a prescription.

SPECIAL WARNINGS
During cataract surgery, some patients previously or currently treated with tamsulosin-containing medications have developed IFIS (“Intraoperative Floppy Iris Syndrome”), also known as “floppy iris” or “flagging iris.” The occurrence of this syndrome may increase surgical complications during and after the procedure. Therefore, initiation of tamsulosin hydrochloride treatment is not recommended in patients scheduled for cataract surgery.
Anecdotal reports suggest that discontinuation of tamsulosin hydrochloride 1 or 2 weeks before surgery may be beneficial. However, the clinical benefit and the required duration of discontinuation have not yet been definitively established.
IFIS has also been reported in patients who discontinued tamsulosin treatment some time before cataract surgery. During preoperative assessment, the surgeon should inquire whether the patient is or has been treated with tamsulosin to ensure appropriate intraoperative measures are taken to manage IFIS.

Driving and use of machines
There are no data indicating that UROMEN affects the ability to drive or operate machinery. However, it should be noted that dizziness may occur in some cases.

DOSAGE, ADMINISTRATION, AND DURATION
One capsule daily, 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 substance.

OVERDOSE
No cases of overdose have been reported. However, in theory, acute overdose could result in acute hypotension, requiring prompt cardiovascular intervention.
Blood pressure and heart rate can be normalized by laying the patient down.
If this is insufficient, plasma expanders and, if necessary, vasoconstrictor agents may be administered. Renal function should be monitored in addition to general supportive measures.
Dialysis is of limited utility due to the high plasma protein binding of tamsulosin.
Measures such as emesis may be employed to prevent absorption.
In cases of ingestion of large amounts, gastric lavage may be useful, and activated charcoal and an osmotic laxative (e.g., sodium sulfate) may be administered.
In case of accidental ingestion of an excessive dose of UROMEN, contact your doctor immediately or go to the nearest hospital.

What to do if you forget to take a dose
If the patient forgets to take the daily dose, it can be taken later on the same day.
If a day of treatment has been missed, therapy should be continued as usual according to 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 adverse reactions have been reported with 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: diarrhoea, nausea, vomiting, constipation
• Skin and subcutaneous tissue disorders: rash, pruritus, urticaria
• General disorders and administration site conditions: 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

Cases of IFIS ("Intraoperative Floppy Iris Syndrome"), also known as "floppy iris" or "flagging iris", have been reported during cataract surgery in patients treated with tamsulosin (see "Special warnings").

Post-marketing experience: In addition to the adverse reactions listed above, atrial fibrillation, arrhythmia, tachycardia, and dyspnoea have been reported in association with tamsulosin use. Since these spontaneously reported events come from post-marketing experience worldwide, their frequency and the role of tamsulosin cannot be determined with certainty.

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

EXPIRY DATE AND STORAGE
Check the expiry date printed on the packaging.
The expiry date refers to the product stored in its original, undamaged packaging under proper storage conditions.
Store at a temperature not exceeding 25°C.
Caution: Do not use the medicine after the expiry date stated on the packaging.
DO NOT USE IF THERE ARE VISIBLE SIGNS OF DETERIORATION.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN

COMPOSITION
Each capsule contains:
Active substance: tamsulosin hydrochloride 0.4 mg
Excipients: sodium alginate; methylacrylic acid-ethyl acrylate copolymer (1:1); glyceryl dibehenate; maltodextrin; sodium lauryl sulfate; macrogol; polysorbate 80; sodium hydroxide; simethicone; anhydrous colloidal silica
Capsule shell: gelatin; purified water; iron oxide red (E 172); titanium dioxide (E 171); iron oxide yellow (E 172)

PHARMACEUTICAL FORM AND CONTENT
Modified-release hard capsule – Pack of 20 capsules in blister
Modified-release hard capsule – Pack of 30 capsules in blister

MARKETING AUTHORISATION HOLDER
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome, Italy

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

REVISION OF THE PACKAGE LEAFLET BY THE
ITALIAN MEDICINES AGENCY (AIFA):