SOLIFENACIN SUCCINATE/TAMSULOSIN HYDROCHLORIDE ZENTIVA

4 mg) once daily taken orally with or without food. 4 mg). The tablet must be swallowed whole, intact without biting or chewing. Do not crush the tablet. Patients with renal impairment The effect of renal impairment on the pharmacokinetics of solifenacin succinate/tamsulosin hydrochloride has not been studied.

2). Solifenacin succinate/tamsulosin hydrochloride can be used in patients with mild to moderate renal impairment (creatinine clearance >30 mL/min). 4). Patients with hepatic impairment The effect of hepatic impairment on the pharmacokinetics of solifenacin succinate/tamsulosin hydrochloride has not been studied.

2). Solifenacin succinate/tamsulosin hydrochloride can be used in patients with mild hepatic impairment (Child-Pugh score ≤7). 4 mg). 3). 4 mg). g. 5). Paediatric population There is no relevant indication for use of solifenacin succinate/tamsulosin hydrochloride in children and adolescents.

Summary of the safety profile Solifenacin succinate/tamsulosin hydrochloride may cause anticholinergic undesirable effectsof, in general, mild to moderate severity. 4%). 5%). 3%, uncommon) is the most serious adverse drug reaction that has been observed during treatment with solifenacin succinate/tamsulosin hydrochloride in clinical studies.

Tabulated list of adverse reactions In the table below the 'solifenacin succinate/tamsulosin hydrochloride frequency' column reflects adverse drug reactions that have been observed during the double- blind clinical studies performed for the development of solifenacin succinate/tamsulosin hydrochloride (based on reports of treatment-related adverse events, which have been reported by at least two patients and occurred with a frequency higher than for placebo in the double-blind studies).

The columns 'solifenacin frequency' and 'tamsulosin frequency' reflect adverse drug reactions (ADRs) previously reported with one of the individual components that may also occur when receiving Solifenacin succinate/tamsulosin hydrochloride (some of these have not been observed during the clinical development program of solifenacin succinate/ tamsulosin hydrochloride).

The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

4 mg# Infections and infestaetions Urinary tract infection Uncommon Cystitis Uncommon Immune system disorders Anaphylactic reaction Not known* Metabolism and nutrition disorders Decreased appetite Not Known* Hyperkalaemia Not Known* Psychiatric disorders Hallucination Very rare* Confusional state Very rare* Delirium Not Known Nervous system disorders Dizziness Common Rare* Common Somnolence Uncommon Dysgeusia Uncommon Headache Rare* Uncommon Syncope Rare Eye disorders Vision blurred Common Common Not Known* Intraoperative floppy Not Known** Iris syndrome (IFIS) Dry eyes Uncommon Glaucoma Not Known* Visual impairment Not Known* Cardiac disorders Palpitations Not Known* Uncommon Torsade de Pointes Not Known* Electrocadiogram QT prolongation Not Known* Atrial fibrillation Not Known* Not Known* Arrhythmia Not Known* Tachycardia Not Known* Not Known* Vascular disorders Orthostatic hypotension Uncommon Respiratory thoracic and mediastinal disorders Rhinitis Uncommon Nasal dryness Uncommon Dyspnoea Not Known* Not known* Epistaxis Not known* Gastrointestinal disorders Dry mouth Common Very common Dyspepsia Common Common Constipation Common Common Uncommon Nausea Common Uncommon Abdominal pain Common Gastro-oesophageal reflux disease Uncommon Diarrhea Uncommon Dry throat Uncommon Vomiting Rare* Uncommon Colonic obstruction Rare Faecal impaction Rare Ileus Not Known* Abdominal discomfort Not Known* Hepatobiliary disorders Liver disorder Not Known* Liver function test abnormal Not Known* Skin and subcutaneous tissue disorder Pruritus Uncommon Rare* Uncommon Dry skin Uncommon Rash Rare* Uncommon utricaria Very rare* uncommon Angioedema Very rare* Rare Stevens-johnson syndrome Very rare Erythema multiforme Very rare* Not known* Exfoliative dermatitis Not Known* Not known* Musculoskeletal and connective tissue disorders Muscular weakness Not Known* Renal and urinary disorders Urinary retention *** Uncommon Rare Difficulty in micturition Uncommon Renal impairment Not Known* Reproductive system and breast disorders Ejaculation disorders including retrograde ejaculation and ejaculation Common Common Failure priapism Very rare General disorders and administration site conditions Fatigue Common Uncommon Peripheral oedema Uncommon asthenia Uncommon #: The ADRs from solifenacin and tamsulosin included in this table are the ADRs listed in the summary of product characteristics of both products.

Solifenacin succinate/tamsulosin hydrochloride should be used with caution in patients with: severe renal impairment, risk of urinary retention, gastrointestinal obstructive disorders, risk of decreased gastrointestinal motility, hiatus hernia/gastroesophageal reflux and/or who are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis, autonomic neuropathy.

The patient should be examined in order to exclude the presence of other conditions, which can cause similar symptoms to benign prostatic hyperplasia. Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Solifenacin succinate/tamsulosin hydrochloride is initiated.

If a urinary tract infection is present, appropriate antibacterial therapy should be started. QT prolongation and Torsade de Pointes have been observed in patients with risk factors, such as pre-existing long QT syndrome and hypokalaemia, who are treated with solifenacin succinate.

Angioedema with airway obstruction has been reported in some patients on solifenacin succinate and tamsulosin. If angioedema occurs, Solifenacin succinate/tamsulosin hydrochloride should be discontinued and not restarted. Appropriate therapy and/or measures should be taken.

Anaphylactic reaction has been reported in some patients treated with solifenacin succinate. In patients who develop anaphylactic reactions, Solifenacin succinate/tamsulosin hydrochloride should be discontinued and appropriate therapy and/or measures should be taken.

As with other alpha1-adrenoceptor antagonists, a reduction in blood pressure can occur in individual cases during treatment with tamsulosin, as a result of which, rarely, syncope can occur. Patients starting treatment with Solifenacin succinate/tamsulosin hydrochloride should be cautioned to sit or lie down at the first signs of orthostatic hypotension (dizziness, weakness) until the symptoms have disappeared.

5), Patients with severe gastrointestinal conditions (including toxic megacolon), myasthenia gravis or narrow-angle glaucoma and patients at risk for these conditions, Patients with a history of orthostatic hypotension.