Package Insert: Information for the User

Solifenacin/Tamsulosin Aurovitas 6 mg/0.4 mg Modified Release Tablets

Containing Solifenacin Succinate/Tamsulosin Hydrochloride

solifenacin, succinato/tamsulosin, hidrocloruro

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

-Keep this package insert, as you may need to refer to it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed for you only, and you should not give it to others who have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Solifenacina/tamsulosina Aurovitas is a combination of two different medications called solifenacina and tamsulosina in a single tablet. Solifenacina belongs to a group of medications called anticholinergics and tamsulosina belongs to a group of medications called alpha-blockers.

Solifenacina/tamsulosina Aurovitas is used in men to treat both moderate to severe filling symptoms and emptying symptoms of the lower urinary tract caused by problems related to the bladder and by an enlarged prostate (benign prostatic hyperplasia). Solifenacina/tamsulosina Aurovitas is used when previous monotherapy treatment for this condition did not adequately relieve symptoms.

When the prostate becomes enlarged, urinary problems (emptying symptoms) such as delayed urination (difficulty starting urination), reduced urine flow (weak stream), dripping, and sensation of incomplete bladder emptying may occur. At the same time, the bladder is also affected and contracts spontaneously at times when urination is not desired. This causes filling symptoms such as changes in bladder sensation, urgency (a strong and sudden desire to urinate without prior warning) and having to urinate more frequently.

Solifenacina reduces involuntary bladder contractions and increases the amount of urine that the bladder can store. Therefore, you can expect to wait longer before having to go to the bathroom. Tamsulosina allows urine to pass more easily through the urethra and facilitates urination.

Do not use Solifenacina/tamsulosina Aurovitas if:

-You are allergic to solifenacina or tamsulosina or to any of the other components of this medication (listed in section 6).

-You are undergoing renal dialysis.

-You have severe liver disease.

-You have severe kidney disease and, at the same time, are being treated with medications that can reduce the elimination of solifenacina/tamsulosina from the body (for example, ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this is the case.

-You have moderate liver disease and, at the same time, are being treated with medications that can reduce the elimination of solifenacina/tamsulosina from the body (for example, ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this is the case.

-You have a severe stomach or intestinal condition (including toxic megacolon, a complication associated with ulcerative colitis).

-You have a muscle disease called myasthenia gravis, which can cause extreme weakness in certain muscles.

-You have increased pressure in the eyes (glaucoma), with gradual loss of vision.

-You experience dizziness due to a decrease in blood pressure when changing position (sitting or standing); this is known as orthostatic hypotension.

Inform your doctor if you think you have any of these conditions.

Warnings and precautions

Consult your doctor or pharmacist before starting to use solifenacina/tamsulosina if:

-You have difficulty eliminating urine (urinary retention).

-You have any obstruction of the digestive system.

-You are at risk of decreased activity of the digestive system (gastrointestinal motility). Your doctor will inform you if this is the case.

-You have a hiatal hernia or heartburn and/or if, at the same time, you are taking medications that can cause or worsen esophagitis.

-You have a certain type of nervous system disease (autonomic neuropathy).

-You have severe kidney disease.

-You have moderate liver disease.

Regular medical check-ups are necessary to monitor the development of the condition being treated.

This medication may affect blood pressure, which can cause dizziness, drowsiness, or, rarely, fainting (orthostatic hypotension). You should sit or lie down if you experience any of these symptoms until they have disappeared.

If you are scheduled to undergo eye surgery due to cataracts or increased pressure in the eyes (glaucoma), please inform your ophthalmologist that you have previously used, are using, or plan to use solifenacina/tamsulosina. The specialist can then take the necessary precautions regarding medication and surgical techniques. Ask your doctor if you should or should not temporarily stop taking this medication when undergoing eye surgery for cataracts or increased pressure in the eye (glaucoma).

Children and adolescents

Do not administer this medication to children and adolescents.

Other medications and Solifenacina/tamsulosina Aurovitas

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

It is especially important to inform your doctor if you are using:

-Medications such as ketoconazole, erythromycin, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, and paroxetine that reduce the rate at which solifenacina/tamsulosina is eliminated from the body.

-Other anticholinergic medications, as the effects and adverse effects of both medications can be intensified if you are taking two medications of the same type.

-Cholinergic medications, as they can reduce the effect of solifenacina/tamsulosina.

-Medications such as metoclopramide and cisapride, which can accelerate the functioning of the digestive system. Solifenacina/tamsulosina can reduce their effect.

-Other alpha-blockers, as they can cause an undesirable decrease in blood pressure.

-Medications such as bisphosphonates, which can cause or exacerbate inflammation of the esophagus (esophagitis).

Taking Solifenacina/tamsulosina Aurovitas with food and drinks

Solifenacina/tamsulosina can be taken with or without food, according to your preferences.

Pregnancy, breastfeeding, and fertility

Solifenacina/tamsulosina is not indicated for use in women.

In men, abnormal ejaculation (ejaculation alteration) has been reported. This means that semen does not release through the urethra, but rather goes to the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and operating machines

This medication may cause dizziness, blurred vision, fatigue, and, less frequently, drowsiness. If you experience these adverse effects, do not drive or operate machines.

Solifenacina/tamsulosina Aurovitas contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The maximum daily dose is one tablet containing 6 mg of solifenacina and 0.4 mg of tamsulosina, taken orally. It can be taken with or without food, according to your preferences. Do not crush or chew the tablet.

If you take more Solifenacina/tamsulosina Aurovitas than you should

If you have taken more tablets than you were told to, or if someone else takes your tablets by mistake, contact your doctor, pharmacist, or hospital immediately for advice.

In case of overdose, your doctor may treat you with activated charcoal; emergency gastric lavage may be useful if performed within one hour of the overdose. Do not induce vomiting.

Overdose symptoms may include: dry mouth, dizziness, and blurred vision, seeing things that are not there (hallucinations), over-excitement, seizures, difficulty breathing, increased heart rate (tachycardia), inability to fully or partially empty the bladder or to urinate (urinary retention), and/or unwanted increase in blood pressure.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Solifenacina/tamsulosina AurovitasAurovitas

Take your next solifenacina/tamsulosina Aurovitas tablet as usual. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Solifenacina/tamsulosina Aurovitas

If you stop taking solifenacina/tamsulosina Aurovitas, your initial symptoms may reappear or worsen. Always consult your doctor if you are considering stopping treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, solifenacin succinate/hydrochloride of tamsulosin, may cause side effects, although not everyone will experience them.

The most serious side effect observed with low frequency (which may affect up to 1 in 100 men) during treatment with solifenacin succinate/tamsulosin hydrochloride in clinical studies is acute urinary retention, which consists of a sudden inability to urinate. If you think you may be experiencing it, go to your doctor immediately. You may need to stop taking this medication.

Solifenacin/tamsulosin may cause allergic reactions:

• Less common signs of allergic reactions may include skin rash (which may cause itching) or hives (urticaria).
• Rare symptoms include swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema). Angioedema has been reported in rare cases with tamsulosin and in very rare cases with solifenacin. In the event of angioedema, treatment with this medication should be stopped immediately and definitively.

If you experience an allergic crisis or a severe skin reaction (for example, blistering and peeling of the skin), you should inform your doctor immediately, and stop using this medication. Appropriate treatment and/or measures should be applied.

Side effectsfrequent(may affect up to 1 in 10 men)

• dizziness
• blurred vision
• dry mouth, indigestion (dyspepsia), constipation, nausea, abdominal pain
• abnormal ejaculation (ejaculatory disorder). This means that semen does not release through the urethra, but goes to the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless
• fatigue (asthenia)

Side effectsinfrequent(may affect up to 1 in 100 men)

• urinary tract infection, bladder infection (cystitis)
• drowsiness, taste disorder (dysgeusia), headache
• dry eyes
• rapid or irregular heartbeat (palpitations)
• sensation of dizziness or weakness, especially when standing up (orthostatic hypotension).
• runny or blocked nose (rhinitis), dry nose
• itching (pruritus), dry skin
• difficulty urinating
• fluid accumulation in the legs (edema), fatigue (asthenia)

Side effectsrare(may affect up to 1 in 1,000 men)

• sensation of fainting (syncope)
• accumulation of a large amount of hardened feces in the large intestine (fecal impaction)
• allergy in the skin that causes swelling in the tissue under the skin surface (angioedema)

Side effectsvery rare(may affect up to 1 in 10,000 men)

• hallucinations, confusion
• skin rash, inflammation, and blistering on the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals (Stevens-Johnson syndrome), skin allergy (erythema multiforme)
• prolonged and painful erection (usually not during sexual activity) (priapism)

Side effectsfrequency unknown(cannot be estimated from available data)

• severe allergic reaction that causes difficulty breathing or dizziness (anaphylactic reaction)
• decreased appetite, elevated potassium levels in the blood (hyperkalemia) that may cause irregular heartbeat
• rapid decrease in consciousness and general mental function (delirium)
• during eye surgery for cataracts or increased eye pressure (glaucoma), it is possible that the pupil (the black circle in the center of the eye) will not dilate sufficiently. Additionally, the iris (the colored part of the eye) may become flaccid during surgery, increased eye pressure (glaucoma), vision alteration
• irregular or abnormal heartbeat (prolongation of the QT interval, Torsades de Pointes, atrial fibrillation, arrhythmia), rapid heartbeat (tachycardia)
• difficulty breathing (dyspnea), voice disorder, nosebleed (epistaxis)
• intestinal obstruction (ileus), abdominal discomfort
• liver disorder
• inflammation in the skin causing redness and peeling on large areas of the body (dermatitis exfoliativa)
• muscle weakness
• kidney disorder

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box or blister after CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and themedicines that you do not need at the SIGRE collection pointof the pharmacy. If in doubt, ask yourpharmacist how to dispose of the packaging and the medicines that you do not need. In this way, you will help to protect the environment.

Composition of Solifenacina/tamsulosina Aurovitas

Appearance of the product and contents of the package

The modified-release tablets of Solifenacina/tamsulosina Aurovitas 6 mg/0.4 mg are round, biconvex, coated with a red film, and marked with "T7S" on one side.

The modified-release tablets of Solifenacina/tamsulosina Aurovitas are available in packages with blisters containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, or 200 modified-release tablets or single-dose blisters containing 10x1, 14x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 100x1, or 200x1 modified-release tablets.

Only some package sizes may be available in your country.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer

Synthon Hispania S.L.

Calle De Castelló 1

08830 Sant Boi De Llobregat

Barcelona

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:April 2023

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(AEMPS)http://www.aemps.gob.es/.