Package Insert: Information for the User

Solifenacin/Tamsulosin Teva6 mg/0.4 mg Modified Release EFG Tablets

solifenacin succinate/ tamsulosin hydrochloride

Read this package insert carefully before starting to use 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 to you alone, 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 Tevais a combination of two different medications called solifenacina and tamsulosina in a tablet. Solifenacina belongs to a group of medications called anticholinergics and tamsulosina belongs to a group of medications called alpha-blockers.

Solifenacina/Tamsulosinais 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/Tamsulosinais 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 (having 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 take Solifenacina/Tamsulosina Teva if:

• You are allergic to solifenacina or tamsulosina or 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 if, at the same time, you 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, you 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 fainting 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 liquid (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.

Solifenacina/tamsulosina 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 will then take the necessary precautions regarding medication and surgical techniques. Ask your doctor if you should or should not postpone or interrupt the use of 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 Teva

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 may reduce their effect.
• Other alpha-blockers (used to lower blood pressure), 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 Teva 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 (alteration of ejaculation) has been reported. This means that semen does not release through the urethra, but goes to the bladder (retrograde ejaculation) or the volume of semen 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.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in 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 preference. Do not crush or chew the tablet.

If you take more Solifenacina/Tamsulosina Teva 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 Teva

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

If you interrupt treatment with Solifenacina/Tamsulosina Teva

If you stop taking this medication, 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, this medicine can 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 medicine.

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 medicine 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 medicine. Appropriate treatment and/or measures should be applied.

Frequent side effects (may affect up to 1 in 10 men)

• dry mouth
• constipation
• indigestion (dyspepsia)
• dizziness
• blurred vision
• fatigue
• abnormal ejaculation (ejaculation disorder). 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.
• nausea
• abdominal pain

Other less frequent side effects (may affect up to 1 in 100 men)

• drowsiness
• itching (pruritus)
• skin rash
• urinary tract infection, bladder infection (cystitis)
• disturbance of taste (dysgeusia)
• dry eyes
• nasal dryness
• gastroesophageal reflux disease (GERD)
• dry throat
• dry skin
• difficulty urinating
• peripheral edema (swelling of the legs)
• headache
• rapid or irregular heartbeat (palpitations)
• sensation of dizziness or weakness, especially when standing up (orthostatic hypotension)
• nasal congestion or obstruction (rhinitis)
• diarrhea
• vomiting
• asthenia (fatigue)

Rare side effects (may affect up to 1 in 1,000 men)

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

Very rare side effects (may affect up to 1 in 10,000 men)

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

Unknown frequency (cannot be estimated from available data)

• anaphylactic reaction (sudden and severe allergic reaction with difficulty breathing, swelling, dizziness, rapid heartbeat, sweating, and loss of consciousness).
• decreased appetite
• elevated potassium levels in the blood (hyperkalemia) that may cause abnormal heart rhythm
• increased pressure in the eyes (glaucoma)
• irregular or abnormal heartbeat (prolongation of the QT interval, Torsades de Pointes, atrial fibrillation, arrhythmia)
• rapid heartbeat
• difficulty breathing (dyspnea)
• 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.
• voice disorder
• liver disorder
• muscle weakness
• renal disorder
• vision disturbance
• nosebleed (epistaxis)
• psychiatric disorders such as confusion (delirium)
• abdominal discomfort

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 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 medicine.

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 pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Solifenacina/Tamsulosina Teva

• The active ingredients are solifenacina succinate and tamsulosin hydrochloride. Each modified-release tablet contains 6 mg of solifenacina succinate and 0.4 mg of tamsulosin hydrochloride.
• The other components are: high molecular weight macrogol, anhydrous colloidal silica (E551), magnesium stearate (E470b), calcium hydrogen phosphate (E341), microcrystalline cellulose (E460), low-substitution hydroxypropyl cellulose (E463), hypromellose (E464), red iron oxide (E172), macrogol, butylhydroxytoluene (E321).

Appearance of the product and contents of the package

Solifenacina/Tamsulosina Teva 6 mg/0.4 mg modified-release tablets are red, round, biconvex film-coated tablets with a diameter of 9 mm, marked with "6 04" on one face.

Solifenacina/Tamsulosina Teva is supplied in a carton box containing PA/Aluminio/PVC/Aluminio blisters or in perforated single-dose PA/Aluminio/PVC/Aluminio blisters.

Available in packs of 30, 50, 90, or 100 tablets (in blisters).

Available in packs of 30 x 1, 50 x 1, 90 x 1, or 100 x 1 tablets (in perforated single-dose blisters).

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva B.V.

Swensweg 5, Haarlem,

2031 GA,

Netherlands

Responsible manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice,

Poland

Or

Adalvo Limited

Malta Life Sciences Park, Building 1 Level 4

Sir Temi Zamit Buildings

San Gwann Industrial Estate

San Gwann, SGN 3000

Malta

Local representative

Teva Pharma, S.L.U.

c/A nabel Segura, 11 Edificio Albatros B, 1st floor

Alcobendas 28108 Madrid,

Spain

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

Last review date of this leaflet: January 2023

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