Prospect: information for the user

Solifenacina/Tamsulosina Alter 6 mg/0.4 mg modified-release EFG tablets

solifenacina succinate/tamsulosin hydrochloride

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others even if they 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 prospect. See section 4.

Solifenacina/Tamsulosina Alteris 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 alleviate symptoms sufficiently.

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 use Solifenacina/Tamsulosina 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 and 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 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 eye pressure (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 urinating (urinary retention).
• You have any obstruction of the digestive system.
• You are at risk of decreased digestive system activity (gastrointestinal motility). Your doctor will inform you if this is the case.
• You have a hiatal hernia or stomach burning and/or 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 eye pressure (glaucoma), please inform your ophthalmologist that you have previously used, are currently 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 eye pressure (glaucoma).

Children and adolescents

Do not administer this medication to children and adolescents.

Other medications and Solifenacina/Tamsulosina Alter

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, as they can cause an undesirable decrease in blood pressure.
• Medications such as bisphosphonates, which can cause or exacerbate esophagitis.

Use of Solifenacina/Tamsulosina Alter with food and beverages

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 rather 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 machinery

Solifenacina/Tamsulosina may cause dizziness, blurred vision, fatigue, and, less frequently, drowsiness. If you experience these adverse effects, do not drive or operate machinery.

Solifenacina/Tamsulosina Alter contains croscarmelosa sódica

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which 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 Alter than you should

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

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

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, convulsions, difficulty breathing, increased heart rate (tachycardia), inability to completely or partially empty the bladder or to urinate (urinary retention), and/or unwanted increase in blood pressure.

If you forgot to take Solifenacina/Tamsulosina Alter

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 Alter

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 using this medication, ask your doctor or pharmacist.

Like all medications, solifenacina/tamsulosinacan 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 withsolifenacina/tamsulosinain 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 takingthis medication.

Solifenacina/tamsulosinamay 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 tamsulosina and in very rare cases with solifenacina. In the event of angioedema, treatment withsolifenacina/tamsulosinashould 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 usingsolifenacina/tamsulosina. 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 into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.
• Nausea
• Abdominal pain

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

• Drowsiness
• Itching (pruritus)
• Urinary tract infection, bladder infection (cystitis)
• Disorder of the sense of taste (dysgeusia)
• Dry eyes
• Runny nose
• Reflux disease (gastroesophageal reflux)
• Dry throat
• Dry skin
• Difficulty urinating
• Swelling of the legs (edema)
• Headache
• Irregular or rapid heartbeat (palpitations)
• Sensation of dizziness or weakness, especially when standing up (orthostatic hypotension)
• Runny or obstructed nose (rhinitis)
• Diarrhea
• Vomiting
• Weakness (asthenia)

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

• Accumulation of a large amount of hardened feces in the large intestine (fecal impaction)
• Sensation of fainting (syncope)

Allergic reaction 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)

• Illusions, confusion
• Allergic reaction in the skin (erythema multiforme)
• Durable and painful erection (usually not during sexual activity) (priapism)

Skin rash, inflammation, and blistering on 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)

• Decreased appetite
• Elevated potassium levels in the blood (hyperkalemia) that may cause irregular heartbeat
• Increased pressure in the eyes (glaucoma)
• Irregular or abnormal heartbeat (prolongation of the QT interval, Torsades de Pointes, atrial fibrillation, arrhythmia)
• Rapid heartbeat (tachycardia)
• Difficulty breathing (dyspnea)
• During eye surgery for cataracts or increased pressure in the eye (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 alteration
• Nasal bleeding (epistaxis)

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 Medicinal Products 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 disposed of through drains or in the trash. Dispose of the containers and themedicines that you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and the medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Solifenacina/Tamsulosina Alter

• The active principles are solifenacin succinate 6 mg and tamsulosin hydrochloride 0.4 mg.
• The other components are microcrystalline cellulose, high molecular weight macrogol, magnesium stearate, calcium hydrogen phosphate, anhydrous colloidal silica, sodium croscarmellose, red iron oxide (E-172), coating material [hypromellose, macrogol, red iron oxide (E-172), titanium dioxide (E-171)].

Appearance of the product and content of the container

TheSolifenacina/Tamsulosina Alter6 mg/0.4 mg tablets are round, biconvex, approximately 9 mm in diameter, coated with a film, red in color, and marked with “T7S” on one side.

TheSolifenacina/Tamsulosina Altermodified-release tablets are available in pre-cut, single-dose blisters of oPA/Al/PVC-Aluminum that contain 30 tablets.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Responsible for Manufacturing

Synthon Hispania S.L.

C/ Castelló, nº1

Sant Boi de Llobregat

08830 Barcelona

Spain

or

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

or

Synthon s.r.o.

Brnenská 32/cp. 597

678 01 Blansko

Czech Republic

Last review date of this leaflet:

July 2024

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