SOLIFENACIN / TAMSULOSIN SANDOZ 6 mg / 0.4 mg MODIFIED-RELEASE TABLETS

Introduction

Leaflet: information for the user

Solifenacin/Tamsulosin Sandoz 6 mg/0.4 mg modified-release tablets EFG

solifenacin succinate/tamsulosin hydrochloride

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• 1. If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Solifenacin/Tamsulosin Sandoz is and what it is used for
2. What you need to know before taking Solifenacin/Tamsulosin Sandoz
3. How to take Solifenacin/Tamsulosin Sandoz
4. Possible side effects

5 Storage of Solifenacin/Tamsulosin Sandoz

1. Package contents and additional information

1. What Solifenacin/Tamsulosin Sandoz is and what it is used for

Solifenacin/Tamsulosin Sandoz is a combination of two different medicines called solifenacin and tamsulosin in one tablet. Solifenacin belongs to a group of medicines called anticholinergics, and tamsulosin belongs to a group of medicines called alpha-blockers.

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

When the prostate size increases, urinary problems (emptying symptoms) such as delayed urination (difficulty starting urination), reduced urine flow (weak stream), dripping, and a feeling of incomplete emptying of the bladder may appear. 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 warning), and having to urinate more frequently.

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

2. What you need to know before taking Solifenacin/Tamsulosin Sandoz

Do not use Solifenacin/Tamsulosin Sandoz if:

• you are allergic to solifenacin or tamsulosin or any of the other ingredients of this medicine (listed in section 6),
• you are undergoing kidney dialysis,
• you have severe liver disease,
• you have severe kidney disease AND you are being treated with medicines that may decrease the elimination of solifenacin/tamsulosin from the body (e.g., ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this is the case,
• you have moderate liver disease AND you are being treated with medicines that may decrease the elimination of solifenacin/tamsulosin from the body (e.g., 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 of 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 posture (when sitting or standing up); this is called orthostatic hypotension.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take solifenacin/tamsulosin if:

• you have difficulty eliminating fluid (urinary retention),
• you have any obstruction of the digestive system,
• you are at risk of decreased activity of the digestive system (stomach and intestine movements). Your doctor will inform you if this is the case, and if you have a hiatal hernia or heartburn and/or are taking medicines that may 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 for which you are being treated.

Solifenacin/tamsulosin 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 going to undergo or have scheduled eye surgery due to cataracts or increased eye pressure (glaucoma), please inform your ophthalmologist that you have previously used, are using, or plan to use solifenacin/tamsulosin. The specialist can then take the necessary precautions regarding medication and surgical techniques to be used. Ask your doctor if you should postpone or temporarily interrupt taking this medicine when undergoing eye surgery for cataracts or increased eye pressure (glaucoma).

Children and adolescents

Do not give this medicine to children and adolescents.

Other medicines and Solifenacin/Tamsulosin Sandoz

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

• medicines such as ketoconazole, erythromycin, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, and paroxetine, which reduce the rate at which solifenacin/tamsulosin is eliminated from the body,
• other anticholinergic medicines, as the effects and side effects of both medicines may be intensified if you are taking two medicines of the same type,
• medicines such as metoclopramide and cisapride, which may speed up the functioning of the digestive system. Solifenacin/tamsulosin may reduce their effect,
• other alpha-blockers, as they may cause an undesirable decrease in blood pressure,
• medicines such as bisphosphonates, which may cause or exacerbate esophagitis.

Using Solifenacin/Tamsulosin Sandoz with food and drinks

Solifenacin/tamsulosin can be taken with or without food, according to your preferences.

Pregnancy, breastfeeding, and fertility

Solifenacin/tamsulosin is not indicated for use in women.

In men, abnormal ejaculation (ejaculation disorder) has been reported. This means that semen is not released through the urethra but goes into the bladder (retrograde ejaculation) or the ejaculated volume is reduced or nonexistent (ejaculatory failure). This phenomenon is harmless.

Driving and using machines

Solifenacin/tamsulosin may cause dizziness, blurred vision, fatigue, and less frequently, drowsiness. If you experience these side effects, do not drive or use machines.

Solifenacin/Tamsulosin Sandoz contains sodium

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

3. How to take Solifenacin/Tamsulosin Sandoz

Follow exactly the administration instructions of this medicine 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 solifenacin and 0.4 mg of tamsulosin, 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 Solifenacin/Tamsulosin Sandoz than you should

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

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

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

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

If you forget to take Solifenacin/Tamsulosin Sandoz

Take your next solifenacin/tamsulosin tablet as normal. Do not take a double dose to make up for forgotten doses.

If you stop taking Solifenacin/Tamsulosin Sandoz

If you stop taking this medicine, 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Solifenacin/tamsulosin may cause allergic reactions:

• uncommon 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, which may cause difficulty swallowing or breathing (angioedema). Angioedema has been reported rarely with tamsulosin and very rarely with solifenacin. In case of angioedema, treatment with solifenacin/tamsulosin should be permanently and immediately discontinued.

If you experience an allergic reaction or a severe skin reaction (e.g., blistering and peeling of the skin), you should inform your doctor immediately and stop using solifenacin/tamsulosin. Appropriate treatment and/or measures should be applied.

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

• dizziness,
• blurred vision,
• dry mouth, indigestion (dyspepsia), constipation, discomfort (nausea), abdominal pain,
• abnormal ejaculation (ejaculation disorder). This means that semen is not released through the urethra but goes into the bladder (retrograde ejaculation) or the ejaculated volume is reduced or nonexistent (ejaculatory failure). This phenomenon is harmless,
• fatigue (fatigue).

Uncommon side effects(may affect up to 1 in 100 men):

• urinary tract infection, bladder infection (cystitis),
• sleepiness (somnolence), altered sense of taste (dysgeusia), headache,
• dry eyes,
• rapid or irregular heartbeat (palpitations),
• feeling of dizziness or weakness, especially when standing up (orthostatic hypotension),
• runny or stuffy nose (rhinitis), dry nose,
• gastroesophageal reflux disease, diarrhea, dry throat, nausea (vomiting),
• itching (pruritus), dry skin,
• difficulty urinating,
• fluid accumulation in the lower legs (edema), fatigue (asthenia).

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

• feeling of fainting (syncope),
• accumulation of a large amount of hardened feces in the large intestine (fecal impaction),
• 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)

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

Frequency not known(cannot be estimated from the available data)

• severe allergic reaction that causes difficulty breathing or dizziness (anaphylactic reaction),
• decreased appetite, high potassium levels in the blood (hyperkalemia) that may cause abnormal heart rhythm,
• rapid decrease in consciousness and overall 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) may not increase in size conveniently. Additionally, the iris (the colored part of the eye) may become flaccid during surgery, increased eye pressure (glaucoma), vision disturbance,
• irregular or abnormal heartbeat (prolonged QT interval, Torsade de Pointes, atrial fibrillation, arrhythmia), rapid heart rate (tachycardia),
• breathing difficulties (dyspnea), voice disorder, nosebleeds (epistaxis),
• intestinal obstruction (ileus), abdominal discomfort,
• liver disorder,
• skin inflammation that causes redness and peeling in large areas of the body (exfoliative dermatitis),
• muscle weakness,
• kidney disorder.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Solifenacin/Tamsulosin Sandoz

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

Do not use this medicine after the expiry date stated on the package and blister after CAD/EXP. The expiry date is the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Solifenacin/Tamsulosin Sandoz

• The active substances are solifenacin succinate/tamsulosin hydrochloride. Each modified-release tablet contains 6 mg of solifenacin succinate and 0.4 mg of tamsulosin hydrochloride.
• The other excipients are: calcium hydrogen phosphate, microcrystalline cellulose (E460), sodium croscarmellose (E468), hypromellose (E464), red iron oxide (E172), magnesium stearate (E470b), macrogol, high molecular weight macrogol, colloidal anhydrous silica, titanium dioxide (E171).

Appearance of the product and package contents

Solifenacin/Tamsulosin Sandoz 6 mg/0.4 mg modified-release tablets are film-coated, red, round, biconvex tablets marked with "T7S" on one side.

Solifenacin/Tamsulosin Sandoz is available in blisters containing 30 or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

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

Date of last revision of this leaflet:April 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/