SOLIFENACIN / TAMSULOSIN Aurovitas 6 mg / 0.4 mg Modified-Release Tablets

Introduction

Package Leaflet: Information for the User

Solifenacin/Tamsulosin Aurovitas 6 mg/0.4 mg modified-release tablets

EFG

solifenacin, succinate/tamsulosin, hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Solifenacin/Tamsulosin Aurovitas is and what it is used for
2. What you need to know before you take Solifenacin/Tamsulosin Aurovitas
3. How to take Solifenacin/Tamsulosin Aurovitas
4. Possible side effects
5. Storage of Solifenacin/Tamsulosin Aurovitas
6. Contents of the pack and other information

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

Solifenacin/Tamsulosin Aurovitas 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 Aurovitas 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 Aurovitas is used when previous monotherapy treatment for this condition did not sufficiently relieve the symptoms.

When the prostate gland enlarges, it can cause 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. At the same time, the bladder is also affected and contracts involuntarily at times when urination is not desired. This causes filling symptoms such as changes in bladder sensation, urgency (having a strong and sudden need to urinate without prior warning), and having to urinate more frequently.

Solifenacin reduces involuntary contractions of the bladder and increases the amount of urine that your bladder can hold. Therefore, you can expect to wait longer before you need 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 you take Solifenacin/Tamsulosin Aurovitas

Do not take Solifenacin/Tamsulosin Aurovitas if:

• You are allergic to solifenacin or tamsulosin or any of the other ingredients of this medicine (listed in section 6).
• You are undergoing renal dialysis.
• You have severe liver disease.
• You have severe kidney disease and 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 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 pressure in the eyes (glaucoma), with gradual loss of vision.
• You experience fainting due to a decrease in blood pressure when changing position (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 use 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 intestinal movements). Your doctor will inform you if this is the case.
• You have a tear in the diaphragm (hiatal hernia) or heartburn and/or are taking medicines that may cause or worsen esophagitis.
• You have a certain type of nerve 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.

This medicine 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 have or have scheduled 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 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 you are going to have eye surgery for cataracts or increased pressure in the eye (glaucoma).

Children and adolescents

Do not give this medicine to children and adolescents.

Other medicines and Solifenacin/Tamsulosin Aurovitas

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 that reduce the rate at which solifenacin/tamsulosin is eliminated from the body.
• Other anticholinergic medicines, as the effects and side effects of both medicines can be intensified if you are taking two medicines of the same type.
• Cholinergics, as they may reduce the effect of solifenacin/tamsulosin.
• Medicines such as metoclopramide and cisapride, which can speed up the functioning of the digestive system. Solifenacin/tamsulosin may reduce their effect.
• Other alpha-blockers, as they may cause an undesired drop in blood pressure.
• Medicines such as bisphosphonates, which may cause or exacerbate inflammation of the esophagus (esophagitis).

Taking Solifenacin/Tamsulosin Aurovitas 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 instead goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory failure). This phenomenon is harmless.

Driving and using machines

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

Solifenacin/Tamsulosin Aurovitas contains sodium

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

3. How to take Solifenacin/Tamsulosin Aurovitas

Follow exactly the administration instructions of this medicine given 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, depending on your preferences. Do not crush or chew the tablet.

If you take more Solifenacin/Tamsulosin Aurovitas 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, your doctor may treat you with activated charcoal; emergency stomach washing may be useful if performed within one hour of overdose. Do not induce vomiting.

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

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 ingested.

If you forget to take Solifenacin/Tamsulosin AurovitasAurovitas

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

If you stop taking Solifenacin/Tamsulosin Aurovitas

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, solifenacin/tamsulosin can cause side effects, although not everybody gets them.

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

Solifenacin/tamsulosin may cause allergic reactions:

• Uncommon signs of allergic reactions may include skin rash (which may itch) or hives (urticaria).
• Rare symptoms include swelling of the face, lips, mouth, tongue, or throat that can cause difficulty swallowing or breathing (angioedema). Angioedema has been reported rarely with tamsulosin and very rarely with solifenacin. In case of angioedema, treatment with this medicine should be definitively 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 this medicine. Treatment and/or measures should be applied.

Frequentside effects (may affect up to 1 in 10 men)

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

Uncommonside effects (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)
• feeling of dizziness or weakness, especially when standing up (orthostatic hypotension)
• runny or stuffy nose (rhinitis), dry nose
• itching (pruritus), dry skin
• difficulty urinating
• fluid accumulation in the legs (edema), fatigue (asthenia)

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

• 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 rareside 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 levels of potassium in the blood (hyperkalemia) that can cause abnormal heart rhythm
• rapid decrease in consciousness and general mental function (delirium)
• 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) does not increase in size properly. Additionally, the iris (the colored part of the eye) may become flaccid during surgery, increased pressure in the eyes (glaucoma), vision changes
• irregular or abnormal heartbeat (prolonged QT interval, Torsades de Pointes, atrial fibrillation, arrhythmia), rapid heartbeat (tachycardia)
• breathing difficulties (dyspnea), voice disorder, nosebleeds (epistaxis)
• intestinal obstruction (ileus), abdominal discomfort
• liver disorder
• inflammation of the skin causing 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Solifenacin/Tamsulosin Aurovitas

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

Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiry date is the last day of the month stated.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicinal products in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicinal products. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Solifenacin/tamsulosin Aurovitas

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

Appearance of the Product and Container Contents

The modified-release tablets of Solifenacin/tamsulosin Aurovitas 6 mg/0.4 mg are round, biconvex, film-coated red, marked with «T7S» on one face.

Solifenacin/tamsulosin Aurovitas modified-release tablets are available in blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 modified-release tablets or unit dose blisters containing 10x1, 14x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 100x1 or 200x1 modified-release tablets.

Only some pack sizes may be available in your country.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Synthon Hispania S.L.

Calle De Castelló 1

08830 Sant Boi De Llobregat

Barcelona

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet:April 2023

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