Solifenacin/tamsulosin Aurovitas 6 mg/0.4 mg modified-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

EFG

solifenacin succinate/tamsulosin hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Solifenacin/tamsulosin Aurovitas is and what it is used for
2. What you need to know before taking Solifenacin/tamsulosin Aurovitas
3. How to take Solifenacin/tamsulosin Aurovitas
4. Possible side effects
5. How to store 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 known as 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 voiding symptoms of the lower urinary tract caused by bladder problems and by an enlarged prostate (benign prostatic hyperplasia). Solifenacin/Tamsulosin Aurovitas is used when prior monotherapy treatment for this condition has not adequately relieved symptoms.

When the prostate enlarges, urinary problems (voiding symptoms) may occur, such as delayed urination (difficulty starting to pass urine), reduced urine flow (weak stream), dribbling, and a sensation of incomplete bladder emptying. 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 sudden, strong need to pass urine), and increased frequency of urination.

Solifenacin reduces involuntary contractions of the bladder and increases the amount of urine that your bladder can hold. Therefore, you may be able to wait longer before needing to go to the toilet. Tamsulosin allows urine to pass more easily through the urethra and helps urination.

2. What you need to know before starting to take Solifenacin/Tamsulosin Aurovitas

Do not use Solifenacin/Tamsulosin Aurovitas if:

• You are allergic to solifenacin or tamsulosin or to 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 renal disease and are simultaneously being treated with medicines that may reduce the elimination of solifenacin/tamsulosin from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this applies to you.
• You have moderate liver disease and are simultaneously being treated with medicines that may reduce the elimination of solifenacin/tamsulosin from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this applies to you.
• You have a severe stomach or intestinal condition (including toxic megacolon, a complication associated with ulcerative colitis).
• You have a muscle disorder 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 drop in blood pressure when changing posture (sitting or standing up); this is known as orthostatic hypotension.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to use solifenacin/tamsulosin if:

• You have difficulty passing urine (urinary retention).
• You have any obstruction of the gastrointestinal tract.
• You are at risk of reduced gastrointestinal motility (stomach and intestinal movements). Your doctor will inform you if this applies to you.
• You have a tear in the diaphragm (hiatal hernia) or suffer from heartburn and/or are simultaneously taking medicines that may cause or worsen esophagitis.
• You have a certain type of nervous system disorder (autonomic neuropathy).
• You have severe renal disease.
• You have moderate liver disease.

Regular medical check-ups are necessary to monitor the condition for which you are being treated.

This medicine may affect blood pressure, which could cause dizziness, lightheadedness, or rarely, fainting (orthostatic hypotension). If you experience any of these symptoms, you should sit or lie down until they disappear.

If you are scheduled for or undergoing eye surgery due to clouding of the lens (cataracts) or increased pressure in the eye (glaucoma), please inform your ophthalmologist that you have previously used, are currently using, or plan to use solifenacin/tamsulosin. The specialist can then take appropriate precautions regarding medication and surgical techniques. Ask your doctor whether you should delay or temporarily discontinue taking this medicine prior to undergoing eye surgery for cataracts or glaucoma.

Children and adolescents

Do not administer this medicine to children or adolescents.

Other medicines and Solifenacin/Tamsulosin Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• 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 when taking two medicines of the same type.
• Cholinergics, as they may reduce the effect of solifenacin/tamsulosin.
• Medicines such as metoclopramide and cisapride, which may accelerate gastrointestinal motility. Solifenacin/tamsulosin may reduce their effect.
• Other alpha-blockers, as they may cause an undesirable drop in blood pressure.
• Medicines such as bisphosphonates, which may cause or worsen inflammation of the oesophagus (oesophagitis).

Taking Solifenacin/Tamsulosin Aurovitas with food and drink

Solifenacin/tamsulosin may be taken with or without food, according to your preference.

Pregnancy, breast-feeding and fertility

Solifenacin/tamsulosin is not indicated for use in women.

In men, abnormal ejaculation (ejaculation disorder) has been reported. This means that semen does not exit through the urethra but enters the bladder (retrograde ejaculation), or that the ejaculated volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and using machines

This medicine may cause dizziness, blurred vision, fatigue, and less frequently, somnolence. If you experience these side effects, do not drive or operate machinery.

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 instructions for use of this medicine as given 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 solifenacin and 0.4 mg of tamsulosin, 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 Solifenacin/Tamsulosin Aurovitas than you should

If you have taken more tablets than prescribed, or if someone else accidentally takes your tablets, 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 helpful if performed within one hour of the overdose. Do not induce vomiting.

Symptoms of overdose may include: dry mouth, dizziness and blurred vision, seeing things that are not there (hallucinations), over-excitability, seizures, 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.

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

If you forget to take Solifenacin/Tamsulosin AurovitasAurovitas

Take your next tablet of Solifenacin/Tamsulosin Aurovitas at your usual time. Do not take a double dose to make up for missed doses.

If you stop taking Solifenacin/Tamsulosin Aurovitas

If you stop taking Solifenacin/Tamsulosin Aurovitas, your original symptoms may return or worsen. Always consult your doctor if you are considering stopping treatment.

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

4. Possible adverse effects

Like all medicines, solifenacin succinate/hydrochloride tamsulosin may cause adverse effects, although not everyone experiences them.

The most serious adverse effect observed infrequently (affecting up to 1 in 100 men) during clinical studies with solifenacin succinate / tamsulosin hydrochloride is acute urinary retention, which involves a sudden inability to urinate. If you think you may be experiencing this, contact 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 be itchy) 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 this medicine must be permanently and immediately discontinued.

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

Frequent adverse 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 (ejaculatory disorder). This means that semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or the ejaculated volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless
• tiredness (fatigue)

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

• urinary tract infection, bladder infection (cystitis)
• drowsiness, disturbance of taste sensation (dysgeusia), headache
• dry eyes
• rapid or irregular heartbeat (palpitations)
• feeling 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), tiredness (asthenia)

Rare adverse 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)
• skin allergy causing swelling in the tissue beneath the skin surface (angioedema)

Very rare adverse 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)

Adverse effects with frequency not known (frequency cannot be estimated from available data)

• severe allergic reaction causing difficulty breathing or dizziness (anaphylactic reaction)
• decreased appetite, elevated blood potassium levels (hyperkalemia) which may cause abnormal heart rhythm
• rapid decrease in consciousness and general mental function (delirium)
• during eye surgery for lens clouding (cataracts) or increased eye pressure (glaucoma), the pupil (the black circle in the center of the eye) may not dilate properly. In addition, the iris (the colored part of the eye) may become flaccid during surgery, increased eye pressure (glaucoma), vision disturbances
• irregular or abnormal heartbeat (prolonged QT interval, Torsades de Pointes, atrial fibrillation, arrhythmia), rapid heart rate (tachycardia)
• difficulty breathing (dyspnea), voice disorder, nosebleed (epistaxis)
• intestinal obstruction (ileus), abdominal discomfort
• liver disorder
• skin inflammation causing redness and peeling over large areas of the body (exfoliative dermatitis)
• muscle weakness
• kidney disorder

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 refers to the last day of the month indicated.

Store below 25°C.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and any waste materials, including packaging, to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Solifenacina/tamsulosina Aurovitas

• The active substances 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 components are: calcium hydrogen phosphate, microcrystalline cellulose (E460), sodium croscarmellose (E468), hypromellose (E464), iron oxide red (E172), magnesium stearate (E470b), high molecular weight polyethylene glycol, polyethylene glycol, colloidal anhydrous silica, titanium dioxide (E171).

Nature of the product and contents of the pack

Solifenacina/tamsulosina Aurovitas 6 mg/0.4 mg modified-release tablets are round, biconvex, film-coated red tablets, marked with «T7S» on one side.

Solifenacina/tamsulosina 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 in unit-dose blisters containing 10x1, 14x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 100x1 or 200x1 modified-release tablets.

Only certain 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 most recent review of this leaflet: April 2023

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