Vesolta 6 mg/0.4 mg modified-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vesolta 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 could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Vesolta is and what it is used for
2. What you need to know before taking Vesolta
3. How to take Vesolta
4. Possible side effects
5. How to store Vesolta
6. Contents of the pack and other information

1. What Vesolta is and what it is used for: and what it is used for

What Vesolta is

Vesolta 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 known as alpha-blockers.

What Vesolta is used for

This medicine 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 prostate enlargement (benign prostatic hyperplasia). This medicine is used when previous treatment with monotherapy for this condition did not adequately relieve 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 urinate without warning), 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 bathroom. Tamsulosin allows urine to pass more easily through the urethra and facilitates urination.

2. What you need to know before taking Vesolta

Do not take Vesolta:

• if you are allergic to solifenacin or tamsulosin or to any of the other ingredients of this medicine (listed in section 6).
• if you are undergoing renal dialysis.
• if you have severe liver disease.
• if you have severe renal disease AND are simultaneously being treated with medicines that may reduce the elimination of this medicine from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this is the case.
• if you have moderate liver disease AND are simultaneously being treated with medicines that may reduce the elimination of this medicine from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this is the case.
• if you have a severe stomach or intestinal condition (including toxic megacolon, a complication associated with ulcerative colitis).
• if you have a muscle disorder called myasthenia gravis, which can cause extreme weakness of certain muscles.
• if you have increased pressure in the eyes (glaucoma), with gradual loss of vision.
• if you experience fainting due to a drop in blood pressure upon changing posture (when 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 this medicine:

• if you have difficulty passing urine (urinary retention).
• if you have any obstruction of the gastrointestinal tract.
• if you are at risk of reduced gastrointestinal motility (stomach and intestinal movements). Your doctor will inform you if this applies.
• if you have a tear in the diaphragm (hiatal hernia) or heartburn and/or are simultaneously taking medicines that may cause or worsen oesophagitis.
• if you have a certain type of nerve disorder (autonomic neuropathy).
• if you have severe renal disease.
• if 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). You should sit or lie down if you experience any of these symptoms until they resolve.

If you are undergoing or have scheduled 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 this medicine. The specialist can then take appropriate precautions regarding medication and surgical techniques. Ask your doctor whether you should delay or temporarily interrupt taking this medicine before undergoing eye surgery for lens opacity (cataracts) or increased eye pressure (glaucoma).

Children and adolescents

Do not administer this medicine to children or adolescents.

Other medicines and Vesolta

Inform 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 this medicine is eliminated from the body.
• other anticholinergic medicines, as the effects and adverse effects of both medicines may be intensified when taking two medicines of the same type.
• cholinergics, as they may reduce the effect of this medicine.
• medicines such as metoclopramide and cisapride, which may accelerate gastrointestinal motility. This medicine 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 Vesolta with food and drinks

This medicine may be taken with or without food, according to your preference.

Pregnancy, breastfeeding and fertility

This medicine 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 instead 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 adverse effects, do not drive or operate machinery.

3. How to use Vesolta

Follow exactly the administration instructions for 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, depending on your preference. Do not crush or chew the tablet.

If you take more Vesolta 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.

If you forget to take Vesolta

Take your next dose of this medicine as usual. Do not take a double dose to make up for missed doses.

If you stop taking Vesolta

If you stop taking this medicine, 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.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The most serious adverse effect observed infrequently (which may affect up to 1 in 100 men) during clinical studies with this medicine is acute urinary retention, which consists of a sudden inability to urinate. If you think you may be experiencing this, seek immediate medical attention. You may need to stop taking this medicine.

This medicine may cause allergic reactions:

• Uncommon signs of allergic reactions may include 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 immediately and permanently discontinued.

If you experience an allergic crisis or a severe skin reaction (for example, 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.

Tell your doctor or pharmacist if you experience any of the following side effects:

Common (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 exit through the urethra but instead goes into the bladder (retrograde ejaculation), or that the volume ejaculated is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.
• Feeling of dizziness (nausea).
• Abdominal pain.

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

• Somnolence.
• Itching (pruritus).
• Urinary tract infection, bladder infection (cystitis).
• Disturbance of taste sensation (dysgeusia).
• Dry eyes.
• Nasal dryness.
• Gastroesophageal reflux disease (gastroesophageal reflux).
• Dry throat.
• Dry skin.
• Difficulty urinating.
• Fluid accumulation in the legs (edema).
• Headache.
• Rapid or irregular heartbeat (palpitations).
• Feeling of dizziness or weakness, especially when standing up (orthostatic hypotension).
• Runny or blocked nose (rhinitis).
• Diarrhea.
• Vomiting.
• Tiredness (asthenia).

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

• Accumulation of a large amount of hardened feces in the large intestine (fecal impaction).
• Feeling of fainting (syncope).
• Skin allergy causing swelling in the tissue beneath the skin surface (angioedema).

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

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

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

• Decreased appetite.
• Elevated blood potassium levels (hyperkalemia), which may cause abnormal heart rhythm.
• Increased pressure in the eyes (glaucoma).
• Irregular or abnormal heartbeat (QT interval prolongation, Torsades de Pointes, atrial fibrillation, arrhythmia).
• Rapid heart rate (tachycardia).
• Difficulty breathing (dyspnea).
• 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 floppy during surgery.
• Voice disorder.
• Liver disorder.
• Muscle weakness.
• Kidney disorder.
• Vision disturbance.
• Nosebleed (epistaxis).

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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vesolta

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

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vesolta

• The active substances are 6 mg of solifenacin succinate and 0.4 mg of tamsulosin hydrochloride.
• The other components are microcrystalline cellulose, high molecular weight polyethylene glycol, colloidal anhydrous silica, magnesium stearate, anhydrous calcium hydrogen phosphate, silicified microcrystalline cellulose (colloidal anhydrous silica and microcrystalline cellulose), low-substituted hydroxypropyl cellulose; coating material: hypromellose; polyethylene glycol; red iron oxide (E172).

Appearance of the product and contents of the pack

Vesolta 6 mg/0.4 mg tablets are film-coated, red, round, 9 mm in diameter, biconvex, and marked with «6 0.4» on one side.

Modified-release Vesolta tablets are available in sealed PA/Al/PVC blisters with an aluminum foil lid, containing 30 tablets.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice, Lodzkie

Poland

 OR

Adalvo Limited

Malta Life Sciences Park,

Building 1, Level 4, Sir Temi Zammit Buildings,

SGN 3000, San Gwann

Malta

Date of the most recent review of this leaflet:

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