VESOLTA 6 MG/0.4 MG EXTENDED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

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

1. What is Vesolta and what is it used for

What isVesolta

Vesolta 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.

What isVesolta used for

This medicine 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). This medicine is used when previous treatment with monotherapy 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 spontaneously 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 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 hold. Therefore, you can wait longer before you have 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 Vesolta

Do not take Vesolta:

• if you are allergic to solifenacin or tamsulosin or 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 kidney disease AND if, at the same time, you are being treated with medicines that may decrease 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 if, at the same time, you are being treated with medicines that may decrease 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 disease 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 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 take this medicine:

• if you have difficulty emptying your bladder (urinary retention).
• if you have any obstruction of the digestive tract.
• if you have a risk of decreased digestive tract activity (stomach and intestine movements). Your doctor will inform you if this is the case.
• if you have a tear in the diaphragm (hiatal hernia) or heartburn and/or if, at the same time, you are taking medicines that may cause or worsen esophagitis.
• if you have a certain type of nerve disease (autonomic neuropathy).
• if you have severe kidney disease.
• if 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 undergo 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 this medicine. The specialist can then take the necessary precautions regarding medication and surgical techniques. Ask your doctor if you should postpone or temporarily stop taking this medicine when you are going to undergo eye surgery for cataracts or increased pressure in the eyes (glaucoma).

Children and adolescents

Do not give this medicine to children and adolescents.

Other medicines and Vesolta

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

It is especially important that you tell 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 side effects of both medicines can be intensified if you are taking two medicines of the same type.
• cholinergics, as they can reduce the effect of this medicine.
• medicines such as metoclopramide and cisapride, which can speed up the functioning of the digestive tract. This medicine may reduce their effect.
• other alpha-blockers, as they can cause an undesired drop in blood pressure.
• medicines such as bisphosphonates, which can cause or exacerbate inflammation of the esophagus (esophagitis).

Using Vesolta with food and drinks

This medicine can be taken with or without food, according to your preferences.

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 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.

3. How to take Vesolta

Follow exactly the instructions for taking this medicine as indicated by your doctor or pharmacist. If you are unsure, 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 Vesolta 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 lavage 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, convulsions, difficulty breathing, increased heart rate (tachycardia), inability to empty the bladder completely or partially or to urinate (urinary retention), and/or undesired increase in blood pressure.

If you forget to take Vesolta

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

If you stop taking Vesolta

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 further questions on the use of this medicine, ask your doctor or pharmacist.

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

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 a frequency of less than 1 in 100 men during treatment with this medicine in clinical studies is acute urinary retention, which is an inability to urinate. If you think you may have this, go to your doctor immediately. You may need to stop taking this medicine.

This medicine 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 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 stopped immediately and definitively.

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.

Tell your doctor or pharmacist if you get 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 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.
• Feeling sick (nausea).
• Abdominal pain.

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

• Drowsiness.
• Itching (pruritus).
• Urinary tract infection, bladder infection (cystitis).
• Taste disorder (dysgeusia).
• Dry eyes.
• Dry nose.
• Gastroesophageal reflux disease (gastroesophageal reflux).
• Dry throat.
• Dry skin.
• Difficulty urinating.
• Fluid accumulation in the legs (edema).
• Headache.
• Fast or irregular heartbeat (palpitations).
• Feeling of dizziness or weakness, especially when standing up (orthostatic hypotension).
• Nasal congestion or stuffiness (rhinitis).
• Diarrhea.
• Vomiting.
• Weakness (asthenia).

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

• A large amount of hardened feces in the large intestine (fecal impaction).
• Fainting (syncope).
• Allergic reaction in the skin that causes swelling in the tissue under the skin surface (angioedema).

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

• Hallucinations, confusion.
• Allergic skin 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 the available data):

• Decreased appetite.
• High levels of potassium in the blood (hyperkalemia) that can cause abnormal heart rhythm.
• Increased pressure in the eyes (glaucoma).
• Abnormal heart rhythm (prolonged QT interval, Torsades de Pointes, atrial fibrillation, arrhythmia).
• Fast heart rate (tachycardia).
• Breathing difficulties (dyspnea).
• During eye surgery for cataracts or increased pressure in the eyes (glaucoma), it is possible that the pupil (the black circle in the center of the eye) may not increase in size properly. Additionally, the iris (the colored part of the eye) may become flaccid during surgery.
• Voice disorder.
• Liver disorder.
• Muscle weakness.
• Kidney disorder.
• Vision disorder.
• Nosebleed (epistaxis).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Vesolta

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 shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. 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 ingredients are microcrystalline cellulose, high molecular weight macrogol, anhydrous colloidal silica, magnesium stearate, anhydrous calcium hydrogen phosphate, silicified microcrystalline cellulose (anhydrous colloidal silica and microcrystalline cellulose); coating material:hypromellose; macrogol; red iron oxide (E172).

Appearance and packaging of Vesolta

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

Vesolta modified release tablets are available in PA/Al/PVC blister packs sealed with an aluminum foil, 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

Adalvo Limited

Malta Life Sciences Park,

Building 1, Level 4, Sir Temi Zammit Buildings,

SGN 3000, San Gwann

Malta

Date of last revision of this leaflet:

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/