Volutsa 6 mg/0.4 mg modified-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Volutsa 6 mg/0.4 mg modified-release tablets

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; 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; do not give it to others, even if they have the same symptoms as you, because it could 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.

Leaflet contents

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

1. What Volutsa is and what it is used for

Volutsa 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.

Volutsa is used in men to treat both moderate to severe filling symptoms and lower urinary tract voiding symptoms caused by bladder-related problems and by enlargement of the prostate (benign prostatic hyperplasia). Volutsa is used when previous treatment with monotherapy for this condition did not adequately relieve symptoms.

When the prostate gland 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 can 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 using Volutsa

Do not use Volutsa 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 at the same time are being treated with medicines that may reduce the elimination of Volutsa 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 at the same time are being treated with medicines that may reduce the elimination of Volutsa 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 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 called 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 Volutsa 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 diaphragmatic tear (hiatal hernia) or heartburn and/or are simultaneously taking medicines that may cause or worsen esophagitis.
• you suffer from a certain type of neurological 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.

Volutsa 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 subside.

If you are scheduled for or planning eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma), please inform your ophthalmologist that you have previously used, are currently using, or plan to use Volutsa. The specialist can then take appropriate precautions regarding medication and surgical techniques. Ask your doctor whether you should delay or temporarily stop taking this medicine before undergoing eye surgery for lens opacity (cataracts) or increased intraocular pressure (glaucoma).

Children and adolescents

Do not administer this medicine to children or adolescents.

Use of Volutsa with other medicines

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 Volutsa 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 Volutsa.
• medicines such as metoclopramide and cisapride, which may accelerate gastrointestinal motility. Volutsa 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 esophagus (esophagitis).

Use of Volutsa with food and drink

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

Pregnancy, breastfeeding and fertility

Volutsa is not indicated for use in women.

In men, abnormal ejaculation (ejaculatory 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

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

3. How to use Volutsa

Follow exactly the administration instructions for this medicine 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 Volutsa 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 useful 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 Volutsa

Take your next Volutsa tablet as usual. Do not take a double dose to make up for missed doses.

If you stop taking Volutsa

If you stop taking Volutsa, 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, Volutsa may produce 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 Volutsa is acute urinary retention, which consists of a sudden inability to urinate. If you think you may be experiencing this, contact your doctor immediately. You may need to stop taking Volutsa.

Volutsa can 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 Volutsa 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 Volutsa. Appropriate treatment and/or measures should be applied.

Common adverse effects (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 enters the bladder (retrograde ejaculation), or the ejaculated volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.
• Feeling of dizziness (nausea)
• Abdominal pain

Uncommon adverse effects (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
• 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 adverse effects (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 adverse effects (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, nose, 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 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 Volutsa

Keep this medicine out of 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 refers to 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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Volutsa

• The active substances are solifenacin succinate 6 mg and tamsulosin hydrochloride 0.4 mg.
• The other components are mannitol (E421), maltose, macrogol, magnesium stearate (E470b), butylated hydroxytoluene (E321), colloidal anhydrous silica (E551), hypromellose (E464), iron oxide red (E172).

Appearance of the product and contents of the pack

Volutsa 6 mg/0.4 mg tablets are round, red film-coated tablets marked with «6/0.4».

Modified-release Volutsa tablets are available in aluminium blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 tablets.

Only certain pack sizes may be available in your country.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Astellas Pharma, S.A.

Paseo de la Castellana, 259 D - 31st Floor

28046 Madrid (Spain)

Manufacturer

Delpharm Meppel B.V.

Hogemaat 2

7942 JG Meppel

The Netherlands

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain, The Netherlands: Volutsa

Date of the most recent review of this leaflet: March 2018

Other sources of information

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