SOLIFENACIN VISO FARMACEUTICA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

SolifenacinViso Pharmaceutical10 mg film-coated tablets EFG

Solifenacin Succinate

Read the package leaflet carefully before starting to take the medicine, as it contains important information for you

• Keep this package leaflet, as 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Solifenacin Viso Pharmaceutical and what is it used for
2. What you need to know before taking Solifenacin Viso Pharmaceutical
3. How to take Solifenacin Viso Pharmaceutical
4. Possible side effects

5 Conservation of Solifenacin Viso Pharmaceutical

1. Contents of the pack and further information

1. What is Viso Pharmaceutical and what is it used for

The active substance of solifenacin belongs to the group of anticholinergics. These medicines are used to reduce the activity of the overactive bladder. This allows you to have more time before you need to urinate and increases the amount of urine that your bladder can hold.

Solifenacin is used to treat the symptoms of overactive bladder syndrome. These symptoms include: having a strong and sudden need to urinate without prior warning, having to urinate frequently, or having urine leakage due to not reaching the toilet in time.

2. What you need to know before taking Solifenacin Viso Pharmaceutical

Do not take SolifenacinViso Pharmaceutical

• if you are allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6).
• if you have difficulty urinating or emptying your bladder completely (urinary retention)
• if you have a severe stomach or intestinal disorder (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 high pressure in the eyes with gradual loss of vision (glaucoma)
• if you are undergoing renal dialysis
• if you have severe liver disease
• if you have severe kidney disease or moderate liver disease and are being treated with medicines that may decrease the elimination of solifenacin from the body (e.g., ketoconazole). Your doctor or pharmacist will inform you if this is the case.

Before starting treatment with solifenacin, inform your doctor if you have or have had any of the above-mentioned diseases.

Warnings and precautions

Consult your doctor or pharmacist before starting to take solifenacin.

• if you have a problem emptying your bladder (obstruction of the bladder) or urinating (e.g., a weak urine flow). The risk of urine accumulation in the bladder (urinary retention) is much higher.
• if you have any obstruction of the digestive system (constipation).
• if you have an increased risk of decreased activity of the digestive system (movements of the stomach and intestine). Your doctor will inform you if this is the case.
• if you have severe kidney disease.
• if you have moderate liver disease.
• if you have a hiatal hernia or heartburn.
• if you have a disorder of the nervous system known as autonomic neuropathy.

Inform your doctor before starting treatment with solifenacin if any of the above-mentioned circumstances have ever occurred to you.

Before starting treatment with solifenacin, your doctor will assess whether there are other causes for your frequent need to urinate (e.g., heart failure or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic (treatment against certain bacterial infections).

Children and adolescents

Solifenacin should not be used in children or adolescents under 18 years of age.

Other medicines and SolifenacinViso Pharmaceutical

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

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

• other anticholinergic medicines, as the activity and side effects of both medicines may increase. Consult your doctor if your medication belongs to this group.
• cholinergic medicines, as they may reduce the effect of solifenacin. Consult your doctor if your medication belongs to this group.
• medicines such as metoclopramide or cisapride, which make the digestive system work faster. Solifenacin may reduce their effect.
• medicines such as ketoconazole, itraconazole (medicines used to treat fungal infections), ritonavir, nelfinavir (medicines used to treat HIV infections), and verapamil, diltiazem (medicines used to treat hypertension and heart disease). These medicines decrease the elimination of solifenacin from the body.
• medicines such as rifampicin (a medicine used to treat tuberculosis and other bacterial infections) and phenytoin, carbamazepine (medicines used to treat epilepsy). These may increase the elimination of solifenacin from the body.
• medicines such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis). Consult your doctor if your medication belongs to this group.

Taking SolifenacinViso Pharmaceuticalwith food and drinks

Solifenacin can be taken with or without food, as you prefer.

Pregnancy, breastfeeding, and fertility

Do not use solifenacin if you are pregnant unless it is absolutely necessary. Do not use solifenacin during breastfeeding, as solifenacin may pass into breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Solifenacin may cause blurred vision and sometimes drowsiness or fatigue. If you experience any of these side effects, do not drive or use machines.

SolifenacinViso Pharmaceuticalcontains lactose monohydrate

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Solifenacin Viso Pharmaceutical

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Swallow the tablet whole with some liquid, e.g., a glass of water. It can be taken with or without food, as you prefer. Do not crush the tablets.

The recommended dose is 5 mg per day, unless your doctor tells you to take 10 mg per day.

Use in children and adolescents

Solifenacin should not be used in children or adolescents under 18 years of age.

If you take more SolifenacinViso Pharmaceuticalthan you should

If you have taken too much solifenacin or if a child has taken solifenacin accidentally, contact your doctor or pharmacist immediately, or call the Toxicological Information Service (Tel. 91 562 04 20).

The symptoms in case of overdose may include: headache, dry mouth, dizziness, drowsiness, and blurred vision, perception of things that are not there (hallucinations), pronounced excitement, convulsions, difficulty breathing, increased heart rate (tachycardia), accumulation of urine in the bladder (urinary retention), and dilation of the pupils (mydriasis).

If you forget to take SolifenacinViso Pharmaceutical

If you forget to take a dose at the usual time, take it as soon as you remember, unless it is time to take the next dose. Never take more than one dose per day. If you have any doubts, always consult your doctor or pharmacist. Do not take a double dose to make up for a forgotten dose.

If you stop taking SolifenacinViso Pharmaceutical

If you stop taking solifenacin, your overactive bladder symptoms may return or worsen. Always consult your doctor if you are thinking of stopping treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking SolifenacinViso Pharmaceuticaland seek medical attention immediately if you notice any of the following side effects

• if you suffer an allergic attack or a severe skin reaction (e.g., blistering and peeling of the skin)
• angioedema (allergy in the skin that results in inflammation that occurs in the tissue under the skin surface) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacin.

Solifenacin may cause the following side effects:

Very common (may affect more than 1 in 10 people)

• dry mouth

Common (may affect up to 1 in 10 people)

• blurred vision
• constipation, nausea, indigestion with symptoms such as a feeling of heaviness in the stomach, abdominal pain, belching, nausea, and heartburn (dyspepsia), stomach discomfort

Uncommon (may affect up to 1 in 100 people)

• urinary tract infection, bladder infection
• drowsiness
• abnormal taste perception (dysgeusia)
• dry eyes (irritated)
• dryness of the nasal passages
• gastroesophageal reflux disease
• dry throat
• dry skin
• difficulty urinating
• fatigue
• fluid accumulation in the lower limbs (edema)

Rare (may affect up to 1 in 1,000 people)

• accumulation of a large amount of hardened feces in the large intestine (fecal impaction)
• accumulation of urine in the bladder due to inability to empty the bladder (urinary retention)
• dizziness, headache
• vomiting
• itching, skin rash

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

• hallucinations, confusion
• allergic skin rash.

Frequency not known (frequency cannot be estimated from the available data)

• decreased appetite, high levels of potassium in the blood that can cause an abnormal heart rhythm.
• increased pressure in the eyes
• changes in the electrical activity of the heart (ECG), irregular heartbeats, palpitations, rapid heartbeat.
• voice disorder
• liver disorder
• 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 package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Solifenacin Viso Pharmaceutical

This medicine does not require special storage conditions.

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

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

Do not use this medicine if the packaging is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of SolifenacinViso Pharmaceutical

The active substance is solifenacin succinate.

Each film-coated tablet contains 10 mg of solifenacin succinate.

The other ingredients are:

Core of the tablet: corn starch, lactose monohydrate, hypromellose (E464), and magnesium stearate.

Film coating: hypromellose (E464), macrogol, talc (E553b), titanium dioxide (E171), and red iron oxide (E172).

Appearance of SolifenacinViso Pharmaceuticaland contents of the pack

Solifenacin Viso Pharmaceutical 10 mg are film-coated tablets, round, light pink in color, with a "391" engraved on one face of the tablet.

Solifenacin Viso Pharmaceutical 10 mg film-coated tablets are supplied in blisters of 10, 30, 50, 90, or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

S.C. Zentiva S.A.

Bd. Theodor Pallady nr 50

032266 Bucuresti

Romania

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª planta

28045 Madrid

Spain

This medicine is authorized in the Member States with the following names:

Date of the last revision of this package leaflet: August 2017