Leaflet: information for the user

Solifenacina Viso Pharmaceutical 5mg film-coated tablets EFG

Solifenacin succinate

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribedonlyfor you, and you must not give it to others even if they have the same symptomsas you, as it may harm them.
• Ifyou experienceadverse effects, consult your doctor or pharmacist,evenifthey are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to take Solifenacina Viso Pharmaceutical

3.How to take Solifenacina Viso Pharmaceutical

4.Possible adverse effects

5Storage of Solifenacina Viso Pharmaceutical

6.Contents of the pack and additional information

The active ingredient of solifenacina belongs to the group of anticholinergics.These medications are used to reduce the activity of an overactive bladder. This allows you to have more time before needing to go and increases the amount of urine that your bladder can hold.

Solifenacinais used to treat the symptoms of overactive bladder syndrome. These symptoms include: having a strong and sudden need to urinate without warning, having to urinate frequently or having urine leakage because you did not make it to the bathroom on time.

Do not take SolifenacinaViso Farmacéutica

• if you are allergic to solifenacina or any of the other components of this medication (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 in certain muscles.
• if you have high eye pressure, 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 medications that can reduce the elimination of solifenacina from the body (e.g. ketoconazole). Your doctor or pharmacist will inform you if this is the case.

Inform your doctor if you have or have had any of the above-mentioned diseases before starting treatment with solifenacina.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take solifenacina

• if you have difficulty emptying your bladder (bladder obstruction) or urinating (e.g. weak urine flow). The risk of urine accumulation in the bladder (urinary retention) is much higher.
• if you have any digestive system obstruction (constipation).
• if you have an increased risk of decreased digestive system activity (gastrointestinal motility). 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 hiatal hernia or heartburn.
• if you have a nervous system disorder known as autonomic neuropathy.

Inform your doctor before starting treatment with solifenacina if any of the above-mentioned circumstances have occurred at any time.

Before starting treatment with solifenacina, your doctor will evaluate if there are other causes for your frequent urination (e.g. heart failure or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic (a treatment for certain bacterial infections).

Children and Adolescents

Solifenacina should not be used in children or adolescents under 18 years old.

Other Medications and SolifenacinaViso Farmacéutica

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

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

Taking SolifenacinaViso Farmacéuticawith Food and Drinks

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

Pregnancy, Breastfeeding, and Fertility

You should not use solifenacina if you are pregnant unless absolutely necessary. Do not use solifenacina during breastfeeding as solifenacina 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 medication.

Driving and Operating Machines

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

SolifenacinaViso Farmacéuticacontains lactose monohydrate

If your doctor has indicated that you have a hereditary intolerance to certain sugars, consult with them before taking this medication.

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

You must swallow the entire tablet with some liquid, for example, a glass of water. You can take it with or without food, according to your preference. 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

Solifenacina should not be used in children or adolescents under 18 years old.

If you take more Solifenacina Viso Farmacéutica than you should

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

The symptoms of an 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), urine accumulation in the bladder (urinary retention), and pupil dilation (mydriasis).

If you forgot to take Solifenacina Viso Farmacéutica

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, consult your doctor or pharmacist always. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Solifenacina Viso Farmacéutica

If you stop taking this medication, your overactive bladder symptoms may return or worsen. Consult your doctor always if you are thinking of interrupting treatment.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Stop taking Solifenacina Viso Farmacéuticaand seek medical attention immediately if you notice any of the following side effects

• if you experience an allergic attack or severe skin reaction (such as blistering and peeling of the skin)
• angioedema (allergic reaction under the skin's surface) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated withsolifenacina.

Solifenacinamay 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 feeling of stomach heaviness, abdominal pain, belching, nausea, and stomach burning (dyspepsia), stomach discomfort

Rare (may affect up to 1 in 100 people)

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

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

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

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

• hallucinations, confusion
• allergic skin eruption.

Unknown frequency (frequency cannot be estimated from available data)

• decreased appetite, high potassium levels in the blood that may cause abnormal heart rhythm.
• increased eye pressure
• changes in heart electrical activity (ECG), irregular heartbeat, palpitations, rapid heartbeat.
• voice disorder
• liver disorder
• muscle weakness
• renal disorder

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

This medication does not require special conditions for storage.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if the packaging is damaged or shows signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of SolifenacinaViso Pharmaceutical

The active ingredient is solifenacina succinate

Each film-coated tablet contains 5 mg of solifenacina succinate.

The other components are:

Tablet core: cornstarch, lactose monohydrate, hypromellose (E464) and magnesium stearate.

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

Appearance of SolifenacinaViso Pharmaceuticaland packaging contents

Solifenacina Viso Pharmaceutical5 mg film-coated tablets are round, yellowish-colored tablets with a “390” engraved on one face of the tablet.

SolifenacinaViso Pharmaceutical5 mg film-coated tablets are supplied inblister packs of 10, 30, 50, 90 or 100 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Glenmark Arzneimittel GmbH

Industriestr. 31,

82194 Gröbenzell,

Germany

Responsible manufacturer

S.C.Zentiva S.A.

Bd. Theodor Pallady nr 50

032266 Bucuresti

Romania

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Viso Pharmaceutical, S.L.U.

c/ Retama 7, 7ª Planta,

28045 Madrid,

Spain

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

Last review date of this leaflet: August 2017