Solifenacin Viso Farmaceutica 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the user

Solifenacina Viso Farmacéutica 10 mg film-coated tablets EFG

Solifenacin succinate

Read all of this leaflet carefully before you start taking this medicine, as 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 pass it on to other people, even if they have the same symptoms as you, as it may 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.

Contents of this leaflet:

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

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

The active substance, solifenacin, belongs to the group of anticholinergic medicines. These medicines are used to reduce the activity of an overactive bladder. This allows you to have more time before needing to go to the toilet and increases the amount of urine your bladder can hold.

Solifenacin is used to treat the symptoms of overactive bladder syndrome. These symptoms include a sudden and strong urge to urinate without prior warning, needing to urinate frequently, or leaking urine because you cannot reach the toilet in time.

2. What you need to know before starting to take Solifenacin Viso Farmacéutica

Do NOT take Solifenacin Viso Farmacéutica

• if you are allergic to solifenacin or to 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 renal disease or moderate liver disease and are simultaneously being treated with medicines that may reduce the elimination of solifenacin from the body (e.g., ketoconazole). Your doctor or pharmacist will inform you if this applies to you.

Before starting treatment with solifenacin, inform your doctor if you have or have ever had any of the conditions listed above.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take solifenacin.

• if you have difficulty emptying your bladder (bladder obstruction) or difficulty urinating (e.g., weak urine stream). 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 are at increased risk of reduced digestive system activity (stomach and intestinal movements). Your doctor will inform you if this applies to you.
• if you have severe kidney disease.
• if you have moderate liver disease.
• if you have a hiatal hernia or heartburn.
• if you have a nervous system disorder known as autonomic neuropathy.

Inform your doctor before starting treatment with solifenacin if any of the above conditions 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 (insufficient pumping capacity of the heart) 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

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

Other medicines and Solifenacin Viso Farmacéutica

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:

• other anticholinergic medicines, as the activity and adverse effects of both medicines could increase. Consult your doctor to determine if your medication belongs to this group.
• cholinergic agents, as they may reduce the effect of solifenacin. Consult your doctor to determine if your medication belongs to this group.
• medicines such as metoclopramide or cisapride, which increase digestive system activity. 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 conditions). These medicines decrease the rate of solifenacin elimination 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 rate of solifenacin elimination from the body.
• medicines such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis). Consult your doctor to determine if your medication belongs to this group.

Taking Solifenacin Viso Farmacéutica with food and drink

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

Pregnancy, breastfeeding, and fertility

You must not use solifenacin if you are pregnant unless 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 are planning 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 operate machinery.

Solifenacin Viso Farmacéutica contains lactose monohydrate

If your doctor has informed you that you have a hereditary intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Solifenacin Viso Farmacéutica

Follow exactly the instructions given by your doctor for administering this medicine. If in doubt, consult your doctor or pharmacist again.

You must swallow the tablet whole with a liquid, e.g. a glass of water. It may be taken with or without food, according to your preference. Do not crush the tablets.

The recommended dose is 5 mg once daily, unless your doctor instructs you to take 10 mg daily.

Use in children and adolescents

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

If you take more Solifenacin Viso Farmacéutica than you should

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

Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness and blurred vision, perception of things that are not present (hallucinations), pronounced excitement, seizures, breathing difficulties, increased heart rate (tachycardia), urine accumulation in the bladder (urinary retention), and pupil dilation (mydriasis).

If you forget to take Solifenacin Viso Farmacéutica

If you forget to take a dose at the usual time, take it as soon as you remember, unless it is almost time for your 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 missed dose.

If you stop taking Solifenacin Viso Farmacéutica

If you stop taking solifenacin, your overactive bladder 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, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking SolifenacinaViso Farmacéutica and seek immediate medical attention if you experience any of the following adverse effects

• if you have an allergic attack or a severe skin reaction (for example, blistering and peeling of the skin)
• angioedema (skin allergy resulting in swelling of the tissue beneath the skin surface) with airway obstruction (difficulty breathing) has been reported in some patients treated with solifenacin.

Solifenacin may cause the following adverse 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 stomach heaviness, abdominal pain, belching, nausea and heartburn (dyspepsia), stomach discomfort

Uncommon (may affect up to 1 in 100 people)

• urinary tract infection, bladder infection
• somnolence
• abnormal taste perception (dysgeusia)
• dry (irritated) eyes
• dry nasal passages
• reflux disease (gastroesophageal reflux)
• 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 large amounts of hardened feces in the colon (fecal impaction)
• urine retention 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 available data)

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

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 Solifenacin Viso Farmacéutica

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 refers to the last day of the month indicated.

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

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

6. Contents of the pack and other information

Composition of Solifenacin Viso Farmacéutica

The active substance is solifenacin succinate.

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

The other components are:

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

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

Appearance of Solifenacin Viso Farmacéutica and contents of the pack

Solifenacin Viso Farmacéutica 10 mg are film-coated tablets, round, light pink in colour, with "391" engraved on one side of the tablet.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

S.C. Zentiva S.A.

Bd. Theodor Pallady nr 50

032266 Bucuresti

Romania

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicine is authorised in the Member States under the following names:

Date of the latest review of this leaflet: August 2017