Solifenacin Vivanta 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Solifenacina Vivanta 5 mg film-coated tablets EFG

solifenacin succinate

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

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Solifenacina Vivanta is and what it is used for
2. What you need to know before taking Solifenacina Vivanta
3. How to take Solifenacina Vivanta
4. Possible adverse effects

5 Storage of Solifenacina Vivanta

1. Contents of the pack and other information

1. What Solifenacina Vivanta is and what it is used for

The active substance in Solifenacina Vivanta 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 needing to go to the toilet and increases the amount of urine your bladder can hold.

Solifenacina Vivanta 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 due to not reaching the toilet in time.

2. What you need to know before starting Solifenacin Vivanta

Do not take Solifenacin Vivanta

• if you have difficulty passing urine or emptying your bladder completely (urinary retention)
• if you have a severe stomach or bowel 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 allergic to solifenacin 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 renal disease or moderate liver disease and are also 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 Vivanta, inform your doctor if you have or have had any of the conditions mentioned above.

Warnings and precautions

Consult your doctor or pharmacist before starting Solifenacin Vivanta

• if you have difficulty emptying your bladder (= bladder obstruction) or passing urine (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 hiatus hernia or heartburn.
• if you have a nervous system disorder (autonomic neuropathy).

Children and adolescents

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

Inform your doctor before starting treatment with Solifenacin Vivanta if any of the above-mentioned conditions has ever occurred in your case.

Before starting treatment with Solifenacin Vivanta, your doctor will assess whether there are other causes for your frequent need to urinate (for example, heart failure (inadequate 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).

Taking Solifenacin Vivanta with other medicines

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.
• cholinergics, as they may reduce the effect of solifenacin.
• medicines such as metoclopramide or cisapride, which increase digestive system activity. Solifenacin may reduce their effect.
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazol, verapamil, and diltiazem, which decrease the rate of elimination of solifenacin from the body.
• medicines such as rifampicin, phenytoin, and carbamazepine, as they may increase the rate of elimination of solifenacin from the body.
• medicines such as bisphosphonates, which may cause or worsen inflammation of the oesophagus (oesophagitis).

Taking Solifenacin Vivanta with food and drink

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

Pregnancy and breastfeeding

You must not use Solifenacin Vivanta during pregnancy unless absolutely necessary.

Do not use Solifenacin Vivanta 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 Vivanta contains lactose.

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Solifenacin Vivanta

Instructions for correct use

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

You must swallow the tablet whole with a liquid. It can be taken with or without food, according to your preference. Do not crush the tablets.

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

If you take more Solifenacin Vivanta than you should

If you have taken too much Solifenacin Vivanta or if a child has accidentally taken Solifenacin Vivanta, 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, blurred vision, perception of things that are not present (hallucinations), marked excitement, seizures, 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 Solifenacin Vivanta

If you forget to take a dose at the usual time, take it as soon as you remember, unless it is almost time for the next dose. Never take more than one dose per day. If you have any doubts, always consult your doctor or pharmacist.

If you stop taking Solifenacin Vivanta

If you stop taking Solifenacin Vivanta, 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 may cause adverse effects, although not everyone will experience them.

If you suffer an allergic attack or a severe skin reaction (for example, blistering and peeling of the skin), you must inform your doctor or pharmacist immediately.

Angioedema (a 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 succinate. If angioedema occurs, treatment with solifenacin succinate (Solifenacina Vivanta) must be immediately discontinued and appropriate treatment and/or measures must be initiated.

Solifenacina Vivanta 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

• drowsiness

• abnormal taste perception (dysgeusia)

• dry (irritated) eyes

• dry nasal passages

• gastroesophageal reflux disease (acid 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 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 pressure in the eyes

• changes in the heart's electrical activity (ECG), irregular heartbeats (Torsades de Pointes), palpitations, rapid heartbeat.

• voice disorder

• liver disorder

• muscle weakness

• kidney disorder

Reporting of adverse effects

If you experience any type of 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 Vivanta

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.

This medicine does not require any special storage conditions.

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. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Solifenacin Vivanta

• The active substance is solifenacin succinate.

Each tablet contains 5 mg of solifenacin succinate, equivalent to 3.8 mg of solifenacin.

• The other components are:

Tablet core: monohydrate lactose, hypromellose (E464), magnesium stearate (E572).

Tablet coating:

Opadry Yellow (hypromellose (E464)), titanium dioxide (E171), triacetin (E1518), talc (E553b), yellow iron oxide (E172).

Appearance of the product and contents of the pack

Film-coated tablet, light yellow in colour, round in shape (6.00 ± 0.1 mm in diameter), biconvex (2.60 ± 0.15 mm in thickness), marked with the inscription "S5" on one side and smooth on the other.

The tablets are packed in PVC/PVdC/Al blisters in cardboard boxes.

Pack sizes: 10, 20, 30, 50, 60, 90, 100 and 200 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Vivanta Generics s.r.o.

Trtinová 260/1, Cakovice

196 00 Prague 9

Czech Republic

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA3000

Malta

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

Local Representative:

Mabo-Farma S.A.

Calle Vía de los Poblados 3, Edificio 6

28033 Madrid

Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Netherlands Solifenacine succinaat Vivanta 5 mg filmomhulde tabletten

Germany Solifenacin Vivanta 5 mg Filmtabletten

Spain Solifenacina Vivanta 5 mg comprimidos recubiertos con película EFG

Ireland Solifenacin succinate Vivanta 5 mg Film-coated tablet

Date of the most recent revision of this leaflet: November 2019

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