Solifenacin Vivanta

Package Leaflet: Information for the User

Solifenacin Vivanta, 5 mg, film-coated tablets

Solifenacin Vivanta, 10 mg, film-coated tablets

Solifenacin succinate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, 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, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Solifenacin Vivanta and what is it used for
• 2. Important information before taking Solifenacin Vivanta
• 3. How to take Solifenacin Vivanta
• 4. Possible side effects
• 5. How to store Solifenacin Vivanta
• 6. Contents of the pack and other information

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

Solifenacin, the active substance of Solifenacin Vivanta, belongs to a group of medicines called antimuscarinics.
These medicines reduce the activity of an overactive urinary bladder. This allows for longer intervals between visits to the toilet and increases the amount of urine held in the bladder.
Solifenacin Vivanta is used to treat the symptoms of an overactive bladder. These include:
urge incontinence, which means episodes of sudden, urgent need to urinate, frequent urination, and incontinence associated with a failure to reach the toilet in time.

2. Important information before taking Solifenacin Vivanta

When not to take Solifenacin Vivanta:

• if you have difficulty emptying your bladder or cannot empty your bladder (urinary retention);
• if you have severe gastrointestinal disorders (toxic megacolon, a complication of ulcerative colitis);
• if you have a muscle disorder called myasthenia gravis, which can cause significant weakness of certain muscles;
• if you have narrow-angle glaucoma (increased pressure in the eyeball, which can lead to gradual loss of vision);
• if you are allergic (hypersensitive) to solifenacin or any of the other ingredients of this medicine (listed in section 6);
• if you are undergoing hemodialysis;
• if you have severe liver function disorders;
• if you have severe kidney disease or moderate liver disease and are taking medicines that may delay the elimination of solifenacin from the body (e.g., ketoconazole). Your doctor or pharmacist will provide information on this.

Before starting treatment with Solifenacin Vivanta, inform your doctor if any of the above situations apply or have applied in the past.

Warnings and precautions

Before starting to take Solifenacin Vivanta, discuss with your doctor or pharmacist:

• if you have difficulty emptying your bladder or urinating (narrowing of the urethra). In this case, the risk of urine accumulation in the bladder (urinary retention) is much higher;
• if you have gastrointestinal disorders (constipation);
• if there is a risk of slowing down the movement of the gastrointestinal tract (peristalsis). Your doctor will provide information on this;
• if you have severe kidney function disorders;
• if you have moderate liver function disorders;
• if you have a condition where the upper part of the stomach slides through the diaphragm into the chest cavity (hiatal hernia) or heartburn;
• if you have nervous system disorders (autonomic nervous system neuropathy).

Children and adolescents

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

Before starting treatment with Solifenacin Vivanta, inform your doctor if any of the above situations apply or have applied in the past.
Before starting treatment with Solifenacin Vivanta, your doctor will assess whether there are other causes of frequent urination (e.g., heart failure or kidney disease). If a urinary tract infection occurs, your doctor will prescribe an antibiotic (an antibacterial medicine).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Solifenacin Vivanta and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
It is particularly important to inform your doctor if you are taking:

• other antimuscarinic medicines, as taking such a medicine with solifenacin may lead to increased therapeutic and adverse effects of both medicines;
• cholinergic receptor agonists, as they may weaken the effect of solifenacin;
• medicines that speed up the movement of the gastrointestinal tract, such as metoclopramide and cisapride, as solifenacin may weaken their effect;
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, as they slow down the metabolism of solifenacin;
• medicines such as rifampicin, phenytoin, and carbamazepine, as they may speed up the metabolism of solifenacin;
• medicines such as bisphosphonates, as they may cause or exacerbate esophagitis.

Solifenacin Vivanta with food and drink

Solifenacin Vivanta can be taken with or without food.

Pregnancy and breastfeeding

Solifenacin Vivanta should not be used during pregnancy, unless it is absolutely necessary.
Solifenacin Vivanta should not be used during breastfeeding, as solifenacin passes into human milk.
Before taking this medicine, consult your doctor or pharmacist.

Driving and using machines

Solifenacin Vivanta may cause blurred vision, and less frequently, drowsiness and fatigue. If such side effects occur, do not drive or operate any machinery.

Solifenacin Vivanta contains lactose

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.

3. How to take Solifenacin Vivanta

Instructions for proper use

Solifenacin Vivanta should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Swallow the tablet whole with a drink of water. The medicine can be taken with or without food, as preferred. Do not crush the tablets.
The usual dose is 5 mg once daily, unless your doctor advises you to take a dose of 10 mg once daily.

Overdose of Solifenacin Vivanta

If you have taken too many tablets of Solifenacin Vivanta or if a child has accidentally taken Solifenacin Vivanta, contact your doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and vision disturbances, hallucinations, excessive excitement, seizures, difficulty breathing, rapid heartbeat, urine accumulation in the bladder, and dilated pupils.

Missed dose of Solifenacin Vivanta

If you miss a dose, take the next dose as soon as possible, unless it is almost time for the next dose. Do not take the medicine more than once a day. If you are unsure, consult your doctor or pharmacist.

Stopping Solifenacin Vivanta treatment

If you stop taking Solifenacin Vivanta, the symptoms of an overactive bladder may return or worsen. Stopping the treatment should always be discussed with your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Solifenacin Vivanta can cause side effects, although not everybody gets them.
If you experience an allergic reaction or severe skin reaction (e.g., blistering and peeling of the skin), inform your doctor or pharmacist immediately.
In some patients taking solifenacin succinate, angioedema (a form of allergic skin reaction that causes swelling of the tissue just below the skin surface) with swelling of the airways has been reported. If you experience angioedema, stop taking Solifenacin Vivanta immediately and initiate appropriate treatment and/or take appropriate measures.
Solifenacin Vivanta may cause other side effects, including:

• Very commonside effects (may affect more than 1 in 10 people):

• dry mouth.

Commonside effects (may affect up to 1 in 10 people):

• blurred vision,
• constipation, nausea, dyspepsia with symptoms such as: feeling of fullness, abdominal pain, belching, nausea, heartburn (dyspepsia), feeling of discomfort in the abdomen.

Uncommonside effects (may affect up to 1 in 100 people):

• urinary tract infection, cystitis,
• drowsiness,
• taste disturbances,
• dry eyes,
• nasal dryness,
• gastroesophageal reflux disease (gastroesophageal reflux),
• throat dryness,
• dry skin,
• difficulty urinating,
• fatigue,
• fluid accumulation in the lower limbs (edema).

Rareside effects (may affect up to 1 in 1,000 people):

• accumulation of a large amount of hard stool in the colon (fecal impaction),
• difficulty urinating despite a full bladder (urinary retention),
• dizziness, headaches,
• vomiting,
• itching, rash.

Very rareside effects (may affect up to 1 in 10,000 people):

• hallucinations, disorientation,
• allergic rash.

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

• decreased appetite, increased potassium levels in the blood, which can cause heart rhythm disorders,
• increased pressure in the eyeball,
• ECG changes, irregular heartbeat, palpitations, rapid heartbeat,
• voice disorders,
• liver function disorders,
• muscle weakness,
• kidney function disorders.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 label. The expiry date refers to the last day of the month.
There are no special storage precautions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Solifenacin Vivanta contains

• The active substance is solifenacin succinate. Solifenacin Vivanta, 5 mg: each film-coated tablet contains 5 mg of solifenacin succinate, equivalent to 3.8 mg of solifenacin. Solifenacin Vivanta, 10 mg: each film-coated tablet contains 10 mg of solifenacin succinate, equivalent to 7.5 mg of solifenacin.
• The other ingredients are: Tablet core: lactose monohydrate, hypromellose 2910, magnesium stearate.

Coating:
Solifenacin Vivanta, 5 mg: Opadry yellow (hypromellose 2910 (6 mPa·s), titanium dioxide (E171), triacetin, talc, yellow iron oxide (E172)).
Solifenacin Vivanta, 10 mg: Opadry pink (hypromellose 2910 (6 mPa·s), titanium dioxide (E171), triacetin, talc, red iron oxide (E172)).

What Solifenacin Vivanta looks like and contents of the pack

Solifenacin Vivanta 5 mg: light yellow, round (diameter 6.00 ± 0.1 mm), biconvex (2.60 ± 0.15 mm) film-coated tablet with "S5" engraved on one side and smooth on the other side.
Solifenacin Vivanta 10 mg: light pink, round (diameter 7.4 ± 0.1 mm), biconvex (3.40 ± 0.15 mm) film-coated tablet with "S10" engraved on one side and smooth on the other side.
Solifenacin Vivanta is available in PVC/PVDC/Aluminum blisters, packaged in cartons.
Pack sizes: 10, 20, 30, 50, 60, 90, 100, or 200 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder:

Pharmalab Poland Sp. z o.o.
ul. Siemianowicka 84
41-902 Bytom
info@pharmalab.pl

Importer:

Pharmadox Healthcare Ltd.
KW20A, Kordin Industrial Park
Paola, PLA3000
Malta

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

Czech Republic:

Retrim

Hungary:

Solifenacin MSN 5 mg/10 mg

Poland:

Solifenacin Vivanta

Romania:

Solifenacin MSN 5 mg film-coated tablets
Solifenacin MSN 10 mg film-coated tablets

Slovakia:

Retrim 5 mg/10 mg

Date of last revision of the package leaflet: