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 package 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 bladder. This action 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 symptoms include:
urinary urgency, which means a sudden, intense need to urinate, frequent urination, and involuntary urination, which may occur when the patient is unable to reach the toilet in time.

2. Important information before taking Solifenacin Vivanta

When not to take Solifenacin Vivanta:

• if the patient is unable to urinate or empty their bladder (urinary retention);
• if the patient has severe gastrointestinal disorders (toxic megacolon, a complication associated with ulcerative colitis);
• in patients with a muscle disease called myasthenia gravis, which can cause significant weakness of certain muscles;
• if the patient has narrow-angle glaucoma (increased pressure in the eyeball, which can lead to gradual vision loss);
• in patients with hypersensitivity (allergy) to solifenacin or any other component of this medicine (listed in section 6);
• if the patient is undergoing kidney dialysis;
• in patients with severe liver dysfunction;
• if the patient has severe kidney disease or moderate liver disease and is taking medicines that may delay the elimination of solifenacin from the body (e.g., ketoconazole). The 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 occurred in the past.

Warnings and precautions

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

• if the patient has difficulty emptying their bladder (narrowing of the urethra) or urinating (weak urine stream). In such cases, the risk of urine accumulation in the bladder (urinary retention) is much higher;
• if the patient has gastrointestinal disorders (constipation);
• if there is a risk of slowed gastrointestinal motility (peristalsis). The doctor will provide information on this;
• if the patient has severe kidney dysfunction;
• if the patient has moderate liver dysfunction;
• if the patient has a condition where the upper part of the stomach slides through the diaphragm into the chest cavity (hiatal hernia) or heartburn;
• if the patient has nervous system disorders (autonomic nervous system neuropathy).

Children and adolescents

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

Before starting treatment with Solifenacin Vivanta, inform your doctor if any of the above situations apply or have occurred in the past.
Before starting treatment with Solifenacin Vivanta, the doctor will assess whether there are other causes of frequent urination (e.g., heart failure or kidney disease). If a urinary tract infection occurs, the doctor will prescribe an antibiotic (an antibacterial medicine).
Before starting treatment with Solifenacin Vivanta, the doctor will also assess whether the patient has other diseases that may affect the treatment.

Solifenacin Vivanta and other medicines

Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
It is especially 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 gastrointestinal motility, 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 accelerate 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 breast 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 machines.

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 recommends a dose of 10 mg once daily.

Overdose of Solifenacin Vivanta

If you have taken too many Solifenacin Vivanta tablets or if a child has accidentally taken the medicine, contact your doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and vision disturbances, hallucinations, excessive stimulation, seizures, breathing difficulties, rapid heartbeat, and urinary retention.

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 more than one dose per day. If you are unsure, consult your doctor or pharmacist.

Stopping treatment with Solifenacin Vivanta

If you stop taking Solifenacin Vivanta, the symptoms of an overactive bladder may return or worsen. Stopping treatment should always be discussed with your doctor.
If you have any further questions about 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 beneath 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):

• impaction of large amounts 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 may cause heart rhythm disturbances,
• increased eye pressure,
• ECG changes, irregular heartbeat, palpitations, rapid heartbeat,
• voice disorders,
• liver dysfunction,
• muscle weakness,
• kidney dysfunction.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Solifenacin Vivanta

Keep the 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 requirements.
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 package 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.
• 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 package

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.
Package sizes: 10, 20, 30, 50, 60, 90, 100, or 200 film-coated tablets.
Not all package 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: