Solifenacin vivanta

Package leaflet: Information for the user

Solifenacin Vivanta, 5 mg, film-coated tablets
Solifenacin Vivanta, 10 mg, film-coated tablets
Solifenacini succinas
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this 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 personally. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Solifenacin Vivanta is and what it is used for
2. What you need to know 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 Solifenacin Vivanta is and what it is used for

Solifenacin, the active substance in Solifenacin Vivanta, belongs to a group of medicines called anticholinergics (cholinolytics).
These medicines reduce the activity of an overactive bladder. This effect allows longer intervals between urinations and increases the amount of urine the bladder can hold.
Solifenacin Vivanta is used to treat the symptoms of an overactive bladder. These symptoms include:
urgency, which is a sudden, strong need to urinate, frequent urination, and urinary incontinence, occurring when the person is unable to reach the toilet in time.

2. Important information before using Solifenacin Vivanta

When not to use Solifenacin Vivanta:

• if the patient is unable to pass urine or empty the bladder (urinary retention);
• if the patient has severe stomach or intestinal disorders (toxic megacolon, a complication associated with ulcerative colitis);
• in patients suffering from a muscle disease called myasthenia gravis, which may cause significant weakness of certain muscles;
• if the patient has narrow-angle glaucoma (increased fluid pressure in the eye leading to gradual loss of vision);
• in patients with hypersensitivity (allergy) to solifenacin or any of the other ingredients of this medicine (listed in section 6);
• if the patient is undergoing kidney dialysis;
• in patients with severe liver function disorders;
• if the patient has severe kidney or moderate liver disease and is simultaneously 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 conditions are present 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 the bladder (obstruction of urinary outflow from the bladder) or difficulty passing urine (weak urine stream). In such cases, the risk of urine retention in the bladder (urinary retention) is significantly higher;
• if the patient has gastrointestinal motility disorders (constipation);
• if there is a risk of slowed gastrointestinal motility (peristalsis). Your doctor will provide further information on this;
• if the patient has severe kidney function disorders;
• if the patient has moderate liver function disorders;
• if the patient has a condition in which the upper part of the stomach slips through the diaphragm into the chest (hiatal hernia) or suffers from heartburn (gastroesophageal reflux);
• if the patient has disorders of the nervous system (autonomic neuropathy).

Children and adolescents
Solifenacin Vivanta must 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 conditions are present or have occurred in the past.
Before initiating treatment with Solifenacin Vivanta, the doctor will assess whether there are other possible causes of frequent urination (e.g. heart failure [inadequate pumping strength of the heart muscle] or kidney disease). If a urinary tract infection occurs, the doctor will prescribe an antibiotic (an antibacterial agent effective against the specific bacteria).

Solifenacin Vivanta and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
It is particularly important to inform the doctor if the patient is taking:

• other anticholinergic medicines, as concomitant use with solifenacin may enhance both the therapeutic effects and adverse reactions of both medicines;
• cholinergic receptor agonists, as they may reduce the effect of solifenacin;
• medicines that increase gastrointestinal motility, such as metoclopramide and cisapride, as solifenacin may reduce their effectiveness;
• 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 worsen oesophagitis.

Solifenacin Vivanta with food and drink
Solifenacin Vivanta can be taken during or independent of meals.
Pregnancy and breastfeeding
Do not use Solifenacin Vivanta during pregnancy unless absolutely necessary.
Do not use Solifenacin Vivanta during breastfeeding, as solifenacin passes into human milk.
Consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
Solifenacin Vivanta may cause blurred vision, and less frequently drowsiness and fatigue. If these adverse effects occur, do not drive or operate machinery.
Solifenacin Vivanta contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Solifenacin Vivanta

Instructions for proper use
Solifenacin Vivanta should always be taken as directed by the physician. If in doubt, consult your doctor or pharmacist.
The tablet should be swallowed whole with liquid. The medicine may be taken during meals or independently of meals, depending on patient preference. Do not crush the tablets.
The usual dose is 5 mg once daily, unless the physician prescribes a dose of 10 mg once daily.

Taking more Solifenacin Vivanta than prescribed
If too many tablets of Solifenacin Vivanta have been taken, or if a child accidentally swallows the medicine, contact your doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness and visual disturbances, hallucinations, excessive excitement, seizures (convulsions), difficulty breathing, rapid heartbeat (tachycardia), urine retention in the bladder (urinary retention), and dilated pupils.

Missed dose of Solifenacin Vivanta
If a dose is missed, take the next dose as soon as possible, unless it is almost time for the next scheduled dose. Do not take the medicine more often than once daily. If in doubt, consult your doctor or pharmacist.

Stopping Solifenacin Vivanta
If treatment with Solifenacin Vivanta is discontinued, symptoms of overactive bladder may return or worsen. Discontinuation of the medicine should always be discussed with the doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences an allergic attack or a severe skin reaction (e.g. blistering and peeling of the skin), the doctor or pharmacist should be informed immediately.
In some patients taking solifenacin succinate, angioedema (a type of allergic skin reaction causing swelling of the tissue just beneath the skin surface) with swelling of the airways (difficulty breathing) has been reported. If angioedema occurs in the patient, treatment with Solifenacin Vivanta should be stopped immediately and appropriate treatment and (or) corrective measures should be initiated.
Solifenacin Vivanta may cause other adverse reactions listed below:
Very common adverse reactions (may occur in more than 1 in 10 people):

• dry mouth.

Common adverse reactions (may occur in less than 1 in 10 people):

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

Uncommon adverse reactions (may occur in less than 1 in 100 people):

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

Rare adverse reactions (may occur in less than 1 in 1,000 people):

• impaction of hard stool in the colon (fecal impaction),
• difficulty passing urine despite a full bladder (urinary retention),
• dizziness, headache,
• vomiting,
• itching, rash.

Very rare adverse reactions (may occur in less than 1 in 10,000 people):

• hallucinations, disorientation,
• allergic rash.

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

• decreased appetite, increased blood potassium levels which may cause cardiac arrhythmia,
• increased intraocular pressure,
• changes in ECG, irregular heartbeat, palpitations, rapid heartbeat,
• voice disorders,
• liver function disorders,
• muscle weakness,
• kidney function disorders.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Solifenacin Vivanta

Keep this medicine out of 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 stated month.
No special storage conditions are required.
Medicines must 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.

• 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, embossed with the code "S5" on one side and plain on the other.
Solifenacin Vivanta 10 mg: Light pink, round (diameter 7.4 ± 0.1 mm), biconvex (3.40 ± 0.15 mm) film-coated tablet, embossed with the code "S10" on one side and plain on the other.

Solifenacin Vivanta is available in PVC/PVDC/Aluminium blisters packed in cartons.
Pack sizes: 10, 20, 30, 50, 60, 90, 100 or 200 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder:
Pharmalab Poland Sp. z o.o.
Siemianowicka 84
41-902 Bytom
Poland
[email protected]

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

This medicinal product is authorised for marketing in 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 comprimate filmate
Solifenacin MSN 10 mg comprimate filmate
Slovakia: Retrim 5 mg/10 mg