Solifenacin stada

Package leaflet: Information for the user

Solifenacin Stada, 5 mg, film-coated tablets
Solifenacin Stada, 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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• 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 Stada is and what it is used for
2. What you need to know before you take Solifenacin Stada
3. How to take Solifenacin Stada
4. Possible side effects
5. How to store Solifenacin Stada
6. Contents of the pack and other information

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

The active substance in Solifenacin Stada belongs to a group of medicines called anticholinergics.
These medicines are used to reduce the activity of an overactive bladder. This allows for longer intervals between the need to go to the toilet and increases the amount of urine the bladder can hold.
Solifenacin Stada is used to treat the symptoms of a condition called "overactive bladder".
These symptoms include: a sudden strong need to pass urine without any prior warning signs, needing to pass urine frequently, or leakage of urine due to not reaching the toilet in time.

2. Important information before using Solifenacin Stada

When NOT TO USE Solifenacin Stada

• if the patient is unable to pass urine or completely empty the bladder (urinary retention)
• in case of severe stomach or intestinal disorders (including toxic megacolon, a complication associated with ulcerative colitis)
• if the patient suffers from myasthenia gravis—a muscle disorder that may cause extreme weakness of certain muscles
• if the patient has increased intraocular pressure associated with gradual loss of vision (glaucoma)
• if the patient is allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6)
• if the patient is undergoing dialysis
• if the patient has severe liver disease
• if the patient has severe kidney disease or moderate liver disease and is also taking medicines that may reduce the elimination of Solifenacin Stada from the body (e.g. ketoconazole). In such cases, the doctor or pharmacist will inform the patient. Before starting treatment with this medicine, the patient must inform their doctor if any of the above conditions are present or have ever been present.

Warnings and precautions
Before taking Solifenacin Stada, consult a doctor or pharmacist:

• if the patient has difficulty emptying the bladder (mechanical obstruction to passing urine) or problems passing urine (e.g. a weak urine stream). The risk of excessive urine accumulation in the bladder (urinary retention) is significantly increased
• if the patient suffers from constipation
• if there is a risk of slowed gastrointestinal motility (stomach and intestinal movement). The doctor will provide further information on this
• if the patient has severe kidney disease
• if the patient has moderate liver disease
• if the patient has a partially displaced stomach into the chest cavity (hiatal hernia) or suffers from heartburn (gastroesophageal reflux)
• if the patient has a nervous system disorder called autonomic neuropathy

Before starting treatment with this medicine, the patient must inform their doctor if any of the above conditions are present or have ever been present.
Before initiating treatment with Solifenacin Stada, the doctor will assess whether the patient may have other causes for frequent urination, such as heart failure (inadequate blood-pumping capacity of the heart) or kidney disease. If the patient has a urinary tract infection, the doctor will prescribe an antibiotic (treatment directed against specific bacterial infections).

Children and adolescents
Solifenacin Stada must not be used in children and adolescents under 18 years of age.

Solifenacin Stada and other medicines
Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
It is especially important to inform the doctor if the patient is taking:

• other anticholinergic medicines, as the effects and side effects of both medicines may be intensified. Ask the doctor whether the medicine the patient is taking belongs to this group
• cholinergic medicines, as they may reduce the effect of Solifenacin Stada. Ask the doctor whether the medicine the patient is taking belongs to this group
• medicines such as metoclopramide and cisapride, which increase gastrointestinal motility. Solifenacin Stada may reduce their effectiveness
• medicines such as ketoconazole, itraconazole (used to treat fungal infections), ritonavir, nelfinavir (used to treat HIV infection), and verapamil, diltiazem (used to treat high blood pressure and heart conditions). These medicines reduce the breakdown rate of Solifenacin Stada in the body
• medicines such as rifampicin (used to treat tuberculosis and other bacterial infections) and phenytoin and carbamazepine (used to treat epilepsy). These medicines may increase the breakdown rate of Solifenacin Stada in the body
• medicines such as bisphosphonates, which may cause or worsen esophagitis. Ask the doctor whether the medicine the patient is taking belongs to this group

Taking Solifenacin Stada with food and drink
This medicine may be taken with or without food, depending on patient preference.

Pregnancy and breastfeeding
Patients who are pregnant must not use Solifenacin Stada unless the doctor considers it necessary. This medicine must not be used during breastfeeding, as solifenacin may pass into breast milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
Solifenacin Stada may cause blurred vision, and sometimes drowsiness or fatigue. Patients experiencing any of these side effects must not drive or operate machinery.

Solifenacin Stada contains lactose
If the doctor has informed the patient of an intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

3. How to use Solifenacin Stada

Instructions for proper use
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult
your doctor or pharmacist.
Dosage
The recommended dose is 5 mg once daily, unless your doctor prescribes 10 mg once daily.
Method of administration
Swallow the tablet whole with liquid, for example a glass of water. It may be taken with or without food, according to patient preference. Do not crush or chew the tablet.
Use in children and adolescents
Solifenacin Stada must not be used in children and adolescents under 18 years of age.
Taking more Solifenacin Stada than prescribed
If a patient takes more Solifenacin Stada than prescribed, or if a child accidentally swallows the medicine, contact a doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision, seeing things that are not real (hallucinations), restlessness, seizures (convulsions), difficulty breathing, increased heart rate (tachycardia), excessive accumulation of urine in the bladder (urinary retention), and dilated pupils.
Missing a dose of Solifenacin Stada
If a patient forgets to take a dose at the usual time, the missed dose should be taken as soon as remembered, provided that it is not almost time for the next dose. Never take more than one dose per day. Do not take a double dose to make up for a forgotten dose. If in doubt, always consult a doctor or pharmacist.
Stopping treatment with Solifenacin Stada
If a patient stops taking this medicine, symptoms of overactive bladder may return or worsen. Always consult your doctor before stopping treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You must stop taking Solifenacin Stada and seek immediate medical help
if you notice any of the following adverse effects

• anaphylactic reaction or severe skin reaction (e.g. blistering and peeling of the skin)
• in some patients taking solifenacin succinate, angioedema (an allergic skin condition causing swelling of tissues just beneath the skin surface) with airway obstruction (breathing difficulties) has been reported.

Solifenacin Stada may cause the following other side 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, dyspepsia (indigestion with symptoms such as bloating, abdominal pain, belching, nausea and heartburn), discomfort in the abdominal area

Uncommon (may affect up to 1 in 100 people)

• urinary tract infection, bladder infection
• feeling sleepy
• taste disturbances
• dry (irritated) eyes
• dryness of nasal passages
• regurgitation of acidic stomach contents into the oesophagus (gastro-oesophageal reflux)
• dry throat
• dry skin
• difficulty passing urine
• fatigue
• fluid accumulation in the lower legs (oedema)

Rare (may affect up to 1 in 1,000 people)

• accumulation of hard stool in the colon causing blockage (faecal impaction)
• excessive accumulation of urine in the bladder due to inability to empty it (urinary retention)
• dizziness, headache
• vomiting
• itching, rash

Very rare (may affect up to 1 in 10,000 people)

• hallucinations, confusion
• allergic rash

Frequency not known (cannot be estimated from available data)

• decreased appetite, high blood potassium levels which may cause heart rhythm disturbances
• increased intraocular pressure
• changes in heart electrical activity (ECG), irregular heartbeat, awareness of heartbeat, faster heartbeat
• voice disorders
• liver disorders
• muscle weakness
• kidney disorders

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Solifenacin Stada

This medicine does not require special temperature storage conditions.
Store in the original packaging to protect from moisture.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following the words Expiry date (EXP). The expiry date refers to the last day of the stated month.
The batch number is indicated after the abbreviation "Lot".
Do not use this medicine if the packaging is damaged or shows signs of having been opened.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Solifenacin Stada contains
The active substance is solifenacin succinate.
Solifenacin Stada 5 mg:
Each coated tablet contains 5 mg of solifenacin succinate, equivalent to 3.8 mg of solifenacin.
Solifenacin Stada 10 mg:
Each coated tablet contains 10 mg of solifenacin succinate, equivalent to 7.5 mg of solifenacin.

The other ingredients are:
Tablet core
Monohydrate lactose, corn starch, hypromellose, magnesium stearate.
Tablet coating
Solifenacin Stada 5 mg:
Hypromellose, titanium dioxide (E171), macrogol 8000, talc, and iron oxide yellow (E172).
Solifenacin Stada 10 mg:
Hypromellose, titanium dioxide (E171), macrogol 8000, talc, and iron oxide red (E172).

What Solifenacin Stada looks like and contents of the pack
Solifenacin Stada 5 mg are light yellow, round, biconvex, film-coated tablets.
Solifenacin Stada 10 mg are light pink, round, biconvex, film-coated tablets.

Solifenacin Stada film-coated tablets in strengths of 5 mg and 10 mg are alternatively packed in PVC/Aluminium, PVC/PVDC/Aluminium, OPA/Aluminium/PVC/Aluminium blisters, or perforated single-dose blisters made of PVC/Aluminium, in cardboard boxes containing 10, 20, 30, 40, 50, 60, 80, 90, 100, 105, 120, 150, 180, and 200 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer/Importer:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria
Centrafarm B.V.
Van de Reijtstraat 31-E
4814 NE Breda
The Netherlands
Clonmel Healthcare Ltd.
Waterford Road
Clonmel, Co. Tipperary
Ireland
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark

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

Austria
Solifenacin STADA 5 mg Filmtabletten
Solifenacin STADA 10 mg Filmtabletten

Belgium
Solifenacine EG 5 mg filmomhulde tabletten
Solifenacine EG 10 mg filmomhulde tabletten

Croatia
Solifenacin STADA 5 mg, filmom obložene tablete
Solifenacin STADA 10 mg, filmom obložene tablete

Germany
Solifenacinsuccinat AL 5 mg Filmtabletten
Solifenacinsuccinat AL 10 mg Filmtabletten

Denmark
Solifenacin STADA 5 mg filmovertrukne tabletter
Solifenacin STADA 10 mg filmovertrukne tabletter

Spain
Solifenacina STADA 5 mg comprimidos recubiertos con película EFG
Solifenacina STADA 10 mg comprimidos recubiertos con película EFG

Finland
Solifenacin STADA 5 mg kalvopäällysteinen tabletti
Solifenacin STADA 10 mg kalvopäällysteinen tabletti

France
SOLIFENACINE EG 5 mg, comprimé pelliculé
SOLIFENACINE EG 10 mg, comprimé pelliculé

Hungary
Urofenacin 5 mg filmtabletta
Urofenacin 10 mg filmtabletta

Ireland
Solifenacin Clonmel 5 mg film-coated tablets
Solifenacin Clonmel 10 mg film-coated tablets

Luxembourg
Solifenacine EG 5 mg comprimé pelliculé
Solifenacine EG 10 mg comprimé pelliculé

The Netherlands
Solifenacinesuccinaat CF 5 mg, filmomhulde tabletten
Solifenacinesuccinaat CF 10 mg, filmomhulde tabletten

Poland
Solifenacin STADA

Romania
VESISTAD 5 mg comprimate filmate
VESISTAD 10 mg comprimate filmate

Sweden
Solifenacin STADA 5 mg filmdragerad tablett
Solifenacin STADA 10 mg filmdragerad tablett

Slovakia
Solifenacin STADA 5 mg
Solifenacin STADA 10 mg

United Kingdom
Solifenacin 5 mg film-coated tablets
Solifenacin 10 mg film-coated tablets