Solifenacin Stada

Leaflet attached to the packaging: Information for the user

Solifenacin Stada, 5 mg, coated tablets

Solifenacin Stada, 10 mg, coated tablets

Solifenacin succinate

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and you should 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 the leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Solifenacin Stada and what is it used for
• 2. Important information before taking 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 is Solifenacin Stada and what is it used for

The active substance of Solifenacin Stada belongs to a group of so-called anticholinergic medicines.
These medicines are used to reduce the activity of an overactive bladder. This allows for longer
intervals between trips to the bathroom and increases the amount of urine that can be held in the bladder.
Solifenacin Stada is used to treat the symptoms of a condition called "overactive bladder".
These symptoms include: a sudden, urgent need to urinate without prior warning signs, frequent urination or involuntary urination due to not being able to get to the bathroom on time.

2. Important information before taking Solifenacin Stada

When NOT to take Solifenacin Stada

• if the patient is unable to urinate or completely empty the bladder (urinary retention)
• in case of severe stomach or intestinal disorders (including toxic megacolon, a complication of ulcerative colitis)
• if the patient suffers from myasthenia - a muscle disease that can cause extreme weakness of certain muscles
• if the patient suffers from increased pressure in the eyeballs, which is accompanied by gradual vision loss (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 they have or have had any of the above-mentioned diseases.

Warnings and precautions

Before taking Solifenacin Stada, you should consult a doctor or pharmacist

• if the patient has problems with emptying the bladder (mechanical obstruction of urination) or difficulty urinating (e.g. a thin stream of urine). The risk of excessive urine accumulation in the bladder (urinary retention) is much higher
• if the patient has constipation
• if there is a risk of slowing down the digestive system (stomach and intestinal movements). The doctor will provide information on this
• if the patient has severe kidney disease
• if the patient has moderate liver disease
• if the patient's stomach is partially displaced into the chest cavity (hiatus hernia) or the patient suffers from heartburn
• if the patient has a nervous system disorder called autonomic nervous system neuropathy

Before starting treatment with this medicine, the patient must inform their doctor if they have or have had any of the above-mentioned diseases.
Before starting treatment with Solifenacin Stada, the doctor will assess whether the patient has other causes of frequent urination, such as heart failure (insufficient blood pumping by the heart) or kidney disease. If the patient has a urinary tract infection, the doctor will prescribe an antibiotic (treatment aimed at specific bacterial infections).

Children and adolescents

Solifenacin Stada should not be used in children and adolescents under the age of 18.

Solifenacin Stada and other medicines

You should tell 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 anticholinergic medicines, as the effects and side effects of both medicines may be enhanced. You should ask your doctor if the medicine you are taking belongs to this group.
• cholinergic medicines, as they may weaken the effect of Solifenacin Stada. You should ask your doctor if the medicine you are taking belongs to this group.
• such medicines as metoclopramide and cisapride, which cause the digestive system to work faster. Solifenacin Stada may weaken their effect.
• such medicines as ketoconazole, itraconazole (medicines used to treat fungal infections), ritonavir, nelfinavir (medicines used to treat HIV infection) and verapamil, diltiazem (medicines used to treat high blood pressure and heart disease). These medicines reduce the rate of breakdown of Solifenacin Stada in the body.
• such medicines as rifampicin (a medicine used to treat tuberculosis and other bacterial infections) and phenytoin and carbamazepine (medicines used to treat epilepsy). These medicines may increase the rate of breakdown of Solifenacin Stada in the body.
• such medicines as bisphosphonates, which may cause or exacerbate esophagitis. You should ask your doctor if the medicine you are taking belongs to this group.

Taking Solifenacin Stada with food and drink

This medicine can be taken with or without food, depending on the patient's preference.

Pregnancy and breastfeeding

Pregnant women should not take Solifenacin Stada, unless the doctor considers it necessary. This medicine should not be taken during breastfeeding, as solifenacin may pass into breast milk.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.

Driving and using machines

Solifenacin Stada may cause blurred vision, and sometimes drowsiness or fatigue.
The patient should not drive vehicles or operate machines if they experience any of these side effects.

Solifenacin Stada contains lactose

If the doctor has informed the patient that they have an intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Solifenacin Stada

Instructions for proper use

This medicine should always be taken according to the doctor's instructions. In case of doubts, you should consult a doctor or pharmacist.

Dosage

The recommended dose is 5 mg per day, unless the doctor recommends taking the medicine at a dose of 10 mg per day.

Method of administration

The tablet should be swallowed whole and taken with a glass of water, for example. It can be taken with or without food, depending on the patient's preference. The tablets should not be crushed or chewed.

Use in children and adolescents

Solifenacin Stada should not be used in children and adolescents under the age of 18.

Taking a higher dose of Solifenacin Stada than recommended

If the patient has taken too much Solifenacin Stada or a child has accidentally swallowed the medicine, they should immediately contact a doctor or pharmacist.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and blurred vision, seeing things that are not there/hallucinations, overexcitement, seizures, difficulty breathing, increased heart rate (tachycardia), excessive urine accumulation in the bladder (urinary retention), and dilated pupils.

Missing a dose of Solifenacin Stada

If the patient misses a dose at the usual time, they should take it as soon as they remember, unless it is time for the next dose.
Never take more than one dose per day. Do not take a double dose to make up for a missed dose. In case of doubts, you should always consult a doctor or pharmacist.

Stopping treatment with Solifenacin Stada

If the patient stops taking this medicine, the symptoms of overactive bladder may return or worsen. You should always consult a doctor if you want to stop treatment.
In case of any further questions about taking this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Solifenacin Stada can cause side effects, although not everybody gets them.

You should stop taking Solifenacin Stada and seek medical help immediately if you notice any of the following side effects

• anaphylactic reaction or severe skin reaction (e.g. blistering and peeling of the skin)
• some patients taking solifenacin succinate have reported angioedema (a skin condition that causes swelling of the tissues just below the surface of the skin) with airway obstruction (difficulty breathing).

Solifenacin Stada may cause 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, indigestion with symptoms such as a feeling of fullness in the stomach, stomach pain, belching, nausea, and heartburn (dyspepsia), feeling of discomfort in the stomach

Uncommon (may affect up to 1 in 100 people)

• urinary tract infection, bladder infection
• feeling of drowsiness
• taste disorders
• dry eyes
• dry nasal passages
• gastroesophageal reflux (acid reflux)
• dry throat
• dry skin
• difficulty urinating
• fatigue
• fluid accumulation in the legs (edema)

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

• accumulation of large amounts of hard stool in the intestine (intestinal obstruction)
• excessive urine accumulation in the bladder due to inability to empty the bladder (urinary retention)
• dizziness, headaches
• 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 the available data)

• decreased appetite, high potassium levels in the blood, which can cause heart rhythm disorders
• increased eye pressure
• changes in the electrical activity of the heart (ECG), irregular heartbeat, feeling of heartbeat, faster heartbeat
• voice disorders
• liver disorders
• muscle weakness
• kidney disorders

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Solifenacin Stada

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

6. Contents of the pack and other information

What Solifenacin Stada contains

The active substance of Solifenacin Stada is solifenacin succinate.
Solifenacin Stada, 5 mg:
Each coated tablet contains 5 mg of solifenacin succinate, which corresponds to 3.8 mg of solifenacin.
Solifenacin Stada, 10 mg:
Each coated tablet contains 10 mg of solifenacin succinate, which corresponds to 7.5 mg of solifenacin.
The other ingredients are:
Core
Lactose monohydrate, corn starch, hypromellose, magnesium stearate.
Coating
Solifenacin Stada, 5 mg:
Hypromellose, titanium dioxide (E171), macrogol 8000, talc, and yellow iron oxide (E172).
Solifenacin Stada, 10 mg:
Hypromellose, titanium dioxide (E171), macrogol 8000, talc, and red iron oxide (E172).

What Solifenacin Stada looks like and contents of the pack

Solifenacin Stada 5 mg has the form of light yellow, round, biconvex, coated tablets.
Solifenacin Stada 10 mg has the form of light pink, round, biconvex, coated tablets.
Solifenacin Stada coated tablets of 5 mg and 10 mg are packaged in blisters of PVC/Aluminum, PVC/PVDC/Aluminum, OPA/Aluminum/PVC/Aluminum or perforated, single-dose blisters of PVC/Aluminum in a cardboard box of 10, 20, 30, 40, 50, 60, 80, 90, 100, 105, 120, 150, 180, and 200 tablets.
Not all pack sizes may be marketed.

Marketing authorization 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
Netherlands
Clonmel Healthcare Ltd.
Waterford Road
Clonmel, Co. Tipperary
Ireland
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark

This medicinal product is authorized 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 5mg comprimé pelliculé
Solifenacine EG 10mg comprimé pelliculé
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

Date of last revision of the leaflet: 03/2022