Solifenacin Stada

Package Leaflet: Information for the User

Solifenacin Stada, 5 mg, film-coated tablets

Solifenacin Stada, 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 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 any not listed in this leaflet, 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 medicines called anticholinergics.
These medicines are used to control overactive bladder.
Solifenacin Stada is used to treat the symptoms of overactive bladder, which include:
• a sudden, urgent need to urinate that is difficult to delay
• needing to urinate frequently
• waking up several times at night to urinate

2. Important information before taking Solifenacin Stada

When NOT to take Solifenacin Stada

• if you have difficulty emptying your bladder or have a condition where the bladder does not empty completely (urinary retention)
• if you have severe gastrointestinal disorders (such as toxic megacolon, a complication of ulcerative colitis)
• if you have myasthenia gravis, a disease that causes extreme muscle weakness
• if you have increased pressure in the eyes, which can lead to vision loss (narrow-angle glaucoma)
• if you are allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6)
• if you are undergoing dialysis
• if you have severe liver disease
• if you have severe kidney disease or moderate liver disease and are taking medicines that may reduce the elimination of Solifenacin Stada from the body (such as ketoconazole). In this case, your doctor or pharmacist will inform you. Before starting treatment with this medicine, you must tell your doctor if you have or have had any of the above conditions.

Warnings and precautions

Before taking Solifenacin Stada, consult your doctor or pharmacist

• if you have problems emptying your bladder (mechanical obstruction of the urinary outflow) or difficulty urinating (e.g., a weak urine stream). The risk of urinary retention is higher
• if you have constipation
• if there is a risk of slowing down the movement of the digestive tract (gastrointestinal motility). Your doctor will provide information on this
• if you have severe kidney disease
• if you have moderate liver disease
• if your stomach is partially displaced into the chest cavity (hiatus hernia) or you have heartburn
• if you have a nervous system disorder called autonomic neuropathy

Before starting treatment with this medicine, you must tell your doctor if you have or have had any of the above conditions.
Your doctor will assess whether you have other causes of frequent urination, such as heart failure (insufficient pumping of blood by the heart) or kidney disease. If you have a urinary tract infection, your 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 18 years of age.

Solifenacin Stada and other medicines

Tell your doctor or pharmacist about all medicines you are 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. Ask your doctor if the medicine you are taking belongs to this group
• cholinergic medicines, as they may weaken the effect of Solifenacin Stada. Ask your doctor if the medicine you are taking belongs to this group
• such medicines as metoclopramide and cisapride, which cause the digestive tract 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 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 breakdown of Solifenacin Stada in the body
• such medicines as bisphosphonates, which may cause or worsen esophagitis. 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 their doctor considers it necessary. This medicine should not be taken during breastfeeding, as solifenacin may pass into breast milk.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Solifenacin Stada may cause blurred vision, and sometimes drowsiness or fatigue.
Patient who experiences any of these side effects should not drive or operate machinery.

Solifenacin Stada contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Solifenacin Stada

Instructions for proper use

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Dosage

The recommended dose is 5 mg once daily, unless your doctor advises you to take 10 mg once daily.

Method of administration

Swallow the tablet whole and take it with a glass of water. It can be taken with or without food, depending on the patient's preference. Do not crush or chew the tablets.

Use in children and adolescents

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

Taking more than the recommended dose of Solifenacin Stada

If you take more than the recommended dose of Solifenacin Stada or if a child accidentally swallows some, contact your doctor or pharmacist immediately.
Overdose symptoms may include: headache, dry mouth, dizziness, drowsiness, blurred vision, hallucinations, agitation, convulsions, difficulty breathing, rapid heartbeat (tachycardia), urinary retention, and dilated pupils.

Missing a dose of Solifenacin Stada

If you miss a dose, take it as soon as you remember, unless it is time for your next dose. Never take more than one dose in 24 hours. Do not take a double dose to make up for a forgotten dose. If you are unsure, always consult your doctor or pharmacist.

Stopping treatment with Solifenacin Stada

If you stop taking this medicine, your overactive bladder symptoms may return or worsen. Always consult your doctor before stopping treatment.
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 Stada can cause side effects, although not everybody gets them.

Stop taking Solifenacin Stada and seek medical help immediately if you experience 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 obstruction of the airways

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, indigestion with symptoms such as feeling full in the stomach, stomach pain, belching, nausea, and heartburn (dyspepsia), feeling uncomfortable in the stomach

Uncommon (may affect up to 1 in 100 people)

• urinary tract infection, bladder infection
• drowsiness
• taste disturbance
• dry eyes
• dry nose
• 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)

• impaction of the large intestine (blockage of the intestine by hard feces)
• urinary retention due to inability to empty the bladder
• 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 the available data)

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell 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
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 this medicine.

5. How to store Solifenacin Stada

This medicine does not require any special storage conditions.
Store in the original package to protect from moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
The batch number is stated after the word "Lot".
Do not use this medicine if the packaging is damaged or shows signs of tampering.
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 Stada contains

The active substance is solifenacin succinate.
Solifenacin Stada 5 mg:
Each film-coated tablet contains 5 mg solifenacin succinate, equivalent to 3.8 mg solifenacin.
Solifenacin Stada 10 mg:
Each film-coated tablet contains 10 mg solifenacin succinate, equivalent to 7.5 mg solifenacin.
The other ingredients are:
Tablet core
Lactose monohydrate, maize starch, hypromellose, magnesium stearate.
Tablet 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 is a light yellow, round, biconvex film-coated tablet.
Solifenacin Stada 10 mg is a light pink, round, biconvex film-coated tablet.
Solifenacin Stada film-coated tablets 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 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 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