SOLIFENACIN STADA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Solifenacin Stada 10mg Film-Coated Tablets EFG

Solifenacin, succinate

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Solifenacin Stada and what is it used for
2. What you need to know before taking Solifenacin Stada
3. How to take Solifenacin Stada
4. Possible side effects

5 Conservation of Solifenacin Stada

1. Contents of the pack and further information

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

The active substance of Solifenacin Stada belongs to the group of anticholinergics. These medications are used to reduce the activity of the overactive bladder. This allows you to have more time before needing to go to the bathroom and increases the amount of urine that your bladder can hold.

Solifenacin Stada is used to treat the symptoms of overactive bladder syndrome. These symptoms include: having a strong and sudden need to urinate without prior warning, needing to urinate frequently, or having urine leaks due to not reaching the bathroom in time.

2. What you need to know before taking Solifenacin Stada

Do not take Solifenacin Stada

• if you have difficulty urinating or emptying your bladder completely (urinary retention)
• if you have a severe stomach or intestinal disorder (including toxic megacolon, a complication associated with ulcerative colitis)
• if you have a muscle disease called myasthenia gravis, which can cause extreme weakness of certain muscles
• if you have high pressure in the eyes with gradual loss of vision (glaucoma)
• if you are allergic to solifenacin or any of the other components of this medication (listed in section 6)
• if you are undergoing renal dialysis
• if you have severe liver disease
• if you have severe kidney disease or moderate liver disease and are being treated with medications that may decrease the elimination of solifenacin from the body (e.g., ketoconazole). Your doctor or pharmacist will inform you if this is the case.

Before starting treatment with solifenacin, inform your doctor if you have or have had any of the diseases mentioned above.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Solifenacin Stada

• if you have problems emptying your bladder (obstruction of the bladder) or urinating (e.g., a weak urine flow). The risk of urine accumulation in the bladder (urinary retention) is much higher.
• if you have any obstruction of the digestive system (constipation).
• if you have an increased risk of decreased activity of the digestive system (movements of the stomach and intestines). Your doctor will inform you if this is the case.
• if you have severe kidney disease.
• if you have moderate liver disease.
• if you have a hiatus hernia or heartburn.
• if you have a nervous system disorder known as autonomic neuropathy.

Inform your doctor before starting treatment with Solifenacin Stada if any of the above circumstances have occurred to you.

Before starting treatment with Solifenacin Stada, your doctor will assess if there are other causes for your frequent need to urinate (e.g., heart failure or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic (treatment against certain bacterial infections).

Children and adolescents

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

Other medications and Solifenacin Stada

Tell your doctor or pharmacist that you are using, have recently used, or may need to use any other medication.

It is especially important that you inform your doctor if you are taking:

• other anticholinergic medications, as the activity and side effects of both medications may increase. Consult with your doctor if your medication belongs to this group.
• cholinergic medications, as they may reduce the effect of Solifenacin Stada. Consult with your doctor if your medication belongs to this group.
• medications such as metoclopramide or cisapride, which make the digestive system work faster. Solifenacin Stada may reduce their effect.
• medications such as ketoconazole, itraconazole (medications used to treat fungal infections), ritonavir, nelfinavir (medications used to treat HIV infections), and verapamil, diltiazem (medications used to treat hypertension and heart disease). These medications decrease the rate of elimination of solifenacin from the body.
• medications such as rifampicin (medication used to treat tuberculosis and other bacterial infections) and phenytoin, carbamazepine (medications used to treat epilepsy). These may increase the rate of elimination of solifenacin from the body.
• medications such as bisphosphonates, which can cause or worsen inflammation of the esophagus (esophagitis). Consult with your doctor if your medication belongs to this group.

Taking Solifenacin Stada with food and drinks

This medication can be taken with or without food, as you prefer.

Pregnancy, breastfeeding, and fertility

Do not use solifenacin if you are pregnant unless it is absolutely necessary. Do not use this medication during breastfeeding, as solifenacin may pass into breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

Solifenacin Stada may cause blurred vision and sometimes drowsiness or fatigue. If you experience any of these side effects, do not drive or use machines.

Solifenacin Stada contains lactose.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Solifenacin Stada

Instructions for correct use

Follow the administration instructions of this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dose

The recommended dose is 5 mg per day, unless your doctor indicates that you should take 10 mg per day.

Method of administration

Swallow the tablet whole with some liquid, e.g., a glass of water. It can be taken with or without food, as you prefer. Do not crush the tablets.

Use in children and adolescents

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

If you take more Solifenacin Stada than you should

If you have taken too much Solifenacin Stada or if a child has taken this medication accidentally, contact your doctor or pharmacist immediately, or call the Toxicological Information Service (Tel. 91 562 04 20).

The symptoms in case of overdose may include: headache, dry mouth, dizziness, drowsiness, and blurred vision, perception of things that are not there (hallucinations), pronounced excitement, convulsions, difficulty breathing, increased heart rate (tachycardia), accumulation of urine in the bladder (urinary retention), and dilation of the pupils (mydriasis).

If you forget to take Solifenacin Stada

If you forget to take a dose at the usual time, take it as soon as you remember, unless it is time to take the next dose. Never take more than one dose per day. If you have any doubts, always consult your doctor or pharmacist.

If you stop taking Solifenacin Stada

If you stop taking this medication, your overactive bladder symptoms may return or worsen. Always consult your doctor if you are thinking of stopping treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Stop taking Solifenacin Stada and seek medical attention immediately if you notice any of the following side effects

• if you suffer an allergic reaction or a severe skin reaction (e.g., blistering and peeling of the skin)
• angioedema (allergy in the skin that results in inflammation that occurs in the tissue under the skin surface) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate

Solifenacin may cause the following 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 heaviness in the stomach, abdominal pain, belching, nausea, and heartburn (dyspepsia), stomach discomfort

Uncommon (may affect up to 1 in 100 people)

• urinary tract infection, bladder infection
• drowsiness
• abnormal taste perception (dysgeusia)
• dry eyes (irritated)
• dryness of the nasal passages
• gastroesophageal reflux disease
• dry throat
• dry skin
• difficulty urinating
• fatigue
• accumulation of fluid in the lower limbs (edema)

Rare (may affect up to 1 in 1000 people)

• accumulation of a large amount of hardened feces in the large intestine (fecal impaction)
• accumulation of urine in the bladder due to inability to empty the bladder (urinary retention)
• dizziness, headache
• vomiting
• itching, skin rash

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

• hallucinations, confusion
• allergic skin rash

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

• decreased appetite, high levels of potassium in the blood that can cause an abnormal heart rhythm
• increased pressure in the eyes
• changes in the electrical activity of the heart (ECG), irregular heartbeats, palpitations, rapid heartbeat
• voice disorder
• liver disorder
• muscle weakness
• kidney disorder

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Solifenacin Stada

This medication does not require any special storage temperature. Keep it in the original packaging to protect it from moisture.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if the packaging is damaged or shows signs of tampering.

Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medications in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Contents of the pack and further information

Composition of Solifenacin Stada

• The active substance is solifenacin succinate

Each film-coated tablet contains 10 mg of solifenacin succinate, equivalent to 7.5 mg of solifenacin.

• The other components are:

Core of the tablet

Lactose, cornstarch, hypromellose, magnesium stearate

Film coating

Hypromellose, titanium dioxide (E171), macrogol 8000, talc, and iron oxide red (E172)

Appearance of the product and contents of the pack

Solifenacin Stada 10 mg film-coated tablets are round, biconvex, film-coated tablets, light pink in color.

Solifenacin Stada tablets are supplied in blisters 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 and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

or

Clonmel Healthcare Ltd.

Waterford Road, Clonmel, Co. Tipperary

Ireland

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

or

IBS-Experts International, d.o.o

Ruševje 15

10290 Zaprešic,

Croatia

Date of the last revision of this package leaflet:June 2017

This medication is authorized in the Member States of the European Economic Area under the following names:

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/