SOLIFENACIN STADA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Solifenacin Stada 5mg Film-Coated Tablets EFG

Solifenacin, succinate

Read all of this leaflet carefully before you start 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 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this 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 you take 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 medicines are used to reduce the activity of the overactive bladder. This allows you to have more time before you need to go to the bathroom and increases the amount of urine 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, having to urinate frequently, or having urine leaks because you cannot get to the bathroom in time.

2. What you need to know before you take 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 ingredients of this medicine (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 medicines 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 intestine). 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 hiatal 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 medicines and Solifenacin Stada

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

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

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

Taking Solifenacin Stada with food and drinks

This medicine 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 medicine 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 medicine.

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 them before taking this medicine.

3. How to take Solifenacin Stada

Instructions for correct use

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If in 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 medicine accidentally, contact your doctor or pharmacist immediately, or call the Toxicological Information Service (Tel. 91 562 04 20).

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 in doubt, consult your doctor or pharmacist.

If you stop taking Solifenacin Stada

If you stop taking this medicine, 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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 attack 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 1,000 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 the 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency through the website www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Solifenacin Stada

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

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

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicines. 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 5 mg of solifenacin succinate, equivalent to 3.8 mg of solifenacin.

• The other ingredients are:

Core of the tablet

Lactose, cornstarch, hypromellose, magnesium stearate

Film coating

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

Appearance of the product and contents of the pack

Solifenacin Stada 5 mg film-coated tablets are round, biconvex, film-coated, and light yellow 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 Zaprešić,

Croatia

Date of the last revision of this leaflet:June 2017

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

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