Solifenacin STADA 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Solifenacin Stada 10 mg 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Solifenacin Stada is and what it is used for
2. What you need to know 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 Solifenacina Stada is and what it is used for

The active substance in Solifenacina Stada belongs to the group of anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This allows you to have more time before needing to go to the toilet and increases the amount of urine your bladder can hold.

Solifenacina Stada is used to treat the symptoms of overactive bladder syndrome. These symptoms include a sudden and strong need to urinate without prior warning, needing to urinate frequently, or leaking urine because you cannot reach the toilet in time.

2. What you need to know before taking Solifenacina Stada

Do NOT take Solifenacina 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 simultaneously being treated with medicines that may reduce the elimination of solifenacin from the body (e.g. ketoconazole). Your doctor or pharmacist will inform you if this applies to you.

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

Warnings and precautions

Consult your doctor or pharmacist before starting Solifenacina Stada

• if you have difficulty emptying your bladder (bladder obstruction) or difficulty urinating (e.g. 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 are at increased risk of reduced digestive system activity (stomach and intestinal movements). Your doctor will inform you if this applies to you.
• 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 Solifenacina Stada if any of the above conditions have ever applied to you.

Before starting treatment with Solifenacina Stada, your doctor will assess whether there are other causes for your frequent need to urinate (for example, heart failure (reduced pumping capacity of the heart) or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic (a treatment for certain bacterial infections).

Children and adolescents

Solifenacina Stada must not be used in children or adolescents under 18 years of age.

Other medicines and Solifenacina Stada

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• other anticholinergic medicines, as the activity and adverse effects of both medicines may increase. Consult your doctor to determine if your medication belongs to this group.
• cholinergic agents, as they may reduce the effect of Solifenacina Stada. Consult your doctor to determine if your medication belongs to this group.
• medicines such as metoclopramide or cisapride, which increase digestive system activity. Solifenacina 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 conditions). These medicines decrease the rate of 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 rate of elimination of solifenacin from the body.
• medicines such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis). Consult your doctor to determine if your medication belongs to this group.

Taking Solifenacina Stada with food and drink

This medicine may be taken with or without food, according to your preference.

Pregnancy, breastfeeding and fertility

You must not use solifenacin during pregnancy unless 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

Solifenacina Stada may cause blurred vision and sometimes drowsiness or fatigue. If you experience any of these side effects, do not drive or operate machinery.

Solifenacina Stada contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Solifenacin Stada

Instructions for correct use

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

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

Method of administration

The tablet should be swallowed whole with liquid, for example, a glass of water. It can be taken with or without food, according to your preference. Do not crush the tablets.

Use in children and adolescents

Solifenacin must 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 accidentally taken this medicine, contact your doctor or pharmacist immediately, or call the Toxicology Information Service (Tel. 91 562 04 20).

Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness and blurred vision, perception of things that are not present (hallucinations), pronounced excitement, seizures, difficulty breathing, increased heart rate (tachycardia), urine retention 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 almost time for your 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 medicine, your overactive bladder symptoms may return or worsen. Always consult your doctor if you are considering stopping treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking Solifenacin Stada and seek immediate medical attention if you notice any of the following adverse effects:

• if you suffer an allergic attack or a severe skin reaction (for example, blistering and peeling of the skin)
• angioedema (an allergic skin reaction causing swelling in the tissue beneath the skin surface) with airway obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate

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

Uncommon (may affect up to 1 in 100 people)

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

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

• accumulation of large amounts of hardened stools in the colon (fecal impaction)
• urine retention 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 which may cause an abnormal heart rhythm
• increased eye pressure
• changes in the heart's electrical activity (ECG), irregular heartbeat, palpitations, rapid heartbeat
• voice disorder
• liver disorder
• muscle weakness
• kidney disorder

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other 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:

Tablet core

Lactose, corn starch, hypromellose, magnesium stearate

Film coating

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

Appearance of the product and contents of the pack

Solifenacin Stada 10 mg tablets are round, biconvex, film-coated, pinkish tablets.

Solifenacin Stada is supplied in blister packs containing 10, 20, 30, 40, 50, 60, 80, 90, 100, 105, 120, 150, 180, and 200 tablets.

Only certain pack sizes may be commercially available.

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

The 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,

Republic of Croatia

Date of the most recent review of this leaflet: June 2017

This medicinal product is authorized in the European Economic Area member states under the following names:

Up-to-date detailed information about this medication is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/