Solifenacin Sandoz 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Solifenacin Sandoz 5 mg film-coated tablets EFG

Solifenacin Sandoz 10 mg film-coated tablets EFG

Solifenacin succinate

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Solifenacin Sandoz is and what it is used for
2. What you need to know before taking Solifenacin Sandoz
3. How to take Solifenacin Sandoz
4. Possible adverse effects
5. How to store Solifenacin Sandoz
6. Contents of the pack and other information

1. What Solifenacina Sandoz is and what it is used for

Solifenacina, the active substance in Solifenacina Sandoz, belongs to the group of anticholinergic medicines. These medicines are used to reduce the activity of the 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 is used for the treatment of symptoms of overactive bladder syndrome. These symptoms include:

• a sudden, strong urge to urinate without prior warning,
• needing to urinate frequently, or
• leaking urine due to not reaching the toilet in time.

2. What you need to know before starting Solifenacin Sandoz

Do not take Solifenacin Sandoz if:

• you are allergic to solifenacin succinate or to any of the other ingredients of this medicine (listed in section 6),
• you have difficulty passing urine or emptying your bladder completely (urinary retention),
• you have a severe stomach or intestinal disorder (including toxic megacolon, a complication associated with ulcerative colitis),
• you have a muscle disease called myasthenia gravis, which can cause extreme weakness of certain muscles,
• you have high pressure in the eyes with gradual loss of vision (glaucoma),
• you are undergoing renal dialysis,
• you have severe liver disease,
• you have severe kidney disease or moderate liver disease and are also taking medicines that may reduce the elimination of solifenacin from the body (e.g., ketoconazole). Your doctor or pharmacist will have informed you if this applies.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• if you have difficulty emptying your bladder (bladder obstruction) or difficulty passing urine (e.g., weak urine stream). 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 risk of reduced activity of the digestive system (stomach and intestinal movements). Your doctor will inform you if this applies,
• 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 (autonomic neuropathy).

Inform your doctor before starting treatment with this medicine if any of the above circumstances have ever occurred to you.

Before starting treatment with solifenacin, your doctor will assess whether there are other causes for your need to urinate frequently (e.g., 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 under 18 years of age

This medicine must not be used in children or adolescents under 18 years of age.

Other medicines and Solifenacin Sandoz

Tell 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,
• cholinergic agents, as they may reduce the effect of solifenacin,
• medicines such as metoclopramide or cisapride, which increase the activity of the digestive system. Solifenacin may reduce their effect,
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which decrease the rate of elimination of solifenacin from the body,
• medicines such as rifampicin, phenytoin, and carbamazepine, which may increase the rate of elimination of solifenacin from the body,
• medicines such as bisphosphonates, which may cause or worsen inflammation of the oesophagus (oesophagitis).

Taking Solifenacin Sandoz with food, drinks and alcohol

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

Pregnancy and breastfeeding

Pregnancy

You should not use solifenacin during pregnancy unless absolutely necessary.

Breastfeeding

Do not use solifenacin while breastfeeding, as solifenacin may pass into breast milk.

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

Driving and using machines

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

Solifenacin Sandoz contains lactose

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

3. How to take Solifenacin Sandoz

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

Instructions for correct use

Swallow the tablet whole with a glass of water, without chewing or crushing it, and at the same time each day. Tablets may be taken with or without food.

The Solifenacin Sandoz 10 mg tablet may be divided into equal doses.

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

If you take more Solifenacin Sandoz than you should

If you have taken more Solifenacin Sandoz than you should, or if a child has accidentally taken Solifenacin Sandoz, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms of overdose may include:

• headache,
• dry mouth,
• dizziness,
• drowsiness and blurred vision,
• perception of things that are not present (hallucinations),
• pronounced excitement,
• seizures,
• breathing difficulty,
• increased heart rate (tachycardia),
• urine accumulation in the bladder (urinary retention),
• pupil dilation (mydriasis).

If you forget to take Solifenacin Sandoz

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 Sandoz

If you stop taking solifenacin, 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.

If you suffer an allergic attack (symptoms may include swelling of the throat, face, lips and mouth, difficulty breathing and swallowing) or a severe skin reaction (e.g., blistering and peeling of the skin), you must inform your doctor or nurse immediately.

Angioedema (a skin allergy resulting in swelling of the tissue beneath the skin surface) with airway obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate. If angioedema occurs, treatment with solifenacin succinate must be stopped immediately and appropriate treatment and/or measures must be taken.

Other adverse effects that may occur with the following frequencies:

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 of stomach heaviness, abdominal pain, belching, nausea and heartburn (dyspepsia).

Uncommon: may affect up to 1 in 100 people

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

Rare: may affect up to 1 in 1,000 people

• accumulation of hardened feces in the large intestine (fecal impaction),
• obstruction in the large intestine (colon),
• urine retention 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 pressure in the eyes,
• changes in the heart's electrical activity (ECG), irregular heartbeat, awareness of heartbeat, rapid heartbeat,
• voice disorder,
• liver disorder or changes in liver function which may be observed in a blood test,
• muscle weakness,
• kidney disorder,
• stomach discomfort, ileus (absence of intestinal movement which may cause intestinal obstruction),
• redness and peeling of the skin,
• delirium.

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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Solifenacin Sandoz

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.

This medicine does not require any special storage conditions.

Tablets in HDPE bottles have a shelf-life of 6 months after first opening of the container. This does not apply to aluminium/plastic blister packs.

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to a pharmacy’s SIGRE point. If in doubt, 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 Sandoz 5 mg

• The active substance is solifenacin succinate. Each tablet contains 5 mg of solifenacin succinate, equivalent to 3.8 mg of solifenacin.
• The other components (excipients) are: monohydrate lactose, hypromellose, pregelatinized corn starch, magnesium stearate, macrogol 6000, talc, titanium dioxide (E-171), and yellow iron oxide (E-172).

Composition of Solifenacin Sandoz 10 mg

• The active substance is solifenacin succinate. Each tablet contains 10 mg of solifenacin succinate, equivalent to 7.5 mg of solifenacin.
• The other components (excipients) are: monohydrate lactose, hypromellose, pregelatinized corn starch, magnesium stearate, macrogol 6000, talc, titanium dioxide (E-171), and red iron oxide (E-172).

Appearance of the product and contents of the pack

Solifenacin Sandoz 5 mg film-coated tablets are yellow, round, film-coated tablets with the number "05" printed on one side.

Solifenacin Sandoz 10 mg film-coated tablets are light pink, round, film-coated tablets with the number "10" printed on one side and a score line on the other.

Blister packs made of PVC/AL containing 10, 20, 30, 90 or 100 film-coated tablets, packed in cardboard boxes.

Polyethylene bottles (with polypropylene screw cap and desiccant) containing 30, 56, 60, 84, 90, 100 or 250 film-coated tablets, packed in cardboard boxes.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovskova 57, 1526

Ljubljana

Slovenia

Lek Pharmaceuticals d.d.

Trimlini 2D, 9220

Lendava

Slovenia

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

Austria Solifenacin 1A Pharma 5 mg – Filmtabletten
Solifenacin 1A Pharma 10 mg – Filmtabletten

Bulgaria Truzor 5 mg Film-coated tablet

Cyprus Solifenacin Sandoz

Czech Republic Muscarisan 5 mg
Muscarisan 10 mg

Denmark Solifenacin "Sandoz"

Finland Solifenacin Sandoz 5 mg tabletti, kalvopäällysteinen
Solifenacin Sandoz 10 mg tabletti, kalvopäällysteinen

Greece Solifenacin/Sandoz 5 mg επικαλυμμένα με λεπτό υμένιο δισκία
Solifenacin/Sandoz 10 mg επικαλυμμένα με λεπτό υμένιο δισκία

Norway Solifenacin Sandoz 5 mg filmdrasjert tablett
Solifenacin Sandoz 10 mg filmdrasjert tablett

Poland Solifenacin Sandoz 5 mg tabletki powlekane
Solifenacin Sandoz 10 mg tabletki powlekane

Slovenia Sulfesa 5 mg filmsko obložene tablete
Sulfesa 10 mg filmsko obložene tablete

Slovakia Solifenacin Sandoz 10 mg

Spain Solifenacina Sandoz 5 mg comprimidos recubiertos con película EFG
Solifenacina Sandoz 10 mg comprimidos recubiertos con película EFG

Date of the most recent revision of this leaflet: October 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS): http://www.aemps.gob.es/