SOLIFENACIN SANDOZ 5 mg FILM-COATED TABLETS

2. What you need to know before you take Solifenacin Sandoz

Do not take Solifenacin Sandoz if:

• you are allergic to solifenacin succinate or any of the other ingredients of this medicine (listed in section 6),
• you have difficulty urinating 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 disorder 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 hemodialysis,
• you have severe liver disease,
• you have severe kidney disease or moderate liver disease and are also 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 this medicine:

• 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 a 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 hiatal hernia or heartburn,
• if you have an autonomic nervous 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 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 under 18 years

This medicine should not be used in children or adolescents under 18 years.

Other medicines and Solifenacin Sandoz

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

• other anticholinergic medicines, the activity and side effects of both medicines may increase,
• cholinergic medicines, as they may reduce the effect of solifenacin,
• medicines such as metoclopramide or cisapride, which make the digestive system work faster. Solifenacin may reduce their effect,
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which decrease the elimination of solifenacin from the body,
• medicines such as rifampicin, phenytoin, and carbamazepine, as they may increase the elimination of solifenacin from the body,
• medicines such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis).

Taking Solifenacin Sandoz with food, drinks, and alcohol

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

Pregnancy and breastfeeding

Pregnancy

Do not use solifenacin if you are pregnant unless it is absolutely necessary.

Breastfeeding

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

Solifenacin Sandoz contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Solifenacin Sandoz

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are 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 every day. The tablets can be taken with or without food.

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

The recommended dose is 5 mg per day, unless your doctor tells you to take 10 mg per day.

If you take more Solifenacin Sandoz than you should

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

The symptoms in case of overdose may include:

• headache,
• dry mouth,
• dizziness,
• drowsiness and blurred vision,
• perceiving things that are not there (hallucinations),
• pronounced excitement,
• seizures,
• breathing difficulties,
• 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 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 Sandoz

If you stop taking solifenacin, 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.

If you suffer an allergic attack (symptoms may include inflammation 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 should inform your doctor or nurse immediately.

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. If angioedema appears, treatment with solifenacin succinate should be discontinued immediately and appropriate treatment and/or measures should be taken.

Other side effects that may occur in 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 a feeling of heaviness in the stomach, 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 eyes (irritated),
• dryness of the nasal passages,
• gastroesophageal 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 a large amount of hardened feces in the large intestine (fecal impaction),
• obstruction in the large intestine (colon), 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, feeling the heart beating, rapid heartbeat,
• voice disorder,
• liver disorder or changes in liver function that can be seen in a blood test,
• muscle weakness,
• kidney disorder,
• stomach upset, ileus (absence of intestinal movement that can cause intestinal obstruction),
• redness and peeling of the skin,
• delirium.

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 through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side 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 which is stated on the carton after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

The tablets in HDPE bottles have a shelf life of 6 months after the first opening of the package. This does not apply to aluminum/plastic blister packs.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If you have any doubts, 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 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 ingredients (excipients) are: lactose monohydrate, 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 ingredients (excipients) are: lactose monohydrate, hypromellose, pregelatinized corn starch, magnesium stearate, macrogol 6000, talc, titanium dioxide (E-171), and red iron oxide (E-172).

Appearance of the product and pack contents

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 scored on the other.

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

HDPE bottles with a screw cap made of polypropylene with a desiccant, containing 30, 56, 60, 84, 90, 100, or 250 film-coated tablets, in cardboard boxes.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals dd

Verovskova 57, 1526

Ljubljana

Slovenia

Lek Pharmaceuticals d.d.

Trimlini 2D, 9220

Lendava,

Slovenia

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

AustriaSolifenacin 1A Pharma 5 mg – Filmtabletten

Solifenacin 1A Pharma 10 mg – Filmtabletten

BulgariaTruzor 5 mg Film-coated tablet

CyprusSolifenacin Sandoz

Czech RepublicMuscarisan 5 mg

Muscarisan 10 mg

DenmarkSolifenacin "Sandoz"

FinlandSolifenacin Sandoz 5 mg tablet, film-coated

Solifenacin Sandoz 10 mg tablet, film-coated

GreeceSolifenacin/Sandoz 5 mg film-coated tablets

Solifenacin/Sandoz 10 mg film-coated tablets

NorwaySolifenacin Sandoz 5 mg film-coated tablets

Solifenacin Sandoz 10 mg film-coated tablets

PolandSolifenacin Sandoz 5 mg film-coated tablets

Solifenacin Sandoz, 10 mg, film-coated tablets

SloveniaSulfesa 5 mg film-coated tablets

Sulfesa 10 mg film-coated tablets

SlovakiaSolifenacin Sandoz 10 mg

SpainSolifenacina Sandoz 5mg film-coated tablets EFG

Solifenacina Sandoz 10 mg film-coated tablets EFG

Date of last revision of this leaflet: October 2020

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