Package Leaflet: Information for the User

Solifenacina Sandoz 5 mg Film-Coated Tablets

Solifenacina Sandoz 10 mg Film-Coated Tablets

Solifenacina, succinate

Read this 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. Do 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 leaflet. See section 4.

Solifenacina, the active ingredient of Solifenacina Sandoz belongs to the group of anticholinergics. These medications are used to reduce the activity of an 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.

Solifenacina is used fortreatment of 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 leakage due to not making it to the bathroom on time.

Do not take Solifenacina Sandoz if:

-you are allergic to solifenacin succinate or any of the other components of this medication (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 disease called myasthenia gravis, which can cause extreme weakness in certain muscles,

-you have high pressure in the eyes, with gradual loss of vision (glaucoma),

-you are undergoing renal dialysis,

-you have a severe liver disease,

-you have a severe kidney disease or moderate liver disease and are being treated with medications that can reduce the elimination of solifenacin from the body (e.g., ketoconazole). Your doctor or pharmacist will inform you if this is the case.

Inform your doctor before starting treatment with solifenacin if you have or have had any of the above-mentioned diseases.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

-if you have difficulty emptying your bladder (bladder obstruction) or 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 have a risk of decreased activity of the digestive system (gastrointestinal motility). Your doctor will inform you if this is the case,

-if you have a severe kidney disease,

-if you have a moderate liver disease,

-if you have a hiatal hernia or heartburn,

-if you have a nervous disorder (autonomic neuropathy).

Inform your doctor before starting treatment with this medication if any of the above-mentioned circumstances have occurred at any time.

Before starting treatment with solifenacin, your doctor will evaluate 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 (a treatment for certain bacterial infections).

Children and adolescents under 18 years

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

Other medications and Solifenacina Sandoz

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

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

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

Taking Solifenacina Sandoz with food, drinks, and alcohol

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

Driving and operating machines

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

Solifenacina Sandoz contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

Instructions for Correct Use

You must swallow the tablet whole with a glass of water, without crushing or chewing it, and at the same time every day. The tablets can be taken with or without food.

The Solifenacina 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 Solifenacina Sandoz Than You Should

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

The symptoms of an overdose may include:

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

If You Forget to Take Solifenacina 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 Interrupt Treatment with Solifenacina Sandoz

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Angioedema (allergic reaction on the skin resulting in inflammation beneath the skin surface) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacina succinato. If angioedema appears, treatment with solifenacina succinato should be stopped immediately and appropriate treatment and/or measures should be taken.

Other side effects that may occur at 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 stomach burning (dyspepsia).

Uncommon,may affect up to 1 in 100 people

• urinary tract infection, bladder infection,
• drowsiness, fatigue,
• altered taste perception (dysgeusia),
• dry, irritated eyes,
• nasal dryness,
• gastroesophageal reflux disease,
• dry throat,
• dry skin,
• difficulty urinating,
• lower extremity edema.

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

• fecal impaction in the large intestine,
• obstruction in the large intestine (colon),
• urinary retention due to inability to empty the bladder,
• 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

• loss of appetite, high potassium levels in the blood that may cause abnormal heart rhythm,
• increased eye pressure,
• changes in heart electrical activity (ECG), irregular heartbeats, feeling the heart beat, rapid heart rate,
• voice disorder,
• liver disorder or changes in its function that may be observed in a blood test,
• muscle weakness,
• renal disorder,
• stomach discomfort, ileus (absence of intestinal movement that may cause intestinal obstruction),
• skin redness and peeling,
• delirium.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

This medication does not require special storage conditions.

Tablets in HDPE bottles have a shelf life after the first opening of the packaging for 6 months. This does not apply to packaging with aluminum/plastic blisters.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Solifenacina Sandoz 5 mg

-Theactive ingredientissolifenacina succinate. Each tablet contains 5 mg of solifenacina succinate equivalent to 3.8 mg of solifenacina.

-Theother components (excipients)are: lactose monohydrate, hypromellose, pregelatinized maize starch, magnesium stearate, macrogol 6000, talc, titanium dioxide (E-171) and yellow iron oxide (E-172).

Composition of Solifenacina Sandoz 10 mg

-Theactive ingredientissolifenacina succinate. Each tablet contains 10 mg of solifenacina succinate equivalent to 7.5 mg of solifenacina.

-Theother components (excipients)are: lactose monohydrate, hypromellose, pregelatinized maize starch, magnesium stearate, macrogol 6000, talc, titanium dioxide (E-171) and red iron oxide (E-172).

Appearance of the product and contents of the package

The coated tablets of Solifenacina Sandoz 5 mg are yellow, round, coated tablets with the number 05 printed on one of the faces.

The coated tablets of Solifenacina Sandoz 10 mg are pale pink, round, coated tablets with the number 10 printed on one of the faces and scored on the other.

PVC/AL blisters containing 10, 20, 30, 90 or 100 coated tablets in carton boxes.

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible for manufacturing

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Lek Pharmaceuticals dd

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 with 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 tabletti, kalvopaallysteinen

Solifenacin Sandoz 10 mg tabletti, kalvopaallysteinen

GreeceSolifenacin/Sandoz 5 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

Solifenacin/Sandoz 10 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

NorwaySolifenacin Sandoz 5 mg filmdrasjert tablett

Solifenacin Sandoz 10 mg filmdrasjert tablett

PolandSolifenacin Sandoz 5 mg tabletki powlekane

Solifenacin Sandoz, 10 mg, tabletki powlekane

SloveniaSulfesa 5 mg filmsko obložene tablete

Sulfesa 10 mg filmsko obložene tablete

SlovakiaSolifenacin Sandoz 10 mg

SpainSolifenacina Sandoz 5mg comprimidos recubiertos con películaEFG

Solifenacina Sandoz 10 mg comprimidos recubiertos con película EFG

Last revision date of this leaflet: October 2020

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/