Package Leaflet: Information for the User

Solifenacin succinate 10 mg film-coated tablets EFG

Solifenacin 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 pass it on to others even if their symptoms are the same as yours. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5Storage of solifenacin succinate

6.Contents of the pack and other information

The active ingredient of solifenacina cinfa 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 cinfa 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 leakage because you did not make it to the bathroom on time.

Do not take solifenacina cinfa

• if you are allergic to solifenacina or any of the other ingredients of this medicine (listed in section 6).
• 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 eye pressure, with gradual loss of vision (glaucoma)
• 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 can reduce the elimination of solifenacina from the body (e.g. ketoconazole). Your doctor or pharmacist will inform you if this is the case.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take solifenacina

• 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 an increased risk of decreased activity of the digestive system (gastrointestinal motility). 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 hiatal hernia or heartburn.
• if you have a nervous disorder (autonomic neuropathy).

Children and adolescents

Inform your doctor before starting treatment with solifenacina, if any of the circumstances mentioned above have occurred at any time.

Solifenacina should not be used in children or adolescents under 18 years old.

Before starting treatment with solifenacina, your doctor will assess whether there are other causes for your need to urinate frequently (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).

Taking solifenacina cinfa with other medicines

Inform your doctor or pharmacist if you are taking or have recently taken any other medicine.

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

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

Taking solifenacina cinfa with food and drinks

Solifenacina cinfa can be taken with or without food, as you prefer.

Pregnancy, breastfeeding, and fertility

You should not use solifenacina if you are pregnant, unless absolutely necessary. Do not use solifenacina during breastfeeding, as solifenacina 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 operating machinery

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

Instructions for correct use

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Swallow the entire tablet with some liquid. You can take it with or without food, according to your preference. Do not crush the tablets.

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

If you take more solifenacin cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The 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), urine accumulation in the bladder (urinary retention), and dilation of the pupils (mydriasis).

If you forget to take solifenacin cinfa

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 interrupt treatment with solifenacin cinfa

If you stop taking solifenacin cinfa, 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 or a severe skin reaction (such as blistering and peeling of the skin), you must inform your doctor or nurse immediately.

Angioedema (allergy on the skin resulting in inflammation that occurs in the tissue beneath 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 must be stopped immediately and appropriate treatment and/or measures must be taken.

Solifenacin cinfa 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 feeling of stomach heaviness, abdominal pain, belching, nausea, and stomach burning (dyspepsia), stomach discomfort

Rare side effects (may affect up to 1 in 100 people)

• Urinary tract infection, bladder infection
• Drowsiness
• Abnormal taste perception (dysgeusia)
• Dry eyes (irritated)
• Runny nose dryness
• Gastroesophageal reflux disease (GERD)
• Sore throat
• Dry skin
• Difficulty urinating
• Fatigue
• Swelling of the lower extremities (edema)

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

• Accumulation of a large amount of hardened feces in the large intestine (fecal impaction)
• Urinary retention due to inability to empty the bladder
• Dizziness, headache
• Vomiting
• Itching, skin rash

Very rare side effects (may affect up to 1 in 10,000 people)

• Hallucinations, confusion
• Allergic skin eruption.

Unknown frequency (frequency cannot be estimated from available data)

• Decreased appetite, high levels of potassium in the blood that may cause an abnormal heart rhythm.
• Increased eye pressure
• Changes in heart electrical activity (ECG), irregular heartbeat, palpitations, rapid heartbeat.
• Voice disorder
• Liver disorder
• Muscle weakness
• Renal disorder

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 the Pharmacovigilance of Medicinal Products for Human Use:https://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 packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C..

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at 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.

Compositionof solifenacin cinfa

• The active ingredient is succinamide of solifenacin: 10 mg.
• The other components are povidone, cornstarch, sodium carboxymethyl starch from potato (type A), anhydrous dibasic calcium phosphate, magnesium stearate, white opadry, and iron oxide red (E172).

Appearance of the product and contents of the packaging

Solifenacin cinfa 10 mg tablets are rough, cylindrical, biconvex, pale pink, unnotched tablets with the logo “S1” on one face.

Solifenacin cinfa 10 mg tablets are supplied in blisters of 30 tablets.

Holder of the marketing authorization and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta.

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet:April 2018

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

You can access detailed and updated information about this medication by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/83023/P_83023.html

QR code to:https://cima.aemps.es/cima/dochtml/p/83023/P_83023.html