Package Insert: Information for the User

Sincal 10 mg Film-Coated Tablets EFG

Solifenacin succinate

Read this package insert carefully before you start taking this medicine, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should 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 package insert. See section 4.

The active ingredient of this medication 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.

Solifenacin 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 experiencing urine leakage due to not reaching the bathroom in time.

Do not takeSincal

• 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 in certain muscles
• if you have high eye pressure with gradual loss of vision (glaucoma)
• if you are allergic to solifenacin or any of the other components of this medication (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 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 diseases mentioned above.

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 an increased risk of decreased digestive system activity (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 system disorder (autonomic neuropathy)

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

Before starting treatment with this medication, your doctor will evaluate 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).

Children and adolescents

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

Other medications and Sincal

Inform your doctor or pharmacist or nurse if you are taking or have taken 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 can reduce the effect of this medication.
• medications such as metoclopramide or cisapride, which make the digestive system work faster. Solifenacin may reduce its effect.
• medications such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which reduce the rate of elimination of this medication from the body.
• medications such as rifampicin, phenytoin, and carbamazepine, which can increase the rate of elimination of this medication from the body.
• medications such as bisphosphonates, which can cause or worsen esophagitis.

Taking Sincal with food, drinks, and alcohol

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

Pregnancy,breastfeeding, and fertility

Do not use solifenacin if you are pregnant unless absolutely necessary. Do not use this medication during breastfeeding as solifenacin may pass into breast milk.

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

Driving and operating machinery

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

Sincal contains lactose

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

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

Swallow the entire tablet with some liquid. It can be taken 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.

Use in children and adolescents

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

If you take more Sincal 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 Sincal

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. In case of doubt, always consult your doctor or pharmacist. Do not take double doses to compensate for the missed dose.

If you interrupt treatment with Sincal

If you stop taking this medication, 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 suffer an allergic attack or a severe skin reaction (for example, blistering and peeling of the skin), you must inform your doctor or pharmacist immediately.

Angioedema (allergy on the skin that results in inflammation that occurs in the tissue under the surface of the skin) 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.

This medicine may cause the following side effects:

Very frequent(may affect more than 1 in 10 people)

• dry mouth

Frequent(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

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

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

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

• fecal impaction (accumulation of a large amount of hardened feces in the large intestine)
• urinary retention (accumulation of urine in the bladder 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 potassium levels in the blood that may cause abnormal heart rhythm.
• increased eye pressure
• changes in heart electrical activity (ECG), irregular heartbeats (torsade de pointes), palpitations, rapid heart rate.
• 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 to the Spanish System for Pharmacovigilance of Medicines 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.

PVC/PVDC-Alu blister packs:

No special storage conditions are required.

Do not use Sincal after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

The active principle is Solifenacina succinato

Each film-coated tablet contains 10 mg of solifenacina succinato equivalent to 7.5 mg of solifenacina

Other ingredients are:

Tablet core: Maize starch, Lactose monohydrate, Hypromellose (E464), Magnesium stearate.

Coating: Hypromellose (E464), Macrogol 8000, Talc (E553b), Titanium dioxide (E171) and Iron oxide red (E172) .

Appearance of the product and content of the container

Sincal 10 mg film-coated tablets EFG are round, light pink, and marked with a code “391” on one side of the tablet.

Sincal 10 mg film-coated tablets EFG are supplied in blisters of 30 tablets.

Only some container sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Q Pharma S.L.

C/ Moratín, nº 15, Entlo. Offices 6 -7

03008 Alicante

Spain

Responsible for manufacturing

Zentiva S.A.

Bd. Theodor Pallady nr 50

032266 Bucuresti

Romania

This medicine is authorized in other member states of the EEA with the following names:

Last revision date of this leaflet: October 2019

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