SINCAL 10 mg FILM-COATED TABLETS

2. What you need to know before taking Sincal

Do not take Sincal

• 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 muscular disease called myasthenia gravis, which can cause extreme weakness of certain muscles.
• if you have high pressure in the eyes, 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 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 aforementioned diseases.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication

• if you have a problem 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 an increased risk of decreased activity of the digestive system (movements of the stomach and intestine). 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 a nervous disorder (autonomic neuropathy).

Inform your doctor before starting treatment with this medication if any of the aforementioned circumstances have occurred to you.

Before starting treatment with this medication, your doctor will assess 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 (treatment against certain bacterial infections).

Children and adolescents

This medication should not be used in children and adolescents under 18 years of age.

Other medications and Sincal

Inform your doctor or pharmacist or nurse if you are taking, have recently taken, or may take any other medication.

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

• other anticholinergic medications, as the activity and side effects of both medications may increase.
• cholinergic medications, as they may reduce the effect of this medication.
• 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 elimination rate of this medication from the body.
• medications such as rifampicin, phenytoin, and carbamazepine, as they may increase the elimination rate of this medication from the body.
• medications such as bisphosphonates, which may cause or worsen inflammation of the esophagus (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 it is 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

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.

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.

3. How to take Sincal

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

Swallow the tablet whole with some liquid. It can be taken with or without food, as you prefer. Do not crush the tablets.

The normal dose is 5 mg per day, unless your doctor indicates that you should take 10 mg per day.

Use in children and adolescents

This medication should not be used in children and adolescents under 18 years of age.

If you take more Sincal than you should

In case of overdose or accidental ingestion, 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 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), accumulation of urine 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 a double dose to make up for the forgotten dose.

If you stop taking Sincal

If you stop taking this medication, 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 medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. If you suffer an allergic reaction or a severe skin reaction (e.g., blistering and peeling of the skin), inform your doctor or pharmacist immediately.

Angioedema (allergic reaction in the skin that results in inflammation of the tissue under the skin surface) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate. If angioedema occurs, treatment with solifenacin succinate should be discontinued immediately, and appropriate treatment and/or measures should be taken.

This medication 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 a feeling of stomach heaviness, abdominal pain, belching, nausea, and heartburn (dyspepsia), stomach discomfort

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

• urinary tract infection, bladder infection
• drowsiness
• abnormal taste perception (dysgeusia)
• dry eyes (irritated)
• dryness of the nasal passages
• gastroesophageal reflux disease (GERD)
• dry throat
• dry skin
• difficulty urinating
• fatigue
• accumulation of fluid in the lower limbs (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)
• accumulation of urine in the bladder due to inability to empty the bladder (urinary retention)
• dizziness, headache
• vomiting
• itching, skin rash

Very rare side effects(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 that can cause an abnormal heart rhythm.
• increased pressure in the eyes
• changes in the electrical activity of the heart (ECG), irregular heartbeats (torsade de pointes), palpitations, rapid heartbeat.
• voice disorder
• liver disorder
• muscle weakness
• kidney disorder

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Sincal

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

PVC/PVDC-Alu blisters:

No special storage conditions are required.

Do not use Sincal after the expiration date stated on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package contents and additional information

The active substance is Solifenacin succinate

Each film-coated tablet contains 10 mg of solifenacin succinate, equivalent to 7.5 mg of solifenacin

Other ingredients are:

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

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

Appearance of the product and package contents

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Q Pharma S.L.

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

03008 Alicante

Spain

Manufacturer

Zentiva S.A.

Bd. Theodor Pallady nr 50

032266 Bucuresti

Romania

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

Date of the last revision of this package leaflet: October 2019

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