SINCAL 5 mg FILM-COATED TABLETS

2. What you need to know before you take Sincal

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 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 ingredients of this medicine (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 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 above-mentioned diseases.

Warnings and precautions

Talk to 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 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 medicine if any of the above circumstances have ever occurred to you.

Before starting treatment with this medicine, 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

This medicine must not be used in children and adolescents under 18 years of age.

Other medicines and Sincal

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

• other anticholinergic medicines, as the activity and side effects of both medicines may increase.
• cholinergic medicines, as they may reduce the effect of this medicine.
• 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 rate of elimination of this medicine from the body.
• medicines such as rifampicin, phenytoin, and carbamazepine, as they may increase the rate of elimination of this medicine from the body.
• medicines such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis).

Taking Sincal with food, drinks, and alcohol

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

Pregnancy, breast-feeding, and fertility

Do not use solifenacin if you are pregnant unless it is absolutely necessary. Do not use this medicine during breast-feeding, as solifenacin may pass into breast milk.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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.

Sincal contains lactose

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

3. How to take Sincal

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask 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 tells you to take 10 mg per day.

Use in children and adolescents

This medicine must not be used in children and adolescents under 18 years of age.

If you take more Sincal than you should

If you have taken more than the prescribed dose, contact your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, stating the medicine and the amount taken.

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. If in 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 medicine, your overactive bladder symptoms may return or worsen.

Always consult your doctor if you are thinking of stopping treatment.

If you have any further questions on 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 from an allergic attack or a severe skin reaction (e.g., blistering and peeling of the skin), tell your doctor or pharmacist 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 occurs, treatment with solifenacin succinate should be discontinued immediately and appropriate treatment and/or measures should be taken.

This medicine 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 heaviness in the stomach, 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 (gastroesophageal reflux)
• dry throat
• dry skin
• difficulty urinating
• fatigue
• fluid accumulation 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)
• urine accumulation 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 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 (torsade de pointes), palpitations, rapid heartbeat.
• voice disorder
• liver disorder
• muscle weakness
• kidney disorder

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 package leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sincal

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

PVC/PVDC-Alu blisters:

No special storage conditions are required.

Do not use Sincal after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and further information

The active substance is Solifenacin succinate

Each film-coated tablet contains 5 mg of solifenacin succinate, equivalent to 3.8 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 Yellow iron oxide (E172).

Appearance of the product and pack contents

Sincal 5 mg film-coated tablets EFG are round, light yellow, and marked with a code "390" on one side of the tablet.

Sincal 5 mg film-coated tablets EFG are supplied in blisters of 30 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 medicine is authorised in other EEA states under the following names:

Date of last revision of this package leaflet: October 2019

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