Sincal 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sincal 5 mg film-coated tablets EFG

Solifenacin succinate

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Sincal is and what it is used for
2. What you need to know before taking Sincal
3. How to take Sincal
4. Possible side effects
5. How to store Sincal
6. Contents of the pack and other information

1. What Sincal is and what it is used for

The active substance in this medicine belongs to the group of anticholinergics. These medicines are used to reduce the activity of the overactive bladder. This allows you to have more time before needing to go to the toilet and increases the amount of urine your bladder can hold.

Solifenacin is used to treat the symptoms of overactive bladder syndrome. These symptoms include a sudden, strong urge to urinate without prior warning, needing to urinate frequently, or leaking urine due to not reaching the toilet in time.

2. What you need to know before starting to take Sincal

Do not take Sincal

• if you have difficulty passing urine 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 renal disease or moderate liver disease and are also being treated with medicines that may reduce the elimination of solifenacin from the body (e.g. ketoconazole). Your doctor or pharmacist will inform you if this applies to you.

Before starting treatment with solifenacin, inform your doctor if you have or have ever had any of the conditions listed above.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine

• if you have difficulty emptying your bladder (bladder obstruction) or difficulty passing urine (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 reduced activity of the digestive system (movements of the stomach and intestines). Your doctor will inform you if this applies to you.
• 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 system disorder (autonomic neuropathy).

Inform your doctor before starting treatment with this medicine if any of the above circumstances have ever applied to you.

Before starting treatment with this medicine, your doctor will assess whether there are other causes for your need to urinate frequently (e.g. heart failure (insufficient pumping capacity of the heart) or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic (a treatment against certain bacterial infections).

Children and adolescents

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

Other medicines and Sincal

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

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

• other anticholinergic medicines, as the activity and adverse effects of both medicines could increase.
• cholinergic agents, as they may reduce the effect of this medicine.
• medicines such as metoclopramide or cisapride, which speed up the digestive system. Solifenacin may reduce their effect.
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which reduce 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 oesophagus (oesophagitis).

Taking Sincal with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using 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 operate machinery.

Sincal contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Sincal

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You must swallow the tablet whole with liquid. It can be taken with or without food, according to your preference. Do not crush the tablets.

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

Use in children and adolescents

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

If you take more Sincal than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision, perception of things that are not there (hallucinations), marked excitement, seizures, 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 almost time for your 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 a missed 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 considering stopping treatment.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences 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 (a skin allergy resulting in swelling of the tissue beneath the skin surface) with airway obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate. If angioedema occurs, treatment with solifenacin succinate must be discontinued immediately, and appropriate treatment and/or measures must be taken.

This medicine may cause the following adverse 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 stomach heaviness, abdominal pain, burping, nausea, and heartburn (dyspepsia), stomach discomfort

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

• urinary tract infection, bladder infection
• somnolence
• abnormal taste perception (dysgeusia)
• dry (irritated) eyes
• 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 adverse effects (may affect up to 1 in 1,000 people)

• accumulation of hardened stool in the colon (fecal impaction)
• urine retention in the bladder due to inability to empty the bladder (urinary retention)
• dizziness, headache
• vomiting
• itching, skin rash

Very rare adverse 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 which may cause abnormal heart rhythm.
• increased pressure in the eyes
• changes in the heart's electrical activity (ECG), irregular heartbeats (torsade de pointes), palpitations, rapid heartbeat.
• voice disorder
• liver disorder
• muscle weakness
• kidney disorder

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other 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, Monohydrate lactose, Hypromellose (E464), Magnesium stearate.

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

Appearance of the product and contents of the pack

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

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

Only certain 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 medicinal product is authorised in other EEA Member States under the following names:

Date of the most recent review of this leaflet: October 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es