SOLIFENACIN SUCCINATE QILU 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Solifenacin Succinate Qilu5mg 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

1. What Solifenacin Succinate Qilu is and what it is used for
2. What you need to know before you take Solifenacin Succinate Qilu
3. How to take Solifenacin Succinate Qilu
4. Possible side effects

1. Storage and Additional Information

1. What Solifenacin Succinate Qilu is and what it is used for

The active substance in Solifenacin Succinate Qilu belongs to a group of medicines called anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This allows you to wait longer before you need to urinate and increases the amount of urine you can hold in your bladder.

This medicine is used to treat the symptoms of a condition called overactive bladder, which include: having a sudden, urgent need to urinate without prior warning, having to urinate frequently, or having involuntary leakage of urine.

2. What you need to know before you take Solifenacin Succinate Qilu

Do not take Solifenacin Succinate Qilu:

• if you are allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6).
• if you are unable to urinate or empty your bladder completely (urinary retention).
• if you have a severe stomach or intestinal disorder (including toxic megacolon, which is a complication associated with ulcerative colitis).
• if you have a muscle disorder called myasthenia gravis, which can cause extreme weakness in certain muscles.
• if you have increased eye pressure, accompanied by a gradual loss of vision (glaucoma).
• if you are undergoing hemodialysis.
• 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 Succinate Qilu from the body (e.g., ketoconazole). Your doctor or pharmacist will inform you if this is the case.

Before starting treatment with Solifenacin Succinate Qilu, tell your doctor if you have or have had any of the disorders described above.

Warnings and Precautions

Consult your doctor or pharmacist before starting Solifenacin Succinate Qilu if:

• You have difficulty emptying your bladder (obstruction of the bladder) or urinating (e.g., weak urine flow). The risk of urine accumulation in the bladder is much higher.
• You have any obstruction of the digestive tract (constipation).
• You are at risk of decreased digestive tract activity (decreased stomach or intestinal movement). Your doctor or pharmacist will have informed you if this is the case.
• You have severe kidney disease.
• You have moderate liver disease.
• You have a hiatus hernia or heartburn.
• You have an autonomic nervous disorder (autonomic neuropathy).

Before starting Solifenacin Succinate Qilu, tell your doctor if you have or have had any of the disorders described above.

Before starting treatment with Solifenacin Succinate Qilu, your doctor will assess whether there are other causes for your frequent need to urinate, such as heart failure (insufficient heart pumping capacity) or kidney disease. If you have a urinary tract infection, your doctor will prescribe an antibiotic (treatment for certain bacterial infections).

Children

This medicine must not be used in children.

Other Medicines and Solifenacin Succinate Qilu

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

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

• Other anticholinergic medicines, as the effects and side effects of both medicines may increase.
• Cholinergics, as they may reduce the effect of Solifenacin Succinate Qilu.
• Medicines such as metoclopramide and cisapride, which make the digestive tract work faster. Solifenacin Succinate Qilu may reduce their effect.

• Medicines such as ketoconazole and itraconazole (medicines used to treat fungal infections).

• Ritonavir and nelfinavir (medicines used to treat HIV infections).
• Verapamil and diltiazem (medicines used to treat high blood pressure and heart disease), which reduce the rate of elimination of Solifenacin Succinate Qilu from the body.
• Medicines such as rifampicin (a medicine used to treat tuberculosis and other bacterial infections).
• Phenytoin and carbamazepine (medicines used to treat epilepsy), as they may increase the rate of elimination of Solifenacin Succinate Qilu from the body.
• Medicines such as bisphosphonates, which may cause inflammation of the throat (esophagitis) or worsen it.

Pregnancy and Breastfeeding

Do not take this medicine if you are pregnant, unless your doctor considers it necessary. Do not take this medicine if you are breastfeeding, as it may pass into breast milk.

If you are pregnant or breastfeeding, 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

This medicine may cause blurred vision and, occasionally, drowsiness or fatigue. If you experience any of these effects, do not drive or use machines.

Solifenacin Succinate Qilu contains Lactose Monohydrate

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

3. How to Take Solifenacin Succinate Qilu

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose is 5 mg once daily, unless your doctor has told you to take 10 mg once daily.

Swallow the tablet whole with a little water. You can take it with or without food, as you prefer. Do not crush the tablets.

If you take more Solifenacin Succinate Qilu than you should

If you have taken more Solifenacin Succinate Qilu than you should, talk to a doctor or pharmacist immediately or go to the nearest hospital casualty department. Take the medicine pack with you.

Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and blurred vision, perceiving things that do not exist (hallucinations), overexcitement, seizures (convulsions), difficulty breathing, rapid heartbeat (tachycardia), urine accumulation in the bladder (urinary retention), and dilated pupils (mydriasis).

If you forget to take Solifenacin Succinate Qilu

If you forget to take a dose at the usual time, take it as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Solifenacin Succinate Qilu

If you stop taking this medicine, the symptoms of overactive bladder that you are experiencing may come back or get worse. If you are considering stopping treatment, consult your doctor.

If you have any further questions on the use of this product, 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 experience a severe allergic reaction or a severe skin reaction (e.g., blisters and peeling of the skin), contact your doctor or pharmacist immediately.

In some patients treated with solifenacin succinate, cases of angioedema (an allergic reaction of the skin that causes inflammation of the tissues under the skin surface) accompanied by respiratory tract obstruction (difficulty breathing) have been reported. If you experience any symptoms of angioedema, stop taking this medicine and contact your doctor immediately.

Other 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 accompanied by symptoms such as abdominal heaviness, abdominal pain, belching, nausea, heartburn (dyspepsia), and stomach discomfort

Uncommon(may affect up to 1 in 100 people)

• urinary tract infection, bladder infection
• drowsiness
• altered sense of taste (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(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 it (urinary retention)
• dizziness, headache
• vomiting
• itching, rash

Very Rare(may affect up to 1 in 10,000 people)

• hallucinations, confusion
• allergic rash

Frequency Not Known(frequency cannot be estimated from the available data)

• decreased appetite, elevated potassium levels in the blood, which can cause an abnormal heart rhythm
• increased eye pressure
• changes in the electrical activity of the heart (ECG), irregular heartbeat, perception of heartbeats, rapid heartbeat
• voice disorders
• liver disorders
• muscle weakness
• kidney disorders

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Solifenacin Succinate Qilu

Store below 25°C. Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Bottles of 30, 90, and 100 tablets: once opened, the tablets can be stored for 3 months. Keep the bottle tightly closed.

Bottles of 2000 tablets: once opened, the tablets can be stored for 6 months. Keep the bottle tightly closed.

Do not use this medicine if you notice that the packaging is damaged or shows signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Additional Information

Composition of Solifenacin Succinate Qilu

• The active substance is solifenacin succinate.

Each film-coated tablet contains 5 mg of solifenacin succinate, equivalent to 3.8 mg of solifenacin.

• The other ingredients are:

Core of the tablet: lactose monohydrate, corn starch, hypromellose (5 cps), magnesium stearate.

Coating: talc, hypromellose (6 cps), macrogol 8000, titanium dioxide (E-171), yellow iron oxide (E-172).

Appearance and Packaging

Film-coated tablets, round, light yellow in color, and engraved with «23» on one side.

Solifenacin succinate film-coated tablets are available in blisters of 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, and 200 tablets and in bottles of 30, 90, 100, and 2000 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Qilu Pharma Spain S.L.

Paseo de la Castellana, 40,

8th floor, 28046 Madrid

Spain

Manufacturer:

KYMOS PHARMA SERVICES, S.L.,

Ronda de Can Fatjó,

7B (Parque Tecnológico del Vallès),

Cerdanyola del Vallès,

08290-Barcelona,

Spain

NETPHARMALAB CONSULTING SERVICES

Carretera de Fuencarral 22,

Alcobendas, Madrid -28108

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of Last Revision of this Leaflet:February 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/