SOLENOTA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Solenota 5 mg film-coated tablets EFG

Solenota 10 mg film-coated tablets EFG

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 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 is Solenota and what is it used for
2. What you need to know before you take Solenota
3. How to take Solenota
4. Possible side effects
5. Storage of Solenota
6. Contents of the pack and further information

1. What is Solenota and what is it used for

The active substance of Solenota 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 you need to urinate and increases the amount of urine your bladder can hold.

Solifenacin succinate 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 having urine leakage due to not reaching the toilet in time.

2. What you need to know before you take Solenota

Do not takeSolenota

• 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 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 succinate from the body (e.g. ketoconazole). Your doctor or pharmacist will inform you if this is the case.

Before starting treatment with this medicine, inform your doctor if you have or have had any of the diseases mentioned before starting treatment with solifenacin.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Solifenacin.

• If you have problems emptying your bladder (= bladder obstruction) 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 a 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 an autonomic nervous disorder (autonomic neuropathy).

Children and adolescents

Solifenacin should not be used in children or adolescents under 18 years of age.

Inform your doctor before starting treatment with solifenacin if any of the above circumstances have ever occurred to you.

Before starting treatment with solifenacin, 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).

TakingSolenotawith other medicines

Inform your doctor 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, the activity and side effects of both medicines could increase.
• Cholinergics, as they may reduce the effect of solifenacin.
• 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 solifenacin from the body.
• Medicines such as rifampicin, phenytoin and carbamazepine, as they may increase the rate of elimination of solifenacin from the body.
• Medicines such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis).

TakingSolenotawith food, drinks and alcohol

Solifenacin 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 solifenacin during breastfeeding as solifenacin 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

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

Solenotacontains lactose

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

3. How to take Solenota

Instructions for correct use

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

The recommended dose is 5 mg per day, unless your doctor tells you to take 10 mg per day.

If you take moreSolenotathan you should

If you have taken too much Solifenacin or if a child has accidentally taken Solifenacin, contact your doctor or pharmacist immediately.

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 medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

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 takeSolenota

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. Do not take a double dose to make up for forgotten doses. If you have any doubts, always consult your doctor or pharmacist.

If you stop taking Solenota

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 an allergic attack or a severe skin reaction (e.g. blistering and peeling of the skin), you should inform 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 appears, treatment with solifenacin should be discontinued immediately and appropriate treatment and/or measures should be taken.

Solifenacin succinate 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 feeling of heaviness in the stomach, abdominal pain, belching, nausea and heartburn (dyspepsia), stomach discomfort.

Uncommon(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.
• accumulation of fluid 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).
• accumulation of urine in the bladder due to inability to empty the bladder (urinary retention).
• dizziness, headache.
• vomiting.
• itching, skin rash.

Very rare(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, 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, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Solenota

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 is the last day of the month shown.

This medicine does not require any special storage conditions.

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 further information

Composition ofSolenota

• The active substance is 5 mg or 10 mg of solifenacin succinate.

The other ingredients are: anhydrous lactose, sodium croscarmellose, hydroxypropylcellulose (Klucel EXF), magnesium stearate, polyvinyl alcohol, polyethylene glycol 8000, talc, titanium dioxide, yellow iron oxide (for 5 mg), red iron oxide (for 10 mg).

Appearance of the product and pack contents

Solenota 5 mg tablets are light yellow, round, biconvex, film-coated, and engraved with “APO” on one side and with “S 5” on the other side.

Solenota 10 mg tablets are light pink, round, biconvex, film-coated, and engraved with “APO” on one side and with “S 10” on the other side.

Solenota film-coated tablets are available in packs of 10, 30 and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

SETONDA S.L.

C/ Joaquim Costa 18, 1º

08390 Montgat (Barcelona)

Spain

Manufacturer:

Apotex Netherlands B.V

Archimedesweg 2, 2333 CN Leiden

Netherlands

This medicine is authorised in the Member States of the EEA under the following names:

Date of last revision of this leaflet: June 2017

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