SOLIFENACIN PENSA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Solifenacin Pensa 10 mg, film-coated tablets EFG

Solifenacin succinate

Read the package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Solifenacin Pensa and what is it used for

The active substance in Solifenacin Pensa belongs to the group of anticholinergics. These medications are used to reduce the activity of the overactive bladder. This allows you to have more time before needing to urinate and increases the amount of urine your bladder can hold.

Solifenacin Pensa is used to treat the symptoms of overactive bladder syndrome. These symptoms include: having a strong and sudden need to urinate without prior warning, needing to urinate frequently, or experiencing involuntary leakage of urine.

2. What you need to know before taking Solifenacin Pensa

Do not take Solifenacin Pensa

• if you are allergic to solifenacin or any of the other ingredients of this medication (listed in section 6)
• 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 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 above-mentioned diseases.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• if you have difficulty 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 an increased risk of decreased digestive system activity (stomach and intestinal movements). 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 and adolescents under 18 years of age.

Inform your doctor before starting treatment with solifenacin if any of the above circumstances have 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).

Taking Solifenacin Pensa with other medications

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

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

• Other anticholinergic medications, as the activity and side effects of both medications may increase.
• Cholinergics, as they may reduce the effect of solifenacin.
• 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 of solifenacin from the body.
• Medications such as rifampicin, phenytoin, and carbamazepine, as they may increase the elimination of solifenacin from the body.
• Medications such as bisphosphonates, which may cause or worsen esophageal inflammation (esophagitis).

Taking Solifenacin Pensa with food and drinks

Solifenacin can be taken with or without food, as preferred.

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 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.

3. How to take Solifenacin Pensa

Instructions for correct use

Follow your doctor's instructions for taking this medication exactly.

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 preferred. Do not crush the tablets.

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

If you take more Solifenacin Pensa 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.

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 Solifenacin Pensa

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, consult your doctor or pharmacist.

If you stop taking Solifenacin Pensa

If you stop taking solifenacin, 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 experiences them.

If you suffer an allergic reaction or a severe skin reaction (e.g., blistering and peeling of the skin), inform your doctor or nurse immediately.

Angioedema (allergic reaction in the skin that results in inflammation under the skin's 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.

Solifenacin 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 (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 (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 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 heart electrical activity (ECG), irregular heartbeats, 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 Medicines and Healthcare Products Agency's (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Solifenacin Pensa

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

Do not use this medication after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medications should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Solifenacin Pensa

• The active substance is solifenacin succinate: 10 mg.
• The other ingredients are povidone, corn starch, sodium starch glycolate (type A), anhydrous calcium hydrogen phosphate, magnesium stearate, white opadry (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol, and talc), and red iron oxide (E172).

Appearance of the product and packaging contents

Solifenacin Pensa 10 mg tablets are rough, cylindrical, biconvex, pale pink in color, without a score, and have the logo "S1" on one side.

Solifenacin Pensa 10 mg tablets are supplied in blisters of 30 tablets

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios Cinfa, S.A.

C/Olaz-Chipi, 10-Polígono Industrial Areta,

31620 Huarte-Pamplona (Navarra)

Spain

Date of last revision of this package leaflet: April 2018

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