SOLIFENACIN PHARMSOL 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Solifenacin PharmSol5mg film-coated tablets EFG

Solifenacin PharmSol 10mg film-coated tablets EFG

solifenacin, succinate

Read the entire 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 doubts, 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 PharmSol and what is it used for
2. What you need to know before taking Solifenacin PharmSol
3. How to take Solifenacin PharmSol
4. Possible side effects

1. Storage of Solifenacin PharmSol
2. Package contents and additional information

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

The active substance of this medication is solifenacin succinate and 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 go to the bathroom and increases the amount of urine your bladder can hold.

This medication is used to treat the symptoms of overactive bladder syndrome in adults. These symptoms include: having a strong and sudden need to urinate without warning, having to urinate frequently, or having urine leaks due to not reaching the bathroom in time.

2. What you need to know before taking Solifenacin PharmSol

Do not take Solifenacin PharmSol

• 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 glaucoma with gradual vision loss
• if you are allergic to solifenacin or any of the other components of this medication (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 medications that may decrease the elimination of Solifenacin PharmSol from the body (e.g., ketoconazole). Your doctor or pharmacist will inform you if this is the case.

Before starting treatment with Solifenacin PharmSol, 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 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 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 PharmSol should not be used in children or adolescents under 18 years of age.

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

Before starting treatment with this medication, your doctor will assess if there are other causes of 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).

Other medications and Solifenacin PharmSol

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

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

• other anticholinergic medications, as the activity and side effects of both medications may increase.
• cholinergic medications, as they may reduce the effect of Solifenacin PharmSol.
• medications such as metoclopramide or cisapride, which make the digestive system work faster. Solifenacin PharmSol may reduce their effect.
• medications such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which decrease the elimination of Solifenacin PharmSol from the body.
• medications such as rifampicin, phenytoin, and carbamazepine, as they may increase the elimination of Solifenacin PharmSol from the body.
• medications such as bisphosphonates, which may cause or worsen esophageal inflammation (esophagitis).

Taking Solifenacin PharmSol with food and drinks

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

Pregnancy, breastfeeding, and fertility

Do not use this medication if you are pregnant unless it is absolutely necessary.

Do not use this medication during breastfeeding, as solifenacin may pass into breast milk.

If you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

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

Solifenacin PharmSol contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Solifenacin PharmSol

Instructions for correct use

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult 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.

The 10 mg tablet can be divided into equal doses.

If you take more Solifenacin PharmSol than you should

If you have taken too much Solifenacin PharmSol or if a child has accidentally taken Solifenacin PharmSol, contact your doctor or pharmacist immediately, or call the Toxicology Information Service (Tel. 91 562 04 20).

Symptoms in case of overdose may include: headache, dry mouth, dizziness, drowsiness, and blurred vision, perception of things that are not there (hallucinations), excessive excitement, convulsions, difficulty breathing, increased heart rate (tachycardia), urine accumulation in the bladder (urinary retention), and pupil dilation (mydriasis).

If you forget to take Solifenacin PharmSol

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 you are unsure, consult your doctor or pharmacist.

Do not take a double dose to make up for forgotten doses

If you stop taking Solifenacin PharmSol

If you stop taking Solifenacin PharmSol, 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 will experience them.

If you suffer an allergic attack 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 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 (Solifenacin PharmSol). If angioedema occurs, treatment with solifenacin succinate (Solifenacin PharmSol) should be discontinued immediately, and appropriate treatment and/or measures should be taken.

Solifenacin PharmSol 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 side effects (may affect up to 1 in 100 people)

• urinary tract infection, bladder infection
• drowsiness
• abnormal taste perception (dysgeusia)
• dry eyes (irritated)
• dry nasal passages
• gastroesophageal reflux disease (GERD)
• 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 large amounts 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 available data)

• decreased appetite, high potassium levels in the blood that can cause an abnormal heart rhythm
• increased eye pressure
• changes in heart electrical activity (ECG), irregular heartbeat, palpitations, rapid heartbeat (ventricular tachycardia)
• 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 Monitoring System: www.notificaRAM.es By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Solifenacin PharmSol

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 CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions

Medications should not be disposed of through wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. If you are unsure, consult your pharmacist on how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Solifenacin PharmSol

• The active substance is solifenacin succinate.
• Solifenacin PharmSol 5 mg: Each Solifenacin PharmSol tablet contains 5 mg of solifenacin succinate, equivalent to 3.8 mg of solifenacin.
• Solifenacin PharmSol 10 mg: Each Solifenacin PharmSol tablet contains 10 mg of solifenacin succinate, equivalent to 7.5 mg of solifenacin.

• The other components are:

Core of the tablet

Lactose monohydrate

Corn starch

Pregelatinized corn starch

Magnesium stearate

Coating

5 mg:

Hypromellose 2910 (5 mPa*s)

Titanium dioxide (E171)

Macrogol 8000

Talc

Yellow iron oxide (E172)

10 mg:

Hypromellose 2910 (5 mPa*s)

Titanium dioxide (E171)

Macrogol 8000

Talc

Red iron oxide (E172)

Yellow iron oxide (E172)

Appearance of the product and package contents

Solifenacin PharmSol 5 mg: film-coated tablets, round, biconvex, light yellow in color, with a diameter of 5.8 mm.

Solifenacin PharmSol 10 mg: film-coated tablets, round, biconvex, pale pink in color, with a score line on one side and smooth on the other, with a diameter of 7.9 mm. The tablet can be divided into equal doses.

Solifenacin PharmSol tablets are supplied in blisters (aluminum/aluminum blister and PVC/PE/PVDC/Aluminum blister) of 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

PharmSol Europe Limited,

The Victoria Centre Unit 2, Lower Ground Floor,

Valletta Road, Mosta MST 9012, Malta

Manufacturer

Genepharm S.A.

18 km Marathon Avenue

153 51 Pallini

Greece

BE PHARMA d.o.o.

Brdnikova ulica 44,

Ljubljana, 1000,

Slovenia

This medication is authorized in the member states of the European Economic Area under the following names:

Malta:Solifenacin PharmSol 5 mg and 10 mg film-coated tablets

Austria:Solifenacin PharmSol 5 mg and 10 mg film-coated tablets

Spain:Solifenacina PharmSol 5 mg and 10 mg film-coated tablets EFG

Croatia:Solifenacin Be Pharma 5 mg and 10 mg film-coated tablets

Slovenia:Solifenacin Be Pharma 5 mg and 10 mg film-coated tablets

Date of last revision of this package leaflet:July 2022

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