SOLIFENACIN NORMON 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Solifenacin Normon 5 mg 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 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 Normon and what is it used for
2. What you need to know before taking Solifenacin Normon
3. How to take Solifenacin Normon
4. Possible side effects
5. Storage of Solifenacin Normon
6. Package contents and additional information

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

The active substance solifenacin 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.

Solifenacin is used to treat the symptoms of overactive bladder syndrome. These symptoms include: having a strong and sudden need to urinate without warning, needing to urinate frequently, or having urine leaks because you cannot reach the bathroom in time.

2. What you need to know before taking Solifenacin Normon

Do not take Solifenacin Normon

• 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 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 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 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 an increased 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 a nervous disorder (autonomic neuropathy).

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 (insufficient pumping capacity of the heart) or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic (treatment against certain bacterial infections).

Children and adolescents

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

Other medications and Solifenacin Normon

Inform your doctor or pharmacist if you are using, have recently used, or may need to use 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.
• cholinergic medications, 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 inflammation of the esophagus (esophagitis).

Taking Solifenacin Normon with food and drinks

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

Pregnancy and breastfeeding

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.

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.

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.

Solifenacin Normon 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 Normon

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you are unsure, 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 normal dose is 5 mg per day, unless your doctor tells you to take 10 mg per day.

If you take more Solifenacin Normon than you should

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

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 take Solifenacin Normon

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 Normon

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 will experience 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 (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. If angioedema occurs, treatment 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 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)
• dryness of the nasal passages
• gastroesophageal reflux disease
• 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 a large amount 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 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 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 (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 Normon

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.

Store below 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Solifenacin Normon

• 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 components are:

Tablet core: lactose monohydrate, hypromellose, corn starch, and magnesium stearate.

Tablet coating: Hypromellose, titanium dioxide (E171), lactose monohydrate, macrogol 6000, talc, and yellow iron oxide (E172).

Appearance of the product and package contents

Light yellow, round, biconvex film-coated tablets, engraved with "S5" on one side.

Solifenacin Normon is available in packages of 3, 5, 10, 20, 30, 50, 60, 90, 100, or 200 tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

C/Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid (Spain)

Date of the last revision of this package leaflet: February 2025

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

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address

https://cima.aemps.es/cima/dochtml/p/83736/P_83736.html.