Solifenacin Normon 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Solifenacin Normon 10 mg film-coated tablets EFG

Solifenacin succinate

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

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

Leaflet contents

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

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

The active substance solifenacin 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 needing to go to the toilet and increases the amount of urine your bladder can hold.

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

2. What you need to know before taking Solifenacin Normon

Do not take Solifenacin Normon

• if you have difficulty passing urine or emptying your bladder completely (urinary retention)
• if you have a severe stomach or bowel condition (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 allergic to solifenacin or any of the other ingredients 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 also being treated with medicines that may reduce the elimination of solifenacin from the body (e.g. ketoconazole). Your doctor or pharmacist will inform you if this applies.

Before starting treatment with solifenacin, tell your doctor if you have or have ever had any of the conditions mentioned above.

Warnings and precautions

Talk to your doctor or pharmacist before taking solifenacin:

• if you have problems emptying your bladder (= bladder obstruction) or difficulty passing urine (e.g. weak urine stream). The risk of urine build-up in the bladder (urinary retention) is much higher.
• if you have any obstruction of the digestive system (constipation).
• if you are at increased risk of reduced digestive system activity (movements of the stomach and intestines). Your doctor will inform you if this applies.
• if you have severe kidney disease.
• if you have moderate liver disease.
• if you have a hiatal hernia or heartburn.
• if you have a nerve disorder (autonomic neuropathy).

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

Before starting treatment with solifenacin, your doctor will assess whether there are other causes for your need to urinate frequently (for example, heart failure (reduced pumping capacity of the heart) or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic (a treatment for certain bacterial infections).

Children and adolescents

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

Other medicines and Solifenacin Normon

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

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

• other anticholinergic medicines, as the activity and adverse effects of both medicines could increase.
• cholinergic agents, as they may reduce the effect of solifenacin.
• medicines such as metoclopramide or cisapride, which speed up the digestive system. Solifenacin may reduce their effect.
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazol, verapamil, and diltiazem, which slow down the elimination of solifenacin from the body.
• medicines such as rifampicin, phenytoin, and carbamazepine, as they may increase the elimination rate of solifenacin from the body.
• medicines such as bisphosphonates, which may cause or worsen inflammation of the oesophagus (oesophagitis).

Taking Solifenacin Normon with food and drink

Solifenacin may be taken with or without food, according to your preference.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You should not use solifenacin during pregnancy unless 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 operate machinery.

Solifenacin Normon contains lactose

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

3. How to take Solifenacina Normon

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

You must swallow the tablet whole with some liquid. It can be taken with or without food, according to your preference. Do not crush the tablets.

The usual dose is 5 mg once daily, unless your doctor tells you to take 10 mg daily.

If you take more Solifenacina 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).

Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision, seeing or sensing things that are not there (hallucinations), pronounced excitement, seizures, 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 Solifenacina Normon

If you forget to take a dose at the usual time, take it as soon as you remember, unless it is almost time for your next dose. Never take more than one dose per day. If you have any doubts, always consult your doctor or pharmacist.

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

If you stop taking Solifenacina Normon

If you stop taking solifenacin, your overactive bladder symptoms may return or worsen. Always consult your doctor if you are considering stopping treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Angioedema (a skin allergy resulting in swelling of the tissue beneath the skin surface), with airway obstruction (difficulty breathing), has been reported in some patients treated with solifenacin. If angioedema occurs, treatment must be stopped immediately and appropriate treatment and/or measures must be taken.

Solifenacin may cause the following adverse 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 adverse effects (may affect up to 1 in 100 people)

• urinary tract infection, bladder infection
• somnolence
• abnormal taste perception (dysgeusia)
• dry (irritated) eyes
• dryness of the nasal passages
• reflux disease (gastroesophageal reflux)
• dry throat
• dry skin
• difficulty urinating
• fatigue
• fluid accumulation in the lower limbs (edema)

Rare adverse effects (may affect up to 1 in 1,000 people)

• accumulation of large amounts of hardened stools in the colon (fecal impaction)
• urine retention in the bladder due to inability to empty the bladder (urinary retention)
• dizziness, headache
• vomiting
• itching, skin rash

Very rare adverse 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 which may cause abnormal heart rhythm
• increased pressure in the eyes
• changes in the heart's electrical activity (ECG), irregular heartbeat, palpitations, rapid heartbeat
• voice disorder
• liver disorder
• muscle weakness
• kidney disorder

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Solifenacin Normon

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Solifenacin Normon

• The active substance is solifenacin succinate. Each film-coated tablet contains 10 mg of solifenacin succinate, equivalent to 7.5 mg of solifenacin.
• The other components are:

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

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

Appearance of the product and contents of the pack

Film-coated, light pink-colored, round, biconvex tablets, marked with "S10" on one side.

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

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
C/Ronda de Valdecarrizo, 6
28760 Tres Cantos, Madrid (Spain)

Date of the most recent revision of this leaflet: February 2025

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging.

You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/83735/P_83735.html.