Solifenacin Normon 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Solifenacina Normon 5 mg film-coated tablets EFG

Solifenacin succinate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, because 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.

Contents of the leaflet

1. What Solifenacina Normon is and what it is used for
2. What you need to know before taking Solifenacina Normon
3. How to take Solifenacina Normon
4. Possible side effects
5. How to store Solifenacina 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 the symptoms of overactive bladder syndrome. These symptoms include a sudden and strong need to urinate without prior warning, frequent urination, or leakage of urine due to not being able to reach the toilet in time.

2. What you need to know before starting 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 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 renal disease or moderate liver disease and are simultaneously 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 starting solifenacin:

• if you have problems emptying your bladder (= bladder obstruction) or difficulty urinating (e.g., weak urine stream). 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 are at increased risk of reduced digestive system activity (stomach and intestinal movements). Your doctor will inform you if this applies.
• if you have severe kidney disease.
• if you have moderate liver disease.
• if you have hiatal hernia or heartburn.
• if you have a nervous system disorder (autonomic neuropathy).

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

Before starting treatment with solifenacin, your doctor will assess whether there are other causes for your frequent need to urinate (e.g., 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

Tell 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.
• cholinergics, as they may reduce the effect of solifenacin.
• medicines such as metoclopramide or cisapride, which speed up digestive system activity. Solifenacin may reduce their effect.
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which reduce 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).

Taking Solifenacin Normon with food and drinks

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 if you are pregnant 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 informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

3. How to take Solifenacin Normon

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

You must swallow the tablet whole with 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 instructs you to take 10 mg daily.

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).

Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision, perception of things that are not present (hallucinations), marked excitement, seizures, difficulty breathing, increased heart rate (tachycardia), urine retention 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 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 Solifenacin 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 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 hardened feces 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 an abnormal heart rhythm
• increased pressure in the eyes
• changes in the electrical activity of the heart (ECG), irregular heartbeat, palpitations, rapid heartbeat
• voice disorder
• liver disorder
• muscle weakness
• kidney disorder

Reporting of adverse effects

If you experience any type of 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 is the last day of the month indicated.

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other 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: monohydrate lactose, hypromellose, corn starch and magnesium stearate.

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

Appearance of the product and contents of the container

Film-coated tablets, light yellow in colour, round, biconvex, engraved with "S5" on one side.

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

Only certain 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 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 on this medicine by scanning the QR code included in the package leaflet and packaging with your mobile phone (smartphone). You may also access this information at the following internet address:

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