Leaflet: information for the user

Solifenacin Normon 5 mg film-coated tablets EFG

Solifenacin succinate

Read this leaflet carefully before you start taking 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 must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

The active ingredient solifenacina belongs to the group of anticholinergics. These medications are used to reduce the activity of an overactive bladder. This allows you to have more time before needing to go to the bathroom and increases the amount of urine that your bladder can hold.

Solifenacina is used to treat the symptoms of overactive bladder syndrome. These symptoms include: having a strong and sudden need to urinate without prior warning, having to urinate frequently or having urine leakage due to not making it to the bathroom on time.

Do not take Solifenacina 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 in certain muscles
• if you have high eye pressure with gradual loss of vision (glaucoma)
• if you are allergic to solifenacina 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 can reduce the elimination of solifenacina from the body (e.g. ketoconazole). Your doctor or pharmacist will inform you if this is the case.

Inform your doctor before starting treatment with solifenacina if you have or have had any of the diseases mentioned above.

Warnings and precautions

Consult your doctor or pharmacist before starting to take solifenacina:

• if you have difficulty emptying your bladder (= bladder obstruction) or urinating (e.g. 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 (gastrointestinal motility). 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 hiatal hernia or heartburn.
• if you have a nervous disorder (autonomic neuropathy).

Inform your doctor before starting treatment with solifenacina if any of the circumstances mentioned above have occurred at any time.

Before starting treatment with solifenacina, your doctor will evaluate whether there are other causes for your frequent urination (e.g. heart failure 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

Solifenacina Normon should not be used in children or adolescents under 18 years old.

Other medications and Solifenacina Normon

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

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

• other anticholinergic medications, the activity and adverse effects of both medications may increase.
• cholinergic medications, which may reduce the effect of solifenacina.
• medications such as metoclopramide or cisapride, which make the digestive system work faster. Solifenacina may reduce their effect.
• medications such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which reduce the elimination of solifenacina from the body.
• medications such as rifampicin, phenytoin, and carbamazepine, which may increase the elimination of solifenacina from the body.
• medications such as bisphosphonates, which may cause or worsen esophagitis.

Taking Solifenacina Normon with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not use solifenacina if you are pregnant, unless absolutely necessary.

Do not use solifenacina during breastfeeding as solifenacina may pass into breast milk.

Driving and operating machinery

Solifenacina may cause blurred vision and sometimes drowsiness or fatigue. If you experience any of these side effects, do not drive or operate machinery.

Solifenacina Normon contains lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Swallow the entire tablet with some liquid. You can take it with or without food, according to your preference. Do not crush the tablets.

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

If you take more Solifenacina Normon than you should

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

The symptoms of an 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), urine accumulation 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 time to take the next dose. Never take more than one dose per day. If you have any doubts, consult your doctor or pharmacist always.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Solifenacina Normon

If you stop taking solifenacina, your overactive bladder symptoms may return or worsen. Consult your doctor always if you are thinking of interrupting treatment.

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

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

If you experience 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 (allergy on the skin that results in inflammation that occurs in the tissue under the surface of the skin) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacin. If angioedema appears, treatment should be stopped immediately and appropriate treatment and/or measures should be taken.

Solifenacin can cause the following side effects:

Very common (can affect more than 1 in 10 people)

• Dry mouth

Common (can 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 stomach burning (dyspepsia), stomach discomfort

Rare side effects (can affect up to 1 in 100 people)

• Urinary tract infection, bladder infection
• Drowsiness
• Abnormal taste perception (dysgeusia)
• Dry eyes (irritated)
• Runny nose dryness
• Gastroesophageal reflux disease (GERD)
• Throat dryness
• Dry skin
• Difficulty urinating
• Fatigue
• Swelling of the lower extremities (edema)

Rare side effects (can affect up to 1 in 1,000 people)

• Accumulation of a large amount of hardened feces in the large intestine (fecal impaction)
• Urinary retention (inability to empty the bladder)
• Dizziness, headache
• Vomiting
• Itching, skin rash

Very rare side effects (can affect up to 1 in 10,000 people)

• Hallucinations, confusion
• Allergic skin eruption.

Unknown frequency (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
• Voice disorder
• Liver disorder
• Muscle weakness
• Kidney disorder

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Solifenacina Normon

• The active ingredient is succinate of solifenacina. Each coated tablet contains 5 mg of succinate of solifenacina, which is equivalent to 3.8 mg of solifenacina.
• The other components are:

Core of the tablet: lactose monohydrate, hypromellose, cornstarch and magnesium stearate.

Coating of the tablet: hypromellose, titanium dioxide (E171), lactose monohydrate, macrogol 6000, talc and iron oxide yellow (E172).

Appearance of the product and content of the packaging

Coated tablets of a light yellow color, round, biconvex, engraved with “S5” on one of the faces.

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

Only some sizes of packaging may be marketed.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

C/Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid (Spain)

Date of the last review of this prospectus: February 2025

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the prospectus and packaging. You can also access this information at the following internet address

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