SOLIFENACIN SUN 5 mg FILM-COATED TABLETS

2. What you need to know before taking Solifenacin SUN

Do not take Solifenacin SUN

• 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 eye pressure with gradual vision loss (glaucoma),

• If you are allergic to solifenacin or any of the other components of this medication (listed in section 6),
• If you are undergoing kidney 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 this medication, inform your doctor if you have or have had any of the aforementioned diseases.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

• If you have problems emptying your bladder (obstruction of the bladder) 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 (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 an autonomic nervous disorder (autonomic neuropathy).

Inform your doctor before starting treatment with this medication if you have or have had any of the aforementioned circumstances.

Before starting treatment with this medication, your doctor will assess whether there are other causes for 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 for certain bacterial infections).

Children and adolescents

This medication should not be used in children and adolescents under 18 years of age.

Use of Solifenacin SUN with other medications

Inform your doctor or pharmacist that 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. This medication may reduce their effect,
• medications such as ketoconazole and itraconazole (antifungals), ritonavir and nelfinavir (medications used to treat HIV infections), verapamil and diltiazem (medications used to treat hypertension and heart disease), which decrease the elimination of solifenacin from the body,
• medications such as rifampicin (an antibacterial medication), phenytoin and carbamazepine (medications used to treat epilepsy), as they may increase the elimination of solifenacin from the body,
• medications such as bisphosphonates (used for osteoporosis), which may cause or worsen esophageal inflammation (esophagitis).

Use of Solifenacin SUN with food, beverages, and alcohol

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 your doctor has indicated it.

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

Consult your doctor or pharmacist before using this medication.

Driving and using machines

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

Solifenacin SUN contains lactose

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

3. How to take Solifenacin SUN

Instructions for correct use

Adults

Always take this medication exactly as your doctor has indicated. If in doubt, 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 recommended dose is 5 mg per day, unless your doctor indicates that you should take 10 mg per day.

If you take more Solifenacin SUN than you should

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

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 SUN

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 in doubt, consult your doctor or pharmacist.

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

If you stop taking Solifenacin SUN

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

If you have any other doubts 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.

Severe side effects

Stop taking this medication and consult your doctor immediately if you experience:

• An allergic reaction (skin rash; swollen eyes, lips, hands, and feet; swelling of the mouth, throat, or tongue, which can cause difficulty breathing and swallowing), or a severe skin reaction (e.g., blistering and peeling of the skin).

• Angioedema (allergy in the skin that results in inflammation that occurs in the tissue under the skin surface) with airway obstruction (difficulty breathing)

Other 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),
• dryness of the nasal passages,
• gastroesophageal reflux disease (GERD), dry throat,
• dry skin,
• difficulty urinating,
• fatigue, accumulation of fluid 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),
• accumulation of urine 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 the electrical activity of the heart (ECG), irregular heartbeat, 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 Medication Surveillance System Website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Solifenacin SUN

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after "EXP". The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the Sigre Collection Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Solifenacin SUN

• The active ingredient is solifenacin succinate 5 mg, equivalent to 3.8 mg of solifenacin.
• The other components are: lactose, hypromellose (E 464), cornstarch, magnesium stearate (E 470b), macrogol (E 1521), titanium dioxide (E171), talc (E 553b), and yellow iron oxide (E172)

Appearance of the product and package contents

The Solifenacin SUN 5 mg film-coated tablets are round, biconvex, white or light yellow in color, and marked with the code "RK75" on one side and smooth on the other. The tablets are approximately 7.5 mm in length.

The Solifenacin SUN tablets are supplied in PVC/PVDC blisters and 40 ml HDPE bottles.

Blister pack sizes: Available in packs of 30, 50, or 90 tablets.

Bottle pack sizes: Available in packs of 30, 50, 90, or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Sun Pharmaceutical Industries (Europe) B.V.

Polarisavenue 87, 2132JH Hoofddorp,

Netherlands

Manufacturer

Terapia S.A.

Str. Fabricii nr. 124,

400 632 Cluj-Napoca,

Romania

Alkaloida Chemical Company Zrt

Kabay János u.29, Tiszavasvári, H-4440,

Hungary

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87, 2132JH, Hoofddorp,

Netherlands

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona, Spain

Tel.: +34 93 342 78 90

This medication is authorized in EEA member states under the following names:

Netherlands: Solifenacinesuccinaat SUN

Germany: SOLIFENACIN BASICS

Spain: Solifenacina SUN

Poland: SILAMIL

United Kingdom: Solifenacin succinate

Date of last revision of this package leaflet:August 2019.

Other sources of information

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/