SOLIFENACIN SUN 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Solifenacin SUN 10 mg film-coated tablets EFG

Solifenacin, succinate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

The active substance in Solifenacin SUN 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 you need to urinate and increases the amount of urine your bladder can hold.

Solifenacin SUN 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 leaks because you cannot get to the toilet in time.

2. What you need to know before you take 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 muscle disease called myasthenia gravis, which can cause extreme weakness of certain muscles,

if you have high eye pressure with gradual loss of vision (glaucoma),

• If you are allergic to solifenacin succinate or any of the other ingredients of this medicine (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 medicines 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 SUN, tell 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 SUN.

• 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 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 hiatus hernia or heartburn,
• If you have a nervous disorder (autonomic neuropathy).

Tell your doctor before starting treatment with Solifenacin SUN if you have or have had any of the above-mentioned circumstances.

Before starting treatment with Solifenacin SUN, your doctor will assess whether 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).

Using Solifenacin SUN with other medicines

Tell your doctor or pharmacist that you are using, have recently used, or might use any other medicines.

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

• other anticholinergic medicines, the activity and side effects of both medicines may increase,
• cholinergic medicines, as they may reduce the effect of solifenacin,
• medicines such as metoclopramide or cisapride, which make the digestive system work faster. Solifenacin SUN may reduce their effect,
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which decrease 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 (used for osteoporosis), which may cause or worsen esophageal inflammation (esophagitis).

Using Solifenacin SUN with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

Do not use Solifenacin SUN if you are pregnant unless your doctor has told you to.

Do not use Solifenacin SUN during breastfeeding, as solifenacin may pass into breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using Solifenacin SUN.

Driving and using machines

Solifenacin SUN 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 medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Solifenacin SUN

Instructions for correct use

Adults

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

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 once daily, unless your doctor tells you to take 10 mg once daily.

For appropriate dosing, 5 mg solifenacin succinate tablets are available.

Children and adolescents

Solifenacin SUN should not be used in children and adolescents under 18 years of age.

If you take more Solifenacin SUN than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

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 you have any doubts, 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 Solifenacin SUN, your overactive bladder symptoms may return or worsen. Always consult your doctor if you are thinking of stopping treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Stop taking this medicine 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 heaviness in the stomach, 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 (gastroesophageal reflux),
• 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 the 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 heartbeat, palpitations, rapid heartbeat,
• Voice disorder,
• Liver disorder,
• Muscle weakness,
• Kidney disorder.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System Website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Solifenacin SUN

Keep this medicine out of the sight and reach of children. No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Solifenacin SUN

• The active substance is solifenacin succinate 10 mg
• The other ingredients (excipients) are: Anhydrous lactose, Hypromellose (E 464), Corn starch, Magnesium stearate (E 470b), Opadry White YS-1-7040: Hypromellose (E464)/HPMC 2910, Macrogol 6000/PEG (E 1521), Titanium dioxide (E171), Talc (E 553b), and Red iron oxide (E172)

Appearance of the product and pack contents

The film-coated tablets of Solifenacin SUN 10 mg are round, biconvex, light pink in color, and marked with the code "RK76" on one side and smooth on the other. The tablets have a length of approximately 7.5 mm.

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 authorisation holder

Sun Pharmaceutical Industries (Europe) B.V.

Polarisavenue 87, 2132JH Hoofddorp,

Netherlands

Local representative

Sun Pharma Laboratories, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

Tel.: +34 93 342 78 90

Manufacturer

S.C. Terapia S.A.

Str. Fabricii nr. 124, Cluj-Napoca,

Romania

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87, 2132JH, Hoofddorp,

Netherlands

Alkaloida Chemical Company Zrt

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

Hungary

This product is authorised in the Member States of the EEA 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 leaflet:April 2017.

Other sources of information

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.gob.es/