Solifenacin Teva

Patient Information Leaflet

Solifenacin Teva 5 mg film-coated tablets, 10 mg film-coated tablets

Solifenacin succinate
Equivalent medicine
Please read this leaflet carefully before taking this medicine, as it contains important
information for you.

• Keep this leaflet. 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. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

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

1. What Solifenacin Teva is and what it is used for
The active substance in Solifenacin Teva belongs to the group of anticholinergic medicines. These medicines are used to reduce the activity of an overactive bladder. This helps delay the need to go to the toilet and increases the amount of urine that can be held in your bladder.
Solifenacin Teva is used to treat the symptoms of a condition called overactive bladder. These symptoms include a strong and sudden urge to urinate without prior warning, frequent need to urinate, or leakage of urine because you cannot reach the toilet in time.

2. What you need to know before taking Solifenacin Teva

Do not take Solifenacin Teva

• if you are allergic to solifenacin or to any of the other ingredients of this medicine (listed in section 6);
• if you have difficulty urinating or completely emptying your bladder (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 causes extreme weakness of certain muscles;
• if you have increased intraocular pressure with gradual loss of vision (glaucoma);
• if you are undergoing renal dialysis;
• if you have severe liver disease;
• if you have severe kidney disease or moderate liver disease and are simultaneously being treated with medicines that may reduce the elimination of Solifenacin Teva from the body (e.g., ketoconazole). Your doctor or pharmacist will inform you about this if it applies to you.

If you have or have had any of the conditions listed above, inform your doctor before starting treatment with Solifenacin Teva.
Warnings and precautions
Talk to your doctor or pharmacist before taking Solifenacin Teva:

• if you have problems emptying your bladder (e.g., bladder obstruction) or have difficulty urinating (e.g., reduced urine flow). The risk of urine accumulation in the bladder (urinary retention) is very high;
• if you have gastrointestinal obstructions (constipation);
• if your gastrointestinal motility (stomach and intestine movements) is at risk of slowing down. Your doctor should inform you of this possibility if it applies to you;
• if you have severe kidney disease;
• if you have moderate liver disease;
• if you have a stomach condition (hiatal hernia) or heartburn;
• if you have a nervous system disorder (autonomic neuropathy).

If you have or have had any of the conditions listed above, inform your doctor before starting treatment with Solifenacin Teva.
Before starting treatment with Solifenacin Teva, your doctor must evaluate whether other causes underlie your frequent need to urinate (e.g., heart failure (insufficient pumping capacity of the heart) or kidney disease). If you have a bacterial urinary tract infection, your doctor should prescribe an antibiotic (a treatment for certain bacterial infections).
Children and adolescents
Solifenacin Teva must not be used in children or adolescents under 18 years of age.
Other medicines and Solifenacin Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important to inform your doctor if you are taking:

• other anticholinergic medicines, as they may increase the effectiveness and side effects of both medicines;
• cholinergic agents, as they may reduce the effect of Solifenacin Teva;
• medicines such as metoclopramide and cisapride, which increase gastrointestinal motility. Solifenacin Teva may reduce their effect;
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazolo, verapamil, and diltiazem, which decrease the rate of elimination of Solifenacin Teva from the body;
• medicines such as rifampicin, phenytoin, and carbamazepine, as they may increase the rate of elimination of Solifenacin Teva from the body;
• medicines such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis).

Solifenacin Teva with food
Solifenacin Teva can be taken with or without food, according to your preference.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not use Solifenacin Teva during pregnancy unless strictly necessary.
Do not use Solifenacin Teva if you are breastfeeding, as solifenacin may pass into your breast milk.
Driving and using machines
Solifenacin Teva may cause blurred vision and sometimes drowsiness or fatigue. If you experience these side effects, do not drive or operate machinery.
Solifenacin Teva contains lactose
If your doctor has diagnosed you with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, you must not take this medicine.

3. How to take Solifenacin Teva

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is 5 mg once daily, unless your doctor has instructed you to take 10 mg daily.
Swallow the tablet whole with liquid. You may take it with or without food, according to your preference. Do not crush the tablets.

If you take more Solifenacin Teva than you should
If you have taken too much Solifenacin Teva or if a child has accidentally ingested it, contact your doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision, perception of non-existent objects (hallucinations), overexcitation, epileptic seizures (convulsions), difficulty breathing, increased heart rate (tachycardia), urine retention in the bladder (urinary retention), and dilated pupils (mydriasis).

If you forget to take Solifenacin Teva
If you forget to take a dose at your 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 are unsure, always consult your doctor or pharmacist.

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

If you have any questions about 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 everyone experiences them.
If you experience an allergic reaction or a severe skin reaction (e.g. blistering and peeling of the skin), contact your doctor or pharmacist immediately.
Cases of angioedema (an allergic skin reaction characterized by swelling of the tissue just beneath the skin surface) with airway obstruction (difficulty breathing) have been reported in some patients treated with solifenacin succinate. If angioedema occurs, Solifenacina Teva must be discontinued immediately and appropriate therapies and/or measures must be taken.
Solifenacina Teva may cause the following 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 abdominal fullness, abdominal pain, belching, nausea and heartburn (dyspepsia), stomach discomfort.

Uncommon (may affect up to 1 in 100 people)

• urinary tract infection, bladder infection;
• drowsiness, altered taste sensation (dysgeusia);
• dry (irritated) eyes;
• dry nose;
• reflux disease (gastroesophageal reflux), dryness of the throat;
• dry skin;
• difficulty urinating;
• fatigue, fluid accumulation in the lower parts of the legs (oedema).

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

• accumulation of large amounts of hardened faeces in the colon (faecal impaction);
• increased urine formation in the bladder caused by inability to empty the bladder (urinary retention);
• dizziness, headache;
• vomiting;
• itching, rash.

Very rare (may affect up to 1 in 10,000 people)

• hallucinations, confusion;
• allergic rash.

Not known (frequency cannot be estimated from the available data)

• decreased appetite, elevated levels of potassium in the blood which may cause heart rhythm abnormalities;
• increased pressure inside the eyes;
• changes in the heart's electrical activity (ECG), irregular heartbeat (torsades de pointes), palpitations, increased heart rate;
• voice disorders;
• liver disorders;
• muscle weakness;
• kidney disorders.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Solifenacin Teva

Keep this medicine out of the 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 that month.
Blister
This medicine does not require any special storage conditions.
Bottles
This medicine does not require any specific storage temperature.
Keep the bottle tightly closed to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Solifenacina Teva contains:

• The active substance is solifenacin succinate.

Each film-coated tablet contains 5 mg or 10 mg of solifenacin succinate, equivalent to 3.8 mg or 7.5 mg of solifenacin. The exact amount is indicated on the outer packaging.

• The other components are:

Tablet core
Microcrystalline cellulose, povidone, crospovidone, lactose, anhydrous colloidal silica, magnesium stearate
Coating:
Solifenacina Teva 5 mg: polyvinyl alcohol (E1203), titanium dioxide (E171), polyethylene glycol 3350, talc (E553b), yellow iron oxide (E172).
Solifenacina Teva 10 mg: polyvinyl alcohol (E1203), titanium dioxide (E171), polyethylene glycol 3350, talc (E553b), carmine (E120), red iron oxide (E172), yellow iron oxide (E172).

Description of the appearance of Solifenacina Teva and contents of the pack
Solifenacina Teva 5 mg is light yellow to yellow, round, biconvex, film-coated tablet, 8 mm in diameter, with "S5" engraved on one side and smooth on the other side.
Solifenacina Teva 10 mg is light pink to pink, round, biconvex, film-coated tablet, 8 mm in diameter, with "S10" engraved on one side and smooth on the other side.
The tablets are packaged in:

• Packs containing aluminium-aluminium blisters
• Packs containing polymer blisters
• HDPE bottles with child-resistant closures

Solifenacina Teva film-coated tablets are available in packs containing 3, 5, 10, 20, 30, 50, 60, 90, 100 or 200 tablets in blister packs, and in bottles containing 30, 100 and 200 (2x100) tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milano (MI), Italy

Manufacturers
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13,
Debrecen
H-4042 Hungary
TEVA UK Ltd
Brampton Road, Hampden Park
Eastbourne, East Sussex
BN22 9AG United Kingdom
Teva Czech Industries s.r.o.
Ostravská 29, č.p. 305
Opava-Komárov
747 70 Czech Republic
Merckle GmbH
Ludwig-Merckle-Strasse 3,
Blaubeuren
89143 Germany
Merckle GmbH
Graf-Arco-Str. 3,
Ulm
89079 Germany
Teva Pharma B.V.
Swensweg 5
Haarlem
2031GA Netherlands
Teva Operations Poland Sp. z.o.o.,
ul. Mogilska 80, Kraków 31-546,
Poland
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.),
Prilaz baruna Filipovića 25, Zagreb 10000,
Croatia
Qualiphar NV
Rijksweg 9, Bornem
2880 Belgium

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Solifenacine Teva 5 mg & 10 mg filmomhulde tabletten
Croatia: Solifenacin Pliva 5 mg & 10 mg filmom obložene tablete
Czech Republic: Solifenacin Teva 5 mg & 10 mg
Denmark: Solifenacinsuccinat “Teva” 5 mg & 10 mg
Finland: Solifenacin ratiopharm 5 & 10 mg mg tabletti, kalvopäällysteinen
France: Solifénacine Teva 5 mg & 10 mg, comprimé pelliculé
Germany: Solifenacin AbZ 5 mg & 10 mg Filmtabletten
Ireland: Solifenacin Teva
Italy: Solifenacina Teva
Netherlands: Solifenacinesuccinaat Teva 5 mg & 10 mg, filmomhulde tabletten
Poland: Solifenacin Teva
Spain: Solifenacina Teva 5 mg & 10 mg comprimidos recubiertos con película EFG
Sweden: Solifenacin Teva
United Kingdom: Solifenacin Succinate 5 mg & 10 mg Film-coated Tablets