Solifenacin Mylan

Patient Information Leaflet

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

Generic medicine
Please read all of this leaflet carefully before you start 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 give it 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Solifenacin Mylan contains the active substance solifenacin, which belongs to a group of medicines called anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This helps to delay the need to go to the toilet and increases the amount of urine your bladder can hold.
Solifenacin Mylan is used to treat the symptoms of a condition called overactive bladder. These symptoms include: a sudden, strong urge to urinate without prior warning, frequent need to urinate, or episodes of urinary incontinence because you cannot reach the toilet in time.

2. What you need to know before taking Solifenacin Mylan

Do not take Solifenacin Mylan:

• if you are allergic to solifenacin or to any of the other ingredients of this medicine (listed in section 6)
• if you have difficulty passing urine or completely emptying your bladder (urinary retention)
• if you have a serious 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 or are at risk of increased eye pressure leading to 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 also being treated with medicines that may reduce the elimination of solifenacin from the body (e.g. ketoconazole). Your doctor or pharmacist will inform you about this if it applies to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Solifenacin Mylan:

• if you have problems emptying your bladder (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 (e.g. constipation).
• if your gastrointestinal motility (stomach and intestinal movements) is at risk of slowing down. Your doctor should inform you about this possibility if it applies to you.
• if you have severe kidney disease.
• if you have moderate liver disease.
• if you are taking certain medicines known as CYP3A4 inhibitors (such as ketoconazole), which may increase the amount of solifenacin in your blood.
• if you have a stomach condition (hiatal hernia) or heartburn and/or are taking certain medicines (such as bisphosphonates) that may cause or worsen oesophageal inflammation.
• if you have a nervous system disorder (autonomic neuropathy).
• if you have heart rhythm disturbances (visible on ECG) or low potassium levels in your blood. Inform your doctor if you have or have previously had any of the above conditions before starting treatment with solifenacin succinate.

Before starting treatment with Solifenacin Mylan, your doctor should evaluate whether there are other causes for your frequent need to urinate (e.g. heart failure (insufficient heart pumping capacity) or kidney disease). If you have a bacterial urinary tract infection, your doctor should prescribe an antibiotic (a treatment against certain bacterial infections).

Children and adolescents
Solifenacin Mylan must not be used in children or adolescents under 18 years of age.

Other medicines and Solifenacin Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is especially important to inform your doctor if you are taking:

• other anticholinergic medicines (such as atropine, oxybutynin, hydroxyzine, bupropion, dextromethorphan), as they may increase the effectiveness and side effects of both medicines.
• cholinergic agents (medicines such as carbachol and pilocarpine), as they may reduce the effect of solifenacin.
• medicines such as metoclopramide and cisapride, which increase gastrointestinal motility. Solifenacin 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.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
You must not use Solifenacin Mylan during pregnancy unless strictly necessary.

Breastfeeding
Do not use this medicine if you are breastfeeding, as solifenacin may pass into your breast milk.

Driving and use of machines
Solifenacin may cause blurred vision and sometimes drowsiness or fatigue. If you experience these side effects, do not drive and do not operate machinery.

Solifenacin Mylan contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Solifenacin Mylan

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
You must swallow the tablet whole with liquid. You may take it with or without food, as you prefer. Do not crush the tablets.
The recommended dose is 5 mg once daily, unless your doctor has told you to take 10 mg daily.

Patients with liver or kidney problems
If you have severe kidney problems or moderate liver problems, you must not take more than 5 mg daily.

If you take more Solifenacin Mylan than you should
If you have taken too much Solifenacin Mylan or if a child has accidentally taken Solifenacin Mylan, 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), breathing difficulties, increased heart rate (tachycardia), urine retention in the bladder (urinary retention), and dilated pupils (mydriasis).

If you forget to take Solifenacin Mylan
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. Do not take a double dose to make up for a forgotten dose. Never take more than one dose per day. If in doubt, always consult your doctor or pharmacist.

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

If you have any questions about how to use 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.
If you notice any of the following side effects, stop taking this medicine and contact your doctor immediately
or go to the nearest hospital emergency department:
Very rare (may affect up to 1 in 10,000 people)

• Angioedema (an allergic skin reaction characterized by swelling of the tissue just beneath the skin surface) with airway obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate.

Not known (frequency cannot be estimated from the available data)
Allergic attack or severe skin reaction (e.g. blistering and peeling of the skin).

Solifenacina Mylan may cause the following additional 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, feeling unwell (nausea), indigestion with symptoms such as abdominal fullness, abdominal pain, belching, nausea and heartburn (dyspepsia).

Uncommon (may affect up to 1 in 100 people)

• Urinary tract infection or bladder infection with symptoms such as pain or burning sensation when passing urine, back pain, cloudy urine or blood in the urine. Inform your doctor if you experience these symptoms.
• Drowsiness, altered sense of taste (dysgeusia)
• Dry (irritated) eyes
• Dry nose
• Reflux disease (gastroesophageal reflux with symptoms such as heartburn, difficulty swallowing, unpleasant sour sensation in the upper throat or back of the mouth)
• Dry 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 large intestine (faecal impaction)
• Blockage in the lower part of the intestine (colon)
• Increased urine formation in the bladder due to 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
• Urticaria (hives)
• A skin rash with circular patches similar to those of measles.

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 electrical activity of the heart (ECG), irregular heartbeat
• Complete intestinal blockage [intestinal obstruction (ileus)]
• Severe confusion, which may be associated with decreased or increased activity, sleep rhythm disturbances and sensation of seeing or hearing things that are not real (hallucinations)
• Voice disorders
• Liver disorders or changes in liver function detectable in blood tests
• Muscle weakness
• Kidney disorders
• Stomach discomfort
• Skin redness and peeling (exfoliative dermatitis)
• Awareness of heartbeat, rapid heartbeat.

Reporting of side effects

If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Solifenacin Mylan

Keep this medicine out of the sight and reach of children.
For bottle pack only: After first opening, use within 100 days.
Do not use this medicine after the expiry date stated on the carton/blister/bottle after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Mylan contains

• The active substance is solifenacin succinate. Each film-coated tablet contains 5 mg of solifenacin succinate, equivalent to 3.8 mg of solifenacin. Each film-coated tablet contains 10 mg of solifenacin succinate, equivalent to 7.5 mg of solifenacin.
• The other components are:

Tablet core:
Monohydrate lactose, corn starch, hypromellose (E464), talc, magnesium stearate (E572)
Tablet coating:
Hypromellose, titanium dioxide (E171), propylene glycol, yellow iron oxide (E172)
Hypromellose, titanium dioxide (E171), propylene glycol, red iron oxide (E172), yellow iron oxide (E172)

Description of the appearance of Solifenacina Mylan and contents of the pack
Yellow, round, biconvex film-coated tablet, engraved with "M" on one side and "SF" above "5" on the other side.
Pink, round, biconvex film-coated tablet, engraved with "M" on one side and "SF" above "10" on the other side.

Pack sizes:
Blister packs containing 3, 5, 10, 20, 30, 30 x 1, 50, 60, 90, 100, or 200 tablets.
Bottle packs containing 30, 50, 90, 100, 200, 250, or 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan, Italy

Manufacturers
Mylan Hungary Kft,
H-2900 Komárom, Mylan utca 1, Hungary.
McDermott Laboratories Limited trading as Gerard Laboratories,
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Mylan B.V.
Dieselweg 25, 3752 LB Bunschoten, Netherlands.

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium: Solifenacine Mylan 5 mg, 10 mg filmomhulde tabletten
Cyprus: Solifenacin / Mylan
Czech Republic: Solifenacin Mylan 5 mg, 10 mg, potahované tablety
Denmark: Solifenacin Mylan
France: SOLIFENACINE MYLAN 5 mg, 10 mg, comprimé pelliculé
Germany: Solifenacinsuccinat Mylan 5 mg, 10 mg Filmtabletten
Greece: Solifenacin / Mylan
Iceland: Solifenacin Mylan
Ireland: Solifenacin succinate 5 mg, 10 mg Film-coated tablets
Italy: Solifenacina Mylan
Luxembourg: Solifenacine Mylan 5 mg, 10 mg comprimés pelliculés
Norway: Solifenacin Mylan
Portugal: Solifenacina Mylan
Slovakia: Solifenacin Mylan 5 mg, 10 mg, filmom obalené tablety
Spain: Solifenacina Mylan 5 mg, 10 mg comprimidos recubiertos con película
Sweden: Solifenacin Mylan
Netherlands: Solifenacinesuccinaat Mylan 5 mg, 10 mg, filmomhulde tabletten
United Kingdom: Solifenacin succinate 5 mg, 10 mg Film-coated tablets