Solifenacin Aurobindo

Patient Information Leaflet: Information for the User

Solifenacin Aurobindo 5 mg Film-coated Tablets

Generic Medicine
Please read all of this leaflet carefully before you start using 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 others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Solifenacina Aurobindo is and what it is used for

The active substance in Solifenacina Aurobindo belongs to the group of anticholinergics. These medicines
are used to reduce the activity of the overactive bladder. This helps delay the need to go to the bathroom and increases the amount of urine that can be held in your bladder.
Solifenacina Aurobindo is used to treat the symptoms of overactive bladder. These symptoms
include: a sudden, strong urge to urinate without prior warning signs, frequent need to urinate, or urine leakage because you cannot reach the toilet in time.

2. What you need to know before taking Solifenacin Aurobindo

Do not take Solifenacin Aurobindo

• 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 severe stomach or intestinal problem (including toxic megacolon, a complication associated with ulcerative colitis)
• if you have the 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 mild liver disease AND are being treated at the same time with medicines that may reduce the elimination of Solifenacin Aurobindo from the body (e.g. ketoconazole). Your doctor or pharmacist will advise you about this.

Before starting treatment with Solifenacin Aurobindo, tell your doctor or pharmacist
if you have or have ever had any of the conditions listed above.
Warnings and precautions
Talk to your doctor or pharmacist before taking Solifenacin Aurobindo

• if you have difficulty emptying your bladder (=bladder obstruction) or if you have problems passing urine (e.g. reduced urine flow). The risk of urine accumulation in the bladder (urinary retention) is very high
• if you have intestinal obstruction (constipation)
• if you are at risk of slowed digestive system (gastric and intestinal motility). Your doctor will advise you about this
• if you have severe kidney disease
• if you have moderate liver disease
• if you have stomach pain (hiatal hernia) or heartburn
• if you have nervous system disorders (autonomic neuropathy).

Children and adolescents
Solifenacin Aurobindo must not be used in children or adolescents under 18
years of age.
Before starting treatment with Solifenacin Aurobindo, inform your doctor if you have or have ever
had any of the conditions listed above.
Before starting treatment with Solifenacin Aurobindo, your doctor will check that there are no other
causes for frequent need to urinate (e.g. heart failure (inadequate ability of the heart to pump blood) or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic (treatment for specific bacterial infections).
Other medicines and Solifenacin Aurobindo
Tell 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, as the effectiveness and side effects of both medicines may increase
• cholinergic agents, which may reduce the effectiveness of Solifenacin Aurobindo
• medicines such as metoclopramide and cisapride that stimulate the digestive system, as Solifenacin Aurobindo may reduce their effectiveness
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil and diltiazem that decrease the rate of elimination of Solifenacin Aurobindo from the body
• medicines such as rifampicin, phenytoin, carbamazepine that may increase the rate of elimination of Solifenacin Aurobindo from the body
• medicines such as bisphosphonates that may cause or worsen inflammation of the oesophagus (oesophagitis).

Solifenacin Aurobindo with food, drinks and alcohol
Solifenacin Aurobindo may be taken with or without food, according to your preference.
Pregnancy, breastfeeding and fertility
You must not take Solifenacin Aurobindo if you are pregnant unless strictly necessary. Do not use Solifenacin Aurobindo if you are breastfeeding, as solifenacin may be excreted
in human milk.
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding with breast milk, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Solifenacin Aurobindo may cause blurred vision and, rarely, drowsiness and fatigue. Do not drive or operate machinery if you experience these side effects.
Solifenacin Aurobindo contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Solifenacin Aurobindo

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

If you take more Solifenacin Aurobindo than you should
If you have taken too much Solifenacin Aurobindo or if a child has accidentally taken it, contact a 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, difficulty breathing, increased heart rate (tachycardia), urine retention in the bladder (urinary retention), and dilation of the pupils (mydriasis).

If you forget to take Solifenacin Aurobindo
If you forget to take a tablet 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 the missed dose. If in doubt, always consult your doctor or pharmacist.

If you stop taking Solifenacin Aurobindo
If you stop treatment with Solifenacin Aurobindo, symptoms of overactive bladder 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, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience an allergic reaction or a severe skin reaction (for example, blistering and peeling of the skin), you must inform your doctor or pharmacist immediately.
Angioedema (an allergic 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 succinylate solifenacin (Solifenacina Aurobindo).
If angioedema occurs, treatment with succinylate solifenacin (Solifenacina Aurobindo) must be stopped immediately and appropriate therapy and/or measures must be initiated.
Solifenacina Aurobindo may cause the following 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 bloating, abdominal pain, belching, nausea and heartburn (dyspepsia), stomach discomfort

Uncommon: (may affect up to 1 in 100 people)

• Urinary tract infections, bladder infections
• Drowsiness, altered taste perception (dysgeusia)
• Dry, irritated eyes
• Dry nose
• Gastroesophageal reflux disease (gastro-esophageal reflux), dry throat
• Dry skin
• Difficulty passing urine
• Fatigue, fluid accumulation in the lower leg (edema)

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

• Accumulation of large amounts of feces in the colon (fecal impaction)
• Increased volume of urine 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
• Allergic rash

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

• Decreased appetite, high levels of potassium in the blood which may cause abnormal heart rhythm
• Increased eye pressure
• Changes in the heart's electrical activity (ECG), irregular heartbeat, sensation of palpitations, rapid heartbeat
• Voice disorders
• Liver disorders
• Muscle weakness
• Kidney disorders

Reporting of side effects
If you experience any side effects, 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 at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Solifenacin Aurobindo

Keep this medicine out of the sight and reach of children.
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 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 Aurobindo contains

• The active substance is solifenacin succinate. Each film-coated tablet contains 5 mg of solifenacin succinate.

The other components are
Tablet core: Lactose monohydrate, corn starch, hypromellose (5 cp), colloidal anhydrous silica,
magnesium stearate.
Tablet coating: Hypromellose (6 cp), macrogol (PEG 4000), titanium dioxide (E171),
talc, yellow iron oxide (E172) (only in 5 mg tablets), red iron oxide (E172) (only in
10 mg tablets).
Description of the appearance of Solifenacina Aurobindo and pack contents
Film-coated tablets.
Light yellow, round-shaped [diameter: 7.6 mm], biconvex, film-coated tablets, marked with “CC” on one side and “31” on the other side.
Solifenacina Aurobindo tablets are available in PVC-aluminum foil blister packs containing 30 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Aurobindo Pharma (Italia) s.r.l. – Via San Giuseppe, 102 – 21047 Saronno (Varese)
Manufacturers
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG
3000, Malta
Milpharm Limited Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom
This medicinal product is authorized in the European Economic Area countries under the
following names:
Portugal: Solifenacina Glob
Spain: Solifenacina Aurovitas 5 mg comprimidos recubiertos con película EFG
Italy: Solifenacina Aurobindo