Solifenacin Aristo

PACKAGE LEAFLET

Package leaflet: information for the patient

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

Solifenacin succinate
Generic medicine
Please read this leaflet carefully before taking this medicine because 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 side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

The active substance of Solifenacina Aristo belongs to the group of anticholinergics. These medicines are used to reduce the activity of an 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 Aristo 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 urinary incontinence because you cannot reach the toilet in time.

2. What you need to know before taking Solifenacin Aristo

Do not take Solifenacin Aristo

• 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 bowel condition (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 high eye 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 also being treated with medicines that may reduce the elimination of Solifenacin Aristo from the body (e.g. ketoconazole). Your doctor or pharmacist will advise you on this. Before starting treatment with Solifenacin Aristo, inform your doctor if you currently have or have ever had any of the conditions listed above.

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

• if you have difficulty emptying your bladder (= bladder obstruction) or if you have trouble urinating (e.g. reduced urine flow). The risk of urine accumulation in the bladder (urinary retention) is significantly increased.
• if you have gastrointestinal obstructions (constipation).
• if you are at risk of reduced gastrointestinal motility (stomach and bowel movements). Your doctor will inform you about this possibility.
• if you have severe kidney disease.
• if you have moderate liver disease.
• if you have a stomach hernia (hiatal hernia) or heartburn.
• if you have nervous system disorders (autonomic neuropathy).

Before starting treatment with Solifenacin Aristo, inform your doctor if you currently have or have ever had any of the conditions listed above.
Before starting treatment with Solifenacin Aristo, your doctor will assess whether there are other causes that may lead to 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 may prescribe an antibiotic (treatment against certain bacterial infections).

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

Other medicines and Solifenacin Aristo
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 the effectiveness and side effects of both medicines may increase.
• cholinergic agents, which may reduce the effectiveness of Solifenacin Aristo.
• medicines such as metoclopramide and cisapride, which stimulate gastrointestinal motility, as Solifenacin Aristo may reduce their effectiveness.
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which decrease the rate of elimination of Solifenacin Aristo from the body.
• medicines such as rifampicin, phenytoin, and carbamazepine, which may increase the rate of elimination of Solifenacin Aristo from the body.
• medicines such as bisphosphonates, which may cause or worsen inflammation of the oesophagus (oesophagitis).

Solifenacin Aristo with food and drink
Solifenacin Aristo can be taken with or without food, according to your preference.

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.
You must not take Solifenacin Aristo during pregnancy unless strictly necessary.
Do not use Solifenacin Aristo while breastfeeding, as solifenacin may be excreted in breast milk.

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

Solifenacin Aristo contains lactose
Each Solifenacin Aristo 5 mg film-coated tablet contains 105 mg of lactose. Each Solifenacin Aristo 10 mg film-coated tablet contains 209 mg of lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking Solifenacin Aristo.

3. How to take Solifenacin Aristo

Take this medicine exactly as described in this leaflet or as your doctor has instructed you. If you are unsure, consult your doctor or pharmacist.
Swallow the tablet with liquid. Do not chew the tablet. You may take the tablet with or without food, according to your preference.
The usual dose is 5 mg once daily, unless your doctor has told you to take 10 mg daily.
Solifenacin Aristo 10 mg film-coated tablet may be divided into two equal doses.

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

If you forget to take Solifenacin Aristo
If you have forgotten 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 the forgotten dose.
If you have any doubts, always consult your doctor or pharmacist.

If you stop taking Solifenacin Aristo
If you stop treatment with Solifenacin Aristo, 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, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience 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 solifenacin succinate. If angioedema occurs, treatment with solifenacin succinate must be stopped immediately and appropriate therapy and/or measures must be initiated.

Solifenacina Aristo 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, nausea, indigestion with symptoms such as bloating, abdominal pain, belching, nausea and heartburn (dyspepsia), gastric discomfort

Uncommon (may affect up to 1 in 100 people)

• urinary tract infections, bladder infections
• drowsiness
• altered taste sensation (dysgeusia)
• dry (irritated) eyes
• dry nose
• reflux disease (gastroesophageal reflux)
• dry throat
• dry skin
• difficulty urinating
• fatigue
• fluid accumulation in the lower legs (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 skin 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 intraocular pressure
• changes in heart 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 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 at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Solifenacin Aristo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label or carton, following "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 Aristo contains
The active substance is solifenacin succinate.
Each Solifenacina Aristo 5 mg tablet contains 5 mg of solifenacin succinate.
Each Solifenacina Aristo 10 mg tablet contains 10 mg of solifenacin succinate.
The other ingredients are pregelatinized maize starch, lactose, hypromellose (E464), magnesium stearate,
silica, macrogol, talc, titanium dioxide (E171) and iron oxide (E172).

Description of the appearance of Solifenacina Aristo and package contents
Solifenacina Aristo 5 mg are round, light pink, film-coated tablets.
Solifenacina Aristo 10 mg are round, light pink, film-coated tablets with a break line.
Solifenacina Aristo 5 mg film-coated tablets are available in packages containing 10, 30, 50, 90 or
100 film-coated tablets.
Solifenacina Aristo 10 mg film-coated tablets are available in packages containing 20, 30, 50, 90
or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder Str. 8 – 10
13435 Berlin
Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria Solifenacin Aristo 5 mg Filmtabletten
Solifenacin Aristo 10 mg Filmtabletten
Germany Solifenacin Aristo 5 mg Filmtabletten
Solifenacin Aristo 10 mg Filmtabletten
Italy Solifenacina Aristo
Netherlands Solifenacin succinaat Aristo 5 mg filmomhulde tabletten
Solifenacin succinaat Aristo 10 mg filmomhulde tabletten
Portugal Solifenacina Aristo
United Kingdom Solifenacin succinate Aristo 5 mg film-coated tablets
Solifenacin succinate Aristo 10 mg film-coated tablets
Spain Solifenacina Aristo 5 mg comprimidos recubiertos con pelicula
Solifenacina Aristo 10 mg comprimidos recubiertos con pelicula