Package Insert: Information for the Patient

Solifenacina Aristo 5 mg Film-Coated Tablets

Solifenacin Succinate

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

5Storage of Solifenacina Aristo

6.Contents of the Package and Additional Information

The active ingredient of Solifenacina Aristo belongs to the group of anticholinergics. These medications are used to reduce the activity of an overactive bladder. This allows you to have more time before needing to go to the bathroom and increases the amount of urine that your bladder can hold.

Solifenacina Aristo 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 leakage due to not making it to the bathroom on time.

Do not take Solifenacina Aristo

• if you are allergic to solifenacina or any of the other ingredients of this medication (listed in section 6);
• 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 may cause extreme weakness in certain muscles;
• if you have high blood pressure in the eyes, 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 being treated with medications that can reduce the elimination of Solifenacina Aristo from the body (e.g. ketoconazole). Your doctor or pharmacist will inform you if this is the case.

Inform your doctor if you have or have had any of the diseases mentioned above before starting treatment with Solifenacina Aristo.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Solifenacina Aristo

• if you have difficulty emptying your bladder (= bladder obstruction) or urinating (e.g. 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 (gastrointestinal motility). 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 hiatal hernia or heartburn;
• if you have a nervous disorder (autonomic neuropathy).

Inform your doctor if you have or have had any of the diseases mentioned above before starting treatment with Solifenacina Aristo.

Before starting treatment with Solifenacina Aristo, your doctor will evaluate if there are other causes for your frequent need to urinate (e.g. heart failure or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic (a treatment for certain bacterial infections).

Children and adolescents

Solifenacina Aristo should not be used in children or adolescents under 18 years old.

Other medications and Solifenacina Aristo

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

• other anticholinergic medications, the activity and adverse effects of both medications may increase;
• cholinergic medications, as they may reduce the effect of solifenacina;
• medications such as metoclopramide or cisapride, which make the digestive system work faster. Solifenacina may reduce their effect;
• medications such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which reduce the rate of elimination of solifenacina from the body;
• medications such as rifampicin, phenytoin, and carbamazepine, which may increase the rate of elimination of solifenacina from the body;
• medications such as bisphosphonates, which may cause or worsen esophagitis.

Taking Solifenacina Aristo with food and drinks

Solifenacina Aristo can be taken with or without food, as you prefer.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

You should not use Solifenacina Aristo if you are pregnant, unless it is absolutely necessary. Do not use Solifenacina Aristo during breastfeeding as solifenacina may pass into breast milk.

Driving and operating machinery

Solifenacina may cause blurred vision and sometimes drowsiness or fatigue. If you experience any of these side effects, do not drive or operate machinery.

Solifenacina Aristo contains lactose

If your doctor has told you that you have a hereditary intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Swallow the entire tablet with some liquid. It can be taken with or without food, according to your preference. Do not crush or chew the tablets.

The usual dose is 5 mg per day, unless your doctor tells you to take 10 mg per day.

If you take more Solifenacina Aristo than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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), urine accumulation in the bladder (urinary retention), and dilation of the pupils (mydriasis).

If you forgot to take Solifenacina Aristo

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 always.

If you interrupt treatment with Solifenacina Aristo

If you stop taking Solifenacina Aristo, your overactive bladder symptoms may return or worsen. Consult your doctor always if you are thinking of interrupting treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience an allergic attack or a severe skin reaction (such as blistering and peeling of the skin), you must inform your doctor or nurse immediately.

Angioedema (allergy on the skin resulting in inflammation that occurs in the tissue beneath the skin surface) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate.If angioedema appears,the treatment with solifenacin succinate should be stopped immediately and appropriate treatment and/or measures should be taken.

Solifenacin Aristo 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 feeling of stomach heaviness, abdominal pain, belching, nausea, and stomach burning (dyspepsia), stomach discomfort.

Uncommon(may affect up to 1 in 100 people)

• urinary tract infection, bladder infection;
• drowsiness;
• abnormal taste perception (dysgeusia);
• dry eyes (irritated);
• nasal dryness;
• gastroesophageal reflux disease (GERD);
• dry throat;
• dry skin;
• difficulty urinating;
• fatigue;
• lower extremity edema.

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

• fecal impaction in the large intestine;
• urinary retention due to inability to empty the bladder;
• dizziness, headache;
• vomiting;
• itching, skin rash.

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

• hallucinations, confusion;
• allergic skin eruption.

Frequency not known(the frequency cannot be estimated from available data)

• decreased appetite, high potassium levels in the blood that may cause abnormal heart rhythm;
• increased eye pressure;
• changes in heart electrical activity (ECG), irregular heartbeat, palpitations, rapid heartbeat;
• voice disorder;
• liver disorder;
• muscle weakness;
• renal disorder.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and themedications that you no longer need at the SIGRE collection point at the pharmacy. Ask yourpharmacist how to dispose of the packaging and the medications that you no longer need. This will help protect the environment.

Composition of Solifenacina Aristo

The active ingredient is solifenacin succinate.

Each Solifenacina Aristo 5 mg film-coated tablet contains 5 mg of solifenacin succinate.

The other components are maize starch, lactose, hypromellose (E464), magnesium stearate, silica, macrogol, talc, titanium dioxide (E171), and iron oxide (E172).

Appearance of the product and contents of the package

Solifenacina Aristo 5 mg film-coated tablets are round, pale pink film-coated tablets.

Solifenacina Aristo 5 mg film-coated tablets are supplied in blisters of 10, 30, 50, 90, or 100 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Responsible manufacturer

Laboratorios Medicamentos Internacionales S.A.

Calle Solana, 26

28850 Torrejón De Ardoz (Madrid)

Spain

Or

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

This medication is authorized in the member states of the European Economic Area with the following names:

PortugalSolifenacina Aristo 5 mg film-coated tablet

Austria Solifenacin Aristo 5 mg Filmtabletten

GermanySolifenacin Aristo 5 mg Filmtabletten

SpainSolifenacina Aristo 5 mg film-coated tablets EFG

ItalySolifenacina Aristo 5 mg compresse rivestite con film

NetherlandsSolifenacinesuccinaat Aristo 5 mg filmomhulde tabletten

SlovakiaAristissa 5 mg filmom obalené tablety

PolandBelaristo 5 mg tabletka powlekana

Romania Solifenacin Aristo 5 mg comprimate filmate

Ireland Solifenacin Aristo 5 mg film-coated tablets

Czech RepublicSolifenacin Aristo 5 mg potahované tablety

NorwaySolifenacin Aristo 5 mg tablett, filmdrasjert

Last review date of this leaflet: July 2022

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/