Solifenacin Aurovitas 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Solifenacina Aurovitas 5 mg film-coated tablets EFG

Solifenacin succinate

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

The active substance in Solifenacina Aurovitas belongs to the group of anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This allows you to have more time before needing to go to the toilet and increases the amount of urine your bladder can hold. Solifenacina is used to treat the symptoms of overactive bladder syndrome. These symptoms include a sudden, strong urge to urinate without warning, needing to urinate frequently, or leaking urine because you cannot reach the toilet in time.

2. What you need to know before taking Solifenacin Aurovitas

Do not take Solifenacin Aurovitas

• 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 emptying your bladder completely (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 can cause extreme weakness of certain muscles.
• If you have high 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 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 if this applies.

Before starting treatment with this medicine, tell your doctor if you have or have ever had any of the conditions mentioned above.

Warnings and precautions

Talk to your doctor or pharmacist before taking Solifenacin Aurovitas.

• If you have problems emptying your bladder (= bladder obstruction) or passing urine (e.g. weak urine stream). 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 are at risk of reduced activity of the digestive system (stomach and intestinal movements). Your doctor will keep you informed if this applies.
• If you have severe kidney disease.
• If you have moderate liver disease.
• If you have hiatus hernia or heartburn.
• If you have a nervous system disorder (autonomic neuropathy).

Children and adolescents

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

Tell your doctor before starting treatment with solifenacin if any of the circumstances mentioned above have ever applied to you.

Before starting treatment with solifenacin, your doctor will assess whether there are other causes for your need to urinate frequently (for example, heart failure (inadequate pumping capacity of the heart) or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic (a treatment for certain bacterial infections).

Taking Solifenacin Aurovitas with other medicines

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

It is especially important that you tell your doctor if you are taking:

• Other anticholinergic medicines, as the activity and adverse effects of both medicines could increase.
• Cholinergics, as they may reduce the effect of solifenacin.
• Medicines such as metoclopramide or cisapride, which speed up the digestive system. Solifenacin may reduce their effect.
• Medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which slow down the 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.
• Medicines such as bisphosphonates, which may cause or worsen inflammation of the oesophagus (oesophagitis).

Taking Solifenacin Aurovitas with food, drinks and alcohol

Solifenacin may be taken with or without food, as preferred.

Pregnancy, breast-feeding and fertility

You must not use solifenacin if you are pregnant unless absolutely necessary. Do not use solifenacin during breast-feeding as solifenacin may pass into breast milk.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Solifenacin may cause blurred vision and, occasionally, drowsiness or fatigue. If you experience any of these adverse effects, do not drive or operate machinery.

Solifenacin Aurovitas contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Solifenacin Aurovitas

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You should swallow the tablet whole with liquid. It can be taken with or without food, according to your preference. Do not crush the tablets.

The recommended dose is 5 mg once daily, unless your doctor instructs you to take 10 mg daily.

If you take more Solifenacin Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine package and leaflet to the healthcare professional. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision, perception of things that are not there (hallucinations), marked excitement, seizures, breathing difficulties, increased heart rate (tachycardia), accumulation of urine in the bladder (urinary retention), and dilation of the pupils (mydriasis).

If you forget to take Solifenacin Aurovitas

If you forget to take a dose at the 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 forgotten doses. If you have any doubts, always consult your doctor or pharmacist.

If you stop taking Solifenacin Aurovitas

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone 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 (a skin allergy resulting in swelling of the tissue beneath the skin surface) with airway obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate (Solifenacina Aurovitas). If angioedema occurs, treatment with solifenacin succinate (Solifenacina Aurovitas) must be stopped immediately, and appropriate treatment and/or measures must be initiated.

Solifenacin may cause the following adverse 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 stomach heaviness, abdominal pain, belching, nausea, and heartburn (dyspepsia), stomach discomfort.

Uncommon (may affect up to 1 in 100 people)

• urinary tract infection, bladder infection.
• somnolence.
• abnormal taste sensation (dysgeusia).
• dry (irritated) eyes.
• dryness of the nasal passages.
• gastroesophageal reflux disease (gastroesophageal reflux), dry throat.
• dry skin.
• difficulty urinating.
• fatigue.
• fluid accumulation in the lower limbs (edema).

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

• accumulation of hardened feces in the colon (fecal impaction).
• urine retention due to inability to empty the bladder (urinary retention).
• dizziness, headache.
• vomiting.
• itching, skin rash.

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

• hallucinations, confusion.
• allergic skin rash.

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

• decreased appetite, high levels of potassium in the blood which may cause abnormal heart rhythm.
• increased pressure in the eyes.
• changes in the heart's electrical activity (ECG), irregular heartbeat, palpitations, rapid heartbeat.
• voice disorder.
• liver disorder.
• muscle weakness.
• kidney disorder.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Solifenacin Aurovitas

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 is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Solifenacin Aurovitas

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

Tablet core: lactose monohydrate, maize 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).

Appearance of the medicinal product and contents of the pack

Film-coated tablets, round (7.6 mm in diameter), light yellow in colour, biconvex, marked "CC" on one side and "31" on the other.

Solifenacin Aurovitas film-coated tablets are available in transparent PVC-aluminum blister packs containing 30 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorised in EEA member states under the following names:

Date of the most recent review of this leaflet: February 2016

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