Package Insert: Information for the Patient

Solifenacin Alter 10 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 should not be given 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.

The active ingredient of Solifenacina Alter 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 Alter 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 leaks due to not making it to the bathroom on time.

Do not take Solifenacina Alter

• if you are allergic to solifenacin succinate or any of the other ingredients of this medicine (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 can cause 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 moderate liver disease and are being treated with medicines that can reduce the elimination of solifenacin 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.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Solifenacina Alter.

• 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 digestive system obstruction (constipation),
• if you have an increased risk of decreased digestive system activity (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 system disorder (autonomic neuropathy).

Children and adolescents

This medicine should not be used in children or adolescents under 18 years old.

Inform your doctor before starting treatment with this medicine, if any of the circumstances mentioned above have occurred at any time.

Before starting treatment with solifenacina, 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).

Other medicines and Solifenacina Alter

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

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

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

Taking Solifenacina Alter with food and drinks

This medicine can be taken with or without food, as you prefer.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not use solifenacina if you are pregnant unless it is absolutely necessary.

Do not use solifenacina during breastfeeding as solifenacina may pass into breast milk.

Driving and operating machines

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

Solifenacina Alter contains lactose.

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

Instructions for Correct Use

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. You can take it with or without food, as you prefer. Do not crush 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 Alter Than You Should

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

The symptoms of an 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 Forget to Take Solifenacina Alter

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. Do not take a double dose to make up for the missed dose. Never take more than one dose per day. If you have any doubts, consult your doctor or pharmacist.

If You Interrupt Treatment with Solifenacina Alter

If you stop taking solifenacina, your overactive bladder symptoms may return or worsen. Consult your doctor 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, treatment with solifenacin succinate must be stopped immediatelyand appropriate treatment and/or measures must be taken.

Solifenacin 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.

Rare (may affect up to 1 in 100 people)

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

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

• accumulation of a large amount of hardened feces in the large intestine (fecal impaction),
• urine accumulation in the bladder 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.

Unknown frequency (frequency cannot be estimated from available data)

• decreased appetite, high levels of potassium in the blood that may cause an abnormal heart rhythm,
• increased pressure in the eyes,
• changes in heart electrical activity (ECG), irregular heartbeats (Torsades des Pointes), palpitations, rapid heart rate,
• 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 Usehttps://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.

No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Solifenacina Alter

• The active ingredient is solifenacin succinate. Each tablet contains 10 mg of solifenacin succinate (equivalent to 7.5 mg of solifenacin).
• The other components are lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, hypromellose, magnesium stearate. The tablet coating contains: hypromellose, titanium dioxide (E171), triacetin, and iron oxide red (E172).

Appearance of the product and content of the container

Coated tablets with a pale pink film, round, biconvex, unnotched.

Solifenacina Alter is presented in blisters of Polyamide/Aluminum/PVC-Aluminum, in containers of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Last review date of this leaflet: November 2017.

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.