Leaflet: information for the user

Solifenacina Qualigen 5 mg film-coated tablets EFG

Solifenacina, succinate

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isSolifenacina Qualigenand what it is used for

2. What you need to know before starting to takeSolifenacina Qualigen

3. How to takeSolifenacina Qualigen

4. Possible side effects

5. Storage ofSolifenacina Qualigen

6. Contents of the pack and additional information

The active ingredient of Solifenacina Qualigen 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 Qualigen 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 because you do not arrive in time to the bathroom.

Do not take Solifenacina Qualigen

• if you are allergic to solifenacin succinate 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 can cause extreme weakness in 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 medications that can reduce the elimination of solifenacina 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 this medication.

• 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 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 medication should not be used in children or adolescents under 18 years old.

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

Before starting treatment with solifenacina, your doctor will evaluate whether there are other causes for your frequent urination (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 medications and Solifenacina Qualigen

Inform your doctor or pharmacist that 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 solifenacina elimination from the body,
• medications such as rifampicin, phenytoin, and carbamazepine, which may increase the rate of solifenacina elimination from the body,
• medications such as bisphosphonates, which may cause or worsen esophagitis.

Use of Solifenacina Qualigen with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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

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

Do not use solifenacina 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 Qualigen contains lactose

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

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

If You Take More Solifenacina Qualigen Than You Should

In case of overdose or accidental ingestion, contact 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 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 Qualigen

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 Qualigen

If you stop taking solifenacina, 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, 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 side effects (may affect up to 1 in 100 people)

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

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

• accumulation 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 side effects (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 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use. Website: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.

This medication does not require special storage conditions.

Do not use Solifenacina Qualigen after the expiration date that appears on the packaging. 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 the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Solifenacina Qualigen

• The active ingredient is solifenacin succinate. Each tablet contains 5 mg of solifenacin succinate (equivalent to 3.8 mg of solifenacin).

• The other components are lactose monohydrate, cornstarch, hypromellose (E464), anhydrous colloidal silica (E551), magnesium stearate (E470b), talc (E553b), macrogol (E1521), titanium dioxide (E171), and yellow iron oxide (E172).

Appearance of the product and contents of the packaging

Solifenacina Qualigen 5 mg is presented in the form of film-coated tablets, round, yellow in color, and with the inscription "E2" on one side.

Solifenacina Qualigen 5 mg film-coated tablets are available in packs of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona 69

08970 Sant Joan Despí (Barcelona), Spain

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí (Barcelona), Spain

Last review date of this leaflet: June 2017

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