Solifenacin Qualigen 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Solifenacin Qualigen 5 mg film-coated tablets EFG

Solifenacin succinate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

The active substance in Solifenacina Qualigen 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 Qualigen is used to treat the symptoms of overactive bladder syndrome. These symptoms include a sudden and strong urge to urinate without prior warning, needing to urinate frequently, or experiencing urine leakage because you cannot reach the toilet in time.

2. What you need to know before starting Solifenacin Qualigen

Do not take Solifenacin Qualigen

• if you are allergic to solifenacin succinate or to 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 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 have informed you if this is the case.

Before starting treatment with solifenacin, inform your doctor if you have or have previously had any of the conditions mentioned above.

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine.

• if you have difficulty emptying your bladder (bladder obstruction) or difficulty urinating (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 increased risk of reduced activity of the digestive system (stomach and intestinal movements). Your doctor will inform you if this applies to you,
• 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

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

Inform your doctor before starting treatment with this medicine if any of the above circumstances 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 (insufficient 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).

Other medicines and Solifenacin Qualigen

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. It is especially important that you inform your doctor if you are taking:

• other anticholinergic medicines, as the activity and adverse effects of both medicines may increase,
• cholinergic agents, as they may reduce the effect of solifenacin,
• medicines such as metoclopramide or cisapride, which increase digestive system activity. Solifenacin may reduce their effect,
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which decrease the rate at which solifenacin is eliminated from the body,
• medicines such as rifampicin, phenytoin, and carbamazepine, as they may increase the rate at which solifenacin is eliminated from the body,
• medicines such as bisphosphonates, which may cause or worsen inflammation of the oesophagus (oesophagitis).

Use of Solifenacin Qualigen with food, drinks and alcohol

This medicine may be taken with or without food, according to your preference.

Pregnancy, breast-feeding and fertility

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.

You must not use solifenacin during pregnancy unless absolutely necessary.

Do not use solifenacin while breast-feeding, as solifenacin may pass into breast milk.

Driving and using machines

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

Solifenacin Qualigen contains lactose

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

3. How to take Solifenacin Qualigen

Instructions for correct use

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

You must 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 tells you to take 10 mg daily.

If you take more Solifenacin Qualigen than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount ingested.

Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision, perception of things that are not present (hallucinations), pronounced excitement, seizures, breathing difficulty, increased heart rate (tachycardia), urine accumulation in the bladder (urinary retention), and pupil dilation (mydriasis).

If you forget to take Solifenacin Qualigen

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. Never take more than one dose per day. If you have any doubts, always consult your doctor or pharmacist.

If you stop taking Solifenacin Qualigen

If you stop taking solifenacin, 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 experiences them.

If you suffer an allergic reaction or a severe skin reaction (for example, blistering and peeling of the skin), you must inform your doctor or nurse 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. If angioedema occurs, treatment with solifenacin succinate must be stopped immediately, and appropriate treatment and/or measures must be taken.

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 adverse effects (may affect up to 1 in 100 people)

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

Rare adverse effects (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 adverse effects (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 an 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 effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products. Website: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Solifenacin Qualigen

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

This medicine does not require any special storage conditions.

Do not use Solifenacin Qualigen after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Solifenacin Qualigen

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

• The other components are monohydrate lactose, corn starch, 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 pack

Solifenacin Qualigen 5 mg is presented as yellow, film-coated, round tablets, marked with "E2" on one side.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona 69

08970 Sant Joan Despí (Barcelona), Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí (Barcelona), Spain

Date of the most recent revision of this leaflet: June 2017

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