SOLIFENACIN COMBIX 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for theuser

Solifenacin Combix 5 mg film-coated tablets EFG

Solifenacin, succinate

Read the entire package leaflet carefully before starting to take this medication, as itcontainsimportant information foryou.

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

Contents of the package leaflet

1. What is Solifenacin Combix and what is it used for
2. What you need to know before taking Solifenacin Combix
3. How to take Solifenacin Combix
4. Possible side effects
5. Storage of Solifenacin Combix
6. Package contents and additional information

1. What is Solifenacin Combix and what is it used for

The active ingredient of Solifenacin Combix belongs to the group of anticholinergics. These medications are used to reduce the activity of the 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.

Solifenacin is used to treat the symptoms of overactive bladder syndrome. These symptoms include: having a strong and sudden need to urinate without warning, having to urinate frequently, or having urine leaks due to not making it to the bathroom in time.

2. What you need to know before taking Solifenacin Combix

Do not take Solifenacin Combix

• if you are allergic to the active ingredient or any of the other components 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 of certain muscles
• if you have high pressure in the eyes, with gradual loss of vision (glaucoma)
• if you are undergoing kidney dialysis
• if you have severe liver disease
• if you have severe kidney disease or moderate liver disease and are being treated with medications that may decrease the elimination of solifenacin from the body (e.g., ketoconazole). Your doctor or pharmacist will inform you if this is the case.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Solifenacin:

• if you have a problem emptying your bladder (= bladder obstruction) or urinating (e.g., a 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 (stomach and intestinal movements). 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 a hiatal hernia or heartburn.
• if you have an autonomic nervous disorder (autonomic neuropathy).

Inform your doctor before starting treatment with Solifenacin Combix if any of the above circumstances have occurred to you.

Before starting treatment with Solifenacin Combix, your doctor will assess whether 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 (treatment against certain bacterial infections).

Children and adolescents

Solifenacin should not be used in children and adolescents under 18 years of age.

Use of Solifenacin Combix with othermedications

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

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

• other anticholinergic medications, as the activity and side effects of both medications may increase.
• cholinergic medications, as they may reduce the effect of solifenacin.
• medications such as metoclopramide or cisapride, which make the digestive system work faster. Solifenacin may reduce their effect.
• medications such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which decrease the elimination of solifenacin from the body.
• medications such as rifampicin, phenytoin, and carbamazepine, as they may increase the elimination of solifenacin from the body.
• medications such as bisphosphonates, which may cause or worsen esophageal inflammation (esophagitis).

Taking Solifenacin Combix with food and drinks

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

Pregnancy, breastfeeding, andfertility

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

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

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

Driving and usingmachines

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

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

3. How to take Solifenacin Combix

Instructions for correct use

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Swallow the tablet whole with some liquid. It can be taken with or without food, as preferred. 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 Solifenacin Combix than youshould

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested, or go to the emergency department of the nearest hospital.

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 forget to takeSolifenacin Combix

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 are unsure, always consult your doctor or pharmacist.

Do not take a double dose to make up for forgotten doses.

If you stop takingSolifenacin Combix

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 other questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If you suffer an allergic reaction or a severe skin reaction (e.g., blistering and peeling of the skin), inform your doctor or nurse immediately.

Angioedema (allergic reaction in the skin that results in inflammation under the skin's surface) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate (solifenacin). If angioedema occurs, treatment with solifenacin succinate (solifenacin) should be discontinued immediately, and appropriate treatment and/or measures should 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 a feeling of stomach heaviness, abdominal pain, belching, nausea, and heartburn (dyspepsia), stomach discomfort

Uncommon side effects (may affect up to 1 in 100 people)

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

Rare side effects (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 side 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 potassium levels in the blood that can cause an abnormal heart rhythm
• increased pressure in the eyes
• changes in heart electrical activity (ECG), irregular heartbeats, palpitations, rapid heartbeat
• voice disorder
• liver disorder
• muscle weakness
• kidney disorder

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Solifenacin Combix

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

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

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition ofSolifenacin Combix

• The active ingredient is solifenacin succinate. Each film-coated tablet contains 5 mg of solifenacin succinate, equivalent to 3.8 mg of solifenacin.
• The other ingredients are:

Tablet core: lactose monohydrate, cornstarch, hypromellose (E464), and magnesium stearate (E470b).

Tablet coating: Instacoat universal ICG-U-10302 (light yellow): Hypromellose (E464), polyethylene glycol 8000 (E1521), talc (E553b), titanium dioxide (E171), and yellow iron oxide (E172)

Appearance of the product andpackage contents

Light yellow, round, biconvex film-coated tablets, engraved with "390" on one side and smooth on the other.

Solifenacin Combix is available in packages of 30 tablets, in PVC/PVDC-Aluminum blisters.

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Date of the last revision of this package leaflet: May 2016

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.