Prospect: information for theuser

Solifenacina Combix 10 mg film-coated tablets

Solifenacina, succinate

Read this prospect thoroughly before starting to take this medication, becauseit containsimportant information foryou.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you must not give it to other peoplealthoughthey may have the same symptoms as you, as it mayharm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in thisprospect. See section 4.

The active ingredient of Solifenacina Combix belongs to the group of anticholinergics. These medications areusedto reduce the activity of an overactive bladder. This allows you to have more timebeforeyou need to go to the bathroom and increases the amount of urine that your bladder canretain.

Solifenacina is used to treat the symptoms of overactive bladder syndrome. These symptoms include:havinga strong and sudden need to urinate without prior warning, having to urinate frequently or havingaccidentswith urine because you do not arrive in time tothebathroom.

Do not take Solifenacina 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 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 Solifenacina:

• 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 disorder (autonomic neuropathy).

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

Before starting treatment with Solifenacina Combix, your doctor will evaluate if 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).

Children and adolescents

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

Use of Solifenacina Combix with other medications

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

Taking Solifenacina Combix with food and drinks

Solifenacina 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 medication.

You should 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 Combix 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, according to your preference. 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 Combix than you should

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

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 take Solifenacina 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 have any doubts, consult your doctor or pharmacist always.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Solifenacina Combix

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 (for example, the formation of blisters and skin peeling), 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 (solifenacin). If angioedema appears, treatment with solifenacin succinate (solifenacin) must be stopped immediately and 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 a 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 eyes (irritated)
• nasal dryness
• gastroesophageal reflux disease (GERD)
• dry throat
• dry skin
• difficulty urinating
• fatigue
• lower extremity edema (fluid accumulation)

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

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

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

• hallucinations, confusion
• allergic skin eruption.

Unknown frequency (frequency cannot be estimated from available data)

• decreased appetite, high potassium levels in the blood that may cause an 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:https://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.

Do not use this medication after the expiration date that appears 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 drains or in the trash. Dispose of packaging and medications you no longer need 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 ofSolifenacina Combix

• The active ingredient is solifenacin succinate. Each film-coated tablet contains 10 mg of solifenacin succinate, which is equivalent to 7.5 mg of solifenacin.
• The other components are:

Core of thetablet:Lactose monohydrate, cornstarch, hypromellose (E464) and magnesium stearate (E470b).

Coating of the tablet: Instacoat universal ICG-U-10308 (pale pink):Hypromellose (E464), polyethylene glycol 8000 (E1521), talc (E553b), titanium dioxide (E171) and iron oxide red (E172).

Appearance of the product and content of thecontainer

Film-coated tablets, pale pink in color, round, biconvex, engraved with “391” on one face and smooth on the other.

Solifenacina Combix is available in containers of 30 tablets, in PVC/PVDC-Aluminum blisters.

Holder of the marketing authorization

Combix Laboratories, S.L.U.

C/ Badajoz 2, Building 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

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

Last review date of this leaflet: May 2016

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.