Solifenacin Combix 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Solifenacina Combix 5 mg film-coated tablets EFG

Solifenacin, succinate

Read the entire leaflet carefully before you start taking this medicine, because 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 should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

The active substance in Solifenacina Combix belongs to the group of anticholinergic medicines. 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 is used to treat the symptoms of overactive bladder syndrome. These symptoms include a sudden, strong need to urinate without warning, needing to urinate frequently, or leaking urine because you cannot reach the toilet in time.

2. What you need to know before starting Solifenacin Combix

Do not take Solifenacin Combix

• if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6)
• if you have difficulty passing urine or emptying your bladder completely (urinary retention)
• if you have a severe stomach or bowel 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 being treated with medicines that may reduce the elimination of solifenacin from the body (e.g. ketoconazole). Your doctor or pharmacist will inform you if this applies to you.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Solifenacin:

• if you have problems emptying your bladder (= bladder obstruction) or difficulty passing urine (e.g. weak urine stream). The risk of urine accumulation in the bladder (urinary retention) is much higher.
• if you have an obstruction in the digestive system (constipation).
• if you are at increased risk of reduced digestive system activity (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 a hiatal hernia or heartburn.
• if you have a nervous system disorder (autonomic neuropathy).

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

Before starting treatment with Solifenacin Combix, your doctor will assess whether there are other causes for your frequent need to urinate (for example, heart failure (reduced 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).

Children and adolescents

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

Taking Solifenacin Combix with other medicines

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 could increase.
• cholinergics, 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 reduce the rate of elimination of solifenacin from the body.
• medicines such as rifampicin, phenytoin, and carbamazepine, as they may increase the rate of elimination of solifenacin from the body.
• medicines such as bisphosphonates, which may cause or worsen inflammation of the oesophagus (oesophagitis).

Taking Solifenacin Combix with food and drink

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

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 solifenacin during pregnancy unless absolutely necessary.

Do not use solifenacin during breastfeeding, 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 Combix contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Solifenacina Combix

Instructions for correct use

Follow exactly the instructions for use of this medicine as given by your doctor. 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 usual dose is 5 mg once daily, unless your doctor tells you to take 10 mg once daily.

If you take more Solifenacina Combix than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone number: 91 562 04 20, stating the medicine and the amount ingested, or go to the nearest hospital emergency department.

Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision, perception of things that are not there (hallucinations), marked excitement, seizures, breathing difficulties, increased heart rate (tachycardia), urine retention 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 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.

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

If you stop taking Solifenacina 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

If you suffer an allergic attack 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 (solifenacin). If angioedema occurs, treatment with solifenacin succinate (solifenacin) must be discontinued 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
• abnormal taste perception (dysgeusia)
• dry (irritated) eyes
• dry 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 hard stool in the colon (fecal impaction)
• urine retention in the bladder 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 eye pressure
• 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Solifenacina Combix

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

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

6. Contents of the pack and other information

Composition of Solifenacin Combix

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

Tablet core: monohydrate lactose, corn starch, 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 and contents of the pack

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

Solifenacin Combix is available in packs 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 Nanter rue

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Date of the most recent revision of this leaflet: May 2016

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