Solifenacin CINFA 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

solifenacina cinfa 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, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, 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.

Contents of the leaflet

1. What solifenacina cinfa is and what it is used for
2. What you need to know before taking solifenacina cinfa
3. How to take solifenacina cinfa
4. Possible side effects

5 Storage of solifenacina cinfa

1. Contents of the pack and other information

1. What is solifenacin cinfa and what is it used for

The active substance in solifenacin cinfa 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.

Solifenacin cinfa is used to treat the symptoms of overactive bladder syndrome. These symptoms include a sudden, strong urge to urinate with no warning, needing to urinate frequently, or leaking urine because you cannot reach the toilet in time.

2. What you need to know before starting to take solifenacin cinfa

Do not take solifenacin cinfa

• if you are allergic to solifenacin 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 renal 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 inform you if this applies.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take solifenacin

• if you have problems 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 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.
• 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).

Children and adolescents

Inform your doctor before starting treatment with solifenacin if any of the above circumstances have ever occurred in your case.

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

Before starting treatment with solifenacin, your doctor will assess whether there are other causes for your frequent need to urinate (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 against certain bacterial infections).

Taking solifenacin cinfa with other medicines

Inform 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.
• 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 decrease 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 esophagus (esophagitis).

Taking solifenacin cinfa with food and drinks

Solifenacin cinfa can be taken with or without food, according to your preference.

Pregnancy, breastfeeding and fertility

You must not use solifenacin if you are pregnant unless absolutely necessary. Do not use solifenacin during breastfeeding, as solifenacin may pass into breast milk.

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

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.

3. How to take solifenacin cinfa

Instructions for correct use

Follow exactly the dosage instructions given by your doctor. If in doubt, consult your doctor or pharmacist again.

You should swallow the tablet whole with liquid. It may 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 instructs you to take 10 mg daily.

If you take more solifenacin cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

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

If you forget to take solifenacin cinfa

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 stop taking solifenacin cinfa

If you stop taking solifenacin cinfa, 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.

solifenacina cinfa 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 hardened feces 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 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 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of solifenacin cinfa

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

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of solifenacin cinfa

• The active substance is solifenacin succinate: 5 mg.
• The other components are povidone, corn starch, sodium carboxymethyl starch from potato (type A), anhydrous calcium dibasic phosphate, magnesium stearate, opadry white, and yellow iron oxide (E172).

Appearance of the medicinal product and contents of the pack

Solifenacin cinfa 5 mg tablets are rough, cylindrical, biconvex, pale yellow tablets without a score line, marked with the logo “S5” on one side.

Solifenacin cinfa 5 mg tablets are supplied in blisters containing 30 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: April 2018

Detailed 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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83024/P_83024.html

QR code to: https://cima.aemps.es/cima/dochtml/p/83024/P_83024.html