Solifenacin Pensa 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Solifenacina Pensa 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. It may harm them, even if their symptoms are the same as yours.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

The active substance in Solifenacina Pensa 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 Pensa is used to treat the symptoms of overactive bladder syndrome. These symptoms include a sudden, strong urge 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 Pensa

Do not take Solifenacin Pensa

• 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 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 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 applies.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 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

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

Inform your doctor before starting treatment with solifenacin 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 against certain bacterial infections).

Taking Solifenacin Pensa 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.
• Cholinergic agents, as they may reduce the effect of solifenacin.
• Medicines such as metoclopramide or cisapride, which increase digestive system motility. 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 esophagus (esophagitis).

Taking Solifenacin Pensa with food and drink

Solifenacin may 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 Pensa

Instructions for correct use

Follow exactly the instructions for administration of this medicine provided by your doctor.

If in doubt, consult your doctor or pharmacist again.

You must swallow the tablet whole with some 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 instructs you to take 10 mg daily.

If you take more Solifenacin Pensa 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, 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), marked 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 Pensa

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 Pensa

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 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. 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 feeling of 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
• drowsiness
• abnormal 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 large intestine (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 can 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 Solifenacin Pensa

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 drains or household waste. Dispose of packaging and unused medicines at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of packaging and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Solifenacina Pensa

• The active substance is solifenacin succinate: 5 mg.
• The other components are povidone, corn starch, sodium carboxymethyl starch from potato (type A), anhydrous calcium hydrogen phosphate, magnesium stearate, Opadry White (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol, and talc), and yellow iron oxide (E172).

Appearance of the medicinal product and contents of the pack

Solifenacina Pensa 5 mg tablets are rough, cylindrical, biconvex, pale yellow tablets, without a breakline, marked with the logo “S5” on one side.

Solifenacina Pensa 5 mg tablets are supplied in blisters containing 30 tablets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios Cinfa, S.A.

C/Olaz-Chipi, 10-Polígono Industrial Areta,

31620 Huarte-Pamplona (Navarra)

Spain

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

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