Dicrisol 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dicrisol 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Dicrisol is and what it is used for

The active substance in Dicrisol 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.

Dicrisol is used to treat the symptoms of overactive bladder syndrome. These symptoms include a sudden and strong urge to urinate without prior warning, needing to urinate frequently, or experiencing urine leakage because you cannot reach the toilet in time.

2. What you need to know before taking Dicrisol

Do not take Dicrisol

• if you are allergic to solifenacin succinate or 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 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 to you.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Dicrisol 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.
• you have any obstruction of the digestive system (constipation),
• you are at increased risk of reduced digestive system activity (stomach and intestinal movements). Your doctor will inform you if this applies to you,
• you have severe kidney disease,
• you have moderate liver disease,
• you have a hiatal hernia or heartburn,
• you have a nervous system disorder (autonomic neuropathy).

Children and adolescents

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

Inform your doctor before starting treatment with this medicine 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 (inadequate 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).

Other medicines and Dicrisol

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 may increase,
• cholinergic agents, 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 slow down the 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 Dicrisol with food and drink

This medicine may be taken with or without food, according to your preference.

Pregnancy, breast-feeding and fertility

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

You must not use solifenacin during pregnancy unless absolutely necessary.

Do not use solifenacin while breast-feeding, 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.

Dicrisol contains lactose

This medicine 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 Dicrisol

Instructions for correct use

Follow exactly the instructions for administration 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 may be taken with or without food, according to your preference. Do not crush the tablets.

The usual dose is 5 mg daily, unless your doctor instructs you to take 10 mg daily.

If you take more Dicrisol than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating 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 retention in the bladder (urinary retention), and pupil dilation (mydriasis).

If you forget to take Dicrisol

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. Do not take a double dose to make up for forgotten doses. Never take more than one dose per day. If you have any doubts, always consult your doctor or pharmacist.

If you stop taking Dicrisol

If you stop taking solifenacin, your symptoms of overactive bladder 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 everybody will experience 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.

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 fullness, abdominal pain, belching, nausea, and heartburn (dyspepsia), stomach discomfort.

Uncommon (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 (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 (may affect up to 1 in 10,000 people)

• hallucinations, confusion,
• allergic skin rash.

Frequency not known (frequency cannot be estimated from the 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 heartbeats (Torsades de Pointes), palpitations, rapid heartbeat,
• voice disorder,
• liver disorder,
• muscle weakness,
• kidney disorder.

Reporting of adverse effects

If you experience any 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 Dicrisol

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

No special storage conditions are required.

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

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

6. Contents of the pack and other information

Composition of Dicrisol

• The active substance is solifenacin succinate. Each tablet contains 5 mg of solifenacin succinate (equivalent to 3.8 mg of solifenacin).
• The other components are monohydrate lactose, microcrystalline cellulose, pregelatinized maize starch, hypromellose, magnesium stearate. The tablet coating contains: hypromellose, titanium dioxide (E171), triacetin, and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Light yellow, film-coated, round, biconvex tablets, without a breakline.

Dicrisol is available in Poliamide/Aluminum/PVC-Aluminum blisters, in pack sizes of 30 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of the most recent revision of this leaflet: November 2017

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/.