DICORYNAN 100 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Dicorynan 100 mg Hard Capsules

Disopyramide

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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Dicorynan and what is it used for
2. What you need to know before you take Dicorynan
3. How to take Dicorynan
4. Possible side effects
5. Storage of Dicorynan

1. Contents of the pack and further information

1. What is Dicorynan and what is it used for

Dicorynan belongs to a group of medicines called class IA anti-arrhythmics.

Dicorynan is indicated for the treatment or prevention of cardiac rhythm disorders such as:

• ventricular tachycardia (fast heart rate of ventricular origin),
• atrial arrhythmia (arrhythmia of atrial origin),
• arrhythmias due to myocardial infarction,

against premature contractions originating from above the ventricle (supra-ventricular extrasystoles).

2. What you need to know before you take Dicorynan

Do not take Dicorynan:

• if you are allergic to disopyramide or any of the other ingredients of this medicine (listed in section 6),
• if you are breast-feeding (see section “Breast-feeding”),

• if you have severe heart disorders, such as cardiac conduction disorders or uncontrolled or severe heart failure,
• if you are suffering from cardiogenic shock (cardiac crisis),
• if you are taking other anti-arrhythmic medicines or other medicines that may cause ventricular arrhythmias or other serious heart rhythm problems (see “Use of other medicines”),
• in case of fluid in your lungs (acute pulmonary edema).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dicorynan.

• Consult your doctor before starting to take Dicorynan if you are pregnant (see section “Pregnancy”),

• if you have or have had heart problems: cardiomyopathies, structural heart disease, proarrhythmia, or heart failure,
  • if you suffer from a new type of arrhythmia or worsening of an existing one, as well as if any other cardiac disorder appears,
  • if you have narrow-angle glaucoma (increased eye pressure),
  • if you are taking medicines to increase urination (diuretics) or defecation,
  • if your kidneys and/or liver are not working properly (renal and/or hepatic insufficiency),
  • if you are an elderly patient, or have nutrition problems, or are diabetic and under treatment, or have kidney problems, due to the risk of hypoglycemia (low blood sugar levels), sometimes very severe. In these cases, your doctor will monitor your blood sugar levels,
  • if you are taking medicines that may cause constipation or if you have high levels of Dicorynan in your blood (for example, due to kidney or liver problems or if you take too much Dicorynan), especially in elderly patients, as it may cause intestinal blockage due to paralysis of the intestinal muscles (paralytic ileus),
  • if you are allergic to lactose (see section “Dicorynan contains lactose”).

Disopyramide should be avoided in patients with glaucoma. In patients with glaucoma or a family history of glaucoma, intraocular pressure should be measured before starting treatment.

Other medicines and Dicorynan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Certain medicines may interact with Dicorynan, in these cases it may be necessary to change the dose or interrupt treatment with one of the medicines, so they should not be used without consulting your doctor.

Do not take Dicorynan if you are being treated with:

?Other heart medicines (class I, II, III or IV anti-arrhythmics).

?Medicines that may cause Torsades de pointes (heart rhythm disorder) such as: antidepressant medicines, antibiotics such as erythromycin, vincamine or sultopride.

Especially, tell your doctor if you are taking:

• Medicines for allergy treatment, such as astemizole and terfenadine.
• Cisapride (intestinal stimulant).
• Antibiotics, such as pentamidine, esparfloxacino, roxithromycin.
• Pimozide (for the treatment of psychosis, a mental disorder characterized by personality problems, judgment disorders, reality disorders, etc.).
• Antibiotics, such as macrolides, azole antifungals (for the treatment of fungal infections) or quinupristin/dalfopristin, rifampicin.
• Anticonvulsants (medicines for the treatment of seizures).
• Medicines that decrease potassium levels in the blood, such as diuretics, stimulant laxatives, some antibiotics (amphotericin B), tetracosactide, systemic corticosteroids.
• Atropine and anticholinergics, such as phenothiazines (for the treatment of severe emotional and mental disorders).
• Theophylline (for the treatment of asthma).
• Antivirals (treatment of viral infections), such as ritonavir, indinavir or saquinavir.
• Warfarin (medicine for blood coagulation).

Pregnancy and breast-feeding

Dicorynan is not recommended during pregnancy, unless your doctor considers that the benefit outweighs the risk.

Disopyramide passes into breast milk, so you should not take this medicine during breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Caution is recommended as disopyramide may affect your ability to drive or use machines (see “Side effects”).

Dicorynan contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Dicorynan

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Dicorynan is administered orally.

The recommended dose is:

Treatment should be started with 100 mg (1 capsule) every 6 hours, increasing or decreasing this dose according to the patient's response.

The usual maintenance dose is usually 300 mg or 400 mg/day, distributed throughout the day in 3 or 4 doses (1 capsule every 3 or 4 hours).

Your doctor will indicate your daily dose and the duration of your treatment. Do not stop treatment before consulting your doctor.

If it is deemed necessary to administer higher doses, the necessary measures will be taken for the adequate follow-up and control of the patient.

In patients with altered liver and/or kidney function, cardiac function will be monitored by electrocardiogram to adjust the dose.

If you think the action of Dicorynan is too strong or too weak, tell your doctor or pharmacist.

If you take more Dicorynan than you should

The most frequent symptoms in cases of overdose are: paralytic ileus (intestinal blockage due to muscle paralysis), hypotension (low blood pressure), heart failure, arrhythmias, respiratory disorders, and coma.

In case of accidental or intentional ingestion of a large amount of medicine, the patient should be immediately hospitalized and subjected to continuous monitoring of cardiac function.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Dicorynan

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most frequent side effects are due to its anticholinergic activity (activity on the nervous system) and depend on the dose. Among these effects, urinary retention is the most serious.

Tell your doctor immediately if you notice any of the following serious side effects; you may need urgent medical treatment:

The following are very rare (may affect up to 1 in 10,000 patients)

• Anaphylactic reaction (general allergic reactions) with angioedema, urticaria, and sometimes shock. The signs may include hives, skin irritation and itching, swallowing or breathing problems, swelling of lips, face, and throat.

Cardiac effects may occur, although they are not the most frequent. The frequency is unknown (the frequency cannot be estimated from the available data)

• Cardiac depression (disorder of heart function).
• Ventricular arrhythmias (changes in heart rhythm), such as ventricular tachycardia (fast heart rate), ventricular fibrillation (uncontrolled, very fast heartbeats), and Torsades de pointes (a type of arrhythmia); other types of arrhythmias, such as bradycardia (slow heart rate), sinus block (another type of arrhythmia).
• Electrocardiogram disorders.
• Severe heart failure, failure, or even cardiogenic shock (in patients with severe structural heart disease). In these cases, the heart cannot pump enough blood to the body.
• Hypotension (low blood pressure), renal failure, and/or acute hepatic ischemia (severe liver disease).

Other side effects

Tell your doctor as soon as possible if you have any of the following side effects:

Rare (may affect up to 1 in 1,000 patients)

• Hypoglycemia (low blood sugar levels), sometimes severe (see section 2 “Special warnings and precautions for use”).

Very rare (may affect up to 1 in 10,000 patients)

• Cholestatic jaundice (yellowing of the eyes and skin).

Frequency not known (the frequency cannot be estimated from the available data)

• Dysuria (painful urination) and acute urinary retention, especially if you have prostate problems.
• Neutropenia, insufficient amount of certain white blood cells called neutrophils, which can manifest as unexplained fever or signs of infection.
• Agranulocytosis, a lack of a type of white blood cells called granulocytes, which can cause sudden high fever, severe sore throat, and mouth ulcers.
• In certain situations, the intestines may become obstructed (paralytic ileus), especially in elderly patients, when Dicorynan capsules are taken with other medicines that may cause constipation or when disopyramide levels in the blood increase due to kidney or liver problems.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dicorynan

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

Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and further information

Composition of Dicorynan

• The active substance is disopyramide. Each capsule contains 100 mg of disopyramide.
• The other ingredients (excipients) are: lactose, corn starch, magnesium stearate, and talc.

Appearance and packaging

Dicorynan 100 mg is presented in the form of hard capsules, for oral administration. They are green and yellow capsules.

Dicorynan 100 mg is presented in packs of 40 hard capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder:

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Local representative

Laboratorios Rubió, S.A.

Industria, 29

Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Manufacturer:

Opella Healthcare International SAS

56, Route de Choisy

60200 Compiègne (France)

Date of last revision of this leaflet: October 2024

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/)