Dicorynan 100 mg hard capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

Dicorynan 100 mg hard capsules

disopyramide

Read all of this leaflet carefully before you start taking this medicine, as 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. Do not pass it on to others, even if they have the same symptoms as you, as it may 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 Dicorynan is and what it is used for

2. What you need to know before taking Dicorynan

3. How to take Dicorynan

4. Possible adverse effects

5. How to store Dicorynan

6. Contents of the pack and other information

1. What Dicorynan is and what it is used for

Dicorynan belongs to a group of medicines known as class IA antiarrhythmics.

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

• accelerated heartbeat of ventricular origin (ventricular tachycardia),
• cardiac rhythm disturbances (arrhythmia) of atrial origin,
• arrhythmias due to myocardial infarction,

as well as premature contractions arising above the ventricle (supraventricular extrasystoles).

2. What you need to know before taking Dicorynan

Do not take Dicorynan:

• if you are allergic to disopyramide or to any of the other components of this medicine (listed in section 6),
• if you are breastfeeding (see section “Breastfeeding”),
• if you have severe heart disorders, such as cardiac conduction disorders or uncontrolled or severe heart failure,
• if you are suffering from cardiogenic shock (a crisis due to heart failure),
• if you are taking other antiarrhythmic medicines or other medicines that may cause ventricular arrhythmias or other serious heart rhythm problems (see “Use of other medicines”),
• if you have 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 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 develop a new type of arrhythmia or worsening of an existing one, or if any other cardiac disturbance occurs,
  • if you have closed-angle glaucoma (increased eye pressure),
  • if you are simultaneously receiving medications to increase urination or bowel movements,
  • if your kidneys and/or liver are not functioning properly (renal and/or hepatic impairment),
  • if you are elderly, malnourished, a diabetic on treatment, or have kidney problems, due to the risk of hypoglycemia (low blood sugar levels), which may sometimes be severe. In such cases, your doctor will monitor your blood glucose levels,
  • if you are simultaneously taking medicines that may cause constipation or if your blood levels of Dicorynan are elevated (for example, due to kidney or liver problems or if you take too much Dicorynan), especially in elderly patients, as intestinal obstruction may occur due to paralysis of intestinal muscles (paralytic ileus),
  • if you are allergic to lactose (see section “Dicorynan contains lactose”).

The administration of 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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Certain medications may interact with Dicorynan; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medications, so they should not be used without consulting a physician.

Do not take Dicorynan if you are being treated with:

? Other heart medications (antiarrhythmics class I, II, III, or IV).

? Medications that may cause Torsades de pointes (a cardiac arrhythmia), such as: antidepressants, antibiotics like erythromycin, vincamine, or sultopride.

Especially, inform your doctor if you are taking:

• Medications for allergy treatment, such as astemizole and terfenadine.
• Cisapride (an intestinal stimulant).
• Antibiotics, such as pentamidine, sparfloxacin, roxithromycin.
• Pimozide (used to treat psychosis, a mental disorder characterized by personality disturbances, impaired judgment, and disturbances of reality, etc.).
• Antibiotics, such as macrolides, azole antifungals (used to treat fungal infections), or quinupristin/dalfopristin, rifampicin.
• Anticonvulsants (medications for the treatment of seizures).
• Medications that reduce potassium levels in the blood, such as diuretics, stimulant laxatives, certain antibiotics (amphotericin B), tetracosactide, systemic corticosteroids.
• Atropine and anticholinergics, such as phenothiazines (used primarily for the treatment of severe emotional and mental disorders).
• Theophylline (for the treatment of asthma).
• Antivirals (for the treatment of viral infections), such as ritonavir, indinavir, or saquinavir.
• Warfarin (a medication for blood coagulation).

Pregnancy and breastfeeding

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

Disopyramide passes into breast milk; therefore, this medication should not be taken during breastfeeding.

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

Driving and operating machinery

Caution is recommended as disopyramide may affect the ability to drive vehicles and operate machinery (see "Adverse Reactions").

Dicorynan contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Dicorynan

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Dicorynan is administered orally.

The recommended dose is:

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

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

Your doctor will determine your daily dose and the duration of your treatment. Do not discontinue treatment before this time without first consulting your doctor.

If higher doses are considered necessary, appropriate measures will be taken for adequate monitoring and control of the patient.

In patients with impaired hepatic and/or renal function, cardiac function will be monitored by electrocardiogram to adjust the dose.

If you feel that the effect of Dicorynan is too strong or too weak, inform 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 paralysis of intestinal muscles), hypotension (low blood pressure), cardiac failure, arrhythmias, respiratory disturbances, and coma.

If a large amount of the medicine is ingested, either accidentally or intentionally, the patient must be immediately hospitalized and placed under continuous monitoring of cardiac function.

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 medicine and the amount taken. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

If you forget to take Dicorynan

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

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 will experience them.

The most common adverse effects are due to its anticholinergic activity (action on the nervous system) and are dose-dependent. Among these effects, urinary retention is the most serious.

Immediately inform your doctor if you notice any of the following serious adverse effects; you may require 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. Signs may include hives, skin irritation and itching, difficulty swallowing or breathing, swelling of the lips, face, and throat.

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

• Cardiac depression (impaired heart function).
• Ventricular arrhythmias (changes in heart rhythm), such as ventricular tachycardia (fast heart rate), ventricular fibrillation (irregular, very rapid, uncontrolled beats), 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 abnormalities.
• Severe heart failure, cardiac arrest, 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 (serious liver disease).

Other adverse effects

Inform your doctor as soon as possible if you experience any of the following adverse effects:

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

• Hypoglycemia (low blood sugar levels), sometimes severe (see section 2, "Take special care with Dicorynan").

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

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

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

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

Inform your doctor or pharmacist if any of the following adverse effects worsen or last longer than a few days, or if you notice any adverse effects not listed in this leaflet:

Frequent (may affect up to 1 in 10 patients)

• Blurred vision.
• Dry mouth and constipation.

Uncommon (may affect up to 1 in 100 patients)

• Eye accommodation problems (difficulty focusing from near to far objects or vice versa; or adapting from light to darkness or vice versa), diplopia (double vision), and acute glaucoma (an eye disease characterized by increased eye pressure and a whitish-greenish coloration of the pupil).
• Epigastric pain (stomach pain), nausea, vomiting, anorexia (loss of appetite), and diarrhea.

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

• Cases of psychosis (mental disorder characterized by personality disturbances, impaired judgment, reality distortions, etc.).

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

• Headache and dizziness.
• Skin rash (rash).

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

• Worsening of myasthenia gravis (a disease causing muscle weakness).
• Increased ocular pressure in patients with closed-angle glaucoma.
• Impotence (inability to achieve penile erection).
• Confusion (cognitive disturbances), insomnia (difficulty falling asleep), depression, anxiety, visual and auditory hallucinations, restlessness, and agitation have been associated with the use of this medicine.

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 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 stated on the container 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 containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This helps protect the environment.

6. Contents of the pack and other information

Composition of Dicorynan

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

Appearance of the product and contents of the pack

Dicorynan 100 mg is presented as hard capsules for oral administration. The capsules are green and yellow in colour.

Dicorynan 100 mg is available in packs containing 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 the most recent revision of this leaflet: October 2024

Other sources of information

Detailed 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/)