Leaflet: information for the user

Dicorynan 100 mg hard capsules

disopyramide

Read this leaflet carefully before you start to take 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

Dicorynan belongs to a group of medications called class IA antiarrhythmics.

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

• ventricular tachycardia (acceleration of heart rate originating from the ventricle),
• auricular arrhythmia (alteration of heart rhythm originating from the auricle),
• arrhythmias due to myocardial infarction,

premature contractions originating above the ventricle (supraventricular extrasystoles).

Do not take Dicorynan:

• if you are allergic to disopyramide or any of the other components of this medication (listed in section 6),
• if you are breastfeeding (see section “Breastfeeding”),

• if you have severe heart problems, such as heart conduction disorder or uncontrolled or severe heart failure,
• if you are experiencing cardiac shock (heart failure crisis),
• if you are taking other antiarrhythmic medications or other medications that may cause ventricular arrhythmias or other serious heart rhythm problems (see “Use of other medications”),
• in the presence 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 Dicorynanif you are pregnant (see section “Pregnancy”),

-if you have or have had heart problems: cardiomyopathies, structural heart disease, proarrhythmia, or heart failure,

• if you experience a new type of arrhythmia or worsening of an existing one, as well as any other heart alteration,
• if you have closed-angle glaucoma (increased eye pressure),
• if you are receiving medications to increase urination or defecation at the same time,
• if your kidneys and/or liver do not function properly (renal and/or hepatic insufficiency),
• if you are an elderly patient, or have nutrition problems, or are diabetic and being treated, or have kidney problems, due to the risk of hypoglycemia (low blood sugar levels), sometimes of a very serious nature. In these cases, your doctor will monitor your blood sugar levels,
• if you are receiving medications that may cause constipation or if you have elevated Dicorynan levels in your blood (for example, due to kidney or liver problems or taking too much Dicorynan), especially in elderly patients, as it may cause intestinal blockage due to paralysis of the intestinal muscles (ileus paralytic),
• if you are allergic to lactose (see section “Dicorynan contains lactose”).

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 medications and Dicorynan

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

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

Do not take Dicorynan if you are being treated with:

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

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

Especially, inform your doctor if you are taking:

• Medications for allergy treatment, such as astemizol and terfenadine.
• Cisaprida (intestinal stimulant).
• Antibiotics, such as pentamidine, sparfloxacine, roxitromycin.
• Pimozide (for the treatment of psychosis, a mental disorder characterized by personality problems, altered judgment, reality distortion, etc.).
• Antibiotics, such as macrolides, azole antifungals (to treat fungal infections) or quinupristin/dalfopristin, rifampicin.
• Anticonvulsants (medications for seizure treatment).
• Medications that decrease potassium levels in the blood, such as diuretics, laxatives, some antibiotics (amphotericin B), tetracosactide, systemic corticosteroids.
• Atropine and anticholinergics, such as phenothiazines (mainly for the treatment of severe emotional and mental disorders).
• Theophylline (for the treatment of asthma).
• Antivirals (virus infection treatment), such as ritonavir, indinavir, or saquinavir.
• Warfarin (blood coagulation medication).

Pregnancy and breastfeeding

It is not recommended to take Dicorynan during pregnancy, unless your doctor considers that the benefits outweigh the risks.

Disopyramide passes into breast milk, so this medication should not be taken during the breastfeeding period.

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 using machines

Caution is recommended as disopyramide may affect your ability to drive vehicles and use machinery (see “Adverse reactions”).

Dicorynan contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Dicorynan is administered orally.

The recommended dose is:

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

The usual maintenance dose is typically 300 mg or 400 mg per 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 discontinue treatment without consulting your doctor first.

If it is necessary to administer higher doses, measures will be taken to ensure proper monitoring and control of the patient.

In patients with altered liver and/or renal functioncardiac function will be monitored using an electrocardiogram to adjust the dose.

If you estimate that Dicorynan's action is too strong or too weak, inform your doctor or pharmacist.

If you take more Dicorynan than you should

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

In the event of ingesting a large amount of medication, either accidentally or intentionally, 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Dicorynan

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The most common 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.

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

These are very rare(they can affect up to 1 in 10,000 patients)

• Anaphylactic reaction (general allergic reactions) with angioedema, urticaria, and sometimesshock. The 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 common. The frequency is unknown(the frequency cannot be estimated from the available data)

• Cardiac depression (alteration of heart function).
• Ventricular arrhythmias (changes in heart rhythm), such as ventricular tachycardia (high heart rate), ventricular fibrillation (irregular, very rapid, uncontrolled heartbeats) and torsades de pointes (a type of arrhythmia); other types of arrhythmias, such as bradycardia (low heart rate), sinoatrial block (another type of arrhythmia).
• Abnormalities in the electrocardiogram.
• 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 insufficiency, and/or acute hepatic ischemia (severe liver disease).

Other side effects

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

Rare(they can affect up to 1 in 1,000 patients)

• Hypoglycemia (low blood sugar levels), sometimes severe (see section 2 "Be careful with Dicorynan").

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

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

Unknown frequency(the frequency cannot be estimated from the available data)

• Urinary urgency and acute urinary retention, especially if you have prostate problems.
• Neutropenia, insufficient number of certain white blood cells called neutrophils, which may manifest as unexplained fever or signs of infection.
• Agranulocytosis, a lack of a type of white blood cell called granulocytes, which can cause sudden high fever, intense throat pain, and mouth ulcers.
• In certain situations, the intestines become obstructed (paralytic ileus), especially in older people, when Dicorynan capsules are taken with other medications that can cause constipation or when disopyramide concentrations in the blood increase due to renal or hepatic problems.

Inform your doctor or pharmacist if any of the following side effects worsen or last more than a few days, or if you notice any side effect not mentioned in this leaflet:

Common(they can affect up to 1 in 10 patients)

• Blurred vision.
• Dry mouth and constipation.

Uncommon(they can affect up to 1 in 100 patients)

• Eye focusing problems (difficulty focusing on a near object or a far object, or vice versa; or adjusting from light to darkness, or vice versa), diplopia (double vision), and acute glaucoma (eye disease characterized by increased eye pressure and a whitish-yellow discoloration of the pupil).
• Epigastralgia (stomach pain), nausea, vomiting, anorexia (loss of appetite), and diarrhea.

Rare(they can affect up to 1 in 1,000 patients)

• Cases of psychosis (mental disorder characterized by personality problems, altered judgment, reality distortion, etc.).

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

• Headache and dizziness.
• Skin rash.

Unknown frequency(the frequency cannot be estimated from the available data)

• Worsening of myasthenia gravis (a disease that causes muscle weakness).
• Increased intraocular pressure in patients with angle-closure glaucoma.
• Impotence (inability to achieve erection of the penis).
• Confusion (cognitive alterations), insomnia (difficulty falling asleep), depression, anxiety, visual and auditory hallucinations, restlessness, and excitement have been associated with the use of this medication.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: htpps://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 25°C.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Dicorynan

- The active ingredient is disopyramide. Each capsule contains 100 mg of disopyramide.

- The other components (excipients) are: lactose, cornstarch, magnesium stearate, and talc.

Appearance of the product and content of the 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 packaging of 40 hard capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

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

Responsible for manufacturing:

Opella Healthcare International SAS

56, Route de Choisy

60200 Compiègne (France)

Last review date of this leaflet: October 2024

Other sources of information

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/ )