Ritmodan

Package leaflet: Information for the patient

Ritmodan 100 mg hard capsules

disopyramide
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ritmodan is and what it is used for

Ritmodan contains disopyramide, an active substance belonging to a class of medicines called
"Class IA antiarrhythmics".
It works by regulating the heartbeat.
Ritmodan is indicated:
for prevention:

• of recurrences of heart rhythm disturbances (complete arrhythmia with atrial fibrillation and flutter), after these disturbances have already been corrected;
• of recurrences of episodes of abnormally increased heart rate (paroxysmal and ventricular tachycardia);
• of heart rhythm disturbances associated with myocardial infarction.

for treatment:

• of abnormal heartbeats (atrial or ventricular extrasystoles).

2. What you should know before taking Ritmodan

Do not take Ritmodan

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have certain heart diseases that can affect your heartbeat, known as: unregulated second- or third-degree atrioventricular block, bundle branch block associated with first-degree atrioventricular block, double bundle branch block (left anterior or posterior hemiblock and right bundle branch block), QT interval prolongation, or severe sinoatrial node dysfunction;
• if your heart is unable to pump enough blood to the body (heart failure not secondary to cardiac arrhythmias) (See "Warnings and precautions");
• if you are also taking other medicines to regulate your heartbeat (antiarrhythmics) or medicines that may cause heart rhythm abnormalities (ventricular arrhythmias, especially torsades de pointes) (See section "Other medicines and Ritmodan").

Warnings and precautions
It is important to read this section carefully if you are to take this medicine.
Talk to your doctor or pharmacist before taking Ritmodan.
Your doctor will perform regular check-ups and electrocardiogram (ECG) monitoring if:

• you have severe heart disease (established cardiac disease), because you may be more sensitive to the reduced heart contraction (negative inotropic effect) caused by disopyramide;
• your existing heart rhythm disorder (pre-existing arrhythmia) worsens, or if a new type of arrhythmia appears;
• if atrioventricular block or bifascicular block develops;
• if you have changes in your electrocardiogram (prolonged QT interval or QRS segment).

Electrolyte imbalance (potassium levels)
Your doctor will monitor your blood potassium levels (kalaemia) and correct any imbalance,
especially if you are also taking medicines called "diuretics", used to lower blood pressure.
If you are taking diuretic medicines or stimulant laxatives (a type of laxative), you may be at risk of low blood potassium (hypokalaemia).

Kidney problems (Renal impairment)
If you have kidney problems, your doctor will reduce your dose of disopyramide and adjust the dosing interval.

Liver problems (Hepatic impairment)
If you have liver problems, your doctor will reduce your dose of disopyramide.

Specific side effects
The following side effects, known as "anticholinergic-like effects", may occur:

• increased eye pressure (ocular hypertension) if you suffer from a condition called "narrow-angle glaucoma";
• acute urinary retention (urine retention in the bladder) if you have a prostate condition (prostatic hypertrophy);
• intestinal obstruction due to paralysis of intestinal muscles, especially in elderly patients, and particularly when Ritmodan is taken with other medicines that may cause constipation or in situations where blood levels of Ritmodan are increased (e.g. due to kidney or liver problems or if an overdose has been taken);
• worsening of your condition if you suffer from a disease causing severe muscle weakness (myasthenia gravis);
• memory, attention, perception, and reasoning disturbances (cognitive disorders) in some elderly patients (for other anticholinergic-like effects, see "Possible side effects").

Blood sugar levels (glycaemia)
Your doctor will monitor your blood sugar levels, as there is a risk of hypoglycaemia (low blood sugar), sometimes severe, particularly if you are elderly or malnourished, if you are taking antidiabetic medicines, or if you have kidney problems.

Heart diseases
If you have serious heart conditions (such as severe arrhythmias, heart failure with decompensation, or established heart disease), your doctor will carefully evaluate whether to prescribe Ritmodan.

Before using Ritmodan, inform your doctor if:

• you have glaucoma (an eye disease often caused by abnormally high eye pressure, which damages the optic nerve and may lead to blindness): in this case, you must not use Ritmodan;
• you have ever had glaucoma or if anyone in your family has had glaucoma: in this case, your doctor will perform an eye pressure test before prescribing Ritmodan.

Children and adolescents
The use of Ritmodan in children and adolescents under 18 years of age has not been sufficiently studied.
Children with hepatic impairment may be at risk of increased exposure.

Other medicines and Ritmodan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effects of Ritmodan may be influenced by, or may influence, the following medicines:

The combination of Ritmodan with the following medicines is contraindicated:

• Other medicines belonging to the same class as Ritmodan (antiarrhythmics), such as:
  • phenytoin;
  • beta-blockers;
  • amiodarone;
  • bretylium;
  • d-sotalol;
  • ibutilide;
  • verapamil;
  • diltiazem;
  • lidoflazine;
  • bepridil.

Your doctor will avoid combining Ritmodan with antiarrhythmic medicines except in special circumstances.

• Medicines that may cause heart rhythm abnormalities known as "torsades de pointes", such as:
  • medicines used to treat depression (tricyclic and tetracyclic antidepressants);
  • erythromycin (an antibiotic), when administered intravenously (IV);
  • vincamine (used to improve cerebral blood flow);
  • sultopride (used to treat mental disorders).

The combination of Ritmodan with the following medicines is not recommended:

• Other medicines that may cause heart rhythm abnormalities known as "torsades de pointes", such as:
  • astemizole and terfenadine (used for allergies);
  • cisapride (used for stomach and intestinal problems);
  • pentamidine and sparfloxacin (antibiotics);
  • pimozide (used to treat mental disorders).
• Medicines known as "phosphodiesterase type 5 inhibitors" (used for erectile dysfunction, such as sildenafil, tadalafil, or vardenafil), which may cause a heart condition called "QT interval prolongation", since concomitant administration with disopyramide may increase this QT prolongation.
• Stimulant laxatives (which increase intestinal motility, such as bisacodyl and senna). Use other types of laxatives instead.

The combination of Ritmodan with the following medicines should be avoided, as the effects may be unpredictable:

• Medicines known as "liver enzyme CYP3A inhibitors" (e.g. certain macrolide antibiotics or azole antifungal antibiotics, quinupristin/dalfopristin), because they may increase disopyramide blood levels.
• Medicines known as "CYP3A inducers" (e.g. rifampicin, certain anticonvulsants such as phenobarbital, primidone, or phenytoin), because they may reduce disopyramide blood levels.

Combining Ritmodan with the following medicines, which may cause low potassium levels in the blood (hypokalaemia) (See "Warnings and precautions"), requires caution:
diuretics (used to reduce blood pressure, such as furosemide);
amphotericin B (an antibiotic);
tetracosactide (a medicine with cortisone-like activity, used in certain inflammatory diseases and laboratory tests);
gluco/mineralocorticoids (e.g. hydrocortisone, betamethasone, or prednisolone, used for allergies and inflammation).

Other conditions to consider:

• Atropine, used as eye drops and in cough and cold medicines, and other medicines known as "anticholinergics" (including phenothiazines): may increase the anticholinergic-like side effects of disopyramide (see sections "Warnings and precautions" and "Possible side effects").
• Roxithromycin (an antibiotic): may increase disopyramide blood levels.
• Theophylline, medicines known as "HIV protease inhibitors" (e.g. ritonavir, indinavir, saquinavir), cyclosporin A (used after organ transplants), warfarin (a blood-thinning medicine): combination with disopyramide may increase blood levels of these medicines.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
If you are pregnant, this medicine should only be used after consulting your doctor, as it may cause uterine contractions during pregnancy and could harm the unborn child.

Breastfeeding
This medicine must not be taken during breastfeeding. Therefore, you must either stop breastfeeding or discontinue disopyramide therapy to avoid risks to the newborn.

Driving and using machines
Some side effects of this medicine may impair your reaction time and concentration, and therefore your ability to drive or operate machinery. (See "Possible side effects").

Ritmodan contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Ritmodan

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is:

• Initial therapy: 4 to 6 capsules per day, divided into 3–4 doses. In certain cases, your doctor may decide to prescribe up to 8 capsules per day.
• Maintenance therapy: your doctor will determine the lowest effective dose by gradually reducing the initial dose. The dose should not be less than 1 capsule every 8 hours; preferably 1 capsule every 6 hours, i.e. 3–4 capsules in 24 hours.

If you have kidney problems
If you have kidney problems (renal insufficiency), your doctor will reduce your disopyramide dose and
adjust the interval between doses.
If you have liver problems
If you have liver problems (hepatic insufficiency), your doctor will reduce your disopyramide dose.
If you take more Ritmodan than you should
If you accidentally ingest or take an excessive dose of Ritmodan, inform your doctor immediately or go to the nearest hospital.
After taking too high a dose of Ritmodan, the following may occur:

• intestinal obstruction due to paralysis of intestinal muscles, dilated pupils (bilateral mydriasis), and coma in cases of very high doses;
• loss of consciousness (syncope), low blood pressure (hypotension), or shock;
• cardiac arrest (intraventricular block or asystole);
• breathing difficulties.

Excessively high blood levels of disopyramide may cause changes in the
electrocardiogram.
If you forget to take Ritmodan
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use Ritmodan, consult your doctor or pharmacist.

4. Possible side effects

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

The following effects on the heart may occur (see section “Do not take Ritmodan”):

• changes in heart rhythm (ventricular arrhythmias), such as increased heart rate (ventricular tachycardia), ventricular fibrillation and torsades de pointes, or worsening of such abnormalities. This effect is more likely if you also have low potassium levels in the blood (hypokalaemia), if you are taking Ritmodan together with other antiarrhythmic medicines, if you have severe heart disease (established heart disease), or if you have a condition known as “prolongation of the QT interval”;
• other types of heart rhythm or electrocardiogram abnormalities (such as: bradycardia, sinus arrest, QT interval prolongation, widening of the QRS complex, atrioventricular and bundle branch block);
• severe heart problems (heart failure), collapse or severe depression of heart function (cardiogenic shock), particularly if you have been diagnosed with severe heart disease (established heart disease). In these cases, the resulting reduction in heart function (low cardiac output) may lead to low blood pressure (hypotension),

kidney problems (renal failure) and/or lack of oxygen supply to the liver (acute hepatic ischemia), which may resemble a severe liver disease (acute hepatocellular hepatitis).

Other side effects
(See “Warnings and precautions”):

• difficulty in urinating (dysuria), urine retention in the bladder (acute urinary retention), particularly if you suffer from prostate problems (prostatism);
• visual disturbances (accommodation disorders), double vision (diplopia);
• dry mouth sensation (xerostomia);
• constipation;
• sexual impotence;
• memory, attention, perception, reasoning impairment (cognitive disorders);
• mental disorders (psychiatric disorders);
• abdominal pain and pain in the upper stomach (epigastralgia);
• nausea;
• vomiting;
• loss of appetite (anorexia);
• diarrhoea;
• skin rash (very rare);
• isolated cases of allergic-type reactions (e.g. urticaria, angioedema) which may lead to shock (these effects usually occur with the injectable formulation);
• rarely, a decrease in blood sugar concentration (hypoglycaemia), sometimes severe (see “Warnings and precautions”);
• very rarely: yellowing of the skin and eyes due to obstruction of bile flow (cholestatic jaundice), headache (cephalalgia), dizziness, decrease in the number of certain blood cells (neutropenia),
• severe reduction in white blood cells called "granulocytes" (agranulocytosis).

Following the instructions contained in this leaflet reduces the risk of side effects.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ritmodan

Do not store above 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Exp.”.
The expiry date refers to the last day of that month.
The stated expiry date applies to the product while unopened and stored correctly.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ritmodan contains:

• The active substance is: disopyramide. Each hard capsule contains 100 mg of disopyramide.
• The other components are: lactose, maize starch, talc, magnesium stearate. Capsule composition: gelatin, iron oxide (E172), titanium dioxide (E171), erythrosine (E127).

Description of the appearance of Ritmodan and package contents
Ritmodan is available as 100 mg hard capsules, packaged in a box containing 40 capsules.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24,
17489 Greifswald,
Germany
Manufacturer
Opella Healthcare International SAS
56, Route de Choisy
60200 Compiègne - France