Ritmodan Retard

Package leaflet: Information for the patient

Ritmodan Retard 250 mg prolonged-release tablets

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, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ritmodan Retard is and what it is used for

Ritmodan Retard contains disopyramide, which belongs to a class of medicines called
"Class IA Antiarrhythmics".
It works by regulating the heartbeat.
Ritmodan Retard is indicated:
to prevent:

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

to treat:

• abnormalities of the heartbeat (atrial or ventricular extrasystoles).

2. What you need to know before taking Ritmodan Retard

Do not take Ritmodan Retard

• 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 alter heart rhythm, known as second- or third-degree unregulated atrioventricular block, bundle branch block associated with first-degree atrioventricular block, left posterior or anterior hemiblock, right bundle branch block, QT interval prolongation, or sinoatrial node disease;
• if your heart is unable to pump a sufficient amount of blood to the body (heart failure not secondary to cardiac arrhythmias) (see "Warnings and precautions");
• if you are also taking other medicines to regulate heart rhythm (antiarrhythmics) or medicines that may cause heart rhythm abnormalities (ventricular arrhythmias and especially torsades de pointes) (see "Other medicines and Ritmodan Retard");
• if it is for a child;
• if you have kidney or liver problems (renal or hepatic insufficiency).

Warnings and precautions
It is important to read this entire section carefully if you are to take this medicine.
Your doctor will carry out medical examinations and electrocardiogram (ECG) checks if:

• you have severe heart disease (established cardiac pathology), because you may be more sensitive to the reduced force of heart contraction (negative inotropic effect) caused by disopyramide;
• you experience worsening of an existing heart rhythm disorder (pre-existing arrhythmia), or if a new type of rhythm disturbance appears;
• you have a heart condition called atrioventricular block or bifascicular block;
• you have electrocardiogram abnormalities (prolongation of the QT interval and QRS segment).

Electrolyte imbalance: Potassium levels
Your doctor will monitor the level of potassium in your blood (serum potassium) 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
potassium levels in the blood (hypokalaemia).

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

• increased eye pressure (ocular hypertension) if you suffer from a type of eye disease called "narrow-angle glaucoma";
• urinary retention (acute retention of urine) if you suffer from a prostate condition (prostatic hypertrophy);
• intestinal obstruction due to paralysis of intestinal muscles, especially if you are elderly, and when Ritmodan Retard is taken with other medicines that may cause constipation or in situations where disopyramide blood levels increase (e.g., due to kidney or liver problems or if you have taken an excessive dose of Ritmodan Retard);
• worsening of your condition if you suffer from a serious disease causing muscle weakness (severe myasthenia gravis);
• disturbances in memory, attention, perception, and reasoning (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 because there is a risk of hypoglycaemia, 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 problems (such as severe arrhythmias, heart failure with decompensation, or established heart disease), your doctor will carefully evaluate the prescription of Ritmodan Retard.
Before taking Ritmodan Retard, inform your doctor if:

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

Children
Ritmodan Retard is contraindicated in children.

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

The combination of Ritmodan Retard with the following medicines is contraindicated:

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

Your doctor will avoid combining Ritmodan Retard with antiarrhythmic medicines except in special circumstances (e.g., beta-blockers for angina pectoris; digoxin with beta-blockers and verapamil for control of atrial fibrillation).

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

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

• Other medicines that may cause heart rhythm abnormalities known as "torsades de pointes":
  • astemizole and terfenadine (used for allergies);
  • cisapride (used for stomach and intestinal problems);
  • pentamidine and sparfloxacin (antibiotics);
  • pimozide (used to treat mental disorders).
• Stimulant laxatives (which act by increasing intestinal motility, such as bisacodyl and senna). Use other types of laxatives instead.
• 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 of disopyramide with these medicines may increase QT prolongation.

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

• Medicines known as "liver enzyme CYP3A inhibitors" (e.g., certain macrolide antibiotics or antifungal azole 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 Retard 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);
• glucocorticoids/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 "Possible side effects").
• Roxithromycin (an antibiotic): may cause an increase in disopyramide blood levels.
• Theophylline, medicines known as "H.I.V. protease inhibitors" (e.g., ritonavir, indinavir, saquinavir), cyclosporin A (used after organ transplants), warfarin (a medicine used to thin the blood): combination with disopyramide may lead to increased blood levels of these medicines.

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

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

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 ability and concentration, and therefore your ability to drive or operate machinery (see "Possible side effects").

Ritmodan Retard contains sucrose and glucose
If your doctor has diagnosed an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Ritmodan Retard

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:

• 1 or 2 tablets daily, taken in two doses, or
• 3 tablets daily, always taken in two doses.

The score line on the tablet is intended to facilitate breaking the tablet, making it easier to adjust to the exact amount you need to take each day.

Your doctor will determine the correct dose and method of administration.
If you require a dose higher than 3 tablets per day, your doctor will carry out careful monitoring.
If you have liver (hepatic insufficiency) or kidney problems (renal insufficiency):
Before taking Ritmodan Retard, you must consult your doctor.
Use in children:
Ritmodan Retard is contraindicated in children.
If you take more Ritmodan Retard than you should
In case of accidental ingestion or overdose of Ritmodan Retard, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use Ritmodan Retard, consult your doctor or pharmacist.
After taking an excessively high dose of Ritmodan Retard, the following may occur:

• intestinal blockage due to paralysis of intestinal muscles, dilated pupils (bilateral mydriasis), and coma in cases of very high doses;
• loss of consciousness (syncope), decreased 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 Retard
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of Ritmodan Retard, consult your doctor or pharmacist.

4. Possible side effects

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

The following effects on the heart may occur (see "Do not take Ritmodan Retard"):

• disturbances in heart rhythm (ventricular arrhythmias), such as increased heart rate (ventricular tachycardia), ventricular fibrillation and torsades de pointes, or worsening of such disturbances. This effect is more likely if you also have low potassium levels in the blood (hypokalaemia), if you are taking Ritmodan Retard together with other antiarrhythmic medicines, if you have severe heart disease (established heart disease), or if you have an abnormality known as "prolongation of the QT interval",
• other types of disturbances in heart rhythm or electrocardiogram (such as: bradycardia, sinus block, QT interval prolongation, QRS complex widening, atrioventricular and bundle branch block);
• serious 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 ischaemia), which may resemble a severe liver disease (acute hepatocellular hepatitis).

Other side effects
(See also "Warnings and precautions"):

• difficulty in urination (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,
• cognitive disturbances,
• mental disorders (psychiatric disorders),
• abdominal and upper stomach pain (epigastralgia),
• nausea,
• vomiting,
• loss of appetite (anorexia),
• diarrhoea,
• skin rash (very rarely),
• 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"), yellowing of the skin and eyes due to obstruction of bile flow (cholestatic jaundice); headache (cephalalgia), dizziness, reduction 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ritmodan Retard

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ritmodan Retard contains:

• The active substance is: disopyramide phosphate. Each prolonged-release tablet contains 322.5 mg of disopyramide phosphate, equivalent to 250 mg of disopyramide base.
• The other components are: glyceryl monostearate, povidone, sucrose, magnesium stearate, anhydrous glucose, hypromellose, propylene glycol.

Description of the appearance of Ritmodan Retard and package contents
Ritmodan Retard is available as prolonged-release tablets, pack size: 20 tablets in a box.
Marketing Authorization Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald, Germany
Manufacturer
Opella Healthcare International SAS
56, Route de Choisy
60200 Compiègne - France