Leaflet: information for the user

Rytmonorm 150 mg coated tablets

Hydrochloride of propafenone

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

6. Contents of the pack and additional information

Rytmonorm is a medication used for various heart rhythm disorders. It belongs to a group of medications called class 1C antiarrhythmics according to Vaughan Williams.

Rytmonorm is used for the treatment and prevention of paroxysmal supraventricular tachycardia, including atrial fibrillation and paroxysmal atrial flutter and paroxysmal tachycardia due to re-entry phenomena affecting the atrioventricular node or accessory pathways (Wolff-Parkinson-White syndrome). For the treatment and prevention of ventricular arrhythmias, including symptomatic ventricular extrasystoles and/or sustained and nonsustained ventricular tachycardia.

Do not take Rytmonorm

• If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).

• If you have a history of Brugada syndrome (a hereditary condition characterized by an abnormality in the electrocardiogram (ECG) and an increased risk of sudden death) (seeWarnings and precautions).
• If you have had a myocardial infarction in the 3 months prior to starting treatment.

• If you have a significant heart disease such as:
• • congestive heart failure
  • cardiogenic shock, unless the cause is a arrhythmia
  • severe bradycardia
  • if you have sinus node dysfunction, atrial conduction defects, second-degree or higher atrioventricular block, or branch or distal block and do not have an artificial pacemaker
  • if you have a severe drop in blood pressure
• If you have an alteration in the balance of salts in the blood (e.g. alterations in potassium metabolism).
• If you have severe chronic obstructive pulmonary disease.
• If you have myasthenia gravis.
• If you are taking ritonavir (an antiretroviral used in the treatment of HIV infection, seeTaking Rytmonorm with other medications).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rytmonorm:

• It is essential that each patient receiving propafenone be clinically evaluated and with an electrocardiogram before and during treatment with Rytmonorm to determine if the response to propafenone justifies continued treatment.
• After treatment with this medication, your doctor should rule out Brugada syndrome that may have been present without previous symptoms.
• If you have a pacemaker, as the treatment may affect it, so it needs to be controlled and, if necessary, reprogrammed.
• If you have atrial fibrillation because Rytmonorm may lead to the appearance of a more serious arrhythmia; see inPossible adverse effects).
• If you have severe heart disease because you may be predisposed to suffer severe adverse reactions and in that case, treatment with this medication will be contraindicated.
• If you have asthma or other chronic obstructive respiratory disease.

Children

Only interaction studies have been conducted in adults, so it is unknown if they are similar in children.

Older patients

Rytmonorm should be used with utmost caution in older patients.

Taking Rytmonorm with other medications

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

More adverse effects may appear with Rytmonorm if administered with local anesthetics (e.g. for the implantation of a pacemaker, surgical or dental interventions), as well as with other drugs that have an inhibitory effect on the heart such as beta-blockers (for hypertension) or some antidepressants.

Inform your doctor if you are taking any of the following medications because they may increase your blood levels:

• venlafaxine (for depression)
• propranolol (for hypertension and angina pectoris)
• metoprolol (for hypertension)
• desipramine (for depression)

• ciclosporin (to decrease the body's defenses)

• theophylline (for asthma)
• digoxin (for heart problems)

If signs of overdose are observed, reduce the doses of these medications, as indicated by your doctor.

Inform your doctor if you are taking any of the following medications because they may increase your hydrochloride propafenone levels in the blood, so you may need to be monitored and have your dose adjusted:

• ketoconazole (against fungi)
• cimetidine (for stomach ulcers)
• quinidine (for heart arrhythmia or against malaria)
• erythromycin (antibiotic)
• fluoxetine (for depression)
• paroxetine (for depression)

Also, an increase in hydrochloride propafenone levels occurs with orange juice.

The concomitant use of Rytmonorm and amiodarone may produce alterations in the heart. It may be necessary to adjust the dose of the two medications.

The concomitant use of propafenone and lidocaine increases the risk of lidocaine's central nervous system effects.

Inform your doctor if you are taking any of the following medications because it may reduce the effectiveness of Rytmonorm:

• rifampicin (antibiotic)
• phenobarbital (sedative and antiepileptic)
• phenytoin (antiepileptic)
• carbamazepine

In the case of chronic treatment with these medications and Rytmonorm, the response to Rytmonorm treatment should be monitored.

Inform your doctor if you are receiving medications to prevent blood coagulation (e.g. acenocoumarol or warfarin) because Rytmonorm may increase the effectiveness of those medications, increasing the risk of bleeding. You may need to reduce the dose of the anticoagulant.

Taking Rytmonorm with food and drinks

Due to its bitter taste and the superficial anesthetic effect of hydrochloride propafenone, Rytmonorm tablets should be taken without chewing or sucking accompanied by some liquid.

Pregnancy, lactation, and fertility

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

No adequate and well-controlled studies have been conducted in pregnant women. Rytmonorm should not be used during pregnancy unless the expected benefit justifies the potential risk to the fetus. Hydrochloride propafenone crosses the placental barrier.

No studies have been conducted on the excretion of hydrochloride propafenone in breast milk. Limited data suggest that hydrochloride propafenone may pass into breast milk, so it should be used with caution in breastfeeding women.

Driving and operating machinery

During treatment, blurred vision, dizziness, fatigue, or a drop in blood pressure may appear, so if you notice these symptoms, you should not drive cars or operate hazardous machinery.

Rytmonorm contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per coated tablet; that is, it is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Rytmonorm is administered orally.

Adults

Your doctor will determine the individual maintenance dose through heart control, that is, with several electrocardiographic and blood pressure controls (adjustment phase). For the adjustment phase and maintenance therapy, a total daily dose of 450 mg to 600 mg divided into two or three daily doses (1 Rytmonorm tablet 150 mg 3 times a day or 1 Rytmonorm tablet 300 mg 2 times a day) is recommended in patients weighing around70 kg.

It may sometimes be necessary to increase the daily dose to 900 mg (2 Rytmonorm tablets 150 mg 3 times a day).

In patients weighing less than70 kg, the daily dose should be reduced appropriately, starting with 150 mg 2 times a day. Dose increases should not be made until the patient has received treatment for 3-4 days.

If you are an elderly patient or have heart damage, Rytmonorm 150 mg, like other antiarrhythmics, will be administered in the adjustment phase with great care, starting with a dose of 150 mg once a day and gradually increasing doses. The maintenance dose for each person should be calculated with heart function controls and repeatedly measuring blood pressure (adjustment phase). Any dose increase that is needed should not be made until after 5 to 8 days of treatment.

The same applies to maintenance therapy. Any dose increase that is needed should not be made until after 5 to 8 days of treatment.

Liver and/or kidney insufficiency

If you have liver or kidney disease, your doctor will start treatment with a dose of 150 mg once a day and adjust the dose according to your response to treatment.

Use in children and adolescents

In children, the average daily dose is10 to 20 mg of hydrochloride of propafenone per kilogram of body weight, divided into3 to 4 daily doses in the initial dose adjustment phase and in maintenance therapy.

Dose increases should not be made until the patient has received treatment for 3-4 days.

The maintenance dose should be calculated for each person with heart function controls and repeatedly measuring blood pressure (adjustment phase).

Your doctor will indicate the duration of your treatment. Do not stop treatment before, as although you may already be feeling better, your disease could worsen or recur.

Remember to take your medication. Take the tablets at the same time every day.

If you estimate that the action of Rytmonorm is too strong or weak, inform your doctor or pharmacist.

If you take more Rytmonorm than you should

If you take more doses than prescribed, contact your doctor immediately so that you can receive medical attention quickly. Severe symptoms may occur.If you have taken more Rytmonorm than you should, you may notice effects on the heart and low blood pressure, which in severe cases can cause cardiovascular shock. Often, headache, dizziness, blurred vision, numbness or tingling of the skin, tremors, nausea, constipation, and dry mouth occur.

In severe cases of poisoning, convulsions, numbness or tingling of the skin, drowsiness, coma, and respiratory arrest are observed. There have been cases of death.

If this occurs, the patient should be monitored in an intensive care unit.

If you have taken more Rytmonorm than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

If you forget to take Rytmonorm

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

In case of forgetting a dose, take the medication as soon as possible and continue treatment as prescribed. However, if the next dose is near, it is better not to take the missed dose and wait for the next one.

If you interrupt treatment withRytmonorm

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

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

Side effects are classified as very common (can affect more than 1 in 10 people), common (can affect up to 1 in 10 people), uncommon (can affect up to 1 in 100 people), and unknown frequency (cannot be estimated from available data).

The very common side effects related to treatment with propafenone are dizziness, cardiac conduction disorders (heart alterations) and palpitations.

Within each group, side effects are presented in order of decreasing severity, from most severe to least severe, when the severity that it represented for the patient could be determined.

The following side effects have been reported:

Blood and lymphatic system disorders:

• Uncommon: decreased platelets (blood cells involved in coagulation).
• Unknown frequency: decreased white blood cells (blood cells that act to defend the body against infections or foreign substances, may manifest as frequent infections with fever, chills or sore throat), decreased granulocytes (a type of white blood cell that may predispose to infections), severe reduction of granulocytes or neutrophils (agranulocytosis, a disease in which the person is more prone to infections).

Immune system disorders:

• Unknown frequency: hypersensitivity1.

1May manifest as cholestasis (bile flow obstruction to the duodenum), blood alterations and skin rash.

Metabolism and nutrition disorders:

• Uncommon: decreased appetite.

Mental and behavioral disorders:

• Common: anxiety, sleep disorders.
• Uncommon: nightmares.
• Unknown frequency: confusion.

Nervous system disorders:

• Very common: dizziness2.
• Common: headache, altered taste perception.
• Uncommon: brief loss of consciousness (syncope), abnormal coordination, sensation of tingling, numbness or aching in any part of the body but more frequently in feet, hands, arms or legs (paresthesia).
• Unknown frequency: convulsions, extrapyramidal symptoms (involuntary movements), restlessness.

2Excluding vertigo.

Eye disorders:

• Common: blurred vision.

Ear and labyrinth disorders:

• Uncommon: vertigo

Cardiac disorders:

• Very common: cardiac conduction disorders3(heart alterations), palpitations
• Common: sinus bradycardia (slow heart rate), reduced heart rate (bradycardia), tachycardia (increased heart rate), atrial flutter (abnormal heart rhythm occurring in the atrium).
• Uncommon: ventricular tachycardia (increased heart rate originating in the ventricles and with more than 100 beats per minute), arrhythmia4(alteration of heart rate that may increase, decrease or become irregular).
• Unknown frequency: ventricular fibrillation, heart failure5, reduced heart rate.

3Including sinoatrial block, atrioventricular block and intraventricular block

4Propafenone may be associated with proarrhythmic effects that manifest as an increase in heart rate (tachycardia) or ventricular fibrillation. Some of these arrhythmias may put the patient's life at risk and may require resuscitation to prevent a potentially fatal outcome.

5A pre-existing heart failure may worsen

Vascular disorders:

• Uncommon: hypotension (decreased blood pressure).
• Unknown frequency: orthostatic hypotension (decreased blood pressure when standing for a long time and/or when standing up).

Respiratory, thoracic and mediastinal disorders:

• Common: dyspnea (shortness of breath).

Gastrointestinal disorders:

• Common: abdominal pain, vomiting, nausea, diarrhea, constipation, dry mouth.
• Uncommon: abdominal distension (abdominal swelling), flatulence (gas).
• Unknown frequency: hiccup, gastrointestinal discomfort.

Hepatobiliary disorders:

• Common: abnormal liver function
• Unknown frequency: liver damage, bile flow obstruction from the liver (cholestasis), hepatitis, jaundice (yellow skin and eyes)

Complementary examinations:

• Common: abnormal liver function tests detected in blood tests such as increased aspartate aminotransferase, increased alanine aminotransferase, increased gamma-glutamyl transferase and increased alkaline phosphatase.

Skin and subcutaneous tissue disorders:

• Uncommon: urticaria, itching, skin rash, erythema (redness of the skin).

Musculoskeletal and connective tissue disorders:

• Unknown frequency: lupus-like syndrome (autoimmune disease).

Reproductive and breast disorders:

• Uncommon: impotence (erectile dysfunction).
• Unknown frequency: decreased sperm count7

7The decrease in sperm count is reversible upon discontinuation of propafenone administration.

General disorders and administration site conditions:

• Common: chest pain, asthenia (sensation of fatigue), fatigue, fever.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://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.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Rytmonorm

The active ingredient is hydrochloride of propafenone. Each tablet contains 150 mg of hydrochloride of propafenone.

The other components (excipients) are: microcrystalline cellulose, sodium croscarmellose, magnesium stearate, cornstarch, hydroxypropylmethylcellulose, macrogol 400, macrogol 6000, titanium dioxide (E 171) and purified water.

Appearance of the product and contents of the package

Rytmonorm 150 mg coated tablets arewhite round tablets with “150” printed on one side.

Each package contains 60 coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Teva B.V.,

Swensweg 5,

2031GA Haarlem,

Netherlands

Responsible for manufacturing:

ITC Production s.r.l.

Via Pontina km 29

00071 Pomezia (RM)

Italy

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

Alcobendas 28108 Madrid

Spain

Date of the last review of thisleaflet: March 2019

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

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This information is intended solely for healthcare professionals:

Treatment of overdose

In addition to general emergency measures, it is necessary to monitorand correct the patient's vital parameters (as needed) in an intensive care unit.

Defibrillation, as well as the infusion of dopamine and isoprenaline, have been effective in controlling the rhythm and blood pressure. Seizures have been alleviated with intravenous diazepam. General supportive measures such as mechanical ventilation and external cardiac massage may be necessary.

Attempts at elimination by hemoperfusion are ineffective.

Hemodialysis has no effect due to the high binding of propafenone to proteins (> 95%) and the large volume of distribution.

Other presentations

Rytmonorm 300 mg coated tablets. Packages with 60 coated tablets.

Rytmonorm 3.5 mg/ml injectable solution. Packages with 5 ampoules of 20 ml.