RYTMOCARD 150 mg. 50 tablets

Contents of one tablet Rytmocard: Active substance: Propaphenone hydrochloride 150 mg; 300 mg
Excipients: microcrystalline cellulose, copovidone, Primoz type A, sodium glycolate starch, wheat starch, magnesium stearate, Opadry paint.

PHARMACEUTICAL FORM AND Pharmaco-therapeutic group
Ritmokard in the form of film coated tablets is a product for the treatment and prevention of cardiac arrhythmias.

INDICATIONS

In what cases can be applied Rytmocard?
Symptomatic and requiring treatment tachycardia (occurring with increased heart rate), supraventricular cardiac arrhythmias (rhythm disturbance), such as AV- nodal (atrial-ventricular), tachycardia, supraventricular tachycardia in WPW - syndrome (additional wire connection between the atrium and camera) or paroxysmal (Appearing attacks) atrial fibrillation. Tezhkostepenni symptomatic ventricular tachycardia heart rhythm disorders, if prescribed by the physician are life-threatening

CONTRAINDICATIONS
In which cases should not apply the product?

The product is absolutely contraindicated in hypersensitivity to the drug and / or any of the excipients, overt cardiac failure, cardiogenic shock (unless it is caused by rhythm disorder), severe symptomatic bradycardia (slow heart rate) in the first three months after a heart attack infarction (except in patients with life-threatening ventricular rhythm disorders) or in restricted cardiac function, as sino-atrial arrhythmias (atrial) block, AV-block grade 2-3 (delayed conduction from the atria to the cameras), bundle branch block syndrome patient sinus clinically significant disturbances in electrolyte balance, severe obstructive lung disease, hypotension (low blood pressure), myasthenia gravis (muscle weakness).
It is desirable to avoid the use during the first trimester of pregnancy and during lactation.

PRECAUTIONS FOR USE

When Rytmocard should be used with caution?
Rytmocard should be used with caution in patients with impaired hepatic and renal function, patients on hemodialysis.
The safety and efficacy of Ritmokard pediatric practice is not established.

SPECIAL WARNING

During treatment with Ritmokard may appear abnormal heart rhythm.
If you are pregnant or suspected pregnancy, tell your doctor and he will consider taking this medicine. Ritmokard should be used during pregnancy only if the benefit outweighs the potential risk to the fetus.
There are no data on whether Ritmokard passes into breast milk.
The product should be avoided when operating a motor vehicle or operate machinery.
The product contains the excipient wheat starch, koetomozhe be dangerous for people with tsyoalikiya.

DRUG INTERACTIONS
What other drugs affect the action of Rytmocard?
Ritmokard of action is influenced by the following medicines:
1 Local anesthetics (local anesthetic): concomitant use of Ritmokard and local anesthetics can increase the risk of adverse effects on the central nervous system.
2.Hinidin (antiarrhythmics): small doses
quinidine decreased metabolism Ritmokard.
3. Digitalis - Digoxin (to treat heart failure): Ritmokard leading to increased serum levels of Digoxin without prejudice to the release of Digoxin in the kidneys.
4.Beta-blockers (used to treat high blood pressure): co-administration of Ritmokard propranolol results in a significant increase in the effect of propranolol.
5.Varfarin (anticlotting medicine) when co-administered Rytmocard and Warfarin effect of warfarin increases. Prothrombin time is also increased.
b.Simetidin (for the treatment of peptic ulcer disease): co-administration of Ritmokard and Cimetidine would increase the effects of Ritmokard without significant changes in electrocardiographic parameters.
7.Dezipramin (used for depression), concurrent administration of Ritmokard and Desipramine may lead to an increase in the action of desipramine.
8Diklosporin (suppresses the immune system): treatment with Rytmocard could increase the effects of cyclosporin.
9 .Teofilin (for asthma) may increase concentrations of theophylline with concomitant treatment with both products and lead to the development of adverse reactions to the medicines theophylline.
Yu.Rifampitsin (to treat tuberculosis) can reduce the effectiveness of antiarrhythmic Ritmokard.


METHOD AND DOSAGE


Ritmskard apply for oral therapy in the following dosages:
1. Low: 300 - 450 mg / day (2 x 150, 3 x 150 mg)
2. moderate: 600 mg / day (2 x 300 mg)
3. High: 900 mg / day (3 x 300 mg)
In patients with low weight or elderly Ritmokard may be administered as a loading dose of 450 mg followed after 8 hours from 300 mg 2 times daily or 150 mg 3 times daily.
Unless otherwise prescribed, as the initial and maintenance treatment recommended daily dose of 450-600 mg, taken 2-3 times daily. Ponyakota may be necessary to increase the daily dosage of 900 mg, divided into three doses.

SIDE EFFECTS

What side effects may occur in the application of Ritmokard?


Side effects can occur from:
- Cardiovascular systematic lowering of blood pressure, increased heart rhythm disorders (eg. A slow heart rate, increase in heart rate, atrial, atrioventricular or vatrekameren block), worsening of heart failure.
- Nervous system- fatigue, headache, mental disorders such as anxiety, confusion, anxiety, nightmares and sleep disturbances, tingling, visual disturbances and dizziness, while predozirane- to seizure disorders
- Pulmonary systematic bronchospasm (narrowing of airways) in patients with bronchial sensitivity.
- Digestive system - loss of appetite, nausea, dry mouth, bitter taste, tendency to vomiting, feeling of fullness, constipation, abnormal liver function in individual cases may be stagnant bile.
- Blood - hematopoietic system disorders (decrease in white blood cell or platelet, a complete lack of white blood cells), which are reversible after discontinuation.
- Skin reactions - allergic reactions (redness, itching, rash, urticaria).
- In individual cases connective tissue disorders. Reproductive system - in high doses can be observed decrease in libido and sperm count. All these events resolved with discontinuation of Ritmokard.
When treatment with Ritmokard is vital, it should not be interrupted without medical advice because of the occurrence of certain side effects.
For all adverse reactions, including listed in the leaflet, the patient should immediately communicate their attending lkar.

SPECIAL INSTRUCTIONS FOR OVERDOSE

What to take if Ritmokard administered in very high doses (intentional overdose or wrong)?

In overdose Ritmokard possible hypotension (low blood pressure), heart rhythm disorders (slow heart rate, and vatrepredsardni vatrekamerni conduction disorders and in rare cases ventricular arrhythmia), somnolence.


Storage Instructions
In the original packaging in a dry and dark place at a temperature below 25 ° C.
Keep out of reach of children!
EXPIRY DATE
Three years from date of manufacture.
Do not use after the expiry date!
DATA PACKAGE

The product is packed in 10 / ten / tablets in a blister of solid PVH- foil and aluminum foil. Three blister (300 mg) or five blister (150 mg) was placed in a punched cardboard box together with a leaflet to the patient.