150 mg and 300 mg film-coated tablets
propafenone hydrochloride
What Rytmonorm is and what it is used for
Rhythm monorm is an irritability reducer used to prevent and normalize severe and difficult-to-treat disorders of the heart rhythm ( antiarrhythmics ).
What you need to know before taking Rytmonorm
Do not take Rytmonorm
- if you are allergic to propafenone or any of the other ingredients of this medicine (listed in section 6)
- if you have a certain type of heart disease (eg Brugada syndrome, sinus node dysfunction, conduction disorders, heart failure )
- if you have very low blood pressure
- if you have had a heart attack in the last 3 months.
- if you have a circulatory failure (not caused by heart rhythm disorders)
- if you have the severe obstructive pulmonary disease (eg severe asthma )
- if you have myasthenia gravis (muscle weakness).
- if you have electrolyte disturbance e.g. disturbed potassium metabolism.
- if you are taking medicines containing ritonavir (medicines for HIV ).
Warnings and Precautions:
You should consult your doctor before starting treatment:
- if you are using a pacemaker.
- if you have impaired heart, liver, or kidney function.
- if you have low blood pressure.
- if you have a disturbance in the salt balance.
- if you have problems with narrow airways e.g. asthma.
- If you experience dizziness or fainting spells, always consult a doctor.
- if you get an infection with symptoms such as fever with severe general deterioration or fever with local symptoms of infection such as sore throat/throat/mouth or urination problems, you should see a doctor as soon as possible so that a blood test can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then have information about your medication.
Rhythm monomers can make heart rhythm disorders worse or worse.
Other medicines and Rytmonorm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
- Rytmonorm should not be used concomitantly with ritonavir ( HIV medicine ).
The effect of Rytmonorm may be affected by or affect other medicines. Tell your doctor if you are using:
- medicines for heart problems or high blood pressure (eg quinidine, mexiletine, propranolol, metoprolol , digoxin, amiodarone )
- drugs that inhibit blood coagulation (eg warfarin )
- medicines for fungal infections (eg ketoconazole )
- antiepileptic drugs (eg phenobarbital)
- medicines for stomach acid problems (eg cimetidine)
- drugs for bacterial infections (eg erythromycin, rifampicin)
- medicines for asthma (eg theophylline)
- drugs that block the immune system (eg cyclosporine)
- antidepressants (eg non-selective monoamine reuptake inhibitors, selective serotonin reuptake inhibitors such as fluoxetine, and paroxetine )
- anesthetics (eg lidocaine ).
Rhythm monorm with food and drink
You should not drink grapefruit juice when you are being treated with Rytmonorm as it may enhance the effect of the medicine.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
There is a risk that the fetus is affected. Therefore, always consult a doctor before using Rytmonorm during pregnancy.
Rytmonorm passes into breast milk.
Consult a physician before using Rytmonorm during breastfeeding.
Driving and using machines
You are responsible for assessing whether you are fit to drive a motor vehicle or perform risky work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Rhythm monorm can in some people impair the ability to react, e.g. due to side effects such as blurred vision, dizziness, weakness, and low blood pressure when getting up. This should be borne in mind at times when sharper attention is required, e.g. while driving.
Rhythm monorm contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
How to take Rytmonorm
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. The usual dose is 150 mg 3 times daily, to begin with. Dose one is then increased depending on the severity of the arrhythmias.
As the active substance has a bitter taste and has a superficial anesthetic effect, the tablets should be swallowed whole with liquid after a meal.
If you take more Rytmonorm than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
The symptoms of overdose of the drug depend on the size of the overdose. Common symptoms are heart attack, headache, dizziness, visual disturbances, abnormal sensations, tremors, nausea, and dry mouth. Severe overdose may also cause convulsions, drowsiness, unconsciousness, drop in blood pressure, and transient respiratory arrest. Deaths have occurred after overdosing with Rytmonorm.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are most common in the initial stages of treatment.
Very common (affects more than 1 in 10 people): dizziness, disorders of the heart’s conduction system, palpitations.
Common (affects more than 1 in 100 people): anxiety, sleep disturbances, headache, taste changes, blurred vision, fast or slow heartbeat, atrial flutter, shortness of breath, abdominal pain, nausea, vomiting, diarrhea, constipation, dry mouth, abnormal liver function, chest pain, fatigue, weakness, fever.
Uncommon (affects less than 1 in 100 people): decreased platelet count, decreased appetite, nightmares, fainting, coordination disorder, tingling or numbness in the skin, irregular heartbeat, low blood pressure, tense and bloated stomach, hives, itching rash, reddening of the skin, erection problem.
No known frequency (can not be calculated from the available data): changes in blood count (eg decreased white blood cell count, see also section 2: Take special care with Rytmonorm). Hypersensitivity, confusion, convulsions, extrapyramidal symptoms such as muscle stiffness and involuntary movements, restlessness, ventricular fibrillation, heart failure, decreased heart rate, low blood pressure when getting up, nausea, and imbalance in the gastrointestinal tract. Liver side effects include liver damage, biliary obstruction, jaundice, and hepatitis. Lupus-like symptoms (including rash, fever, joint pain, and fatigue). Blister-filled blisters. Decrease in sperm count.
Drug treatment must not be stopped abruptly due to possible side effects without consulting a treating physician.
How to store Rytmonorm
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the packaging and other information
Content declaration
The active substance is: Propafenone hydrochloride 150 mg and 300 mg per tablet respectively
The other ingredients are Microcrystalline cellulose, carmellose sodium, pregelatinized starch, magnesium stearate, hypromellose, macrogol, and titanium dioxide (E 171).
What the medicine looks like and the contents of the pack
White to off-white film-coated tablets, biconvex marked “150” on one side.
White to off-white film-coated tablets, biconvex marked “300” on one side.
Blister with 100 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
BGP Products AB
Box 23033
104 35 Stockholm
Manufacturer:
Mylan Hungary Kft.,
Mylan utca 1,
Komárom 2900,
Hungary