Active ingredients: Fecainide
Flecainide Sandoz 100 mg tablets
Why is Flecainide used - Generic drug? What is it for?
FLECAINIDE SANDOZ belongs to the group of medicines that fight cardiac arrhythmias (known as anti-arrhythmics). This medicine inhibits the conduction stimulus in the heart and prolongs the time the heart is at rest, resulting in the heart pumping normally again.
FLECAINIDE SANDOZ is prescribed
- for some severe cardiac arrhythmias, usually manifesting as severe heart palpitations or tachycardia;
- for severe cardiac arrhythmias that have not responded well to treatment with other medicines or when other treatments cannot be tolerated.
Contraindications When Flecainide should not be used - Generic drug
Do not take Flecainide Sandoz:
- if you are allergic to flecainide or any of the other ingredients of the medicine (listed in section 6 "Further information");
- if you have any other heart disease other than the heart disease for which you are taking this medicine. If you are unsure or would like more information, consult your doctor or pharmacist;
- if you are taking certain other antiarrhythmics (sodium channel blockers, such as disopyramide and quinidine).
Precautions for use What you need to know before taking Flecainide - Generic drug
Tell your doctor before taking Flecainide Sandoz
- if you suffer from impaired liver function and / or reduced kidney function, as the concentration of flecainide in the blood may increase. In this case, the doctor should regularly check the concentration of flecainide in the blood,
- if you have a permanent pacemaker or temporary electrodes,
- if you have suffered from cardiac arrhythmia after heart surgery,
- if you suffer from severe bradycardia or pronounced hypotension,
- if you have had a heart attack. These conditions must be corrected before taking Flecainide Sandoz.
Low or high levels of potassium in the blood can affect the effect of Flecainide Sandoz. Potassium levels must be corrected before taking Flecainide Sandoz.
Children under 12
Flecainide is not approved for use in children less than 12 years of age, but flecainide toxicity has been reported during treatment with flecainide in infants who have reduced their milk intake, and in infants who have switched from breastfeeding. with milk powder to that with dextrose.
Interactions Which drugs or foods can modify the effect of Flecainide - Generic drug
If you use other medicines together with Flecainide Sandoz, please note that the medicines can sometimes affect each other in the way they work and / or side effects (ie there may be interactions).
Interactions may occur when taking this medicine. For instance:
- sodium channel blockers (class I antiarrhythmics), such as disopyramide and quinidine: see section "Do not take Flecainide Sandoz",
- beta blockers such as propranolol (medicines that reduce the pumping function of the heart),
- amiodarone (for heart disease); the dose of Flecainide Sandoz may need to be reduced for some patients,
- calcium channel blockers, such as verapamil (lowers blood pressure),
- diuretics, laxatives (medicines that stimulate bowel movement) and hormones of the adrenal cortex (corticosteroids): your doctor may check the amount of potassium in your blood,
- mizolastine and terfenadine (medicines to treat allergies called "antihistamines"),
- ritonavir, lopinavir and indinavir (medicines to treat HIV infections),
- fluoxetine, paroxetine and some other antidepressants called "tricyclic antidepressants",
- phenytoin, phenobarbital and carbamazepine (medicines for epilepsy): these substances can accelerate the elimination of flecainide,
- clozapine, haloperidol and risperidone (medicines to treat psychotic disorders called "neuroleptics"), - quinine (medicine against malaria),
- terbinafine (medicine to treat fungal infections called "antifungals"),
- cimetidine (an antacid): may increase the effect of Flecainide Sandoz,
- bupropion (cigarette smoking cessation medicine),
- digoxin (medicine to stimulate the heart): Flecainide Sandoz can increase the levels of digoxin in the blood.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to non-prescription medicines, herbal medicines or natural products.
Flecainide Sandoz with dairy products
Dairy products (milk, infant formula and possibly yogurt) may reduce the absorption of flecainide in children and infants. Flecainide is not approved for use in children under the age of 12, but flecainide toxicity has been reported. during flecainide treatment in infants who have reduced their milk intake, and in infants who have switched from formula to dextrose.
Warnings It is important to know that:
Pregnancy and breastfeeding
Flecainide crosses the placenta and passes into breast milk in small quantities. If you are pregnant or breastfeeding, think you are pregnant, or are planning to have a baby, tell your doctor before taking this medicine. Do not take this medicine during pregnancy and breastfeeding unless your doctor has specifically advised you to.
Driving and using machines
If you suffer from side effects such as dizziness, double or blurred vision or if you feel light-headed, your ability to react may be reduced. This can be dangerous in situations that require concentration and attention, such as driving vehicles, handling dangerous machinery, or working overhead. If you are not sure if this medicine is adversely affecting your ability to drive, talk to your doctor.
Dose, Method and Time of Administration How to use Flecainide - Generic drug: Posology
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, you should consult your doctor or pharmacist. Your doctor will prescribe a personalized dose, adjusted to suit your ailments. Treatment with Flecainide Sandoz should normally start under the supervision of a doctor (in hospital if necessary).
When and how should the tablets be taken?
Take the tablets by swallowing them with sufficient liquid (e.g. water). The daily dose is usually taken split over the day, on an empty stomach or at least one hour before meals.
The general dose is only a guideline and is as follows: the usual starting dose is between 50 and 200 mg. This dose can be increased by your doctor up to a maximum of 400 mg per day.
Elderly patients
Your doctor may prescribe a lower dose for you. The dose for elderly patients should not exceed 300 mg per day (or 150 mg twice daily).
Patients with impaired liver or kidney function
Your doctor may prescribe a lower dose for you.
Patients with permanent pacemakers
The daily dose should not exceed 100 mg twice a day.
Patients treated concomitantly with cimetidine (medicine for stomach disorders) or amiodarone (medicine for heart arrhythmias)
Your doctor should check you regularly and a lower dose may be prescribed for some patients.
During treatment, the doctor must regularly determine the levels of flecainide in the blood and what is known as an electrocardiogram (ECG) should be done. A simple ECG should be done once a month and a more thorough ECG once every 3 months. An ECG should be taken every 2-4 days at the start of therapy or when the dose is increased.
An ECG should be done more frequently for patients taking a lower dose than is normally prescribed. Your doctor may make dose adjustments at intervals of 6 to 8 days. In these patients, an ECG should be performed in the second and third weeks after initiation of therapy.
Use in children
These tablets should not be taken by children under the age of 12.
If you forget to take Flecainide Sandoz
Take the dose as soon as you find out you have forgotten it, unless you only find out when it is time for your next dose. In the latter case, you should not take the additionally forgotten dose, but should continue to follow your schedule. It is very important that you take your tablets as prescribed. Consult your doctor if you have any questions. Do not take a double dose to make up for the forgotten tablet.
If you stop taking Flecainide Sandoz
If you suddenly stop taking Flecainide Sandoz you may not have withdrawal symptoms. However, your arrhythmia may not be controlled as needed. So do not stop taking it without telling your doctor. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Overdose What to do if you have taken an overdose of Flecainide - Generic Medication
If you suspect an overdose, tell your doctor immediately.
Side Effects What are the side effects of Flecainide - Generic drug
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects that can occur include the following:
Very common (in more than 1 in 10 people):
dizziness, visual disturbances, such as double vision and blurred vision.
Common (in more than 1 in 100 people):
appearance of a more severe type of arrhythmia or increase in the frequency or severity of a pre-existing arrhythmia, shortness of breath, weakness, tiredness (fatigue), fever and accumulation of fluid in the tissues (edema).
Uncommon (in more than 1 in 1,000 people):
decreased red blood cells, white blood cells or platelets, increased heart rate in patients with atrial flutter, nausea, vomiting, constipation, abdominal pain, decreased appetite, diarrhea, indigestion, wind, allergic skin reactions such as rash, loss hair.
Rare (in more than 1 in 10,000 people):
seeing, hearing or feeling things that are not there (hallucinations), depression, confusion, anxiety, amnesia, insomnia, tingling of the skin ("as if ants were walking on it"), coordination problems, decreased sensitivity, increased sweating , fainting, tremors, flushing, drowsiness, headache, nervous disorders such as arms and legs, convulsions, difficulty moving (tics), ringing in the ears, feeling dizzy (vertigo), inflammation of the lungs, increased liver enzymes with or without yellowing of the eyes and skin, and severe hives.
Very rare (in less than 1 in 10,000 people):
Increased levels of some antibodies which may indicate an autoimmune disease (with or without inflammation in the body), deposits in the cornea of the eye, increased sensitivity of the skin to sunlight.
Frequency not known (cannot be estimated from the available data):
some changes in the electrocardiogram (increase in PR and QRS intervals), increase in the pacing threshold in patients with pacemakers or temporary pacing electrodes, impaired conduction between the atria and ventricles of the heart (second or third degree atrioventricular block), heartbeat, slow or faster heartbeat, loss of the heart's ability to pump enough blood to body tissues, abdominal pain, low blood pressure, heart attack, perception of heartbeat, a pause in normal heart rhythm (stop sinus), life-threatening irregular heartbeat (ventricular fibrillation), manifestation of a pre-existing heart disease (Brugada syndrome) that was not seen before treatment with Flecainide Sandoz, scarring of the lungs or lung disease (called lung disease causing difficulty in breathing), liver disorders.
If you get any side effects, please tell your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it / it / responsible. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton after "Do not use after" or "EXP". The expiry date refers to the last day of the month.
Do not throw any medicines down the drain. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Deadline "> Other information
What Flecainide Sandoz contains
- The active ingredient is flecainide acetate. Each tablet contains 100 mg of flecainide acetate.
- The other ingredients are: croscarmellose sodium (E468), magnesium stearate (E470b), pregelatinised maize starch, maize starch and microcrystalline cellulose (E460).
What Flecainide Sandoz looks like and contents of the pack
The 100 mg tablet is circular, white, scored on one side, with the inscription "FJ" on one side of the line and "C" on the other; and on the other side of the tablet only score line.
Al / PVC / PVDC blisters
Pack sizes: 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168 and 180 tablets
PP container
Pack sizes: 100, 250, 500 and 1000 tablets
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
FLECAINIDE SANDOZ 100 MG TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
One tablet contains 100 mg flecainide acetate
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM -
Tablet.
White, circular, biconvex uncoated tablets, scored on one side with the identification letter "C" above the line and "FJ" below the line; break line on the other side.
The tablet can be divided into equal halves.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Treatment of
1. Reciprocating nodal AV tachycardia; arrhythmias associated with Wolff-Parkinson-White syndrome and similar conditions with other abnormal conduction pathways, when other treatments have proved ineffective.
2. Severe symptomatic and life-threatening paroxysmal ventricular arrhythmia that has failed to respond to other forms of therapy. Even in cases where other treatments have not been tolerated.
3. Paroxysmal atrial arrhythmias (atrial fibrillation, atrial flutter and atrial tachycardia) in patients with disabling symptoms after conversion, provided there is a clear need for treatment based on the severity of clinical symptoms, if other treatments have been ineffective. Structural heart disease and / or impaired left ventricular function should be excluded due to the increased risk of proarrhythmic effects.
04.2 Posology and method of administration -
Dosage
Initiation of flecainide acetate therapy and dose modifications should be done under the supervision of a physician and accompanied by monitoring of ECG and plasma levels. Hospitalization may be necessary during these procedures in some patients, especially those suffering from life-threatening cardiac arrhythmias. Such decisions must be made by a specialist. In patients with underlying organic heart disease and especially in those with a history of myocardial infarction, treatment with flecainide should only be initiated if other arrhythmic agents, except those of class IC (particularly amiodarone), have proved ineffective or have not been tolerated and when non-pharmacological treatment (surgery, ablation, defibrillator) is not indicated. Close medical monitoring of ECG and plasma levels is required during treatment.
Adults and adolescents (13-17 years) :
Supraventricular arrhythmia: The recommended starting dose is 50 mg twice daily and the condition of most patients remains under control at this dose. If necessary, the dose can be increased to a maximum daily of 300 mg.
Ventricular arrhythmia: The recommended starting dose is 100 mg twice a day. The maximum daily dose is 400 mg and is usually reserved for patients of large build or where rapid control of the arrhythmia is required. After 3-5 days it is recommended to gradually adjust the dose to the minimum level necessary to maintain control of blood. arrhythmia. & EGRAVE; It is possible to reduce the dose in long-term treatment.
Senior citizens :
In elderly patients the maximum starting dose should be 100 mg / day (or 50 mg twice daily) as the elimination rate of flecainide from plasma may be reduced in the elderly. This should be taken into consideration when making a dose adjustment. The dose for elderly patients should not exceed 300 mg / day (or 150 mg twice daily).
Pediatric population :
The use of flecainide acetate is not recommended in children below 12 years of age due to a lack of data on the drug's safety and efficacy.
Plasma levels:
Based on the suppression of CPV, it appears that plasma levels of 200-1000 ng / mL are required to achieve maximum therapeutic effect. Plasma levels above 700-1000 ng / mL are associated with a higher likelihood of adverse events.
Patients with kidney damage :
In patients with significant renal impairment (creatinine clearance 35 ml / min / 1.73 m² or less) the maximum starting dose should be 100 mg / day (or 50 mg twice daily). When used in these patients, frequent monitoring of plasma levels is strongly recommended. Depending on the effect and tolerability, the dose can then be cautiously increased. After 6-7 days the dose can be adjusted, based on effect and tolerability. Some patients with severe renal insufficiency may have a very slow clearance of flecainide and therefore a prolonged half-life (60-70 hours).
Patients with hepatic impairment :
In patients with hepatic impairment, the patient should be closely monitored and the dose should not exceed 100 mg per day (or 50 mg twice daily).
Patients with a permanent pacemaker in place should be treated with caution and the dose should not exceed 100 mg twice daily.
Close monitoring is required in patients receiving cimetidine or amiodarone concurrently. In some patients the dose may need to be reduced and should not exceed 100 mg twice a day. Patients should be monitored during the initial stages of therapy and during maintenance therapy.
Monitoring of plasma levels and an ECG check are recommended at regular intervals (ECG check once a month and long-term ECG every 3 months) during therapy. In the early stages of therapy and when the dose is increased, perform an ECG every 2-4 days.
When flecainide is administered to patients with dose restrictions, frequent ECG checks (in addition to regular plasma monitoring of flecainide) should be performed. Make dose adjustments at 6-8 day intervals. In these patients, an ECG should be performed in the second and third week to check the individual dose.
Method of administration
For oral use. To avoid the possibility of food affecting the absorption of the drug, take flecainide on an empty stomach or one hour before a meal.
04.3 Contraindications -
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• Flecainide is contraindicated in heart failure and in patients with a history of myocardial infarction with asymptomatic ventricular ectopias or asymptomatic non-sustained ventricular tachycardia.
• Flecainide is contraindicated in the presence of cardiogenic shock.
• Patients with prolonged atrial fibrillation in whom no attempt has been made to convert to sinus rhythm, and patients with haemodynamically significant valvular heart disease.
• Patients with reduced or impaired ventricular function, cardiogenic shock, severe bradycardia (less than 50 bpm), severe hypotension
• Use in combination with class I antiarrhythmics (calcium channel blockers)
• Known Brugada syndrome
• Until rhythm can be restored, flecainide should not be given to patients with sinus node dysfunction, atrial conduction defects, second degree or greater atrioventricular block, bundle branch block or distal block.
• Patients with asymptomatic or mildly symptomatic ventricular arrhythmias should not receive flecainide.
04.4 Special warnings and appropriate precautions for use -
Treatment with oral flecainide should be done directly in the hospital or under the supervision of a specialist for patients with:
• AV nodal alternate tachycardia; arrhythmias associated with Wolff-Parkinson-White syndrome and similar conditions with accessory pathways
• paroxysmal atrial fibrillation in patients with disabling symptoms.
Treatment for patients with other indications should be initiated in the hospital.
Intravenous flecainide treatment should be initiated in the hospital.
Flecainide has been shown to increase the risk of mortality in patients with post-myocardial infarction and asymptomatic ventricular arrhythmia.
Flecainide, like other antiarrhythmics, may cause proarrhythmic effects, i.e. it may result in the appearance of a more severe type of arrhythmia, increase the frequency of an existing arrhythmia or the severity of symptoms (see section 4.8).
Flecainide should not be used in patients with structural heart disease or abnormal left ventricular function (see section 4.8).
Use flecainide with caution in patients with acute onset of atrial fibrillation following heart surgery.
Continuous ECG monitoring is recommended in all patients treated with bolus injection.
Flecainide prolongs the QT interval and widens the QRS complex by 12-20%. The effect on the JT interval is insignificant.
Brugada syndrome could be exposed by flecainide therapy. In case of development of ECG changes during treatment with flecainide that may indicate Brugada syndrome, treatment discontinuation should be considered.
As the elimination of flecainide from plasma may be markedly slower in patients with significant hepatic impairment, flecainide should not be used in these patients unless the potential benefits outweigh the risks. Monitoring of plasma levels is recommended.
Use flecainide with caution in patients with impaired renal function (creatinine clearance ≤ 35 ml / min / 1.73 m²) and perform therapeutic drug monitoring.
The rate of elimination of flecainide from plasma may be reduced in the elderly. This should be taken into consideration when making dose adjustments.
Flecainide is not recommended in children below 12 years of age as there is insufficient evidence of its use in this patient group.
Electrolyte disturbances (e.g. hypo- and hyperkalaemia) must be corrected before using flecainide (see section 4.5 for some drugs that cause electrolyte disturbances).
Severe bradycardia or marked hypotension should be corrected before using flecainide.
Flecainide is known to increase the endocardial rhythm threshold, i.e. reduce the sensitivity of the endocardial rhythm. This effect is reversible and more marked on the acute rhythm threshold than on the chronic one. Flecainide should therefore be used with caution in all patients with permanent pacemakers or temporary electrodes and should not be administered to patients with low-threshold or non-programmable pacemakers until rhythm can be restored.
Generally, doubling the pulse width or voltage is sufficient to reestablish capture, but it can be difficult to achieve ventricular thresholds below 1 Volt at initial implantation in the presence of flecainide.
Difficulties have been encountered in defibrillating some patients. Many of the reported cases had pre-existing heart disease with heart muscle enlargement, a history of myocardial infarction, arteriosclerotic heart disease, and "heart failure."
An "acceleration of the ventricular rate of atrial fibrillation in the event of therapeutic failure has been reported.
Flecainide has a selective effect which increases the refractory period of the antegrade and especially retrograde course. These effects are reflected in the ECG with a prolongation of the QTc interval in the majority of patients; consequently there is little effect on the JT interval. However, prolongations of the JT interval up to 4% have been reported. This effect is however less marked than that observed with class 1a antiarrhythmic drugs.
Dairy products (milk, infant formula and possibly yogurt) may reduce the absorption of flecainide in children and infants. Flecainide is not approved for use in children under the age of 12, but flecainide toxicity has been reported. during flecainide treatment in infants who have reduced their milk intake, and in infants who have switched from formula to dextrose.
For further warnings and precautions see section 4.5.
04.5 Interactions with other medicinal products and other forms of interaction -
Class I antiarrhythmics: flecainide should not be administered concomitantly with other class I antiarrhythmics (see section 4.3).
Class II antiarrhythmics: The possibility of additive adverse inotropic effects of class II antiarrhythmics, i.e. beta-blockers, with flecainide should be considered.
Class III antiarrhythmics: if flecainide is administered in the presence of amiodarone, the usual dose of flecainide should be reduced by 50% and the patient should be carefully monitored for side effects. In these circumstances, monitoring of plasma levels is strongly recommended.
Class IV antiarrhythmics: If flecainide is used in combination with calcium channel blockers, eg verapamil, caution should be exercised.
Life-threatening or even fatal adverse events due to interactions causing increased plasma concentrations may occur (see section 4.9). Flecainide is metabolised to a large extent by CYP2D6, and concomitant use of inhibitory drugs (eg antidepressants, neuroleptics, propranolol, ritonavir, some antihistamines) or inducers (eg phenytoin, phenobarbital, carbamazepine) of this iso-enzyme may respectively increase or decrease plasma concentrations of flecainide (see below).
An increase in plasma levels may also result from renal insufficiency due to a reduction in the clearance of flecainide (see section 4.4).
Hypokalaemia, but also hyperkalaemia or other electrolyte disturbances should be corrected prior to administration of flecainide. Hypokalaemia may result from concomitant use of diuretics, corticosteroids or laxatives.
Antihistamines: increased risk of ventricular arrhythmias with mizolastine And terfenadine (avoid concomitant use).
Antivirals: Plasma concentrations increased by ritonavir, lopinavir And indinavir (increased risk of ventricular arrhythmias) (avoid concomitant use).
Antidepressants: fluoxetine, paroxetine and other antidepressants increase the plasma concentration of flecainide; increased risk of arrhythmias with tricyclic antidepressants.
Antiepileptics: limited data from patients undergoing treatment with known enzyme inducers (phenytoin, phenobarbital, carbamazepine) indicate only a 30% increase in the elimination rate of flecainide.
Antipsychotics: clozapine - increased risk of arrhythmias.
Antimalarials: quinine increases plasma concentrations of flecainide.
Antifungals: terbinafine may increase plasma concentrations of flecainide due to inhibition of CYP2D6 activity.
Diuretics: class effect due to hypokalaemia which causes increased cardiotoxicity.
H2 antihistamines (for the treatment of gastric ulcers): the anti-H2 antagonist cimetidine inhibits the metabolism of flecainide. In healthy subjects treated with cimetidine (1 g daily) for 1 week, the AUC of flecainide increased by approximately 30% and the half-life increased by approximately 10%.
Anti-smoking drugs: the co-administration of bupropion (metabolised by CYP2D6) with flecainide should be conducted with caution and initiated considering the lowest dose of the concomitant drug. Self bupropion added to the treatment of a patient who is already taking flecainide, the need to decrease the dose of the original drug should be considered.
Cardiac glycosides: Flecainide may increase plasma digoxin levels by approximately 15%, which is unlikely to be of clinical significance for patients whose plasma levels are in the therapeutic range.
It is recommended that digoxin plasma levels be measured in patients receiving digitalis treatment not less than six hours after each digoxin administration, before or after flecainide administration.
Anticoagulants: treatment with flecainide is compatible with the use of oral anticoagulants.
04.6 Pregnancy and breastfeeding -
Pregnancy
There is no evidence for the safety of the drug in pregnancy. In New Zealand white rabbits, high doses of flecainide caused some fetal abnormalities, but these effects were not observed in Dutch Belted-type rabbits or rats (see section 5.3). The relevance of these findings to humans has not been established. Available data have shown that flecainide crosses the placenta and reaches the fetus in patients treated with flecainide during pregnancy. Flecainide should only be used in pregnancy if the benefits outweigh the risks.
Feeding time
Flecainide is excreted in human milk (see section 5.2). The plasma concentrations obtained in an infant are 5-10 times lower than the therapeutic concentrations of the drug. Although the risk of harmful effects to the infant is very small, flecainide should only be used during breastfeeding if the benefits obtained outweigh the risks.
04.7 Effects on ability to drive and use machines -
The ability to drive, use machines and work unsafe may be affected by adverse reactions such as dizziness and visual disturbances, if any.
04.8 Undesirable effects -
Like other antiarrhythmics, flecainide can induce arrhythmias.
Pre-existing arrhythmias may worsen or new ones may arise. The risk of proarrhythmic effects is more likely in patients with structural heart disease and / or significant left ventricular compromise.
The most common cardiovascular adverse events were second and third degree AV block, bradycardia, heart failure, chest pain, myocardial infarction, hypotension, sinus arrest, tachycardia (AT and VT) and palpitations.
The most common adverse events are dizziness and visual disturbances, which appear in approximately 15% of treated patients. These adverse events are usually transient and disappear with continuing treatment or reducing the dose of the drug. The following list of adverse events is based on experiences from clinical trials and reported post-marketing.
Adverse events are listed below by system organ class and frequency. Frequencies are defined as follows:
very common (≥1 / 10)
common (≥1 / 100,
uncommon (≥1 / 1 000,
rare (≥1 / 10,000,
very rare (
not known (frequency cannot be estimated from the available data).
Disorders of the blood and lymphatic system
Uncommon: decreased red blood cell count, decreased white blood cell count and decreased platelet count
Disorders of the immune system
Very rare: anti-nucleus antibody increased with or without systemic inflammatory involvement
Psychiatric disorders
Rare: hallucinations, depression, confusional state, anxiety, amnesia, insomnia
Nervous system disorders
Very common: dizziness, usually transient
Rare: paraesthesia, ataxia, hypoesthesia, hyperhidrosis, syncope, tremor, flushing, somnolence, headache, peripheral neuropathy, convulsions, dyskinesia
Eye disorders
Very common: visual disturbances such as diplopia and blurred vision
Very rare: corneal deposits
Ear and labyrinth disorders
Rare: tinnitus, dizziness
Cardiac pathologies
Common: Proarrhythmia (more likely in patients with structural heart disease).
Uncommon: Patients with atrial flutter may develop 1: 1 AV conduction with increased heart rate.
Frequency not known: Dose-dependent increases in the PR and QRS intervals may occur (see section 4.4). Altered pacing threshold (see section 4.4).
Second degree atrioventricular block and third degree atrioventricular block, cardiac arrest, bradycardia, heart failure / congestive heart failure, chest pain, hypotension, myocardial infarction, palpitations, sinus arrest and tachycardia (AT and VT) or ventricular fibrillation. Exposing a pre-existing Brugada syndrome.
Respiratory, thoracic and mediastinal disorders
Common: dyspnoea
Rare: pneumonia
Frequency not known: pulmonary fibrosis, interstitial lung disease
Gastrointestinal disorders
Uncommon: nausea, vomiting, constipation, abdominal pain, decreased appetite, diarrhea, dyspepsia, flatulence
Hepatobiliary disorders
Rare: elevated liver enzymes with or without jaundice
Frequency not known: hepatic dysfunction
Skin and subcutaneous tissue disorders
Uncommon: allergic dermatitis, including rash, alopecia
Rare: severe urticaria
Very rare: photosensitivity reaction
General disorders and administration site conditions
Common: asthenia, fatigue, pyrexia, edema
Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose -
Overdose with flecainide is a potentially life-threatening medical emergency. Increases in drug sensitivity and plasma levels above therapeutic levels may also result from drug interactions (see section 4.5). No specific antidote is known. Unknown a method of rapidly removing flecainide from the body. Neither dialysis nor hemoperfusion are helpful. Treatment should be supportive and may include removal of unabsorbed drug from the gastrointestinal tract. Additional measures may include inotropic agents or cardiac stimulants such as dopamine, dobutamine or isoproterenol as well as mechanical ventilation and circulatory assistance (eg balloon pumping). Temporary insertion of a transvenous pacemaker may be considered in the event of conduction blockage. Assuming that the plasma half-life is approximately 20 hours, these supportive treatments should continue for an extended period of time. Forced diuresis with acidification of the urine theoretically promotes drug elimination.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: antiarrhythmics, class IC, flecainide
ATC code: C01 BC 04
Flecainide acetate is a class IC arrhythmic agent used for the treatment of severe symptomatic life-threatening ventricular arrhythmias and severe supraventricular arrhythmias.
From an electrophysiological point of view, flecainide is an antiarrhythmic compound of the local anesthetic type (class IC). It is an amide type of local anesthetic, structurally related to procainamide and encainide as these agents are also benzamide derivatives.
The characterization of flecainide as a class IC compound is based on a triad of properties: marked depression of the rapid sodium channel in the heart; slow kinetics of the beginning and end of sodium channel inhibition (which reflects slow binding to sodium channels and slow dissociation from them); differential effect of the drug on the duration of action potential in the ventricular muscle compared to Purkinje fibers , producing no effect on one and markedly reducing it on the others. The set of properties leads to a marked reduction of the conduction speed in the fibers dependent on the fibers of the fast channel for depolarization but with a modest increase in the effective refractory period when studied in isolated heart tissues. These electrophysiological properties of flecainide acetate can lead to prolongation of the PR interval and QRS duration on ECG. At very high concentrations, flecainide exerts a mild depressant effect on the slow channel in the myocardium. This is accompanied by a negative inotropic effect.
05.2 "Pharmacokinetic properties -
Absorption
After oral administration, flecainide is almost completely absorbed and does not undergo extensive first pass metabolism. The bioavailability of the flecainide acetate tablets is approximately 90%.
The therapeutic plasma concentration range is generally accepted between 200 and 1000 ng per ml. With intravenous administration the mean time to reach the peak serum concentration is 0.67 hours and the mean bioavailability is 98%, compared to 1 hour and 78% for the oral solution and 4 hours and 81% for the tablet.
Distribution
Flecainide is approximately 40% bound to plasma proteins. Flecainide crosses the placenta and is excreted in breast milk.
Biotransformation
Flecainide is extensively metabolised (subject to genetic polymorphism). The 2 major metabolites are dealkylated m-O-flecainide and flecainide m-O-dealkylated lactam; both may have some activity. Its metabolism appears to involve the cytochrome P450 isoenzyme CYP2D6 which demonstrates genetic polymorphism.
Elimination
Flecainide is mainly excreted in the urine, approximately 30% as unchanged drug and the remainder as metabolites. About 5% is excreted in the faeces. Flecainide excretion is reduced in renal insufficiency, liver disease, heart failure and in alkaline urine. Hemodialysis removes only 1% unchanged flecainide.
The half-life for plasma elimination of flecainide is approximately 20 hours.
05.3 Preclinical safety data -
The only preclinical data that are important to the prescribing physician to add to those already included in the other sections of the SmPC are the following effects on reproduction. In one breed of rabbits, flecainide caused teratogenicity and embryotoxicity. Data to establish a margin safety for this effect is insufficient, however these effects were not observed in other breeds of rabbits, rats and mice.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Croscarmellose sodium (E 468)
Magnesium stearate (E 470b)
Pregelatinised maize starch
Cornstarch
Microcrystalline cellulose (E460)
06.2 Incompatibility "-
Not relevant
06.3 Period of validity "-
3 years
06.4 Special precautions for storage -
No particular precautions for storage
06.5 Nature of the immediate packaging and contents of the package -
PVC / PVDC / Al blisters and polypropylene containers with polyethylene snap-lock lids.
Pack sizes:
Blisters: 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168 and 180 tablets
Container: 100, 250, 500 and 1000 tablets.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling -
No special instructions
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Sandoz S.p.A. Largo U. Boccioni, 1 21040 Origgio
08.0 MARKETING AUTHORIZATION NUMBER -
100 mg tablets 20 tablets in PVC / PVDC / AL AIC blister n. 037415015
100 mg tablets 28 tablets in PVC / PVDC / AL AIC blister n. 037415027
100 mg tablets 30 tablets in PVC / PVDC / AL AIC blister n. 037415039
100 mg tablets 50 tablets in PVC / PVDC / AL AIC blister n. 037415041
100 mg tablets 56 tablets in PVC / PVDC / AL AIC blister n. 037415054
100 mg tablets 60 tablets in PVC / PVDC / AL AIC blister n. 037415066
100 mg tablets 84 tablets in PVC / PVDC / AL AIC blister n. 037415078
100 mg tablets 90 tablets in PVC / PVDC / AL AIC blister n. 037415080
100 mg tablets 100 tablets in PVC / PVDC / AL AIC blister n. 037415092
100 mg tablets 112 tablets in PVC / PVDC / AL AIC blister n. 037415104
100 mg tablets 120 tablets in PVC / PVDC / AL AIC blister n. 037415116
100 mg tablets 168 tablets in PVC / PVDC / AL AIC blister n. 037415128
100 mg tablets 180 tablets in PVC / PVDC / AL AIC blister n. 037415130
100 mg tablets 100 tablets in container PP AIC n. 037415142
100 mg tablets 250 tablets in container PP AIC n. 037415155
100 mg tablets 500 tablets in container PP AIC n. 037415167
100 mg tablets 1000 tablets in container PP AIC n. 037415179
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
August 2007 / May 3, 2011
10.0 DATE OF REVISION OF THE TEXT -
24 September 2015
