Flecainide 50 mg and 100 mg Tablets * Pharmacy Only: Prescription
Company:
Gerard LaboratoriesStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 16 September 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 September 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.2:
Supraventricular arrhythmias
Adults: The recommended starting dose is 50mg twice daily and most patients will be
controlled at this dose the dose may be increased to a maximum of 300 mg daily.
Ventricular arrhythmias:
Adults only: The usual recommended dose is 100 mg twice daily initially with subsequent
increments of 50 mg daily every 4 days to the level of optimal response of a maximum dose of
400 mg daily with subsequent reduction after 3-5 days to the lowest dose compatible with
control.Some patients, particularly those with supra-ventricular tachycardia will be adequately
controlled on 50 mg twice daily. Further reductions may be possible during long-term
treatment.
Patients with renal impairment: In patients with significant renal impairment (creatinine
clearance of 35 ml/min/1.73sq.m2. or less) the maximum initial dosage should be 100 mg daily
(or 50 mg twice daily). When used in such patients, frequent plasma monitoring is strongly
recommended.
Treatment with oral Flecainide should be under direct hospital or specialist
supervision for patients with:
a) AV nodal reciprocating tachycardia: arrhythmias associated with WPW Syndrome and
similar conditions with accessory pathways.
b) Paroxysmal atrial fibrillation in patients with disabling symptoms.
Treatment for patients with other indications should continue to be initiated in hospital.
Section 4.4:
Flecainide as a narrow therapeutic index drug requires caution and close monitoring when
switching a patient to a different formulation.
Section 4.6:
Pregnancy
There is no evidence as to drug safety in human pregnancy.In New Zealand White rabbits, high
doses of flecainide caused some foetal abnormalities, but these effects were not seen in Dutch
Belted rabbits or rats (see section 5.3). The relevance of these findings to humans has not been
established. Data have shown that flecainide crosses the placenta to the foetus in patients taking
flecainide during pregnancy. Flecainide should only be used in pregnancy if the benefit
outweighs the risks.
Section 5.1:
Flecainide is a potent sodium channel blocking agent. Flecainide slows conduction through the
heart having his greatest effect on His Bundle conduction. It also acts selectively to increase
anterograde and particularly retrograde accessory pathway refractoriness. Its actions may be
reflected in the ECG by prolongation of the PR interval and widening of QRS complex. The
effect on the JT interval is insignificant.
Section 5.2:
Recovery of unchanged flecainide in urine of healthy subjects was approximately 42 % of a
200 mg oral dose, whilst the two major metabolites (meta-O-dealkylated and dealkylated
lactam metabolites) accounted for a further 14 % each. The elimination half-life was 12 to 27
hours. The volume of distribution is 8.7 l/kg.
Section 5.3:
No information given. In New Zealand white rabbits, high doses of flecainide produced some
embryotoxic effects (increased resorption) and teratogenic effects (increased incidence of
clubbed paws and skeletal abnormalities in sternebrae and vertebrae). Based on mg/kg body
weight a safety margin of 8.7 for embryotoxic effects and 10.5 for teratogenic effects was
calculated. These effects were not seen in Dutch belted rabbits or rats. The relevance of these
findings to humans has not been established. Prolongation of gestation was seen in rats under a
dose of 50mg/kg. No effects on fertility were observed
Supraventricular arrhythmias
Adults: The recommended starting dose is 50mg twice daily and most patients will be
controlled at this dose the dose may be increased to a maximum of 300 mg daily.
Ventricular arrhythmias:
Adults only: The
increments of 50 mg daily every 4 days to the level of optimal response of a maximum dose of
400 mg daily with subsequent reduction after 3-5 days to the lowest dose compatible with
control.
controlled on 50 mg twice daily.
treatment.
Patients with renal impairment: In patients with significant renal impairment (creatinine
clearance of 35 ml/min/1.73
(or 50 mg twice daily). When used in such patients, frequent plasma monitoring is strongly
recommended.
Treatment with oral Flecainide should be under direct hospital or specialist
supervision for patients with:
a) AV nodal reciprocating tachycardia: arrhythmias associated with WPW Syndrome and
similar conditions with accessory pathways.
b) Paroxysmal atrial fibrillation in patients with disabling symptoms.
Treatment for patients with other indications should continue to be initiated in hospital.
Section 4.4:
Flecainide as a narrow therapeutic index drug requires caution and close monitoring when
switching a patient to a different formulation.
Section 4.6:
Pregnancy
There is no evidence as to drug safety in human pregnancy.
doses of flecainide caused some foetal abnormalities, but these effects were not seen in Dutch
Belted rabbits or rats (see section 5.3). The relevance of these findings to humans has not been
established.
flecainide during pregnancy. Flecainide should only be used in pregnancy if the benefit
outweighs the risks.
Section 5.1:
Flecainide is a potent sodium channel blocking agent. Flecainide slows conduction through the
heart having his greatest effect on His Bundle conduction. It also acts selectively to increase
anterograde and particularly retrograde accessory pathway refractoriness. Its actions may be
reflected in the ECG by prolongation of the PR interval and widening of QRS complex. The
effect on the JT interval is insignificant.
Section 5.2:
Recovery of unchanged flecainide in urine of healthy subjects was approximately 42 % of a
200 mg oral dose, whilst the two major metabolites (meta-O-dealkylated and dealkylated
lactam metabolites) accounted for a further 14 % each. The elimination half-life was 12 to 27
hours. The volume of distribution is 8.7 l/kg.
Section 5.3:
embryotoxic effects (increased resorption) and teratogenic effects (increased incidence of
clubbed paws and skeletal abnormalities in sternebrae and vertebrae). Based on mg/kg body
weight a safety margin of 8.7 for embryotoxic effects and 10.5 for teratogenic effects was
calculated. These effects were not seen in Dutch belted rabbits or rats. The relevance of these
findings to humans has not been established. Prolongation of gestation was seen in rats under a
dose of 50mg/kg. No effects on fertility were observed
Updated on 15 September 2015
File name
PIL_12824_254.pdf
Reasons for updating
- New PIL for new product
Updated on 15 September 2015
Reasons for updating
- Change to, or new use for medicine
- Change of contraindications
- Change to date of revision
- Change to dosage and administration
Updated on 16 June 2015
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 1 - Name of medicinal product
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
All sections of SmPC updated in line with Brand leader and QRD.
Updated on 05 May 2015
Reasons for updating
- Change of manufacturer
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 27 February 2013
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 10 December 2012
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.3:
Section 4.4:
Treatment with oral flecainide acetate should be under direct hospital or specialist supervision for patients with:
• AV nodal reciprocating tachycardia; arrhythmias associated with Wolff-Parkinson-White Syndrome and similar conditions with accessory pathways.
• Paroxysmal atrial fibrillation in patients with disabling symptoms.
Flecainide acetate has been shown to increase mortality risk of post-myocardial infarction patients with asymptomatic ventricular arrhythmia.
Flecainide acetate, like other antiarrhythmics, may cause proarrhythmic effects, i.e. it may cause the appearance of a more severe type of arrhythmia, increase the frequency of an existing arrhythmia or the severity of the symptoms (see 4.8).
Flecainide acetate should be avoided in patients with structural heart disease or abnormal left ventricular function (see 4.8).
Flecainide acetate should be used with caution in patients with acute onset of atrial fibrillation following cardiac surgery.
Treatment for patients with other indications should continue to be initiated in hospital.
Intravenous treatment with flecainide acetate should be initiated in hospital.
Continuous ECG monitoring is recommended in all patients receiving bolus injection.
Flecainide prolongs the QT interval and widens the QRS complex by 12-20 %. The effect on the JT interval is insignificant.
A Brugada syndrome may be unmasked due to flecainide acetate therapy. In the case of development of ECG changes during treatment with flecainide acetate that may indicate Brugada syndrome, consideration to discontinue the treatment should be made.
Since flecainide elimination from the plasma can be markedly slower in patients with significant hepatic impairment, flecainide should not be used in such patients unless the potential benefits clearly outweigh the risks. Plasma level monitoring is strongly recommended in these circumstances.
This product should be used with caution in patients with severe hepatic disease.
Flecainide acetate should be used with caution in patients with impaired renal function (creatinine clearance ≤ 35 ml/min/1.73 m2) and therapeutic drug monitoring is recommended.
The rate of flecainide acetate elimination from plasma may be reduced in the elderly. This should be taken into consideration when making dose adjustments.
Electrolyte disturbances (e.g. hypo- and hyperkalaemia) should be corrected before using Flecainide, and should be checked during therapy particularly if diuretics are being administered (see section 4.5).
Flecainide is not recommended in children under 18 years of age, as there is insufficient evidence of its use in this age group.
Severe bradycardia or pronounced hypotension should be corrected before using flecainide.
For further warnings and precautions please refer to 4.5.
Section 4.5:
Flecainide is a class I anti-arrhythmic and interactions are possible with other anti-arrhythmic drugs where additive effects may occur or where drugs interfere with the metabolism of flecainide. The following known categories of drugs may interact with flecainide:
Cardiac glycosides: Flecainide acetate can cause the plasma digoxin level to rise by about 15%, which is unlikely to be of clinical significance for patients with plasma levels in the therapeutic range. It is recommended that the digoxin plasma level in digitalised patients should be measured not less than six hours after any digoxin dose, before or after administration of flecainide.
Class I antiarrhythmics: Flecainide acetate should not be administered concomitantly with other class I antiarrythmics.
Class II antiarrhythmics: The possibility of additive negative inotropic effects of Class II antiarrhythmics, i.e. beta-blockers with flecainide should be recognised.
Class III antiarrhythmics: If flecainide acetate is given in the presence of amiodarone the usual flecainide acetate dosage should be reduced by 50% and the patient monitored closely for adverse effects. Plasma level monitoring is strongly recommended in these circumstances.
Class IV antiarrhythmics: The use of flecainide acetate with calcium channel blockers, e.g. verapamil, should be considered with caution.
Life-threatening or even lethal adverse events due to interactions causing increased plasma concentrations may occur (see section 4.9). Flecainide is metabolized by CYP2D6 to a large extent, and concurrent use of drugs inhibiting or inducing this iso-enzyme can increase or decrease plasma concentrations of flecainide, respectively.
An increase of plasma levels may also result from renal impairment due to a reduced clearance of flecainide (see section 4.4).
Hypokalaemia but also hyperkalaemia or other electrolyte disturbances should be corrected before administration of flecainide. Hypokalaemia may result from the concomitant use of diuretics, corticosteroids or laxatives.
Antidepressants: Fluoxetine and other antidepressants increases plasma flecainide concentration; increased risk of arrhythmias with tricyclics. manufacturer of reboxetine advises caution.
Antiepileptics: Limited data in patients receiving known enzyme inducers (phenytoin, phenobarbital, carbamazepine) indicate only a 30% increase in the rate of flecainide elimination.
Antipsychotics: Clozapine – increased risk of arrhythmias.
Antihistamines:Increased risk of ventricular arrhythmias with mizolastine and terfenadine (avoid concomitant use).
Antimalarials: Quinine increases plasma concentrations of flecainide.
Antivirals: Plasma concentrations are increased by ritonavir, lopinavir and indinavir (increased risk of ventricular arrhythmias) (avoid concomitant use).
Antifungals: Terbinafine may increase plasma concentrations of flecainide resulting from its inhibition of CYP2D6 activity.
Diuretics: Class effect due to hypokalaemia giving rise to cardiac toxicity.
H2 antihistamines (for the treatment of gastric ulcers): The H2 antagonist cimetidine inhibits metabolism of flecainide. In healthy subjects receiving cimetidine (1g daily) for 1 week, the AUC of flecainide increased by about 30% and the half-life increased by about 10%.
Antismoking aids: Co-administration of bupropion (metabolised by CYP2D6) with flecainide should be approached with caution and should be initiated at the lower end of the dose range of the concomitant medication. If bupropion is added to the treatment regimen of a patient already receiving flecainide acetate, the need to decrease the dose of the original medication should be considered.
Anticoagulants: The treatment with flecainide acetate is compatible with the use of oral anticoagulants.
Section 4.6:
Pregnancy information
There is no evidence as to drug safety in human pregnancy. In New Zealand White rabbits, high doses of flecainide acetate caused some foetal abnormalities, but these effects were not seen in Dutch Belted rabbits or rats (see section 5.3). The relevance of these findings to humans has not been established. Data have shown that flecainide crosses the placenta to the foetus in patients taking flecainide during pregnancy. Flecainide should only be used in pregnancy if the benefit outweighs the risks.
Breastfeeding
Flecainide acetate is excreted in human milk. Plasma concentrations obtained in a nursing infant are 5-10 times lower than therapeutic drug concentrations (see section 5.2). Although the risk of adverse effects to the nursing infant is very small, flecainide acetate should only be used during lactation if the benefit outweighs the risks.
Section 4.7:
Driving ability, operation of machinery and work without a secure fit may be affected by adverse reactions such as dizziness and visual disturbances, if present.
Section 4.8:
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/l0), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥ 1/10,000 and <1/1000) and very rare (<1/10,000), not known (cannot be estimated from the available data).
Blood and lymphatic system disorders:
Uncommon: red blood cell count decreased, white blood cell count decreased and platelet count decreased
Immune system disorders:
Very rare: antinuclear antibody increased with and without systemic inflammation
Psychiatric disorders:
Rare: hallucination, depression, confusional state, anxiety, amnesia, insomnia
Nervous system disorders:
Very common: giddiness, dizziness and light headedness, which is usually transient
Rare: paraesthesia, ataxia hypoaesthesia, hyperhidrosis, syncope, tremor, flushing, somnolence, headache, neuropathy peripheral, convulsion, dyskinesia
Eye disorders:
Very common: visual impairment, such as diplopia and vision blurred
Very rare: corneal deposits
Ear and labyrinth disorders:
Rare: tinnitus, vertigo
Cardiac disorders:
Common: Proarrhythmia (most likely in patients with structural heart disease and/or significant left ventricular impairment).
Uncommon: Patients with atrial flutter can develop a 1:1 AV conduction with increased heart rate.
Not known: Dose-related increases in PR and QRS intervals may occur (see section 4.4). Altered pacing threshold (see section 4.4), atrioventricular block-second-degree and atrioventricular block third degree, cardiac arrest, bradycardia, cardiac failure/ cardiac failure congestive, chest pain, hypotension, myocardial infarction, palpitations, sinus arrest, and tachycardia (AT or VT). Demasking of a pre-existing Brugada syndrome.
Respiratory, thoracic and mediastinal disorders:
Common: dyspnoea
Rare: pneumonitis
Not known: pulmonary fibrosis, insterstitial lung disease
Gastrointestinal disorders:
Uncommon: nausea, vomiting, abdominal pain, constipation, decreased appetite diarrhoea, dyspepsia, flatulence
Hepatobiliary disorders:
Rare: hepatic enzymes increased with and without jaundice
Frequency not known (cannot be estimated from the available data): hepatic dysfunction, cholestasis and hepatic failure
Skin and and subcutaneous tissue disorders:
Uncommon:dermatitis allergic, including rash, alopecia.
Rare: serious urticaria
Very rare: photosensitivity reaction
General disorders and administration site conditions:
Common: Asthenia, fatigue, pyrexia, oedema
Section 4.9:
Overdosage with flecainide acetate is a potentially life-threatening medical emergency. Increased drug susceptibility and plasma levels exceeding therapeutic levels may also result from drug interaction (see section 4.5). No specific antidote is known. There is no known way to rapidly remove flecainide acetate from the system. Neither dialysis nor haemoperfusion is effective.
Treatment should be supportive and may include removal of unabsorbed drug from the GI tract. Further measures may include inotropic agents or cardiac stimulants such as dopamine, dobutamine or isoproterenol as well as mechanical ventilation and circulatory assistance (e.g. ballon pumping). Temporarily inserting a transvenous pacemaker in the event of conduction block should be considered. Assuming a plasma half-life of approximately 20 h, these supportive treatments may need to be continued for an extended period of time. Forced diuresis with acidification of the urine theoretically promotes drug excretion.
Hypersensitivity to flecainide or to any of the excipients listed in section 6.1.
Flecainide is contraindicated in patients with left ventricular dysfunction or cardiac failure, regardless of the type of arrhythmia, and in patients with a history of myocardial infarction who have either asymptomatic ventricular ectopics or asymptomatic non-sustained ventricular tachycardia.
Flecainide is contraindicated in the presence of cardiogenic shock.
It is also contraindicated in patients with long standing atrial fibrillation in whom there has been no attempt to convert to sinus rhythm, and in patients with haemodynamically significant valvular heart disease.
Known Brugada syndrome.
Unless pacing rescue is available, flecainide acetate should not be given to patients with sinus node dysfunction, atrial conduction defects, second degree or greater atrio-ventricular block, bundle branch block or distal block.
Section 4.4:
Treatment with oral flecainide acetate should be under direct hospital or specialist supervision for patients with:
• AV nodal reciprocating tachycardia; arrhythmias associated with Wolff-Parkinson-White Syndrome and similar conditions with accessory pathways.
• Paroxysmal atrial fibrillation in patients with disabling symptoms.
Flecainide acetate has been shown to increase mortality risk of post-myocardial infarction patients with asymptomatic ventricular arrhythmia.
Flecainide acetate, like other antiarrhythmics, may cause proarrhythmic effects, i.e. it may cause the appearance of a more severe type of arrhythmia, increase the frequency of an existing arrhythmia or the severity of the symptoms (see 4.8).
Flecainide acetate should be avoided in patients with structural heart disease or abnormal left ventricular function (see 4.8).
Flecainide acetate should be used with caution in patients with acute onset of atrial fibrillation following cardiac surgery.
Treatment for patients with other indications should continue to be initiated in hospital.
Intravenous treatment with flecainide acetate should be initiated in hospital.
Continuous ECG monitoring is recommended in all patients receiving bolus injection.
Flecainide prolongs the QT interval and widens the QRS complex by 12-20 %. The effect on the JT interval is insignificant.
A Brugada syndrome may be unmasked due to flecainide acetate therapy. In the case of development of ECG changes during treatment with flecainide acetate that may indicate Brugada syndrome, consideration to discontinue the treatment should be made.
Since flecainide elimination from the plasma can be markedly slower in patients with significant hepatic impairment, flecainide should not be used in such patients unless the potential benefits clearly outweigh the risks. Plasma level monitoring is strongly recommended in these circumstances.
This product should be used with caution in patients with severe hepatic disease.
Flecainide acetate should be used with caution in patients with impaired renal function (creatinine clearance ≤ 35 ml/min/1.73 m2) and therapeutic drug monitoring is recommended.
The rate of flecainide acetate elimination from plasma may be reduced in the elderly. This should be taken into consideration when making dose adjustments.
Electrolyte disturbances (e.g. hypo- and hyperkalaemia) should be corrected before using Flecainide, and should be checked during therapy particularly if diuretics are being administered (see section 4.5).
Flecainide is not recommended in children under 18 years of age, as there is insufficient evidence of its use in this age group.
Severe bradycardia or pronounced hypotension should be corrected before using flecainide.
For further warnings and precautions please refer to 4.5.
Section 4.5:
Flecainide is a class I anti-arrhythmic and interactions are possible with other anti-arrhythmic drugs where additive effects may occur or where drugs interfere with the metabolism of flecainide. The following known categories of drugs may interact with flecainide:
Cardiac glycosides: Flecainide acetate can cause the plasma digoxin level to rise by about 15%, which is unlikely to be of clinical significance for patients with plasma levels in the therapeutic range. It is recommended that the digoxin plasma level in digitalised patients should be measured not less than six hours after any digoxin dose, before or after administration of flecainide.
Class I antiarrhythmics: Flecainide acetate should not be administered concomitantly with other class I antiarrythmics.
Class II antiarrhythmics: The possibility of additive negative inotropic effects of Class II antiarrhythmics, i.e. beta-blockers with flecainide should be recognised.
Class III antiarrhythmics: If flecainide acetate is given in the presence of amiodarone the usual flecainide acetate dosage should be reduced by 50% and the patient monitored closely for adverse effects. Plasma level monitoring is strongly recommended in these circumstances.
Class IV antiarrhythmics: The use of flecainide acetate with calcium channel blockers, e.g. verapamil, should be considered with caution.
Life-threatening or even lethal adverse events due to interactions causing increased plasma concentrations may occur (see section 4.9). Flecainide is metabolized by CYP2D6 to a large extent, and concurrent use of drugs inhibiting or inducing this iso-enzyme can increase or decrease plasma concentrations of flecainide, respectively.
An increase of plasma levels may also result from renal impairment due to a reduced clearance of flecainide (see section 4.4).
Hypokalaemia but also hyperkalaemia or other electrolyte disturbances should be corrected before administration of flecainide. Hypokalaemia may result from the concomitant use of diuretics, corticosteroids or laxatives.
Antidepressants: Fluoxetine and other antidepressants increases plasma flecainide concentration; increased risk of arrhythmias with tricyclics. manufacturer of reboxetine advises caution.
Antiepileptics: Limited data in patients receiving known enzyme inducers (phenytoin, phenobarbital, carbamazepine) indicate only a 30% increase in the rate of flecainide elimination.
Antipsychotics: Clozapine – increased risk of arrhythmias.
Antihistamines:Increased risk of ventricular arrhythmias with mizolastine and terfenadine (avoid concomitant use).
Antimalarials: Quinine increases plasma concentrations of flecainide.
Antivirals: Plasma concentrations are increased by ritonavir, lopinavir and indinavir (increased risk of ventricular arrhythmias) (avoid concomitant use).
Antifungals: Terbinafine may increase plasma concentrations of flecainide resulting from its inhibition of CYP2D6 activity.
Diuretics: Class effect due to hypokalaemia giving rise to cardiac toxicity.
H2 antihistamines (for the treatment of gastric ulcers): The H2 antagonist cimetidine inhibits metabolism of flecainide. In healthy subjects receiving cimetidine (1g daily) for 1 week, the AUC of flecainide increased by about 30% and the half-life increased by about 10%.
Antismoking aids: Co-administration of bupropion (metabolised by CYP2D6) with flecainide should be approached with caution and should be initiated at the lower end of the dose range of the concomitant medication. If bupropion is added to the treatment regimen of a patient already receiving flecainide acetate, the need to decrease the dose of the original medication should be considered.
Anticoagulants: The treatment with flecainide acetate is compatible with the use of oral anticoagulants.
Section 4.6:
Pregnancy information
There is no evidence as to drug safety in human pregnancy. In New Zealand White rabbits, high doses of flecainide acetate caused some foetal abnormalities, but these effects were not seen in Dutch Belted rabbits or rats (see section 5.3). The relevance of these findings to humans has not been established. Data have shown that flecainide crosses the placenta to the foetus in patients taking flecainide during pregnancy. Flecainide should only be used in pregnancy if the benefit outweighs the risks.
Breastfeeding
Flecainide acetate is excreted in human milk. Plasma concentrations obtained in a nursing infant are 5-10 times lower than therapeutic drug concentrations (see section 5.2). Although the risk of adverse effects to the nursing infant is very small, flecainide acetate should only be used during lactation if the benefit outweighs the risks.
Section 4.7:
Driving ability, operation of machinery and work without a secure fit may be affected by adverse reactions such as dizziness and visual disturbances, if present.
Section 4.8:
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/l0), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥ 1/10,000 and <1/1000) and very rare (<1/10,000), not known (cannot be estimated from the available data).
Blood and lymphatic system disorders:
Uncommon: red blood cell count decreased, white blood cell count decreased and platelet count decreased
Immune system disorders:
Very rare: antinuclear antibody increased with and without systemic inflammation
Psychiatric disorders:
Rare: hallucination, depression, confusional state, anxiety, amnesia, insomnia
Nervous system disorders:
Very common: giddiness, dizziness and light headedness, which is usually transient
Rare: paraesthesia, ataxia hypoaesthesia, hyperhidrosis, syncope, tremor, flushing, somnolence, headache, neuropathy peripheral, convulsion, dyskinesia
Eye disorders:
Very common: visual impairment, such as diplopia and vision blurred
Very rare: corneal deposits
Ear and labyrinth disorders:
Rare: tinnitus, vertigo
Cardiac disorders:
Common: Proarrhythmia (most likely in patients with structural heart disease and/or significant left ventricular impairment).
Uncommon: Patients with atrial flutter can develop a 1:1 AV conduction with increased heart rate.
Not known: Dose-related increases in PR and QRS intervals may occur (see section 4.4). Altered pacing threshold (see section 4.4), atrioventricular block-second-degree and atrioventricular block third degree, cardiac arrest, bradycardia, cardiac failure/ cardiac failure congestive, chest pain, hypotension, myocardial infarction, palpitations, sinus arrest, and tachycardia (AT or VT). Demasking of a pre-existing Brugada syndrome.
Respiratory, thoracic and mediastinal disorders:
Common: dyspnoea
Rare: pneumonitis
Not known: pulmonary fibrosis, insterstitial lung disease
Gastrointestinal disorders:
Uncommon: nausea, vomiting, abdominal pain, constipation, decreased appetite diarrhoea, dyspepsia, flatulence
Hepatobiliary disorders:
Rare: hepatic enzymes increased with and without jaundice
Frequency not known (cannot be estimated from the available data): hepatic dysfunction, cholestasis and hepatic failure
Skin and and subcutaneous tissue disorders:
Uncommon:dermatitis allergic, including rash, alopecia.
Rare: serious urticaria
Very rare: photosensitivity reaction
General disorders and administration site conditions:
Common: Asthenia, fatigue, pyrexia, oedema
Section 4.9:
Overdosage with flecainide acetate is a potentially life-threatening medical emergency. Increased drug susceptibility and plasma levels exceeding therapeutic levels may also result from drug interaction (see section 4.5). No specific antidote is known. There is no known way to rapidly remove flecainide acetate from the system. Neither dialysis nor haemoperfusion is effective.
Treatment should be supportive and may include removal of unabsorbed drug from the GI tract. Further measures may include inotropic agents or cardiac stimulants such as dopamine, dobutamine or isoproterenol as well as mechanical ventilation and circulatory assistance (e.g. ballon pumping). Temporarily inserting a transvenous pacemaker in the event of conduction block should be considered. Assuming a plasma half-life of approximately 20 h, these supportive treatments may need to be continued for an extended period of time. Forced diuresis with acidification of the urine theoretically promotes drug excretion.
Updated on 21 July 2011
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 7 - Marketing authorisation holder
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Change to section 2 - Qualitative and quantitative composition
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2: For a full list of excipients, see section 6.1
Section 3: 100mg: The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Section 4.7: Not relevant.
Section 7: Ireland added to the address.
Section 9: Date of last renewal: 28 February 2010
Section 10: September 2010
Section 3: 100mg: The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Section 4.7: Not relevant.
Section 7: Ireland added to the address.
Section 9: Date of last renewal: 28 February 2010
Section 10: September 2010
Updated on 19 July 2011
Reasons for updating
- Change to date of revision
- Change due to harmonisation of PIL
Updated on 15 February 2008
Reasons for updating
- New PIL for new product
Updated on 20 April 2007
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)