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TAMBOCOR 10MG/ML INJECTION OR INFUSION

Active substance(s): FLECAINIDE ACETATE

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• Antiepileptics: Known enzyme inducers (phenytoin,
phenobarbital, carbamazepine) increase the rate of
flecainide elimination by approximately 30 %
• Antipsychotics: Clozapine increases the risk of arrhythmias
• Antihistamines: Mizolastine and terfenadine increase the risk
of ventricular arrhythmias
• Antimalarials: Quinine increases plasma flecainide
concentration
• Antivirals: plasma flecainide concentrations are increased by
ritonavir, lopinavar and indinavir to increase risk of
ventricular arrhythmias. Avoid concomitant use
• Diuretics: Hypokalaemia may cause cardiac toxicity
• Cimetidine: Increases plasma flecainide by approximately
30 %
• Anti-smoking aids: Bupropion: May increase flecainide
plasma concentration by inhibitory effects on CYP2D6, the
isoenzyme responsible for flecainide metabolism.
• Tambacor injection is compatible with oral anticoagulants.
Side effects
• Body as a whole: asthenia, fatigue, fever oedema
• Cardiovascular: Pro-arrhythmic effects - most likely in
patients with structural heart disease and/or significant left
ventricular impairment. Dose related increases in PR and
QRS intervals may occur. Altered pacing threshold. 1:1 AV
conduction following initial atrial slowing with resultant
ventricular acceleration may occur (most commonly seen
following use of the injection for acute conversion). This
effect is usually short lived and abates quickly once therapy
is stopped.
• Other reported effects: AV block-second-degree and
third degree, bradycardia, cardiac arrest, cardiac failure/
congestive cardiac failure, chest pain, hypotension,
myocardial infarction, palpitation, sinus pause or arrest
and tachycardia (AT or VT) or ventricular fibrillation.
Demasking of a pre-existing Brugada syndrome.
• Skin and appendages: Allergic skin reactions, rashes,
urticaria, photosensitivity
• Immune system: Increased anti-nuclear antibodies with and
without systemic inflammatory involvement
• Haematological: Reductions in red and white blood cells
and platelets reported occasionally
• Psychiatric: Hallucinations, depression, confusion, amnesia,
anxiety, insomnia
• Gastrointestinal: Nausea, vomiting, abdominal pain,
anorexia, constipation, diarrhoea, dyspepsia, flatulence
• Liver and biliary system: elevated liver enzymes, jaundice
which is reversible on
stopping treatment, hepatic dysfunction
• Neurological: Giddiness, dizziness, light-headedness,
dyskinesia, convulsions. During long-term therapy peripheral
neuropathy, paraesthesia, ataxia, flushing, headache,
hypoaesthesia, increased sweating, somnolence, syncope,
tinnitus, tremor, vertigo
• Ophthalmological: Double vision, blurred vision, corneal
deposits
• Respiratory: Dyspnoea, pneumonitis, pulmonary fibrosis,
interstitial lung disease.
• Ear and labyrinth disorders: tinnitus, vertigo
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation
of the medicinal product is important. It allows continued
monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
Overdosage: No specific antidote or rapid method of
removing flecainide from the system is known. Forced acid
diuresis may be helpful (theoretically), but dialysis and
haemoperfusion are not. Injections of anticholinergics are not
recommended. Treatment of flecainide overdosage may
include use of an inotropic agent, intravenous calcium,
circulatory assistance (e.g. balloon pumping), mechanically
assisting respiration, or temporarily inserting a transvenous
pacemaker if there are severe conduction disturbances or the
patient’s left ventricular function is otherwise compromised.

Handling and storage: Tambocor injection should be diluted
with, or injected into, sterile solutions of 5 % glucose. If
chloride containing solutions, such as sodium chloride or
Ringer’s lactate are used, the injection should be added to a
volume of not less than 500 ml, otherwise a precipitate will
form.

Patient Information Leaflet

Tambocor 10 mg/ml Solution for injection or infusion
Flecainide acetate

Do not store above 30 °C. Do not freeze. Protect from light.
PL 15142/0077

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for
you. This medicine is an injection and will only be given to
you by a doctor in hospital.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you. Do not pass it
on to others. It may harm them, even if their symptoms are
the same as yours.
What is in this leaflet:
1. What Tambocor injection is and what it is used for
2. What you need to know before you are given Tambocor
injection
3. How you will be given Tambocor injection
4. Possible side effects
5. How to store Tambocor injection
6. Contents of the pack and other information.
1. What Tambocor injection is and what it is used for
Tambocor injection belongs to a group of medicines called
anti-arrhythmics. Anti-arrhythmics work by controlling the rate
and rhythm of the heart. Tambocor injection is used to treat
arrhythmias (irregular heart beat), tachycardia (heart beat too
fast), and atrial fibrillation (rapid contractions of muscles in the
heart). Tambocor injection is used by your doctor when a
rapid response is required to control one or more of these
conditions.
It is important for your doctor to treat these conditions quickly
and effectively in order to prevent more serious heart problems
from developing.
2. What you need to know before you are given
Tambocor injection

56UK1833110-03
Tambocor is a trademark of MEDA AB.
The Triangle Logo on the packaging is a
trademark of 3M and is used under license.

Do not use Tambocor injection if:
• You are allergic to flecainide acetate or any of the other
ingredients of Tambocor injection
• You have heart failure
• You have cardiogenic shock (your heart is unable to pump
as much blood as your body needs)
• You have heart block (your heart misses beats)
• You have or have had any heart problems including
problems with the valves in your heart or conduction
problems
• You have sinus node dysfunction (a specific condition where
your heart beats abnormally)
• You have had a myocardial infarction (heart attack)
• You have Brugada Syndrome, a genetic disease that causes
severe disturbances of the rhythm of the heart and may lead
to sudden death in apparently healthy individuals.
• You are pregnant or breast-feeding.
Tambocor injection is not recommended for use in children
under 12 years of age, however, dairy products such as milk,
infant formula and possibly yoghurt, may reduce how much
Tambocor Injection is absorbed in children and infants.
If any of the above applies to you tell your doctor or nurse.
Before you are given Tambocor injection your ­doctor or
nurse may check
• Your fluid levels are correct
• Your liver and kidney functions.
This is to check that Tambocor injection is right for you and to
help the doctor calculate the dose you need.
Check with the doctor or nurse before they give you
Tambocor injection if:
• You have high blood pressure
• You have angina (chest pains)
• You have heart disease

• You have kidney disease or kidney problems
• You have liver disease or liver problems
• You wear a pacemaker.
Tell your doctor if you are taking any of the ­following
medicines:
• Any other medicine used to treat heart arrhythmias or heart
problems such as cardiac glycosides,
beta-blockers, verapamil, propranol or amiodarone
• Medicines to treat high blood pressure
• Antidepressants (medicines to treat depression), such as
tricyclic antidepressants, Prozac, paroxetine, fluoxetine or
reboxetine
• Anticonvulsants (medicines used to prevent epileptic fits) such
as phenytoin, phenobarbital or carbamazepine
• Antipsychotics (medicines to treat mental illness) such as
clozapine
• Antihistamines (medicines to treat allergic reactions) such as
mizolastine or terfenadine
• Quinine (medicine to treat malaria)
• Medicines to treat HIV such as ritonavir, lopinavar or
indinavir
• Diuretics (water tablets)
• Cimetidine (medicine to treat stomach ulcers)
• Bupropion (a medicine to help you stop smoking)
• Any other medicine, including medicines obtained without
a prescription.
These medicines may interfere with your treatment.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
nurse for advice before being given Tambocor.
Driving and using machines:
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).
3. How you will be given Tambocor injection
Tambocor injection will only be given to you by a doctor in
hospital.
Important: Your doctor will choose the dose that
is right for your condition. The doctor will also decide
whether you receive Tambocor as an injection from the
syringe, or in the form of an infusion (drip). The doctor or
nurse will monitor ethe drip if this is chosen for you.
If you have switched from a different formulation (e.g.
from Tambocor tablets) your doctor should do so with
caution and monitor you closely
Adults
• The usual dose is 2 mg per kg body weight
• The doctor will give the injection slowly into your vein over at
least 10 minutes by slow injection
• If the medicine is given via a drip, the maximum dose should
not exceed 600 mg over 24 hours
• When given as a drip, Tambocor injection is diluted with a
sterile solution containing 5 % dextrose.
The elderly and patients with kidney/heart problems
• For elderly patients, and patients with kidney or heart
problems, the doctor may give a lower dose and perform the
injection or the infusion (drip) more slowly.
During your treatment with Tambocor injection the doctor or
nurse will monitor your heart with an electrocardiogram (ECG).
This is to make sure that your medicine is working properly
and that the dose you are taking is right for you.

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If you are given more Tambocor injection than
you should
This is unlikely as Tambocor will be injected slowly by a
doctor who will monitor your heart continuously during
treatment. If any problem occurs, Tambocor injection can be
stopped and any symptoms of overdosage treated urgently.
If you have any further questions about the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines Tambocor injection can cause side effects,
although not everybody gets them.
Some side effects could be serious. If you have any of
the side effects listed below, seek immediate medical
help:
Common (affects 1 in 100 people):
• Your rapid or irregular heart beat seems to get
worse
• You have chest pain
• You become breathless
• You have a fever, become flushed or sweat.
• You faint or feel faint
Rare (affects 1 in 10,000 people):
• You have ringing in your ears
• Your skin and eyes begin to go yellow (jaundice)
• You have fits (convulsions)
Other side effects (how often they happen is unknown):
•h
 eart attack
•c
 ardiac failure/arrest (loss of breathing, and
consciousness and loss of heart function)
Other side effects include the following, if they get
serious, please tell your doctor:
Very common (affects more than 1 in 10 people):
• Dizziness
• Double or blurred vision
Common (affects 1 in 100 people):
• Feeling week or tired
• Lack of energy and strength
• Swelling (fluid retention)
Uncommon (affects 1 in 1,000 people):
• Blood disorders (reduced red and white blood cell count and
reduced platelet count)
• Feeling or being sick
• Constipation
• Stomach pain or indigestion
• Loss of appetite
• Diarrhoea
• Wind
• Feeling bloated
• Red, itchy or swollen skin rash
• Hair loss
Rare (affects 1 in 10,000 people):
• Vertigo (feeling like the room is spinning)
• Confusion and hallucinations
• Depression
• Feeling anxious (worried)
• Forgetfulness
• Difficulty sleeping
• Numbness, tingling, tickling, prickling or burning sensation
of the skin
• Unsteady walking, uncontrolled movements or poor
coordination, difficulty speaking
• Reduced sense of touch
• Excessive sweating and flushed skin
• Shaking (tremors)
• A strong desire to sleep or sleep for long periods
• Headache

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Very rare (affects less than 1 in 10,000 people):
• Small cloudy spots on the eyeball
• Sensitivity of the skin to sunlight
Other side effects (how often they happen is unknown):
• lung disease and scarring of the lungs
• liver disease
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 Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Tambocor injection
Keep out of the reach and sight of children.
For single use only.
Do not use Tambocor injection after the expiry date on the
carton. The expiry date refers to the last day of that month.
Do not store above 30 °C.
Do not freeze.
Protect from light.
Medicines should not be disposed of via wastewater or
household waste. Return any medicine you no longer need to
your pharmacist.
6. Contents of the pack and other information
What Tambocor injection contains
• The active ingredient is flecainide acetate. Each millilitre (ml)
of solution contains
10 milligrams (mg) of flecainide acetate.
• The other ingredients are: sodium acetate, glacial acetic
acid and water.
What Tambocor injection looks like
Tambocor injection comes in sealed 15 ml glass containers
called ampoules.
Each box of Tambocor injection contains five
15 ml ampoules.
Marketing Authorisation Holder:
Meda Pharmaceuticals Ltd, Skyway House,
Parsonage Road, Takeley, Bishop’s Stortford, CM22
6PU, United Kingdom.
Manufacturer:
Cenexi
52, rue Marcel et Jacques Gaucher
94120 Fontenay-Sous-Bois
France
This leaflet was last revised 12/2014.

If this leaflet is difficult to see or read or
you would like it in a different format,
please contact Meda Pharmaceuticals Ltd,
Skyway House, Parsonage Road,
Takeley, Bishop’s Stortford,
CM22 6PU, United Kingdom.

Patient Page 2

56UK1833110-03
Tambocor is a trademark of MEDA AB.
The Triangle Logo on the packaging is a
trademark of 3M and is used under license.

Technical Information Leaflet for Professionals

Tambocor 10 mg/ml Solution for injection or infusion
Flecainide acetate

Presentation:
Each 15 ml ampoule contains 15 ml of flecainide acetate
10 mg/ml, solution for injection or infusion. The other
ingredients are sodium acetate, glacial acetic acid and water.
Therapeutic indications:
For the rapid control of the following arrhythmias:
• Treatment-resistant ventricular tachyarrhythmias
• 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. Recent onset arrhythmias respond more readily.
Directions for use:
Tambocor injection may be given as a bolus injection in an
emergency or for rapid effect, or as a slow intravenous
infusion when prolonged administration is required.
a) 
Bolus injection: Administer 2 mg/kg over not less than 10
minutes, or in divided doses. Alternatively, dilute with 5%
glucose and give as a mini-infusion. Continuous ECG
monitoring is recommended. Stop the injection when the
arrhythmia is controlled.
For sustained ventricular tachycardia, or people with a
history of cardiac failure (who may become decompensated
during administration) give the initial dose over 30 minutes
and monitor the ECG carefully.
The maximum recommended bolus dose is 150 mg.
b) Intravenous infusion: The recommended procedure is to
start with a slow injection of 2 mg/kg over 30 minutes, then
continue intravenous infusion at the following rates:
First hour: 1.5 mg/kg per hour
Second and later hours: 0.1-0.25 mg/kg per hour.
The maximum recommended infusion duration is 24 hours;
if exceeded, and in patients receiving high doses, monitor
plasma levels. The maximum cumulative dose over the first
24 hours should not exceed 600 mg.
In severe renal impairment (creatinine clearance
<35 ml/min/1.73 sq.m.) reduce the above dosage
recommendations by half.
Oral maintenance dosing should be started as soon as
possible after stopping the infusion.
Children: Not recommended in children under 12 years,
however, dairy products such as milk, infant formula and
possibly yoghurt, may reduce how much Tambocor Injection is
absorbed in children and infants.
Elderly Patients: The rate of elimination of flecainide may be
reduced, so dose adjustment may be necessary.
Contraindications
• Hypersensitivity to flecainide or to any of the excipients
• Cardiac failure
• History of myocardial infarction with either asymptomatic
ventricular ectopics, or asymptomatic non-sustained
ventricular tachycardia.
• Long-standing atrial fibrillation where there has been no
attempt to convert to sinus rhythm
• Haemodynamically significant valvular heart disease
• In the presence of cardiogenic shock.
• Known Brugada Syndrome.
• Unless pacing rescue is available, do not give to patients
with sinus node dysfunction, atrial conduction effects,
second degree or greater atrio-ventricular block, bundle
branch block or distal block.
Precautions
• Correct any electrolyte disturbances before
using Tambocor injection

• Plasma elimination of flecainide may be markedly slower in
patients with significant hepatic impairment. Do not use,
unless the potential benefits clearly outweigh the risks.
Careful plasma monitoring is recommended
• Flecainide 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 elimination from plasma may be
reduced in the elderly. This should be taken into
consideration when making dose adjustments.
• Severe bradycardia or pronounced hypotension should be
corrected before using flecainide.
• Flecainide has been shown to increase mortality risk of ­postmyocardial infarction patients with asymptomatic ventricular
arrhythmia.
• Flecainide, 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).
• Decreased endocardial pacing sensitivity may occur; this
effect is reversible and more marked on the acute pacing
threshold than on the chronic
• Use with caution in all patients with permanent pacemakers
or temporary pacing electrodes. Do not administer to
patients with existing poor thresholds, or non-programmable
pacemakers, unless suitable pacing rescue is available
• Flecainide’s minor negative inotropic effect may become
important in patients predisposed to cardiac failure.
Difficulty in defibrillating some patients has been reported.
The majority of these cases had pre-existing heart disease
with cardiac enlargement, a history of myocardial infarction,
arteriosclerotic heart disease and cardiac failure
• Use cautiously in patients with acute onset atrial fibrillation
following cardiac surgery.
• Flecainide as a narrow therapeutic index drug requires
caution and close monitoring when switching a patient to
a different formulation
Use in pregnancy and lactation: Flecainide crosses the
placenta; however, the safety of Tambocor injection in
pregnancy has not been established. Flecainide is excreted in
human milk and appears in concentrations which reflect those
in maternal blood. The risk of adverse effects to the nursing
infant is very small.
Drug interactions: Flecainide is a class I antiarrythmic.
Possible interactions include:
• Additive effects with other anti-arrhythmic drugs or with
drugs affecting the metabolism of flecainide
• Cardiac glycosides: flecainide can cause plasma digoxin to
rise by about 15 %. 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 II antiarrythmics: additive negative inotropic effects of
beta-blockers and other cardiac depressants with
concomitant flecainide should be recognised
• Class III antiarrythmics: Reduce the dose of flecainide by
50 % in the presence of amiodarone to avoid additive
effects. Monitor patients for adverse events and plasma
level monitoring is strongly recommended
• Class IV antiarrythmics: use of flecainide with other sodium
channel blockers is not recommended
• Antidepressants: Fluoexetine, paroxetine and other
antidepressants increases plasma flecainide concentration.
Tricyclics increase the risk of arrhythmias. Reboxetine
manufacturer advises caution

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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