TAMBOCOR 10MG/ML INJECTION OR INFUSION

Active substance: FLECAINIDE ACETATE

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• Use cautiously in patients with acute onset
atrial fibrillation following cardiac surgery.
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 increases plasma
flecainide concentration. Tricyclics increase the
risk of arrhythmias. Reboxetine manufacturer
advises caution
• 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.

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 failure/congestive
cardiac failure, chest pain, hypotension,
myocardial infarction, palpitation, sinus pause
or arrest and tachycardia (AT or VT)
• 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.
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.
Do not store above 30 °C. Do not freeze. Protect
from light.
PL 15142/0077

56UK1833110-02
Tambocor is a trademark of MEDA AB.
The Triangle Logo on the packaging is a
trademark of 3M and is used under license.

Patient Information Leaflet

Tambocor 10 mg/ml Solution for injection or infusion
Flecainide acetate
Read all of this leaflet carefully. 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.
In this leaflet:
1. What Tambocor injection is for
2. 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. Further information.
1. What Tambocor injection is 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. Before you are given Tambocor injection
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 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.
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 or amiodarone
• Medicines to treat high blood pressure
• Antidepressants (medicines to treat depression),
such as tricyclic antidepressants, Prozac 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, trying to become pregnant, or
breast-feeding, 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
the drip if this is chosen for you.
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

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• 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.
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.
Seek immediate medical help if you have any
of the following symptoms:
• Your rapid or irregular heart beat seems to
get worse
• You have chest pain
• You become breathless
• You have ringing in your ears
• Your skin and eyes begin to go yellow (jaundice)
• You have a fever, become flushed or sweat.
Other side effects:
• Feeling sick
• Constipation
• Feeling bloated
• Wind
• Stomach pain
• Loss of appetite
• Confusion and hallucinations
• Difficulty sleeping
• Feeling anxious (worried)
• Red, itchy or swollen skin rash
• Feeling weak and tired
• Headache
• Double or blurred vision
• Dizziness or feeling that the room is spinning
(vertigo)
• Swelling
• Depression.
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. Further 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 11/2013.

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.

56UK1833110-02
Tambocor is a trademark of MEDA AB.
The Triangle Logo on the packaging is a
trademark of 3M and is used under license.

Patientl Page 2

Patient Information Leaflet

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.
Elderly Patients: The rate of elimination of
flecainide may be reduced, so dose adjustment
may be necessary.

Contraindications
• 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 post-myocardial 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

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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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