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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: Mizoiastine and terfenadine increase the risk of ventricular arrhythmias

•    Antimaiariais: Quinine increases plasma flecainide concentration

•    Antivirals: plasma flecainide concentrations are increased by ritonavir, iopinavar and indinavir to increase risk of ventricular arrhythmias. Avoid concomitant use

•    Diuretics: Hypokaiaemia 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 biock-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.

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1014_G LTambocorJnj_56UK1833110-03.indd 1    Professional Page 2

Patient Information Leaflet

Tambocor 10 mg/ml Solution for injection or infusion

Flecainide acetate

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

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, propranoi oramiodarone

•    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 mizoiastine 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.

Like all medicines Tambocor injection can cause side effects, although not everybody gets them.

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 ceil 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

MCDQ

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/yeiiowcard 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 mi glass containers called ampoules.

Each box of Tambocor injection contains five 15 ml ampoules.

Marketing Authorisation Holder:

Meda Pharmaceuticals Ltd, Skyway House,

Parsonage Road, Takeiey, 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,

Takeiey, Bishop’s Stortford,

CM22 6PU, United Kingdom.

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.

1014_GLTambocorJnj_56UK1833110-03.indd 2    Patient Page2

Technical Information Leaflet for Professionals

Tambocor 10 mg/ml Solution for injection or infusion

Flecainide acetate

Presentation:

Each 15 ml ampoule contains 15 mi 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 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-prog ram mabie 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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