Flecainide Teva

Patient Information Leaflet: Information for the User

Flecainide Teva 100 mg tablets

Flecainide acetate
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Flecainide Teva is and what it is used for
2. What you need to know before taking Flecainide Teva
3. How to take Flecainide Teva
4. Possible side effects
5. How to store Flecainide Teva
6. Contents of the pack and other information

1. What Flecainide Teva is and what it is used for

Flecainide belongs to a group of medicines that act against cardiac arrhythmia (known as antiarrhythmics). It inhibits the conduction of electrical impulses in the heart and prolongs the period during which the heart is at rest, thereby restoring normal pumping function.
Flecainide Teva is used for:

• certain severe cardiac arrhythmias, often manifesting as severe palpitations or tachycardia;
• severe cardiac arrhythmias that have not responded adequately to treatment with other medicines or when other drug therapies cannot be tolerated.

2. What you need to know before taking Flecainide Teva

Do not take Flecainide Teva

• If you are allergic to flecainide or to any of the other ingredients of this medicine (listed in section 6).
• If you suffer from other heart conditions different from the one for which you are taking the medicine. If you are unsure or would like further information, consult your doctor or pharmacist.
• If you are taking other antiarrhythmics (sodium channel blockers) at the same time.
• If you have been diagnosed with Brugada syndrome.

Warnings and precautions
Talk to your doctor or pharmacist before taking Flecainide Teva:

• If you have impaired liver and/or kidney function, as the concentration of flecainide in the blood may increase. In such cases, your doctor will regularly monitor the levels of Flecainide Teva in your blood. The rate of elimination of flecainide from plasma may be reduced in elderly patients. This should be taken into account when adjusting the dose.
• If you have a permanent pacemaker or temporary pacing electrodes.
• If you have experienced cardiac arrhythmias after heart surgery.
• Severe bradycardia or severe hypotension must be corrected before using flecainide.

Like other antiarrhythmics, flecainide may cause pro-arrhythmic effects, meaning it may trigger a more serious type of arrhythmia, increase the frequency of an existing arrhythmia, or worsen symptom severity (see section 4 “Possible side effects”).

Oral treatment with flecainide should be initiated in hospital or under the supervision of a specialist for patients with:

• Reciprocating AV nodal tachycardia; arrhythmias associated with Wolff-Parkinson-White syndrome and similar conditions involving accessory conduction pathways;
• Paroxysmal atrial fibrillation in patients with disabling symptoms.

Treatment of patients with other indications should also be initiated in hospital.
Intravenous flecainide treatment must be started in hospital.
Continuous ECG monitoring is recommended for all patients receiving flecainide administered as an intravenous bolus.
Low or high blood potassium levels may affect the action of flecainide.
Electrolyte imbalances (e.g. hypo- or hyperkalemia) must be corrected before using flecainide (see section “Other medicines and Flecainide Teva” for medicines causing electrolyte disturbances).
Diuretics, medicines that stimulate bowel movements (laxatives), and corticoadrenal hormones (corticosteroids) may reduce blood potassium levels. In such cases, your doctor should monitor your blood potassium levels.

Children and adolescents
Flecainide is not recommended in children under 12 years of age, as there is insufficient evidence on its use in this age group.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

Other medicines and Flecainide Teva
If you take other medicines together with flecainide, they may affect each other’s action and/or side effects (i.e. drug interactions may occur).
Potentially life-threatening or even fatal adverse events may occur due to interactions that increase plasma concentrations (see section “If you take more Flecainide Teva than you should”).
Increased plasma concentrations may also result from renal impairment due to reduced clearance of flecainide (see section “Warnings and precautions”).
Hypokalemia, hyperkalemia, or other electrolyte imbalances must be corrected before administering flecainide. Hypokalemia may result from concomitant use of diuretics, corticosteroids, or laxatives.

Interactions may occur, for example, when taking the following medicines:

• Digoxin (a medicine that stimulates the heart): flecainide may increase digoxin blood levels;
• Medicines that reduce cardiac pump function, such as beta-blockers;
• Certain antiepileptic drugs (e.g. phenytoin, phenobarbital, and carbamazepine): these may accelerate the breakdown of flecainide;
• Cimetidine (an antacid): may increase the effect of flecainide;
• Amiodarone (for heart disorders): in some patients, the dose of flecainide may need to be reduced;
• Medicines for depression (paroxetine, fluoxetine, and some other antidepressants);
• Avoid concomitant use of astemizole, mizolastine, and terfenadine (antiallergic medicines);
• Quinine and halofantrine (medicines for malaria);
• Verapamil or other calcium channel blockers (used to reduce blood pressure);
• Quinidine;
• Medicines for the treatment of HIV infections (ritonavir, lopinavir, and indinavir);
• Thiazides and loop diuretics, as hypokalemia caused by these drugs may lead to cardiotoxicity;
• Other antiarrhythmics (sodium channel blockers); do not take flecainide if you are already taking these medicines;
• Terbinafine (for fungal infections);
• Bupropion (a smoking cessation aid);
• Clozapine (an antipsychotic): increased risk of arrhythmias.

Flecainide treatment may be taken together with oral anticoagulants.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Flecainide Teva with food and drink
Flecainide should be taken on an empty stomach, or at least one hour before meals.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
There are insufficient data on the safety of flecainide during pregnancy. Available data show that flecainide crosses the placenta and reaches the fetus in patients treated with flecainide during pregnancy. Flecainide should be used during pregnancy only if the benefits outweigh the risks. If flecainide is used during pregnancy, drug levels in the mother’s plasma should be monitored throughout pregnancy. Consult your doctor as soon as you suspect you are pregnant or if you plan to have a baby.

Breastfeeding
Flecainide is excreted in breast milk. Plasma concentrations in a breastfed infant are 5–10 times lower than therapeutic drug concentrations. Although the risk of harmful effects on the infant is low, flecainide should be used during breastfeeding only if the benefits outweigh the risks.

Driving and using machines
Flecainide acetate has a moderate effect on the ability to drive and use machines. Your ability to drive, operate machinery, or work safely may be impaired by adverse reactions such as dizziness and visual disturbances.
If you experience side effects such as dizziness, double or blurred vision, or a sensation of light-headedness, your reaction ability may be reduced. If you have any doubts about the actual negative effect of flecainide on your ability to drive, discuss this with your doctor.

3. How to take Flecainide Teva

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will prescribe a personalized dose appropriate for your condition. Treatment with flecainide is usually started in a hospital setting. Follow your doctor's advice and instructions carefully while taking flecainide. If in doubt, consult your doctor or pharmacist.

When and how to take the tablets
Take the tablets with a sufficient amount of liquid (e.g. water). The daily dose is usually divided throughout the day and should be taken on an empty stomach or at least one hour before meals.

The following dosage is only indicative:
The usual initial dose ranges between 100 and 200 mg; your doctor may increase the dose up to a maximum of 400 mg per day.

Elderly patients
Your doctor may prescribe a lower dose for you. The dose for elderly patients should not exceed 300 mg per day (or 150 mg twice daily).

Use in children
These tablets are not suitable for children under 12 years of age.

Patients with renal or hepatic impairment
Your treating physician may prescribe a lower dose for you.

Patients with a permanent pacemaker
The daily dose must not exceed 100 mg twice daily.

Patients treated concomitantly with cimetidine (a medicine for gastric disorders) or amiodarone (a medicine for cardiac arrhythmia)
Your doctor must monitor you closely and may prescribe a lower dose for some patients.

During treatment, your doctor must regularly monitor flecainide blood levels and perform electrocardiograms (ECG). A simple ECG should be performed once a month, while a more detailed ECG should be carried out every three months. At the beginning of treatment and when the dose is increased, an ECG should be performed every 2–4 days. Patients treated with a lower than usual dose should undergo ECG monitoring more frequently. Your doctor may adjust the dose at intervals of 6–8 days. These patients should undergo ECGs during the second and third weeks after starting treatment.

If you take more Flecainide Teva than you should
If you suspect an overdose, inform your doctor immediately.
Overdose with flecainide is a potentially life-threatening medical emergency.
Pharmacological interactions with other medicines may lead to increased plasma concentrations of flecainide (above therapeutic levels) (see section “Other medicines and Flecainide Teva”). No specific antidote is known. If appropriate, measures to reduce absorption may be taken (e.g. gastric lavage or administration of activated charcoal).
There are no known methods to rapidly remove flecainide from the body. Neither dialysis nor hemoperfusion are effective. Supportive treatment is required, which may include removal of unabsorbed drug from the gastrointestinal tract. Additional measures may include inotropic or cardiac stimulant agents such as dopamine, dobutamine, or isoproterenol, intravenous calcium, mechanical ventilation, and circulatory support (e.g. balloon dilation). Temporary transvenous pacemaker insertion should be considered in case of conduction block or if left ventricular function is in any way impaired.
Due to the long plasma half-life of flecainide (approximately 20 hours), supportive measures may need to be continued for prolonged periods. Forced diuresis with acidification of urine may theoretically enhance urinary excretion of the drug.

If you forget to take Flecainide Teva
Take the missed dose as soon as you remember, unless you remember only when it is almost time for the next dose. In this case, do not take the missed dose, but continue with your regular dosing schedule. It is important to remember to take the tablets as prescribed. If you have any doubts, consult your doctor.
Do not take a double dose to make up for a forgotten tablet.

If you stop taking Flecainide Teva
If you suddenly stop taking flecainide, there is no risk of withdrawal symptoms. However, your cardiac arrhythmia may no longer be adequately controlled. Therefore, do not stop taking this medicine without informing your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Like other antiarrhythmics, flecainide may have the effect of inducing arrhythmia. An existing arrhythmia may worsen or a new arrhythmia may occur. The risk of proarrhythmic effects is higher in patients with structural heart disease and/or significant impairment of cardiac function.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 and < 1/10), uncommon (≥ 1/1,000 and < 1/100), rare (≥ 1/10,000 and < 1/1,000), very rare (< 1/10,000), not known (frequency cannot be estimated from the available data).

Blood and lymphatic system disorders:
Uncommon: decreased red blood cell count, decreased white blood cell count, decreased platelet count.

Immune system disorders:
Very rare: increase in antinuclear antibodies with or without systemic inflammation.

Psychiatric disorders:
Rare: hallucinations, depression, confusion, anxiety, amnesia, insomnia.

Nervous system disorders:
Very common: dizziness (usually transient, disappearing with continued treatment or dose reduction), drowsiness, and sensation of emptiness in the head.
Rare: paresthesia, ataxia, hypoesthesia, hyperhidrosis, syncope, tremor, hot flushes, somnolence, headache, peripheral neuropathy, seizures, dyskinesia.

Eye disorders:
Very common: visual disturbances such as diplopia and blurred vision, and accommodation disorders.
Very rare: corneal deposits.

Ear and labyrinth disorders:
Rare: tinnitus, vertigo.

Cardiac disorders:
Common: proarrhythmia (more likely in patients with structural heart disease).
Uncommon: patients with atrial flutter may develop 1:1 AV conduction following initial atrial slowing with increased heart rate. This has been observed more commonly after intravenous injection for acute conversion. This effect is usually short-lived and resolves rapidly upon discontinuation of therapy.
Not known: dose-related increases in PR and QRS intervals may occur; altered stimulation threshold, second- and third-degree atrioventricular block, cardiac arrest, bradycardia, heart failure/congestive heart failure, chest pain, hypotension, myocardial infarction, palpitations, sinus pause or arrest, and tachycardia (AT or VT). Ventricular arrhythmias may worsen and ventricular fibrillation that is not reversible may occasionally occur. Unmasking of pre-existing Brugada syndrome.

Respiratory, thoracic and mediastinal disorders:
Common: dyspnea.
Rare: pneumonia.
Not known: pulmonary fibrosis, interstitial lung disease.

Gastrointestinal disorders:
Uncommon: nausea, vomiting, constipation, abdominal pain, decreased appetite, diarrhea, dyspepsia, flatulence, dry mouth, and taste disturbances.

Hepatobiliary disorders:
Rare: increased liver enzymes with or without jaundice.
Not known: hepatic dysfunction.

Skin and subcutaneous tissue disorders:
Uncommon: allergic dermatitis, including skin rash, alopecia.
Rare: severe urticaria.
Very rare: photosensitivity reactions.

General disorders and administration site conditions:
Common: asthenia, fatigue, fever, edema, malaise.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Flecainide Teva

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month. If you have any doubts about the shelf life, consult your pharmacist.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Flecainide Teva contains

• The active substance is flecainide acetate.
• One tablet contains 100 mg of flecainide acetate.
• The excipients are: sodium croscarmellose (E468), magnesium stearate (E470b), pregelatinized corn starch, corn starch, and microcrystalline cellulose (E460).

Description of the appearance of Flecainide and the contents of the pack
The 100 mg tablet is round and white, with a score line on one side, marked with the imprint “FJ” on one side of the line and “C” on the other, and a score line on the opposite side. The 100 mg tablet can be divided into two equal parts.
Pack sizes:
Blister packs: 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168 and 180 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy
Manufacturer
Accord-UK Limited, Whiddon Valley, Barnstaple, N. Devon, EX32 8NS (United Kingdom)
Merckle GmbH, Ludwig-Merckle-Strasse 3, Blaubeuren, Baden-Wuerttemberg, 89143 (Germany)