Almarytm

Package leaflet: Information for the patient

ALMARYTM 100 mg tablets

flecainide acetate
Please read all of 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, as it may be harmful.
• If you experience any side effect, including any not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Almarytm is and what it is used for

Almarytm contains the active substance flecainide acetate, which belongs to a class of medicines called "antiarrhythmics". It works by controlling the rate and rhythm of the heartbeat, as it inhibits the conduction of electrical impulses in the heart and prolongs the resting phase of the heart, thereby helping it to pump normally again.
Almarytm is used in adults and adolescents over 12 years of age for:

• certain types of cardiac arrhythmias (abnormal heart rhythms, i.e. changes in the number of heartbeats per minute), some of which may potentially be life-threatening
• tachycardia (very rapid heartbeat)
• atrial fibrillation/atrial flutter (disorganized, very rapid contractions of the atria, which are chambers of the heart).

Treatment with Almarytm tablets in patients with sustained ventricular tachycardia must be carried out in a hospital setting and monitored by a specialist physician.

2. What you should know before taking Almarytm

Do not take Almarytm

• if you are allergic to flecainide acetate or to any of the other ingredients of this medicine (listed in section 6)
• if you have heart failure (a condition in which the heart cannot pump enough blood to meet the body's needs, leading to fluid accumulation in the legs, lungs, and other tissues) and if you have had a heart attack
• if you have cardiogenic shock (low blood pressure with severe reduction in heart function)
• if you have cardiac block (the heart misses beats)
• if you currently suffer or have previously suffered from other heart conduction disorders
• if you have Brugada syndrome (a genetic heart disease characterized by abnormal electrocardiogram)
• if you suffer from other heart conditions different from those for which this medicine is being prescribed.

Warnings and precautions
Talk to your doctor or pharmacist before taking Almarytm.
Treatment with this medicine will begin in a hospital setting or under the supervision of a specialist doctor if you suffer from certain heart rhythm disorders (see section 3).
Your doctor will avoid prescribing Almarytm:

• if you have heart disease or if heart function is abnormal;
• if you suffer from chronic atrial fibrillation (chronic, very rapid, and disorganized contraction of the heart's atria);
• if liver function is severely reduced.

Your doctor will exercise particular caution when prescribing Almarytm:

• if you have heart diseases (including atrioventricular block and heart failure);
• if you have experienced atrial fibrillation after heart surgery;
• if you have a heart disease affecting the sinoatrial node (the area where the heartbeat originates);
• if you have a permanent pacemaker or temporary cardiac pacing electrodes;
• if you have imbalances in water and electrolyte levels in the body (for example, low or high blood potassium levels). Before administering Almarytm, your doctor will check your blood electrolyte levels and initiate appropriate treatment to normalize them;
• if you suffer from severe bradycardia (severely reduced heart rate) or marked hypotension (low blood pressure). Before administering Almarytm, your doctor will check your heart rate and blood pressure and initiate appropriate treatment to normalize these values;
• if you have reduced liver and/or kidney function, as blood levels of flecainide may increase. In such cases, your doctor may decide to monitor flecainide blood levels regularly;
• if you are elderly, as blood levels of flecainide may increase.

Children and adolescents
Do not give Almarytm to children under 12 years of age, as the safety and efficacy of this medicine have not been established.

Other medicines and Almarytm
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

• other antiarrhythmic medicines (medicines used to treat arrhythmias, e.g. amiodarone, verapamil, diltiazem), as your doctor will decide whether to administer Almarytm or reduce the dose;
• antihistamines (medicines used to treat allergic reactions, e.g. mizolastine and terfenadine);
• antivirals (medicines used to treat viral infections, e.g. ritonavir alone or in combination with lopinavir and indinavir);
• antidepressants (medicines used to treat depression, e.g. fluoxetine and other tricyclic antidepressants);
• antipsychotics (medicines used to treat mental disorders, e.g. clozapine);
• antiepileptics (medicines used to treat epilepsy, e.g. phenytoin, phenobarbital, carbamazepine);
• antimalarials (medicines used to treat malaria, e.g. quinine);
• antifungals (medicines used to treat fungal infections, e.g. terbinafine);
• propranolol (a medicine used for hypertension, angina pectoris, and other indications);
• diuretics (medicines that promote urine formation and excretion), laxatives (medicines that stimulate intestinal movement), and corticosteroids (hormones from the adrenal cortex), as they may cause serious heart-related adverse effects due to decreased blood potassium levels (see section “Warnings and precautions”);
• H2 antihistamines (medicines used to treat gastric ulcers, e.g. cimetidine);
• medicines for smoking cessation (e.g. bupropion);
• cardiac glycosides (medicines used to stimulate the heart).

Almarytm with food and drinks
Dairy products (milk, formula milk, and possibly yogurt) may reduce the absorption of Almarytm in children and infants. The use of Almarytm is not authorized in children under 12 years of age. However, flecainide toxicity has been reported during treatment in children who reduced milk intake and in infants switching from formula milk to dextrose feeding.

Pregnancy and breastfeeding
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
Avoid taking Almarytm during pregnancy unless the benefits outweigh the risks.

Breastfeeding
If you are breastfeeding, your doctor will decide whether to discontinue breastfeeding or stop treatment with Almarytm, taking into account the benefits of breastfeeding for the child and the benefits of treatment for you.

Driving and using machines
After taking Almarytm, undesirable effects such as dizziness or visual disturbances may occur, which may impair your reaction ability and pose a risk in situations requiring concentration and alertness, such as driving or operating machinery or working at heights.

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

3. How to take Almarytm

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Treatment with Almarytm 100 mg tablets should be initiated under the supervision of a doctor, and if necessary in a hospital setting, if:

• you suffer from certain types of tachycardia (nodal reciprocating AV tachycardia and sustained ventricular tachycardia)
• you have heart rhythm disorders and have been diagnosed with a condition caused by abnormal electrical conduction in the heart (Wolff-Parkinson-White syndrome).

Dosage
Supraventricular arrhythmia (a type of arrhythmia)
The initial dose is 50 mg every 12 hours, i.e. ½ tablet twice daily.
Your doctor may increase the dose by increments of 50 mg twice daily every 4 days, as deemed necessary.
The maximum dose is 300 mg, i.e. 3 tablets, per day.

Sustained ventricular tachycardia (a type of tachycardia)
The initial dose is 100 mg every 12 hours, i.e. 1 tablet twice daily.
Your doctor may increase the dose by increments of 50 mg, i.e. ½ tablet twice daily every 4 days.
The maximum dose is 400 mg, i.e. 4 tablets per day.

Paroxysmal atrial fibrillation (a type of fibrillation)
The initial dose is 50 mg, i.e. ½ tablet twice daily.
Your doctor may increase the dose to 100 mg, i.e. 1 tablet twice daily.
If your symptoms do not improve, your doctor may instruct you to take the tablets every 8 hours.

If you have reduced kidney function
Your doctor will determine the appropriate dose for you by monitoring flecainide blood levels.
The initial dose may be 100 mg once daily (or 50 mg twice daily), or 100 mg every 12 hours, i.e. twice daily.

If you are elderly
The initial dose is 100 mg twice daily, which may be reduced after the first week of treatment.

Use in children and adolescents
Almarytm is not recommended in children under 12 years of age, as there is insufficient evidence on its use in this age group.
The tablet can be divided into equal parts.

If you take more Almarytm than you should
If you take more Almarytm than prescribed, consult your doctor immediately or go to the nearest hospital, as you may experience adverse effects, even serious ones:

• disturbances in heart conduction
• reduced heart rate and contractility
• decreased blood pressure
• rapid deterioration of respiratory function and cessation of heartbeat, which may lead to death.
  Your doctor will initiate appropriate treatment and supportive measures.

If you forget to take Almarytm
Do not take a double dose to make up for the missed dose.

If you stop taking Almarytm
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone who is administered it will experience them.
If you experience any of the following serious side effects while being treated with Almarytm, inform your doctor immediately, as they will assess whether treatment should be stopped:

• disturbances in the conduction of heartbeats if you have not had surgery to implant a cardiac "pacemaker";
• changes in the electrocardiogram (ECG) trace (a test used to evaluate heart function) that may indicate Brugada syndrome;
• yellowish discoloration of the skin and whites of the eyes without apparent cause, or signs of impaired liver function (e.g. increased liver enzymes, substances present in the liver);
• blood disorders (haematological dyscrasias).

The following side effects have been observed and reported during treatment with Almarytm, according to the following frequency:

Very common (may affect more than 1 in 10 people):

• dizziness, usually transient
• visual disturbances, such as double or blurred vision

Common (may affect up to 1 in 10 people):

• occurrence of a more severe type of arrhythmia or increased frequency or severity of a pre-existing arrhythmia (proarrhythmia)
• shortness of breath (dyspnoea)
• lack of physical strength (asthenia)
• fatigue (tiredness)
• fever
• fluid accumulation in tissues (oedema)
• malaise

Uncommon (affects less than 1 in 100 people):

• decrease in red blood cells, white blood cells, or platelets
• inability to achieve an erection (impotence)
• changes in personality (depersonalisation)
• reduced sexual desire (decreased libido)
• excessive feeling of well-being (euphoria)
• increased dreaming (increased dream activity)
• lack of interest or participation (apathy)
• stupor
• eye irritation
• discomfort caused by light (photophobia)
• rapid and repetitive eye movements (nystagmus)
• increased blood pressure (hypertension)
• irregular heartbeat with increased heart rate
• narrowing of the bronchi causing breathing difficulty (bronchospasm)
• nausea
• vomiting
• constipation
• stomach pain (abdominal pain)
• decreased appetite
• diarrhoea
• difficulty digesting (dyspepsia)
• excessive gas formation in the stomach or intestines (flatulence)
• dry mouth
• altered taste
• itching (pruritus)
• skin inflammation with superficial peeling (exfoliative dermatitis)
• allergic skin inflammation (allergic dermatitis), including skin rash
• loss or thinning of hair and body hair (alopecia)
• joint pain (arthralgia)
• muscle pain (myalgia)
• increased urine production (polyuria)
• inability of the urinary bladder to empty completely (urinary retention)
• swelling of lips, tongue, and mouth

Rare (affects less than 1 in 1,000 people):

• seeing, hearing, or sensing things that are not there (hallucinations)
• depression
• confusion
• anxiety
• memory loss (amnesia)
• sleep disorders (insomnia)
• altered sensation in limbs or other body parts (paraesthesia)
• reduced motor coordination and gait (ataxia)
• decreased sensitivity (hypoesthesia)
• excessive sweating (hyperhidrosis)
• loss of consciousness due to circulatory or respiratory disturbances (syncope)
• tremor
• sudden sensation of warmth (hot flushes)
• drowsiness
• headache (cephalalgia)
• peripheral nerve damage (peripheral neuropathy)
• involuntary body movements (convulsions)
• movement difficulties (dyskinesia)
• inability to move (paresis)
• speech disorders
• involuntary contractions
• ringing or buzzing in the ears (tinnitus)
• dizziness
• lung inflammation (pneumonitis)
• increased liver enzymes with or without jaundice (yellowing of the skin and whites of the eyes)
• severe hives (urticaria)

Very rare (affects less than 1 in 10,000 people):

• increased levels of certain antibodies, which may indicate an autoimmune disease, with or without systemic inflammation in the body
• deposits on the surface of the eye (corneal deposits)
• skin reactions following exposure to light (photosensitivity reactions)

Not known (frequency cannot be determined from available data):

• changes in the electrocardiogram
• changes in stimulation threshold in patients with pacemakers or temporary pacing electrodes
• severe disturbance of the heart's electrical conduction system (second- and third-degree atrioventricular block)
• cardiac arrest
• slow heart rate (bradycardia)
• loss of the heart's ability to pump sufficient blood to body tissues (heart failure/congestive heart failure)
• chest pain
• low blood pressure (hypotension)
• heart attack (myocardial infarction)
• awareness of heartbeat (palpitations)
• pause in the normal heart rhythm (sinus arrest)
• fast heartbeat (tachycardia)
• lack of coordination in the pulsations of the heart's ventricles (ventricular fibrillation)
• emergence of a pre-existing heart condition that was not previously diagnosed (unmasking of pre-existing Brugada syndrome)
• lung damage (pulmonary fibrosis)
• lung disease causing breathing difficulties (interstitial lung disease)
• liver dysfunction

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Almarytm

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
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 Almarytm contains

• The active substance is flecainide acetate. Each tablet contains 100 mg of flecainide acetate.
• The other components are: pregelatinized starch, microcrystalline cellulose, hydrogenated vegetable oil, magnesium stearate, sodium croscarmellose.

Description of the appearance of Almarytm and contents of the pack
It is presented as white, round, biconvex, orally administered scored tablets with a break line, packaged in blisters containing 20, 30 or 60 tablets.
The tablet can be divided into equal doses.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN,
Ireland
Manufacturer
Mylan Hungary Kft, Mylan utca 1 - Komárom, H-2900, Hungary

Patient Information Leaflet

Almarytm 150 mg/15 ml intravenous solution for injection

flecainide acetate
Please read this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Almarytm is and what it is used for
2. What you need to know before you are given Almarytm
3. How Almarytm will be administered to you
4. Possible side effects
5. How to store Almarytm
6. Contents of the pack and other information

1. What Almarytm is and what it is used for

Almarytm contains the active substance flecainide acetate, which belongs to a class of medicines called "antiarrhythmics". It works by controlling the rate and rhythm of the heartbeat, as it inhibits the conduction of electrical impulses in the heart and prolongs the resting phase of the heart, thereby restoring normal pumping function.
Almarytm is used in adults and adolescents over 12 years of age for the rapid control or short-term prevention of:

• certain types of cardiac arrhythmias (abnormal heart rhythms, i.e. the number of heartbeats per minute), including potentially life-threatening ones
• tachycardia (very rapid heartbeat)
• atrial fibrillation/flutter (disorganized, very rapid contractions of the atria, chambers of the heart).

Treatment with Almarytm 150 mg/15 ml injection solution for intravenous use must be carried out in a hospital setting and supervised by a specialist physician.

2. What you need to know before Almarytm is administered to you

Almarytm must not be administered to you if:

• you are allergic to flecainide acetate or to any of the other ingredients of this medicine (listed in section 6);
• you have heart failure (a condition in which the heart is unable to pump an adequate amount of blood to meet the body's needs, resulting in fluid accumulation in the legs, lungs, and other tissues) and you have had a heart attack;
• you have cardiogenic shock (a drop in blood pressure with severe reduction in heart function);
• you have a heart block (the heart misses beats);
• you currently have or have previously had other disorders affecting the heart's rhythm conduction;
• you have Brugada syndrome (a genetic heart disease characterized by an abnormal electrocardiogram);
• you have uncompensated heart failure (a severe heart condition);
• you have other heart conditions different from those for which this medicine is being administered to you.

Warnings and precautions
This medicine is available only in a hospital setting. Therefore, Almarytm will be administered to you
only under strict supervision by qualified medical personnel.
Your doctor will avoid administering Almarytm to you:

• if you have heart disease or abnormal heart function;
• if you have chronic atrial fibrillation (chronic, disorganized, and very rapid contraction of the heart's atria);
• if your liver function is severely impaired.

Your doctor will exercise particular caution when administering Almarytm to you:

• if you have heart diseases (including atrioventricular block and heart failure);
• if you have experienced atrial fibrillation after heart surgery;
• if you have a heart condition affecting the sinus node (the area where the heartbeat originates);
• if you have a permanent pacemaker (a device that electrically stimulates your heart to contract) or temporary cardiac pacing electrodes;
• if you have imbalances in water and electrolyte levels in the body (for example, low or high levels of potassium in the blood). Before administering Almarytm, your doctor will check your blood electrolyte levels and initiate appropriate therapy to restore them to normal;
• if you have severe bradycardia (severely reduced heart rate) or marked hypotension (low blood pressure). Before administering Almarytm, your doctor will monitor your heart rate and blood pressure and initiate appropriate therapy to normalize these values. Your doctor will perform continuous electrocardiogram monitoring (a test to assess heart function) during administration of this medicine;
• if you have reduced liver and/or kidney function, as blood levels of flecainide may increase. In such cases, your doctor may decide to regularly monitor flecainide blood concentrations;
• if you are elderly, as blood levels of flecainide may increase.

Children and adolescents
Your doctor will avoid administering Almarytm to children under 12 years of age, as the safety and
efficacy of this medicine have not been established.

Other medicines and Almarytm
Inform your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other
medicines.
In particular, inform your doctor if you are taking:

• other antiarrhythmic medicines (medicines used to treat arrhythmias, e.g. amiodarone, verapamil, diltiazem), as your doctor will decide whether to administer Almarytm or reduce the dose;
• antihistamines (medicines used to treat allergic symptoms, e.g. mizolastine and terfenadine);
• antivirals (medicines used to treat viral infections, e.g. ritonavir alone or in combination with lopinavir and indinavir);
• antidepressants (medicines used to treat depression, e.g. fluoxetine and other tricyclic antidepressants);
• antipsychotics (medicines used to treat mental disorders, e.g. clozapine);
• antiepileptics (medicines used to treat epilepsy, e.g. phenytoin, phenobarbital, carbamazepine);
• antimalarials (medicines used to treat malaria, e.g. quinine);
• antifungals (medicines used to treat fungal infections, e.g. terbinafine);
• propranolol (a medicine used for hypertension, angina pectoris, and other conditions);
• diuretics (medicines that increase urine production and elimination), laxatives (medicines that stimulate intestinal movement), and corticosteroids (hormones from the adrenal cortex), as these may cause serious heart-related side effects due to decreased potassium levels in the blood (see section "Warnings and precautions");
• H2 antihistamines (medicines used to treat gastric ulcers, e.g. cimetidine);
• medicines for smoking cessation (e.g. bupropion);
• cardiac glycosides (medicines used to stimulate the heart).

Almarytm with food and drinks
Dairy products (milk, formula milk, and possibly yogurt) may reduce the absorption of Almarytm in
children and infants. The use of Almarytm is not authorized in children under 12 years of age. However,
flecainide toxicity has been reported in children during treatment when milk intake was reduced, and in
newborns switching from formula milk to dextrose feeding.

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

Pregnancy
Your doctor will avoid administering Almarytm during pregnancy unless the benefits outweigh the risks.

Breastfeeding
If you are breastfeeding, your doctor will decide whether to discontinue breastfeeding or stop treatment
with Almarytm, taking into account the benefits of breastfeeding for the child and the benefits of therapy
for you.

Driving and using machines
After taking Almarytm, you may experience side effects such as dizziness or visual disturbances, which
may reduce your reaction ability and pose a danger in situations requiring concentration and alertness,
such as driving, operating machinery, or working at heights.

Almarytm contains sodium
This medicine contains 38 mg of sodium (the main component of table salt) per 15 ml vial. This corresponds to 1.9% of the maximum daily recommended dietary intake of sodium for an adult.

3. How Almarytm will be administered to you

Treatment with Almarytm 150 mg/15 ml concentrate for solution for infusion (injection into a vein) should be initiated and carried out in a hospital setting.
Your doctor will determine the dose according to your health status.
Your doctor will discontinue intravenous administration of Almarytm 150 mg/15 ml as soon as your health condition improves and will prescribe Almarytm 100 mg tablets instead.
If you are given more Almarytm than you should have received
It is very unlikely that you will be given a higher dose of Almarytm than required. However, if an excessive dose of this medicine is administered, or its concentration increases because you have taken other medicines (see section “Other medicines and Almarytm”), you may experience even serious adverse effects:

• disturbances in heart conduction
• reduced heart rate and heart contraction
• decreased blood pressure
• rapid respiratory depression and cardiac arrest, which may lead to death.

Your doctor will initiate appropriate treatment and take necessary supportive measures.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone who is administered it will experience them.
If you experience any of the following serious side effects while being treated with Almarytm, inform your doctor immediately, as they will assess whether treatment should be discontinued:

• disturbances in the conduction of heartbeats if you have not undergone heart surgery involving the implantation of a pacemaker;
• changes in the electrocardiogram (ECG) trace (a test used to evaluate heart function) that may indicate Brugada syndrome;
• yellowing of the skin and whites of the eyes without apparent cause, or signs of impaired liver function (e.g. increased liver enzymes, substances present in the liver);
• blood disorders (haematological dyscrasias).

During treatment with Almarytm, the following side effects have been observed and reported according to the following frequency:
Very common (may affect more than 1 in 10 people)

• dizziness, usually transient
• visual disturbances, such as double or blurred vision

Common (may affect up to 1 in 10 people)

• occurrence of a more severe type of arrhythmia, or increased frequency or severity of a pre-existing arrhythmia (proarrhythmia)
• shortness of breath (dyspnoea)
• lack of strength (asthenia)
• tiredness (fatigue)
• fever
• fluid accumulation in tissues (oedema)

Uncommon (affects less than 1 in 100 patients)

• decrease in red blood cells, white blood cells, or platelets
• irregular heartbeat with increased heart rate
• nausea
• vomiting
• constipation
• stomach pain (abdominal pain)
• loss of appetite
• diarrhoea
• difficulty digesting (dyspepsia)
• excessive gas formation in the stomach or intestines (flatulence)
• skin inflammation due to allergy (allergic dermatitis), including skin rash
• loss or thinning of hair and body hair (alopecia)

Rare (affects less than 1 in 1,000 patients)

• seeing, hearing, or sensing things that are not there (hallucinations)
• depression
• confusion
• anxiety
• memory loss (amnesia)
• sleep disturbances (insomnia)
• altered sensation in limbs or other body parts (paraesthesia)
• reduced motor coordination and gait (ataxia)
• decreased sensitivity (hypoesthesia)
• excessive sweating (hyperhidrosis)
• loss of consciousness due to circulatory and respiratory disturbances (syncope)
• tremor
• sudden feeling of warmth (hot flushes)
• drowsiness
• headache (cephalalgia)
• peripheral nerve damage (peripheral neuropathy)
• involuntary body movements (convulsions)
• movement difficulties (dyskinesia)
• ringing or buzzing in the ears (tinnitus)
• vertigo
• lung inflammation (pneumonitis)
• increased liver enzymes with or without jaundice (yellowing of the skin and whites of the eyes)
• severe hives (urticaria)

Very rare (affects less than 1 in 10,000 patients)

• increased levels of certain antibodies, which may indicate an autoimmune disease, with or without systemic inflammation in the body
• deposits on the surface of the eye (corneal deposits)
• reactions following skin exposure to light (photosensitivity reactions)

Not known (frequency cannot be determined from available data)

• changes in electrocardiogram
• changes in stimulation threshold in patients with pacemakers or temporary pacing electrodes
• severe disturbance of the heart's electrical conduction system (second- and third-degree atrioventricular block)
• cessation of heartbeat
• slow heart rate (bradycardia)
• loss of the heart's ability to pump sufficient blood to body tissues (heart failure/congestive heart failure)
• chest pain
• low blood pressure (hypotension)
• heart attack (myocardial infarction)
• awareness of heartbeat (palpitations)
• pause in normal heart rhythm (sinus arrest)
• fast heartbeat (tachycardia)
• lack of coordination in the pulsations of the heart's ventricles (ventricular fibrillation)
• emergence of a pre-existing heart condition that was not previously diagnosed (unmasking of pre-existing Brugada syndrome)
• lung damage (pulmonary fibrosis)
• lung disease causing breathing difficulties (interstitial lung disease)
• liver dysfunction

In addition, the following adverse effects have been reported:
Disorders affecting the mouth, stomach, and intestines

• Swelling of the tongue, lips, and mouth

Disorders affecting metabolism and nutrition

• decreased appetite (anorexia)

Disorders affecting the nervous system

• inability to move (paresis)
• weakness
• altered taste
• dry mouth
• speech disturbances
• stupor
• reduced sexual desire (decreased libido)
• personality changes (depersonalisation)
• excessive sense of well-being (euphoria)
• increased dreaming (dream activity)
• lack of interest or participation (apathy)

Disorders affecting the reproductive system and breast

• inability to achieve an erection (impotence)

Disorders affecting muscles and bones

• joint pain (arthralgia)
• muscle pain (myalgia)
• instability

Disorders affecting the respiratory system

• narrowing of the bronchi causing breathing difficulty (bronchospasm)

Disorders affecting the cardiovascular system

• angina pectoris

Disorders affecting the eyes

• eye pain or irritation
• discomfort caused by light (photophobia)
• rapid, repetitive eye movements (nystagmus)

Disorders affecting the urinary system

• increased urine production (polyuria)
• inability of the urinary bladder to empty completely (urinary retention)

Disorders affecting the skin

• skin inflammation with shedding of superficial layers (exfoliative dermatitis)
• hives (urticaria)
• itching (pruritus)

General disorders and those related to the site of administration

• dizziness, feeling of fatigue, malaise

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ALMARYTM

Keep this medicine out of the sight and reach of children.
This medicine has no special storage requirements.
Do not use this medicine after the expiry date stated on the container after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines 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 ALMARYTM contains

• The active substance is flecainide acetate. Each 15 ml vial contains 150 mg of flecainide acetate.
• The other components are: glacial acetic acid; sodium acetate; water for injections (see section “Almarytm contains sodium”).

Description of the appearance of ALMARYTM and contents of the pack
The solution is clear and colourless, contained in a transparent glass vial.
Each pack of ALMARYTM contains 5 vials of 15 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Manufacturers
Cenexi - 52, rue Marcel et Jacques Gaucher - 94120 Fontenay-sous-Bois, France

The following information is intended for healthcare professionals only:

Dosage and administration
Treatment with Almarytm 150 mg/15 ml injectable solution for intravenous use must be initiated and
conducted in a hospital setting and supervised by a specialist physician.

a) Bolus injection
In emergency situations or when a rapid effect is desired, Almarytm may be administered by slow
intravenous injection at a dose of 1–2 mg/kg body weight, given over a period of not less than 10 minutes.
Alternatively, the dose may be diluted in 5% dextrose solution and administered as a mini-infusion (50–100 ml).

It is recommended that Almarytm be administered more slowly and under careful electrocardiographic
monitoring in patients with sustained ventricular tachycardia, as well as in those with a history of heart
failure, who may be at risk of decompensation during administration. For such patients, the initial dose
should be administered over not less than 30 minutes.

The maximum recommended bolus dose is 150 mg.

b) Intravenous infusion
Infusion: when prolonged parenteral administration is required, therapy should be initiated with a slow
intravenous injection (over not less than 30 minutes) as described above, followed by continuous infusion
at the following rates:

• First hour: 1.5 mg/kg body weight/hour
• Second hour and thereafter: 0.1–0.25 mg/kg body weight/hour.

The total duration of infusion should not exceed 24 hours. However, when necessary, or in patients
receiving the maximum dose per kg per hour, plasma level monitoring is strongly recommended. The
maximum cumulative dose administered within the first 24 hours must not exceed 600 mg.

In patients with severe renal impairment (creatinine clearance ≤35 ml/min/1.73 m²), each of the above
doses should be halved; plasma level monitoring is also strongly recommended in these patients.

Transition to oral administration
Transition to oral administration is achieved by administering one Almarytm 100 mg tablet, followed by
gradual discontinuation of the infusion over four hours, with hourly reductions of 20% of the maintenance
infusion rate. Twelve hours after the first oral dose, another oral dose of one to two Almarytm 100 mg
tablets is administered. Oral dosing is then continued as indicated in the tablet instructions.

The use of higher initial doses and more rapid dose adjustments has been associated with an increased
incidence of proarrhythmic effects and congestive heart failure, particularly during the first days of
treatment (see section “Warnings and precautions”). Therefore, a loading dose is not recommended.

Once adequate arrhythmia control has been achieved, it may be possible in some patients to reduce the
dose below the usual maintenance level to minimize adverse effects or effects on conduction. In such
patients, the efficacy at the lower dose should be evaluated.

Almarytm should be used with caution in patients with a history of congestive heart failure or myocardial
dysfunction (see section “Warnings and precautions”) and in patients with renal and/or hepatic
impairment.

Elderly patients: the plasma elimination rate of flecainide may be reduced in the elderly. Based more on
theoretical considerations than on experimental data, the following is suggested: when switching from
another antiarrhythmic drug to Almarytm, allow two to four plasma half-lives of the discontinued drug to
elapse before starting Almarytm at the usual dosage. In patients in whom discontinuation of a previous
antiarrhythmic agent may precipitate severe arrhythmias, hospitalization should be considered.

When flecainide is administered concomitantly with amiodarone, the usual dose of flecainide should be
reduced by 50%, and the patient should be closely monitored, including plasma level monitoring.

Plasma level monitoring
It has been observed that the vast majority of patients successfully treated with Almarytm have plasma
drug concentrations between 0.2 and 1.0 µg/ml.

The likelihood of adverse effects, particularly cardiac effects, may increase with higher plasma
concentrations, especially when these exceed 1.0 µg/ml. Periodic monitoring of plasma levels may be
useful during therapy. Plasma level monitoring is particularly important in patients with severe hepatic or
renal impairment, in whom elimination may be delayed. It is also recommended in patients receiving
concomitant amiodarone and may be useful in patients with congestive heart failure and even mild renal
impairment.

Special warning
Dilution: when required, Almarytm vials should be diluted or injected into sterile 5% dextrose solutions.

If chloride-containing solutions such as sodium chloride or Ringer's lactate are used, the injection must
be added to a volume of not less than 500 ml to avoid potential precipitation.

Overdose
Overdose with Almarytm is a potentially life-threatening medical emergency. Increased sensitivity to the
drug and plasma concentrations above therapeutic levels may also result from pharmacological
interactions (see section “Other medicines and Almarytm”).

Animal studies suggest that the following events may occur following overdose: prolongation of the PR
interval, increased QRS duration, QT interval prolongation, and increased T-wave amplitude; reduced
myocardial rate and contractility; conduction disturbances; hypotension; and death due to respiratory
failure or asystole.

No specific antidote is known. There are no known methods to rapidly remove flecainide from the body.
Neither dialysis nor hemoperfusion are effective. Treatment must therefore be supportive and may include
removal of unabsorbed drug from the gastrointestinal tract. Intravenous sodium bicarbonate 8.4% reduces
flecainide activity. Additional measures may include inotropic or cardiac stimulant agents such as
dopamine, dobutamine, or isoproterenol, as well as mechanical ventilation and circulatory support (e.g.,
balloon dilation). Temporary transvenous pacemaker insertion should be considered in the event of
conduction block. Due to the long plasma half-life of flecainide (approximately 20 hours) and the
possibility of markedly non-linear elimination kinetics at very high doses, supportive measures may need
to be continued for a prolonged period. Forced diuresis with acidification of urine may theoretically
enhance urinary excretion of flecainide. Intravenous lipid emulsion and ECMO may be considered on a
case-by-case basis.