AMIODARONE AUROVITAS 200 mg TABLETS

2. What you need to know before you take Amiodarona Aurovitas

Do not take Amiodarona Aurovitas:

• if you are allergic to iodine, amiodarone or any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction include: skin rash, difficulty swallowing or breathing and swelling of the lips, face, throat or tongue,
• if you have a slower than normal heart rate (sinus bradycardia) or suffer from another condition called sino-atrial block,
• if you suffer from other heart rhythm disorders and do not have a pacemaker,
• if you have ever had thyroid problems. Your doctor should check your thyroid before giving you this medicine,
• if you are taking other medicines that may affect your heart rhythm (see section “Other medicines and Amiodarona Aurovitas”),
• if you are breast-feeding (see section “Pregnancy and breast-feeding”).

Do not take this medicine if you are affected by any of the above. If you are not sure, consult your doctor or pharmacist before taking Amiodarona Aurovitas.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amiodarona Aurovitas:

• if you have heart failure,
• if you have liver problems,
• if you have any lung problems or suffer from asthma,
• if you have any vision problems, including a condition called optic neuritis,
• if you are going to have surgery,
• if you are elderly (over 65 years). Your doctor will need to monitor you closely,
• if you have a pacemaker or an implantable cardioverter defibrillator (ICD). Your doctor will check that the device is working properly before you start taking the tablets, or if your dose is changed,
• very rare cases of potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of amiodarone. The symptoms can include: symptoms similar to flu followed by a painful, widespread, red or purple rash and blisters,
• you are currently taking a medicine that contains sofosbuvir for the treatment of hepatitis C, as it may cause a potentially life-threatening decrease in heart rate. Your doctor may consider alternative treatments. If treatment with amiodarone and sofosbuvir is needed, you may need additional heart monitoring.

Consult your doctor immediately if you are taking a medicine that contains sofosbuvir for the treatment of hepatitis C and during treatment you experience:

• slow or irregular heartbeats or heart rhythm problems;
• shortness of breath or worsening of existing shortness of breath;
• chest pain;
• dizziness;
• palpitations;
• fainting or feeling like you are about to faint.

If you are on a waiting list for a heart transplant, your doctor may change your treatment. This is because taking amiodarone before a heart transplant has been shown to increase the risk of a life-threatening complication (primary graft dysfunction) in which the transplanted heart fails to function properly within the first 24 hours after surgery.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Amiodarona Aurovitas.

Other medicines and Amiodarona Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines without a prescription and herbal medicines. This is because amiodarone can change the response to other medicines. Similarly, some medicines can change the effect of amiodarone.

In particular, do not take this medicine and consult your doctor if you are taking:

• other medicines for fast or irregular heartbeats (such as sotalol, quinidine, procainamide, disopyramide or bretylium),
• medicines for infections (such as intravenous erythromycin, cotrimoxazole, moxifloxacin or pentamidine),
• medicines for schizophrenia (such as chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, amisulpride or sertindole),
• medicines for other mental illnesses (such as lithium, doxepin, maprotiline or amitriptyline),
• medicines for malaria (such as quinine, mefloquine, chloroquine and halofantrine),
• medicines used for allergic rhinitis, rash or other allergies, called antihistamines (such as terfenadine, astemizole or mizolastine).

Consult your doctor if you are taking any of the following medicines:

• medicines that prolong your heartbeats (QT interval) such as medicines for infections (such as clarithromycin, ciprofloxacin, oxofloxacin or levofloxacin),
• medicines for heart problems called beta-blockers (such as propranolol),
• medicines for treating hepatitis C, a liver disease, such as sofosbuvir, daclatasvir, simeprevir, ledipasvir,
• medicines called calcium channel blockers – for chest pain (angina) or high blood pressure (such as diltiazem or verapamil),
• medicines for constipation (laxatives) such as bisacodyl or senna,
• medicines for high cholesterol (statins) such as simvastatin or atorvastatin.

The following medicines may increase the risk of side effects when taken with Amiodarona Aurovitas:

• amphotericin (when given intravenously) – used for fungal infections,
• medicines for inflammation (corticosteroids) such as hydrocortisone, betamethasone or prednisolone,
• tablets to help produce urine (diuretics),
• general anesthetics or high doses of oxygen – used in surgery,
• tetracosactide – used to investigate some hormonal problems.

Amiodarona Aurovitas may increase the effect of the following medicines:

• ciclosporin, tacrolimus, sirolimus – used to prevent transplant rejection,
• medicines for impotence such as sildenafil, tadalafil or vardenafil,
• fentanyl – used for pain relief,
• ergotamine – used for migraines,
• midazolam – used to relieve anxiety or help you relax before an operation,
• colchicine – used for gout,
• flecainide – another medicine used for fast and irregular heartbeats. Your doctor should monitor your treatment and may reduce your dose of flecainide by half,
• lidocaine – used as an anesthetic,
• coumarins – used to prevent blood clotting,
• phenytoin – used to prevent seizures,
• digitalis – used for certain heart conditions,
• dabigatran – used to thin the blood.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking Amiodarona Aurovitas.

Taking Amiodarona Aurovitas with food, drinks and alcohol

Do not drink grapefruit juice while taking this medicine. This is because drinking grapefruit juice while taking Amiodarona Aurovitas can increase the risk of side effects.

Limit the amount of alcohol you drink while taking this medicine. This is because drinking alcohol while taking it will increase the risk of liver problems. Consult your doctor or pharmacist about the amount of alcohol you can drink.

Protect your skin from sunlight

Stay away from direct sunlight while taking this medicine and for a few months after you have finished taking it. This is because your skin will become much more sensitive to the sun and may burn, sting or form severe blisters if you do not take the following precautions:

• Make sure you use high-factor sun cream.
• Always wear a hat and clothing that covers your arms and legs from the sun.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

• Amiodarona Aurovitas is not normally given during pregnancy.
• Do not take if you are breast-feeding or planning to breast-feed. This is because small amounts of the medicine pass into breast milk.

Driving and using machines

Amiodarona Aurovitas may cause blurred vision or other symptoms that may affect your ability to drive or use machines. If you notice any of these effects, avoid driving vehicles or using machines.

Amiodarona Aurovitas contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Amiodarona Aurovitas contains sodium

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

3. How to take Amiodarona Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again. This will help you get the best results and the minimum risk of side effects.

Initial dose

The recommended dose is 200 mg of amiodarone three times a day (600 mg per day in total) for 8 to 10 days.

Maintenance dose

Once the desired effect has been achieved, the dose may be reduced to 100-400 mg (half a tablet to 2 tablets of amiodarone 200 mg) per day. In certain cases, amiodarone 200 mg may be given every other day (200 mg every other day is equivalent to 100 mg once a day).

The amiodarone 200 mg tablets should be taken with or immediately after meals with water (for example, a glass).

Use in children and adolescents

Data on safety and efficacy in children are limited. Your doctor will decide the appropriate dose.

The tablet can be divided into equal doses.

If you take more Amiodarona Aurovitas than you should

If you take more Amiodarona Aurovitas than you should, consult your doctor or go to the emergency department immediately. Take the medicine pack with you. This will help your doctor know what you have taken. The following symptoms may occur: feeling dizzy, weak or tired, confusion, slow heart rate, liver damage or feeling sick.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Amiodarona Aurovitas

If you forget a dose, take it as soon as you remember. However, if the next dose is near, skip the missed dose. Do not take a double dose to make up for the missed doses.

If you stop taking Amiodarona Aurovitas

Take Amiodarona Aurovitas until your doctor tells you to stop. Do not stop taking Amiodarona Aurovitas just because you feel better. If you stop taking this medicine, the fast and irregular heartbeats may return. This can be dangerous.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

Tests

Your doctor will perform regular checks to see how your liver is working. Amiodarona Aurovitas may affect liver function. If this happens, your doctor will decide whether you should continue taking these tablets.

Your doctor may perform regular thyroid checks while you are taking this medicine. This is because Amiodarona Aurovitas contains iodine, which can cause thyroid problems.

Your doctor may perform other regular checks such as blood tests, chest X-rays, electrocardiogram (electrical analysis of heartbeats) and eye exams, both before and while you are taking Amiodarona Aurovitas.

If you have any other questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Amiodarona Aurovitas may remain in your blood for up to a month after stopping treatment, so adverse effects may appear at that time.

Stop taking Amiodarona Aurovitas and go immediately to the doctor or hospital if:

• You have an allergic reaction. The signs may include: skin rash, swelling or breathing problems, swollen eyelids, face, lips, throat or tongue.

Frequent(affects less than 1 in 10 people):

• Yellowish skin or eyes (jaundice), feeling sick or tired, loss of appetite, stomach pain or high temperature. These may be signs of liver damage or problems, which can be very dangerous.
• Difficulty breathing or tightness in the chest, persistent cough, wheezing, weight loss and fever. This may be due to lung inflammation, which can be very dangerous.
• Itching, red rash (eczema).

Uncommon(affects less than 1 in 100 people):

• Irregular or erratic heartbeats. This can lead to a heart attack, so you should go to the hospital immediately.
• Dry mouth.

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

• Vision loss in one eye or blurred and colorless vision. The eyes may feel painful or sensitive and hurt when moving them. This may be a disease called "optic neuropathy" or "neuritis".
• Heartbeat that becomes very slow or stops. If this happens, go to the hospital immediately.
• Lung inflammation, which can be very dangerous.

Frequency Not Known(frequency cannot be estimated from available data):

• Severe allergic reaction (anaphylactic reaction, anaphylactic shock); sudden pancreas inflammation (acute pancreatitis); decreased appetite; unusual muscle movements, stiffness, tremors and agitation (parkinsonism); abnormal sense of smell (parosmia); confusion (delirium); potentially fatal skin reactions with rash, blisters, skin peeling and pain ((toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), bullous dermatitis, drug reaction with eosinophilia and systemic symptoms (DRESS)); acute bleeding from the lungs. Potentially fatal complication after a heart transplant (primary graft dysfunction) in which the transplanted heart stops working properly (see section 2, Warnings and Precautions).

Stop taking Amiodarona Aurovitas and go immediately to the doctor if you notice any of the following serious adverse effects – you may need urgent medical treatment:

Frequent(affects less than 1 in 10 people):

• Feeling numb or weak, tingling or prickling sensation in any part of the body.

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

• Skin rash caused by narrow or blocked blood vessels (vasculitis).
• May have headache (which is usually worse in the morning and appears after coughing or making an effort), feeling unwell (nausea), seizures, weakness, vision problems or confusion may occur. These symptoms may be signs of brain problems.
• Moving agitatedly or stumbling, stuttering and slow speech.
• Feeling weak, dizzy, unusually tired and short of breath. These may be signs of a very slow heart rate (especially in people over 65 years old) or other problems with the heart's natural rhythm.

Some cases of bleeding in the lungs have been reported in patients taking Amiodarona Aurovitas. Inform your doctor immediately if you cough up blood.

Frequency Not Known(frequency cannot be estimated from available data):

• Chest pain, shortness of breath and irregular heartbeat. These may be signs of a condition called "Torsades de pointes".

Tell your doctor as soon as possible if you experience any of the following adverse effects:

Very Frequent(affects more than 1 in 10 people):

• Blurred vision or seeing a colored halo in bright light.

Frequent(affects less than 1 in 10 people):

• Feeling extremely restless or agitated, weight loss, increased sweating and being unable to tolerate heat. These may be signs of a disease called "hyperthyroidism".
• Feeling extremely tired, weak or exhausted, weight gain, being unable to tolerate cold, constipation and muscle pain. These may be signs of a disease called "hypothyroidism".
• Tremors when moving arms or legs.
• Blue or gray marks on skin exposed to sunlight, especially on the face.

Uncommon(affects less than 1 in 100 people):

• Muscle cramps, stiffness or spasms.

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

• Inflammation of the testicles.
• Red, scaly areas of skin, hair loss or loss of nails (called "exfoliative dermatitis").
• Feeling tired, weak, dizzy or having pale skin. These may be signs of anemia.
• Bleeding or bruising more than usual. This may be due to a blood disorder (called "thrombocytopenia").
• Feeling unwell, confused or weak, dizzy (nausea), loss of appetite, feeling irritable. This may be due to a blood disorder called "syndrome of inappropriate antidiuretic hormone secretion" (SIADH).

Frequency Not Known(frequency cannot be estimated from available data):

• You may have more infections than usual. This may be due to a decrease in the number of white blood cells (neutropenia).
• Severe decrease in the number of white blood cells that makes infections more likely (agranulocytosis).

Tell your doctor or pharmacist if any of the following adverse effects become serious or last more than a few days:

Very Frequent(affects more than 1 in 10 people):

• Feeling sick (nausea) or being sick (vomiting).
• Changes in the taste of things.
• Changes in the amount of liver enzymes at the start of treatment. This may be seen in a blood test.
• Burning more easily when exposed to the sun (see "Protect your skin from sunlight" in section 2).

Frequent(affects less than 1 in 10 people):

• Slightly slower heart rate.
• Nightmares.
• Sleep problems.
• Decreased sexual desire.

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

• Headache.
• Balance problems, feeling dizzy (vertigo).
• Difficulty maintaining an erection or ejaculating.
• Hair loss, baldness.
• Skin rash.
• Red skin during radiotherapy.
• Increased creatinine in blood, which may appear in a blood test. This may be a sign of decreased kidney function.

Frequency Not Known(frequency cannot be estimated from available data):

• Hives (itching, lumpy rash).
• Granulomas, small red lumps on the skin or inside the body that are visible on X-rays.
• Pancreatitis / acute pancreatitis.
• Dry mouth.
• Anaphylactic reactions.
• Decreased appetite
• Parkinsonism.
• Parosmia (abnormal sense of smell).
• Confusion, seeing, hearing or feeling things that do not exist (hallucinations).
• Bullous dermatitis.

Other Adverse Effects Reported:

Lupus-like syndrome (a disease in which the immune system attacks several parts of the body and causes pain, stiffness and swelling in the joints and redness of the skin, sometimes in the shape of butterfly wings on the face).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Amiodarona Aurovitas

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Amiodarona Aurovitas

• The active ingredient is amiodarone hydrochloride.

Each tablet contains 200 mg of amiodarone hydrochloride.

• The other ingredients are: lactose monohydrate, anhydrous colloidal silica, sodium carboxymethyl starch (type A) (derived from potato starch), povidone (K-30) and magnesium stearate.

Appearance of the Product and Package Contents

Tablet.

Uncoated tablets, white to off-white, round and biconvex, marked with '8' and '4' separated by a score line on one side and with an 'A' on the other side of the tablet.

Amiodarona Aurovitas is presented in white opaque PVC-aluminum blisters.

Package Sizes:

Blister: 10, 20, 30 and 60 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91.630.86.45

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the EEA Member States with the following names:

Italy: Amiodarona Aurobindo

Portugal: Amiodarona Aurovitas

Spain: Amiodarona Aurovitas 200 mg tablets EFG

Date of the Last Revision of this Leaflet:December 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/