Prospecto: information for the user

Amiodarona Aurovitas 200 mg tablets EFG

amiodarone hydrochloride

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What isAmiodarona Aurovitasand for what it is used

2.What you need to know before starting to takeAmiodarona Aurovitas

3.How to takeAmiodarona Aurovitas

4.Possible adverse effects

5.Storage ofAmiodarona Aurovitas

6.Contents of the package and additional information

Amiodarona Aurovitas contains an active ingredient called amiodarone hydrochloride. It belongs to a group of medications known as antiarrhythmic agents.

This works by controlling the irregular heartbeat (arrhythmias). By taking the tablets, it helps your cardiac rhythm to return to normal.

Amiodarona Aurovitas can be used for:

• Treating irregular heart rhythms when no other medication has worked or cannot be used.
• Treating a condition in which the heart beats abnormally fast (Wolff-Parkinson-White syndrome), when no other medication can be used or has not worked.
• Treating other types of rapid or irregular heart rhythms known as "atrial flutter" or "atrial fibrillation". Amiodarona Aurovitas is used only when other medications cannot be used.
• Treating sudden onset rapid heartbeats that may be irregular.

Amiodarona Aurovitas is used only when other medications cannot be used.

Do not take Amiodarona Aurovitas:

• if you are allergic to iodine, amiodarone, or any of the other ingredients in this medication (listed in section 6). Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, and inflammation of the lips, face, throat, or tongue,
• if you have a slower than normal heart rate (sinus bradycardia) or have another condition called sino-atrial block,
• if you have other heart rhythm disorders and do not have a pacemaker,
• if you have had thyroid problems. Your doctor must check your thyroid before giving you this medication,
• if you are taking other medications that can affect your heart rhythm (see section “Other Medications and Amiodarona Aurovitas”),
• if you are breastfeeding (see section “Pregnancy and Breastfeeding”).

Do not take this medication if you are affected by any of the above points. If you are unsure, 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 have asthma,
• if you have any vision problems, including a condition called optic neuritis,
• if you are about to undergo surgery,
• if you are over 65 years old. 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 correctly before you start taking the tablets, or if your dose is changed,
• there have been rare cases of potentially life-threatening skin eruptions (Stevens-Johnson syndrome, toxic epidermal necrolysis) with the use of amiodarone. Symptoms may include: flu-like symptoms followed by a painful, red, or purple rash, and blisters,
• currently taking a medication containing sofosbuvir for the treatment of hepatitis C, as it may cause potentially life-threatening bradycardia. Your doctor may consider alternative treatments. If amiodarone treatment is needed and sofosbuvir, you may require additional cardiac monitoring.

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

-slow or irregular heartbeats or heart rhythm problems;

-shortness of breath or worsening of existing shortness of breath;

-chest pain;

-dizziness;

-palpitations;

-loss of consciousness or near loss of consciousness.

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 shown a higher risk of a life-threatening complication (primary graft dysfunction) in which the transplanted heart fails to function correctly within the first 24 hours after surgery.

If you are unsure whether any of the above points affect you, speak with your doctor or pharmacist before taking Amiodarona Aurovitas.

Other Medications and Amiodarona Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This includes over-the-counter and herbal medications. This is because amiodarone may alter the response of other medications. Similarly, some medications may alter the functioning of amiodarone.

Particularly, do not take this medication and consult your doctor if you are taking:

• other medications for rapid or irregular heartbeats (such as sotalol, quinidine, procainamide, disopyramide, or bretylium),
• medications for infections (such as intravenous erythromycin, co-trimoxazole, moxifloxacin, or pentamidine),
• medications for schizophrenia (such as chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, amisulpride, or sertindole),
• medications for other mental health conditions (such as lithium, doxepin, maprotiline, or amitriptyline),
• medications for malaria (such as quinine, mefloquine, chloroquine, and halofantrine),
• medications used for allergic rhinitis, rashes, or other allergies, called antihistamines (such as terfenadine, astemizole, or mizolastine).

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

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

The following medications may increase the likelihood of experiencing adverse effects when taken with Amiodarona Aurovitas:

• amphotericin B (when administered intravenously) – used for fungal infections,
• medications for inflammation (corticosteroids) such as hydrocortisone, betamethasone, or prednisolone,
• diuretics – used to promote urine elimination,
• general anesthetics or high doses of oxygen – used in surgery,
• tetracosactide – used to analyze certain hormonal problems.

Amiodarona Aurovitas may increase the effect of the following medications:

• ciclosporin, tacrolimus, sirolimus – used to prevent transplant rejection,
• medications for erectile dysfunction such as sildenafil, tadalafil, or vardenafil,
• fentanyl – used for pain relief,
• ergotamine – used for migraines,
• midazolam – used to alleviate anxiety or help relax before surgery,
• colchicine – used for gout treatment,
• flecainide – another medication used for rapid or irregular heartbeats. Your doctor will need to monitor your treatment and may reduce your dose of flecainide to 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 unsure whether any of the above points affect 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 medication. This is because drinking grapefruit juice while taking Amiodarona Aurovitas may increase the likelihood of experiencing adverse effects.

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

Protect your skin from the sun

Stay away from direct sunlight while taking this medication 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, itch, or form severe blisters if you do not take the following precautions:

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

• Amiodarona Aurovitas is usually not administered during pregnancy.
• Do not take this medication if you are breastfeeding or plan to be. This is because small amounts of the medication pass into breast milk.

Driving and operating machinery

Amiodarona Aurovitas may cause blurred vision or other symptoms that may impair your ability to drive. If you notice any of these effects, avoid driving vehicles or operating machinery.

Amiodarona Aurovitas contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Amiodarona Aurovitas contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. This will help you achieve the best results and the minimum risk of adverse effects.

Starting 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

When the desired effect is achieved, the dose can be reduced to 100-400 mg (from half a tablet to 2 tablets of amiodarone 200 mg) per day. In certain cases, amiodarone 200 mg can be administered once every two days (200 mg every two days are equivalent to 100 mg per day).

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

Use in children and adolescents

The data on safety and efficacy in children are limited. Your doctor will decide on 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 service immediately. Bring the medication packaging with you. This way, the doctor will know what you have taken. You may experience the following symptoms: 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot 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 compensate for the missed doses.

If you interrupt treatment with 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 medication, the rapid and irregular heartbeats may return. This can be dangerous.

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

Tests

Your doctor will perform regular checks to check how your liver is functioning. Amiodarona Aurovitas may alter liver function. If this occurs, your doctor will decide whether you should continue taking these tablets.

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

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 taking Amiodarona Aurovitas.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Stop taking Amiodarona Aurovitas and seek immediate medical attention if:

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

Common(affects less than 1 in 10 people):

• Yellowing of the 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 serious.
• Difficulty breathing or tightness in the chest, cough that does not go away, wheezing, weight loss, and fever. This may be due to inflammation of the lungs, which can be very serious.
• 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.

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

• Loss of vision in one eye or blurred vision and lack of color. The eyes may feel painful or sensitive and painful when moving. 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.
• Inflammation of the lungs, which can be very serious.

Frequency not known(the frequency cannot be estimated from the available data):

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

Stop taking Amiodarona Aurovitas and seek immediate medical attention if you notice any of the following serious side effects – you may need urgent medical treatment:

Common(affects less than 1 in 10 people):

• Feeling numb or weak, tingling or pins and needles in any part of the body.

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

• Skin rash caused by narrowed or blocked blood vessels (vasculitis).
• You may experience headache (which is usually worse in the morning and occurs after coughing or making an effort), feeling unwell (nausea), convulsions, weakness, vision problems, or confusion. These symptoms may be signs of brain problems.
• Moving agitatedly or stumbling, slurred speech, 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 natural heartbeat.

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

Frequency not known(the frequency cannot be estimated from the available data):

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

Inform your doctor as soon as possible if you experience any of the following side effects:

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

• Blurred vision or seeing a halo of color in a bright light.

Common(affects less than 1 in 10 people):

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

Uncommon(affects less than 1 in 100 people):

• Muscle cramps, stiffness, or spasms.

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

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

Frequency not known(the frequency cannot be estimated from the 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 reduction in the number of white blood cells, making infections more likely (agranulocytosis).

Inform your doctor or pharmacist if any of the following side effects become severe or last for more than a few days:

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

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

Common(affects less than 1 in 10 people):

• Heartbeat slightly slower.
• Nightmares.
• Sleep problems.
• Decreased libido.

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

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

Frequency not known(the frequency cannot be estimated from the available data):

• Urticaria (itching, hives).
• Granulomas, small red spots on the skin or inside the body that are seen on X-rays.
• Pancreatitis / acute pancreatitis.
• Dry mouth.
• Anaphylactic reactions.
• Decreased appetite
• Parkinsonism.
• Parosmia (alteration in the sense of smell).
• Confusion, seeing, hearing, or feeling things that do not exist (hallucinations).
• Dermatitis bullosa.

Other reported side effects:

Syndrome similar to lupus (a disease in which the immune system attacks various parts of the body and causes pain, stiffness, and swelling in the joints and redness of the skin, sometimes in the form of butterfly wings on the face).

Reporting of side effects

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

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

Do not use this medication 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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medicationsthat you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist howto dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Amiodarona Aurovitas

• The active ingredient is amiodarone hydrochloride.

Each tablet contains 200 mg of amiodarone hydrochloride.

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

Appearance of the product and contents of the packaging

Tablet.

Uncoated tablets, white to off-white, round, and biconvex, marked with ‘8’ and ‘4’ separated by a groove on one face and with an ‘A’ on the other face of the tablet.

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

Packaging sizes:

Blister: 10, 20, 30, and 60 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91.630.86.45

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Italy:Amiodarona Aurobindo

Portugal:Amiodarona Aurovitas

Spain:Amiodarona Aurovitas 200 mgtablets EFG

Last review date of this leaflet:December 2021

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/