Amiodarone Doc Generici

Italy
Brand name Amiodarone Doc Generici
Form tablets
Active substance / Dosage
AMIODARONE
Prescription type Prescription only
ATC code
C01BD01
Registration number 050630
Manufacturer DOC GENERICI SRL

Table of Contents

Patient Information Leaflet: Information for the User

AMIODARONE DOC 200 mg tablets

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 effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What AMIODARONE DOC is and what it is used for

AMIODARONE DOC contains the active substance amiodarone hydrochloride, which belongs to a class of medicines called "class III antiarrhythmics" that work by regulating the heartbeat.
AMIODARONE DOC is indicated for:

  • the treatment and prevention of serious heart rhythm disorders when other medicines have not worked: abnormally fast heartbeat, sometimes characterized by sudden stops and restarts (paroxysmal and non-paroxysmal supraventricular tachycardias), irregular heartbeat characterized by premature contraction of the heart muscle disrupting the regular sequence of beats (atrial extrasystoles), irregular and excessively rapid heartbeat (atrial flutter), and irregular and accelerated heartbeat (atrial fibrillation);
  • sudden and abrupt changes in heartbeat with increased frequency (reciprocating paroxysmal supraventricular tachycardias) in patients affected by conditions such as Wolff-Parkinson-White syndrome, a disorder characterized by rapid heartbeat, dizziness, loss of consciousness, easy fatigue, and anxiety. Heart rhythm disorders in which extra beats interfere with the normal heartbeat and may sometimes cause a sensation of having missed a beat in the chest area (ventricular extrasystoles), and heart rhythm disorders characterized by very rapid heartbeat (ventricular tachycardias);
  • preventive treatment of angina pectoris attacks, a heart disease caused by reduced blood flow to the heart, mainly manifested by chest pain.

2. What you should know before taking AMIODARONE DOC

Do not take AMIODARONE DOC

  • if you are allergic to amiodarone or iodine, or to any of the other ingredients of this medicine (listed in section 6);
  • if you have a slower than normal heartbeat (sinus bradycardia) or a condition known as sinoatrial block, characterized by delayed formation of heartbeats;
  • if you suffer from serious disorders in the generation of heartbeats and do not have a pacemaker (severe atrioventricular blocks, bi- or trifascicular blocks);
  • if you suffer from a condition affecting heart rhythm and do not have a pacemaker, with risk of abnormal heartbeats (sinus arrest);
  • if you are taking medicines that can cause heart rhythm abnormalities (torsades de pointes) (see “Other medicines and AMIODARONE DOC”);
  • if you have or have had thyroid disorders (dysfunctions). In doubtful cases (uncertain previous disorders, family history of thyroid problems), your doctor will perform a thyroid examination before starting treatment with this medicine;
  • if you are pregnant, except in exceptional cases where your doctor prescribes it (see “Pregnancy and breastfeeding”);
  • if you are breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking AMIODARONE DOC:

  • if you have a pacemaker or an implantable cardioverter defibrillator. In such cases, your doctor will check that the device is functioning properly before and during treatment;
  • if you are elderly. Your doctor will monitor you more closely;
  • if you have serious heart conditions (cardiomyopathies and severe coronary artery disease) and during treatment develop productive cough (with phlegm), breathing difficulties, fever, or weight loss;
  • if you are scheduled for surgery under general anesthesia;
  • if you have liver problems; your doctor will perform careful monitoring of liver function, both at the beginning and during treatment. In case of severe liver function abnormalities, your doctor will discontinue the medicine and initiate appropriate therapy;
  • if you have vision problems, particularly reduced blood supply or inflammation of the optic nerve (optic neuropathy and optic neuritis). In this case, your doctor will discontinue the medicine;
  • if you have muscle problems;
  • if you have thyroid problems;
  • if you are currently taking a medicine containing sofosbuvir for the treatment of hepatitis C, as it may cause a life-threatening slowing of the heartbeat. Your doctor may consider alternative treatments. If treatment with amiodarone and sofosbuvir is necessary, additional cardiac monitoring may be required;
  • if you are taking other medicines (see “Other medicines and AMIODARONE DOC”). AMIODARONE DOC will only be administered after your doctor has carefully evaluated your health status. Your doctor will perform close monitoring during treatment.

Before starting treatment with AMIODARONE DOC, your doctor will perform an electrocardiogram (ECG), a test that allows analysis of heart activity, and will check your blood potassium levels. During treatment with this medicine, you will undergo blood tests for liver function (transaminases) and ECGs.
Since the likelihood of adverse effects (see “Possible side effects”) increases with higher doses of the medicine (dose-dependent), your doctor will administer the lowest effective dose to control your heart rhythm. If your heart rhythm disturbances worsen or new ones appear, your doctor will determine whether this is due to loss of medicine efficacy or worsening of the underlying disease.
Inform your doctor immediately if you are taking a medicine containing sofosbuvir for the treatment of hepatitis C and during treatment you experience:

  • slow or irregular heartbeat, or heart rhythm disturbances;
  • shortness of breath or worsening of existing shortness of breath;
  • chest pain;
  • dizziness;
  • palpitations;
  • near-fainting or fainting.

If you are on a waiting list for a heart transplant, your doctor may modify your treatment. This is because taking amiodarone before heart transplantation has been associated with an increased risk of potentially fatal complications (primary graft dysfunction), where the transplanted heart fails to function properly within the first 24 hours after surgery.
During treatment with AMIODARONE DOC or even long after stopping treatment, you may develop increased thyroid function with symptoms such as weight loss, heart rhythm disturbances, and chest pain. Your doctor will perform careful monitoring and, if necessary, discontinue the medicine.
AMIODARONE DOC may cause serious muscle problems (sensory-motor peripheral neuropathy and myopathy). In such cases, your doctor will discontinue the medicine.
Skin disorders (skin reactions), including very severe and life-threatening conditions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (see “Possible side effects”), may occur. These manifest as progressive skin redness (rash), often accompanied by blisters, bullae, and may also affect mucous membranes. In such cases, stop taking amiodarone and contact your doctor immediately.
If during treatment with AMIODARONE DOC you develop dry cough, fever, breathing difficulties associated with severe general malaise, your doctor will perform a chest X-ray and other tests to assess your lung function. This is because pulmonary toxicity may occur during treatment with AMIODARONE DOC, which, if not diagnosed promptly, can be life-threatening. If necessary, your doctor may reduce the dose or discontinue the medicine and initiate appropriate therapy.
Avoid sun exposure and use protective measures (use sunscreen with high protection factor, wear a hat, and wear clothing covering arms and legs) during treatment with this medicine (see “Possible side effects”).

Children
The use of AMIODARONE DOC is not recommended in children.

Other medicines and AMIODARONE DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The combination of AMIODARONE DOC with the following medicines is contraindicated:

  • medicines that may cause a specific type of heart rhythm disturbance (torsades de pointes), such as medicines used to prevent and control heart rhythm disturbances (Class IA antiarrhythmics, sotalol, bepridil), vincamine (an antibiotic), medicines for mental illnesses (such as sultopride), cisapride (a medicine used to treat gastric reflux, i.e., stomach contents rising into the esophagus), intravenous erythromycin (an antibiotic), intravenous pentamidine (used for certain types of pneumonia);
  • antibiotics known as fluoroquinolones;
  • medicines used to treat depression (MAO inhibitors).

The combination of AMIODARONE DOC with the following medicines is not recommended:

  • medicines that slow the heartbeat (beta-blockers and calcium antagonists) such as verapamil and diltiazem;
  • medicines that may cause low blood potassium levels (hypokalemia), such as stimulant laxatives (medicines that increase intestinal motility and evacuation);
  • sofosbuvir, a medicine used in combination with others for the treatment of chronic hepatitis C.

The combination of AMIODARONE DOC with the following medicines requires caution:

  • medicines that may cause a specific type of heart rhythm disturbance known as QT prolongation;
  • medicines that promote urine production (diuretics), alone or in combination;
  • medicines for controlling inflammation and allergies (systemic glucocorticoids and mineralocorticoids);
  • tetracosactide, used to investigate certain hormonal disorders;
  • intravenous amphotericin B, used to treat fungal infections.

The effects of AMIODARONE DOC may be influenced by, or may influence, the following medicines:

  • general anesthesia and high doses of oxygen during surgery;
  • digoxin, used to increase the force of heart contraction;
  • dabigatran and warfarin, anticoagulants used to thin the blood;
  • phenytoin, a medicine for treating epilepsy;
  • flecainide, a medicine for controlling heart rhythm;
  • statins, used to reduce blood cholesterol levels, such as simvastatin, atorvastatin, and lovastatin, whose combination increases the risk of muscle disorders (e.g., rhabdomyolysis). Your doctor will prescribe the appropriate statin to take with amiodarone;
  • cyclosporine, tacrolimus, and sirolimus, used to suppress the immune system and help prevent transplant rejection;
  • fentanyl and ergotamine, medicines for pain control;
  • lidocaine, used as an anesthetic;
  • sildenafil, used to treat impotence;
  • midazolam and triazolam, used to treat anxiety or help you relax;
  • dihydroergotamine, used to treat certain types of headache (migraine);
  • colchicine, used to treat joint inflammation causing pain and swelling (gout).

AMIODARONE DOC with food and drink
Do not drink grapefruit juice while taking this medicine, as it may increase the likelihood of side effects.

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

Pregnancy
Do not take AMIODARONE DOC during pregnancy unless your doctor considers it necessary, as it may harm the fetus.

Breastfeeding
Do not take AMIODARONE DOC if you are breastfeeding. AMIODARONE DOC passes into breast milk and may harm your baby.

Driving and using machines
AMIODARONE DOC does not impair the ability to drive or operate machinery.

AMIODARONE DOC contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

AMIODARONE DOC contains an azo dye that may cause allergic reactions.

3. How to take AMIODARONE DOC

AMIODARONE DOC is indicated for use in adults.
Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the route of administration, the initial dose, and the maintenance dose based on the severity of your condition and your response to treatment.
The recommended doses are:

For the treatment of heart rhythm disorders
The initial dose is 600 mg (3 tablets) daily for at least two weeks. Afterwards, your doctor will reduce the dose until establishing a maximum maintenance dose of 400 mg daily, or establishing an intermittent therapy (e.g. taking AMIODARONE DOC for 2 or 3 weeks per month or for 5 days per week).

For preventive treatment of episodes of chest pain
Initial dose: 600 mg (3 tablets) daily for approximately 7 days.
Maintenance dose: maximum dose of 400 mg daily or intermittent therapy (5 days per week or 2 or 3 weeks per month).

Concomitant therapy with statins
If you are taking statins during treatment with AMIODARONE DOC to reduce cholesterol levels in the blood, your doctor will prescribe a specific statin (see also “Other medicines and AMIODARONE DOC”).

Use in children
The use of AMIODARONE DOC is not recommended in children.

If you take more AMIODARONE DOC than you should
There is limited data available regarding overdose with AMIODARONE DOC. Possible adverse effects due to overdose may include: slowed heartbeat (sinus bradycardia), cardiac arrest (cardiac arrest), rapid heartbeat (ventricular tachycardia), heart rhythm abnormalities (torsades de pointes), circulatory disturbances (circulatory failure), and liver damage (hepatic injury).
In case of accidental ingestion or overdose of AMIODARONE DOC, contact your doctor immediately or go to the nearest hospital.

If you forget to take AMIODARONE DOC
Do not take a double dose to make up for a missed tablet.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur, according to the following frequency:

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

  • Vision disorders such as blurred vision or seeing coloured halos around lights in bright light conditions, due to small deposits of fat in the eye; this side effect resolves upon discontinuation of treatment;
  • Allergic reactions to light (photosensitisation). See also "Warnings and precautions";
  • At the beginning of therapy, changes in blood tests specific for liver monitoring (increase in transaminases) may occur. These test results return to normal with dose reduction or spontaneously, i.e. without any specific intervention;
  • Nausea, vomiting and altered sense of taste (dysgeusia), which generally resolve with dose reduction.

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

  • Slow heart rate (bradycardia); this side effect is generally mild and caused by increasing the dose;
  • Greyish or bluish skin discoloration, especially after prolonged treatment or with high daily doses. These side effects resolve upon discontinuation of treatment;
  • Thyroid disorders (hypothyroidism and hyperthyroidism), sometimes life-threatening;
  • Liver disorders with abnormal liver function tests and yellowing of the skin and whites of the eyes. These disorders can be serious (liver failure) and sometimes life-threatening;
  • Sleep disturbances and nightmares;
  • Hand tremor;
  • Constipation;
  • Itching, red-coloured skin rash (eczema);
  • Pulmonary toxicity: inflammation of the lungs (pneumonitis) characterised by fever, cough, chest pain and difficulty breathing; severe lung disease presenting with scarring of the tissue lining the lungs, cough, difficulty breathing, weight loss and fatigue (pulmonary fibrosis); inflammation of the membrane covering the outer part of the lungs (pleuritis); inflammatory lung disease with symptoms such as fever, cough, general malaise, loss of appetite, weight loss and difficulty breathing (bronchiolitis obliterans with organising pneumonia);
  • Decreased sexual desire.

Uncommon (may affect up to 1 in 100 people) :

  • Severe heart rhythm disorders (sino-atrial block, A-V block of varying degrees) (see also "Warnings and precautions");
  • Onset or worsening of heart rhythm disorders, up to cardiac arrest (see also "Warnings and precautions" and "Other medicines and AMIODARONE DOC");
  • Deterioration or malfunction of peripheral nerves manifesting as: tingling, prickling, reduced ability to feel pain, and numbness in hands and feet (sensory-motor peripheral neuropathy) and/or muscle disorders with symptoms such as loss of strength, fatigue, pain, cramps and muscle stiffness (myopathy), which generally resolve upon discontinuation of the medicine ("Warnings and precautions");
  • Dry mouth.

Rare (may affect up to 1 in 1,000 people) :

  • Rupture of red blood cells (haemolytic anaemia);
  • Reduced ability of the bone marrow to produce red blood cells (aplastic anaemia);
  • Reduced number of blood platelets (thrombocytopenia);
  • Severe slowing of the heart rate, especially in elderly patients (bradycardia);
  • Reduced blood supply and inflammation of the optic nerve (optic neuropathy and optic neuritis), up to loss of vision (see "Warnings and precautions");
  • Redness and irritation of the skin following radiotherapy;
  • Skin irritations;
  • Inflammation of the skin with peeling (exfoliative dermatitis);
  • Hair loss (alopecia);
  • Long-term liver disorders (chronic hepatopathies such as pseudo-alcoholic hepatitis and cirrhosis), sometimes life-threatening;
  • Constriction of the bronchi and worsening of breathing difficulties (bronchospasm) in patients with breathing difficulties (severe respiratory failure) and especially in patients with asthma or severe lung disease where the lungs are unable to function properly (adult respiratory distress syndrome), sometimes life-threatening, usually observed shortly after surgery (possible interaction with high oxygen concentration) (see "Warnings and precautions");
  • Increased blood creatinine levels (a blood test);
  • Brain disorders such as loss of balance, tremor, difficulty controlling limb and eye movements, difficulty speaking and writing (cerebellar ataxia);
  • Increased pressure inside the skull (benign intracranial hypertension, pseudotumor cerebri);
  • Headache;
  • Inflammation of the epididymis, the small tube located behind the testicles that stores and transports sperm (epididymitis);
  • Inability in males to achieve and/or maintain an erection sufficient for satisfactory sexual intercourse (impotence);
  • Inflammation of blood vessels (vasculitis);
  • Excessive secretion of antidiuretic hormone (syndrome of inappropriate antidiuretic hormone secretion, SIADH), with fluid retention in the body.

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

  • Bone marrow abnormalities (granulomas);
  • Heart rhythm abnormalities (torsade de pointes) (see also "Other medicines and AMIODARONE DOC");
  • Liver abnormalities (granulomas);
  • Severe bleeding in the lungs (pulmonary haemorrhage);
  • Swelling of the face, hands and feet, lips, tongue or throat (Quincke's oedema);
  • Itching (urticaria), life-threatening skin reactions characterised by rashes, blisters, skin peeling and pain (toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), bullous dermatitis, drug reaction with eosinophilia and systemic symptoms (DRESS));
  • Severe allergic reaction (anaphylactic reaction/shock);
  • Decreased appetite;
  • Sudden inflammation of the pancreas (pancreatitis (acute));
  • Unusual muscle movements, stiffness, agitation and restlessness (parkinsonism);
  • Altered sense of smell (parosmia);
  • Confusion (delirium);
  • Lupus-like syndrome (a disease in which the immune system attacks various parts of the body, leading to pain, stiffness and swelling of joints and skin redness, sometimes in a butterfly-shaped rash on the face);
  • Potentially fatal complication after heart transplantation (primary graft dysfunction) in which the transplanted heart fails to function properly (see "Warnings and precautions");
  • Seeing, hearing or perceiving things that are not there (hallucinations);
  • You may get more infections than usual. This could 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).

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 http://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 AMIODARONE DOC

Do not store at temperatures above 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton. 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. Contents of the pack and other information

What AMIODARONE DOC contains

  • The active substance is amiodarone hydrochloride. Each tablet contains 200 mg of amiodarone hydrochloride, equivalent to 189.30 mg of amiodarone.
  • The other components are: Monohydrate lactose, sodium croscarmellose, Allura AC leak, pregelatinized maize, polysorbate 80, povidone K-90, anhydrous colloidal silica, purified talc, magnesium stearate.

Description of the appearance of AMIODARONE DOC and contents of the pack
AMIODARONE DOC tablets are round, 10 mm in size, pinkish-white to pink in colour, with “A with vertical line A (A|A)” engraved on one side and “200” on the other.
They are available in PVC/PVDC-Aluminum blisters containing 20 or 40 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati, 40
20121 – Milan, Italy

Manufacturer
Flavine Pharma France
3, voie d’Allemagne
Vitrolles, 13127, France