Trangorex 200 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Trangorex 200 mg tablets

Amiodarone

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Trangorex is and what it is used for

Trangorex belongs to a group of medicines known as antiarrhythmic agents (used to control fast or irregular heartbeats).

Trangorex is used to prevent or treat disturbances in heart rhythm, such as:

• Arrhythmias associated with Wolff-Parkinson-White syndrome.
• Atrial fibrillation and atrial flutter.
• All types of paroxysmal tachyarrhythmias including: supraventricular, nodal and ventricular tachycardia, ventricular fibrillation.

2. What you need to know before starting Trangorex

Do not take Trangorex

• if you are allergic to iodine, amiodarone, or any of the other components of this medicine (listed in section 6)
• if you have a slow heart rate (sinus bradycardia) or suffer from other rhythm or cardiac conduction disorders (sino-atrial block, sinus node disease, severe atrioventricular conduction disturbances), unless a pacemaker is implanted
• if you have any thyroid gland-related disease
• if you are pregnant, except under special circumstances, or during breastfeeding
• in combination with medicines that may cause "torsades de pointes" (serious heart rhythm problems): see section "Use of Trangorex with other medicines".

Warnings and precautions

If you experience unusual shortness of breath, persistent cough, fatigue, unexplained prolonged fever, diarrhea, weight loss, or recurrence of a very rapid heartbeat, consult your doctor.

Reduction in heart rate may be more pronounced in elderly patients.

Trangorex may cause changes in the electrocardiogram, such as QT interval prolongation (related to prolonged repolarization), which may not indicate toxicity.

There are cases where new arrhythmias may occur or existing arrhythmias may worsen, sometimes resulting in death. This usually occurs when combined with other medicines or electrolyte imbalances (for example, abnormal blood calcium levels). In such cases, your doctor will consider discontinuing treatment with this medicine.

Treatment with amiodarone must be discontinued if cardiac block develops (second- or third-degree atrioventricular block, sinoatrial block, or bifascicular block).

Consult your doctor or pharmacist before starting Trangorex if you are currently taking a medicine containing 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 both amiodarone and sofosbuvir is required, you may need additional cardiac monitoring.

Contact 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 problems;
• shortness of breath or worsening of existing shortness of breath;
• chest pain;
• dizziness;
• palpitations;
• fainting or near-fainting.

Trangorex contains iodine and may interfere with the uptake of radioactive iodine.

Your doctor will reduce or discontinue your amiodarone treatment if your liver enzyme levels (transaminases) exceed three times the normal value due to severe liver impairment.

Neuromuscular disturbances may occur, which usually resolve upon discontinuation of the medicine.

Consult your doctor if you experience visual disturbances: blurred vision, decreased vision, colored halos, or a sensation of fog. If any of these problems occur, a complete eye examination should be performed.

Before starting treatment, your doctor may recommend tests: full clinical examination, thyroid function tests, liver enzymes, blood potassium levels, chest X-ray, and electrocardiogram.

During treatment, your doctor may recommend periodic tests to monitor thyroid and liver function every 6 months. Additionally, lung function tests, chest X-ray, electrocardiogram, or eye examinations may be performed if symptoms appear or worsen. If you are scheduled for surgery or will receive anesthesia, inform your doctor that you are taking Trangorex.

If you have an implanted pacemaker or cardioverter-defibrillator (devices used to ensure proper heart function), taking Trangorex may affect the effectiveness of these devices. Your doctor will perform tests before and after treatment with Trangorex to ensure these devices are functioning properly.

During treatment, skin reactions (serious blistering reactions) such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, which could be very serious or even fatal (see section 4). If symptoms or signs of Stevens-Johnson syndrome or toxic epidermal necrolysis (progressive skin rash often with blisters or mucosal lesions) appear, amiodarone treatment must be stopped immediately.

The safety and efficacy of amiodarone in children have not been established; therefore, administration of amiodarone in children is not recommended.

You should avoid exposure of your skin to sunlight or sunlamps and take protective measures throughout the duration of treatment.

Before starting amiodarone treatment, low blood potassium levels (hypokalemia) should be corrected.

If you are on a waiting list for a heart transplant, your doctor may change your treatment. This is because taking amiodarone before heart transplantation has been associated with an increased 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.

Use of Trangorex with other medicines

This medicine may alter the response of other medicines; therefore, inform your doctor if you are using or have recently used any other medicines, including those obtained without a prescription. Your doctor will decide whether any medication should be discontinued or if the dose should be adjusted.

1- Medicines that may induce torsades de pointes (serious heart rhythm disturbances) or QT interval prolongation:

• Medicines that induce torsades de pointes

Concomitant use with medicines that may induce torsades de pointes is contraindicated:

• Class Ia antiarrhythmic medicines (quinidine, hydroquinidine, disopyramide), sotalol, bepridil.

• Non-antiarrhythmic medicines such as vincamine (used to treat cerebral blood circulation disorders), certain neuroleptics (used to treat psychosis and agitation, such as: chlorpromazine, levomepromazine, thioridazine, trifluoperazine, haloperidol, amisulpride, sulpiride, tiapride, pimozide), intravenous erythromycin (antibiotic), parenteral pentamidine (antibiotic), due to an increased risk of potentially fatal torsades de pointes.

• Medicines that prolong the QT interval

The administration of amiodarone together with medicines that prolong the QT interval should be based on a careful assessment of risks and benefits for each patient, as the risk of torsades de pointes may increase. QT interval prolongation should be monitored.

The use of certain antibiotics (fluoroquinolones) should also be avoided during treatment with amiodarone.

2- Medicines that reduce heart rate or cause automaticity or conduction disorders:

Treatment with the following medicines is not recommended:

• Other antiarrhythmics or medicines that may cause arrhythmia (phenothiazines, tricyclic antidepressants, terfenadine – an antihistamine).
• Beta-blockers and calcium channel blockers that reduce heart rate (verapamil, diltiazem).
• Sofosbuvir, used for the treatment of hepatitis C.

3- Agents that may induce hypokalemia:

Combined treatment with the following medicines is not recommended:

• Stimulant laxatives, which may reduce blood potassium levels and thereby increase the risk of torsades de pointes.

Special caution is required when amiodarone is combined with the following medicines:

• Diuretics that reduce blood potassium levels (alone or in combination), corticosteroids, tetracosactide (used to diagnose adrenal problems and treat ulcerative colitis), intravenous amphotericin B (antibiotic).
• Oral anticoagulants (acenocoumarol, warfarin, dabigatran), as they increase the risk of bleeding.
• Digitalis glycosides (used to treat heart failure), phenytoin (antiepileptic), flecainide (used to treat heart rhythm disorders), fentanyl (used to treat pain), lidocaine (used to treat pain), sildenafil (used to treat erectile dysfunction), midazolam (muscle relaxant and antiepileptic), triazolam (used to treat anxiety), dihydroergotamine (used to treat migraines), ergotamine (used to treat migraines), colchicine (used to treat gout), as blood concentrations of these medicines may increase.
• Cyclosporine, tacrolimus, and sirolimus (used to help prevent transplant rejection), as their effects may be enhanced.
• Statins such as simvastatin, atorvastatin, and lovastatin (medicines used to lower high blood fat levels, mainly cholesterol and triglycerides), as the risk of muscle toxicity (e.g., rhabdomyolysis, a condition characterized by breakdown of muscle tissue) increases.

General anesthesia

Potentially serious complications have been observed when amiodarone is used in combination with general anesthetics.

Amiodarone contains iodine and may interfere with the uptake of labeled iodine. However, thyroid function tests (free T3, free T4, and TSHus) remain interpretable.

It is recommended to avoid grapefruit juice during treatment with amiodarone, as it may increase amiodarone levels.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Pregnancy and breastfeeding

Trangorex must not be taken during pregnancy unless the benefits clearly outweigh the risks, as it may affect the fetal thyroid gland. Inform your doctor if you are pregnant or suspect you may be pregnant.

Trangorex must not be taken during breastfeeding, as it passes into breast milk in significant amounts.

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

Driving and using machines

There is no specific information indicating that Trangorex affects the patient's ability to drive or operate machinery.

Trangorex contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Trangorex

Treatment must only be initiated under the supervision of a specialist physician. For proper use of this medication, regular medical monitoring is essential, which may include laboratory tests.

If in doubt, consult your doctor again.

Trangorex should be administered orally.

Always use the lowest effective dose according to each patient's response. The usual dosage regimen is:

• Initial treatment: 3 tablets (600 mg) daily for 8 to 10 days. In certain cases, the initial dose may be higher, up to 4–5 tablets (1000 mg) daily. After the initial treatment, reduce the dose to 2 tablets (400 mg) daily for the following week.
• Maintenance treatment: from half a tablet (100 mg) to 1 tablet (200 mg) daily. It is recommended to include rest periods (2 days per week); these are possible due to the effect of this medication. Occasionally, a higher maintenance dose may be required. Maintenance treatment should be reviewed regularly, especially when more than 1 tablet is taken daily.

In patients over 65 years of age, it is recommended to start with the lowest dose, taking into account the patient's heart, kidney, and liver function, as well as any other diseases or medications being taken.

Use in children and adolescents

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

Always follow your doctor's exact instructions for taking Trangorex. If you have any doubts, consult your doctor or pharmacist.

Your doctor will advise you on how long your treatment with Trangorex should last. Do not stop treatment prematurely.

If you take more Trangorex than you should

Like other medicines, an overdose may be dangerous.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Trangorex

It is best to take the next dose as usual.

Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

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

The adverse effects observed, according to their frequency of occurrence—very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people); frequency not known (cannot be estimated from available data)—are listed below:

Blood and lymphatic system:

• Very rare: Anaemia (reduced number of red blood cells), failure of bone marrow development (aplastic anaemia), reduction in the number of blood platelets (thrombocytopenia).
• Frequency not known: You may have more infections than usual. This may be due to a reduction in the number of white blood cells (neutropenia). Severe reduction in white blood cells, increasing the likelihood of infections (agranulocytosis).

Cardiac:

• Common: Mild bradycardia (slow heart rate), dose-dependent.
• Uncommon: Onset or worsening of heart rhythm disturbances (arrhythmia), sometimes followed by cardiac arrest. Impulse conduction disturbances in the heart.
• Very rare: Marked bradycardia or sinus arrest (lack of electrical impulses in the heart), especially in patients with sinus dysfunction and/or over 65 years of age.
• Frequency not known: Torsades de pointes.

Endocrine:

• Common: Hypothyroidism (underactive thyroid gland); hyperthyroidism, sometimes fatal (overactive thyroid gland).
• Very rare: Increased creatinine (a substance related to kidney function) in blood. Problems with antidiuretic hormone (a hormone that controls the amount of water the body excretes).

Eye disorders:

• Very common: Seeing colored halos in bright light or blurred vision, reduced vision, which resolve upon discontinuation of treatment.
• Very rare: Inflammation of the optic nerve (optic neuritis), which may progress to blindness.

Gastrointestinal:

• Very common: Nausea, vomiting, altered taste, which usually resolve upon dose reduction.
• Common: Constipation.
• Uncommon: Dry mouth.
• Frequency not known: Acute inflammation of the pancreas (acute pancreatitis).

General and at the site of administration:

• Frequency not known: Granuloma (a type of hard, reddish nodule), including granuloma in the bone marrow.

Hepatobiliary:

• Very common: Isolated, moderate increase in transaminases (substances related to liver function), which resolves upon dose reduction or spontaneously.
• Common: Acute liver disorders with increased blood transaminases and/or jaundice (yellowing of the skin). Liver failure (sometimes fatal).
• Very rare: Chronic liver disorders (sometimes fatal).

Immune system:

• Frequency not known: Swelling due to fluid accumulation under the skin (angioedema). Severe allergic reaction (anaphylactoid reaction, anaphylactic shock), including life-threatening allergic reactions (shock).

Other:

• Very rare: Increased blood creatinine.

Metabolism and nutrition:

• Frequency not known: Decreased appetite.

Musculoskeletal and connective tissue:

• Frequency not known: Lupus-like syndrome (a disease in which the immune system attacks various parts of the body, causing joint pain, stiffness, swelling, and red skin rashes, sometimes with a butterfly-shaped rash on the face).

Nervous system:

• Common: Tremor, nightmares, sleep disturbances.
• Uncommon: Loss of sensation in the limbs (peripheral neuropathies) and/or muscle problems (myopathies), which resolve upon discontinuation of treatment.
• Very rare: Problems with voluntary movements (ataxia), benign intracranial hypertension, headache.
• Frequency not known: Abnormal muscle movements, rigidity, tremor, and restlessness (parkinsonism); abnormal sense of smell (parosmia).

Psychiatric:

• Common: Decreased libido.
• Frequency not known: Confusion (delirium). Seeing, hearing, or feeling things that are not real (hallucinations).

Reproductive system:

• Very rare: Testicular inflammation, impotence.

Respiratory:

• Common: Lung toxicity, sometimes fatal (see section 2 “Warnings and precautions”).
• Very rare: Bronchial muscle contraction (bronchospasm) in patients with severe respiratory failure or asthma. Acute respiratory distress syndrome (difficulty breathing) in adults, usually after surgery.
• Frequency not known: Pulmonary hemorrhage.

Skin and subcutaneous tissue:

• Very common: Increased sensitivity to light (photosensitivity).
• Common: Itchy, red skin rash (eczema). Gray or lilac-colored skin spots when high doses are taken for a long time. These fade slowly after stopping treatment.
• Very rare: Skin redness (erythema) when combined with radiotherapy. Skin eruptions. Skin inflammation (dermatitis). Hair loss (alopecia).
• Frequency not known: Urticaria characterized by hives, irritation, and itching. Life-threatening skin reactions characterized by rash, blisters, peeling, and pain (toxic epidermal necrolysis (TEN)), Stevens-Johnson syndrome (SJS), bullous dermatitis, drug reaction with eosinophilia and systemic symptoms (DRESS).

Vascular:

• Very rare: Inflammation of blood vessels (vasculitis).

Injury, poisoning and procedural complications:

• Frequency not known: Life-threatening complication after heart transplantation (primary graft dysfunction), in which the transplanted heart fails to function properly (see section 2, Warnings and precautions).

Adverse reactions with amiodarone are common, particularly affecting the heart, lungs, and liver. Sometimes these manifestations are dose-related and resolve after dose reduction.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

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

5. Storage of Trangorex

Do not store above 25°C.

Keep in the outer packaging to protect from light.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Trangorex

• The active substance is amiodarone.
• The other components are: lactose monohydrate, maize starch, magnesium stearate, povidone, colloidal silicon dioxide, and purified water.

Appearance of the product and contents of the pack

Trangorex 200 mg are white, round, bevelled tablets, scored on one side and smooth on the other. The scored side is engraved with "200".

Each pack contains 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Manufacturer:

sanofi-aventis, S.A.

Ctra. C-35 (La Batlloria-Hostalric, km 63.09

17404 Riells i Viabrea (Gerona)

Spain

or

Sanofi Winthrop Industrie

1, rue de la Vierge

Ambarès et Lagrave

33565 Carbon Blanc Cedex

France

Date of most recent review of this leaflet: January 2022

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