Package Insert: Information for the User

Digoxina Teofarma 0.25 mg Tablets

Digoxina

Read this entire package insert carefully before starting to take this medication because it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, 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 package insert. See section 4.

Digoxina belongs to a group of medications known as cardiac glycosides. These medications are used for the treatment of certain heart diseases, such as heart failure, and for the treatment of certain irregular heart rhythms.

Do not take Digoxina Teofarma

• if you are allergic (hypersensitive) to digoxin, digitoxin, or any of the other components of this medication (listed in section 6).
• if you have heart rhythm disturbances due to poisoning with other cardiac glycosides
• if you have severe heart problems such as heart inflammation, heart muscle enlargement, conduction problems in the heart, or irregular heart rhythm, including Wolff-Parkinson-White syndrome (a type of heart condition).

Warnings and precautions

This medication should be used exclusively under the supervision and control of a doctor.

Consult your doctor before starting to take this medication:

• if you have heart rhythm disturbances
• if you have recently had a heart attack (myocardial infarction)
• if you are currently taking or have taken in the last two weeks any other cardiac glycoside
• if you have any kidney disease
• if your doctor has told you that you have high levels of calcium in your blood, or that you have low levels of magnesium or potassium in your blood
• if you have any thyroid disease
• if you have any lung or respiratory disease
• if you have any stomach or intestinal disease

Digoxin may cause changes in the electrocardiogram that do not reflect toxicity.

If you are to undergo surgery or receive anesthesia, you must inform your doctor that you are taking digoxin beforehand.

Use of Digoxina Teofarma with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, especially if it is any of the following:

• Medications used to treat stomach and intestinal problems (sucralfate, propantelina) including laxatives and those used to treat indigestion (antacids, caolín, carbón medicinal) diarrhea (sulfasalazina, difenoxilato with atropina) and vomiting (metoclopramida).
• Phenitoin, used to treat epilepsy
• Itraconazol, anfotericina B, used in the treatment of fungal infections.
• Alprazolam, diazepam, used to treat anxiety
• Beta-blockers (propanolol or atenolol), used to treat high blood pressure or irregular heart rhythm (arrhythmias)
• Anti-inflammatory medications such as carbenoxolona, glucocorticoids, ACTH, indometacina, fenilbutazona, and salicylates
• Colestiramina, colestipol, used to lower cholesterol
• Ciclosporina, used after a transplant and also used to treat eczema, psoriasis, rheumatic diseases, and ulcerative colitis
• Salbutamol and teofilina, used to treat asthma
• Nefazodona, trazodona, tricyclic antidepressants, used to treat depression
• Quinina, used to treat malaria
• Penicilamina, used to treat rheumatoid arthritis
• Muscle relaxants (chloruro de suxametonio, pancuronio)
• Calcium salts
• Medications used to treat irregular heart rhythm (amiodarona, flecainida, propafenona, quinidina)
• Medications used to treat high blood pressure (hypertension) (prazosin, captopril, nisoldipina, lacidipina, nitrendipina, felodipino, tiapamilo, verapamilo, diltiazem, reserpina)
• Diuretics (espironolactona, triamtereno, amilorida) used to help eliminate fluids from the body
• Medications used to treat cancer
• Medications used to treat bacterial infections (tetraciclinas, eritromicina, claritromicina, roxitromicina, trimetropina, gentamicina, neomicina, rifampicina)
• Sympathomimetic agents, such as adrenaline

Pregnancy and lactation

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

The dose administered is less predictable in pregnant women, so they may need a higher dose of digoxin during pregnancy. Like with other medications, the use of digoxin during pregnancy should only be considered when the expected clinical benefit for the mother outweighs any possible risk to the developing fetus.

Fetal adverse effects, such as abortion or fetal death, have been reported in mothers with digital toxicity when a large amount of digoxin was ingested.

Although digoxin is excreted in breast milk, the amounts are minimal, so it is not necessary to interrupt breastfeeding, although the heart rate of the infant should be monitored.

Driving and operating machinery

Digoxin administration may affect your vision. Therefore, caution is advised when driving or operating machinery until you know how this medication affects you.

Digoxina Teofarma 0.25 mg tablets contain lactose

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Your doctor will indicate the amount you should take of this medication based on your age, body weight, renal function, if you have any disease, or if you are taking any other medication.

The groove is only used to break the tablet if it is difficult to swallow it whole, but not to divide it into equal doses.

Adults, adolescents, and children over 10 years:

• Initial dose

Oral administration:

0.75 to 1.5 mg (3 to 6 tablets) as a single dose.

In less urgent cases or if there is a risk of toxicity, such as in the elderly, the oral dose should be administered in divided doses every 6 hours, administering approximately half of the total dose in the first dose.

Slow oral administration:

0.25 to 0.75 mg (1 to 3 tablets) daily for 1 week followed by a maintenance dose.

Your doctor will evaluate your response to treatment.

• Maintenance dose

Your doctor will decide the maintenance dose you should take based on your response to treatment. The normal dose is 0.125 to 0.75 mg of digoxin per day. If you are more sensitive to the adverse effects of digoxin, a maintenance dose of 0.0625 mg per day or less may be sufficient.

Newborns, infants, and children under 10 years

• Initial oral dose:

0.025 to 0.045 mg per kg of body weight over 24 hours.

This initial dose should be administered in divided doses, approximately half of the total dose as the first dose and additional fractions of the total dose at intervals of 4 to 8 hours. The doctor will evaluate the child's response to treatment before administering each additional dose.

• Maintenance dose:

Newborns premature:

- daily dose = 20% of the initial dose in 24 hours (intravenous or oral).

Newborns at term and children up to 10 years:

- daily dose = 25% of the initial dose in 24 hours (intravenous or oral).

These schemes are only a guideline, the doctor should perform a careful observation of the child's response and a control of the digoxin levels in serum, to adjust the dose in this group of patients.

If the child has been administered cardiac glycosides in the two weeks prior to the start of treatment with digoxin, your doctor will prescribe the child lower doses than those recommended previously.

In premature and immature newborns, the recommended dose should also be reduced, as their renal function is decreased.

Use in children

The tablets are not a suitable pharmaceutical form for children under 5 years or who cannot swallow whole tablets.

Older adults

Your doctor may prescribe lower doses than those recommended for adults to avoid toxic effects due to the increase in digoxin levels in serum as a result of the alteration of your renal function or low net body mass. Your doctor will regularly monitor your digoxin and potassium levels in blood.

If you take more Digoxina Teofarma than you should:

If you take more digoxin than you should or if you think your child has ingested some tablets, consult your doctor immediately, or pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forgot to take Digoxina Teofarma

Take the medication as soon as you remember, unless it is close to the time of the next dose. Then follow your normal medication schedule as instructed by your doctor.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Digoxina Teofarma

Your doctor will determine the duration of treatment with this medication. Do not interrupt treatment without consulting your doctor.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Frequent adverse effects (between 1 and 10 per 100 patients)

Alterations in heart rhythm and conduction, loss of appetite, nausea, vomiting, anorexia, abdominal pain.

Less frequent adverse effects (between 1 and 10 per 1,000 patients)

Headache, fatigue, insomnia.

Rare adverse effects (between 1 and 10 per 10,000 patients)

Diarrhea, mood alterations, depression, hallucinations, psychosis, vision disturbances, breast swelling, allergic reactions such as erythema, lupus erythematosus, skin rash, decreased platelet count in blood, fatigue.

Adverse effects of unknown frequency(cannot be estimated from available data)

Mesenteric infarction.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

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

Digoxin Teofarma 0.25 mg Tablets Composition

• The active ingredient is digoxin. Each tablet contains 0.25 mg of digoxin.
• The other components (excipients) are: lactose monohydrate, polyvinylpyrrolidone (E-1201), microcrystalline cellulose (E-460), sodium starch glycolate, colloidal silicon dioxide (E551), magnesium stearate (E572).

Product Appearance and Packaging Contents

This medication is presented as small, round, white, scored tablets.

The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Each package contains 50 tablets in a blister.

Marketing Authorization Holder and Responsible Manufacturer

Teofarma S.r.l.

Via F.lli Cervi, 8

27010 Valle Salimbene

Pavia-Italy

Last Review Date of this Leaflet October 2013

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

________________________________________________________________________

This information is intended solely for healthcare professionals

Symptoms of Intoxication

A digoxin overdose may potentiate the occurrence of adverse effects.

The symptoms of intoxication include cardiac, gastrointestinal, and central nervous system manifestations. Cardiac symptoms of intoxication are the most severe and life-threatening.

In children and infants, an overdose is initially characterized by the appearance of cardiac arrhythmias (alterations in heart rhythm). In adults, it is more common for anorexia, nausea, vomiting, diarrhea, and central nervous system alterations to occur.

The severity of the intoxication will depend on the amount of digoxin ingested and the concentrations of extracellular and intracellular potassium.

Treatment of Intoxication

If the intoxication has occurred within the first 4 hours of ingestion, in patients with bradycardia, an injection of atropine (0.5 - 1.0 mg IV or SC) is recommended. In all other cases, patients should receive activated charcoal.

Antidote

A fragment of digoxin antibody (Fab) has been developed for severe cases of digitalis poisoning, with cardiac arrhythmias and significant complications, following attempted suicide or accidental poisoning.

Forced diuresis, hemodialysis, and peritoneal dialysis should not be performed as they are ineffective in eliminating digital glycosides.

Symptomatic Treatment of Intoxication

In the case of tachycardias::

Potassium infusions. Potassium levels must be closely monitored for the appearance of hyperkalemia. Potassium is contraindicated in advanced cardiac block.

For arrhythmia correction::

Fenitoin 125-250 mg IV slow injection followed by oral therapy, or lidocaine 50-100 mg IV slow injection followed by IV infusion (2-4 mg/min). If the previously mentioned therapeutic measures are ineffective, cardioversion should be considered.

For bradycardia (pulse <60

Atropine 0.5 mg IV, repeat as necessary; if ineffective, a temporary pacemaker may be indicated.

All therapeutic measures must be performed under ECG monitoring.