DIGOXIN TEOFARMA 0.25 mg TABLETS

2. What you need to know before you take Digoxina Teofarma

Do not take Digoxina Teofarma

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

Warnings and precautions

This medicine must be used exclusively under medical supervision and control.

Consult your doctor before starting to take this medicine:

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

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

If you are going to undergo surgery or receive treatment with anesthetics, you should inform your doctor that you are taking digoxin.

Using Digoxina Teofarma with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, especially if they are any of the following:

• Medicines used to treat stomach and intestine problems (sucralfate, propanteline) including laxatives and those used for indigestion problems (antacids, kaolin, medicinal charcoal) diarrhea (sulfasalazine, diphenoxylate with atropine) and vomiting (metoclopramide).
• Phenytoin, used to treat epilepsy
• Itraconazole, amphotericin B, used to treat fungal infections.
• Alprazolam, diazepam, used to treat anxiety
• Beta-blockers (propranolol or atenolol), used to treat high blood pressure (hypertension) or irregular heart rhythm (arrhythmias)
• Anti-inflammatory drugs such as carbenoxolone, glucocorticoids, ACTH, indomethacin, phenylbutazone and salicylates
• Cholestyramine, colestipol, used to lower cholesterol
• Cyclosporin, used after a transplant and also used to treat eczema, psoriasis, rheumatic diseases and ulcerative colitis)
• Salbutamol and theophylline, used to treat asthma
• Nefazodone, trazodone, tricyclic antidepressants, used to treat depression
• Quinine, used to treat malaria
• Penicillamine, used to treat rheumatoid arthritis
• Muscle relaxants (suxamethonium chloride, pancuronium)
• Calcium salts
• Medicines used to treat heart rhythm disorders (amiodarone, flecainide, propafenone, quinidine)
• Medicines used to treat high blood pressure (hypertension) (prazosin, captopril, nisoldipine, lacidipine, nitrendipine, felodipine, tiapamil, verapamil, diltiazem, reserpine)
• Medicines that help eliminate fluids from the body (diuretics) (spironolactone, triamterene, amiloride)
• Medicines used to treat cancer
• Medicines used to treat bacterial infections (tetracyclines, erythromycin, clarithromycin, roxithromycin, trimethoprim, gentamicin, neomycin, rifampicin
• Sympathomimetic medicines, such as adrenaline

Tell your doctor if you are taking a medicine that contains enzalutamide (for the treatment of prostate cancer). It may interfere with your digoxin tests.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

The administered dose is less predictable in pregnant women, so they may need a higher dose of digoxin during pregnancy. As with other medicines, the use of digoxin during pregnancy should only be considered when the expected clinical benefit to 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 should be monitored in the breastfed baby.

Driving and using machines

Taking digoxin may affect your vision. Therefore, caution is advised when driving or using machines until you know how this medicine affects you.

Digoxina Teofarma 0.25 mg tablets contain lactose

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

3. How to take Digoxina Teofarma

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor again.

Your doctor will tell you the amount of this medicine you should take based on your age, weight, kidney function, if you have any disease or if you are taking any other medicine.

The score line is only for breaking the tablet if you find it difficult to swallow it whole, but not for dividing it into equal doses.

Adults, adolescents and children over 10 years:

• Initial dose

Rapid 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 six 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 assess your response to treatment.

• Maintenance dose

Your doctor will decide the maintenance dose you should take depending on your response to treatment. The usual 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 assess the child's response to treatment before administering each additional dose.

• Maintenance dose:

Preterm newborns:

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

Full-term newborns 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 carefully observe the child's response and control the levels of digoxin in serum to adjust the dose in this group of patients.

If the child has been given cardiac glycosides in the two weeks prior to starting treatment with digoxin, the doctor will prescribe lower doses than those recommended above.

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

Use in children

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

Elderly patients

Your doctor may prescribe lower doses than those recommended for adults to avoid toxic effects resulting from increased digoxin serum levels due to impaired renal function or low net body mass. Your doctor will regularly monitor your digoxin and potassium blood levels.

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 any tablets, consult your doctor, pharmacist or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Digoxina Teofarma

Take the medicine as soon as you remember unless it is almost time for the next dose. Then continue taking your medicine as usual according to the instructions given by your doctor.

Do not take a double dose to make up for forgotten doses.

If you stop taking Digoxina Teofarma

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (between 1 and 10 in every 100 patients)

Conduction and heart rhythm disorders, loss of appetite, nausea, vomiting, anorexia, abdominal pain.

Uncommon side effects (between 1 and 10 in every 1,000 patients)

Headache, fatigue, insomnia.

Rare side effects (between 1 and 10 in every 10,000 patients)

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

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

Mesenteric infarction.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Digoxina Teofarma

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

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Digoxina Teofarma 0.25 mg tablets

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

Appearance of the product and contents of the pack

This medicine is presented as small, round, white tablets with a score line.

The score line is only for breaking the tablet if you find it difficult to swallow it whole, but not for dividing it into equal doses.

Each pack contains 50 tablets in blister packs.

Marketing authorization holder and manufacturer

Teofarma S.r.l.

Via F.lli Cervi, 8

27010 Valle Salimbene

Pavia-Italy

Date of last revision of this leaflet: August 2025

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

________________________________________________________________________

This information is intended only for healthcare professionals

Overdose symptoms

An overdose of digoxin can enhance the appearance of side effects.

The symptoms of an overdose include cardiac, gastrointestinal and central nervous system manifestations. The cardiac symptoms of overdose are the most serious and life-threatening.

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

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

Overdose treatment

If the overdose 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 digoxin antibody fragment (Fab) has been developed for severe cases of digital poisoning, with cardiac arrhythmias and significant complications, after a suicide attempt or accidental poisoning.

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

Symptomatic treatment of overdose

In case of tachycardias:

Potassium infusions. It will be necessary to closely monitor the appearance of hyperkalemia. Potassium is contraindicated in advanced cardiac block.

For arrhythmia correction:

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

For bradycardia correction (pulse <60>

Atropine 0.5 mg IV, repeat if necessary; if not effective, a pacemaker (temporary) may be indicated.

All therapeutic measures should be performed under ECG monitoring.