Digoxin 0.05mg/ml oral solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

Talk to your doctor, pharmacist or nurse before using this medicine:

• If you are taking this medicine, your doctor may ask you to have regular blood tests to determine the amount of Digoxin oral solution in the blood. This may be useful in the case of patients with kidney disorders.
• If you develop digoxin toxicity, this can lead to various forms of heart rhythm disturbances, some of which resemble the rhythm disturbances for which the product was prescribed.
• If you have abnormal heart rhythm (heart block) and you are taking this medicine, contact your doctor immediately if you feel one or more of the following symptoms: fainting, short-lasting loss of consciousness, dizziness or light-headedness, fatigue (tiredness), shortness of breath, chest pain, irregular heart-beat or confusion.
• If you have a sinoatrial disorder (a disorder in the conduction of electrical impulses in the heart such as Sick Sinus Syndrome), in some patients with a sinoatrial disorder this medicine can cause a slow and/or irregular heart-beat. Sometimes this will cause tiredness, weakness and dizziness and when your heartbeat is very slow you may faint.
• If you have recently suffered a heart attack.
• When heart failure occurs along with the collection of an abnormal protein in the heart tissue (cardiac amyloidosis), an alternative therapy may be prescribed by the doctor.
• If you have myocarditis (inflammation of the heart muscle) this may cause vasoconstriction (narrowing of the blood vessels) on rare occasions. Your doctor may prescribe you a different medicine.
• If you have Beri-beri disease (caused by a vitamin B1 deficiency).
• If you have constrictive pericarditis (inflammation of the sac which contains the heart).
• If you are taking diuretics (drugs which promote urine production and help reduce the amount of water in your body) with or without an ACE inhibitor (mainly used to treat high blood pressure), your doctor will prescribe a lower dose of Digoxin oral solution. Do not stop taking Digoxin oral solution without talking to your doctor.
• If you have a heart test called an ECG (electrocardiogram), tell the person doing the test that you are taking Digoxin oral solution as it can affect the meaning of the results.
• If you have severe respiratory (lung) disease (as you may have an increased sensitivity to Digoxin oral solution).
• If you have low levels of oxygen reaching certain parts of your body, low levels of potassium, abnormally low levels of magnesium or increased levels of calcium in your blood.
• If you have thyroid disease (such as an under-active or over-active thyroid) as you might require changes in the dose of this medicine.
• If you have malabsorption syndrome (you cannot absorb minerals from your food properly) or if you have ever had gastrointestinal reconstruction surgery.
• If you will receive electric shock treatment to correct an abnormal heart-beat.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Taking several medicines can sometimes have harmful consequences or lead to unwanted interactions.

Sensitivity to Digoxin oral solution can be increased by medicines which lower the level of potassium in the blood. These include:

• diuretics,
• lithium salts (antidepressants),
• corticosteroid based products,
• carbenoxolone (a product which strengthens the gastric mucosa),

The following medicines increase the level of Digoxin oral solution in the blood, which can increase the risk of toxicity:

• certain products which affect the heart: amiodarone, flecainide, prazosin, propafenone, quinidine,
• canagliflozin (used to treat of type 2 diabetes mellitus),
• certain antibiotics: erythromycin, clarithromycin, tetracycline, gentamicin, trimethoprim,
• daclatasvir (used in combination with other medications to treat hepatitis C),
• flibanserin (used to treat low sexual desire in women who have not gone through menopause),
• isavuconazole (used to treat fungal infections),
• itraconazole (used to treat fungal infections),
• ivacaftor (used to treat cystic fibrosis),
• spironolactone (a drug which increases the amount of urine you produce),
• alprazolam (a sedative which may be used to treat anxiety),
• indomethacin (used to treat inflammation),
• quinine (may be used to prevent malaria infection),
• propantheline (used to prevent muscle spasms),
• mirabegron (used to treat overactive bladder that causes a sudden urge to urinate resulting in involuntary loss of urine),
• nefazodone (an antidepressant),
• atorvastatin (lowers blood cholesterol),
• cyclosporine (an immunosuppressant often used to prevent transplant rejection),
• epoprostenol (used to treat pulmonary arterial hypertension),
• tolvaptan (used to treat low blood sodium levels),
• conivaptan (used to treat low blood sodium levels),
• carvedilol (used to treat mild to severe congestive heart failure and high blood pressure),
• ritonavir (used to treat HIV infection and AIDS),
• taleprevir (used to treat hepatitis C infection),
• dronedarone (used to treat irregular heart-beat),
• ranolazine (used to treat chest pain),
• simeprevir (used in combination with other medications to treat hepatitis C),
• telmisartan (used to treat high blood pressure),
• lapatinib (used to treat breast cancer),
• ticagrelor (used to prevent heart attack or stroke),
• verapamil (used to treat high blood pressure),
• felodipine (used to treat high blood pressure),
• tiapamil (used to treat chest pain),
• vandetanib (used to treat certain cancers of the thyroid gland),
• velpatasvir (used in combination with other medications to treat hepatitis C),
• P-glycoprotein inhibitors.
• Venetoclax (is used to treat patients with chronic lymphocytic leukaemia)
• Vemurafenib (used to treat adult patients with a type of cancer called melanoma)
• Proton pump inhibitors (PPIs) (used to relieve symptoms of acid reflux, or gastroesophageal reflux disease (GERD)

The following medicines may increase or have no effect on the levels of Digoxin oral solution in the blood:

• nifedipine, diltiazem, angiotensin receptor blockers (ARBs) and ACE inhibitors (used to treat high blood pressure and congestive heart failure),
• non-steroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase-2 enzyme (COX-2) inhibitors (used to treat pain and inflammation).

If you have heart failure and are taking sennosides (increase the amount of stools you produce to help you have bowel movements) along with Digoxin oral solution you may have a moderately increased risk of Digoxin oral solution toxicity.

The following medicines reduce the level of Digoxin oral solution in the blood:

• antacids (used to treat gastric acidity),
• some bulk-forming laxatives (increase the amount of stools you produce to help you have bowel movements),
• kaolin-pectin (used to treat diarrhoea),
• acarbose (used to treat some types of diabetes),
• certain antibiotics: neomycin, penicillamine, rifampicin,
• some cytostatic drugs (used as chemotherapy for cancer treatment),
• metoclopramide (a product for treating nausea and vomiting),
• sulfasalazine (a product to counteract inflammatory diseases of the intestine),
• adrenaline (used to treat severe allergic reactions),
• salbutamol (a product used to treat asthma),
• colestyramine (lowers blood cholesterol),
• phenytoin (used to treat epilepsy),
• St. John’s wort (Hypericum perforatum) (used to treat depression),
• bupropion (used to treat depression),
• P-glycoprotein inducers,
• supplemental enteral nutrition (being fed by a feeding tube).

If you are taking digoxin along with the following medicines you may have an increased risk of irregular heart rhythm:

• intravenous calcium
• betablockers
• sympathomimetics (used to treat heart attack and low blood pressure)

If you are taking Digoxin oral solution and suxamethonium (used to help muscle relaxation and treat short-term paralysis), you may have an increased risk of high potassium levels in the blood.

This medicine may be taken on an empty stomach or with most meals. However, you should avoid taking Digoxin oral solution with foods that are high in fibre, also known as 'dietary fibre', because the level of Digoxin oral solution absorbed by the body can be reduced.

Pregnancy

Your doctor will prescribe this medicine with caution during pregnancy.

You may require a higher dose of this medicine if you are pregnant.

This medicine could be given to the mother to treat abnormally high heart rate and congestive heart failure in the unborn child.

Side effects of Digoxin oral solution treatment affecting the mother may also affect the unborn child.

Breastfeeding

This medicine is excreted in breast milk, but in very small amounts. Therefore, this medicine can be used by women who are breast-feeding.

Fertility

There is no information available on the effect of Digoxin oral solution on fertility.

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

Since dizziness and blurred or yellow vision have been reported, you should exercise caution before driving a vehicle, using machinery or participating in dangerous activities.

Digoxin oral solution contains methyl parahydroxybenzoate (E218), sucrose, ethanol and sodium

Methyl parahydroxybenzoate (E218):

• May cause allergic reactions (possibly delayed).

Sucrose:

• Digoxin oral solution contains less 0.3 g of sucrose in each ml of oral solution, i.e. 1.5 g of sucrose in a 5 ml (0.25 mg digoxin) dose. Depending on the dose the amount of sucrose will vary. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Ask your doctor to explain this further if your child is taking this medicine. May be harmful to teeth.

Ethanol:

• Digoxin oral solution contains less than 0.1 ml of ethanol (alcohol) in each ml of oral solution, i.e. up to 0.44 g of ethanol in a 5 ml (0.25 mg digoxin) dose which is equivalent to less than 12.5 ml (less than 3 teaspoons) beer, less than 4.5 ml (less than one teaspoon) wine per 0.25 mg digoxin dose. Depending on the dose the amount of ethanol will vary. Ask your doctor to explain this further if your child is taking this medicine. Harmful to those suffering from alcoholism. To be taken into account in pregnant or breast-feeding woman, children and high-risk groups such as patients with liver disease, or epilepsy.

Sodium:

• Adults and children over 10 years: This medicine contains 38.019 mg sodium (main component of cooking/table salt), or less, in each dose. This is equivalent to 1.9 % of the recommended maximum daily dietary intake of sodium for an adult.
• Children under 10 years: This medicine contains less than 1 mmol sodium (23 mg) per 1 ml of oral solution, that is to say essentially ‘sodium-free’

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

Your doctor will tell you how long you should take Digoxin. Do not stop your treatment early without consulting your doctor.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system:

or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of medicine.

Marketing Authorisation Holder:

Manufactured by:

Product name Digoxin 0.05mg/ml oral solution

Reference number PL 39699/0007