50 micrograms / ml oral solution
Digoxin
What Lanoxin is and what it is used for
Lanoxin contains the active substance digoxin which is a so-called cardiac glycoside. Digoxin increases the contractile force of the heart and reduces the number of heartbeats per minute.
Lanoxin is used in the treatment of heart failure and in irregular heartbeats e.g. atrial fibrillation .
What you need to know before taking Lanoxin
Do not take Lanoxin:
- if you are allergic to digoxin or any of the other ingredients of this medicine (listed in section 6)
- if you have certain types of heart rhythm disorder such as Wolff-Parkinson-White syndrome or AV block
- if you have obstructive cardiomyopathy (a disease of the heart muscle)
- if you have arrhythmias caused by cardiac glycoside poisoning
Warnings and cautions
Talk to your doctor or pharmacist before taking Lanoxin if you have:
- acute myocardial infarction
- congenital heart disease (Fallot’s tetrad)
- decreased oxygen content in the body tissues ( hypoxia )
- renal impairment
- decreased circulation in the coronary arteries of the heart
- myocarditis ( myocarditis )
- pericarditis (constrictive pericarditis)
- used cardiac glycosides in the last two weeks
- severe lung disease
- abnormally low levels of potassium , abnormally low levels of magnesium or elevated levels of calcium in the blood
- underactive or overactive thyroid gland
- malabsorption syndrome or have a reconstructed gastrointestinal tract (that is, you have a reduced ability to absorb the nutrients in your food).
Digoxin poisoning can lead to various types of arrhythmias, and some of them may be similar to the arrhythmias for which this medicine has been prescribed.
In some cases (in case of a sick sinus node, so-called Sick Sinus Syndrome), Lanoxin can make the heart beat slower.
If you are having an ECG ( electrocardiogram ) test , tell the person performing the test that you are using Lanoxin as it may affect the interpretation of the results.
Other drugs and Lanoxin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines / herbal medicines can affect or be affected by treatment with Lanoxin, eg:
- diuretics (antihypertensive drugs)
- spironolactone (a medicine that increases the amount of urine you produce to reduce swelling ( edema ) or lower blood pressure )
- certain medicines for irregular heartbeat such as amiodarone , flecainide , propafenone , quinidine , dronedarone
- Certain medications used to treat cardiovascular disease such as high blood pressure , heart failure and angina. Examples are prazosin, carvedilol, verapamil, diltiazem , felodipine, nifedipine, eplerone, ranolazine, beta blockers , angiotensin receptor blockers eg telmisartan and ACE inhibitors eg captopril
- kanagliflozin (used to treat type 2 diabetes )
- daclatasvir (used in combination with other medicines to treat hepatitis C infection )
- flibanserin (used in the treatment of low sex drive in women who are still menstruating, ie who have not yet undergone menopause )
- lithium salts (medicines for manic-depressive illness)
- corticosteroids (medicines that reduce inflammation )
- carbenoxolone (an agent used to treat ulcers in the gastrointestinal tract)
- certain antibiotics (medicines for infections )
- isavuconazole (used to treat fungal infections)
- itraconazole (used to treat fungal infections)
- ivakaftor (used in the treatment of cystic fibrosis )
- alprazolam (a sedative that can be used to treat anxiety)
- quinine (an anti- malarial drug )
- mirabegron (used to treat overactive bladder that causes a sudden need to urinate and involuntary urine leakage)
- propantheline (used to prevent muscle spasms)
- nefazodone (an antidepressant)
- atorvastatin, cholestyramine (medicines that lower blood fats)
- ciclosporin (immune-suppressing drug commonly used to prevent post-transplant rejection)
- epoprostenol (used to treat high blood pressure in the blood vessels of the lungs)
- tolvaptan (used to treat low sodium levels in the blood)
- ritonavir / ritonavir containing treatments (used to treat HIV – infection )
- taleprevir (used to treat hepatitis C infection )
- lapatinib (used to treat breast cancer)
- tikagrelor (used to prevent blood clots)
- antacids (used to treat heartburn and acid reflux)
- certain bulking agents (fiber-containing laxatives )
- kaolin pectin (used to treat diarrhea)
- acarbose (used to treat certain types of diabetes )
- certain chemotherapy drugs (used to treat cancer)
- metoclopramide (used to treat nausea and vomiting)
- sulfasalazine (medicine for rheumatoid arthritis and inflammatory bowel disease)
- adrenaline (used to treat severe allergic reactions)
- salbutamol (a medicine used to treat asthma )
- phenytoin , phenobarbital, carbamazepine (used to treat epilepsy )
- St. John’s wort ( Hypericum perforatum )
- non-steroidal anti-inflammatory drugs ( NSAIDs such as indomethacin, ibuprofen ) (used to treat pain and inflammation )
- cyclooxygenase -2 enzyme ( COX-2 ) inhibitors (used to treat pain and inflammation )
- sennosides (for temporary constipation)
- simeprevir (used in combination with other medicines to treat hepatitis C infection )
- calcium (used for example in case of calcium deficiency )
- rifampicin (medicine for turberculosis)
- thyroid hormones (drugs for thyroid dysfunction)
- velpatasvir (used in combination with other medicines to treat hepatitis C infection )
- vandetanib (used to treat certain types of thyroid cancer)
- venetoclax (used to treat certain types of leukemia (blood cancer))
- vemurafenib (used to treat metastatic melanoma (skin cancer))
- proton pump inhibitors (eg omeprazole) (used to treat heartburn and stomach ulcers )
Pregnancy and breastfeeding
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.
Pregnancy
No significant adverse reactions were observed in fetuses or neonates when maternal levels of digoxin were maintained within the normal range. The use of Lanoxin during pregnancy should be considered if the benefits outweigh the potential risks to the fetus.
Digoxin given to the mother has been used to treat abnormally fast heartbeats and heart failure in fetuses.
Breast-feeding
Lanoxin is excreted in breast milk, but is unlikely to affect breast-fed infants.
Driving and using machines
As central nervous system and visual disturbances have been reported, caution should be exercised when driving vehicles, using machines or engaging in hazardous activities.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Lanoxin contains methyl parahydroxybenzoate (E218), sucrose, sodium and ethanol
Methyl parahydroxybenzoate (E218)
- May cause allergic reactions (possibly delayed).
Sucrose:
- If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Lanoxin. Because Lanoxin oral solution contains sucrose, it can be harmful to the teeth.
Sodium:
- This medicine contains 0.0551 mmol sodium per 1 ml oral solution. Depending on dose one, the amount of sodium may vary. This should be considered by patients on a low-salt diet.
Ethanol:
- This medicine contains less than 8.5% v / w ethanol (alcohol) in a dose of 5 ml, equivalent to 12.5 ml beer or 4.5 ml wine. The amount of ethanol varies depending on the size of the dose. Harmful to people suffering from alcoholism. This information should be considered for pregnant or lactating women, children and high-risk groups such as patients with liver disease or epilepsy .
How to take Lanoxin
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by the doctor, who adjusts it individually for you.
The difference between the effective dose and the dose that causes side effects is usually small. It is therefore important to follow the doctor’s prescription .
Lanoxin oral solution comes with a graduated pipette to be used to measure all doses .
Lanoxin oral solution should not be diluted.
Recommended maintenance dose to:
- Adults and children over 10 years of age are 0.125 and 0.25 mg (2.5-5 ml) of oral solution daily.
- Children under the age of 10 are determined on the basis of the child’s weight and are usually between 0.005 and 0.01 mg / kg (0.1-0.2 ml / kg) body weight.
A lower dose may be needed in case of impaired renal function.
Sometimes treatment with Lanoxin is started with a slightly higher dose for a few days (so-called digitization). This is done to achieve a certain level (concentration) of digoxin in the body, which is then maintained with a lower maintenance dose.
When using Lanoxin, you may have to take blood samples regularly. This is to be able to determine how you respond to the treatment.
If you take more Lanoxin than you should
If you have taken too large a dose of medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital or the Poison Information Center (tel. 112) for risk assessment and advice.
The signs of Lanoxin poisoning can be heart rhythm disturbances, nausea, vomiting, headache, fatigue, confusion, altered consciousness, hallucinations, seizures, blurred vision, disturbed color vision.
If you forget to take Lanoxin
Do not take a double dose to make up for a forgotten dose .
If you stop using Lanoxin
Do not stop treatment without consulting a doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
If side effects occur, they are almost always signs of overdose. Contact a doctor if side effects occur.
Common (may affect up to 1 in 10 people)
– Impact on the central nervous system , dizziness.
– Visual disturbance (blurred vision, yellow-green vision).
– Irregular heartbeat, disturbance in the heart’s conduction system (eg too low pulse ).
– Nausea, vomiting, diarrhea.
– Skin rash similar to hives .
Uncommon (may affect up to 1 in 100 people)
– Depression.
Very rare (may affect up to 1 in 10,000 people)
– Decreased number of platelets ( blood cells that cause the blood to clot), increased number of white blood cells ( blood cells that participate in the body’s infection defense).
– Loss of appetite
– Severe psychological influence ( psychosis ), indifference, confusion.
– Headache.
– Abnormal heartbeat
– Stomach pain, caused by lack of blood supply to the intestines or damage to them, which can lead to tissue death.
– Enlargement of the mammary glands ( gynecomastia ).
– Fatigue, a general feeling of discomfort, weakness.
How to store Lanoxin
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Do not use this medicine after the expiry date which is stated on the carton.
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 to protect the environment
Contents of the package and other information
Content declaration
- The active substance is digoxin 50 micrograms / ml.
- The other ingredients are anhydrous disodium phosphate, citric acid monohydrate, methyl parahydroxybenzoate ( preservative E 218), sucrose, quinoline yellow (dye E 104), lime (flavoring), ethanol 96%, propylene glycol and purified water.
What the medicine looks like and contents of the pack
Glass bottle with measuring pipette containing 60 ml oral solution.
Marketing Authorization Holder and Agent
Aspen Pharma Trading Limited
3016 Lake Drive,
Citywest Business Campus,
Dublin 24, Ireland
0046 856642572