Digoxin 62.5 Micrograms Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER_
_Digoxin 62.5 micrograms Tablets_
Read all of this leaflet carefully before you start taking this medicine because it contains important infoimation for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Digoxin Tablets are and what they are used for
2. What you need to know before you take Digoxin tablets
3. How to take Digoxin Tablets
4. Possible Side Effects
5. How to store Digoxin Tablets
6. Contents of the pack and other information
1. What are Digoxin Tablets and what are they used for
Digoxin Tablets belong to a group of medicines called cardiac glycosides, these slow down the rate of heart but increase the force with which the heart muscle contracts, making the heart work more efficiently.
Digoxin Tablets help the heart work more efficiently, especially in patients with congestive heart failure or atrial fibrillation (irregular rapid heart beats).
• heart failure
This is when your heart muscle can't pump strongly enough to supply blood around your whole body. It is not the same as a heart attack and does not mean that your heart stops.
• certain types of irregular heart beats
These include ‘atrial flutter' or ‘fibrillation'. They are caused by problems in the way the upper chambers of your heart send electrical signals. They cause your heart to beat too fast or in an uneven way.
| 2. What you need to know before you take Digoxin Tablets |
Do not take Digoxin Tablets if you:
• are allergic (hypersensitive) to Digoxin tablets, other related medicines such as digitoxin, or any of the ingredients in the tablets (see section 6). An allergic reaction may include a rash, difficulty in breathing or swelling of the face, lips, throat or tongue. If this is the first time your doctor has prescribed this medicine for you, tell them if you have taken any cardiac glycoside (such as digoxin, digitoxin) within the last two weeks.
• have any serious heart problems such as inflammation of the heart, enlargement of the heart muscle, problems in conduction of the electrical impulses in the heart or irregular heart beats including Wolff-Parkinson-
White syndrome. Although digoxin is used to treat serious heart problems, it may make others worse.
Warnings and Precautions:
Check with your doctor or pharmacist before using your medicine if you:
• have recently had a heart attack (myocardial infarction)
• have been told that you have low potassium or magnesium levels in your blood (hypokalaemia or hypomagnesaemia)
• have been told that you have high calcium levels in your blood (hypercalcaemia)
• have a heart problem caused by a lack of vitamin B, known as ‘Beri- Beri disease'
• have kidney problems
• have lung problems
• have thyroid problems
• have digestion problems
• have serious lung or breathing disorders
• have syndrome of stomach or bowel problems
• have been suffering from abnormal heart rhythm
• have congestive heart failure
• have an inflammation of the fibrous sac surrounding the heart (pericardium)
• have false positive changes on electrocardiogram (ECG) during exercise testing
• are under periodic monitoring of blood electrolytes (solutions of acids, bases or salts) and kidney function
• have an additional monitoring in patients receiving long-term treatment
• have gastro-intestinal reconstruction
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine. Your doctor may change your dose or you may need a different medicine.
Digoxin can interact with lots of medicines, including ones you bought yourself without a prescription. please ask your pharmacist to check that any medicine you take will not affect your digoxin tablets.
Other medicines and Digoxin Tablets
Tell your doctor or pharmacist if you are taking or might take any other medicines
• the herbal remedy St Johns Wort (Hypericum perforatum,) this should not be taken at the same time as digoxin. Consult your doctor before you stop taking St Johns Wort.
• telmisartan, prazosin, captopril, nifedipine, nisoldipine, verapamil, diltiazem, nitroprusside, hydralazine, acetazolamide, furosemide, triamterene, spironolactone, or amiloride (used to treat high blood pressure)
• sulfasalazine, penicillamine, chloroquine or hydroxychloroquine (used to treat rheumatoid arthritis)
• atorvastatin, colestipol or colestyramine (used to lower cholesterol)
• kaolin (used to treat stomach upsets) and antacids (used for indigestion)
• amiodarone, disopyramide, flecainide, moracizine, propafenone, or quinidine (used to treat irregular heart rhythms), beta blockers (eg propranolol or atenolol used to treat various heart conditions)
• tetracycline, azithromycin, clarithromycin, erythromycin, telithromycin, neomycin, rifampicin, trimethoprim (used to treat infections caused by bacteria) or amphotericin, itraconazole (used to treat infections caused by fungi)
• nefazodone, trazodone or lithium (used to treat depression) and alprazolam or diazepam (used to treat anxiety)
• acarbose (used to treat diabetes)
• phenytoin, topiramate (used to treat epilepsy)
• quinine (used to treat malaria and night-time leg cramps)
• calcium salts (eg calcium gluconate or calcium lactate) and vitamin D
• carbimazole (used to treat hyperthyroidism)
• ciclosporin (used following organ transplants)
• corticosteroids (eg prednisolone, hydrocortisone)
• medicines used to treat cancer
• edrophonium, suxamethonium, pancuronium, or tizanidine (muscle relaxants)
• aspirin, azapropazone, diclofenac, fenbufen, ibuprofen, indometacin, tiaprofenic acid, or phenylbutazone (medicines known as Non-Steroidal Anti-inflammatory Drugs (NSAIDs) and used to treat pain)
• salbutamol (used to treat asthma)
• carbenoxolone, omeprazole, pantoprazole, rabeprazole, or sucralfate (used to treat stomach ulcers)
Pregnancy, breast-feeding and Fertility
• Do not take this medicine if you are pregnant, think you have become pregnant or intend to become pregnant whilst taking these tablets.
• Always ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines:
• This medicine may make you feel drowsy, dizzy and affect your vision. DO NOT drive or operate machinery if affected.
• If in any doubt, talk to your pharmacist or doctor.
Important information about some of the ingredients of these Tablets
• This medicine contains LACTOSE.
• If you have been told by your doctor that you have intolerance to some sugars (such as lactose), contact your doctor before taking this medicine.
| 3. How to take Digoxin Tablets ~
• Always take Digoxin Tablets exactly as prescribed by your doctor.
SAME SIZE ARTWORK
260 x 140 mm
Front
You should check with your doctor or pharmacist if you are not sure.
• Check the label to see how often you should take your tablets.
• Swallow the tablets whole with a drink of water or milk.
• Do not crush or chew the tablets.
Your doctor will have decided how much digoxin is right for you:
• It depends on what heart problem you have and how serious it is.
• It also depends on your age, weight and how well your kidneys work.
• Your dose may go up or down depending on how you respond to the medicine. Your doctor will do checks to see how well the medicine is working. These may involve blood and urine tests.
This medicine is usually taken in two stages:
• Stage 1: loading or starting dose
The loading dose gets your digoxin levels up to the correct level quickly. You will either:
- take one large dose and then begin your maintenance dose or
- take a smaller dose each day for a week and then begin your maintenance dose
• Stage 2: maintenance dose
After your loading dose you will take a much smaller dose every day, until your doctor tells you to stop.
Adults and children over 10 years Loading/Starting dose:
- Usually between 0.75mg and 1.5mg (12 and 24 tablets) as a single dose.
- For some patients, like the elderly, this dose may be reduced or given in divided doses 6 hours apart.
- Alternatively a starting dose between 0.25mg and 0.75mg (4 and 12 tablets) may be given each day for a week.
- You may take a higher strength tablet for the loading dose.
Maintenance dose:
- Your doctor will decide this, depending on your response to digoxin
- It is usually between 0.125mg and 0.25mg (2 and 4 tablets daily).
Children under 10 years
• Loading/Starting dose:
- This is worked out using your child's weight
- Usually between 0.025mg and 0.045mg per kg of body weight. This should be given in divided doses between 4 and 8 hours apart.
• Maintenance dose:
- The doctor will decide this depending on your child's response to digoxin.
- It is usually a 1/5 (fifth) or a 1/4 (quarter) of the loading dose, to be taken daily. If you take more Digoxin Tablets than you should
If you take too much or if somebody takes your medicine by mistake, go to a hospital casualty department (A&E) immediately. You may get any of the side effects and symptoms listed in Section 4, but these can be serious.
If you forget to take Digoxin Tablets
• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
• DO NOT take a double dose to make up for the one you have missed.
If you stop taking Digoxin Tablets
• Do not stop taking this medicine, as your heart problem may get worse.
Talk to your doctor if you want to stop.
• If you have any further questions on the use of this product, ask your doctor or pharmacist.
I 4. Possible side effects |
• Like all medicines Digoxin can cause side effects, although not everybody gets them.
Tell your doctor immediately if:
• You have palpitations, chest pains, and shortness of breath or sweating. These can be symptoms of a serious heart problem caused by new irregular heartbeats. If these happen, tell your doctor immediately.
Other side effects that you should tell your doctor about include: Common (may affect up to 1 in 10 people)
• slow or irregular heart rate or heart failure (new or worsening of an old condition)
• feeling sick, being sick or diarrhoea
• skin rash that may be itchy
• drowsiness or dizziness
• visual disturbances, with blurred or yellow-green sight
• headache, fatigue, weakness, sleepiness, bad dreams, restlessness, nervousness, agitation and lack of interest in everyday life.
• loss of appetite or abdominal pain Uncommon (may affect up to 1 in 100 people)
• depression
Rare (may affect up to 1 in 1,000 people)
• Severe reduction in number of white blood cells which makes infections more likely.
• disorientation, confusion, forgetfulness, delirium, psychosis, depression, hearing or seeing things that are not there and fits.
• stomach pain caused by lack of blood supply or damage to your intestines Stop taking the tablets and tell your doctor immediately or contact the casualty department at your nearest hospital if the following allergic reaction occurs: skin rash, which might be itchy and/or red and swelling of the mouth, tongue and throat causing difficulty swallowing or breathing. This is a rare but serious side effect, you may need urgent medical attention or hospitalisation.
Very Rare (may affect up to 1 in 10,000 people)
• bruising or bleeding more easily than normal
• mental disturbances, you may feel confused, indifferent or unable to
judge clearly
• weakness, tiredness or a general feeling of being unwell
• breast enlargement in men
• headache
Reporting of side effects
If you get 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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Digoxin Tablets
• Keep this medicine out of the sight and reach of children
• Do not use this medicine after the expiry date (EXP.) which is stated on the carton. The expiry date refers to the last day of that month.
• Do not store above 250C. Store in the original package.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
| 6. Contents of the pack and other information
What Digoxin Tablets Contain:
• The active ingredient is digoxin, each tablet contains 62.5 micrograms (0.0625mg).
• The other ingredients are lactose monohydrate, maize starch, industrial methylated spirit, stearic acid, indigo carmine aluminium lake (E132) and magnesium stearate.
What Digoxin tablet looks like and contents of the pack
• Digoxin 62.5 microgram tablets are blue coloured, round, biconvex, unscored tablets with 'BL' embossed on one side of the tablet.
• The tablets are supplied in blister packs of 14, 28, 56 or 84 tablets.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, United Kingdom, HP4 1EG Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
Email: info@bristol-labs.co.uk
Digoxin 62.5 micrograms Tablets; PL 17907/0186 This leaflet was last revised in October 2015 To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
V7 14-10-15 D0
SAME SIZE ARTWORK
260 x 140 mm
Back
_Digoxin 62.5 micrograms Tablets_
Read all of this leaflet carefully before you start taking this medicine because it contains important infoimation for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Digoxin Tablets are and what they are used for
2. What you need to know before you take Digoxin tablets
3. How to take Digoxin Tablets
4. Possible Side Effects
5. How to store Digoxin Tablets
6. Contents of the pack and other information
1. What are Digoxin Tablets and what are they used for
Digoxin Tablets belong to a group of medicines called cardiac glycosides, these slow down the rate of heart but increase the force with which the heart muscle contracts, making the heart work more efficiently.
Digoxin Tablets help the heart work more efficiently, especially in patients with congestive heart failure or atrial fibrillation (irregular rapid heart beats).
• heart failure
This is when your heart muscle can't pump strongly enough to supply blood around your whole body. It is not the same as a heart attack and does not mean that your heart stops.
• certain types of irregular heart beats
These include ‘atrial flutter' or ‘fibrillation'. They are caused by problems in the way the upper chambers of your heart send electrical signals. They cause your heart to beat too fast or in an uneven way.
2. What you need to know before you take Digoxin Tablets
Do not take Digoxin Tablets if you:
• are allergic (hypersensitive) to Digoxin tablets, other related medicines such as digitoxin, or any of the ingredients in the tablets (see section 6).
An allergic reaction may include a rash, difficulty in breathing or swelling of the face, lips, throat or tongue. If this is the first time your doctor has prescribed this medicine for you, tell them if you have taken any cardiac glycoside (such as digoxin, digitoxin) within the last two weeks.
• have any serious heart problems such as inflammation of the heart, enlargement of the heart muscle, problems in conduction of the electrical
impulses in the heart or irregular heart beats including Wolff-Parkinson White syndrome. Although digoxin is used to treat serious heart problems, it may make others worse.
Warnings and Precautions
Check with your doctor or pharmacist before using your medicine if you:
• have recently had a heart attack (myocardial infarction)
• have been told that you have low potassium or magnesium levels in your blood (hypokalaemia or hypomagnesaemia)
• have been told that you have high calcium levels in your blood (hypercalcaemia)
• have a heart problem caused by a lack of vitamin B, known as ‘Beri- Beri disease'
• have kidney problems
• have lung problems
• have thyroid problems
• have digestion problems
• have serious lung or breathing disorders
• have syndrome of stomach or bowel problems
• have been suffering from abnormal heart rhythm
• have congestive heart failure
• have an inflammation of the fibrous sac surrounding the heart (pericardium)
• have false positive changes on electrocardiogram (ECG) during exercise testing
• are under periodic monitoring of blood electrolytes (solutions of acids, bases or salts) and kidney function
• have an additional monitoring in patients receiving long-term treatment
• have gastro-intestinal reconstruction
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine. Your doctor may change your dose or you may need a different medicine.
Digoxin can interact with lots of medicines, including ones you bought yourself without a prescription. please ask your pharmacist to check that any medicine you take will not affect your digoxin tablets.
Other medicines and Digoxin Tablets
Tell your doctor or pharmacist if you are taking or might take any other medicines
• the herbal remedy St Johns Wort (Hypericum perforatum,) this should not be taken at the same time as digoxin. Consult your doctor before you stop taking St Johns Wort.
• telmisartan, prazosin, captopril, nifedipine, nisoldipine, verapamil, diltiazem, nitroprusside, hydralazine, acetazolamide, furosemide, triamterene, spironolactone, or amiloride (used to treat high blood pressure)
• sulfasalazine, penicillamine, chloroquine or hydroxychloroquine (used to treat rheumatoid arthritis)
• atorvastatin, colestipol or colestyramine (used to lower cholesterol)
• kaolin (used to treat stomach upsets) and antacids (used for indigestion)
• amiodarone, disopyramide, flecainide, moracizine, propafenone, or quinidine (used to treat irregular heart rhythms), beta blockers (eg propranolol or atenolol used to treat various heart conditions)
• tetracycline, azithromycin, clarithromycin, erythromycin, telithromycin, neomycin, rifampicin, trimethoprim (used to treat infections caused by bacteria) or amphotericin, itraconazole (used to treat infections caused by fungi)
• nefazodone, trazodone or lithium (used to treat depression) and alprazolam or diazepam (used to treat anxiety)
• acarbose (used to treat diabetes)
• phenytoin, topiramate (used to treat epilepsy)
• quinine (used to treat malaria and night-time leg cramps)
• calcium salts (eg calcium gluconate or calcium lactate) and vitamin D
• carbimazole (used to treat hyperthyroidism)
• ciclosporin (used following organ transplants)
• corticosteroids (eg prednisolone, hydrocortisone)
• medicines used to treat cancer
• edrophonium, suxamethonium, pancuronium, or tizanidine (muscle relaxants)
• aspirin, azapropazone, diclofenac, fenbufen, ibuprofen, indometacin, tiaprofenic acid, or phenylbutazone (medicines known as Non-Steroidal Anti-inflammatory Drugs (NSAIDs) and used to treat pain)
• salbutamol (used to treat asthma)
• carbenoxolone, omeprazole, pantoprazole, rabeprazole or sucralfate (used to treat stomach ulcers)
Pregnancy, breast-feeding and Fertility
• Do not take this medicine if you are pregnant, think you have become pregnant or intend to become pregnant whilst taking these tablets.
• Always ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines:
• This medicine may make you feel drowsy, dizzy and affect your vision. DO NOT drive or operate machinery if affected.
• If in any doubt, talk to your pharmacist or doctor.
Important information about some of the ingredients of these Tablets
• This medicine contains LACTOSE.
• If you have been told by your doctor that you have intolerance to some sugars (such as lactose), contact your doctor before taking this medicine.
| 3. How to take Digoxin Tablets |
• Always take Digoxin Tablets exactly as prescribed by your doctor.
You should check with your doctor or pharmacist if you are not sure.
SAME SIZE ARTWORK
260 x 140 mm
Front
• Check the label to see how often you should take your tablets.
• Swallow the tablets whole with a drink of water or milk.
• Do not crush or chew the tablets.
Your doctor will have decided how much digoxin is right for you:
• It depends on what heart problem you have and how serious it is.
• It also depends on your age, weight and how well your kidneys work.
• Your dose may go up or down depending on how you respond to the medicine. Your doctor will do checks to see how well the medicine is working.
These may involve blood and urine tests.
This medicine is usually taken in two stages:
• Stage 1: loading or starting dose
The loading dose gets your digoxin levels up to the correct level quickly. You will either:
- take one large dose and then begin your maintenance dose or
- take a smaller dose each day for a week and then begin your maintenance dose
• Stage 2: maintenance dose
After your loading dose you will take a much smaller dose every day, until your doctor tells you to stop.
Adults and children over 10 years Loading/Starting dose:
- Usually between 0.75mg and 1.5mg (12 and 24 tablets) as a single dose.
- For some patients, like the elderly, this dose may be reduced or given in divided doses 6 hours apart.
- Alternatively a starting dose between 0.25mg and 0.75mg (4 and 12 tablets) may be given each day for a week.
- You may take a higher strength tablet for the loading dose.
Maintenance dose:
- Your doctor will decide this, depending on your response to digoxin
- It is usually between 0.125mg and 0.25mg (2 and 4 tablets daily).
Children under 10 years
• Loading/Starting dose:
- This is worked out using your child's weight
- Usually between 0.025mg and 0.045mg per kg of body weight. This should be given in divided doses between 4 and 8 hours apart.
• Maintenance dose:
- The doctor will decide this depending on your child's response to digoxin.
- It is usually a 1/5 (fifth) or a 1/4 (quarter) of the loading dose, to be taken daily.
If you take more Digoxin Tablets than you should
If you take too much or if somebody takes your medicine by mistake, go to a hospital casualty department (A&E) immediately. You may get any of the side effects and symptoms listed in Section 4, but these can be serious.
If you forget to take Digoxin Tablets
• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
• DO NOT take a double dose to make up for the one you have missed.
If you stop taking Digoxin Tablets
• Do not stop taking this medicine, as your heart problem may get worse.
Talk to your doctor if you want to stop.
• If you have any further questions on the use of this product, ask your doctor or pharmacist.
_4. Possible side effects_
Like all medicines Digoxin can cause side effects, although not everybody gets them.
Tell your doctor immediately if:
• You have palpitations, chest pains, and shortness of breath or sweating. These can be symptoms of a serious heart problem caused by new irregular heartbeats. If these happen, tell your doctor immediately.
Other side effects that you should tell your doctor about include: Common (may affect up to 1 in 10 people)
• slow or irregular heart rate or heart failure (new or worsening of an old condition)
• feeling sick, being sick or diarrhoea
• skin rash that may be itchy
• drowsiness or dizziness
• visual disturbances, with blurred or yellow-green sight
• headache, fatigue, weakness, sleepiness, bad dreams, restlessness, nervousness, agitation and lack of interest in everyday life.
• loss of appetite or abdominal pain Uncommon (may affect up to 1 in 100 people)
• depression
Rare (may affect up to 1 in 1,000 people)
• Severe reduction in number of white blood cells which makes infections more likely.
• disorientation, confusion, forgetfulness, delirium, psychosis, depression, hearing or seeing things that are not there and fits.
• stomach pain caused by lack of blood supply or damage to your intestines Stop taking the tablets and tell your doctor immediately or contact the casualty department at your nearest hospital if the following allergic reaction occurs: skin rash, which might be itchy and/or red and swelling of the mouth, tongue and throat causing difficulty swallowing or breathing. This is a rare but serious side effect, you may need urgent medical attention or hospitalisation.
Very Rare (may affect up to 1 in 10,000 people)
• bruising or bleeding more easily than normal
• mental disturbances, you may feel confused, indifferent or unable to judge clearly
• weakness, tiredness or a general feeling of being unwell
• breast enlargement in men
• headache
If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. How to store Digoxin Tablets
• Keep this medicine out of the sight and reach of children
• Do not use this medicine after the expiry date (EXP.) which is stated on the carton. The expiry date refers to the last day of that month.
• Do not store above 250C. Store in the original package.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
| 6. Contents of the pack and other information ~
What Digoxin Tablets Contain:
• The active ingredient is digoxin, each tablet contains 62.5 micrograms (0.0625mg).
• The other ingredients are lactose monohydrate, maize starch, industrial methylated spirit, stearic acid, indigo carmine aluminium lake (E132) and magnesium stearate.
What Digoxin tablet looks like and contents of the pack
• Digoxin 62.5 microgram tablets are blue coloured, round, biconvex, unscored tablets with 'BL' embossed on one side of the tablet.
• The tablets are supplied in blister packs of 14, 28, 56 or 84 tablets.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,
United Kingdom, HP4 1EG Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
Email: info@bristol-labs.co.uk
Digoxin 62.5 micrograms Tablets; PL 17907/0222 This leaflet was last revised in October 2015 To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
V5 20-10-15 D0 |
SAME SIZE ARTWORK
260 x 140 mm
Back