ARYTHMOL 150MG TABLETS
Active substance: PROPAFENONE HYDROCHLORIDE
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Label Center Ludwigshafen
Black
LCR No.: 01513-2012, 01514-2012 AD No.: 01980-2012 Commodity No.: 26114121 GB/GI 2 Draft No.: 2 Revision date: 10. Apr. 2012 Font: Neue Helvetica Graphic Artist: Th. Wrzburger Font size: 8 pt
ARYTHMOL
150 & 300 mg Tablets Propafenone Hydrochloride
3. How should you take Arythmol? Follow your doctors directions about when and how to take your tablets and look at the label on the carton. Your pharmacist will also help if you are not sure. The number of tablets that you will need to take will be decided by your doctor. This may be between one Arythmol 150 mg tablet three times a day to one Arythmol 300 mg tablet three times a day. You may need a lower dose of Arythmol if you are elderly, if you have problems with your kidneys or liver, or if you have a low bodyweight. Swallow your tablets without chewing them. It is best to take them after food with some water. Do not take with grapefruit juice. IF YOU OR SOMEONE YOU KNOW TAKES MORE ARYTHMOL THAN PRESCRIBED (AN OVERDOSE) you should contact a doctor or go to the nearest hospital casualty department IMMEDIATELY, taking your tablets with you. IF YOU FORGET TO TAKE YOUR ARYTHMOL TABLETS take them as soon as you remember, unless it is almost time for your next dose. If it is, do not take the
1. What is Arythmol & what is it used for? Arythmol belongs to a group of medicines called antiarrhythmic agents. Arythmol slows down the heart rate and helps to regulate the heartbeat. Arythmol tablets are used to treat and prevent arrhythmias (abnormal heart rhythms). 2. What should you know before taking Arythmol? If the answer to any of these questions is YES, tell your doctor or pharmacist BEFORE you start to take Arythmol. Are you sensitive (allergic) to propafenone or any of the other ingredients in the tablets (see section 6)? Have you had a heart attack in the previous 3 months? Are you pregnant or planning to become pregnant, or are you breast feeding? Do you suffer from heart failure or any heart problems other than your abnormal heart rhythm? Do you have a heart condition called Brugada Syndrome, which causes you to have a potentially lifethreatening heart rhythm? Do you have an unusually slow heart rate or hypotension (low blood pressure)? Do you suffer from any breathing problems, such as
IMPORTANT INFORMATION Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet as you may need to read it again This leaflet provides a summary of the information currently available for Arythmol For further information or advice ask your doctor or pharmacist This medicine is for you only and should never be given to anyone else, even if they appear to have the same symptoms as you Tell your doctor or pharmacist if you experience any side effects
26114121 GB_GI 2.indd 1
10.04.12 09:59
26114121 GB/GI 5203
OTHER IMPORTANT INFORMATION If you need to have an operation it is important to tell the surgeon or dentist, Arythmol may affect the anaesthetic or other treatments used. If you have a pacemaker, it may need to be altered. Arythmol is NOT suitable for children. Your doctor may perform ECGs and blood pressure monitoring prior to and during treatment to monitor your individual dose.
schw.
M096/M097
Leaflet Contents: 1. What is Arythmol & what is it used for? 2. What should you know before taking Arythmol? 3. How should you take your Arythmol? 4. Possible side effects of Arythmol. 5. How should you store Arythmol? 6. Further information about Arythmol.
asthma or chronic bronchitis or emphysema? Have you been diagnosed as having the condition known as myasthenia gravis? Has your doctor told you that you have a disturbance in the salts (e.g. sodium or potassium) in your blood? Are you going to be receiving an anaesthetic? Are you taking any of the following? medicines that affect the activity of the heart such as amiodarone, digoxin, quinidine; tablets to prevent blood clots (e.g. warfarin); antibiotics (e.g. erythromycin or rifampicin); any of the group of medicines known as beta-blockers (these are used to treat high blood pressure); any antiviral agents (e.g. ritonavir); any of the group of medicines known as major tranquillisers, or an antidepressant of the tricyclic or related group (e.g. amitriptyline, dothiepin, desipramine); any other antidepressants, such as venlafaxine, fluoxetine, paroxetine; cimetidine (an ulcer medicine), ciclosporin (an immunosuppressant, used after transplant operations, or in the treatment of arthritis or psoriasis), theophylline (used in the treatment of asthma), ketoconazole (an antifungal agent), phenobarbitol (for epilepsy) or grapefruit juice.
DRIVING AND USING MACHINERY It is NOT advisable to drive, operate machinery or do anything that requires you to be alert until you know how the tablets affect you. This is because Arythmol can cause blurred vision, dizziness, tiredness and low blood pressure in some people.
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missed dose at all. Never double up on a dose to make up for the one you have missed. IF YOU STOP TAKING ARYTHMOL, without your doctors advice, your condition may get worse. It is important that you keep taking these tablets until your doctor tells you to stop. Do NOT stop just because you feel better. 4. Possible side effects of Arythmol. As well as benefits, all medicines may sometimes have unwanted effects in some people. Tell your doctor IMMEDIATELY if you develop any of the following conditions: a rash, itching or skin reddening or other signs of an allergic reaction such as difficulty breathing. Although these are rare, they can be serious. yellowing of the skin and/or eyes, as these may be a sign of liver problems you start to bruise easily or if you develop a very sore throat with a high fever, as in very rare cases, treatment may affect the amount of white blood cells and platelets in the blood. Other side effects with Arythmol may include: Very Common side effects (occurring in more than 1 in 10 users): - Dizziness - Irregular (slow or fast) heart beat - Heart palpitations (being aware of your heart beat) Common side effects (occurring in 1 to 10 users in 100): - Anxiety - Difficulty sleeping
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Headache Alteration of taste or a bitter taste Blurred vision Abnormal heart rhythm Shortness of breath Stomach pain Feeling or being sick Diarrhoea Constipation Dry mouth Liver disorders Chest pain Feeling tired or weak Fever
-
Rigidity (stiffness) Restlessness Life threatening irregular heart beat Heart problems which can cause shortness of breath or ankle swelling A fall in the blood pressure on standing up which may cause dizziness, light headedness or fainting Yellowing of the skin or whites of the eyes caused by liver or blood problems Retching Lupus-like syndrome (an allergic condition which causes joint pain, skin rashes and fever)
26114121 GB_GI 2.indd 2
26114121 GB/GI 5203 schw. M096/M097 000 2 359
6. Further information about Arythmol. The active ingredient in Arythmol is propafenone hydrochloride. The tablets are white and are available in two strengths, containing either 150 mg or 300 mg of propafenone hydrochloride. Other ingredients include: microcrystalline cellulose, maize starch, hypromellose, croscarmellose sodium, purified water, macrogol, titanium dioxide (E171) and magnesium stearate. Each pack of Arythmol 150 mg tablets contains 90 tablets. Each pack of Arythmol 300 mg tablets contains 60 tablets. Marketing Authorisation Holder: Abbott Laboratories Ltd., Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom Manufacturer: Abbott GmbH & Co. KG, Knollstrasse 50, 67061 Ludwigshafen, Germany The leaflet was last approved in January 2012.
A reversible drop in sperm count has occasionally been reported with high doses. If you experience any other unusual symptoms whilst taking your tablets, tell your doctor or pharmacist. 5. How should you store Arythmol? Your tablets should be stored in a safe place out of the reach and sight of children. They should be kept below 30C and in their original packaging. Do NOT use Arythmol after the expiry date printed on the packaging. The date refers to the last day of that month. If your doctor decides to stop the treatment, return any left over tablets to your pharmacist. Only keep the tablets if your doctor tells you to. Do not dispose of the leftover tablets carelessly (e.g. down the toilet or in with your general rubbish).
Uncommon side effects (occurring in 1 to 10 users in 1000): - Reduction in blood platelets, which increases risk of bleeding or bruising - Loss of appetite - Nightmares - Fainting - Ataxia (problems with or loss of coordination) - Low blood pressure - Vertigo (spinning sensation) - A tingling or pricking sensation of the skin - Numbness - Bloating - Flatulence (passing wind/gas) - Redness of skin and itchy skin - Impotence The following are side effects with an unknown frequency: - Severe reduction in the number of white blood cells which makes infections more likely - Confusion - Seizures - Tremor (feeling shaky)
10.04.12 09:59
Black
LCR No.: 01513-2012, 01514-2012 AD No.: 01980-2012 Commodity No.: 26114121 GB/GI 2 Draft No.: 2 Revision date: 10. Apr. 2012 Font: Neue Helvetica Graphic Artist: Th. Wrzburger Font size: 8 pt
ARYTHMOL
150 & 300 mg Tablets Propafenone Hydrochloride
3. How should you take Arythmol? Follow your doctors directions about when and how to take your tablets and look at the label on the carton. Your pharmacist will also help if you are not sure. The number of tablets that you will need to take will be decided by your doctor. This may be between one Arythmol 150 mg tablet three times a day to one Arythmol 300 mg tablet three times a day. You may need a lower dose of Arythmol if you are elderly, if you have problems with your kidneys or liver, or if you have a low bodyweight. Swallow your tablets without chewing them. It is best to take them after food with some water. Do not take with grapefruit juice. IF YOU OR SOMEONE YOU KNOW TAKES MORE ARYTHMOL THAN PRESCRIBED (AN OVERDOSE) you should contact a doctor or go to the nearest hospital casualty department IMMEDIATELY, taking your tablets with you. IF YOU FORGET TO TAKE YOUR ARYTHMOL TABLETS take them as soon as you remember, unless it is almost time for your next dose. If it is, do not take the
1. What is Arythmol & what is it used for? Arythmol belongs to a group of medicines called antiarrhythmic agents. Arythmol slows down the heart rate and helps to regulate the heartbeat. Arythmol tablets are used to treat and prevent arrhythmias (abnormal heart rhythms). 2. What should you know before taking Arythmol? If the answer to any of these questions is YES, tell your doctor or pharmacist BEFORE you start to take Arythmol. Are you sensitive (allergic) to propafenone or any of the other ingredients in the tablets (see section 6)? Have you had a heart attack in the previous 3 months? Are you pregnant or planning to become pregnant, or are you breast feeding? Do you suffer from heart failure or any heart problems other than your abnormal heart rhythm? Do you have a heart condition called Brugada Syndrome, which causes you to have a potentially lifethreatening heart rhythm? Do you have an unusually slow heart rate or hypotension (low blood pressure)? Do you suffer from any breathing problems, such as
IMPORTANT INFORMATION Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet as you may need to read it again This leaflet provides a summary of the information currently available for Arythmol For further information or advice ask your doctor or pharmacist This medicine is for you only and should never be given to anyone else, even if they appear to have the same symptoms as you Tell your doctor or pharmacist if you experience any side effects
26114121 GB_GI 2.indd 1
10.04.12 09:59
26114121 GB/GI 5203
OTHER IMPORTANT INFORMATION If you need to have an operation it is important to tell the surgeon or dentist, Arythmol may affect the anaesthetic or other treatments used. If you have a pacemaker, it may need to be altered. Arythmol is NOT suitable for children. Your doctor may perform ECGs and blood pressure monitoring prior to and during treatment to monitor your individual dose.
schw.
M096/M097
Leaflet Contents: 1. What is Arythmol & what is it used for? 2. What should you know before taking Arythmol? 3. How should you take your Arythmol? 4. Possible side effects of Arythmol. 5. How should you store Arythmol? 6. Further information about Arythmol.
asthma or chronic bronchitis or emphysema? Have you been diagnosed as having the condition known as myasthenia gravis? Has your doctor told you that you have a disturbance in the salts (e.g. sodium or potassium) in your blood? Are you going to be receiving an anaesthetic? Are you taking any of the following? medicines that affect the activity of the heart such as amiodarone, digoxin, quinidine; tablets to prevent blood clots (e.g. warfarin); antibiotics (e.g. erythromycin or rifampicin); any of the group of medicines known as beta-blockers (these are used to treat high blood pressure); any antiviral agents (e.g. ritonavir); any of the group of medicines known as major tranquillisers, or an antidepressant of the tricyclic or related group (e.g. amitriptyline, dothiepin, desipramine); any other antidepressants, such as venlafaxine, fluoxetine, paroxetine; cimetidine (an ulcer medicine), ciclosporin (an immunosuppressant, used after transplant operations, or in the treatment of arthritis or psoriasis), theophylline (used in the treatment of asthma), ketoconazole (an antifungal agent), phenobarbitol (for epilepsy) or grapefruit juice.
DRIVING AND USING MACHINERY It is NOT advisable to drive, operate machinery or do anything that requires you to be alert until you know how the tablets affect you. This is because Arythmol can cause blurred vision, dizziness, tiredness and low blood pressure in some people.
000 2 359
missed dose at all. Never double up on a dose to make up for the one you have missed. IF YOU STOP TAKING ARYTHMOL, without your doctors advice, your condition may get worse. It is important that you keep taking these tablets until your doctor tells you to stop. Do NOT stop just because you feel better. 4. Possible side effects of Arythmol. As well as benefits, all medicines may sometimes have unwanted effects in some people. Tell your doctor IMMEDIATELY if you develop any of the following conditions: a rash, itching or skin reddening or other signs of an allergic reaction such as difficulty breathing. Although these are rare, they can be serious. yellowing of the skin and/or eyes, as these may be a sign of liver problems you start to bruise easily or if you develop a very sore throat with a high fever, as in very rare cases, treatment may affect the amount of white blood cells and platelets in the blood. Other side effects with Arythmol may include: Very Common side effects (occurring in more than 1 in 10 users): - Dizziness - Irregular (slow or fast) heart beat - Heart palpitations (being aware of your heart beat) Common side effects (occurring in 1 to 10 users in 100): - Anxiety - Difficulty sleeping
-
Headache Alteration of taste or a bitter taste Blurred vision Abnormal heart rhythm Shortness of breath Stomach pain Feeling or being sick Diarrhoea Constipation Dry mouth Liver disorders Chest pain Feeling tired or weak Fever
-
Rigidity (stiffness) Restlessness Life threatening irregular heart beat Heart problems which can cause shortness of breath or ankle swelling A fall in the blood pressure on standing up which may cause dizziness, light headedness or fainting Yellowing of the skin or whites of the eyes caused by liver or blood problems Retching Lupus-like syndrome (an allergic condition which causes joint pain, skin rashes and fever)
26114121 GB_GI 2.indd 2
26114121 GB/GI 5203 schw. M096/M097 000 2 359
6. Further information about Arythmol. The active ingredient in Arythmol is propafenone hydrochloride. The tablets are white and are available in two strengths, containing either 150 mg or 300 mg of propafenone hydrochloride. Other ingredients include: microcrystalline cellulose, maize starch, hypromellose, croscarmellose sodium, purified water, macrogol, titanium dioxide (E171) and magnesium stearate. Each pack of Arythmol 150 mg tablets contains 90 tablets. Each pack of Arythmol 300 mg tablets contains 60 tablets. Marketing Authorisation Holder: Abbott Laboratories Ltd., Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom Manufacturer: Abbott GmbH & Co. KG, Knollstrasse 50, 67061 Ludwigshafen, Germany The leaflet was last approved in January 2012.
A reversible drop in sperm count has occasionally been reported with high doses. If you experience any other unusual symptoms whilst taking your tablets, tell your doctor or pharmacist. 5. How should you store Arythmol? Your tablets should be stored in a safe place out of the reach and sight of children. They should be kept below 30C and in their original packaging. Do NOT use Arythmol after the expiry date printed on the packaging. The date refers to the last day of that month. If your doctor decides to stop the treatment, return any left over tablets to your pharmacist. Only keep the tablets if your doctor tells you to. Do not dispose of the leftover tablets carelessly (e.g. down the toilet or in with your general rubbish).
Uncommon side effects (occurring in 1 to 10 users in 1000): - Reduction in blood platelets, which increases risk of bleeding or bruising - Loss of appetite - Nightmares - Fainting - Ataxia (problems with or loss of coordination) - Low blood pressure - Vertigo (spinning sensation) - A tingling or pricking sensation of the skin - Numbness - Bloating - Flatulence (passing wind/gas) - Redness of skin and itchy skin - Impotence The following are side effects with an unknown frequency: - Severe reduction in the number of white blood cells which makes infections more likely - Confusion - Seizures - Tremor (feeling shaky)
10.04.12 09:59
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
