Package leaflet: Information for the user
/.../ 0.2 mg film-coated tablets Moxonidine
Read all of this leaflet carefully before you start taking this medicine because it contains important information 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet 1. What /.../ is and what it is used for 2. What you need to know before you take /.../ 3. How to take /.../ 4. Possible side effects 5. How to store /.../ 6. Contents of the pack and other information
1. What /…/ is and what it is used for
/.../ is a medication used to reduce high blood pressure. They act through the central nervous system to lower the blood pressure.
/.../ is used in the treatment of mild to moderate forms of high blood pressure that are not organ-related (essential hypertension).
2. What you need to know before you take /…/
Do not take /.../ - if you are allergic to the active substance moxonidine or to any of the other ingredients of this medicine (listed in section 6). - if you suffer from certain types of disturbances in heart rhythm (sick sinus syndrome or 2nd or 3rd degree atrioventricular block) - if your resting heart rate is very slow (less than 50 beats per minute at rest) (bradycardia) - if you suffer from heart failure or heart insufficiency (a condition in which the heart does not pump enough blood through the body, resulting in e.g. shortness of breath and swelling of the lower extremities).
Warnings and precautions Talk to your doctor or pharmacist before using /…/ - if you have a heart problem called “1st degree AV-block”
- if you suffer from a severe disturbance in blood supply to the heart muscle (coronary artery disease) or symptoms such as chest pain while at rest or with minimal effort (unstable angina pectoris). - if you suffer from a kidney function disorder. Your doctor will check your blood pressure regularly, especially at the start of treatment (if in doubt, please ask your doctor) - if you are taking a beta-blocker at the same time. In this instance, the beta-blocker must be stopped first, and then /.../ after a few days have elapsed. This will prevent an excessive increase in blood pressure.
Elderly The elderly may be more affected by the blood pressure lowering effects of /…/. Therefore your doctor may want to start you on a lower dose and gradually increase the dose over time.
Children and adolescents /.../ should not be taken by children and adolescents under 16 years of age (see section 3 “How to take /.../”).
Treatment with /.../ must not be stopped abruptly, but should be withdrawn gradually on the instructions of a doctor over a two-week period.
Other medicines and /…/ Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The following interactions with other medicines are possible and should be considered when taking this medicine:
Simultaneous administration of other medications to treat high blood pressure can increase the effect of /.../ /…/ can increase the sedative effects of medicines to treat depression such as imipramine or amitriptyline (tricyclic antidepressants). At the same time tricyclic antidepressants can reduce the effectiveness of /…/. Concomitant use is not recommended. /…/ can increase the effects of tranquillisers, sedatives or sleeping tablets such as benzodiazepines (diazepam, lorazepam). The active substance in /.../ is excreted via the kidneys (tubular secretion). Other medications that are also excreted via the same mechanism can interact with /.../ Examples are: - sulfonylurea tablets and insulin to treat diabetes mellitus - nitrates to treat chest pain (angina pectoris) - digitalis glycosides (such as digoxin or digitoxin) to treat weak heart - medications to treat rheumatism - medications used to reduce blood lipids - allopurinol, probenicide and colchicine to treat gout - cimetidine to treat among others heartburn and ulcer - thyroid extracts to treat insufficient thyroid function Tolazoline (a medication used for example to dilate blood vessels) can weaken the effect of /.../.
/.../ with food, drink and alcohol /.../ can intensify the effect of alcohol.
/.../ can be taken before, during or after a meal with sufficient liquid (e.g. a glass of water).
Pregnancy, breast-feeding and 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.
Because of a lack of therapeutic experience, /.../ should not be used during pregnancy. If treatment does become necessary, the treating physician will decide, by carefully weighing up the benefits and the risks.
As the active substance moxonidine is excreted in breast milk, /.../ should not be taken while breast-feeding. If treatment with /.../ should become necessary, the mother should stop breast-feeding first.
Driving and using machines No studies have been carried out on the effects of /.../ on ability to drive and operate machinery. However, there have been reports of drowsiness and dizziness. You should be aware of this when performing these activities.
/.../ contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take /…/
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Unless otherwise prescribed by your doctor, the recommended dose is…
Adults
Start of treatment: One /.../ 0.2 mg film-coated tablet in the morning (equivalent to 0.2 mg Moxonidine/day).
Your doctor will adjust the dose if the effect is not adequate after three weeks: Two /.../ 0.2 mg film-coated tablets daily (either two tablets in the morning or in divided doses - one tablet in the morning and one tablet in the evening; equivalent to 0.4 mg Moxonidine/day). To simplify use, /.../ 0.4 mg film-coated tablets are also available.
If the effect is still not adequate after a further three weeks your doctor will adjust the dose again: 0.3 mg Moxonidine twice daily (one /.../ 0.3 mg film-coated tablet in the morning and one /.../ 0.3 mg film-coated tablet in the evening; equivalent to 0.6 mg Moxonidine/day). /.../ 0.3 mg film-coated tablets are available for this purpose.
Maximum doses: The maximum single dose is 0.4 mg Moxonidine taken at once. The maximum total daily dose is 0.6 mg Moxonidine.
Elderly patients
Provided kidney function is not impaired, the recommended dosage is the same as for adults.
Use in children and adolescents
As there is insufficient experience with children and adolescents under 16 years of age, /.../ should not be taken by this age group.
Kidney function disorder
If you suffer from a moderately impaired kidney function your doctor will adjust the dose to suit you. Dosing should be initiated with 0.2 mg daily and can be increased to a maximum of 0.4 mg daily if clinically indicated and well tolerated.
If you suffer from severely impaired kidney function your doctor will adjust the dose to suit you. Dosing should be started from 0.2 mg daily and can be increased to a maximum of 0.3 mg daily if clinically indicated and well tolerated.
Liver function disorder
Patients with mild to moderately impaired liver function: The recommended dosage is the same as for adults.
Please speak to your doctor if you feel that the effect of /.../ is too strong or too weak.
If you take more /.../ than you should Signs of inadvertent use in small children are the following: sedation, small pupils, hypotension, breathing difficulties, coma.
The following are signs of overdosage in adults: headache, sedation, drowsiness, low blood pressure in rest or when changing the position, causing e.g. dizziness or light-headedness, weakness, very slow heartbeat, dry mouth, vomiting, fatigue, upper abdominal pain.
In severe overdosage, patients can suffer clouding of consciousness and severe breathing difficulties.
If you have taken more moxonidine than you should, contact your doctor or nearest hospital casualty department immediately.
If you forget to take /.../ Do not take a double dose to make up for a forgotten dose. Take the next dose when it is the time to take it.
If you stop taking /.../ Treatment with moxonidine must not be stopped abruptly. Do not interrupt or stop taking /.../ unless on the express instruction of your doctor. /.../ should then be withdrawn gradually over a two-week period.
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.
Very common (in more than 1 in 10 patients treated): dry mouth
Common (in less than 1 in 10, but more than 1 in 100 patients treated): altered thought processes (among others inability to think clearly) sleep disturbances, drowsiness, lethargy, headache, vertigo, dizziness, insomnia nausea, vomiting, diarrhoea, constipation, upset stomach, and other gastrointestinal symptoms weakness dilated vessels (manifesting among others in slight flushing, mild swelling of skin) back pain rash, pruritus
Uncommon (in less than 1 in 100, but more than 1 in 1000 patients treated): Enlargement of the breasts in men (gynaecomasty), impotence, loss of sexual drive depression, anxiety, sedation, nervousness, fainting dry, itchy or burning eyes tinnitus neck pain slow heart rhythm disturbances (bradycardia) allergic skin reactions, swelling beneath the skin (angioedema) inability to urinate (urinary retention) or loss of bladder control causing urine leakage (incontinence) fluid retention (oedema) in various parts of the body weakness of the legs short-term loss of consciousness loss of appetite pain in the parotid glands low blood pressure, orthostatic hypotension (fall in blood pressure when changing position into an upright position), paraesthesias (tingling sensation in the arms and legs), painful whitening of the fingers and toes, followed by a temporary blushiness and finally redness (Raynaud’s syndrome), disturbances of the peripheral circulation.
You should see your doctor immediately if you experience symptoms of angioneurotic oedema, such as allergic reaction causing swelling of the skin of the extremities or face, swelling of lips, tongue, or the mucous membranes in mouth, throat, or airways, resulting in shortness of breath or difficulty to swallow.
Very rare (in less than 1 in 10 000 patients treated, including isolated cases): liver reactions (liver inflammation, cholestasis (blocked excretion of bile from liver)) causing abdominal pain, jaundice (yellow coloration of the skin or eye whites), itching of the skin.
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store /…/
Do not store above 30°C.
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 pack and the outer packaging after "EXP". The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw awaymedicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What /.../ contains
The active substance is moxonidine. One film-coated tablet contains 0.2 mg moxonidine.
The other ingredients are:
Tablet core: Lactose monohydrate, crospovidone, povidone K25, magnesium stearate
Tablet coating: Hypromellose, titanium dioxide (E171), macrogol 400, iron (III) oxide (E 172).
What /.../ looks like and contents of the pack
/.../ are round and coloured light pink. /.../ are available in packs of 10, 20, 28, 30, 50, 98, 100, 400 (20 x 20, 10 x 40, as hospital pack sizes only) film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
[To be completed nationally]
Manufacturer
Chanelle Medical IDA Industrial Estate Loughrea, Co. Galway Ireland
Rottendorf Pharma GmbH Ostenfelder Str. 51-61, 59320 Ennigerloh Germany
This medicinal product is authorised in the member states of the European Economic Area (EEA) under the following names:
Czech Republic: Moxondine Actavis 0.2 mg Denmark: Moxonidin Actavis Estonia: Moxondine Actavis 0.2 mg Finland: Moxonidin Actavis Norway: Moxonidin Actavis Hungary: Moxondine Actavis 0.2 mg filmtabletta Lithuania: Moxondine Actavis 0.2 mg plėvele dengta tabletė Sweden: Moxonidin Actavis Slovakia: Moxondine Actavis 0.2 mg filmom obalená tableta
This leaflet was last revised in 04/2013
Package leaflet: Information for the user /…/ 0.3 mg film-coated tablets Moxonidine
Read all of this leaflet carefully before you start taking this medicine because it contains important information 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet 1. What /.../ is and what it is used for 2. What you need to know before you take /.../ 3. How to take /.../ 4. Possible side effects 5. How to store /.../ 6. Contents of the pack and other information
1. What /…/ is and what it is used for
/.../ is a medication used to reduce high blood pressure. They act through the central nervous system to lower the blood pressure.
/.../ is used in the treatment of mild to moderate forms of high blood pressure that are not organ- related (essential hypertension).
2. What you need to know before you take /…/
Do not take /.../ - if you are allergic to the active substance moxonidine or to any of the other ingredients of this medicine (listed in section 6). - if you suffer from certain types of disturbances in heart rhythm (sick sinus syndrome or 2nd or 3rd degree atrioventricular block) - if your resting heart rate is very slow (less than 50 beats per minute at rest) (bradycardia) - if you suffer from heart failure or heart insufficiency (a condition in which the heart does not pump enough blood through the body, resulting in e.g. shortness of breath and swelling of the lower extremities).
Warnings and precautions Talk to your doctor or pharmacist before using /…/
- if you have a heart problem called “1st degree AV-block” - if you suffer from a severe disturbance in blood supply to the heart muscle (coronary artery disease) or symptoms such as chest pain while at rest or with minimal effort (unstable angina pectoris). - if you suffer from a kidney function disorder. Your doctor will check your blood pressure regularly, especially at the start of treatment (if in doubt, please ask your doctor)
- if you are taking a beta-blocker at the same time. In this instance, the beta-blocker must be stopped first, and then /.../ after a few days have elapsed. This will prevent an excessive increase in blood pressure.
Elderly The elderly may be more affected by the blood pressure lowering effects of /…/. Therefore your doctor may want to start you on a lower dose and gradually increase the dose over time.
Children and adolescents /.../ should not be taken by children and adolescents under 16 years of age (see section 3 “How to take /.../“).
Treatment with /.../ must not be stopped abruptly, but should be withdrawn gradually on the instructions of a doctor over a two-week period.
Other medicines and /…/ Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The following interactions with other medicines are possible and should be considered when taking this medicine:
Simultaneous administration of other medications to treat high blood pressure can increase the effect of /…/ /…/ can increase the sedative effects of medicines to treat depression such as imipramine or amitriptyline (tricyclic antidepressants). At the same time tricyclic antidepressants can reduce the effectiveness of /…/. Concomitant use is not recommended. /…/ can increase the effects of tranquillisers, sedatives or sleeping tablets such as benzodiazepines (diazepam, lorazepam). The active substance in /…/ is excreted via the kidneys (tubular secretion). Other medications that are also excreted via the same mechanism can interact with /…/. Examples are: - sulfonylurea tablets and insulin to treat diabetes mellitus - nitrates to treat chest pain (angina pectoris) - digitalis glycosides (such as digoxin or digitoxin) to treat weak heart - medications to treat rheumatism - medications used to reduce blood lipids - allopurinol, probenicide and colchicine to treat gout - cimetidine to treat among others heartburn and ulcer - thyroid extracts to treat insufficient thyroid function Tolazoline (a medication used for example to dilate blood vessels) can weaken the effect of /…/.
/.../ with food, drink and alcohol /.../ can intensify the effect of alcohol. /.../ can be taken before, during or after a meal with sufficient liquid (e.g. a glass of water).
Pregnancy, breast-feeding and 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.
Because of a lack of therapeutic experience, /.../ should not be used during pregnancy. If treatment does become necessary, the treating physician will decide, by carefully weighing up the benefits and the risks.
As the active substance moxonidine is excreted in breast milk, /.../ should not be taken while breast- feeding. If treatment with /.../ should become necessary, the mother should stop breast-feeding first.
Driving and using machines No studies have been carried out on the effects of /.../ on ability to drive and operate machinery. However, there have been reports of drowsiness and dizziness. You should be aware of this when performing these activities.
/.../ contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take /…/
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Unless otherwise prescribed by your doctor, the recommended dose is…
Adults
Start of treatment: The treatment should be started with 0.2 mg Moxonidine per day. /…/ 0.2 mg film-coated tablets are available for this purpose.
Your doctor will adjust the dose if the effect is not adequate after three weeks: The dose can be increased to 0.4 mg Moxonidine per day. To simplify use, /…/ 0.4 mg film-coated tablets are also available.
If the effect is still not adequate after a further three weeks your doctor will adjust the dose again: 0.3 mg Moxonidine twice daily (one /…/ 0.3 mg film-coated tablet in the morning and one /…/ 0.3 mg film-coated tablet in the evening; equivalent to 0.6 mg Moxonidine/day).
Maximum doses: The maximum single dose is 0.4 mg Moxonidine taken at once. The maximum total daily dose is 0.6 mg Moxonidine.
Elderly patients
Provided kidney function is not impaired, the recommended dosage is the same as for adults.
Use in children and adolescents
As there is insufficient experience with children and adolescents under 16 years of age, /.../ should not be taken by this age group.
Kidney function disorder
If you suffer from a moderately impaired kidney function your doctor will adjust the dose to suit you. Dosing should be initiated with 0.2 mg daily and can be increased to a maximum of 0.4 mg daily if clinically indicated and well tolerated.
If you suffer from severely impaired kidney function your doctor will adjust the dose to suit you. Dosing should be started from 0.2 mg daily and can be increased to a maximum of 0.3 mg daily if clinically indicated and well tolerated.
Liver function disorder
Patients with mild to moderately impaired liver function: The recommended dosage is the same as for adults.
Please speak to your doctor if you feel that the effect of /.../ is too strong or too weak.
If you take more /.../ than you should Signs of inadvertent use in small children are the following: sedation, small pupils, hypotension, breathing difficulties, coma.
The following are signs of overdosage in adults: headache, sedation, drowsiness, low blood pressure in rest or when changing the position, causing e.g. dizziness or light-headedness, weakness, very slow heartbeat, dry mouth, vomiting, fatigue, upper abdominal pain.
In severe overdosage, patients can suffer clouding of consciousness and severe breathing difficulties.
If you have taken more Moxonidine than you should, contact your doctor or nearest hospital casualty department immediately.
If you forget to take /.../ Do not take a double dose to make up for a forgotten dose. Take the next dose when it is the time to take it.
If you stop taking /.../ Treatment with moxonidine must not be stopped abruptly. Do not interrupt or stop taking /.../ unless on the express instruction of your doctor. /.../ should then be withdrawn gradually over a two-week period.
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.
Very common (in more than 1 in 10 patients treated): dry mouth
Common (in less than 1 in 10, but more than 1 in 100 patients treated): altered thought processes (among others inability to think clearly), sleep disturbances, drowsiness, lethargy, headache, vertigo, dizziness, insomnia nausea, vomiting, diarrhoea, constipation, upset stomach, and other gastrointestinal symptoms weakness dilated vessels (manifesting among others in slight flushing, mild swelling of skin) back pain rash, pruritus
Uncommon (in less than 1 in 100, but more than 1 in 1000 patients treated): Enlargement of the breasts in men (gynaecomasty), impotence, loss of sexual drive depression, anxiety, sedation, nervousness, fainting dry, itchy or burning eyes tinnitus neck pain slow heart rhythm disturbances (bradycardia) allergic skin reactions, swelling beneath the skin (angioedema) inability to urinate (urinary retention) or loss of bladder control causing urine leakage (incontinence) fluid retention (oedema) in various parts of the body weakness of the legs
short-term loss of consciousness loss of appetite pain in the parotid glands low blood pressure, orthostatic hypotension (fall in blood pressure when changing position into an upright position), paraesthesias (tingling sensation in the arms and legs), painful whitening of the fingers and toes, followed by a temporary blushiness and finally redness (Raynaud’s syndrome), disturbances of the peripheral circulation.
You should see your doctor immediately if you experience symptoms of angioneurotic oedema, such as allergic reaction causing swelling of the skin of the extremities or face, swelling of lips, tongue, or the mucous membranes in mouth, throat, or airways, resulting in shortness of breath or difficulty to swallow.
Very rare (in less than 1 in 10 000 patients treated, including isolated cases): liver reactions (liver inflammation, cholestasis (blocked excretion of bile from liver)) causing abdominal pain, jaundice (yellow coloration of the skin or eye whites), itching of the skin.
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store /…/
Do not store above 30°C.
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 pack and the outer packaging after "EXP". The expiry date refers to the last day of that month.
Do not throw away 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 /.../ contain
The active substance is moxonidine. One film-coated tablet contains 0.3 mg moxonidine.
The other ingredients are:
Tablet core: Lactose monohydrate, crospovidone, povidone K25, magnesium stearate
Tablet coating: Hypromellose, titanium dioxide (E171), macrogol 400, iron (III) oxide (E 172).
What /.../ looks like and contents of the pack
/.../ are round and coloured pink. /.../ are available in packs of 10, 20, 28, 30, 50, 98, 100, 400 (20 x 20, 10 x 40, as hospital pack sizes only) film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
[To be completed nationally]
Manufacturer
Chanelle Medical IDA Industrial Estate Loughrea, Co. Galway Ireland
Rottendorf Pharma GmbH Ostenfelder Str. 51-61, 59320 Ennigerloh Germany
This medicinal product is authorised in the member states of the European Economic Area (EEA) under the following names:
Czech Republic: Moxondine Actavis 0.3 mg Denmark: Moxonidin Actavis Estonia: Moxondine Actavis 0.3 mg Finland: Moxonidin Actavis Hungary: Moxondine Actavis 0.3 mg filmtabletta Latvia: Moxondine Actavis 0.3 mg apvalkotā tablete Lithuania: Moxondine Actavis 0.3 mg plėvele dengta tabletė Slovakia: Moxondine Actavis 0.3 mg filmom obalená tableta
This leaflet was last revised in 04/2013
Package leaflet: Information for the user /…/ 0.4 mg film-coated tablets Moxonidine
Read all of this leaflet carefully before you start taking this medicine because it contains important information 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet 1. What /.../ is and what it is used for 2. What you need to know before you take /…/ 3. How to take /…/ 4. Possible side effects 5. How to store /…/ 6. Contents of the pack and other information
1. What /.../ is and what it is used for
/.../ is a medication used to reduce high blood pressure. They act through the central nervous system to lower the blood pressure.
/.../ is used in the treatment of mild to moderate forms of high blood pressure that are not organ- related (essential hypertension).
2. What you need to know before you take /…/
Do not take /…/ - if you are allergic to the active substance moxonidine or to any of the other ingredients of this medicine (listed in section 6). - if you suffer from certain types of disturbances in heart rhythm (sick sinus syndrome, or 2nd or 3rd degree atrioventricular block) - if your resting heart rate is very slow (less than 50 beats per minute at rest) (bradycardia) - if you suffer from heart failure or heart insufficiency (a condition in which the heart does not pump enough blood through the body, resulting in e.g. shortness of breath and swelling of the lower extremities).
Warnings and precautions Talk to your doctor or pharmacist before using /…/ - if you have a heart problem called “1st degree AV-block” - if you suffer from a severe disturbance in blood supply to the heart muscle (coronary artery disease) or symptoms such as chest pain while at rest or with minimal effort (unstable angina pectoris). - if you suffer from a kidney function disorder. Your doctor will check your blood pressure regularly, especially at the start of treatment (if in doubt, please ask your doctor)
- if you are taking a beta-blocker at the same time. In this instance, the beta-blocker must be stopped first, and then /.../after a few days have elapsed. This will prevent an excessive increase in blood pressure.
Elderly The elderly may be more affected by the blood pressure lowering effects of /…/. Therefore your doctor may want to start you on a lower dose and gradually increase the dose over time.
Children and adolescents /.../should not be taken by children and adolescents under 16 years of age (see section 3 “How to take /../“).
Treatment with /.../must not be stopped abruptly, but should be withdrawn gradually on the instructions of a doctor over a two-week period.
Other medicines and /…/ Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The following interactions with other medicines are possible and should be considered when taking this medicine:
Simultaneous administration of other medications to treat high blood pressure can increase the effect of /…/ /…/ can increase the sedative effects of medicines to treat depression such as imipramine or amitriptyline (tricyclic antidepressants). At the same time tricyclic antidepressants can reduce the effectiveness of /…/. Concomitant use is not recommended. /…/ can increase the effects of tranquillisers, sedatives or sleeping tablets such as benzodiazepines (diazepam, lorazepam). The active substance in /…/ is excreted via the kidneys (tubular secretion). Other medications that are also excreted via the same mechanism can interact with /…/ Examples are: - sulfonylurea tablets and insulin to treat diabetes mellitus - nitrates to treat chest pain (angina pectoris) - digitalis glycosides (such as digoxin or digitoxin) to treat weak heart - medications to treat rheumatism - medications used to reduce blood lipids - allopurinol, probenicide and colchicine to treat gout - cimetidine to treat among others heartburn and ulcer - thyroid extracts to treat insufficient thyroid function Tolazoline (a medication used for example to dilate blood vessels) can weaken the effect of /…/.
/.../ with food, drink and alcohol /.../ can intensify the effect of alcohol. /.../ can be taken before, during or after a meal with sufficient liquid (e.g. a glass of water).
Pregnancy, breast-feeding and 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.
Because of a lack of therapeutic experience, /.../ should not be used during pregnancy. If treatment does become necessary, the treating physician will decide, by carefully weighing up the benefits and the risks.
As the active substance moxonidine is excreted in breast milk, /.../ should not be taken while breast- feeding. If treatment with /.../ should become necessary, the mother should stop breast-feeding first.
Driving and using machines No studies have been carried out on the effects of /.../on ability to drive and operate machinery. However, there have been reports of drowsiness and dizziness. You should be aware of this when performing these activities.
/.../ contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take /…/
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Unless otherwise prescribed by your doctor, the recommended dose is…
Adults
Start of treatment: The treatment should be started with 0.2 mg Moxonidine per day. /…/ 0.2 mg film-coated tablets are available for this purpose.
Your doctor will adjust the dose if the effect is not adequate after three weeks: The dose can be increased to 0.4 mg Moxonidine per day (equivalent to one Moxondine 0.4 mg film-coated tablet).
If the effect is still not adequate after a further three weeks your doctor will adjust the dose again: 0.3 mg moxonidine twice daily. /../ 0.3 mg film-coated tablets are available for this purpose.
Maximum doses: The maximum single dose is 0.4 mg Moxonidine taken at once. The maximum total daily dose is 0.6 mg Moxonidine.
Elderly patients
Provided kidney function is not impaired, the recommended dosage is the same as for adults.
Use in children and adolescents
As there is insufficient experience with children and adolescents under 16 years of age, /.../ should not be taken by this age group.
Kidney function disorder
If you suffer from a moderately impaired kidney function your doctor will adjust the dose to suit you. Dosing should be initiated with 0.2 mg daily and can be increased to a maximum of 0.4 mg daily if clinically indicated and well tolerated.
If you suffer from severely impaired kidney function your doctor will adjust the dose to suit you. Dosing should be started from 0.2 mg daily and can be increased to a maximum of 0.3 mg daily if clinically indicated and well tolerated.
Liver function disorder
Patients with mild to moderately impaired liver function: The recommended dosage is the same as for adults.
Please speak to your doctor if you feel that the effect of /.../ is too strong or too weak.
If you take more /.../ than you should Signs of inadvertent use in small children are the following: sedation, small pupils, hypotension, breathing difficulties, coma.
The following are signs of overdosage in adults: headache, sedation, drowsiness, low blood pressure in rest or when changing the position, causing e.g. dizziness or light-headedness, weakness, very slow heartbeat, dry mouth, vomiting, fatigue, upper abdominal pain.
In severe overdosage, patients can suffer clouding of consciousness and severe breathing difficulties.
If you have taken more Moxonidine than you should, contact your doctor or nearest hospital casualty department immediately.
If you forget to take /…/ Do not take a double dose to make up for a forgotten dose. Take the next dose when it is the time to take it.
If you stop taking /.../ Treatment with moxonidine must not be stopped abruptly. Do not interrupt or stop taking /.../unless on the express instruction of your doctor. /.../should then be withdrawn gradually over a two-week period.
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.
Very common (in more than 1 in 10 patients treated): dry mouth
Common (in less than 1 in 10, but more than 1 in 100 patients treated): altered thought processes (among others inability to think clearly), sleep disturbances, drowsiness, lethargy, headache, vertigo, dizziness, insomnia nausea, vomiting, diarrhoea, constipation, upset stomach, and other gastrointestinal symptoms weakness dilated vessels (manifesting among others in slight flushing, mild swelling of skin) back pain rash, pruritus
Uncommon (in less than 1 in 100, but more than 1 in 1000 patients treated): Enlargement of the breasts in men (gynaecomasty), impotence, loss of sexual drive depression, anxiety, sedation, nervousness, fainting dry, itchy or burning eyes tinnitus neck pain slow heart rhythm disturbances (bradycardia) allergic skin reactions, swelling beneath the skin (angioedema) inability to urinate (urinary retention) or loss of bladder control causing urine leakage (incontinence) fluid retention (oedema) in various parts of the body weakness of the legs short-term loss of consciousness loss of appetite pain in the parotid glands low blood pressure, orthostatic hypotension (fall in blood pressure when changing position into an upright position), paraesthesias (tingling sensation in the arms and legs), painful whitening of the
fingers and toes, followed by a temporary blushiness and finally redness (Raynaud’s syndrome), disturbances of the peripheral circulation.
You should see your doctor immediately if you experience symptoms of angioneurotic oedema, such as allergic reaction causing swelling of the skin of the extremities or face, swelling of lips, tongue, or the mucous membranes in mouth, throat, or airways, resulting in shortness of breath or difficulty to swallow.
Very rare (in less than 1 in 10 000 patients treated, including isolated cases): liver reactions (liver inflammation, cholestasis (blocked excretion of bile from liver)) causing abdominal pain, jaundice (yellow coloration of the skin or eye whites), itching of the skin.
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store /…/
Do not store above 30°C.
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 pack and the outer packaging after "EXP". The expiry date refers to the last day of that month.
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 /.../ contains
The active substance is moxonidine. One film-coated tablet contains 0.4 mg moxonidine.
The other ingredients are:
Tablet core: Lactose monohydrate, crospovidone, povidone K25, magnesium stearate
Tablet coating: Hypromellose, titanium dioxide (E171), macrogol 400, iron (III) oxide (E 172).
What /.../ looks like and contents of the pack
/.../ are round and coloured dark pink. /.../ are available in packs of 10, 20, 28, 30, 50, 98, 100, 400 (20 x 20, 10 x 40, as hospital pack sizes only) film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
[To be completed nationally]
Manufacturer
Chanelle Medical IDA Industrial Estate Loughrea, Co. Galway Ireland
Rottendorf Pharma GmbH Ostenfelder Str. 51-61, 59320 Ennigerloh Germany
This medicinal product is authorised in the member states of the European Economic Area (EEA) under the following names:
Czech Republic: Moxondine Actavis 0.4 mg Denmark: Moxonidin Actavis Estonia: Moxondine Actavis 0.4 mg Finland: Moxonidin Actavis Norway: Moxonidin Actavis Hungary: Moxondine Actavis 0.4 mg filmtabletta Latvia: Moxondine Actavis 0.4 mg apvalkotā tablete Lithuania: Moxondine Actavis 0.4 mg plėvele dengta tabletė Sweden: Moxonidin Actavis Slovakia: Moxondine Actavis 0.4 mg filmom obalená tableta
This leaflet was last revised in 04/2013