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Physiotens 200microgram Tablets

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MOXONIDINE 200 microgram TABLETS


(moxonidine)

Patient Information Leaflet


Please read this information leaflet about Moxonidine 200 microgram tablets carefully before you start taking your tablets. It contains all the information you should need to know. If you have any further questions or are not sure about anything, ask your doctor or pharmacist. Please keep this leaflet in a safe place, you may wish to refer to it again.

Your medicine is called Moxonidine 200 microgram tablets. Each tablet contains 200 micrograms of the active ingredient, Moxonidine in a pale pink round, tablet marked ‘0.2' on one side and plain on the reverse.

Moxonidine 200 microgram tablets also contain the following:

Lactose, hypromellose, magnesium stearate, crospovidone, povidone, ethyl cellulose, talc, macrogol 6000, titanium dioxide (E171) and red iron oxide (E172).

Moxonidine 200 microgram tablets are available in calendar blister strips in blister packs of 28 tablets.

Moxonidine belongs to a group of medicines called anti-hypertensives.

iPOMl    PL No: 6464/1895

This product is manufactured by Abbott Healthcare SAS, Route de Belleville, Lieu - dit - Maillard,

01400 Chatillon Sur Chalaronne, France and is procured from within the EU and repacked by the Product Licence holder:and is procured from within the EU and repacked by the Product Licence holder:



Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR..


Why you need to take this medicine:

Moxonidine 200 microgram tablets are used in the treatment of high blood pressure.


Before you take your medicine:

Make sure it is safe for you to take Moxonidine 200 microgram tablets.

Check to see if any of the following apply to you, and consult your doctor before taking these tablets if the answer is YES to any of them:


Do you have a heart complaint? (For example, heart failure or abnormal rhythm).

Do you have a serious liver or kidney complaint?

Have you ever had an allergic reaction to Moxonidine 200 microgram tablets, moxonidine or any of the other ingredients of these tablets? (An allergic reaction may include itching, reddening of the skin, difficulty in breathing).


Have you had attacks of angioneurotic oedema (unusual swellings)?

Moxonidine 200 microgram tablets are a new medicine and have not yet been given to patients who:


Have leg pains caused by poor blood circulation

Have Raynaud's disease (where your fingers go pale and blue and are painful in the cold) Have Parkinson's disease (disease of the nerves which causes shakiness and stiffness) Have epilepsy (fits)

Are pregnant, or think they might be pregnant Are breast feeding

Have glaucoma (swelling behind the eyes)

Are depressed


Are under 16 years old.

Tell your doctor if you think that any of these apply to you.

Some medicines can affect the way other medicines work. Before you start taking Moxonidine 200 microgram tablets tell your doctor or pharmacist if you are taking other medicines to reduce blood pressure, antidepressants (tricyclic antidepressants such as imipramine and amitriptyline) or sleeping tablets (known as benzodiazepines).

As we do not know whether alcohol affects the way Moxonidine 200 microgram tablets work, you should not drink alcohol while you are taking Moxonidine 200 microgram tablets.

Moxonidine 200 microgram tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.


When to take your tablets:

Follow the doctor's instructions, and check the directions on the pharmacy label, which should tell you how many tablets to take in a day. If they do not, or you are unsure about anything, consult your doctor or pharmacist.

Take your tablets with a drink of water, before, during or after a meal.

Your treatment will normally start with one 200 microgram tablet each morning. After about three weeks, your doctor may increase this dose to 400 micrograms each day. After another three weeks, your doctor may need to increase this dose to 600 micrograms each day. You should not take 600 micrograms as one dose - take 400 micrograms in the morning and 200 micrograms in the evening. Your doctor may tell you to take a lower dose than normal if you have a kidney complaint.

Keep taking your tablets unless your doctor decides you should stop. If this happens, your doctor will tell you how to reduce your dose gradually. If you are taking more than one medicine for high blood pressure, your doctor will tell you which medicine to stop first so that your body can adjust gradually to the change.

If you are still not sure, ask your doctor or pharmacist.

These tablets are not recommended for children under 16 years of age.


What to do if an overdose is taken:

If you or someone else take too many tablets, consult your doctor or go to the nearest hospital casualty department immediately. Take any remaining tablets or this leaflet with you to show the doctor what has been taken.


What to do if you miss a dose:

If you miss a dose, ignore that dose completely and take the next dose at the normal time. Do not take two doses together to make up for the one you have missed.



LEAFLET SIZE A DATE 13/08/12 VERSION 1 DT



Side Effects:

As with all medicines Moxonidine 200 microgram tablets can cause unwanted side-effects in some patients.

You may have some of the following side effects when you first start to take Moxonidine 200 microgram tablets:

-a dry mouth    -dizziness    -headaches

-lack of energy    -feeling sick    -problems sleeping    -skin flushing

The side effects listed above will ease as the treatment continues.

Rarely, people who take Moxonidine 200 microgram tablets complain of drowsiness. If you feel drowsy, do not drive or use machinery.

Very rarely, people taking Moxonidine 200 microgram tablets may develop allergic skin reactions (rash, itching, inflamed or reddened skin) and angioedema (unusual swellings). Please tell your doctor if you have any of the above side effects.

You should also consult your doctor if you feel any other unusual or untoward effects not mentioned above during or after taking the tablets. He or she will have more information about Moxonidine 200 microgram tablets and will tell you what to do.

Expiry Date:

Do not use after the expiry date printed on the carton label or blister strip.

Storage:

Moxonidine 200 microgram tablets should not be stored above 25°C.

KEEP ALL MEDICINES OUT OFTHESIGHTAND REACH OF CHILDREN.

If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.

If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist, who will tell you what to do.

IMPORTANT:

This medicine is for YOUR use only. It can only be prescribed by a doctor. Never give it to anyone else. It may harm them even if their symptoms are the same as yours.

This leaflet does not contain complete information about your medicine. If you have any questions, or are not sure about anything, ask your doctor or pharmacist who has access to additional information. Leaflet revision and issue date (Ref.) 13.08.2012

WHAT IS BLOOD PRESSURE?

Blood pressure is the pressure of your blood inside your arteries. Your blood pressure depends on how much blood is being pumped round your body with each heartbeat and how narrow your arteries are.

Your blood pressure is not always the same and usually goes down when you are asleep and increases when you are stressed or exercising.

Why is high blood pressure (hypertension) a problem?

High blood pressure becomes a problem if you have it most of the time. It puts stress on your heart and blood vessels and can lead to a stroke, heart failure, angina or a heart attack, often without warning. It can also cause kidney disease and eye problems.

But I feel well. Why do I need medicine?

High blood pressure does not usually make you feel ill. However, if your blood pressure is higher than normal, taking medication to reduce it will lower the risk of you having serious heart disease and strokes in the future.

Are there other ways I can lower my risk of heart disease and stroke?

The lifestyle changes below have been recommended by the British Hypertension Society. Always follow your own doctor's advice.

Keep your weight down and eat a healthy diet. If you think you may be overweight, talk to your doctor about whether you need to diet. Being overweight puts a strain on your heart. Too much fat in your diet increases the cholesterol in your blood, and can increase your risk of having a stroke or a heart attack. Exercise regularly (two or more times a week for at least half an hour). If you do not already do this, ask your doctor how much exercise it is safe for you to do. Slowly build up the amount of exercise you do. Keep within the recommended limits for alcohol. The limits are no more than 4 units a day for men and no more than 3 units a day for women. (A unit is half a pint of ordinary strength beer, a single measure of spirits or a small glass of sherry or wine.)

Eat less salt. Salt can raise the blood pressure in some people. Do not add extra salt to your food at the table.

Give up smoking. Smoking increases your pulse rate, reduces the oxygen in your blood, and is a very important cause of heart attacks.

Are only men at risk from heart disease?

No. Younger women get some protection from heart disease by their female hormones (oestrogens). But after the menopause (the ‘change of life'), women's bodies make less oestrogen. The risk for men and women then becomes similar, although women taking Hormone Replacement Therapy (HRT) may be protected.

You can find out more from the following organisations:

The British Heart Foundation:

14 Fitzhardinge Street, London W1H 4DH Tel: 020 7935 0185

The Stroke Association:

Stroke House, Whitecross Street, London EC1Y 8JJ Advice line: 0845 3033100 (local rates)

The above are independent organisations and are not associated to Waymade Plc.

Unt±kd-1


2


13/08/2012,11:41


PHYSIOTENS 200 microgram TABLETS/ MOXONIDINE 200 microgram TABLETS

(moxonidine)

Patient Information Leaflet

r    ;    a

Please read this information leaflet about Physiotens 200 microgram tablets/Moxonidine 200

microgram tablets carefully before you start taking your tablets. It contains all the information you should need to know. If you have any further questions or are not sure about anything, ask your doctor or pharmacist. Please keep this leaflet in a safe place, you may wish to refer to it again.

Your medicine is called Physiotens 200 microgram tablets/Moxonidine 200 microgram tablets. Each tablet contains 200 micrograms of the active ingredient, Moxonidine in a pale pink round, tablet marked ‘0.2' on one side and plain on the reverse.

Physiotens 200 microgram tablets/Moxonidine 200 microgram tablets also contain the following:

Lactose, hypromellose, magnesium stearate, crospovidone, povidone, ethyl cellulose, talc, macrogol 6000, titanium dioxide (E171) and red iron oxide (E172).

Physiotens 200 microgram tablets/Moxonidine 200 microgram tablets are available in calendar blister strips in blister packs of 28 tablets.

Moxonidine belongs to a group of medicines called anti-hypertensives.

iPOMl    PL No: 6464/1895

This product is manufactured by Abbott Healthcare SAS, Route de Belleville, Lieu - dit - Maillard,

01400 Chatillon Sur Chalaronne, France and is procured from within the EU and repacked by the Product Licence holder:

Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR..

Why you need to take this medicine:

Physiotens 200 microgram tablets/Moxonidine 200 microgram tablets are used in the treatment of high blood pressure.

Before you take your medicine:

Make sure it is safe for you to take Physiotens 200 microgram tablets/ Moxonidine 200 microgram tablets.

Check to see if any of the following apply to you, and consult your doctor before taking these tablets if the answer is YES to any of them:

Do you have a heart complaint? (For example, heart failure or abnormal rhythm).

Do you have a serious liver or kidney complaint?

Have you ever had an allergic reaction to Physiotens 200 microgram tablets/Moxonidine

200 microgram tablets, moxonidine or any of the other ingredients of these tablets? (An allergic reaction may include itching, reddening of the skin, difficulty in breathing).

Have you had attacks of angioneurotic oedema (unusual swellings)?

Physiotens 200 microgram tablets/Moxonidine 200 microgram tablets are a new medicine and have not yet been given to patients who:

Have leg pains caused by poor blood circulation

Have Raynaud's disease (where your fingers go pale and blue and are painful in the cold) Have Parkinson's disease (disease of the nerves which causes shakiness and stiffness) Have epilepsy (fits)

Are pregnant, or think they might be pregnant Are breast feeding

Have glaucoma (swelling behind the eyes)

Are depressed

Are under 16 years old.

Tell your doctor if you think that any of these apply to you.

Some medicines can affect the way other medicines work. Before you start taking Physiotens 200 microgram tablets/Moxonidine 200 microgram tablets tell your doctor or pharmacist if you are

taking other medicines to reduce blood pressure, antidepressants (tricyclic antidepressants such as imipramine and amitriptyline) or sleeping tablets (known as benzodiazepines).

As we do not know whether alcohol affects the way Physiotens 200 microgram tablets/ Moxonidine 200 microgram tablets work, you should not drink alcohol while you are taking Physiotens 200 microgram tablets/Moxonidine 200 microgram tablets.

Physiotens 200 microgram tablets/Moxonidine 200 microgram tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

When to take your tablets:

Follow the doctor's instructions, and check the directions on the pharmacy label, which should tell you how many tablets to take in a day. If they do not, or you are unsure about anything, consult your doctor or pharmacist.

Take your tablets with a drink of water, before, during or after a meal.

Your treatment will normally start with one 200 microgram tablet each morning. After about three weeks, your doctor may increase this dose to 400 micrograms each day. After another three weeks, your doctor may need to increase this dose to 600 micrograms each day. You should not take 600 micrograms as one dose - take 400 micrograms in the morning and 200 micrograms in the evening. Your doctor may tell you to take a lower dose than normal if you have a kidney complaint.

Keep taking your tablets unless your doctor decides you should stop. If this happens, your doctor will tell you how to reduce your dose gradually. If you are taking more than one medicine for high blood pressure, your doctor will tell you which medicine to stop first so that your body can adjust gradually to the change.

If you are still not sure, ask your doctor or pharmacist.

These tablets are not recommended for children under 16 years of age.

What to do if an overdose is taken:

If you or someone else take too many tablets, consult your doctor or go to the nearest hospital casualty department immediately. Take any remaining tablets or this leaflet with you to show the doctor what has been taken.

WAYMADE

LEAFLET SIZE A DATE 13/08/12 VERSION 1 DT

J


V,

If you miss a dose, ignore that dose completely and take the next dose at the normal time. Do not take two doses together to make up for the one you have missed.

What to do if you miss a dose:


If you are not sure what to do, ask your doctor or pharmacist.

Side Effects:

As with all medicines Physiotens 200 microgram tablets/Moxonidine 200 microgram tablets

can cause unwanted side-effects in some patients.

You may have some of the following side effects when you first start to take Physiotens 200 microgram tablets/Moxonidine 200 microgram tablets:

-a dry mouth    -dizziness    -headaches

-lack of energy    -feeling sick    -problems sleeping    -skin flushing

The side effects listed above will ease as the treatment continues.

Rarely, people who take Physiotens 200 microgram tablets/Moxonidine 200 microgram tablets complain of drowsiness. If you feel drowsy, do not drive or use machinery.

Very rarely, people taking Physiotens 200 microgram tablets/Moxonidine 200 microgram tablets may develop allergic skin reactions (rash, itching, inflamed or reddened skin) and angioedema (unusual swellings).

Please tell your doctor if you have any of the above side effects.

You should also consult your doctor if you feel any other unusual or untoward effects not mentioned above during or after taking the tablets. He or she will have more information about Physiotens 200 microgram tablets/Moxonidine 200 microgram tablets and will tell you what to do.

Expiry Date:

Do not use after the expiry date printed on the carton label or blister strip.

Storage:

Physiotens 200 microgram tablets/Moxonidine 200 microgram tablets should not be stored above 25°C.

KEEP ALL MEDICINES OUT OFTHESIGHTAND REACH OF CHILDREN.

If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.

If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist, who will tell you what to do.

IMPORTANT:

This medicine is for YOUR use only. It can only be prescribed by a doctor. Never give it to anyone else.

It may harm them even if their symptoms are the same as yours.

This leaflet does not contain complete information about your medicine. If you have any questions, or are not sure about anything, ask your doctor or pharmacist who has access to additional information. Leaflet revision and issue date (Ref.) 02.08.2012

Physiotens® is a registered trademark of SOLVAY PHARMACEUTICALS GmbH

WHAT IS BLOOD PRESSURE?

Blood pressure is the pressure of your blood inside your arteries. Your blood pressure depends on how much blood is being pumped round your body with each heartbeat and how narrow your arteries are.

Your blood pressure is not always the same and usually goes down when you are asleep and increases when you are stressed or exercising.

Why is high blood pressure (hypertension) a problem?

High blood pressure becomes a problem if you have it most of the time. It puts stress on your heart and blood vessels and can lead to a stroke, heart failure, angina or a heart attack, often without warning.

It can also cause kidney disease and eye problems.

But I feel well. Why do I need medicine?

High blood pressure does not usually make you feel ill. However, if your blood pressure is higher than normal, taking medication to reduce it will lower the risk of you having serious heart disease and strokes in the future.

Are there other ways I can lower my risk of heart disease and stroke?

The lifestyle changes below have been recommended by the British Hypertension Society. Always follow your own doctor's advice.

Keep your weight down and eat a healthy diet. If you think you may be overweight, talk to your doctor about whether you need to diet. Being overweight puts a strain on your heart. Too much fat in your diet increases the cholesterol in your blood, and can increase your risk of having a stroke or a heart attack. Exercise regularly (two or more times a week for at least half an hour). If you do not already do this, ask your doctor how much exercise it is safe for you to do. Slowly build up the amount of exercise you do. Keep within the recommended limits for alcohol. The limits are no more than 4 units a day for men and no more than 3 units a day for women. (A unit is half a pint of ordinary strength beer, a single measure of spirits or a small glass of sherry or wine.)

Eat less salt. Salt can raise the blood pressure in some people. Do not add extra salt to your food at the table.

Give up smoking. Smoking increases your pulse rate, reduces the oxygen in your blood, and is a very important cause of heart attacks.

Are only men at risk from heart disease?

No. Younger women get some protection from heart disease by their female hormones (oestrogens).

But after the menopause (the ‘change of life'), women's bodies make less oestrogen. The risk for men and women then becomes similar, although women taking Hormone Replacement Therapy (HRT) may be protected.

You can find out more from the following organisations:

The British Heart Foundation:

14 Fitzhardinge Street, London W1H 4DH Tel: 020 7935 0185

The Stroke Association:

Stroke House, Whitecross Street, London EC1Y 8JJ Advice line: 0845 3033100 (local rates)

The above are independent organisations and are not associated to Waymade Plc.

Untitled-1


2


11/30/2006, 3:43 PM


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