PATIENT INFORMATION LEAFLET

Your medicine is called Physiotens 200 micrograms Tablets, but will be referred to as Physiotens throughout the remainder of this leaflet.

What you should know about Physiotens

Please read this leaflet before you take your Physiotens. It gives you important information about your tablets. Please keep this leaflet safe. You may want to read it again. If you have any questions or you are not sure about anything, ask your doctor or a pharmacist.

What is Physiotens for?

Physiotens reduces high blood pressure. Medicines which reduce blood pressure are known as anti-hypertensives.

Before taking your tablets

Please tell your doctor or a pharmacist before you start to take your tablets if you:

•    have a heart complaint (for example, heart failure or abnormal rhythm);

•    have a serious liver or kidney complaint;

•    have ever had an allergic reaction to any of the ingredients; or

•    have had attacks of angioneurotic oedema (a serious allergic reaction which causes swellings of the face or throat).

There is limited experience on the use of Physiotens by patients who:

•    are pregnant, or think they might be;

•    are breast-feeding;

•    have leg pains caused by poor blood circulation;

•    have Raynaud's disease (poor circulation which makes the toes and fingers numb and pale);

•    have Parkinson's disease (a disease of the nerves which causes tremor, stiffness and shuffling);

•    have epilepsy (fits);

•    have glaucoma (swelling behind the eyes);

•    are depressed; or

•    are under 16 years old.

Tell your doctor if you think any of the above apply to you.

Some medicines can affect the way other medicines work. Before you start taking Physiotens, tell your doctor or a pharmacist if you are taking other medicines to reduce your 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 works, you shouldn't drink alcohol while you are taking Physiotens.

Physiotens also contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take your tablets

Your treatment will normally start with 200 micrograms 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. Do not take 600 micrograms as one dose - take 300 micrograms in the morning and 300 micrograms in the evening. Physiotens is not recommended for children under 16.

Your doctor may tell you to take a lower dose than normal if you have kidney complaint.

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

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 miss a dose, ignore it and take the next dose at the normal time. Don't take two doses together to make up for the one you have missed.

If someone takes an overdose (too many Physiotens tablets), call a doctor or go to the nearest hospital casualty department immediately. Show the pack to the doctor.

Possible side effects

You may have some of the following side effects when you first start to take Physiotens:

•    A dry mouth

•    Headaches

•    General weakness

•    Dizziness

•    Feeling sick

•    Difficulty sleeping

•    Skin flushing

The side effects listed above will ease as your treatment continues. Sometimes, people who take Physiotens tablets complain of drowsiness.

If you feel drowsy, don't drive or use machinery. Occasionally, people taking Physiotens may develop allergic skin reactions (rash, itching, inflamed or reddened skin) and very rarely angioedema (a serious allergic reaction which causes swelling of the face or throat). Please tell your doctor if you think you have these or any other side effects.

How to store your tablets

•    Do not store above 25°C.

•    Store in the original package.

•    Do not take the tablets after the expiry date printed on the carton.

•    Keep out of the reach and sight of children.

•    Take any tablets you haven't used to a pharmacist.

These tablets are for you. Please do not give them to anyone else, even if they have the same symptoms as you.

If your tablets appear to be discoloured or show any other signs of deterioration, take them to your pharmacist who will advise you.

If your doctor advises you to stop taking the tablets, please return any which are left over to your pharmacist for safe disposal. Only keep them if your doctor tells you to.

What's in your tablets?

Each tablet contains 200 micrograms of moxonidine.

The tablets also contain lactose, povidone, crospovidone, magnesium stearate, hydroxypropyl methylcellulose 2910, ethylcellulose 30% aqueous suspension, macrogol 6000, talc, red ferric oxide (E172) and titanium dioxide (E171).

The film-coated tablets are round, biconvex, light pink marked with 0.2 on one side and plain on the reverse.

The tablets are available in blister packs of 28 tablets.

Manufactured by:

Solvay Pharmaceuticals, 01400 Chatillon-sur-Chalaronne, France.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: BR Lewis Pharmaceutical Ltd., Kirk Sandall, Doncaster, DN3 1QR.

PL No: 08929/0554

Leaflet revision and issue date (Ref): 14.05.09

Physiotens® is a registered trademark of Solvay Pharmaceuticals GmbH.

PATIENT INFORMATION LEAFLET

Your medicine is called Moxonidine 200 micrograms Tablets, but will be referred to as Moxonidine Tablets throughout the remainder of this leaflet.

What you should know about Moxonidine Tablets

Please read this leaflet before you take your Moxonidine Tablets. It gives you important information about your tablets. Please keep this leaflet safe. You may want to read it again. If you have any questions or you are not sure about anything, ask your doctor or a pharmacist.

What are Moxonidine Tablets for?

Moxonidine Tablets reduce high blood pressure. Medicines which reduce blood pressure are known as anti-hypertensives.

Before taking your tablets

Please tell your doctor or a pharmacist before you start to take your tablets if you:

•    have a heart complaint (for example, heart failure or abnormal rhythm);

•    have a serious liver or kidney complaint;

•    have ever had an allergic reaction to any of the ingredients; or

•    have had attacks of angioneurotic oedema (a serious allergic reaction which causes swellings of the face or throat).

There is limited experience on the use of Moxonidine Tablets by patients who:

•    are pregnant, or think they might be;

•    are breast-feeding;

•    have leg pains caused by poor blood circulation;

•    have Raynaud's disease (poor circulation which makes the toes and fingers numb and pale);

•    have Parkinson's disease (a disease of the nerves which causes tremor, stiffness and shuffling);

•    have epilepsy (fits);

•    have glaucoma (swelling behind the eyes);

•    are depressed; or

•    are under 16 years old.

Tell your doctor if you think any of the above apply to you.

Some medicines can affect the way other medicines work. Before you start taking Moxonidine Tablets, tell your doctor or a pharmacist if you are taking other medicines to reduce your 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 Tablets work, you shouldn't drink alcohol while you are taking Moxonidine Tablets.

Moxonidine Tablets also contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take your tablets

Your treatment will normally start with 200 micrograms 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. Do not take 600 micrograms as one dose - take 300 micrograms in the morning and 300 micrograms in the evening. Moxonidine Tablets are not recommended for children under 16.

Your doctor may tell you to take a lower dose than normal if you have kidney complaint.

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

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 miss a dose, ignore it and take the next dose at the normal time. Don't take two doses together to make up for the one you have missed.

If someone takes an overdose (too many Moxonidine Tablets), call a doctor or go to the nearest hospital casualty department immediately. Show the pack to the doctor.

Possible side effects

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

•    A dry mouth

•    Headaches

•    General weakness

•    Dizziness

•    Feeling sick

•    Difficulty sleeping

•    Skin flushing

The side effects listed above will ease as your treatment continues. Sometimes, people who take Moxonidine Tablets complain of drowsiness.

If you feel drowsy, don't drive or use machinery. Occasionally, people taking Moxonidine Tablets may develop allergic skin reactions (rash, itching, inflamed or reddened skin) and very rarely angioedema (a serious allergic reaction which causes swelling of the face or throat). Please tell your doctor if you think you have these or any other side effects.

How to store your tablets

•    Do not store above 25°C.

•    Store in the original package.

•    Do not take the tablets after the expiry date printed on the carton.

•    Keep out of the reach and sight of children.

•    Take any tablets you haven't used to a pharmacist.

These tablets are for you. Please do not give them to anyone else, even if they have the same symptoms as you.

If your tablets appear to be discoloured or show any other signs of deterioration, take them to your pharmacist who will advise you.

If your doctor advises you to stop taking the tablets, please return any which are left over to your pharmacist for safe disposal. Only keep them if your doctor tells you to.

What's in your tablets?

Each tablet contains 200 micrograms of moxonidine.

The tablets also contain lactose, povidone, crospovidone, magnesium stearate, hydroxypropyl methylcellulose 2910, ethylcellulose 30% aqueous suspension, macrogol 6000, talc, red ferric oxide (E172) and titanium dioxide (E171).

The film-coated tablets are round, biconvex, light pink marked with 0.2 on one side and plain on the reverse.

The tablets are available in blister packs of 28 tablets.

Manufactured by:

Solvay Pharmaceuticals, 01400 Chatillon-sur-Chalaronne, France.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: BR Lewis Pharmaceutical Ltd., Kirk Sandall, Doncaster, DN3 1QR.

PL No: 08929/0554

Leaflet revision and issue date (Ref): 14.05.09

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