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Physiotens 200microgram Tablets

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1. What Physiotens is and what it is used for


2. Before you take Physiotens


3. How to take Physiotens


PACKAGE LEAFLET: INFORMATION FOR THE USER Physiotens® 200 Microgram Tablets

(moxonidine)

The name of your medicine is Physiotens 200 Microgram Tablets, but will be referred to as Physiotens throughout the remainder of this leaflet. This product is available in multiple strengths and all strengths will be referred to throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine.

•    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 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.

In this leaflet:

1.    What Physiotens is and what it is used for

2.    Before you take Physiotens

3.    How to take Physiotens

4.    Possible side effects

5.    How to store Physiotens

6.    Further information

Physiotens contains a medicine called moxonidine. This medicine belongs to a group of medicines called “antihypertensives”.

Physiotens is used to treat high blood pressure (hypertension). It works by making your blood vessels relax and widen. This helps to lower your blood pressure.

Do not take Physiotens if:

•    you are allergic (hypersensitive) to moxonidine or any of the other ingredients of Physiotens (listed in Section 6)

•    you have a slow heart rate caused by a heart problem called “sick sinus syndrome” or “2nd or 3rd degree AV-block”

• you have heart failure.

• you have serious kidney problems

Do not take Physiotens if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Physiotens.

Take special care with Physiotens

Check with your doctor or pharmacist before taking your medicine if:

•    you have a heart problem called “1st degree AV-block”

•    you have a severe heart problem such as angina or chest pain at rest

•    you have kidney problems. Your doctor may need to adjust your dose.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Physiotens.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines.

This is because Physiotens can affect the way some other medicines work. Also some other medicines can affect the way Physiotens works.

In particular, tell your doctor or pharmacist if you are taking any

of the following medicines:

•    other medicines to lower your blood pressure. Physiotens may increase the effect of these medicines

•    medicines for depression such as imipramine or amitriptyline

•    tranquillisers, sedatives or sleeping tablets such as benzodiazepines

•    beta-blockers (see “If you stop taking Physiotens” in Section 3)

•    Physiotens is removed from your body by your kidneys through a process called "tubular excretion”. Other medicines removed from the kidneys in the same way could affect how Physiotens works.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Physiotens.

Taking Physiotens with food and drink

•    You can take the tablets with or without food.

•    Do not drink alcohol while you are taking Physiotens. This is because Physiotens may increase the effects of alcohol.

Pregnancy and breast-feeding

•    Tell your doctor if you are pregnant or might become pregnant. Your doctor will normally advise you to stop taking Physiotens. Your doctor will advise you to take another medicine instead of Physiotens.

•    Tell your doctor if you are breast-feeding or about to start breast-feeding. Physiotensis not recommended for mothers who are breast-feeding. Your doctor may advise you to take another medicine if you want to breast-feed, or may ask you to stop breast-feeding.

Ask your doctor or pharmacist for advice before taking any

medicine if you are pregnant or breast-feeding.

Driving and using machines

You may feel sleepy or dizzy while taking Physiotens. If this happens, talk to your doctor before driving or using any tools or machines.

Important information about some of the ingredients of Physiotens

Physiotens contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest certain sugars, talk to your doctor before taking this medicine.

Always take Physiotens exactly as your doctor has told you.

You should check with your doctor or pharmacist if you are not

sure.

Taking this medicine

•    Swallow the tablets whole with a full glass of water.

•    Try to take your tablets around the same time each day.

This will help you remember to take them.

The days of the week printed on the blister strips translate as

follows:

Lundi    Mardi    Mercredi Jeudi    Vendredi    Samedi    Dimanche

MON    TUE WED THU FRI    SAT SUN

How much to take

The usual starting dose is 200 micrograms a day.

•    Your doctor may increase this dose to up to 600 micrograms a day.

•    If your doctor has told you to take 600 micrograms a day, this should be split in two (300 micrograms in the morning and300 micrograms in the evening).

•    Your doctor may tell you to take a lower dose if you have kidney problems.

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4. Possible side effects


5. How to store Physiotens


6. Further information


Children and young people

Physiotens should not be given to children and young people under 18 years.

If you take more Physiotens than you should

If you take more Physiotens than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. The following effects may happen: headache, feeling sleepy (somnolence, sedation), fall in blood pressure hypotension), slow heart rate (bradycardia), feeling dizzy (vertigo), being sick (vomiting), feeling tired (fatigue), weakness and pain in your stomach (abdominal pain).

If you forget to take Physiotens

•    If you forget to take a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.

•    Do not take a double dose to make up for a forgotten dose.

How to stop taking Physiotens

•    Keep taking your tablets until your doctor decides that you should stop.

•    If you need to stop, your doctor will lower your dose slowly over a few weeks. If you are taking more than one medicine for high blood pressure (such as beta-blockers), your doctor will tell you which medicine to stop first. This is so that your body can adjust slowly to the change.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Physiotens can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Stop taking Physiotens and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:

• swelling of the face, lips or mouth (angioedema). This is uncommon, affecting less than 1 in 100 people.

Other side effects include:

Very Common (affects more than 1 in 10 people)

•    dry mouth.

Common (affects less than 1 in 10 people)

•    back pain

•    headache

•    weakness (asthenia)

•    feeling dizzy (vertigo)

•    rash or itching (pruritus)

•    difficulty sleeping (insomnia), feeling sleepy (somnolence)

•    feeling sick (nausea), diarrhoea, being sick (vomiting), indigestion (dyspepsia).

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

•    Do not store above 25°C.

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    If your doctor tells you to stop taking the tablets, take any unused medicine to your pharmacist for safe disposal. Only keep the tablets if your doctor tells you to. If you notice the tablets become discoloured or show any other signs of deterioration, ask your pharmacist for advice.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Physiotens contains

•    Each tablet contains 200 micrograms of the active ingredient moxonidine.

•    It also contains the following ingredients: lactose, crospovidone, povidone, magnesium stearate, hypromellose, ethylcellulose talc, macrogol 6000, titanium dioxide (E171) and iron oxides (E172).

What Physiotens looks like and contents of the pack

Your tablets are small, round and pinkish coloured, one side is

marked '0,2' and the other side is plain. Your tablets are in

blister packs of 30 tablets.

Manufacturer

This product is manufactured by:

Abbott Healthcare SAS Route de Belleville Lieu dit Maillard

F 01400 Chatillon-sur-Chalaronne, France.

Procured from within the EU. Repackaged by the PL holder:

G Pharma Ltd, Dakota Avenue, Salford M50 2PU.

PL NO. 16369/0602

Leaflet revised: 20h November 2012

Physiotens is a registered trademark belonging to Abbott Pharmaceuticals GmbH.

Uncommon (affects less than 1 in 100 people)

•    neck pain

•    feeling nervous

•    fainting (syncope)

•    swelling (oedema)

•    ringing or noise in the ears (tinnitus)

•    unusually slow heartbeat (bradycardia)

•    low blood pressure, including low blood pressure when standing up.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.