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Moxonidine 400 Microgram Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Moxonidine

200 microgram Tablets

Moxonidine

300 microgram Tablets

Moxonidine

400 microgram Tablets

Moxonidine

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

In this leaflet:

1.    What Moxonidine Tablets are and what they are used for

2.    Before you take Moxonidine Tablets

3.    How to take Moxonidine Tablets

4.    Possible side effects

5.    How to store Moxonidine Tablets

6.    Further information

Q What Moxonidine Tablets are and what they are used for

Moxonidine is a type of medicine known as an antihypertensive, and which may be used for treatment of mild to moderate high blood pressure (hypertension).

Q Before you take Moxonidine Tablets

Do not take Moxonidine Tablets if you

•    Are allergic (hypersensitive) to Moxonidine or any of the other ingredients of Moxonidine Tablets

•    Have heart problems (for example, heart failure or abnormal rhythm)

•    Have severe coronary artery disease (which can cause heart attack) or unstable angina

•    Have serious liver or kidney problems

•    Have had a serious allergic reaction to any medicine in the past that caused swelling of the face or throat (angioneurotic oedema)

If any of these apply to you, consult your doctor or pharmacist.

Take special care with Moxonidine Tablets

Please tell your doctor if you have:

•    Leg pains caused by poor blood circulation

•    Poor circulation which makes the toes and fingers numb and pale (including Raynaud's disease)

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

•    Epilepsy (fits)

•    Increased pressure in the eyes (glaucoma)

•    Depression

•    Moderate kidney problems

•    Problems with blood vessels in your brain (severe cerebrovascular insufficiency)

•    Recently had a heart attack

•    Moderate heart failure

Before you start taking Moxonidine, tell your doctor

or pharmacist if you are taking any of the following

medicines:

•    Medicines to reduce your blood pressure (antihypertensives)

•    Medicines used to reduce fluid retention (diuretics such as furosemide, chlortalidone, spironolactone)

•    Medicines to treat depression (tricyclic antidepressants such as imipramine and amitriptyline or monoamine-oxidase inhibitors (MAOIs) such as phenelzine, isocarboxazid and tranylcypromine)

•    Sleeping tablets (known as benzodiazepines)

•    Medicines to control blood sugar levels (insulin, sulfonylureas)

•    Medicines to control heart rhythms (digitalis)

•    Medicines derived from nitrates used for angina (such as glyceryl trinitrate, isosorbide dinitrate or isosorbide mononitrate)

•    Medicines for arthritis

•    Medicines to lower blood-lipid levels

•    Medicines to treat gout (allopurinol or colchicine)

•    A medicine to treat kidney problems (probenecid)

•    Medicines to treat ulcers

•    Tolazoline (used to treat high blood pressure in newborns)

•    Medicines to increase thyroid activity

•    Corticosteroids such as hydrocortisone (used to treat inflammation)

•    Medicines for pain and inflammation (non-steroidal anti-inflammatory drugs such as ibuprofen or diclofenac)

•    Medicines used in psychoses (phenothiazine antipsychotics e.g. chlorpromazine, fluphenazine or pericyazine)

•    Medicines that contain oestrogens

e.g. hormone replacement therapy (HRT) or contraceptive pills

•    Alprostadil (for erectile dysfunction)

•    Moxisylyte (for Raynaud's syndrome)

•    Levodopa (for Parkinson's disease)

•    Medicines used to relief muscle spasm (baclofen or tizanidine)

Moxonidine may interact with general anaestatics. Tell your doctor or dentist that you are taking moxonidine before any surgical or dental procedure.

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

Taking Moxonidine Tablets with alcohol

As it is not known whether alcohol affects the way Moxonidine works, you shouldn't drink alcohol while you are taking Moxonidine.

Pregnancy and breast-feeding

Do not take Moxonidine if you are pregnant, or think you might be pregnant or are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Moxonidine Tablets may make you feel drowsy or dizzy or make you feel less alert particularly when you first start using them or when the dose is changed.

Do not drive or use any tools or machines if you notice any of these effects whilst taking Moxonidine Tablets.

Important information about some of the ingredients of Moxonidine Tablets

Moxonidine Tablets contain lactose monohydrate, a type of sugar. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

Q How to take Moxonidine Tablets

Always take Moxonidine Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will tell you how many tablets to take. You will usually start taking a low dose which is then increased gradually to the most appropriate dose to treat your condition. Your tablets should be taken with a drink of water before, during or after a meal.

Adults and Elderly

Your treatment will start with one 200 microgram tablet each morning. After about three weeks, your doctor may need to increase this dose to 400 micrograms each day. This dose can be given as a single dose (to be taken in the morning) or as a divided daily dose (morning and evening).

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.

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.

Patients with Kidney Problems

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

Children

Moxonidine is not recommended for children or adolescents under 16 years old.

If you take more Moxonidine Tablets than you should

If you take more tablets that you should, contact your doctor or hospital immediately, and show the pack to the doctor.

If you forget to take Moxonidine Tablets

Do not take a double dose to make up for a forgotten dose. If you forget to take your dose of Moxonidine Tablets just take the next dose at the usual time.

If you stop taking Moxonidine Tablets

Do not stop taking Moxonidine Tablets unless your doctor has told you to. Your doctor will tell you how to gradually reduce and stop taking Moxonidine Tablets.

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

O Possible side effects

Like all medicines, Moxonidine Tablets can cause side effects, although not everybody gets them.

Stop taking Moxonidine Tablets and consult your doctor or hospital immediately if you experience:

•    Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing. This may be a very rare but serious allergic reaction known as angioedema.

Very common side effects (affecting more than 1 in 10 people)

•    Dry mouth

•    Headaches

•    Drowsiness

•    Dizziness

•    Sleepiness

The side effects above will ease as your treatment continues.

Common side effects (affecting less than 1 in 10 people)

•    Nausea, constipation, tummy discomfort or pain

•    Sleep disturbance

•    Skin flushing

•    Altered thought processes

•    Feeling of weakness

Uncommon side effects (affecting less than 1 in 100 people)

•    Leg weakness

•    Depression or anxiety

•    Sedation

•    Dry itching or burning sensation of the eye

•    Breast enlargement in men

•    Impotence and loss of interest in sex

•    Incontinence or difficulty urinating

•    Swelling

•    Fainting

•    Fluid retention

•    Pain of salivary glands

•    Loss of appetite

•    Dizziness or feeling faint particularly on standing (low blood pressure)

•    Tingling, burning or prickling sensations in the hand and feet

•    Poor circulation which makes the toes and fingers numb and pale (including Raynaud's syndrome)

•    Allergic skin reactions (rash, itching, inflamed or reddened skin)

Very rare side effects

(affecting less than 1 in 10 000 people)

•    Yellowing of the skin or whites of the eyes (liver problems)

•    A type of glaucoma (angle closure glaucoma)

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.

0 How to store Moxonidine Tablets

Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use Moxonidine Tablets after the expiry date which is stated on the carton after 'EXP:'. The expiry date refers to the last day of that month. 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 Moxonidine Tablets contain

The active substance is moxonidine. Each tablet contains 200 micrograms, 300 micrograms or 400 micrograms of moxonidine.

The other ingredients are lactose monohydrate, crospovidone, povidone K25, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400 and red iron oxide (E172).

What Moxonidine Tablets look like and the contents of the pack

Moxonidine 200 microgram tablets are round, light pink tablets.

Moxonidine 300 microgram tablets are round, pink tablets.

Moxonidine 400 microgram tablets are round, dark pink tablets.

They are available in blister packs of 10, 20,

28, 30, 50, 98,100, 400 (20 X 20,10 X 40 as hospital packs only) film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

PLIVA Pharma Ltd Vision House Bedford Road Petersfield

Hampshire, GU32 3QB United Kingdom

Manufacturer

Chanelle Medical IDA Industrial Estate Loughrea Co. Galway Ireland

This leaflet was last approved in

October 2008.

PL 10622/0212-214 ® PLIVA