Moxonidine 200microgram, 300microgram and 400microgram film-coated tablets

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 sections 4.

What is in this leaflet:

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

Moxonidine tablets are used to reduce high blood pressure. They act through the central nervous system to widen the blood vessels to lower the blood pressure. Moxonidine tablets are used to treat mild to moderate forms of high blood pressure which has no specific cause (essential hypertension).

2.    What you need to know before you take Do not take Moxonidine tablets if you

•    are allergic to moxonidine or any of the other ingredients of this medicine (listed in section 6)

•    suffer from an uncontrollable heartbeat disorder (malignant arrhythmia)

•    have a very slow heart rate (less than 50 beats per minute at rest)

•    suffer from heart failure (a condition in which the heart does not pump enough blood through the body, resulting in shortness of breath and swelling of the lower extremities)

Warnings and precautions

Talk to your doctor or pharmacist before taking Moxonidine tablets if you

•    have kidney problems. Your doctor will check your blood pressure regularly, especially at the start of treatment (if in doubt, please ask your doctor)

•    are taking a beta-blocker as the beta-blocker must be stopped first, and then Moxonidine tablets taken a few days after. This will prevent an excessive increase in blood pressure

•    have or are at risk of a heart problem called 1^st degree AV-block

•    suffer from a severe disturbance in blood supply to the heart muscle (severe coronary artery disease) or have unstable angina pectoris (causing chest pain at rest)

•    have moderate cardiac insufficiency (heart is unable to pump enough blood to fully meet the bodies needs).

•

are pregnant or breast-feeding (see Pregnancy and breast-feeding)

Children and adolescents

Moxonidine tablets should not be taken by children and adolescents under 16 years of age.

Other medicines and Moxonidine tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines especially: • other medicines for high blood pressure as they can increase the effect of Moxonidine

•    anti depressants (such as tricyclic antidepressants), tranquillisers, sedatives and hypnotics as the effect of these medicines can be increased

•    benzodiazepines including lorazepam can reduce mental function if taken with Moxonidine

•    tolazoline (to dilate blood vessels) as this can weaken the effect of Moxonidine

•    moxonidine 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 moxonidine works. 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

Moxonidine tablets with food, and alcohol

Moxonidine can increase the effect of alcohol and alcohol should be avoided during treatment. Moxonidine tablets can be taken with or without food and should be taken with plenty of fluid (e.g. 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.

The effect of Moxonidine during pregnancy is not known. If treatment does become necessary, the doctor will decide, by carefully weighing up the benefits and the risks.

As moxonidine is excreted in breast milk, Moxonidine tablets should not be taken while breast-feeding. If treatment with Moxonidine tablets is necessary, the mother should stop breast-feeding first.

Driving and using machines

Moxonidine tablets can cause drowsiness and dizziness. If you are affected in this way, do not drive or operate machinery.

Moxonidine contains lactose

This medicine contains a sugar called lactose. If a doctor has told you 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

•    Starting dose: 200micrograms in the morning

•    Your doctor will increase the dose if the effect is not adequate after three weeks: 400micrograms a day (taken as either 200micrograms morning and evening or 400micrograms in the morning).

•    If the effect is still not adequate after a further three weeks your doctor will increase the dose again: 600micrograms a day given in divided doses.

Maximum doses:

The maximum single dose is 400micrograms taken at once.

The maximum total daily dose is 600micrograms.

Elderly patients

Provided kidney function is not impaired, the recommended dosage is the usual adult dose.

Use in children and adolescentsAs there is insufficient experience with this age group, Moxonidine tablets should not be taken by children and adolescents under 16 years of age.

Patients with kidney function problems

Your doctor will adjust the dose to suit you. If in doubt, please ask your doctor.

Patients with impaired liver function

The recommended dosage is the usual adult dose.

If you take more Moxonidine tablets than you should

If you have taken more Moxonidine than you should, contact your doctor or nearest hospital casualty department immediately. Signs of overdose in adults are sedation, low blood pressure, causing dizziness or light-headedness, very slow heartbeat or dry mouth. In rare cases vomiting may occur. In severe cases, clouding of consciousness and severe breathing difficulties can occur.

If you forget to take Moxonidine tablets

Do not take a double dose to make up for a forgotten dose. Just take the next dose when it is due.

If you stop taking Moxonidine tablets

Treatment with moxonidine must not be stopped suddenly. Do not interrupt or stop taking Moxonidine tablets unless your doctor advises you to. Moxonidine tablets 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.

Contact your doctor at once if you experience any of the following rare effects:

•    allergic reactions such as: skin reactions, swelling of the hands, feet, face, lips, tongue, the mucous membranes in mouth, throat, or airways, resulting in shortness of breath or difficulty swallowing.

•    effects on the liver causing abdominal pain, jaundice (yellow coloration of the skin or eye whites), itching of the skin (these occur very rarely).

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

Very common (in more than 1 in 10 patients treated):

•    dry mouth

•    drowsiness

Common (in less than 1 in 10 patients treated):

•    inability to think clearly

•    weakness, lethargy

•    headache

•    back pain

•    dizziness, or feeling of “spinning”

•    sleepiness, or difficulty in falling and/or staying asleep

•    dry, itching or burning sensation of the eye

•    itching rash

•    nausea, vomiting, diarrhoea, constipation, indigestion and other digestive symptoms

•    dilated blood vessels (causing slight flushing, mild swelling of skin)

Uncommon (in less than 1 in 100 patients treated):

•    enlargement of the breasts in men (gynaecomasty), impotence, loss of sexual drive

•    depression, anxiety, sedation

•    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

•    ringing in the ears

•    pain in the salivary glands in the face and neck

•    neck pain

•    slower heart beat

•    low blood pressure, fall in blood pressure on standing, disturbances of the peripheral circulation (numbness, tingling, cold or pale skin), ‘pins and needles’

•    Raynaud’s syndrome (painful whitening of the fingers and toes in the cold, followed by a temporary blueness and then redness)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/vellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Moxonidine tablets

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 Moxonidine tablets contain

Each tablet contains either 200micrograms, 300micrograms or 400micrograms of the active substance moxonidine (which makes the medicine work).

The other ingredients are:

Tablet core: lactose monohydrate, crospovidone, povidone K25, magnesium stearate

Tablet coating: hypromellose, titanium dioxide (E171), macrogol 400, red iron (III) oxide (E 172).

What Moxonidine tablets look like and contents of the pack:

All the tablets are round, film coated in the following colours:

200micrograms - light pink

300micrograms - pink

400micrograms - dark pink

Moxonidine tablets are available in packs of 28.

Marketing Authorisation Holder

Actavis, Barnstaple, EX32 8NS, UK

Manufacturers

Rottendorf Pharma GmbH, Ostenfelder Str. 51 - 61, 59320 Ennigerloh Actavis Group PTC ehf, Reykjavikurvegur 76-78, IS-220 HafnarfjorQur, Iceland Revision date: Feburary 2014