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MOXONIDINE 0.2 MG FILM-COATED TABLETS

Active substance(s): MOXONIDINE

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MOXONIDINE 0.2 mg
FILM-COATED TABLETS
MOXONIDINE 0.3 mg
FILM-COATED TABLETS
MOXONIDINE 0.4 mg
FILM-COATED TABLETS
moxonidine

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 section 4.
What is in this leaflet:
1. What Moxonidine is and what it is
used for
2. What you need to know before you
take Moxonidine
3. How to take Moxonidine
4. Possible side effects
5. How to store Moxonidine
6. Contents of the pack and other
information
1. WHAT MOXONIDINE IS AND WHAT
IT IS USED FOR
Moxonidine belongs to a group of
medicines called anti-hypertensives,
which reduce blood pressure.
Moxonidine is used to treat high
blood pressure (hypertension).
2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE MOXONIDINE

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Do not take Moxonidine if you
• are allergic to moxonidine or any
of the other ingredients of this
medicine (listed in section 6).
• have a slow heart rate (below
50 beats/minute at rest) or suffer
from an abnormal heart rhythm or a
change in the rate of the heart beat
(called “sick-sinus syndrome” or “2nd or
3rd degree AV-block”).
• have heart function insufficiency.
Warnings and precautions
Talk to your doctor or pharmacist
before taking moxonidine if you:
• have a type of irregular heart beat
called “1st degree AV-block” or a high
risk of developing AV-block.
• have severe coronary artery disease
or chest pain (unstable angina
pectoris).
• have kidney problems. Your doctor
may need to adjust your dose.
• are elderly. Your doctor may start you
on the lowest dose and increase it
gradually.
Children and adolescents
This medicine should not be given
to children and adolescents under
18 years old.
Other medicines and Moxonidine
Tell your doctor or pharmacist if
you are taking, have recently taken,
or might take any other medicines,
especially any of the following:
• beta-blockers such as propanolol
or atenolol, used to treat heart
problems (see “If you stop taking
Moxonidine” in section 3)

• other medicines used to reduce
blood pressure such as furosemide (a
diuretic), captopril (an angiotensinconverting enzyme inhibitor) or
tolazoline (an alpha-blocker)
• medicines used to treat anxiety such
as benzodiazepines (e.g. diazepam,
lorazepam) and depression e.g.
amitriptyline
• sleeping tablets and tranquilisers
• moxonidine is removed from the
body by kidneys through the process
called “tubular excretion”. Other
medicines removed from the kidneys
in the same way could affect how
moxonidine works.
Moxonidine with alcohol
Do not drink alcohol while taking this
medicine.
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. This product should not
be used in pregnancy unless clearly
necessary. Moxonidine has been shown
to pass in to breast milk and should
therefore not be used during breastfeeding. If therapy with moxonidine is
considered absolutely necessary, the
breast-feeding shall be stopped.
Driving and using machines
Do not drive or operate machinery if
you feel dizzy or drowsy while taking
this medicine.
Moxonidine 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
3. HOW TO TAKE MOXONIDINE
Always take this medicine exactly as
your doctor has told you. Check with
your doctor or pharmacist if you are
not sure.
• Swallow your tablets with a glass of
water
• Take before, during or after a meal.
The recommended dose is:
Adults (including the elderly)
The recommended starting dose is one
0.2 mg tablet taken in the morning.
After three weeks, your doctor may
increase this to 0.4 mg of moxonidine
(given as a single dose in the morning
or as 0.2 mg in the morning and
0.2 mg in the evening). If needed, after
another three weeks, the dose may be
increased to the maximum daily dose
of 0.6 mg (given as a divided dose in
the morning and evening).
Patients with kidney problems
You may be more sensitive to the
effects of Moxonidine.
A single dose should not be more than
0.2 mg and the maximum daily dose
is 0.4mg of Moxonidine. If you have
severe kidney problems, the maximum
daily dose is 0.3mg of Moxonidine.
Use in children and adolescents
Moxonidine should not be given
to children and adolescents under
18 years old.
If you take more Moxonidine than
you should
Contact your doctor or nearest
hospital emergency department
immediately. Take the container
and any remaining tablets with
you. Symptoms of overdose include
headache, feeling sleepy (somnolence,

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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sedation), fall in blood pressure
(hypotension), feeling dizzy, unusual
weakness (asthenia), slow heart rate
(bradycardia), dry mouth, being sick
(vomiting), feeling tired and pain in
the stomach (abdominal pain).
If you forget to take Moxonidine
Take it as soon as you remember
unless it is almost time for your next
dose. Do not take a double dose to
make up for a forgotten dose.
If you stop taking Moxonidine
Do not suddenly stop taking
Moxonidine as this may cause serious
changes in your blood pressure. Speak
to your doctor first. Your doctor will
slowly reduce the dose over 2 weeks.
If you are taking Moxonidine and a
beta-blocker (e.g propranolol) at the
same time, treatment with the betablocker should be stopped a few days
before treatment with Moxonidine
is stopped. This is because stopping
both treatments at the same time
could result in an increased blood
pressure.
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.
If any of the following happens,
stop taking Moxonidine and tell
your doctor immediately or go to
your nearest hospital emergency
department.
Uncommon (may affect up to 1 in
100 people):
• Difficulty in breathing, tightness of
the chest, swelling of the face, lips,
mouth, throat or tongue, or skin
rashes. You may be experiencing an
allergic reaction to the medicine.
Very rare (may affect up to 1 in
10,000 people):
• Liver problems, dark urine, pale
stools, yellowing of the skin or whites
of the eyes.
These side effects are serious. You may
need urgent medical attention.
In decreasing order of frequency,
other side effects can include:
Very common (may affect more than
1 in 10 people):
• dry mouth.
Common (may affect up to 1 in
10 people):
• headache,
• feeling dizzy/vertigo,
• back pain,
• abnormal thinking,
• sleep problems, difficulty sleeping
(insomnia), feeling sleepy
(somnolence),
• rash/itching,
• feeling sick (nausea), stomach upset,
indigestion, constipation, diarrhoea,
being sick (vomiting),
• feeling flushed,
• weakness (asthenia).
Uncommon (may affect up to 1 in
100 people):
• feeling anxious or nervous,
• swelling of different parts of the
body (e.g hands or ankles), fluid
retention, leg weakness,
• fainting,
• drowsiness,
• loss of appetite (anorexia)

• neck pain, painful parotid glands
(glands below the ears),
• low blood pressure, including low
blood pressure when standing up,
• ringing or noise in the ears,
• dry itchy or burning eyes,
• pins and needles or abnormal
sensations (paraesthesia) in the
extremities,
• painful or cold fingers or toes and
other circulation problems,
• swollen breasts in male patients,
• inability to get or maintain an
erection, loss of sexual drive,
• slow heart beat.
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes
any side effects not listed in this
leaflet.
You can also report side effects
directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help
provide more information on the
safety of this medicine.
5. H
 OW TO STORE MOXONIDINE
Keep this medicine out of the sight
and reach of children.
Do not use this medicine after the
expiry date, which is shown on the
label or carton. The expiry date refers
to the last day of that month. Do not
store this medicine above 30°C.
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 to protect the
environment.
6. C
 ONTENTS OF THE PACK AND
OTHER INFORMATION
What Moxonidine contains
- The active substance is 0.2 mg,
0.3 mg or 0.4 mg moxonidine.
- The other ingredients are lactose
monohydrate, crospovidone
(Type A), povidone K-25 and
magnesium stearate. The coating
contains hypromellose, titanium
dioxide (E171), macrogol 400 and
red iron oxide (E172).
What Moxonidine looks like and
contents of the pack
Your medicine comes as a round
film-coated tablet.
The 0.2 mg tablets are light pink, the
0.3 mg tablets are pink and the 0.4 mg
tablets are dark pink.
Moxonidine is available in blister
packs of 10, 28, 28 x 1, 30, 50, 98 and
100 tablets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
Manufacturers
Chanelle Medical, IDA Industrial Estate,
Loughrea, Co. Galway, Ireland
Generics [UK] Ltd., Potters Bar,
Hertfordshire, EN6 1TL, United
Kingdom
Gerard Laboratories, 35/36 Baldoyle
Industrial Estate, Dublin, Ireland
Mylan dura GmbH, Wittichstr., 6,
D. 64295 Darmstadt, Germany
Mylan Hungary Kft., H-2900 Komarom,
Mylan utca 1, Hungary

This leaflet was last revised in June 2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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