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MOXONIDINE 200 MICROGRAM TABLETS

Active substance(s): MOXONIDINE

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MOXONIDINE 200, 300 and
400 microgram TABLETS
PACKAGE LEAFLET:
INFORMATION FOR THE USER

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 get 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 is and what it is
used for
2. Before you take Moxonidine
3. How to take Moxonidine
4. Possible side effects
5. How to store Moxonidine
6. Further information

1

Ask your doctor or pharmacist for
advice before taking any medicine if
you are pregnant or breast-feeding.
Driving and using machines
Moxonidine may cause dizziness or
drowsiness, if affected do not drive or
operate machinery.
Important information about some of
the ingredients of Moxonidine
Patients who are intolerant to lactose
should note that Moxonidine tablets
contain a small amount of 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 Moxonidine exactly as
your doctor has told you. You should
check with your doctor or pharmacist
if you are not sure.
The tablets should be swallowed,
preferably with a drink of water.

WHAT MOXONIDINE IS AND
WHAT IT IS USED FOR

The usual dose is:
Adults (including the elderly):
Your treatment will normally start with
• Moxonidine belongs to a group of
one 200 microgram tablet, taken in
drugs called anti-hypertensives that the morning. After three weeks, your
lower blood pressure
doctor may increase this dose to
• Moxonidine is used to treat high
400 micrograms daily, given in a
blood pressure.
single dose in the morning, or in
divided doses in the morning and
2 BEFORE YOU TAKE MOXONIDINE evening. After another three weeks,
your doctor may need to increase this
Do NOT take Moxonidine if you:
dose to 600 micrograms daily, given
• are allergic (hypersensitive) to
in divided doses (morning and
moxonidine or any of the other
evening). You should not take more
ingredients of this medicine
than 400 micrograms as a single dose
• have a slow heart rate or suffer from or more than 600 micrograms in any
an abnormal heart rhythm or a
one day.
change in the rate of the heart beat
called “sick sinus syndrome” or “2nd Patients with kidney problems:
or 3rd degree AV-block”
If you have moderate problems with
• have, or have had, heart failure or
your kidneys, you should not take
other heart problems.
more than one 200 microgram tablet
as
a single dose or more than 400
Take special care with Moxonidine
micrograms
in total, a day.
Tell your doctor before you start to
take this medicine if you:
Children under 16 years of age:
• have a heart problem called
Moxonidine is not recommended for
st
“1 degree AV-block”
use in children.
• have a severe coronary heart
disease, or have angina (chest pain If you take more Moxonidine than you
at rest)
should
• have poor circulation
If you (or someone else) swallow a lot
• have kidney disease
of the tablets all together, or if you
• have a rare hereditary problem of
think a child has swallowed any of the
galactose intolerance, Lapp lactase tablets, contact your nearest hospital
deficiency or glucose-galactose
casualty department or your doctor
malabsorption as you should not
immediately. An overdose is likely to
take this medicine.
cause headache, sleepiness, dry
mouth, loss of balance, dizziness, low
Taking other medicines
blood pressure and slowing of the
Talk to your doctor if you are taking
pulse, vomiting, feeling tired,
any of the following:
weakness and pain in your stomach.
• beta-blockers, such as propranolol
Please take this leaflet, any remaining
or atenolol, used to treat heart
tablets and the container with you to
problems
the hospital or doctor so that they
• other medicines used to reduce
blood pressure such as furosemide know which tablets were consumed.
a diuretic, or captopril an
If you forget to take Moxonidine
angiotensin-converting enzyme
If you forget to take a dose, take one
inhibitor
as soon as you remember, unless it is
• antidepressants such as
nearly time to take the next one. Do
amitriptyline
not take a double dose to make up for
• sleeping tablets such as zopiclone,
a forgotten dose.
tranquilizers such as nitrazepam,
lorazepam or phenobarbital
• Moxonidine is removed from body If you stop taking Moxonidine
Do not suddenly stop taking
by kidneys through the process
Moxonidine. Your medicine should be
called “tubular excretion”. Other
reduced gradually over two weeks,
medicines removed from the
your doctor will advise you on how
kidneys in the same way could
and when to do this.
affect how moxonidine works.
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 with food and
drink
Do not drink alcohol whilst taking
Moxonidine.
Pregnancy and breast-feeding
Moxonidine is not recommended if
you are pregnant, planning on
becoming pregnant or are
breast-feeding.

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

4

POSSIBLE SIDE EFFECTS

Like all medicines, Moxonidine can
cause side effects, although not
everybody gets them.
If the following happens, stop taking
the tablets and tell your doctor
immediately or go to the casualty
department at your nearest hospital:
• an allergic reaction (swelling of the
lips, face or neck leading to severe
difficulty in breathing; skin rash or
hives).
This is a very serious but rare side
effect. You may need urgent medical
attention or hospitalisation.
The following side effects have been
reported at the approximate
frequencies shown:
Very common (affecting more than one
person in 10):
• dry mouth
• drowsiness.
Common (affecting fewer than one
person in 10 but more than one
person in 100):
• headache
• dizziness (vertigo)
• flushing (vasodilation)
• weakness or loss of strength
• confusion
• sleep disturbances (difficulty
sleeping – insomnia or feeling
sleepy – somnolence)
• nausea (feeling sick), being sick
(vomiting), stomach upsets
(dyspepsia), diarrhoea
• rash or itching (pruritus)
• back pain.

6

FURTHER INFORMATION

What Moxonidine tablets contain:
• The active ingredient is moxonidine
200, 300 or 400 micrograms
• The other ingredients are lactose
monohydrate, crospovidone,
povidone K25 and magnesium
stearate. The film coating contains
hypromellose, titanium dioxide
(E171), macrogol 400 and red iron
oxide (E172).
What Moxonidine tablets look like
and contents of the pack:
• The 200 microgram tablets are light
pink, round, film-coated tablets
• The 300 microgram tablets are pink,
round, film-coated tablets
• The 400 microgram tablets are dark
pink, round, film-coated tablets
• The product is available in packs of
10, 20, 28, 30, 50, 56, 98, 100 and 400
film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation holder:
TEVA UK Limited, Eastbourne,
BN22 9AG.
Company responsible for
manufacture: Merckle GmbH
Ludwig-Merckle Straße 3 89143
Blaubeuren, Germany.
This leaflet was last revised in
May 2013.
PL 00289/0596-8

Uncommon (affecting fewer than one
person in 100 but more than one
person in 1,000):
• feeling nervous
• swelling, particularly of the lower
legs and feet
• neck pain
• fainting
• unusually slow heart beat
(bradycardia)
• low blood pressure, which may
result in dizziness or
light-headedness on standing
• circulatory disorders, which may
produce numbness, coldness or
pins-and-needles in the hands or
feet
• ringing or noise in the ears (tinnitus)
• leg weakness
• anorexia
• painful neck glands
• dry, itchy or burning sensation in
the eyes
• anxiety
• sexual problems such as impotence,
or the development of breasts in
men, or loss of sexual desire.
If any of the side effects get serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.

5

HOW TO STORE MOXONIDINE

Keep out of the reach and sight of
children.
Do not store above 30°C. Keep blister
in the outer carton in order to protect
from light. Do not use Moxonidine
after the expiry date that is stated on
the outer packaging. 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.

41662-A
420 x 148

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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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