Skip to Content

MOXONIDINE 0.4 MG FILM-COATED TABLETS

Active substance(s): MOXONIDINE / MOXONIDINE / MOXONIDINE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the patient

Moxonidine 0.2 mg
Film-coated Tablets
Moxonidine 0.3 mg
Film-coated Tablets
Moxonidine 0.4 mg
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 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
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 “second or
third degree AV-block”)
• have heart function insufficiency.

Warnings and precautions

• 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 and breast-feeding

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 during
pregnancy unless clearly necessary.
Moxonidine has been shown to pass in
to breast milk and should therefore not
be used during breast-feeding. 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
medicine.

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:

Use in 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).

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.

Use in patients with kidney problems

Children and adolescents

If you take more Moxonidine than
you should

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 propranolol or
atenolol, used to treat heart problems
(see “If you stop taking Moxonidine” in
section 3)

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
0.4 mg of Moxonidine. If you have severe
kidney problems, the maximum daily
dose is 0.3 mg of Moxonidine.

Use in children and adolescents

Moxonidine should not be given to children
and adolescents under 18 years old.

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, 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).
50061833

If you forget to take Moxonidine

• swollen breasts in male patients,
• inability to get or maintain an erection,
loss of sexual drive,
• slow heart beat.

If you stop taking Moxonidine

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.

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.
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 betablocker (e.g propranolol) at the same
time, treatment with the beta-blocker
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,

Reporting of side effects

5. How 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 stated on the label or
carton after ‘EXP’. 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 protect the environment.

6. Contents of the pack and
other information
What Moxonidine contains

• Each tablet contains 0.2 mg, 0.3 mg
or 0.4 mg of the active substance
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., Station Close,
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
January 2017.

942626
50061833

Expand Transcript

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.

Hide