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CLONIDINE HYDROCHLORIDE 25 MICROGRAM TABLETS

Active substance(s): CLONIDINE HYDROCHLORIDE / CLONIDINE HYDROCHLORIDE / CLONIDINE HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

If you take more Dixarit than you
should
If you take more Dixarit than you should,
talk to a doctor or go to a hospital
straight away. Take the medicine pack
with you, even if there are no tablets
left.

Dixarit ® 25 microgram
Tablets
(clonidine hydrochloride)

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
troublesome or serious, or if you notice
any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
Your medicine is known by the above
name but will be referred to as Dixarit
Tablets throughout this leaflet.
In this leaflet:
1. What Dixarit Tablets are and what
they are used for
2. Before you take Dixarit Tablets
3. How to take Dixarit Tablets
4. Possible side effects
5. How to store Dixarit Tablets
6. Further information
1. WHAT DIXARIT TABLETS ARE AND
WHAT THEY ARE USED FOR
Dixarit Tablets contain a medicine called
clonidine. This belongs to a group of
medicines called vasodilators.
Vasodilators widen the blood vessels
and this helps the blood to flow more
easily.
Dixarit Tablets are used to prevent
migraine attacks and similar types of
headache. It is also used to prevent hot
flushes that may occur in women during
the menopause (change of life).
2. BEFORE YOU TAKE DIXARIT
TABLETS
Do not take Dixarit if:
• You are pregnant, likely to get
pregnant or are breast-feeding
• You are allergic (hypersensitive) to
clonidine or any of the other
ingredients of Dixarit (see section 6:
Further information)
• You have a slow heart rate due to
heart problems
• You are already taking other
medicines that contain clonidine
Do not take this medicine if any of the
above apply to you. If you are not sure,
talk to your doctor or pharmacist before
using Dixarit.
Take special care with Dixarit
Check with your doctor or pharmacist
before taking Dixarit if:
• You have Raynaud’s disease (a
problem with circulation to the fingers
and toes) or other blood circulation
problems, including circulation to the
brain
• You have heart or kidney problems
• You have or have ever had depression
• You have constipation
• You have a nerve disorder that causes
your hands and feet to feel different
(‘altered sensation’)
If you are not sure if any of the above
apply to you, talk to your doctor or
pharmacist before taking Dixarit.

Taking other medicines
Please tell your doctor or pharmacist if
you are taking or have recently taken
any other medicines. This includes
medicines that you buy without a
prescription and herbal medicines. This
is because Dixarit can affect the way
some other medicines work. Also some
other medicines can affect the way
Dixarit works.
In particular, tell your doctor or
pharmacist if you are taking any of the
following medicines:
• Other medicines that make you
drowsy
• Medicines for depression such as
imipramine or mirtazapine
• Medicines for severe mental illness
such as schizophrenia. These are also
known as ‘antipsychotics’ and include
chlorpromazine
• Beta blockers such as atenolol
• Water tablets (‘diuretics’) such as
frusemide
• Alpha blockers such as prazosin or
doxazosin. These can also be used for
prostate problems in men
• Vasodilators such as diazoxide or
sodium nitroprusside
• Cardiac glycosides such as digoxin
• Medicines to lower blood pressure
If you are not sure if any of the above
apply to you, talk to your doctor or
pharmacist before taking Dixarit.
Taking Dixarit with food and drink
You may feel drowsy while taking
Dixarit. Drinking alcohol while taking
Dixarit can make this worse.
Pregnancy and breast-feeding
Do not take Dixarit if you are pregnant,
likely to get pregnant or are
breast-feeding.
Driving or using machines
You may feel drowsy, dizzy or could
have some disturbances of vision. If
affected, you should not drive, operate
machinery or take part in any activities
where these may put you or others at
risk.
Important information about some of
the ingredients of Dixarit
Dixarit contains lactose and sucrose
(types of sugar). If you have been told
by your doctor that you cannot tolerate
or digest some sugars, talk to your
doctor before taking this medicine.
3. HOW TO TAKE DIXARIT TABLETS
Always take Dixarit exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you are
not sure.
Taking this medicine
• Take this medicine by mouth
• The usual starting dose is 50
micrograms (two tablets), two times
a day
• If necessary, after two weeks, your
doctor may increase the dose to 75
micrograms (three tablets), two times
a day

If you forget to take Dixarit
If you forget a dose, take it as soon as
you remember it. However, if it is nearly
time for the next dose, skip the missed
dose. Do not take a double dose to
make up for a forgotten dose.
If you stop taking Dixarit
Do not stop taking Dixarit without first
talking to your doctor.
If you have any further questions on the
use of Dixarit, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Dixarit can cause
side effects, although not everybody
gets them.
The side effects described below have
been experienced by people taking
Dixarit. They are listed as either very
common, common, uncommon, rare or
not known.
Very common (affects more than 1 in 10
people)
• Dizziness, feeling tired and more
relaxed than usual (sedation)
• Feeling dizzy when you stand up
(because your blood pressure has
fallen sharply)
• Dry mouth
Common (affects less than 1 in 10
people, more than 1 in 100 people)
• Depression, sleeping problems
• Headache
• Constipation, feeling sick (nausea),
pain below the ear (from the salivary
gland), being sick (vomiting)
• Erectile dysfunction
• Fatigue
Uncommon (affects less than 1 in 100
people, more than 1 in 1,000 people)
• Problems with understanding what is
happening around you, hallucinations,
nightmares
• Your hands and feet feeling different
(‘altered sensation’)
• Regular unusually slow heart beat
• Raynaud’s phenomenon (a problem
with circulation to the fingers and toes)
• Itching, rash, urticaria (nettle rash)
• A feeling of discomfort and fatigue
(‘malaise’)
Rare (affects less than 1 in 1,000
people, more than 1 in 10,000 people)
• Breast growth (‘gynaecomastia’) in
men
• Dry eyes
• Irregular heartbeat
• Drying out of the lining of the nose
• Pseudo-obstruction of the large bowel,
which causes colicky pain, vomiting
and constipation. Contact your doctor
straight away if you have all these side
effects.
• Hair loss
• Increase in your blood sugar

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
Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help
provide more information on the safety
of this medicine.
5. HOW TO STORE DIXARIT
TABLETS
Keep out of the sight and reach of
children.
Do not store above 25°C.
Keep the blister strips in the outer
carton.
Do not use Dixarit after the expiry date
which is stated on the packaging after
‘EXP’. The expiry date refers to the last
day of that month.
If your tablets become discoloured, or
you notice any other signs of
deterioration, please contact your
pharmacist who will advise you what to
do.
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 protect the
environment.
6. FURTHER INFORMATION
What Dixarit contains
• The active substance is clonidine
hydrochloride.
Each coated tablet contains 25
micrograms of clonidine hydrochloride.
• The other ingredients are: calcium
hydrogen phosphate, lactose
monohydrate, maize starch, colloidal
anhydrous silica, povidone, starch,
magnesium stearate, sucrose, talc,
acacia, macrogol 6000, carnauba wax,
white wax, indigo carmine (E132),
titanium dioxide (E171).
What Dixarit looks like and contents
of the pack
Dixarit tablets are blue, biconvex,
sugar-coated tablets.
Dixarit tablets are available in blister
packs of 100 Tablets.
Manufactured by: Delpharm Reims, 10
rue Colonel Charbonneaux, 51100
Reims, France.
Procured from within the EU by the
Product Licence Holder: Expono Ltd,
Cornwall Road, Smethwick, B66 2JT,
UK.
Repackaged by: N.G. Ltd, West
Midlands, B66 2JT, UK.
PL 22961/0168 - Dixarit® 25 microgram
Tablets
POM
Revision Date: 15.11.2016

Dixarit® is a registered trademark of
Boehringer Ingelheim Pharma GmbH &
Co. KG.

Not known
• Confusion, loss of libido
• Blurred vision
• Abnormally slow heart beat

Dixarit is not recommended for children.

As you may get dry eyes whilst taking
this medicine, this may be a problem if
you wear contact lenses.
Ref: 777

Ref: 777

PACKAGE LEAFLET:
INFORMATION FOR THE USER

If you take more Clonidine than you
should
If you take more Clonidine than you
should, talk to a doctor or go to a
hospital straight away. Take the
medicine pack with you, even if there
are no tablets left.

Clonidine Hydrochloride
25 microgram Tablets
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
troublesome or serious, or if you notice
any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
Your medicine is known by the above
name but will be referred to as Clonidine
Tablets throughout this leaflet.
In this leaflet:
1. What Clonidine Tablets are and what
they are used for
2. Before you take Clonidine Tablets
3. How to take Clonidine Tablets
4. Possible side effects
5. How to store Clonidine Tablets
6. Further information
1. WHAT CLONIDINE TABLETS ARE
AND WHAT THEY ARE USED FOR
Clonidine Tablets contain a medicine
called clonidine. This belongs to a group
of medicines called vasodilators.
Vasodilators widen the blood vessels
and this helps the blood to flow more
easily.
Clonidine Tablets are used to prevent
migraine attacks and similar types of
headache. It is also used to prevent hot
flushes that may occur in women during
the menopause (change of life).
2. BEFORE YOU TAKE CLONIDINE
TABLETS
Do not take Clonidine if:
• You are pregnant, likely to get
pregnant or are breast-feeding
• You are allergic (hypersensitive) to
clonidine or any of the other
ingredients of Clonidine (see section 6:
Further information)
• You have a slow heart rate due to
heart problems
• You are already taking other
medicines that contain clonidine
Do not take this medicine if any of the
above apply to you. If you are not sure,
talk to your doctor or pharmacist before
using Clonidine.
Take special care with Clonidine
Check with your doctor or pharmacist
before taking Clonidine if:
• You have Raynaud’s disease (a
problem with circulation to the fingers
and toes) or other blood circulation
problems, including circulation to the
brain
• You have heart or kidney problems
• You have or have ever had depression
• You have constipation
• You have a nerve disorder that causes
your hands and feet to feel different
(‘altered sensation’)
If you are not sure if any of the above
apply to you, talk to your doctor or
pharmacist before taking Clonidine.

Taking other medicines
Please tell your doctor or pharmacist if
you are taking or have recently taken
any other medicines. This includes
medicines that you buy without a
prescription and herbal medicines. This
is because Clonidine can affect the way
some other medicines work. Also some
other medicines can affect the way
Clonidine works.
In particular, tell your doctor or
pharmacist if you are taking any of the
following medicines:
• Other medicines that make you
drowsy
• Medicines for depression such as
imipramine or mirtazapine
• Medicines for severe mental illness
such as schizophrenia. These are also
known as ‘antipsychotics’ and include
chlorpromazine
• Beta blockers such as atenolol
• Water tablets (‘diuretics’) such as
frusemide
• Alpha blockers such as prazosin or
doxazosin. These can also be used for
prostate problems in men
• Vasodilators such as diazoxide or
sodium nitroprusside
• Cardiac glycosides such as digoxin
• Medicines to lower blood pressure
If you are not sure if any of the above
apply to you, talk to your doctor or
pharmacist before taking Clonidine.
Taking Clonidine with food and drink
You may feel drowsy while taking
Clonidine. Drinking alcohol while taking
Clonidine can make this worse.
Pregnancy and breast-feeding
Do not take Clonidine if you are
pregnant, likely to get pregnant or are
breast-feeding.
Driving or using machines
You may feel drowsy, dizzy or could
have some disturbances of vision. If
affected, you should not drive, operate
machinery or take part in any activities
where these may put you or others at
risk.
Important information about some of
the ingredients of Clonidine
Clonidine contains lactose and sucrose
(types of sugar). If you have been told
by your doctor that you cannot tolerate
or digest some sugars, talk to your
doctor before taking this medicine.
3. HOW TO TAKE CLONIDINE
TABLETS
Always take Clonidine exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you are
not sure.
Taking this medicine
• Take this medicine by mouth
• The usual starting dose is 50
micrograms (two tablets), two times
a day
• If necessary, after two weeks, your
doctor may increase the dose to 75
micrograms (three tablets), two times
a day

If you forget to take Clonidine
If you forget a dose, take it as soon as
you remember it. However, if it is nearly
time for the next dose, skip the missed
dose. Do not take a double dose to
make up for a forgotten dose.
If you stop taking Clonidine
Do not stop taking Clonidine without first
talking to your doctor.
If you have any further questions on the
use of Clonidine, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Clonidine can cause
side effects, although not everybody
gets them.
The side effects described below have
been experienced by people taking
Clonidine. They are listed as either very
common, common, uncommon, rare or
not known.
Very common (affects more than 1 in 10
people)
• Dizziness, feeling tired and more
relaxed than usual (sedation)
• Feeling dizzy when you stand up
(because your blood pressure has
fallen sharply)
• Dry mouth
Common (affects less than 1 in 10
people, more than 1 in 100 people)
• Depression, sleeping problems
• Headache
• Constipation, feeling sick (nausea),
pain below the ear (from the salivary
gland), being sick (vomiting)
• Erectile dysfunction
• Fatigue
Uncommon (affects less than 1 in 100
people, more than 1 in 1,000 people)
• Problems with understanding what is
happening around you, hallucinations,
nightmares
• Your hands and feet feeling different
(‘altered sensation’)
• Regular unusually slow heart beat
• Raynaud’s phenomenon (a problem
with circulation to the fingers and toes)
• Itching, rash, urticaria (nettle rash)
• A feeling of discomfort and fatigue
(‘malaise’)
Rare (affects less than 1 in 1,000
people, more than 1 in 10,000 people)
• Breast growth (‘gynaecomastia’) in
men
• Dry eyes
• Irregular heartbeat
• Drying out of the lining of the nose
• Pseudo-obstruction of the large bowel,
which causes colicky pain, vomiting
and constipation. Contact your doctor
straight away if you have all these side
effects.
• Hair loss
• Increase in your blood sugar

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
Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help
provide more information on the safety
of this medicine.
5. HOW TO STORE CLONIDINE
TABLETS
Keep out of the sight and reach of
children.
Do not store above 25°C.
Keep the blister strips in the outer
carton.
Do not use Clonidine after the expiry
date which is stated on the packaging
after ‘EXP’. The expiry date refers to the
last day of that month.
If your tablets become discoloured, or
you notice any other signs of
deterioration, please contact your
pharmacist who will advise you what to
do.
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 protect the
environment.
6. FURTHER INFORMATION
What Clonidine contains
• The active substance is clonidine
hydrochloride.
Each coated tablet contains 25
micrograms of clonidine hydrochloride.
• The other ingredients are: calcium
hydrogen phosphate, lactose
monohydrate, maize starch, colloidal
anhydrous silica, povidone, starch,
magnesium stearate, sucrose, talc,
acacia, macrogol 6000, carnauba wax,
white wax, indigo carmine (E132),
titanium dioxide (E171).
What Clonidine looks like and
contents of the pack
Clonidine tablets are blue, biconvex,
sugar-coated tablets.
Clonidine tablets are available in blister
packs of 100 Tablets.
Manufactured by: Delpharm Reims, 10
rue Colonel Charbonneaux, 51100
Reims, France.
Procured from within the EU by the
Product Licence Holder: Expono Ltd,
Cornwall Road, Smethwick, B66 2JT,
UK.
Repackaged by: N.G. Ltd, West
Midlands, B66 2JT, UK.
PL 22961/0168 - Clonidine
Hydrochloride 25 microgram Tablets
Revision Date: 15.11.2016

POM

Not known
• Confusion, loss of libido
• Blurred vision
• Abnormally slow heart beat

Clonidine is not recommended for
children.

As you may get dry eyes whilst taking
this medicine, this may be a problem if
you wear contact lenses.
Ref: 776

Ref: 776

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.

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