Skip to Content

CLONIDINE HYDROCHLORIDE 25 MICROGRAMS TABLETS

Active substance(s): CLONIDINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET:
PATIENT INFORMATION LEAFLET

Dixarit®
25 micrograms
Tablets



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

(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.
®

The name of your medicine is Dixarit
25 micrograms Tablets but it will be
referred as Dixarit throughout this leaflet.
In this leaflet:
1. What Dixarit is and what it is used for
2. Before you take Dixarit
3. How to take Dixarit
4. Possible side effects
5. How to store Dixarit
6. Further information
1. WHAT DIXARIT IS AND IT IS USED
FOR
Dixarit contains 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 is 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
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

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

Dixarit is not recommended for children.
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.
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 heart beat
• 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

Not known
• Confusion, loss of libido
• Blurred vision
• Abnormally slow heart beat
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 Yellow Card Scheme Website
at: 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. The blister
strips should be kept in the outer
carton.
Do not take your tablets after the expiry
date which is stated on the carton and
blister labels after ‘Exp’. 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 protect the
environment.
6. FURTHER INFORMATION
What Dixarit contains
The active substance in Dixarit is clonidine
hydrochloride.
Each coated tablet contains 25 micrograms
of clonidine hydrochloride.
The other ingredients are: calcium
hydrogen phosphate anhydrous, lactose
monohydrate, maize starch, colloidal
anhydrous silica, povidone, starch maize
soluble, indigo carmine (E132),
magnesium stearate, sucrose, talc, acacia,
titanium dioxide (E171), macrogol,
carnauba wax and white beeswax.
What Dixarit looks like and contents of
the pack
Dixarit is blue, sugar-coated, biconvex
shaped tablets. Dixarit is available in blister
packs of 112 tablets.
Manufactured by: Delpharm Reims
S.A.S., 10 Rue Colonel Charbonneaux,
51100 Reims, France.
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
®
Dixarit 25 micrograms Tablets;
PL: 18799/2811
POM
Leaflet date: 22.02.2016

PACKAGE LEAFLET:
PATIENT INFORMATION LEAFLET

Clonidine
Hydrochloride
25 micrograms
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.
The name of your medicine is Clonidine
Hydrochloride 25 micrograms Tablets but it
will be referred as Clonidine throughout
this leaflet.
In this leaflet:
1. What Clonidine is and what it is used
for
2. Before you take Clonidine
3. How to take Clonidine
4. Possible side effects
5. How to store Clonidine
6. Further information
1. WHAT CLONIDINE IS AND IT IS
USED FOR
Clonidine contains 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 is 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
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.
As you may get dry eyes whilst taking this
medicine, this may be a problem if you
wear contact lenses.
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

Clonidine is not recommended for children.
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.
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 heart beat
• 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

Not known
• Confusion, loss of libido
• Blurred vision
• Abnormally slow heart beat
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 Yellow Card Scheme Website
at: 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. The blister
strips should be kept in the outer
carton.
Do not take your tablets after the expiry
date which is stated on the carton and
blister labels after ‘Exp’. 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 protect the
environment.
6. FURTHER INFORMATION
What Clonidine contains
The active substance in Clonidine is
clonidine hydrochloride.
Each coated tablet contains 25 micrograms
of clonidine hydrochloride.
The other ingredients are: calcium
hydrogen phosphate anhydrous, lactose
monohydrate, maize starch, colloidal
anhydrous silica, povidone, starch maize
soluble, indigo carmine (E132),
magnesium stearate, sucrose, talc, acacia,
titanium dioxide (E171), macrogol,
carnauba wax and white beeswax.
What Clonidine looks like and contents
of the pack
Clonidine is blue, sugar-coated, biconvex
shaped tablets. Clonidine is available in
blister packs of 112 tablets.
Manufactured by: Delpharm Reims
S.A.S., 10 Rue Colonel Charbonneaux,
51100 Reims, France.
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Clonidine Hydrochloride 25 micrograms
Tablets;
PL: 18799/2811
POM
Leaflet date: 22.02.2016

Expand view ⇕

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