DIXARIT TABLETS

Active substance: CLONIDINE HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Dixarit® Tablets
25 micrograms

AbCD

(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.

03.04.2014

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
In this leaflet:
imipramine or mirtazapine
1. What DIXARIT Tablets are and what • Medicines for severe mental illness
they are used for
such as schizophrenia. These are
2. Before you take DIXARIT Tablets
also known as ‘antipsychotics’ and
3. How to take DIXARIT Tablets
include chlorpromazine
4. Possible side effects
• Beta blockers such as atenolol
5. How to store DIXARIT Tablets
• Water tablets (‘diuretics’) such as
6. Further information
frusemide
• Alpha blockers such as prazosin or
1. WHAT DIXARIT TABLETS ARE AND doxazosin. These can also be used for
WHAT THEY ARE USED FOR
prostate problems in men
DIXARIT Tablets contain a medicine
• Vasodilators such as diazoxide or
called clonidine. This belongs to a
sodium nitroprusside
group of medicines called vasodilators. • Cardiac glycosides such as digoxin
Vasodilators widen the blood vessels
• Medicines to lower blood pressure
and this helps the blood to flow more
If you are not sure if any of the above
easily.
apply to you, talk to your doctor or
pharmacist before taking DIXARIT.
DIXARIT Tablets are used to prevent
migraine attacks and similar types of
Taking DIXARIT with food and drink
headache. It is also used to prevent hot You may feel drowsy while taking
flushes that may occur in women
DIXARIT. Drinking alcohol while taking
during the menopause (change of life). DIXARIT can make this worse.
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.
As you may get dry eyes whilst taking
this medicine, this may be a problem if
you wear contact lenses.

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.

315745-011

P001489
011
09.04.2014
PAN Black

315745-011
Min. font size :

11.5pt
V4.0 01/OCT/2012 (please do not change or remove it)

PPM SKU Description : PI DIXARIT 0,025MG 112 SUCTA GB
160 x 420 mm
186
PR31

F

6

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.

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 (see details below).
By reporting side effects you can help
provide more information on the safety
of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
FREEPOST
Pharmacovigilance Section
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Ireland
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie
5. HOW TO STORE DIXARIT TABLETS
Keep out of the reach and sight of
children.

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

The tablets should be stored below
25°C and the blister strips should be
kept in the outer carton.

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

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.

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

Do not use DIXARIT after the expiry
date which is stated on the packaging.
The expiry date refers to the last day of
that month.

6. FURTHER INFORMATION
What DIXARIT contains
• The active substance is clonidine
hydrochloride. Each tablet contains
25 micrograms.
• The other ingredients are: calcium
hydrogen phosphate anhydrous,
lactose monohydrate, maize starch,
colloidal anhydrous silica, povidone,
maize starch 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 tablets are blue, biconvex,
sugar-coated tablets.
DIXARIT tablets are available in blister
packs of 112 tablets.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation for
DIXARIT is held by:
Boehringer Ingelheim Limited,
Ellesfield Avenue, Bracknell, Berkshire,
RG12 8YS, United Kingdom
and the tablets are manufactured at:

Delpharm Reims S.A.S.
10 Rue Colonel Charbonneaux,
51100 Reims, France
This leaflet was revised in April 2014.
©Boehringer Ingelheim Limited 2014
315745-011

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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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