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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.

30.04.2015

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.

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PAN Black

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11.5pt

Min. font size :

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

PPM SKU Description : PI DIXARIT 0,025MG 112 GB
160 x 420 mm
475
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.
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

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
HPRA Pharmacovigilance
Earlsfort Terrace
IRL – Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
5. HOW TO STORE DIXARIT TABLETS
Keep out of the reach and sight of
children.
The tablets should be stored below
25°C and the blister strips should be
kept in the outer carton.
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.
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 tablet contains
25 micrograms.
• The other ingredients are: calcium
hydrogen phosphate anhydrous,
lactose monohydrate, maize starch,
colloidal anhydrous silica, povidone,
Uncommon (affects less than 1 in 100
maize starch soluble, indigo carmine
people, more than 1 in 1,000 people)
(E132), magnesium stearate, sucrose,
• Problems with understanding what is talc, acacia, titanium dioxide (E171),
happening around you, hallucinations, macrogol, carnauba wax and white
nightmares
beeswax.
• Your hands and feet feeling different
(‘altered sensation’)
What DIXARIT looks like and contents
• Regular unusually slow heart beat
of the pack
• Raynaud’s phenomenon (a problem DIXARIT tablets are blue, biconvex,
with circulation to the fingers and sugar-coated tablets.
toes)
• Itching, rash, urticaria (nettle rash)
DIXARIT tablets are available in blister
• A feeling of discomfort and fatigue packs of 112 tablets.
(‘malaise’)
Marketing Authorisation Holder and
Rare (affects less than 1 in 1,000
Manufacturer
p
people, more than 1 in 10,000 eople)
The Marketing Authorisation for
• Breast growth (‘gynaecomastia’) in DIXARIT is held by:
men
• Dry eyes
Boehringer Ingelheim Limited,
• Irregular heartbeat
Ellesfield Avenue, Bracknell, Berkshire,
• Drying out of the lining of the nose
RG12 8YS, United Kingdom
• Pseudo-obstruction of the large
bowel, which causes colicky pain, and the tablets are manufactured at:
vomiting and constipation. Contact
your doctor straight away if you have Delpharm Reims S.A.S.
all these side effects.
10 Rue Colonel Charbonneaux,
• Hair loss
51100 Reims, France
• Increase in your blood sugar
This leaflet was revised in May 2015.
Not known
• Confusion, loss of libido
©Boehringer Ingelheim Limited 2015
• Blurred vision
• Abnormally slow heart beat

316647-012

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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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