Dixarit 25microgram tablets

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Clonidine hydrochloride

Доступно од:

Boehringer Ingelheim Ltd

АТЦ код:

N02CX02

INN (Међународно име):

Clonidine hydrochloride

Дозирање:

25microgram

Фармацеутски облик:

Oral tablet

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 04070402; GTIN: 5012816027251

Информативни летак

PACKAGE LEAFLET:
INFORMATION FOR THE USER
DIXARIT
® TABLETS
25 MICROGRAMS
(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.
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 p

Карактеристике производа

OBJECT 1
DIXARIT
Summary of Product Characteristics Updated 07-Jul-2014 | Boehringer
Ingelheim Limited
1. Name of the medicinal product
Dixarit
®
Tablets 25 micrograms
2. Qualitative and quantitative composition
Each tablet contains clonidine hydrochloride 25 micrograms.
For Excipients, see 6.1.
3. Pharmaceutical form
Coated tablet.
Blue, biconvex, sugar-coated tablet.
4. Clinical particulars
4.1 Therapeutic indications
a) The prophylactic management of migraine or recurrent vascular
headache.
b) The management of vasomotor conditions commonly associated with the
menopause and characterised
by flushing.
4.2 Posology and method of administration
_ADULTS:_
Initially 2 tablets twice daily. If after two weeks there has been no
remission, increase to 3 tablets twice
daily.
The duration of treatment depends upon the severity of the condition.
If symptoms continue to occur the patient should be informed that it
may take 2 - 4 weeks until Dixarit is
fully effective.
_ELDERLY:_
No specific information on the use of this product in the elderly is
available.
Clinical trials have included patients over 65 years and no adverse
reactions specific to this age group
have been reported.
_PAEDIATRIC POPULATION:_
There is insufficient evidence for the application of clonidine in
children and adolescents younger than 18
years. Therefore the use of clonidine is not recommended in paediatric
subjects under 18 years.
_PATIENTS WITH RENAL IMPAIRMENT_
Dixarit
®
should be used with caution in patients with renal insufficiency.
Careful monitoring of blood
pressure is required.
4.3 Contraindications
Dixarit should not be used in patients with severe bradyarrhythmia
resulting from either sick-sinus
syndrome or AV block of 2nd or 3rd degree, or in patients with known
hypersensitivity to the active
ingredient, clonidine, or other components of the product.
In case of rare hereditary conditions that may be incompatible with an
excipient of the product (please
refer to section 4.4 Special Warnings and Precautions for Use) the use
of the produc