DIXARIT 0.025 Milligram Tablets

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

CLONIDINE HYDROCHLORIDE

Доступно од:

Boehringer Ingelheim Limited

АТЦ код:

N02CX02

INN (Међународно име):

CLONIDINE HYDROCHLORIDE

Дозирање:

0.025 Milligram

Фармацеутски облик:

Tablets

Тип рецептора:

Product subject to prescription which may be renewed (B)

Терапеутска област:

Other antimigraine preparations

Статус ауторизације:

Authorised

Датум одобрења:

1987-05-07

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

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dixarit Tablets 25 micrograms
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains clonidine hydrochloride 25 micrograms.
Excipients with known effect: Each tablet contains 16.85 mg lactose and 20.388 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet
Blue, biconvex, sugar-coated tablets.
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 (INCLUDING ELDERLY PATIENTS):
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.
_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.
_RENAL INSUFFICIENCY_
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 2
nd
or 3
rd
degree, or in patients with known hypersensitivity to the active ingredient, clonidine, or other
components of the product.
HEALTH PRODUCTS REGULATORY AUTHORITY
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