Bramox 5mg tablets

Страна: Великобритания

Език: английски

Източник: myHealthbox

Активна съставка:

midodrine hydrochloride

Предлага се от:

Brancaster Pharma Limited

АТС код:

C01CA17

INN (Международно Name):

midodrine hydrochloride

дозиране:

5mg

Лекарствена форма:

Tablets

Начин на приложение:

Oral use

Броя в опаковка:

100 tablets

Вид предписание :

POM - Prescription Only Medicine

Произведено от:

Cross Vetpharm Group UK Limited

Терапевтична група:

Cardiac Therapy, Adrenergic and dopaminergic agents

Терапевтични показания:

indicated in adults for the treatment of severe orthostatic hypotension due to autonomic dysfunction when corrective factors have been ruled out and other forms of treatment are inadequate

Статус Оторизация:

Authorised

Дата Оторизация:

2015-03-18

Листовка

210 mm
35 mm
280 mm
By keeping your head elevated at night 
the potential risk of your blood pressure 
rising when you lie down is reduced.
You should be monitored by your doctor 
for possible secondary effects 
of high blood pressure.
ALSO TALK TO YOUR DOCTOR IF YOU: 
• have a serious disorder of the nervous system (autonomic nervous
system  
  disorders), since taking this medicine may lead to a further drop
in blood  
  pressure when you stand up. If this occurs, further treatment with
this    
  medicine should be stopped.
• suffer from problems with your circulation.
• suffer from a disease of the prostate, as you may find passing
urine is    
  difficult when taking this medicine.
You should have your kidney function and blood pressure checked by
your 
doctor before you start using this medicine. During treatment with
this 
medicine, your blood pressure will be checked from time to time, and
if 
necessary your dose adjusted. 
It is important that you immediately report symptoms related to high
blood 
pressure, such as elevated heart rate, headache and blurred vision.
Your 
doctor will then decide whether to adjust dosage or discontinue your 
treatment with Bramox tablets.
If any of the warnings apply to you, or have in the past, talk to your
doctor.
CHILDREN AND ADOLESCENTS 
Do not give this medicine to children and adolescents under the age
18 
because the safety and efficacy of Bramox tablets in this age group
have 
not been established.
OTHER MEDICINES AND BRAMOX TABLETS 
Tell your doctor or pharmacist if you are taking, have recently taken
or might 
take any other medicines.
IN PARTICULAR, TELL YOUR DOCTOR OR PHARMACIST  
IF YOU ARE TAKING ANY OF THE FOLLOWING:
• Reserpine and guanethidine (medicines used to reduce high blood 
  pressure), antihistamines (used to treat allergies), hormones for
the thyroid 
  (used when the thyroid is not working properly), tricyclic
antidepressants 
  and MAO-inhibitors (both used to treat depression) and other

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Bramox 5 mg tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each tablet contains 5 mg of midodrine hydrochloride. 

Excipients with known effect: 
Each tablet contains 0.2 mg Sunset Yellow FCF (E110). 

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Tablet. 

Orange, round tablet of diameter 7 mm. Plain on one side with
“MID” debossed 
above the score line and “5” debossed below the score line
on the other side. 

The scoreline is only to
facilitate breaking for ease of swallowing and not to divide 
into equal doses. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
Bramox 5 mg tablets are indicated in adults for the treatment
of severe orthostatic 
hypotension due to autonomic dysfunction when corrective factors
have been ruled 
out and other forms of treatment are inadequate. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Posology 

Initial dose: 2.5 mg three times a day (Bramox 2.5 mg tablets are
also available). 
Depending on the results
of supine and standing blood pressure recordings, this dose 
may be increased weekly up to a dose of 10 mg three times a
day. This is the usual 
maintenance dosage. 

A careful evaluation of the response to treatment and of the
overall balance of the 
expected benefits and risks needs to be undertaken before
any dose increase and 
advice to continue therapy for long periods. 

The last daily dose should be taken at least 4 hours before
bedtime in order to prevent 
supine hypertension (see also section 4.4). 

Bramox 5 mg tablets may be taken with food (see section 5.2). 

_Paediatric population _

The safety and efficacy of midodrine in children have not been
established. No data 
are available.  

_Elderly population _
_ _
There is limited data on dos