Midodrin Evolan 2,5 mg Tablett

Страна: Швеция

Язык: шведский

Источник: Läkemedelsverket (Medical Products Agency)

Активный ингредиент:

midodrinhydroklorid

Доступна с:

Evolan Pharma AB

код АТС:

C01CA17

ИНН (Международная Имя):

midodrinhydroklorid

дозировка:

2,5 mg

Фармацевтическая форма:

Tablett

состав:

midodrinhydroklorid 2,5 mg Aktiv substans

Тип рецепта:

Receptbelagt

Обзор продуктов:

Förpacknings: Blister, 20 tabletter; Blister, 30 tabletter; Blister, 50 tabletter; Blister, 90 tabletter; Blister, 100 tabletter; Blister, 10 tabletter; Blister, 40 tabletter; Blister, 60 tabletter; Blister, 70 tabletter; Blister, 80 tabletter; Blister, 500 tabletter

Статус Авторизация:

Godkänd

Дата Авторизация:

2017-05-12

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE USER
MIDODRIN EVOLAN 2.5 MG TABLETS
MIDODRIN EVOLAN
5 MG TABLETS
midodrine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, or pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Content of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
The name of your medicine is . It contains the
substance midodrine hydrochloride.
This
belongs
to
a
group
of
medicines
called
adrenergic
and
dopaminergic
agents.
Midodrine
hydrochloride is a medicine that raises your blood pressure and is
used to treat certain severe forms of
low blood pressure in adults when other treatments have not worked.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE :
•
if you are allergic to midodrine hydrochloride or any of the other
ingredients of this medicine
(listed in section 6)
•
if you have high blood pressure
•
if you have a slow pulse
•
if you have difficulty urinating
•
if you have certain forms of cardiovascular disease (ask your doctor
if this applies to you)
•
if you have elevated pressure in the eye (glaucoma) or poor vision as
a result of diabetes
•
if you have an overactive thyroid gland
•
if you have hormonal disorders caused by a tumour in the adrenal
medulla (pheochromocytoma)
•
if you have acute kidney disease or se

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Midodrin Evolan 2.5 mg tablets
Midodrin Evolan 5 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg of midodrine hydrochloride
Each tablet contains 5 mg of midodrine hydrochloride
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Tablet.
White, flat, round tablets embossed with “2.5” 7 mm in diameter.
White, flat, round tablets embossed with “5” 10 mm in diameter.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
is indicated in adults for the treatment of severe
orthostatic hypotension due to
autonomic dysfunction when other forms of treatment and corrective
factors are inadequate.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Initial dose: 2.5 mg three times a day. Depending on the individual
response, the dose may be increased
weekly up to a maximum dose of 10 mg three times a day.
The blood pressure should repeatedly be measured at the start of the
treatment and monitored closely
after each dose increase. An ambulatory 24 h blood pressure
measurement can be considered to optimize
the dosage schedule.
The last daily dose can be lower and should be taken at least 4 hours
before bedtime in order to prevent
supine hypertension (see also section 4.4).
may be taken with or without 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 dosing in the elderly and there are no
specific studies which have focused on a
possible dose reduction in the elderly population. Cautious dose
titration is recommended.
_Patients with renal impairment_
There are no specific studies that have focused on a possible dose
reduction in patients with renal
impairment. A careful dose titration is recommended. Typically,
midodrine is contraindicated in patients
with acute renal impairment or severe renal impairment (see section
4.3).
_Pati