Eprosartan 400mg tablets

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Eprosartan mesilate

Доступна с:

Teva UK Ltd

код АТС:

C09CA02

ИНН (Международная Имя):

Eprosartan mesilate

дозировка:

400mg

Фармацевтическая форма:

Oral tablet

Администрация маршрут:

Oral

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 02050502; GTIN: 5017007082712

тонкая брошюра

TEVA UK Ref: FEBRUARY 2015
Version:
4
T
Version:
4
EPROSARTAN
300 MG, 400 MG AND 600 MG
FILM-COATED TABLETS
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.
• 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. This
includes any possible side effects not
listed in this leaflet. See section 4.
1. WHAT EPROSARTAN IS AND WHAT IT IS
USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE EPROSARTAN
3. HOW TO TAKE EPROSARTAN
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE EPROSARTAN
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
WHAT EPROSARTAN IS AND
WHAT IT IS USED FOR
Eprosartan contains the active
substance eprosartan.
Eprosartan belongs to a group of
medicines called ‘angiotensin
II
receptor antagonists’. It blocks the
action of a substance in your body
called ‘angiotensin
II
’. This substance
causes your blood vessels to narrow.
This makes it more difficult for the
blood to flow through the vessels and
so your blood pressure increases. By
blocking this substance, the vessels
relax and your blood pressure decreases.
Eprosartan is used to treat high blood
pressure (hypertension).
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE
EPROSARTAN
DO NOT TAKE EPROSARTAN:
• if you are allergic to eprosartan or
any of the other ingredients of this
medicine (listed in Section 6)
• if you have SEVERE liver disease
• if you have SEVERE problems with the
blood flow in your kidneys or serious
restriction to blood flow in a single
functioning kidney
• if you are more than 3 months
pregnant (it is also better to avoid
eprosartan in early pregnancy – see
pregnancy section)
• if you have diabetes or impaired
kidney function and you are treated
with a blood pressure lowering
medic

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Eprosartan 400 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 490.56 mg eprosartan mesilate
equivalent to 400 mg
eprosartan.
Excipient(s) with known effect:
28 mg lactose monohydrate per tablet.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Peach coloured, oval shaped, biconvex film-coated tablets. Tablets are
approximately
18 x 7 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Eprosartan is indicated in adults for the treatment of essential
hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 600 mg eprosartan once daily.
Achievement of maximal blood pressure reduction in most patients may
take 2 to 3
weeks of treatment.
Eprosartan may be used alone or in combination with other
anti-hypertensives (see
sections 4.3, 4.4, 4.5 and 5.1). In particular, addition of a
thiazide-type diuretic such
as hydrochlorothiazide or a calcium channel blocker such as sustained
release
nifedipine has been shown to have an additive effect with eprosartan.
Duration of treatment is not limited.
_Older people_
No dose adjustment is required in older people.
_Patients with Hepatic impairment _
There is limited experience in patients with hepatic insufficiency
_(see section 4.3, _
_Contraindications)_.
_ _
_Patients with Renal impairment _
In patients with moderate or severe renal impairment (creatinine
clearance <60
ml/min), the daily dose should not exceed 600 mg.
_Paediatric population _
Eprosartan 400 mg Film-coated Tablets is not recommended for use in
children and
adolescents. The safety and efficacy of eprosartan in children and
adolescents under
18 years have not been established. No data are available.
Method of administration
Oral use. Eprosartan may be taken with or without food.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
Severe hepatic impairment.
Secon