Eprosartan 300mg tablets

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Eprosartan mesilate

Beszerezhető a:

A A H Pharmaceuticals Ltd

ATC-kód:

C09CA02

INN (nemzetközi neve):

Eprosartan mesilate

Adagolás:

300mg

Gyógyszerészeti forma:

Oral tablet

Az alkalmazás módja:

Oral

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 02050502

Betegtájékoztató

TEVA UK
26 JANUARY 2015
Version:
3
TEVA UK
26 JANUARY 2015
Version:
3
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 pres

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Eprosartan 300mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Film-coated Tablet contains eprosartan mesilate equivalent to
300mg
eprosartan free base
Excipient(s) with known effect:
Each Film-coated Tablet contains 27.25mg of lactose anhydrous
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablets
White to off white, oval shaped, biconvex film-coated tablets debossed
with “I” on
one side and “120” on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Eprosartan is indicated for the treatment of essential hypertension
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 600mg eprosartan once daily.
The dose may be increased to 800mg eprosartan once daily if further
response
is required. 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.
Eprosartan may be taken with or without food.
_Geriatric patients _
No dose adjustment is required in the elderly_._
_Dosage in hepatically impaired patients _
There is limited experience in patients with hepatic insufficiency
(see section
4.3)
_Dosage in renally impaired patients _
In patients with moderate or severe renal impairment (creatinine
clearance
<60ml/min), the daily dose should not exceed 600mg.
_Paediatric population _
Eprosartan is not recommended for use in children and adolescents due
to lack
of data on safety and efficacy.
Method of the administration
For oral administration
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1
Second and third trimester of pregnancy (see sectio