Eprosartan 400mg tablets

Country: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Eprosartan mesilate

Disponibbli minn:

A A H Pharmaceuticals Ltd

Kodiċi ATC:

C09CA02

INN (Isem Internazzjonali):

Eprosartan mesilate

Dożaġġ:

400mg

Għamla farmaċewtika:

Oral tablet

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 02050502; GTIN: 5025903012221

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE USER
Eprosartan 300mg
Film-coated Tablets
Eprosartan 400mg
Film-coated Tablets
Eprosartan 600mg
Film-coated Tablets
eprosartan mesilate
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.
WHAT IS IN THIS LEAFLET:
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
1. WHAT EPROSARTAN IS AND WHAT IT IS USED FOR
Eprosartan 300mg, 400mg and 600mg film-coated tablets contains
a medicine called eprosartan mesilate. This belongs to a group of
medicines called ‘angiotensin II receptor antagonists’.
This medicine is used to treat high blood pressure, also called
hypertension.
The main cause of high blood pressure is narrowing of the blood
vessels.
This increases the amount of work your heart must do to pump blood
around your body. You may not feel unwell, but if high blood pressure
is
not treated, it can lead to heart disease and stroke.
HOW EPROSARTAN WORKS:
Angiotensin II is a chemical found in the body which makes your
blood vessels contract. This makes it more difficult for blood to pass
through them
This causes your blood pressure to rise
Eprosartan works by preventing the chemical, angiotensin II, from
causing your blood vessels to contract. This has the effect of
lowering
your blood pressure.
You may be given Eprosartan on its own or with another medicine used
to treat high blood pressure. Using both medicines together will lower
your b

Karatteristiċi tal-prodott

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