ACERIL 50

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

CAPTOPRIL

Tilgjengelig fra:

DEXCEL LTD, ISRAEL

ATC-kode:

C09AA01

Legemiddelform:

TABLETS

Sammensetning:

CAPTOPRIL 50 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

DEXCEL LTD, ISRAEL

Terapeutisk gruppe:

CAPTOPRIL

Terapeutisk område:

CAPTOPRIL

Indikasjoner:

-HypertensionCongestive Heart Failure-insulin dependent diabetic nephropathy in hypertensive and non hypertensive patients in cases where the serum creatinine level < 2.5 mg/dl.-improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction less or equals to 40% and to reduce the incidence of overt heart failure and subsequent hospitalization for congestive heart failure in these patients.

Autorisasjon dato:

2022-07-31

Informasjon til brukeren

PATIENT PACKAGE INSERT
ACCORDING TO PHARMACISTS’ REGULATIONS (PREPARATIONS
)
– 1986
This medicine can be sold with a physician’s prescription
only
ACERIL
®
12.5, 25, 50 MG, TABLETS
Each tablet contains Captopril 12.5, 25 or 50 mg respectively.
Inactive ingredients and allergens in the medicine
–
see section 6 "Additional information" and in
section 2 "Important information about some of the ingredients of the
medicine".
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains concise
information about the medicine. If you have any further questions, ask
the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
you think that their medical condition is the same as yours.
1.
WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the treatment of high blood pressure,
congestive heart failure, diabetic
nephropathy (kidney damage caused by diabetes), for treatment after a
heart attack.
THERAPEUTIC GROUP: Angiotensin Converting Enzyme (ACE) inhibitors.
Angiotensin converting enzyme inhibitors work by dilating your blood
vessels, so that it will be
easier for your heart to pump blood through them.
2.
BEFORE USING THE MEDICINE:
DO NOT USE THE MEDICINE IF:

You are hypersensitive (allergic) to the active ingredient
(captopril), to any of the other
ingredients this medicine contains (see section 6) or to other
medicines of the ACE inhibitors
group.

You have ever had a reaction which included swelling of the hands,
lips, face or tongue where
the cause was unknown.

You have diabetes or impaired kidney function and you are treated with
a blood pressure
lowering medicine containing aliskiren.

You are more than three months pregnant (it is also better to avoid
taking ACERIL in early
pregnancy
–
see section "Pregnancy and breastfeeding").

If you have taken or are currently taking sacubitril/valsartan, a
medicine used to treat a type of
long-term (chronic) heart failure in adults, as the risk of angi

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Aceril 12.5, 25, 50
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Aceril 12.5
Each tablet contains 12.5 mg of Captopril.
Excipient with known effect:
Each tablet contains approximately 17 mg of lactose.
Aceril 25
Each tablet contains 25 mg of Captopril.
Excipient with known effect:
Each tablet contains approximately 33 mg of lactose.
Aceril 50
Each tablet of contains 50 mg of Captopril.
Excipient with known effect:
Each tablet contains approximately 67 mg of lactose.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Tablet.
White, round, biconvex, scored tablet.
The score line is not intended for breaking the tablet.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Hypertension

Congestive heart failure

Insulin depended diabetic nephropathy in hypertensive and
non-hypertensive patients in
cases where the serum creatinine level < 2.5 mg/dl.

Improve survival following myocardial infarction in clinically stable
patients with left ventricular
dysfunction manifested as an ejection fraction less or equals to 40%
and to reduce the
incidence of overt heart failure and subsequent hospitalization for
congestive heart failure in
these patients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Dose should be individualised according to patient's profile (see
section 4.4) and blood pressure
response. The recommended maximum daily dose is 150 mg.
Aceril may be taken before, during and after meals.
ADULTS
_Hypertension: _Treatment with captopril should be at the lowest
effective dose which should be
titrated according to the needs of the patient.
The recommended starting dose is 25-50 mg daily in two divided doses.
The dose may be
increased incrementally, with intervals of at least 2 weeks, to
100-150 mg/day in two divided
doses as needed to reach target blood pressure. Captopril can be used
alone or with other
antihypertensive agents (see sections 4.3, 4.4, 4.5 and 5.1). A
once-daily dosing regimen may be