Lisinopril 20mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Lisinopril

Disponível em:

Lupin Healthcare (UK) Ltd

Código ATC:

C09AA03

DCI (Denominação Comum Internacional):

Lisinopril

Dosagem:

20mg

Forma farmacêutica:

Oral tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 02050501; GTIN: 8901107000875

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
LISINOPRIL 2.5 MG, 5 MG, 10 MG AND 20 MG TABLETS
LISINOPRIL DIHYDRATE
PLEASE 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 Lisinopril Tablets are and what they are used for.
2 What you need to know before you take Lisinopril Tablets.
3 How to take Lisinopril Tablets.
4 Possible side effects.
5 How to store Lisinopril Tablets.
6 Contents of the pack and other information.
RE USED FOR
1.
WHAT LISINOPRIL TABLETS ARE AND WHAT THEY ARE USED FOR
Lisinopril belongs to a group of medicines called ACE inhibitors
(Angiotensin Converting
Enzyme inhibitors). Lisinopril works by widening your blood vessels,
which helps reduce
your blood pressure and makes it easier for your heart to pump blood
to all parts of your
body. Your doctor has prescribed Lisinopril for one of the following
reasons:
• Your blood pressure is too high (hypertension).
• You have a heart condition known as symptomatic heart failure,
where the heart does not
pump your blood around your body as well as it should.
• You have had a heart attack (myocardial infarction) that may lead
to a weakening of your
heart. Lisinopril slows the weakening down.
• You have kidney problems related to your diabetes and high blood
pressure.
• Lisinopril is recommended in children (above 6 years old) only for
the treatment of high
blood pressure (hypertension).
• Lisinopril should not be used in children with severe kidney
impairment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LISINOPRIL TABLETS
DO NOT TAKE

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lisinopril 20 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
20mg: Each tablet contains 20mg of lisinopril as the dihydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
20mg: Round, pale pink coloured, uncoated, biconvex tablet with
‘20’ on one
side and plain on other side
Diameter: 8.00mm x 3.90mm
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HYPERTENSION
Treatment of hypertension
HEART FAILURE
Treatment of symptomatic heart failure
ACUTE MYOCARDIAL INFARCTION
Short-term (6 weeks) treatment of haemodynamically stable patients
within 24
hours of an acute myocardial infarction
RENAL COMPLICATIONS OF DIABETES MELLITUS
Treatment of renal disease in hypertensive patients with Type 2
diabetes
mellitus and incipient nephropathy (see section 5.1)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Lisinopril should be administered orally in a single daily dose. As
with all other
medication taken once daily, lisinopril should be taken at
approximately the same
time each day. The absorption of lisinopril tablets is not affected by
food.
The dose should be individualised according to patient profile and
blood pressure
response (see section 4.4).
HYPERTENSION
Lisinopril may be used as monotherapy or in combination with other
classes of
antihypertensive therapy (see sections 4.3, 4.4, 4.5 and 5.1).
Starting dose
In patients with hypertension the usual recommended starting dose is
10 mg. Patients
with a strongly activated renin-angiotensin-aldosterone system (in
particular,
renovascular hypertension, salt and /or volume depletion, cardiac
decompensation, or
severe hypertension) may experience an excessive blood pressure fall
following the
initial dose. A starting dose of 2.5-5 mg is recommended in such
patients and the
initiation of treatment should take place under medical supervision. A
lower starting
dose is required in the presence of renal impairment (see Table 1
below).
Maintenance dose
The usual effective mainte