Cardinol LA

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Propranolol hydrochloride 160mg

Disponível em:

Viatris Limited

DCI (Denominação Comum Internacional):

Propranolol hydrochloride 160 mg

Dosagem:

160 mg

Forma farmacêutica:

Modified release capsule

Composição:

Active: Propranolol hydrochloride 160mg Excipient: Gelatin Maize starch Purified talc Shellac Sucrose

Unidades em pacote:

Blister pack, 30 capsules

Classe:

Prescription

Tipo de prescrição:

Prescription

Fabricado por:

Cosma SpA

Indicações terapêuticas:

CARDINOL LA indicated for the following: · Management of angina pectoris. · Control of hypertension. · Long term prophylaxis after recovery from acute myocardial infarction.

Resumo do produto:

Package - Contents - Shelf Life: Blister pack, - 30 capsules - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE with white PP wadded (Cello LDPE & Alcoflex foil) tampertel closure - 100 capsules - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with white PP tamper evident cap and LDPE wad - 100 capsules - 24 months from date of manufacture stored at or below 25°C

Data de autorização:

1984-02-22

Folheto informativo - Bula

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
CARDINOL LA
_PROPRANOLOL HYDROCHLORIDE, MODIFIED RELEASE CAPSULES 160MG_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CARDINOL LA.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT CARDINOL LA
IS USED FOR
CARDINOL LA capsules contain the
active ingredient propranolol
hydrochloride, which belongs to a
group of medicines called beta-
blockers. These medicines work by
changing the body's response to
some nerve impulses, especially in
the heart.
CARDINOL LA is used to lower
blood pressure, help in the
prevention of chest pain (angina)
and for the long-term prevention of
future heart attacks.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribe it
for another reason.
There is no evidence that
CARDINOL LA is addictive.
This medicine is available only with
a doctor’s prescription.
CARDINOL LA is not recommended
for use in children.
BEFORE YOU TAKE
CARDINOL LA
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE CARDINOL LA IF YOU
HAVE AN ALLERGY TO:

propranolol

any of the ingredients listed at
the end of this leaflet

any other similar medicines such
as beta-blockers
Symptoms of an allergic reaction
may include: shortness of breath;
wheezing or difficulty breathing;
swelling of the face, lips, tongue or
other parts of the body; rash, itching
or hives on the skin.
DO NOT TAKE CARDINOL LA IF YOU
HAVE:

asthma or severe breathing
problems

heart problems such as, heart
failure, low blood pressure,
problems with your circulation,
Prinzmetal’s angina or a slow
heart beat

low blood sug

Características técnicas

Page 1 of 9
NEW ZEALAND DATA SHEET
CARDINOL LA
1. PRODUCT NAME
CARDINOL LA, 160mg, modified release capsule.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified release capsule contains 160mg of propranolol
hydrochloride BP.
Excipient with known effect: Sugars
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
CARDINOL LA is presented as size 1 gelatin capsules with a clear
colourless body and opaque,
green cap containing cream and white pellets.
CARDINOL LA capsules contain spheroids of the beta-blocker propranolol
hydrochloride which have
a sustained release coating to provide long action.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
CARDINOL LA is indicated for the following:
1.
Control of hypertension.
2
Management of angina pectoris.
3.
Long term prophylaxis after recovery from acute myocardial infarction.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
ADULTS
_HYPERTENSION_
The starting dose is one capsule daily, taken either morning or
evening. An adequate response is
seen in most patients at this dosage. If necessary, it can be
increased to two capsules and a further
reduction in blood pressure can be attained if a diuretic or other
antihypertensive agent is given in
addition to CARDINOL LA.
_ANGINA_
An adequate response is usually obtained with one capsule daily either
morning or evening,
dependant on patient convenience.
Page 2 of 9
_POST MYOCARDIAL INFARCTION_
Treatment should start between days 5 and 21 after myocardial
infarction with one 40 mg propranolol
tablet four times a day for 2 or 3 days.
In order to achieve maximum compliance, the total daily dosage of 160
mg propranolol may
thereafter be given as a single CARDINOL LA capsule. Compliance is
extremely important as beta-
blockade may have to be continued indefinitely.
_SPECIAL POPULATIONS_
ELDERLY
Evidence concerning the relation between blood level and age is
conflicting. With regard to the
elderly, the optimum dose should be individually determined according
to clinical response.
CHILDREN
CARDINOL LA is not