Hybloc
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
19-04-2020
Summary of Product characteristics
(SPC)
19-04-2020
Active ingredient:
Labetalol hydrochloride 100mg; ; Labetalol hydrochloride 100mg
Available from:
Viatris Limited
INN (International Name):
Labetalol hydrochloride 100 mg
Dosage:
100 mg
Pharmaceutical form:
Film coated tablet
Composition:
Active: Labetalol hydrochloride 100mg Excipient: Carnauba wax Lactose monohydrate Magnesium stearate Maize starch Opaspray orange K-1R-2433 Pregelatinised maize starch Sodium starch glycolate Active: Labetalol hydrochloride 100mg Excipient: Carnauba wax Diethyl phthalate Ethanol Hypromellose E-15 Lactose monohydrate Magnesium stearate Maize starch Opaspray orange K-1R-2433 Pregelatinised maize starch Purified water Sodium starch glycolate
Units in package:
Bottle, plastic, 100 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Olon SpA
Product summary:
Package - Contents - Shelf Life: Bottle, plastic, - 100 tablets - 36 months from date of manufacture stored at or below 25°C
Authorization date:
1985-01-31
Patient Information leaflet
Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
HYBLOC
_LABETALOL HYDROCHLORIDE FILM-COATED TABLETS_
_50 MG, 100 MG AND 200 MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking HYBLOC.
This leaflet answers some common
questions about HYBLOC.
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 taking HYBLOC
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 HYBLOC IS
USED FOR
Your HYBLOC tablets contain the
active ingredient labetalol
hydrochloride. It belongs to a group
of medicines known as beta
blockers. It works by changing the
body's response to some nerve
impulses. As a result, it widens
blood vessels in the body causing
blood pressure to fall.
HYBLOC is used to treat
High blood pressure
(hypertension)
Chest pain (angina
pectoris) in patients who
also suffer from high blood
pressure.
Your doctor may, however,
prescribe HYBLOC for another
reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY HYBLOC
HAS BEEN PRESCRIBED FOR YOU.
There is no evidence that HYBLOC
is addictive.
HYBLOC is available on
prescription from your doctor.
There is not enough information to
recommend the use of HYBLOC for
children.
BEFORE YOU TAKE
HYBLOC
_WHEN YOU MUST NOT TAKE_
_IT_
DO NOT TAKE HYBLOC IF YOU HAVE
AN ALLERGY TO:
any medicine containing
labetalol hydrochloride.
any of the ingredients listed
at the end of this leaflet.
Some of the 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 HYBLOC IF:
You have certain other
heart problems, including
uncontrolled heart failure
You have a very slow heart
Read the complete document
Summary of Product characteristics
Page 1 of 8 NEW ZEALAND DATA SHEET
HYBLOC
1. PRODUCT NAME
HYBLOC, 50 mg, 100 mg or 200 mg, film coated tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 50 mg, 100 mg or 200 mg of labetalol.
HYBLOC tablets contain lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
HYBLOC 50 mg Tablets: Orange film coated, biconvex tablets, 7/32”
(5.6 mm) diameter, imprinted
LB on one side and blank on the other side
HYBLOC 100 mg Tablets: Orange film coated biconvex tablets, 9/32”
diameter, imprinted ‘LB’ over
‘100’ on one side and blank on the other side
HYBLOC 200 mg Tablets: Orange film coated biconvex tablet, 3/8”
diameter, imprinted ‘LB’ over
‘200’ on one side and blank on the other side
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
HYBLOC tablets are indicated for the treatment of all forms of
hypertension, and all grades of
hypertension (mild, moderate and severe) when oral antihypertensive
therapy is desirable.
HYBLOC tablets are also indicated for the treatment of patients with
angina pectoris coexisting with
hypertension.
_4.2 _
_DOSE AND METHOD OF ADMINISTRATION _
DOSE
_ADULTS _
Treatment may start with one 100 mg tablet twice daily but in some
patients, including those already
being treated with antihypertensive medicines, the elderly, and those
of low body weight and for
patients with newly diagnosed mild hypertension one 50 mg tablet twice
daily may be more
appropriate. The first dose is best taken at night before retiring.
If the blood pressure is not controlled by the initial dosage,
increases should be made at intervals of
one to two weeks. By prescribing tablets of increasing strength, the
dose can be maintained until a
total daily dose of 800 mg is reached. Daily doses of up to 2400 mg
have been given in the treatment
Page 2 of 8
of severe and refractory hypertension. In such patients it is
preferable to administer labetalol three
or four times daily. Blood pressure should be monitored regularly and
the dose adju
Read the complete document
