Nadolol

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Nadolol 80mg;  ;  

Available from:

Clinect NZ Pty Limited

INN (International Name):

Nadolol 80 mg

Dosage:

80 mg

Pharmaceutical form:

Tablet

Composition:

Active: Nadolol 80mg     Excipient: Colloidal silicon dioxide Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose

Units in package:

Blister pack, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Signa SA de CV

Therapeutic indications:

Prophylaxis of angina pectoris

Product summary:

Package - Contents - Shelf Life: Blister pack, - 30 tablets - 24 months from date of manufacture stored at or below 30°C protect from light - Bottle, plastic, HDPE bottle, white PP lift n peel cap - 50 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE bottle, blue PP lift n peel cap - 50 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE bottle, white PP lift n peel cap - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE bottle, blue PP lift n peel cap - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE bottle, white PP lift n peel cap - 500 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE bottle, blue PP lift n peel cap - 500 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

1992-11-05

Patient Information leaflet

1
New Zealand Consumer Medicine Information
APO-NADOLOL
_NADOLOL _
40mg and 80mg Tablets
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Apo-Nadolol.
This leaflet answers some common questions about Apo-Nadolol. 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
Apo-Nadolol against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT APO-NADOLOL IS USED FOR
The name of your medicine is Apo-Nadolol tablet. It contains the
active ingredient
Nadolol. It belongs to a group of medicines called beta-blockers. It
works by relaxing
blood vessels and slowing heart rate to improve blood flow or lowering
your blood
pressure.
Apo-Nadolol is used to treat:
•
Chest pain (angina)
•
High blood pressure (hypertension)
•
Irregular heart beat (arrhythmias)
•
Migraine headaches
•
Overactive thyroid gland
Your doctor may have prescribed Apo-Nadolol for another reason.
Ask your doctor if you have any questions about why Apo-Nadolol has
been
prescribed for you.
This medicine is available only with a doctor's prescription.
There is no evidence that this medicine is addictive.
Apo-Nadolol should not be administered to children.
2
BEFORE YOU USE APO-NADOLOL
_WHEN YOU MUST NOT USE IT _
Do not use Apo-Nadolol if:
•
YOU ARE HYPERSENSITIVE TO, OR HAVE HAD AN ALLERGIC REACTION TO NADOLOL
OR
ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET.
Symptoms of an allergic reaction may include: cough, shortness of
breath,
wheezing, difficulty breathing or tightness in chest; swelling of the
face, lips,
tongue, throat or other parts of the body; rash, itching or hives on
the skin;
fainting; or hay fever-like symptoms.
IF YOU THINK YOU ARE HAVING AN ALLERGIC REACTION, DO NOT TAKE ANY MORE
OF
THE MEDICINE

Summary of Product characteristics

NEW ZEALAND DATA SHEET
APO-NADOLOL
1.
APO-NADOLOL (40MG AND 80MG)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nadolol 40mg
Nadolol 80mg
Excipient with known effect
_ _
_Lactose: _Apo-Nadolol 40mg and 80mg tablets contain Lactose. If you
have been told
by your doctor that you may have intolerance to some sugars, please
contact your
doctor before taking this medicinal product.
_Gluten:_ Apo-Nadolol 40mg and 80mg tablets are gluten free.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
APO-NADOLOL 40mg tablets are white, round, biconvex tablets, 8.0mm
diameter,
identified APO over breakline over N40 on one side. Each tablet
contains 40mg nadolol
and typically weighs 200mg.
APO-NADOLOL 80mg tablets are white, round, biconvex tablets, 11.2mm
diameter,
identified APO over breakline over N80 on one side. Each tablet
contains 80mg nadolol
and typically weighs 400mg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Prophylaxis of angina pectoris
•
Management of mild to moderate hypertension. Although nadolol may be
used
alone,
it
is
more
commonly
prescribed
in
combination
with
other
medicines,
particularly thiazide diuretics. Nadolol is not recommended for the
emergency
treatment of hypertensive crises.
•
Treatment of cardiac arrhythmias
•
Prophylaxis of common and classic migraine headache
•
Symptomatic treatment of hyperthyroidism and preoperative preparation
of patients
for thyroidectomy. It may be used with conventional antithyroid
therapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
Angina Pectoris
The initial starting dose is 40mg once daily. This may be increased by
40mg at weekly
intervals until an optimal response is obtained or excessive
bradycardia exceeding 55
beats/minute results. Most patients will respond to 160mg or less per
day.
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 12
APO-NADOLOL
Hypertension
The initial starting dose is 40mg once daily either alone or in
combination with another
anti-hypertensive agent, usually a