INDERAL propranolol hydrochloride 40mg tablet bottle

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

propranolol hydrochloride, Quantity: 40 mg

Beschikbaar vanaf:

Atnahs Pharma Australia Pty Ltd

farmaceutische vorm:

Tablet, film coated

Samenstelling:

Excipient Ingredients: carmellose calcium; magnesium stearate; carmine; lactose monohydrate; hypromellose; Gelatin; titanium dioxide; glycerol

Toedieningsweg:

Oral

Eenheden in pakket:

100 tablets

klasse:

Medicine Registered

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

1. Angina pectoris, 2. Hypertension, 3. Prevention of migraine, 4. Cardiac dysrhythmias: certain intrinsic cardiac dysrhythmias; dysrhythmias associated with thyrotoxicosis; anxiety tachycardia; certain drug-induced dysrhythmias (e.g. tachycardia due to digitalis or adrenaline overdosage), 5. Essential tremor, including familial and senile tremor, 6.Phaeochromocytoma (only with concurrent alpha-receptor blockade), 7. Hypertrophic subaortic stenosis, 8. Suspected or definite myocardial infarction, 9. Fallot's Tetralogy.

Product samenvatting:

Visual Identification: Pink, round, biconvex, film-coated tablets. Intagliated on one face with 40 and bisected on the reverse face.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Autorisatie-status:

Registered

Autorisatie datum:

1991-07-11

Bijsluiter

INDERAL
®
I
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D
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®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING INDERAL?
INDERAL contains the active ingredient propranolol hydrochloride .
INDERAL is used to treat or prevent a number of conditions,
most of which are related to the heart. For more information, see
Section 1. Why am I using INDERAL? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE INDERAL?
Do not use if you have ever had an allergic reaction to propranolol
hydrochloride or any of the ingredients listed at the end of the
CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS,
TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO
BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see
Section 2. What should I know before I use INDERAL? in the
full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with INDERAL and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I USE INDERAL?
•
Your doctor will tell you what dose to take.
•
More instructions can be found in Section 4. How do I use INDERAL? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING INDERAL?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
INDERAL.
•
If you are about to be started on any new medicine, remind your doctor
and pharmacist that you are
taking INDERAL.
•
CALL YOUR DOCTOR STRAIGHT AWAY IF YOU have a severe allergic reaction
to foods, medicines or insect
stings, feel light-headed, dizzy or faint, and this problem gets worse
or continues, plan to have surgery
(even at the dentist) that needs a general anaesthetic or become
pregnant while taking INDERAL.
THINGS YOU
SHOULD NOT DO
•
Do not give INDERAL to anyone else even if they have the same
condition as you.
•
Do not use INDERAL to treat any other complaints unless your doctor
tells you to.
•
Do not

Productkenmerken

1
AUSTRALIAN PRODUCT INFORMATION - INDERAL
®
(PROPRANOLOL HYDROCHLORIDE)
1. NAME OF THE MEDICINE
Propranolol hydrochloride.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
INDERAL tablets contain 10 mg and 40 mg of propranolol hydrochloride
for oral administration.
Excipients with known effect: sugars as lactose and sulfites.
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
10 mg – pink, round, biconvex, film-coated, tablets. Intagliated on
one face with 10 and bisected on the
reverse face.
40 mg – pink, round, biconvex, film-coated, tablets. Intagliated on
one face with 40 and bisected on the
reverse face.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Angina pectoris
•
Hypertension
•
Prevention of migraine
•
Cardiac dysrhythmias: certain intrinsic cardiac dysrhythmias;
dysrhythmias associated with
thyrotoxicosis; anxiety tachycardia; certain drug-induced dysrhythmias
(eg tachycardia due to
digitalis or adrenaline overdosage)
•
Essential tremor, including familial and senile tremor
•
Phaeochromocytoma (only with concurrent α-receptor blockade)
•
Hypertrophic subaortic stenosis
•
Suspected or definite myocardial infarction
•
Fallot’s tetralogy
4.2 DOSE AND METHOD OF ADMINISTRATION
NOTE: Tablets may be taken before or after food.
ADULT
_HYPERTENSION _
The standard starting dose is 40 mg twice daily, increasing by the
same amount at weekly intervals
according to patient response. An adequate response is usually seen in
the range 120 to 320 mg/day.
Although higher doses may be required, and have been used, the value
and safety of doses exceeding 320
mg/day have not been established.
_ANGINA PECTORIS AND ESSENTIAL TREMOR _
40 mg two or three times daily, increasing by the same amount at
weekly intervals according to patient
response. An adequate response in essential tremor is usually seen in
the range 80 to 160 mg/day and in
angina 120 to 320 mg/day.
_MIGRAINE _
The standard starting dose is 40 mg twice daily. If a response occurs,
this is usual