Apo-Timol

Country: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Timolol maleate 10mg;  ;  ;  

Disponibbli minn:

Apotex NZ Ltd

INN (Isem Internazzjonali):

Timolol maleate 10 mg

Dożaġġ:

10 mg

Għamla farmaċewtika:

Tablet

Kompożizzjoni:

Active: Timolol maleate 10mg       Excipient: Brilliant blue FCF Croscarmellose sodium Indigo carmine Lactose monohydrate Magnesium stearate Microcrystalline cellulose

Unitajiet fil-pakkett:

Bottle, 1 x 100, 100 tablets

Klassi:

Prescription

Tip ta 'preskrizzjoni:

Prescription

Manifatturat minn:

Santen Oy

Indikazzjonijiet terapewtiċi:

Timolol is indicated for patients with: - Essential hypertension including the hyperkinetic heart syndrome - the management of atrial fibrillation or flutter. - angina pectoris due to ischaemic heart disease. - prophylaxis of common or classical migraine. - ischaemic heart disease to reduce the risk of cardiac death, including sudden death, and reinfarction in those who have survived the acute phase of myocardial infarction.

Sommarju tal-prodott:

Package - Contents - Shelf Life: Bottle, - 100 tablets - 36 months from date of manufacture stored at or below 30°C

Data ta 'l-awtorizzazzjoni:

1989-03-15

Fuljett ta 'informazzjoni

New Zealand Consumer Medicine Information
APO-TIMOL
_TIMOLOL MALEATE _
10mg Tablets USP
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Apo-Timol.
This leaflet answers some common questions about Apo-Timol. 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-Timol 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-TIMOL IS USED FOR
The name of your medicine is Apo-Timol tablet. It contains the active
ingredient
timolol maleate.
Timolol is a hydrophilic non-cardioselective beta-adrenergic blocking
agent.
Apo-Timol is indicated for patients with
•
high blood pressure, including conditions that makes your heart work
harder than normal
•
the management of irregular heartbeat
•
chest pain due to reduced supply of blood to the heart
•
treatment of common or classical migraine
•
reduced supply of blood to the heart to reduce the risk of cardiac
death,
including sudden death, and another heart attack in those who have
survived the acute phase of a heart attack
Your doctor may have prescribed Apo-Timol for another reason.
Ask your doctor if you have any questions about why Apo-Timol has been
prescribed
for you.
2
If you have any concerns, you should discuss this with your doctor.
This medicine is available only with a doctor's prescription.
There is no evidence that this medicine is addictive.
Apo-Timol should not be administered to children.
BEFORE YOU USE APO-TIMOL
_ _
_WHEN YOU MUST NOT USE IT _
Do not use Apo-Timol if:
•
YOU ARE ALLERGIC TO TIMOLOL OR ANY OF THE INGREDIENTS LISTED AT THE
END OF
THIS LEAFLET INCLUDING LACTOSE AND THE DYES FD&C BLUE NO. 1 AND FD&C
BLUE NO. 2.
Symptoms of an allergic reaction may include cough, shortness of
breath, wheezing
or

Karatteristiċi tal-prodott

NEW ZEALAND DATA SHEET
APO-TIMOL
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 11
1. PRODUCT NAME
APO-TIMOL (10MG TABLETS)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg timolol maleate 10mg equivalent to 10mg
timolol.
EXCIPIENT(S) WITH KNOWN EFFECT_ _
APO-TIMOL contains lactose, FD&C Blue No. 1 and FD&C Blue No. 2.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
APO-TIMOL tablets are round, light blue, flat-faced, bevelled-edged
tablets. Scored and
engraved T10 on one side, other side plain.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Timolol is indicated for patients with:
•
Essential hypertension including the hyperkinetic heart syndrome
•
the management of atrial fibrillation or flutter.
•
angina pectoris due to ischaemic heart disease.
•
prophylaxis of common or classical migraine.
•
ischaemic heart disease to reduce the risk of cardiac death, including
sudden death, and
re-infarction in those who
have survived the acute phase of myocardial infarction.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
Hypertension:
Therapy should be initiated with a daily single or divided oral dose
of 10mg, increasing to
a maximum daily dose of 60mg, subject to the patient’s response.
Daily dosages above
20mg should be administered on a divided dose schedule. Timolol may
also be used with
thiazides, hydralazine, or methyldopa, although dosage adjustments are
usually required.
For concomitant use with catecholamine-depleting medicines such as
reserpine or
guanethidine (see section 4.4 Special Warnings and Precautions for
Use. When Timolol
is administered concomitantly with hydrochlorothiazide and amiloride
hydrochloride, most
patients will respond to a regimen of 10 or 20mg of timolol given
orally once daily and one
tablet of 50mg hydrochlorothiazide/5mg amiloride hydrochloride.
APO-TIMOL
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 2 of 11
Angina:
Therapy should begin with a