VASOCARDOL diltiazem hydrochloride 60mg tablet bottle

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

diltiazem hydrochloride, Quantity: 60 mg

Доступна с:

Sanofi-Aventis Australia Pty Ltd

Фармацевтическая форма:

Tablet, film coated

состав:

Excipient Ingredients: magnesium stearate; methyl hydroxybenzoate; quinoline yellow; sunset yellow FCF; hypromellose; colloidal anhydrous silica; lactose monohydrate; microcrystalline cellulose; hyprolose; macrogol 3350; macrogol 400

Администрация маршрут:

Oral

Штук в упаковке:

90 tablets

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

Patients with moderate to severe angina pectoris due to atherosclerotic coronary artery disease or coronary artery spasm (vasospastic angina).

Обзор продуктов:

Visual Identification: Clear coated, light yellow, round double (13/32" or 1.03cm) convex tablets with characteristic direct compression speckle. MARION engraved on one side; the other side is scored and engraved 1772.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Статус Авторизация:

Licence status A

Дата Авторизация:

2000-05-09

тонкая брошюра

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TABLETS
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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 VASOCARDOL?
Vasocardol CD capsules or Vasocardol tablets both contain an active
ingredient diltiazem hydrochloride. Vasocardol tablets are
used to prevent angina. Vasocardol CD capsules are used to prevent
angina or to treat hypertension (high blood pressure).
For more information, see Section 1. Why am I using Vasocardol? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE VASOCARDOL?
Do not use if you have ever had an allergic reaction to Vasocardol CD
capsules or Vasocardol tablets 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
Vasocardol? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Vasocardol 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 VASOCARDOL?
•
Vasocardol CD capsules can be taken once a day, preferably at the same
time every day.
•
Vasocardol tablets can be taken three or four times a day.
•
Swallow the capsules or the tablets with a glass of water. Do not chew
them.
•
Your doctor will tell you how often and how much Vasocardol CD or
Vasocardol tablets to take.
More instructions can be found in Section 4. How do I use Vasocardol?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING VASOCARDOL?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Vasocardol CD or Vasocardol
tablets.
•
If you are taking these medicines for angina, tell your doctor if you
continue to have

Характеристики продукта

vasocardol-ccdsv13-piv17-11mar20
Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION - VASOCARDOL
®
(DILTIAZEM HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Diltiazem hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of VASOCARDOL contains 60 mg diltiazem hydrochloride.
Diltiazem hydrochloride is a white to off-white crystalline powder
with a bitter taste. It is
freely soluble in water, methanol, and chloroform.
Excipients with known effect: lactose monohydrate and methyl
hydroxybenzoate.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Film coated tablet
VASOCARDOL 60 mg tablets are clear coated, light yellow, round double
(13/32” or 1.03
cm) convex tablets with characteristic direct compression speckle. The
word “Marion” is
engraved on one side while the other side is scored and engraved with
1772.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Patients with moderate to severe angina pectoris due to
atherosclerotic coronary artery
disease or coronary artery spasm (vasospastic angina).
4.2
DOSE AND METHOD OF ADMINISTRATION
For oral administration.
ANGINA
Dosage must be adjusted to each patient's needs. Starting with 30 mg
four times daily, before
meals and at bedtime, dosage should be increased gradually (given in
divided doses three or
four times daily) at one to two day intervals until optimum response
is obtained. Although
individual patients may respond to any dosage level, the average
optimum dosage range
appears to be 180 to 240 mg/day. The maximum recommended dose is 360
mg daily. There
vasocardol-ccdsv13-piv17-11mar20
Page 2 of 18
are no available data concerning dosage requirements in patients with
impaired renal or
hepatic function. If the drug must be used in such patients, titration
should be carried out
with particular caution.
USE IN THE ELDERLY
Pharmacokinetics of diltiazem in elderly patients has not been fully
elucidated. Preliminary
results in elderly patients (over 65 years old) suggest that a lower
dosage might be required in
this age gr