PANADOL OSTEO (reformulation) paracetamol 665 mg modified release tablet blister pack

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

paracetamol, Quantity: 665 mg

Sẵn có từ:

Haleon Australia Pty Ltd

INN (Tên quốc tế):

Paracetamol

Dạng dược phẩm:

Tablet, modified release

Thành phần:

Excipient Ingredients: magnesium stearate; stearic acid; povidone; pregelatinised maize starch; hypromellose; Carnauba Wax; croscarmellose sodium; triacetin

Tuyến hành chính:

Oral

Các đơn vị trong gói:

6, 96, 24, 12

Loại thuốc theo toa:

(S3) Pharmacist Only Medicine

Chỉ dẫn điều trị:

Effective relief from persistent pain for up to 8 hours. Effective for the relief of persistent pain associated with osteoarthritis and muscular aches and pains such as backache. Provides effective temporary relief of pain and discomfort associated with: headache, tension headache, cold and flu, period pain, toothache and pain after dental procedures. Reduces fever.

Tóm tắt sản phẩm:

Visual Identification: White to off-white film coated capsule shaped tablets with flat edges. Embossed with the logo "8" on the front face and plain on the back face.; Container Type: Blister Pack; Container Material: Al laminated with PVC/paper; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius

Tình trạng ủy quyền:

Licence status A

Ngày ủy quyền:

2015-09-24

Tờ rơi thông tin

PANADOL OSTEO
P
A
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A
D
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ACTIVE INGREDIENT(S): _665 mg Paracetamol_
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
PANADOL OSTEO. YOU SHOULD ALSO SPEAK TO YOUR DOCTOR
OR PHARMACIST IF YOU WOULD LIKE FURTHER INFORMATION OR
IF YOU HAVE ANY CONCERNS OR QUESTIONS ABOUT USING
[MEDICINE NAME].
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1. Why am I using [medicine name]?
2. What should I know before I use [medicine name]?
3. What if I am taking other medicines?
4. How do I use [medicine name]?
5. What should I know while using [medicine name]?
6. Are there any side effects?
7. Product details
1.
WHY AM I USING PANADOL OSTEO?
PANADOL OSTEO CONTAINS THE ACTIVE INGREDIENT
PARACETAMOL. PANADOL OSTEO is effective for the relief of
persistent pain associated with:
•
Osteoarthritis
•
Muscle aches and pains such as backache
PARACETAMOL, the active ingredient in this medicine, is
also used for the fast effective temporary relief of pain and
discomfort associated with:
•
Headache
•
Tension headache
•
Period pain
•
Toothache and pain after dental procedures
•
Colds and flu
PARACETAMOL ALSO REDUCES FEVER.
PARACETAMOL WORKS TO STOP THE PAIN MESSAGES FROM
GETTING THROUGH TO THE BRAIN. IT ALSO ACTS IN THE BRAIN TO
REDUCE FEVER.
ASK YOUR PHARMACIST OR DOCTOR IF YOU HAVE ANY QUESTIONS
ABOUT THIS MEDICINE.
YOUR PHARMACIST OR DOCTOR MAY HAVE RECOMMENDED IT FOR
ANOTHER REASON.
2.
WHAT SHOULD I KNOW BEFORE I USE PANADOL
OSTEO?
DO NOT TAKE MORE THAN THE RECOMMENDED DOSE AS IT MAY
CAUSE SERIOUS HARM TO YOUR LIVER.
WHEN YOU MUST NOT USE IT
DO NOT USE PANADOL OSTEO IF YOU HAVE IF YOU HAVE AN
ALLERGY TO:
•
Any medicine containing paracetamol
Always check the ingredients to make sure you can use
this medicine.
•
Any of the ingredients listed at the end of this leaflet.
Do not take this medicine if you are taking other
prescription or non-prescription medicines containing
paracetamol to treat pain, fever, symptoms of cold and
flu, or to aid sleep.
•
Always read and follo

Đặc tính sản phẩm

PRODUCT INFORMATION
PANADOL OSTEO
1.
NAME OF THE MEDICINE
Paracetamol
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: _
_Paracetamol 665 mg _
_ _
Chemical structure:
ACTIVE INGREDIENTS
CHEMICAL STRUCTURE
CAS REGISTRY
NUMBER
Paracetamol
103-90-2
_Excipients: _
For the full list of excipients, see section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
White to off-white film coated capsule shaped tablets with flat edges.
Embossed
with the logo “8” on the front face and plain on the back face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PANADOL OSTEO provides effective relief from persistent pain for up to
8 hours.
Effective for the relief of persistent pain associated with
osteoarthritis and muscular
aches and pains such as backache. Provides effective temporary relief
of pain and
discomfort associated with: headache, tension headache, cold and flu,
period pain,
toothache and pain after dental procedures. Reduces fever.
4.2
DOSE AND METHOD OF ADMINISTRATION
Adults and children aged 12 years and over: 2 caplets swallowed whole
three times a
day every 6 to 8 hours. Do not chew or suck, as it impairs the
sustained relese
properties. Maximum of 6 caplets in 24 hours.
Do not use for more than a few days at a time in adults except on
medical advice.
Children under 12 years: Not recommended for children under the age of
12 years.
Page 1 of 9
PANADOL OSTEO – Product Information
Page 2 of 9
Should not be used for more than 48 hours for children aged 12 – 17
years except on
medical advice.
Take with water or other fluid.
Can be taken with or without food.
Doses should be equally spaced throughout the day.
The caplets must not be crushed.
Do not exceed the stated dose.
The lowest dose necessary to achieve efficacy should be used for the
shortest duration
of treatment.
Should not be used with other paracetamol-containing products.
Minimum dosing interval: 6 hours.
Maximum daily dose: 4000 mg
4.3
CONTRAINDICATIONS
Contraindicated in patients with a previous history of
hypersensitivity to paraceta