ELMIRON PENTOSAN POLYSULFATE SODIUM 100mg capsule bottle

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

pentosan polysulfate sodium, Quantity: 100 mg

Sẵn có từ:

Arthropharm Pty Ltd

Dạng dược phẩm:

Capsule, hard

Thành phần:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; ethanol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; titanium dioxide; Gelatin; sodium lauryl sulfate; silicon dioxide

Tuyến hành chính:

Oral

Các đơn vị trong gói:

100 capsules

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

INDICATIONS AS AT 5 August 2021: ELMIRON is indicated for the treatment of interstitial cystitis. Relief of symptoms in patients with interstitial cystitis may not be experienced until 6 to 8 weeks of therapy with ELMIRON. Continuing long-term therapy is necessary for persistent relief of symptoms. Relief of symptoms may not occur in all patients, and relapse is likely to occur gradually if treatment is discontinued, even after long periods of therapy.

Tóm tắt sản phẩm:

Visual Identification: White hard gelatin capsules imprinted 'ELM' with black printing ink.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

1994-04-21

Tờ rơi thông tin

If your bladder condition or symptoms become worse, you should consult
your doctor immediately and STOP taking ELMIRON.
Some people may experience mild effects of swelling, headache,
dizziness, nausea, indigestion, or diarrhoea. If any of these occur
and are
bothersome, contact your doctor. Other unwanted effects not listed may
also occur in some patients. Tell your doctor if you notice any other
effects.
Rare cases of retinal disorders (pigmentary maculopathy) have been
reported
with use of Elmiron (especially after long term use). Tell your doctor
immediately if you experience visual changes such as reading
difficulty and
slower adjustment to low or reduced light. Your doctor will discuss
with you
whether the treatment should be continued. For early detection of
retinal
disorders, eye examination will be performed.
If you accidentally take too many capsules, you should contact your
Doctor or contact the Poisons Information Centre on 131126
(Australia)There
are no known instances of people suffering damage from taking too much
ELMIRON.
•
Keep ELMIRON out of the reach of children.
•
Keep the capsules away from sunlight and away from the damp and
store in a cool place. Therefore, do not store ELMIRON in the
bathroom or near the kitchen sink.
•
Keep ELMIRON in the bottle given to you by your pharmacist.
•
Do not use the capsules past the expiry date on the bottle.
•
If your doctor tells you to stop taking ELMIRON, return any leftover
capsules to your pharmacist for disposal.
This is not all the information that is available on ELMIRON. If you
have any
more questions or are not sure about anything, ask your doctor or
pharmacist.
ARTHROPHARM PTY LTD IS COMMITTED TO THE BETTER HEALTH OF ALL
AUSTRALIANS.
CONSUMER PRODUCT INFORMATION IS PART OF THIS COMMITMENT.
Revised 30/07/2021
ARTHROPHARM PTY LIMITED
111 Bronte Road, Bondi Junction NSW 2022
CONSUMER PRODUCT INFORMATION
IT IS VERY IMPORTANT THAT YOU READ AND UNDERSTAND THIS LEAFLET.
IF IT IS NOT CLEAR OR CONCERNS YOU, TALK TO YOUR DOCTOR OR PHARMACIST.
THIS

Đặc tính sản phẩm

AUSTRALIAN PRODUCT INFORMATION
ELMIRON
®
(PENTOSAN POLYSULFATE SODIUM)
CAPSULES
1. NAME OF THE MEDICINE
Pentosan polysulfate sodium.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100mg pentosan polysulfate sodium.
For the full list of excipients, (see Section 6.1 LIST OF EXCIPIENTS).
3. PHARMACEUTICAL FORM
Elmiron 100mg is supplied in white opaque hard gelatin capsules.
It is formulated for oral use.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Elmiron is indicated for the treatment of interstitial cystitis.
Relief of symptoms in patients with
interstitial cystitis may not be experienced until after 6 to 8 weeks
of therapy with Elmiron.
Continuing long-term therapy is necessary for persistent relief of
symptoms.
Relief of symptoms may not occur in all patients, and relapse is
likely to occur gradually if
treatment is discontinued, even after long periods of therapy.
4.2 DOSE AND METHOD OF ADMINISTRATION
The recommended dose of Elmiron is 300 mg/day taken as one 100 mg
capsule orally three
times daily or as directed by the physician. The capsules should be
taken with water at least 1
hour before meals or 2 hours after meals.
4.3 CONTRAINDICATIONS
Elmiron is contraindicated in patients with known hypersensitivity to
it or related compounds,
haemophilia, active (or a recent history of) bleeding and concurrent
heparin or oral anti-
coagulant therapy.
4.4 SPECIAL WARNING AND PRECAUTIONS FOR USE
Because of its weak anti-coagulant action, Elmiron should be used with
caution in patients with
bleeding disorders or who are taking anti-coagulant therapy or who are
at greater risk of
bleeding (e.g.the elderly or the alcoholic patient). Elmiron should
not be used as empirical
treatment for undiagnosed urogenital bleeding or symptoms. The
diagnosis of interstitial cystitis
should be established before treatment commences.
Rare cases of pigmentary maculopathy have been reported with use of
pentosan polysulfate
sodium (PPS), especially after long term use. Visual symptoms might
include complaints of
r