ACTONEL EC ONCE-A-WEEK risedronate sodium 35mg enteric-coated tablet blister pack

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

risedronate sodium, Quantity: 35 mg

Pieejams no:

Theramex Australia Pty Ltd

SNN (starptautisko nepatentēto nosaukumu):

Risedronate sodium

Zāļu forma:

Tablet, enteric coated

Kompozīcija:

Excipient Ingredients: polysorbate 80; stearic acid; purified talc; microcrystalline cellulose; triethyl citrate; iron oxide yellow; magnesium stearate; disodium edetate; methacrylic acid - ethyl acrylate copolymer (1:1); sodium starch glycollate type A; simethicone; colloidal anhydrous silica

Ievadīšanas:

Oral

Vienības iepakojumā:

2 tablet, 4 tablet, 10 tablet, 1 (sample) tablet, 16 tablet, 12 tablet

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

Treatment of osteoporosis. Treatment of glucocorticoid-induced osteoporosis. Preservation of bone mineral density in patients on long term corticosteroid therapy.

Produktu pārskats:

Visual Identification: oval, yellow, enteric-coated tablets, engraved with 'EC 35' on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 60 Months; Container Temperature: Store below 30 degrees Celsius

Autorizācija statuss:

Registered

Autorizācija datums:

2011-03-10

Lietošanas instrukcija

ACTONEL
® EC
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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 ACTONEL EC?
Actonel EC contains the active ingredient risedronate sodium. Actonel
EC is used to treat bone disease and belongs to a group of
medicines called bisphosphonates.
For more information, see Section 1. Why am I using Actonel EC? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ACTONEL EC?
Do not use if you have ever had an allergic reaction to Actonel EC 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
Actonel EC? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Actonel EC 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 ACTONEL EC?
•
For osteoporosis, the usual dose is one Actonel EC 35mg enteric-coated
tablet once a week
•
Take your Actonel EC tablet while sitting or standing upright.
•
Swallow your Actonel EC tablet whole with a glass of plain water (at
least 120mL). Do not chew, cut, crush or suck the tablet.
•
Actonel EC should be taken in the morning either with or without food.
More instructions can be found in Section 4. How do I use Actonel EC?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ACTONEL EC?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using Actonel EC.
•
If you require a dental procedure, tell your dentist that you are
taking Actonel EC. Invasive dental
procedures should be avoided where possible.
•
If you develop a toothache, jaw pain, painful exposed bone or
swelling, especially following dental work,
tell your doctor or dentist immediately.
THINGS YOU
SH

Produkta apraksts

ACTONEL EC (Risedronate sodium)
Theramex Australia Pty Ltd
Version 2.0
1
AUSTRALIAN PRODUCT INFORMATION- ACTONEL EC ONCE-A-
WEEK (RISEDRONATE SODIUM) ENTERIC-COATED TABLET
1
NAME OF THE MEDICINE
Risedronate sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Actonel EC enteric-coated tablet contains the equivalent of 35 mg
of anhydrous
risedronate sodium in the form of the hemi-pentahydrate with small
amounts of monohydrate.
Actonel EC tablets have a pH-sensitive enteric coating and contain a
chelating agent disodium
edetate (EDTA). The formulation is designed to allow dosing with food,
reducing the impact
of food on risedronate absorption.
For the full list of excipients, see Section 6.1- List of excipients
.
3
PHARMACEUTICAL FORM
Enteric-coated-tablet
Actonel EC tablets are oval, yellow enteric-coated tablets engraved
with EC 35 on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
•
Treatment of osteoporosis
•
Treatment of glucocorticoid-induced osteoporosis
•
Preservation of bone mineral density in patients on long term
corticosteroid therapy
4.2
D
OSE AND METHOD OF ADMINISTRATION
Actonel EC should be taken in the morning, either with or without
food. To facilitate delivery
to the stomach, and thus reduce the potential for oesophageal
irritation, enteric-coated Actonel
35 mg once-a-week should be swallowed whole while the patient is in an
upright position with
plain water. Patients should not chew, cut or crush the tablet because
of a potential for
oropharyngeal irritation, and because the tablet coating is an
important part of the formulation.
Patients should avoid lying down for 30 minutes after taking the
medication.
The recommended dose is 35 mg once a week taken on the same day each
week.
USE IN THE ELDERLY:
No dose adjustment is necessary.
ACTONEL EC (Risedronate sodium)
Theramex Australia Pty Ltd
Version 2.0
2
RENAL INSUFFICIENCY:
No dose adjustment is necessary in patients with mild to moderate
renal insufficiency
(creatinine clearance 30 to 60 mL/minute). Enteric-coated Actonel 35