METHOTREXATE CIPLA 10 methotrexate10 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

methotrexate, Quantity: 10 mg

Available from:

Cipla Australia Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: calcium hydrogen phosphate; lactose monohydrate; sodium starch glycollate type A; microcrystalline cellulose; purified talc; magnesium stearate

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Antineoplastic chemotherapy,Treatment of breast cancer, gestational choriocarcinoma and in patients with chorioadenoma destruens and hydatidiform mole. Palliation of acute and subacute lymphocytic leukaemia. Greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemias. In combination with corticosteroids, methotrexate may be used for induction of remission. The drug is now most commonly used for the maintenance of induced remissions. Methotrexate Cipla is also effective in the treatment of the advanced stages (III and IV, Peters Staging System) of lymphosarcoma, particularly in children and in advanced cases of mycosis fungoides.,Psoriasis chemotherapy,(See Warnings box and section 4.4 Special warnings and precautions for use),Because of the high risk attending to its use, Methotrexate Cipla is only indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and / or after dermatologic consultations.,Rheumatoid Arthritis Chemotherapy,(See Warnings box and section 4.4 Special warnings and precautions for use),Management of severe, recalcitrant, active rheumatoid arthritis in adults not responding to or intolerant of an adequate trial of NSAIDs and one or more disease modifying drugs. Aspirin, NSAIDs and/or low dose steroids may be continued, although the possibility of increased toxicity with concomitant use of NSAIDs including salicylate has not been fully explored (see sections 4.4 Special warnings and precautions for use and 4.5 Interactions with other medicines and other forms of interactions).,Steroids may be reduced gradually in patients who respond to methotrexate.,Combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine or cytotoxic agents has not been studied and may increase the incidence of adverse effects. Rest and physiotherapy as indicated should be continued.

Product summary:

Visual Identification: Yellow coloured, capsule shaped, biconvex uncoated tablet with central breakline on one side and plain on other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2023-05-15

Patient Information leaflet

METHOTREXATE CIPLA
1
METHOTREXATE CIPLA
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about taking this medicine, speak to your doctor or
pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the
full CMI
. Read before taking this medicine.
1.
WHY AM I TAKING METHOTREXATE CIPLA?
Methotrexate Cipla contains the active ingredient methotrexate.
Methotrexate Cipla is used to treat certain types of cancers,
severe psoriasis or rheumatoid arthrtis when the condition does not
improve with other medicines.
For more information, see Section 1. Why am I taking Methotrexate
Cipla? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE METHOTREXATE CIPLA?
Do not take if you have ever had an allergic reaction to Methotrexate
Cipla 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 take
Methotrexate Cipla? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Methotrexate Cipla 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 TAKE METHOTREXATE CIPLA?
The dose of medicine given to you will depend on the condition being
treated, your medical condition, your age, your size and
how well your kidneys and liver are working.
More instructions can be found in Section 4. How do I take
Methotrexate Cipla? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING METHOTREXATE CIPLA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
Methotrexate Cipla.
•
You and your partner must use a reliable method of contraception
(birth control pills or condom)
while taking Methotrexate Cipla and for at least 6 months after you
stop treatment.
•
Discuss with your doctor how muc