ERLOTINIB CIPLA erlotinib (as hydrochloride) 150 mg tablet blister pack

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

erlotinib hydrochloride, Quantity: 163.9 mg (Equivalent: erlotinib, Qty 150 mg)

Commercializzato da:

Cipla Australia Pty Ltd

Forma farmaceutica:

Tablet, film coated

Composizione:

Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; sodium starch glycollate type A; magnesium stearate; sodium lauryl sulfate; titanium dioxide; hypromellose; hyprolose; macrogol 400

Via di somministrazione:

Oral

Confezione:

30 Tablet

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

Non-small cell lung cancer ERLOTINIB CIPLA is indicated for the first-line treatment of patients with advanced (Stage IIIB) or metasttic (Stega IV) non-small cell lung cancer (NSCLC) with activating EGFR mutations. ERLOTINIB CIPLA is indicated for matintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutations who have not progressed on first-line chemotherapy. ERLOTINIB CIPLA is also indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer after failure of prior chemotherapy.,Pancreatic cancer ERLOTINIB CIPLA in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Dettagli prodotto:

Visual Identification: White, round, biconvex film-coated tablet debossed with C3 on one side and plain on the other; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2021-04-30

Foglio illustrativo

ERLOTINIB CIPLA
1
ERLOTINIB CIPLA
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 ERLOTINIB CIPLA?
Erlotinib Cipla contains the active ingredient erlotinib. Erlotinib
Cipla is used for the treatment of non‐small cell lung cancer
(NSCLC). It is also used in combination with gemcitabine for the
treatment of pancreatic cancer.
For more information, see Section 1. Why am I using
Erlotinib Cipla? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ERLOTINIB CIPLA?
Do not use if you have ever had an allergic reaction to erlotinib 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
Erlotinib Cipla? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Erlotinib 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 USE ERLOTINIB CIPLA?
•
The usual dose for non‐small‐cell lung cancer
one 150 mg tablet each day and pancreatic cancer in combination with
gemcitabine
is one 100 mg tablet each day.
•
Do not take Erlotinib Cipla with food. Take Erlotinib Cipla exactly as
your doctor has prescribed.
More instructions can be found in Section 4. How do I use Erlotinib
Cipla? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ERLOTINIB CIPLA?
THINGS YOU SHOULD DO
•
Tell all doctors, dentists and pharmacists who are treating you that
you are taking Erlotinib
Cipla. Tell your doctor if you become pregnant while taking Erlotinib
Cipla.
•
Tell your doctor if, for any reason, you have not taken your medicine
exactly as prescribed.
•
Tell your doctor if you feel the tablets are not helping your
condition.
•
Be sure to keep all of your a

Scheda tecnica

AUSTRALIAN PRODUCT INFORMATION - ERLOTINIB CIPLA
(ERLOTINIB (AS HYDROCHLORIDE))
FILM-COATED TABLETS
1.
NAME OF THE MEDICINE
Erlotinib (as hydrochloride)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Erlotinib Cipla film coated tablets are available in 3 dosage
strengths containing erlotinib hydrochloride
equivalent to 25 mg, 100 mg or 150 mg of erlotinib.
Excipients with known effect
Each 25 mg film-coated tablet contains 17.333 mg lactose monohydrate.
Each 100 mg film-coated tablet contains 69.333 mg lactose monohydrate.
Each 150 mg film-coated tablet contains 104.000 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Erlotinib Cipla 25 mg film-coated tablets are white, round, biconvex
film coated tablets debossed with
‘C1’ on one side and plain on the other. Dimensions- thickness:
2.40 mm – 3.0 mm; diameter: 5.30
mm – 5.70 mm.
Erlotinib Cipla 100 mg film-coated tablets are white, round, biconvex
film coated tablets debossed
with ‘C2’ on one side plain on the other. Dimensions- thickness:
3.90 mm – 4.50 mm;
diameter: 8.80 mm – 9.20 mm.
Erlotinib Cipla 150 mg film-coated tablets are white, round, biconvex
film coated tablets debossed
with ‘C3’ on one side plain on the other. Dimensions- thickness:
4.40 mm – 5.00 mm;
diameter: 10.30 mm – 10.70 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non-small cell lung cancer
Erlotinib Cipla is indicated for the first-line treatment of patients
with advanced (Stage IIIB) or
metastatic (Stage IV) non-small cell lung cancer (NSCLC) with
activating EGFR mutations.
Erlotinib Cipla is indicated for maintenance therapy in patients with
locally advanced or metastatic
non-small cell lung cancer (NSCLC) with activating EGFR mutations who
have not progressed on
first-line chemotherapy.
Erlotinib Cipla is also indicated for the treatment of patients with
locally advanced or metastatic non-
small cell lung cancer after failure of prior chemotherapy.
Pancreatic cancer
Erlotinib Cipla in com