Afinitor 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Everolimus

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

L04AA18

INN (International Name):

Everolimus

Dosage:

10mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010500; GTIN: 5010678901054

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AFINITOR
® 2.5 MG TABLETS
AFINITOR
® 5 MG TABLETS
AFINITOR
® 10 MG TABLETS
Everolimus
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Afinitor is and what it is used for
2.
What you need to know before you take Afinitor
3.
How to take Afinitor
4.
Possible side effects
5.
How to store Afinitor
6.
Contents of the pack and other information
1.
WHAT AFINITOR IS AND WHAT IT IS USED FOR
Afinitor is an anticancer medicine containing the active substance
everolimus. Everolimus reduces the
blood supply to the tumour and slows down the growth and spread of
cancer cells.
Afinitor is used to treat adult patients with:

hormone receptor-positive advanced breast cancer in postmenopausal
women, in whom other
treatments (so called “non-steroidal aromatase inhibitors”) no
longer keep the disease under
control. It is given together with a medicine called exemestane, a
steroidal aromatase inhibitor,
which is used for hormonal anticancer therapy.

advanced tumours called neuroendocrine tumours that originate from the
stomach, bowels, lung
or pancreas. It is given if the tumours are inoperable and do not
overproduce specific hormones
or other related natural substances.

advanced kidney cancer (advanced renal cell carcinoma), where other
treatments (so-called
“VEGF-targeted therapy”) have not helped stop your disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AFINITOR
Afinitor will only be prescribed for you by a doctor with experience
in cancer treat

Summary of Product characteristics

OBJECT 1
AFINITOR 10MG TABLETS
Summary of Product Characteristics Updated 31-Oct-2018 | Novartis
Pharmaceuticals UK Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Afinitor
®
2.5 mg tablets
Afinitor
®
5 mg tablets
Afinitor
®
10 mg tablets
2. Qualitative and quantitative composition
Afinitor 2.5 mg tablets
Each tablet contains 2.5 mg everolimus.
Excipient with known effect:
Each tablet contains 74 mg lactose.
Afinitor 5 mg tablets
Each tablet contains 5 mg everolimus.
Excipient with known effect:
Each tablet contains 149 mg lactose.
Afinitor 10 mg tablets
Each tablet contains 10 mg everolimus.
Excipient with known effect:
Each tablet contains 297 mg lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet.
Afinitor 2.5 mg tablets
White to slightly yellow, elongated tablets with a bevelled edge and
no score, engraved with “LCL” on
one side and “NVR” on the other.
Afinitor 5 mg tablets
White to slightly yellow, elongated tablet