Hycamtin 1mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Topotecan hydrochloride

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

L01XX17

INN (International Name):

Topotecan hydrochloride

Dosage:

1mg

Pharmaceutical form:

Capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010500; GTIN: 5000123112579

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
HYCAMTIN
® 0.25 MG HARD CAPSULES
HYCAMTIN
® 1 MG HARD CAPSULES
topotecan
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. Do not pass it on to
others. It may harm them, even
if their symptoms seem to be 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 Hycamtin is and what it is used for
2.
What you need to know before you take Hycamtin
3.
How to take Hycamtin
4.
Possible side effects
5.
How to store Hycamtin
6.
Contents of the pack and other information
1.
WHAT HYCAMTIN IS AND WHAT IT IS USED FOR
Hycamtin helps to destroy tumours.
HYCAMTIN IS USED TO TREAT SMALL CELL LUNG CANCER
that has come back after chemotherapy.
Your doctor will decide with you whether Hycamtin therapy is better
than further treatment with your
initial chemotherapy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE HYCAMTIN
DO NOT TAKE HYCAMTIN:

if you are allergic to topotecan or any of the other ingredients of
this medicine (listed in
section 6).

if you are breast-feeding.

if your blood cell counts are too low. Your doctor will tell you
whether this is the case, based on
the results of your last blood test.
TELL YOUR DOCTOR
if any of these applies to you.
WARNINGS AND PRECAUTIONS
Before you are given this medicine your doctor needs to know:

if you have any kidney or liver problems. Your dose of Hycamtin may
need to be adjusted.

if you are pregnant or plan to become pregnant. See section
“Pregnancy and breast-feeding”
below.

if you plan to father a child. See section “Pregnancy and
breast-feeding” below.
TELL YOUR DOCTOR
if any of these applies to you.
OTHER MEDICINES AND HYCAMTIN

Summary of Product characteristics

OBJECT 1
HYCAMTIN 0.25MG HARD CAPSULE
Summary of Product Characteristics Updated 03-May-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
HYCAMTIN
®
0.25 mg hard capsules
HYCAMTIN
®
1 mg hard capsules
2. Qualitative and quantitative composition
HYCAMTIN 0.25 mg hard capsules
Each capsule contains 0.25 mg of topotecan (as hydrochloride).
HYCAMTIN 1 mg hard capsules
Each capsule contains 1 mg of topotecan (as hydrochloride).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule.
HYCAMTIN 0.25 mg hard capsules
The capsules are opaque, white to yellowish white and imprinted with
“HYCAMTIN” and “0.25 mg”.
HYCAMTIN 1 mg hard capsules
The capsules are opaque, pink and imprinted with “HYCAMTIN” and
“1 mg”.
4. Clinical particulars
4.1 Therapeutic indications
HYCAMTIN capsules are indicated as monotherapy for the treatment of
adult patients with relapsed
small cell lung cancer (SCLC) for whom re-treatment with the
first-line regimen is not considered
appropriate (see section 5.1).
4.2 Posology and method of administration
HYCAMTIN capsules should only be prescribed and therapy supervised by
a physician experienced in
the use of chemotherapeutic agents.
Posology
Prior to administration of the first course of topotecan, patients
must have a baseline neutrophil count of
≥1.5 x 10
9
/l, a platelet count of ≥100 x 10
9
/l and a haemoglobin level of ≥9 g/dl (after transfusion if
necessary).
_Initial dose _
The recommended dose of HYCAMTIN capsules is 2.3 mg/m
2
body surface area per day administered
for five consecutive days with a three-week interval between the start
of each course. If well tolerated,
treatment may continue until disease progression (see sections 4.8 and
5.1).
The capsule(s) must be swallowed whole, and must not be chewed crushed
or divided.
Hycamtin capsules may be taken with or without food (see section 5.2).
_Subsequent doses _
Topotecan should not be re-administered unless the neutrophil count is
≥1 x 10
9
/l, the platelet coun