Xermelo 250mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Telotristat ethyl

Available from:

Ipsen Ltd

INN (International Name):

Telotristat ethyl

Dosage:

250mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 3582186005033

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XERMELO 250 MG FILM-COATED TABLETS
telotristat ethyl
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Xermelo is and what it is used for
2.
What you need to know before you take Xermelo
3.
How to take Xermelo
4.
Possible side effects
5.
How to store Xermelo
6.
Contents of the pack and other information
1.
WHAT XERMELO IS AND WHAT IT IS USED FOR
WHAT XERMELO IS
This medicine contains the active substance telotristat ethyl.
WHAT XERMELO IS USED FOR
This medicine is used in adults with a condition called ‘carcinoid
syndrome’. This is when a tumour,
called a ‘neuroendocrine tumour’, releases a substance called
serotonin into your bloodstream.
Your doctor will prescribe this medicine if your diarrhoea is not well
controlled with injections of
other medicines called ‘somatostatin analogues’ (lanreotide or
octreotide). You should keep having
injections of these other medicines when taking Xermelo.
HOW XERMELO WORKS
When the tumour releases too much serotonin into your bloodstream you
can get diarrhoea.
This medicine works by reducing the amount of serotonin made by the
tumour. It will reduce your
diarrhoea.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XERMELO
DO NOT TAKE XERMELO:
-
if you are allergic to telo

Summary of Product characteristics

OBJECT 1
XERMELO 250 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 05-Feb-2018 | Ipsen Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Xermelo 250 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains telotristat etiprate equivalent to
250 mg telotristat ethyl.
Excipient with known effect
Each tablet contains 168 mg of lactose (as anhydrous).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White to off-white film-coated oval tablets (approximately 17 mm long
by 7.5 mm wide) with 'T-E'
debossed on one side and '250' debossed on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Xermelo is indicated for the treatment of carcinoid syndrome diarrhoea
in combination with somatostatin
analogue (SSA) therapy in adults inadequately controlled by SSA
therapy.
4.2 Posology and method of administration
Posology
The recommended dose is 250 mg three times daily (tid).
Available data suggest that clinical response is usually achieved
within 12 weeks of treatment.
It is recommended to reassess the benefit of continued therapy in a
patient not responding within this time
period.
Based on the high inter-subject variability observed, accumulation in
a subset of patients with carcinoid
syndrome cannot be excluded. Therefore, intake of higher doses is not
recommended (see section 5.2).
_Missed doses _
In the event of a missed dose, patients should take their subsequent
dose at the next scheduled time point.
Patients should not take a double dose to make up for a missed dose.
_Elderly patients (65 years of age and above)_
No specific dose recommendations are available for elderly patients
(see section 5.2).
_Renal impairment_
No specific study has been performed in pat