Tretinoin 10mg capsules

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Tretinoin

Fáanlegur frá:

Esteve Pharmaceuticals Ltd

ATC númer:

L01XF01

INN (Alþjóðlegt nafn):

Tretinoin

Skammtar:

10mg

Lyfjaform:

Oral capsule

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 08010500

Upplýsingar fylgiseðill

PACKAGE LEAFLET:
INFORMATION FOR THE USER
TRETINOIN
10 MG SOFT CAPSULES
TRETINOIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDI-
CINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have 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 Tretinoin is and what it is used for
2. What you need to know before you take Tretinoin
3. How to take Tretinoin
4. Possible side effects
5. How to store Tretinoin
6.
Contents of the pack and other information 1.
WHAT TRETINOIN IS AND WHAT IT IS USED FOR
Tretinoin
10
mg
soft
capsules
contains
a
medicine
called
tretinoin. This belongs to a group of medicines called
‘retinoids’.
These medicines are similar to vitamin A.
Tretinoin is used to treat a type of blood problem called ‘acute
pro-
myelocytic leukaemia’. It works by slowing the growth of certain
types of diseased blood cells. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRETINOIN
DO NOT TAKE TRETINOIN IF YOU ARE ALLERGIC TO:
•
tretinoin or any of the other ingredients of this medicine
(listed in section 6)
•
other ‘retinoid’ medicines. These include isotretinoin, acitretin
and tazarotene
•
peanuts or soya. This is because Tretinoin contains soya-bean oil.
DO NOT TAKE TRETINOIN IF:
•
you
are
pregnant,
planning
to
become
pregnant
or
breast-
feeding (see section 2, Pregnancy, breast-feeding and fertility)
• you are taking vitamin A, tetracyclines or retinoids.
DO NOT TAKE THIS MEDICINE IF ANY OF THE ABOVE APPLY TO YOU.
IF YOU ARE NOT SURE, TALK TO YOUR DOCTOR OR PHARMACIST BEFORE
TAKING TRETINOIN.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Tretinoin if:
• you

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Vesanoid
10 mg soft capsules
Tretinoin 10mg soft capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
1 soft capsule contains 10 mg of tretinoin (all-trans retinoic acid,
ATRA)
Excipients with known effect:
1 soft capsule contains 107.92 mg of soya-bean oil.
The capsule-shell contains between 1.93 – 2.94 mg of sorbitol.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsule, soft
Oval, bi-coloured orange-yellow/reddish-brown capsules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vesanoid/Tretinoin is indicated in combination with arsenic trioxide
or chemotherapy
for the treatment of patients with acute promyelocytic leukaemia (APL)
which is
newly diagnosed, relapsed or refractory to chemotherapy (see sections
4.2 and 5.1).
Treatment regimens
Combination of tretinoin with chemotherapy or arsenic trioxide is
known to be
effective and to induce very high rates of haematologic remission in
patients with
genetically confirmed APL, i.e. patients whose blasts harbor the
t(15;17) by
karyotyping or FISH or the PML-RARa fusion as detected by PCR. Thus,
genetic
confirmation of diagnosis is mandatory. Combination treatment with
arsenic trioxide
has been shown an effective treatment option in patients with newly
diagnosed low-
to-intermediate risk APL. However, because APL is characterized by
high risk of
early haemorrhagic death, current recommendations dictate that early
treatment with
tretinoin is started as soon as possible upon morphologic suspicion
only.
For the selection of treatment strategy the relapse risk - indicated
by pre-therapeutic
white blood cell count (WBC) and platelet count (Sanz score) with
high-risk (WBC
>10x10
9
/L), intermediate risk (WBC
≤
10x10
9
/L, platelet count
≤
40x10
9
/L), and low
risk (WBC
≤
10x10
9
/L, platelet count > 40x10
9
/L) - should be taken into
consideration.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For all therapy phases a total daily dose of 45 mg/m
2