Patient leaflet - Siklos 100 mg tablets
1. WHAT SIKLOS IS AND WHAT IT IS U
Siklos is used to prevent painful crises,
or
u take Siklos
ormation
SED FOR
including sudden
chest pain, caused by sickle cell diseas adolescents and children older than 2 Sickle cell disease is an inherited blood affects the disc shaped red cells of the Some cells become abnormal, rigid an or sickle shape which leads to anemia. The sickle cells also get stuck in blood blood flow. This can cause acute pain c damage.
For severe painful crises, most patients hospitalisation. Siklos will decrease the
e, in adults,
years.
disorder that blood.
d take a crescent
vessels, blocking rises and organ
require
number of
painful crises as well as the need for ho linked with the disease.
The active substance of Siklos, hydroxy
spitalisation
carbamide, is a
substance which inhibits growth and p some cells, such as blood cells. These e a reduction of circulating red, white an blood cells (myelosuppressive effect). I disease, hydroxycarbamide helps also t
roliferation of ffects lead to d coagulation n sickle cell
o prevent red
blood cells from taking abnormal shap
2. WHAT YOU NEED TO KNOW BEFORE
e.
YOU TAKE SIKLOS
Do not take Siklos
if you are allergic to hydroxycarbam
other ingredients of this medicine (
- if you suffer from severe liver disea
- if you suffer from severe kidney dis
if you are myelosuppressed (if you
production of red, white, or coagu cells) as described in section 3 “Ho Treatment follow-up”,
if you are breast-feeding (see secti
breast-feeding and fertility”).
ide or any of the listed in section 6), se,
ease,
have decreased lating blood
w to take Siklos,
on “Pregnancy,
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Siklos
- if you have a liver disease,
- if you have a kidney disease,
- if you have leg ulcers,
if you are taking other myelosuppressive medicines
(decrease production of red, white, or coagulating
blood cells) or
- if you have a k
if you are using
to test your blo may affect you higher glucose This may lead t (hypoglycaemi sugar if you us insulin dose. Ta prescribed you while you are t If you experience (o
receiving radiation therapy,
nown lack of vitamin B12 or folate, a continuous glucose monitor (CGM) od glucose. Hydroxycarbamide r sensor glucose results and show readings than you actually have.
o missing signs of low blood sugar a), and it can also cause low blood e these readings to adjust your lk to your healthcare provider that r CGM about whether it is safe to use aking SIKLOS.
r have experienced) any of the
above, please tell y please ask your doc If you experience p redness and pain o or worsening vision please consult a do be indicative of a ra limbal stem cell de Patients and/or par person must be abl administration of t
our doctor. If you have any question, tor or pharmacist or nurse.
ersistent eye problems such as f the eyes, sensitivity to light, and/ while taking hydroxycarbamide, ctor promptly because these can re but serious ocular disease called ficiency. See also section 4.
ents or the legal responsible e to follow directions regarding the his medicine, their monitoring and
care.
Other medicines a
Tell your doctor or recently taken or m Information sharin
some antiretro
destroy a retro stavudine and count may occ
myelosuppress
production of r
nd Siklos
pharmacist if you are taking, have ight take any other medicines. g is especially required for
viral medicines (those that inhibit or virus such as HIV), e.g. didanosine, indinavir (a drop in your white cell ur),
ive medicines (those that decrease ed, white, or coagulating blood cells)
and radiation t
- some vaccines
Pregnancy, breast-
If you are pregnant pregnant or are pla for advice before ta Siklos is not recom contact your docto pregnant. The use o recommended.
herapy,
.
feeding and fertility
or breast-feeding, think you may be nning to have a baby, ask your doctor king this medicine.
mended during pregnancy. Please r immediately if you think you may be f effective contraception is strongly
If you become preg while taking Siklos, potential benefits a For male patients t pregnant or plans t will discuss with yo continuing using Si The active substan milk. You must not Hydroxycarbamide male patients while
nant or plan to become pregnant your doctor will discuss with you the nd risks of continuing using Siklos. aking Siklos, if your partner becomes
o become pregnant, your doctor u the potential benefits and risks of klos.
ce of Siklos passes into human breast-breast-feed while taking Siklos. may decrease sperm production in they are being treated.
Driving and using machines
Some people may experience dizziness when using Siklos. Do not drive or use any tools or machines if you experience dizziness whilst taking Siklos.
3. HOW TO TAKE SIKLOS
Always take Siklos exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Dose
The usual starting dose for adults, adole children older than 2 years is 15 mg/kg The usual maintenance dose is between Your doctor will tell you how much of each day and will describe the dose in quarter tablets.
The prescribed dose of Siklos must be t preferably in the morning before breakf It can be taken with a glass of water or a amount of food.
If you cannot swallow the tablets, you c
scents and
each day.
15-30 mg/kg. Siklos to take whole, half or
aken once daily, ast.
very small
an disintegrate
them in water immediately before use
Place the required dose (preferably
1 000 mg tablet is used) in a teaspo water.
As soon as the tablet is disintegrate
the content of the teaspoon. You ca of syrup or mix the content with fo possible bitter taste.
- Then drink a large glass of water or
Handling
:
broken if Siklos on and add some
d, swallow
n add a drop od to mask a
any other drink.
Siklos is a cytotoxic medicine that must care.
Any person, in particular pregnant wom taking Siklos should avoid direct contac when breaking a tablet. Wash your han after contact with the tablets.
In case the prescribed dose requires bre in halves or quarters, this should be don reach of food. Powder spilled from the b should be wiped up with a damp dispo which must be thrown out. For the stor broken tablets, see section 5 “How to st
be handled with
en, who are not t with the parts ds before and
aking the tablet e out of the
roken tablet sable towel
age of unused ore Siklos”.
Treatment follow-up
Your doctor will tell you how long to tak When taking Siklos you will have regu and check your liver and kidney. Depe dose you take, these tests may be perf or every two months.
Depending on these results your docto dose of Siklos.
If you take more Siklos than you shoul
e Siklos.
lar blood tests nding on the ormed monthly
r will adjust your
d
If you take more Siklos than you should taken any, contact your doctor or the n immediately as you may need urgent m The most common symptoms of overd are:
- Redness of the skin,
Soreness (touch is painful) and swe
of hands and soles of feet followed and feet becoming scaly,
Skin becoming strongly pigmented
of colour),
Soreness or swelling in the mouth.
or if a child has earest hospital edical treatment. ose with Siklos
lling of the palms by the hands
(locally changes
If you forget to take Siklos
Do not take a double dose to make up for a forgotten tablet. Continue as normal when it is time to take the next dose as prescribed by your doctor.
If you stop taking Siklos
Do not stop your treatment unless advised by your doctor.
If you have any furt medicine, ask your d
4. POSSIBLE SIDE E
Like all medicines, S not everybody gets Tell your doctor im following serious si
- A severe infecti
- Tiredness and/o
Unexplained br
the skin) or ble
her question on the use of this octor or pharmacist.
FFECTS
iklos can cause side effects, although them.
mediately if you notice any of the de effects:
on,
r looking pale,
uising (accumulation of blood under eding,
- Unusual heada
- Difficulties in br
Tell your doctor as of the following si
- Fever or chills,
- Feeling sick, or
- Rash (itching re
- Ulcers or woun
- Sore (open skin
Disorientation (
che,
eathing.
soon as possible if you notice any de effects:
a general feeling of being unwell, d eruption of the skin),
ds on your legs,
infection) on your skin,
confusion) and dizziness.
DETAILS OF SIDE Very common side 10 people):
Low blood cell coun of red blood cells, Absence or low amo (azoospermia or olig decrease the ability Common side effec
Reduced number of platelet count, head
EFFECTS
effects (may affect more than 1 in
ts (myelosuppression), enlargement
unt of sperm in the semen
ospermia). Siklos may hence of men to father children.
ts (may affect up to 1 in 10 people):
red blood cells (anaemia), low ache, skin reactions, inflammation or
ulceration of the mo Uncommon side eff
Dizziness, nausea, it black nails (melano Rare side effects (m
Wounds on the legs function.
Very rare side effec people) or unknow estimated from the
uth (oral mucositis).
ects (may affect up to 1 in 100 people):
ching red eruption of the skin (rash), nychia), and hair loss.
ay affect up to 1 in 1 000 people):
(leg ulcers), and modification of liver
ts (may affect up to 1 in 10 000 n frequency (frequency cannot be available data):
Inflammation of the possibly occurring t Isolated cases of ma (leukaemia), skin ca gastrointestinal dist ulcer, severely low l skin dryness, fever, a (amenorrhoea), and Persistent eye probl eyes, sensitivity to li stem cell deficiency
skin causing red scaly patches and ogether with pain in the joints. lignant disease of blood cells ncer in elderly patients, bleeding, urbances, vomiting, gastrointestinal evels of magnesium in the blood, bsence of menstrual cycles weight gain.
ems such as redness and pain of the ght, and/or worsening vision (limbal ). See also section 2.
Reporting of side effects
If you get any side effects, talk to your doctor or, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more
i
nformation on the safety of this medicin
5. HOW TO STORE SIKLOS
Keep this medicine out of the sight and children.
Do not use Siklos after the expiry date w the carton and the bottle after EXP. Store below 30°C.
Unused broken tablets must be replaced and must be used within three months. Do not throw away any medicines via w household waste. Ask your pharmacist h
e.
reach of
hich is stated on
in the bottle
astewater or
ow to throw
away medicines you no longer use. Thes help to protect the environment.
6. CONTENTS OF THE PACK AND OTHE INFORMATION
What Siklos contains
The active substance is hydroxycarb
Each Siklos 100 mg film-coated tabl 100 mg hydroxycarbamide. Each Siklos 1 000 mg film-coated ta 1 000 mg hydroxycarbamide.
e measures will
R
amide.
et contains
blet contains
The other ingredients are sodium st
silicified microcrystalline cellulose a butylated methacrylate copolymer.
What Siklos looks like and contents of t
Siklos 100 mg film-coated tablets are off shaped tablets with a break line on both can be divided into two equal parts. Each half of tablet is embossed “H” on on Siklos 100 mg is supplied in plastic bottl 90 or 120 tablets.
earyl fumarate, nd basic
he pack
-white, oblong- sides. The tablet
e side.
es containing 60,
Siklos 1 000 mg film-coated tablets are o capsule-shaped tablets marked with thr on both sides. The tablet can be divided parts.
Each quarter of tablet is embossed “T” o Siklos 1 000 mg is supplied in plastic bot 30 tablets.
All pack sizes may not be marketed.
ff-white,
ee score lines into four equal
n one side.
tles containing
Marketing Authorisation Holder
THERAVIA
16 rue Montrosier 92200 Neuilly-sur-Seine France
Manufacturer
Delpharm Lille
Parc d’Activités Roubaix-Est
22 rue de Toufflers CS 50070
59452 Lys-lez-Lanno France
This leaflet was last
EN
For any information contact the local rep Authorisation Holde
y revised in 08/2026.
about this medicine, please resentative of the Marketing r:
Great-Britain
Norgine
Tel: +44 1895 826606 hydroxycarbamide
hydroxycarbamide 44406601