Siklos
hydroxycarbamide
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, or pharmacist or nurse.
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 or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
What Siklos is and what it is used for
What you need to know before you take Siklos
How to take Siklos
Possible side effects
5 How to store Siklos
6. Contents of the pack and other information
Siklos is used to prevent painful crises, including sudden chest pain, caused by sickle cell disease, in adults, adolescents and children older than 2 years.
Sickle cell disease is an inherited blood disorder that affects the disc shaped red cells of the blood. Some cells become abnormal, rigid and take a crescent or sickle shape which leads to anemia.
The sickle cells also get stuck in blood vessels, blocking blood flow. This can cause acute pain crises
and organ damage.
For severe painful crises, most patients require hospitalisation. Siklos will decrease the number of painful crises as well as the need for hospitalisation linked with the disease.
The active substance of Siklos, hydroxycarbamide, is a substance which inhibits growth and proliferation of some cells, such as blood cells. These effects lead to a reduction of circulating red, white and coagulation blood cells (myelosuppressive effect). In sickle cell disease, hydroxycarbamide helps also to prevent red blood cells from taking abnormal shape.
if you are allergic to hydroxycarbamide or any of the other ingredients of this medicine (listed in section 6),
if you suffer from severe liver disease,
if you suffer from severe kidney disease,
if you are myelosuppressed (if you have decreased production of red, white, or coagulating blood cells) as described in section 3 “How to take Siklos, Treatment follow-up”,
if you are breast-feeding (see section “Pregnancy, breast-feeding and fertility”).
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 receiving radiation therapy,
if you have a known lack of vitamin B12 or folate.
If you experience (or have experienced) any of the above, please tell your doctor. If you have any question, please ask your doctor or pharmacist or nurse.
Patients and/or parents or the legal responsible person must be able to follow directions regarding the administration of this medicine, their monitoring and care.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Information sharing is especially required for
some antiretroviral medicines (those that inhibit or destroy a retrovirus such as HIV), e.g. didanosine, stavudine and indinavir (a drop in your white cell count may occur),
myelosuppressive medicines (those that decrease production of red, white, or coagulating blood cells) and radiation therapy,
some vaccines.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Siklos is not recommended during pregnancy. Please contact your doctor immediately if you think you may be pregnant. The use of effective contraception is strongly recommended.
If you become pregnant or plan to become pregnant while taking Siklos, your doctor will discuss with you the potential benefits and risks of continuing using Siklos.
For male patients taking Siklos, if your partner becomes pregnant or plans to become pregnant, your doctor will discuss with you the potential benefits and risks of continuing using Siklos.
The active substance of Siklos passes into human breast-milk. You must not breast-feed while taking Siklos.
Hydroxycarbamide may decrease sperm production in male patients while they are being treated.
Some people may experience dizziness when using Siklos. Do not drive or use any tools or machines if you experience dizziness whilst taking Siklos.
Always take Siklos exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The prescribed dose of Siklos must be taken once daily, preferably in the morning before breakfast. It can be taken with a glass of water or a very small amount of food.
If you cannot swallow the tablets, you can disintegrate them in water immediately before use:
Place the required dose (preferably broken if Siklos 1 000 mg tablet is used) in a teaspoon and add some water.
As soon as the tablet is disintegrated, swallow the content of the teaspoon. You can add a drop of syrup or mix the content with food to mask a possible bitter taste.
Then drink a large glass of water or any other drink.
Siklos is a cytotoxic medicine that must be handled with care.
Any person, in particular pregnant women, who are not taking Siklos should avoid direct contact with the parts when breaking a tablet. Wash your hands before and after contact with the tablets.
In case the prescribed dose requires breaking the tablet in halves or quarters, this should be done out of
the reach of food. Powder spilled from the broken tablet should be wiped up with a damp disposable towel which must be thrown out. For the storage of unused broken tablets, see section 5 “How to store Siklos”.
Your doctor will tell you how long to take Siklos.
Depending on these results your doctor will adjust your dose of Siklos.
If you take more Siklos than you should or if a child has taken any, contact your doctor or the nearest hospital immediately as you may need urgent medical treatment. The most common symptoms of overdose with Siklos are:
Redness of the skin,
Soreness (touch is painful) and swelling of the palms of hands and soles of feet followed by the hands and feet becoming scaly,
Skin becoming strongly pigmented (locally changes of colour),
Soreness or swelling in the mouth.
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.
Do not stop your treatment unless advised by your doctor.
If you have any further question on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, Siklos can cause side effects, although not everybody gets them.
A severe infection,
Tiredness and/or looking pale,
Unexplained bruising (accumulation of blood under the skin) or bleeding,
Unusual headache,
Difficulties in breathing.
Fever or chills,
Feeling sick, or a general feeling of being unwell,
Rash (itching red eruption of the skin),
Ulcers or wounds on your legs,
Sore (open skin infection) on your skin,
Disorientation (confusion) and dizziness.
Low blood cell counts (myelosuppression), enlargement of red blood cells,
Absence or low amount of sperm in the semen (azoospermia or oligospermia). Siklos may hence decrease the ability of men to father children.
Reduced number of red blood cells (anaemia), low platelet count, headache, skin reactions, inflammation or ulceration of the mouth (oral mucositis).
Dizziness, nausea, itching red eruption of the skin (rash), black nails (melanonychia), and hair loss.
Wounds on the legs (leg ulcers), and modification of liver function.
Inflammation of the skin causing red scaly patches and possibly occurring together with pain in the
joints.
Isolated cases of malignant disease of blood cells (leukaemia), skin cancer in elderly patients, bleeding, gastrointestinal disturbances, vomiting, skin dryness, fever, absence of menstrual cycles (amenorrhoea), and weight gain.
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use Siklos after the expiry date which is stated on the carton and the bottle after EXP. Store below 30°C.
Unused broken tablets must be replaced in the bottle and must be used within three months.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
The active substance is hydroxycarbamide.
Each Siklos 100 mg film-coated tablet contains 100 mg hydroxycarbamide. Each Siklos 1 000 mg film-coated tablet contains 1 000 mg hydroxycarbamide.
The other ingredients are sodium stearyl fumarate, silicified microcrystalline cellulose and basic butylated methacrylate copolymer.
Siklos 100 mg film-coated tablets are off-white, oblong-shaped tablets with a break line on both sides. The tablet can be divided into two equal parts.
Each half of tablet is embossed “H” on one side.
Siklos 100 mg is supplied in plastic bottles containing 60, 90 or 120 tablets.
Siklos 1 000 mg film-coated tablets are off-white, capsule-shaped tablets marked with three score lines on both sides. The tablet can be divided into four equal parts.
Each quarter of tablet is embossed “T” on one side.
Siklos 1 000 mg is supplied in plastic bottles containing 30 tablets.
All pack sizes may not be marketed.
Addmedica
37 rue de Caumartin 75009 Paris
France
Delpharm Lille
Parc d’Activités Roubaix-Est 22 rue de Toufflers
CS 50070
59452 Lys-lez-Lannoy France
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Addmedica
Tel : +32-(0)2-808 2973
Addmedica
37 rue de Caumartin 75009 Paris - Prancūzija
Tel : +33 (0)1 72 69 01 86
Addmedica
37 rue de Caumartin 75009 Paris - Франция Tel : +33 (0)1 72 69 01 86
Addmedica
37 rue de Caumartin 75009 Paris/Parijs
France/Frankreich/Frankrijk Tel : +33 (0)1 72 69 01 86
Addmedica
37 rue de Caumartin 75009 Paris - Francie
Tel : +33 (0)1 72 69 01 86
Addmedica
37 rue de Caumartin
75009 Párizs - Franciaország Tel : +33 (0)1 72 69 01 86
Øresund Pharma ApS Dronningens Tværgade 9
1302 København K Danmark
+45 53 63 39 16
Addmedica
37 rue de Caumartin 75009 Pariġi - Franza
Tel : +33 (0)1 72 69 01 86
Addmedica
Tel : +49-(0)30-8878 9408
Addmedica
Tel : +31-(0)20-208 2161
Addmedica
37 rue de Caumartin 75009 Pariis - Prantsusmaa Tel : +33 (0)1 72 69 01 86
Øresund Pharma ApS Dronningens Tværgade 9
1302 København K
Danmark
+45 53 63 39 16
DEMO ABEE
Τηλ : +30 210 81 61 802
Addmedica
37 rue de Caumartin 75009 Paris - Frankreich
Tel : +33 (0)1 72 69 01 86
Laboratorios Farmacéuticos ROVI, S.A. Tel : +34 91 375 62 30
Addmedica
37 rue de Caumartin 75009 Paryż - Francja
Tel : +33 (0)1 72 69 01 86
Addmedica
37 rue de Caumartin 75009 Paris
Tel : +33 (0)1 72 69 01 86
Laboratórios Farmacêuticos ROVI, S.A. Tel : +351 213 105 610
Addmedica
37 rue de Caumartin 75009 Pariz
Tel : +33 (0)1 72 69 01 86
Addmedica
37 rue de Caumartin 75009 Paris - Franţa
Tel : +33 (0)1 72 69 01 86
Addmedica
Tel : +353-(0)1-903 8043
Addmedica
37 rue de Caumartin 75009 Pariz - Francija
Tel : +33 (0)1 72 69 01 86
Addmedica
37 rue de Caumartin 75009 Paris - Frakkland Tel : +33 (0)1 72 69 01 86
Addmedica
37 rue de Caumartin 75009 Paris - Francúzsko Tel : +33 (0)1 72 69 01 86
Addmedica
37 rue de Caumartin 75009 Parigi - Francia
Tel : +33 (0)1 72 69 01 86
Øresund Pharma ApS Dronningens Tvaergade 9
1302 Kööpenhamina K Tanska
+45 53 63 39 16
The Star Medicines Importers Co Ltd
Τηλ : +357 25 37 1056
Øresund Pharma ApS Dronningens Tvaergade 9
1302 Köpenhamn K
Danmark
+45 53 63 39 16
Addmedica
37 rue de Caumartin 75009 Paris - Francija
Tel : +33 (0)1 72 69 01 86
Addmedica
Tel : +44-(0)203-695 9305
This leaflet was last revised in MM/YYYY.
. There are also links to other websites about rare diseases and treatments.