Patient leaflet - Siklos 100 mg film-coated tablets
1. WHAT SIKLOS IS AND WHAT IT IS USED FOR
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SIKLOS
Do not take Siklos
- 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”).
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 receiving radiation therapy,
- if you have a known lack of vitamin B12 or folate,
- if you are using a continuous glucose monitor (CGM) to test your blood glucose. Hydroxycarbamide may affect your sensor glucose results and show higher glucose readings than you actually have. This may lead to missing signs of low blood sugar (hypoglycaemia), and it can also cause low blood sugar if you use these readings to adjust your insulin dose. Talk to your healthcare provider that prescribed your CGM about whether it is safe to use while you are taking Siklos.
If you experience (or have experienced) any of the above, please tell your
doctor. If you have any questions, 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.
Other medicines and Siklos
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.
Pregnancy, breast-feeding and fertility
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.
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
Your doctor will tell you how much of Siklos to take each day and will describe the dose in whole, half or quarter tablets.
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.
Handling
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”.
Treatment follow-up
Your doctor will tell you how long to take Siklos.
When taking Siklos you will have regular blood tests and check your liver and kidney. Depending on the dose you take, these tests may be performed monthly or every two months.
Depending on these results your doctor will adjust your dose of Siklos.
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If you take more Siklos than you should
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.
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 further question on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Siklos can cause side effects, although not everybody
gets them.
Tell your doctor immediately if you notice any of the following serious side effects:
- A severe infection,
- Tiredness and/or looking pale,
- Unexplained bruising (accumulation of blood under the skin) or bleeding,
- Unusual headache,
- Difficulties in breathing.
Tell your doctor as soon as possible if you notice any of the following side effects:
- 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.
DETAILS OF SIDE EFFECTS
Very common side effects (may affect more than 1 in 10 people):
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.
Common side effects (may affect up to 1 in 10 people):
Reduced number of red blood cells (anaemia), low platelet count, headache, skin reactions, inflammation or ulceration of the mouth (oral mucositis).
Uncommon side effects (may affect up to 1 in 100 people):
Dizziness, nausea, itching red eruption of the skin (rash), black nails (melanonychia), and hair loss.
Rare side effects (may affect up to 1 in 1 000 people):
Wounds on the legs (leg ulcers), and modification of liver function.
Very rare side effects (may affect up to 1 in 10 000 people) or unknown frequency (frequency cannot be estimated from the available data):
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.
Reporting of side effects
If you get any side effects, talk to your doctor, 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 information on the safety of this medicine.
5. HOW TO STORE SIKLOS
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.
Do not store above 30°C.
Unused broken tablets must be replaced in the bottle and must be used within three months.
If your tablets show any signs of deterioration or discolouration, you should seek the advice of your pharmacist who will tell you what to do.
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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Siklos contains.
- The active substance is hydroxycarbamide.
- Each tablet contains 100 mg hydroxycarbamide.
- The other ingredients are sodium stearyl fumarate, silicified microcrystalline cellulose and basic butylated methacrylate copolymer.
What Siklos looks like and contents of the pack
Siklos 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 tablets are supplied in plastic bottles containing 60 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by
Delpharm Lille, Z.I. de Roubaix Est, Rue de Toufflers, 59390 Lys-lez-Lannoy, France.
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
Leaflet revision and issue date (Ref): 11.10.24[5]
For any information about this medicine, please contact the
Product Licence Holder: Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Email: regulatory@drugsrus.co.uk
Siklos is a trademark of THERAVIA.
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POM
PLGB 20636/3319