50 mg coated tablet
cyclophosphamide
What Sendoxan is and what it is used for
Sendoxan is an anti-cancer agent that damages the genetic material in the cells in a way that inhibits cell division and kills the cells. Sendoxan also inhibits the immune system.
Sendoxan is mainly used in various types of cancer and against certain so-called autoimmune diseases, such as long-term and severe rheumatoid arthritis ( rheumatoid arthritis ).
What you need to know before using Sendoxan
Do not use Sendoxan:
- If you have ever had an allergic reaction to cyclophosphamide or any of the other ingredients of Sendoxan. An allergic reaction may have symptoms such as difficulty breathing, wheezing, rash, itching, or swelling of the face and lips.
- If your bone marrow is not working properly (especially if you have previously been treated with chemotherapy and/or radiation therapy). Your blood will be tested to check your bone marrow function.
- if you have an ongoing inflammation of the bladder, which is manifested by pain when urinating ( cystitis )
- if you have an ongoing infection.
- if you have difficulty urinating due to any urinary tract obstruction.
- if you are breastfeeding.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Sendoxan:
- if you are receiving or have recently received radiation therapy or chemotherapy.
- if you have liver problems.
- if you have kidney problems. Your doctor will take blood samples to check how well your kidneys and liver are working.
- if you have heart problems or have received radiation therapy to the heart area.
- if you have generally poor health and are weak.
- if you are older.
- if you are planning to become pregnant (see section “Pregnancy, breast-feeding and fertility )
- Sendoxan contains lactose . If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Sendoxan can in rare cases affect the white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/pharynx/mouth or urination problems, you should see a doctor immediately so that a blood test can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then have information about your medication.
Stop taking Sendoxan and contact your doctor as soon as possible if you experience unexplained muscle pain, muscle cramps, or muscle weakness.
Effects on the blood and immune system
- The blood cells are produced in the bone marrow. There are three types: red blood cells, which carry oxygen around the body, white blood cells that fight infection, and platelets, which cause the blood to clot.
- After taking Sendoxan, the number of all three types of blood cells will decrease. This is an unavoidable side effect of Sendoxan. The number of blood cells will reach its lowest level about 5 – 10 days after you start taking Sendoxan, and will remain low until a few days after the end of the treatment. Most people achieve normal blood cell counts within 21-28 days. If you have received a lot of chemotherapy before, it may take longer to reach a normal level.
- You will probably get an infection when the number of blood cells decreases. Try to avoid close contact with people who cough, have a cold, or have other infections.
- Your doctor will check if the blood cell count is high enough before and during treatment with Sendoxan.
Impact of the gums
Careful oral hygiene is important as sores and infections in your mouth can occur. Talk to your doctor about this if you are unsure.
Effects on the bladder
- Sendoxan can damage the inner walls of the bladder and cause bleeding. Your doctor knows that this may occur, and if necessary you will be given a medicine called Uromitexan (Mesna) which protects the bladder.
- Uromitexane (Mesna) can be given as an injection, mixed in the intravenous solution, or as tablets.
- Most people who receive Sendoxan together with the mesna experience no problems with the bladder, but the doctor may want to test the urine for any blood content by using a urine stick or microscope.
- Tell your doctor immediately if you notice blood in your urine.
Other medicines and Sendoxan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
When Sendoxan is used at the same time as other medicines, the effect may affect or be affected by the other medicines. This increases the risk of side effects and other unwanted effects.
Examples of medicines that affect or are affected by Sendoxan:
- Allopurinol, used against gout, may aggravate the side effects of Sendoxan.
- Suxamethone, a muscle relaxant used during surgeries, may have an enhanced effect.
- Medicines used in connection with the treatment of cancer
- Some medicines for inflammation and pain (indomethacin) increase the risk of slower excretion of water, which can lead to water accumulation in the body.
- Certain medicines for epilepsy (phenobarbital, phenytoin, carbamazepine)
- Certain medicines for stomach ulcers (cimetidine)
- Some medicines for high blood pressure (hydrochlorothiazide)
- Some medicines for infection (such as ciprofloxacin, sulfonamides, clarithromycin, and telithromycin)
- Some antifungal medicines ( fluconazole , itraconazole, ketoconazole , posaconazole, voriconazole)
- Some medicines for nausea (aprepitant)
- Some drugs that inhibit the immune system (azathioprine, ciclosporin, natalizumab)
- Rifampicin used for tuberculosis
- Busulfan given in bone marrow transplants
- Bupropion used in smoking cessation may affect the effect of Sendoxan
- Drugs that inhibit blood clotting, e.g. warfarin and prasugrel
- Some antibiotics such as amphotericin B
- Zidovudine, which is used to treat viral infections and a type of medicine called a protease inhibitor
- Tamoxifen, used in hormone therapy for breast cancer
- Certain types of drugs for irregular heartbeat, such as amiodarone
- Some medicines for heart failure ( digoxin )
- Medicines for high blood pressure such as verapamil, ACE inhibitors
- Radiation therapy of the heart area
- Medicines that belong to the group of corticosteroids
- If you are going to be vaccinated, you must tell them that you are being treated with Sendoxan, as the effect of the vaccine can sometimes be impaired, and in some cases, the vaccination can cause an infection.
- Medicines for mild depression also called hypericum such as St. John’s wort
Sendoxan with food, drink, and alcohol
The risk of nausea and vomiting increases with alcohol consumption.
Pregnancy, breastfeeding, and fertility
You should not get pregnant while taking cyclophosphamide. This is because the fetus can be injured. Tell your doctor if you are pregnant, suspect you may be pregnant, or are planning to have a baby.
- Neither men nor women should try to have children within 6-12 months after finishing treatment. Use an effective contraceptive. Ask your doctor for advice.
- Talk to your doctor about the possibility of freezing semen or eggs before starting treatment. Do not breastfeed during treatment with cyclophosphamide. Ask your doctor for advice.
Driving and using machines
Certain side effects such as dizziness, blurred vision, and impaired vision can indirectly affect the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to take Sendoxan
Dose one is determined by the doctor, who adjusts it individually for you.
Do not split or crush the tablet.
The usual dose for adults is 1-2 (-4) tablets per day.
Dose one is determined by the doctor, who adjusts it individually for you. Factors that determine the size of the dose are:
- what disease you are being treated for
- your height and weight
- your general condition
- if you are taking any other medicines for cancer or radiation therapySendoxan is usually given as a series of cures. After each treatment, a break is taken (a period without the addition of Sendoxan) before the next treatment.
If you use too much Sendoxan
If you have ingested too much medicine, always contact a doctor or hospital.
Possible side effects
Like all medicines, Sendoxan can cause side effects, although not everybody gets them.
Common (affects more than 1 user in 100):
- Impaired bone marrow function, can lead to a lack of white blood cells (susceptibility to infection), platelets (risk of bleeding), and anemia
- Inflammation of the conjunctiva of the eye
- Nausea, vomiting, diarrhea, constipation, abdominal pain
- Skin rash including hives
- Liver effects
- Hair loss
- Inflammation of the bladder with blood in the urine
Rare (affects less than 1 user in 1,000): - Severe hypersensitivity reaction (anaphylactic shock )
- Tumor disease/cancer caused by the treatment
- Reduced salinity in the blood
- Fluid accumulation
- Loss of appetite and weight loss
- Dizziness
- Dimsyn.
- Heart effect.
- Connective tissue changes in the lungs
- Suva
- Inflammation and ulcers of the mucous membranes
- Inflammation of the pancreas
- Bleeding and inflammation of the gastrointestinal tract
- Skin and nail changes
- Changes in kidney, ureter, and bladder
- Failure to menstruate,
- Absence/reduction of sperm in the semen
- Headache
- Fever
- Local reactions at the injection site (swelling, redness, sores)
Very rare (affects less than 1 user in 10,000): - Severe mucositis – and skin inflammation with high fever ( Stevens-Johnson syndrome ) and severe skin reactions with skin detachment ( toxic epidermal necrolysis ).
Has been reported (occurs in an unknown number of users): - Pneumonia, blood poisoning
- Rapid decay of tumor cells
- Tumor/cancer disease in offspring
- Uncontrolled blood clotting ( DIC )
- Hemolytic uremic syndrome (complex symptom picture with, among other things, anemia, spotty bleeding in the skin, and sometimes acute kidney failure .)
- Immunocompromised
- Water poisoning (eg confusion, headache, dizziness)
- Blood sugar changes
- Confusion
- Brain effects, seizures, nerve effects (odor and taste changes)
- Impaired vision, increased tear flow
- Earrings, deafness
- Cardiac arrhythmias
- Heart failure
- Myocardial infarction, angina (chest pain)
- Blood clots in vessels and lungs
- Blood pressure changes
- Acute Respiratory Syndrome (ARDS)
- Lung impact e.g. shortness of breath, cough, and lack of oxygen
- Cramps in the trachea
- Nasal congestion, sneezing
- Inflammation of the parotid gland
- Stop in the bile ducts
- Jaundice
- Fluid in the abdomen
- Muscle breakdown, muscle cramps
- Increased sweating ( hyperhidrosis )
- Severe skin changes ( scleroderma )
- Muscle and joint pain
- Renal impairment including renal failure
- Cystitis , bladder contraction (contracture)
- Large amounts of urine ( diabetes insipidus )
- Urinary tract bleeding including bleeding urinary tract infection
- Inability to have children ( infertility )
- Premature birth
- Fetal death, malformations, or growth disorders in the fetus
- Weakness, fatigue, the feeling of weakness
- Flu-like illness, pain, chills
- Changes in blood test results contact a doctor immediately if you see blood in the urine, get a sudden and unexplained fever, have unusual pain or swelling in the legs, hold in the chest and difficulty breathing or have a feeling of pain and heaviness in the chest.
Some side effects may occur after the end of treatment with Sendoxan. Therefore, also contact the hospital staff or your doctor if you suspect that you have experienced side effects after the end of treatment.
How to store Sendoxan
Keep out of sight and reach of children.
Store below 25 ° C.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is cyclophosphamide monohydrate equivalent to cyclophosphamide 50 mg.
- The other ingredients are sucrose, corn starch, lactose monohydrate 24.6 mg, talc, calcium hydrogen phosphate dihydrate, titanium dioxide (dye E 171), calcium carbonate, and macrogol 35,000, colloidal silicon dioxide, magnesium stearate, gelatin, povidone, polysorcolosol % wax.
What the medicine looks like and the contents of the pack
Printed packaging, 100 tablets
Marketing Authorization Holder and Manufacturer
Baxter Medical AB
Box 63
SE-16494 Kista
Manufacturer:
Baxter Oncology GmbH
Plant Künsebeck
Kantstrasse 2
D-33790 Halle Künsebeck
Germany