40 mg hard lomustine capsules
What Lomustine medac is and what it is used for
Lomustine medac belongs to a group of anticancer medicines called nitrosourea compounds. These drugs inhibit the growth of cancer cells.
Lomustine medac is used to treat different types of cancer, especially for the treatment of brain tumors, malignant melanoma (a type of skin cancer), and lymphoma (a tumor of the lymph nodes).
Lomustine contained in Lomustine medac may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before taking Lomustine medac
Before you start taking lomustine, your doctor will check that your lung, liver, and kidney function are adequate. These tests will be performed throughout the treatment.
Be aware that lomustine can affect the function of blood formation and that this effect may occur after a certain time. It may increase the risk of bleeding or getting an infection.
The toxic (toxic) effects that lomustine has on your blood formation system are gradually increasing. Therefore, your doctor will check your blood levels, probably once a week during the whole treatment and up to 6 weeks after the end of the treatment.
Do not take Lomustine medac
- if you are allergic to lomustine or any of the other ingredients of this medicine (listed in section 6)
- if you have a history of hypersensitivity to similar drugs (nitrosurea compounds)
- if you do not have enough blood cells (before the treatment, always take some blood samples to check that you have enough blood cells )
- if you have impaired kidney function
- if you have celiac disease (a severe digestive disorder in the small intestine) or are allergic to wheat
- if you have been vaccinated against yellow fever or any other live vaccine and have a weakened immune system
- if you are pregnant
- if you are breast-feeding.
Warnings and cautions
Talk to your doctor or pharmacist before taking Lomustine medac.
Be aware that you are handling a cancer drug. Be careful not to come in contact with the contents of the capsule and wash your hands with soap and water after handling lomustine.
Both female and male patients of childbearing potential should use contraception during treatment and for at least 6 months after stopping treatment. See also under the heading “Pregnancy and breastfeeding”.
It has been reported that long-term use of nitrosoureas compounds may be associated with the development of new cancerous tumors (secondary cancer).
Other medicines and Lomustine medac
The interaction (interaction) between lomustine and other drugs has not been specifically investigated. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Treatment may be affected if you use certain other medicines such as medicines containing
- theophylline (used for asthma , for example )
- cimetidine (used to treat stomach ulcers, for example )
- phenobarbital (used to treat epilepsy )
- second cytostatic (cell inhibitor), as the coadministration may result in complications due to interaction s between drug.
You should also tell your doctor if you have been recently vaccinated.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Lomustine medac should not be used during pregnancy or if you are planning to become pregnant. Both men and women should use contraception during treatment with lomustine and for at least six months after stopping treatment.
If you are planning to become pregnant, consult your doctor first. Also contact your doctor immediately if you become pregnant during treatment, as taking lomustine may have a detrimental effect on the fetus.
Breast-feeding
You should not breastfeed while being treated with Lomustine medac, as lomustine may be excreted in human milk. If you need to be treated with lomustine, you should not breastfeed.
Fertility
Men treated with lomustine should not have children during treatment and up to 6 months after stopping treatment. Ask your doctor about any precautions, such as preserving your sperm before starting treatment, as lomustine may affect fertility.
Driving and using machines
Lomustine medac can have negative effects on the ability to drive and use machines, for example, due to nausea and vomiting.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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, nurse, or pharmacist.
Lomustine medac contains lactose and wheat starch
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine also contains wheat starch. Patients with wheat allergy or celiac disease should not take this medicine (see above “Do not take Lomustine medac”).
How to take Lomustine medac
Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
Dose one is determined by the doctor, who adjusts it individually for you.
Dose one depends on your blood counts and other chemotherapy treatments. Your doctor will calculate the dose according to your weight and the measured blood values. Your doctor will reduce the dose one if you are also receiving other chemotherapy or radiotherapy.
Dose one for a normal-sized person can be expected to be about 200 mg lomustine. Lomustine medac capsules are usually taken at one time or spread over 3 days every six to eight weeks. You should take lomustine exactly as your doctor advised and at least 6 weeks apart.
Swallow the capsules whole with at least half a glass of water. Do not break the Lomustine medac capsules. If you accidentally get the contents of the capsules on the skin or in your mouth, rinse it off with copious amounts of water.
It is important to complete the treatment exactly as your doctor prescribed. Do not stop treatment prematurely without first consulting your doctor.
Your doctor may change the dose and how often you should take the capsules depending on your blood test, your general condition, other treatments, and the effect of Lomustine medac. If you have any further questions on the use of this product, ask your doctor, nurse, or pharmacist.
If you have the impression that the effect of Lomustine medac is too strong or too weak, talk to your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if any of the following side effects occur:
Very common (may affect more than 1 user in 10)
- Various types of effects on the blood, such as insufficient number of red blood cells , white blood cells and / or platelets . This can i.a. turn out that you get bruises more easily than usual or suffer from repeated infections , such as sore throat or cough. If this happens, you should contact your doctor immediately.
- Nausea, vomiting and loss of appetite. Nausea and vomiting usually occur approximately 3-6 hours after you have taken your dose and may last for 24-48 hours, possibly followed by decreased appetite for 2-3 days. Your doctor may prescribe other medicines (antiemetics) that you can take at the same time to relieve this. It may also help to take lomustine on an empty stomach.
Common (may affect up to 1 in 10 people)
- Effect on the liver (usually transient) and increase in liver enzymes. In rare cases , jaundice may occur due to decreased bile flow. You should contact a doctor immediately if you experience symptoms of liver damage such as yellow skin and whites of the eyes.
Uncommon (may affect up to 1 in 100 people)
- Apathy , orientation difficulties, confusion and stuttering.
Rare (may affect up to 1 in 1000 users )
- Pneumonia . You should contact a doctor immediately if you experience symptoms such as dry, non-productive cough or shortness of breath.
Very rare (may affect up to 1 in 1,000 people)
- Kidney failure , decreased kidney size and kidney damage. You should contact a doctor immediately if you experience symptoms of kidney damage such as swelling of the hands, ankles or feet or changes in how often you need to urinate, decreased urine output or lack of urine.
Other possible side effects:
Common (may affect up to 1 in 10 people)
- Inflammation of the mouth ( stomatitis )
- Diarrhea
Rare (may affect up to 1 in 1,000 people)
- Lung reactions with changes in lung tissue seen on X-ray, shortness of breath and dry cough
Very rare (may affect up to 1 in 10,000 people)
- Emergence of cancer of another type (secondary malignancy )
- Persistent visual impairment (in combination with radiation therapy)
- Hair loss
Has been reported (occurs in an unknown number of users)
- Acute leukemia (blood cancer) and myelodysplastic syndrome (blood disease associated with insufficient formation of blood cells in the bone marrow )
- Abnormal coordination
- Sleepiness, inertia
- Speech difficulties, unclear speech
- Increase in bilirubin (degradation product in the red pigment of the blood)
How to store Lomustine medac
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Store the capsules in the original package. Sensitive to light. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the carton.
Medicines 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 lomustine. One capsule contains 40 mg of lomustine.
- The other ingredients are anhydrous lactose , wheat starch, talc and magnesium stearate. The capsule shell consists of gelatin and the dyes titanium dioxide (E 171) and indigo carmine (E 132).
What the medicine looks like and contents of the pack
The capsules are blue and hard.
Pack size: 20 capsules.
Marketing Authorization Holder and Manufacturer
medac
Society for Clinical Specialties MBH
Theater. 6
22880 Wedel
Germany
Tel: +49 4103 8006-0
Fax: +49 4103 8006-100
Information is provided by
medac
Box 120
432 23 Varberg
Tel: 0340 64 54 70