Active ingredient
- fostamatinib disodium hexahydrate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/19/1405/002.
Tavlesse
Package leaflet: Information for the patient
TAVLESSE 100 mg film-coated tablets
TAVLESSE 150 mg film-coated tablets
fostamatinib disodium hexahydrate
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What TAVLESSE is and what it is used for
2. What you need to know before you take TAVLESSE
3. How to take TAVLESSE
4. Possible side effects
5. How to store TAVLESSE
6. Contents of the pack and other information
1. What TAVLESSE is and what it is used for
What TAVLESSE is
TAVLESSE contains the active substance fostamatinib. It specifically targets an enzyme called spleen tyrosine kinase, that plays an important part in the destruction of platelets. In this way TAVLESSE limits platelet destruction by the immune system and increases platelet count in the body. This helps reduce the risk of severe bleeding.
What TAVLESSE is used for
TAVLESSE is used to treat adults with low platelet counts due to chronic immune thrombocytopenia (ITP) when an earlier treatment for ITP has not worked well enough. ITP is an autoimmune disease, in which the body’s own immune system attacks and destroys platelets in the blood. Platelets are needed to help create clots and stop bleeding.
2. What you need to know before you take TAVLESSE
Do not take TAVLESSE
Warnings and precautions
Talk to your doctor or pharmacist before taking TAVLESSE, about all of your medical conditions, particularly if you:
Tell your doctor, pharmacist or nurse immediately if you get any of the following symptoms while you are taking this medicine:
Children and adolescents
TAVLESSE should not be used in patients less than 18 years of age. This medicine has not been studied in this age group.
Other medicines and TAVLESSE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Taking TAVLESSE with certain other medicines may affect how the other medicines work and other medicines may affect how TAVLESSE works.
In particular, tell your doctor if you are taking anything in this list:
Pregnancy, breast-feeding and fertility
Pregnancy
TAVLESSE should not be used during pregnancy. It can cause harm or birth defects to your unborn baby.
If you are pregnant, if think you may be pregnant or if you are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you are a woman who could become pregnant, you must use reliable contraception while you are taking TAVLESSE, and you must continue to use reliable contraception for at least 1 month after taking your last dose.
Contact your doctor straight away if you become pregnant while taking this medicine.
Breast-feeding
TAVLESSE is not recommended while breast-feeding. You should not breastfeed during treatment with TAVLESSE and for at least 1 month after your last dose.
If you are breast-feeding, or are planning to breast-feed, ask your doctor or pharmacist for advice before taking this medicine.
Fertility
TAVLESSE may affect the ability of a woman to get pregnant and have a child. Talk to your doctor if this is a concern for you. There is no impact on males.
TAVLESSE contains sodium
TAVLESSE 100 mg film-coated tablets contains 23 mg sodium (main component of cooking/table salt) per tablet. This is equivalent to 1.2% of the recommended maximum daily dietary intake of sodium for an adult.
TAVLESSE 150 mg film-coated tablets contains 34 mg sodium (main component of cooking/table salt) per tablet. This is equivalent to 1.7% of the recommended maximum daily dietary intake of sodium for an adult.
3. How to take TAVLESSE
How much to take
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Before starting treatment, your doctor will measure your platelet count.
The recommended dose of TAVLESSE is 100 mg twice daily (one tablet of 100 mg).
However, your doctor will check your platelet counts during your treatment with TAVLESSE and may change your dose as needed.
After starting treatment with TAVLESSE, the dose can be increased to 150 mg twice daily (one tablet of 150 mg) based on platelet count and tolerability. A daily dose of 300 mg (two tablets of 150 mg) daily must not be exceeded.
If you do not respond to treatment with fostamatinib, your doctor will stop treatment
If you have liver problems or high blood pressure, your doctor may start you on a lower dose.
If you get serious side effects (such as high blood pressure, liver problems, diarrhoea or a decrease in white blood cell counts), your doctor may lower your dose or stop your treatment temporarily or permanently.
How to take TAVLESSE
Swallow the tablets whole with water.
TAVLESSE can be taken with food or between meals.
In case of stomach upset, take the tablets with food.
If you are sick
If you are sick at any time after taking TAVLESSE, do not take an additional tablet. Take your next dose at its regularly scheduled time.
If you take more TAVLESSE than you should
If you take too much TAVLESSE, call your doctor or pharmacist right away or go to the nearest hospital emergency room.
If you forget to take TAVLESSE
Do not take a double dose to make up for a forgotten tablet. Take your next dose at its regularly scheduled time.
If you stop taking TAVLESSE
It is important to take TAVLESSE for as long as your doctor prescribes it. Do not stop taking this medicine unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
TAVLESSE may cause serious side effects. Tell your doctor immediately if you have any of the following serious side effects, either for the first time or if they get worse (see also section 2):
Other side effects
Besides the serious side effects mentioned above, you may also get other side effects.
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Reporting of side effects
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist. 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.
5. How to store TAVLESSE
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special temperature storage conditions. Store in the original package to protect from moisture. Keep the bottle tightly closed.
Do not use this medicine after the expiry date which is stated on the bottle after EXP. The expiry date refers to the last day of that month.
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 protect the environment.
6. Contents of the pack and other information
What TAVLESSE contains
What TAVLESSE looks like and contents of the pack
TAVLESSE 100 mg film-coated tablets
The tablet is round, curved on both sides with a dark orange film coat. The commercial tablets debossed with “R” on one side and “100” on the reverse side.
Available in bottle of 30 and 60 film-coated tablets. Each bottle has 2 desiccants.
Not all pack sizes may be marketed.
TAVLESSE 150 mg film-coated tablets
The tablet is oval, curved on both sides, with a light orange film coat. The commercial tablets are debossed with “R” on one side and “150” on the reverse side.
Available in bottle of 30 and 60 film-coated tablets. Each bottle has 2 desiccants.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in April/2020.
Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu/en
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