Land: Den europeiske union
Språk: engelsk
Kilde: EMA (European Medicines Agency)
dexamethasone
THERAVIA
H02AB02
dexamethasone
Corticosteroids for systemic use
Multiple Myeloma
Treatment of multiple myeloma.
Revision: 11
Authorised
2016-03-16
23 B. PACKAGE LEAFLET 24 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NEOFORDEX 40 MG TABLET dexamethasone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Neofordex is and what it is used for 2. What you need to know before you take Neofordex 3. How to take Neofordex 4. Possible side effects 5. How to store Neofordex 6. Contents of the pack and other information 1. WHAT NEOFORDEX IS AND WHAT IT IS USED FOR Neofordex is a medicine that contains the active substance dexamethasone. Dexamethasone is a type of hormone called a glucocorticoid, sometimes called a corticoid or corticosteroid, with various actions including effects on white blood cells, which form part of the immune system (the body’s natural defences). Dexamethasone is similar to glucocorticoids which are naturally produced in the body. Neofordex is used to treat adult patients with multiple myeloma, a cancer of the blood affecting the white blood cells that produce antibodies. Neofordex will be given in combination with other medicines for multiple myeloma. They act together by killing cancerous white blood cells. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEOFORDEX _ _ DO NOT TAKE NEOFORDEX − if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6); − if you have a viral infection, especially viral hepatitis, herpes, chickenpox or shingles; − if you have an untreated psychiatric illness. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist, nurse, before taking Neofordex esp Les hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Neofordex 40 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains dexamethasone acetate equivalent to 40 mg dexamethasone. Excipient with known effect Each tablet contains 98.1 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White, oblong (11 mm × 5.5 mm) tablet, with “40 mg” engraved on one side.. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Neofordex is indicated in adults for the treatment of symptomatic multiple myeloma in combination with other medicinal products. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment must be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma. Posology The dose and administration frequency varies with the therapeutic protocol and the associated treatment(s). Neofordex administration should follow instructions for dexamethasone administration when described in the Summary of Product Characteristics of the associated treatment(s). If this is not the case, local or international treatment protocols and guidelines should be followed. Prescribing physicians should carefully evaluate which dose of dexamethasone to use, taking into account the condition and disease status of the patient. The usual posology of dexamethasone is 40 mg once per day of administration. At the end of dexamethasone treatment, the dose should be tapered in a stepwise fashion until a complete stop. _Missed dose_ The tablet should be taken immediately if the dose was missed for less than 12 hours. The next tablet should be taken at the usual time, if the dose was missed for more than 12 hours. In case of a missed dose, a double dose must not be taken. Special population _Elderly _ 3 In elderly and/or frail patients, where the dose needs to be reduced, it can be decided to prescribe another product containing a lower dose of dexamethasone, according to the appropriate treatment regimen. _ _ _ _ Les hele dokumentet