PACKAGE LEAFLET: INFORMATION FOR Do not take Thalidomide Celgene • you have experienced or have existing You must stop treatment and inform If you have any further questions on the use of • Feeling weak, faint or unsteady, lack of THE USER • If you are pregnant or think you may be neuropathy i.e. tingling, abnormal co-ordi- your doctor straight away if: this product, ask your doctor, pharmacist or energy or strength, low blood pressure. 6. FURTHER INFORMATION pregnant or are planning to become preg- nation or pain in your hands or feet. • You miss or think you have missed a nurse. • Fever, feeling generally unwell. —————————————————————— nant, as Thalidomide Celgene causes • you have experienced sleepiness. period, or you have unusual menstrual • A spinning feeling in your head, making it What Thalidomide Celgene contains: ® Thalidomide Celgene 50 mg birth defects and foetal death. • you have a high total amount of tumor bleeding, or suspect you are pregnant. difficult to stand up and move normally. • The active substance is thalidomide. Each hard capsules • If you are able to become pregnant but are throughout the body, including your bone • You have heterosexual intercourse 4. POSSIBLE SIDE EFFECTS • Blurred vision. capsule contains 50 mg of thalidomide. Thalidomide unable to follow the necessary pregnancy marrow. This could lead to a condition without using an effective method of • Chest infection (pneumonia), lung disease. • The other excipients are pregelatinized —————————————————————— prevention measures (outlined in the i-SE- where the tumors break down and cause contraception. Like all medicines, this medicine can cause • A slow heart rate, heart failure. starch and magnesium stearate. The CURE program). unusual levels of chemicals in the body If you do become pregnant during the treat- side effects although not everybody gets them. • Depression, confusion, mood changes, capsule shell contains gelatin and titanium • If you are allergic (hypersensitive) to thalid- which can lead to kidneys failure (this ment with thalidomide, you must stop the anxiety. dioxide (E171). The printing ink is condition is called Tumor Lysis Syndrome). WARNING omide or any of the other ingredients of treatment and inform your doctor immediately. The following side effects may happen with composed of shellac, black iron oxide • you have experienced fever, chills and Thalidomide causes birth defects and Thalidomide Celgene (listed in section 6. this medicine: Uncommon (may affect up to 1 in 100 people) (E172) and propylene glycol. severe shaking, and possibly complicated foetal death. Do not take thalidomide if "What Thalidomide Celgene contains:”). For men taking Thalidomide Celgene who • Inflammation and swelling of the tubes in by low blood pressure and confusion (these you are pregnant or could become preg- have a female partner who is able to become your lungs (bronchitis). What Thalidomide Celgene looks like and may be symptoms of severe infections). Stop taking Thalidomide Celgene and see nant. You must follow the contraception Do not take Thalidomide Celgene if any of the • Inflammation of the cells lining your stom- contents of the pack • you have had an allergic reaction whilst pregnant, please see section 2 “Take special a doctor straight away if you notice the advice given to you by your doctor. above applies to you. If you are not sure, talk ach wall. Thalidomide Celgene are white hard capsules taking thalidomide such as rash, itching, care with Thalidomide Celgene”. If your following serious side effects – you may to your doctor or pharmacist before taking • A hole in part of your large bowel (colon) marked “Thalidomide Celgene 50 mg”. The swelling, dizziness or trouble breathing. partner becomes pregnant whilst you are need urgent medical treatment: Thalidomide Celgene. taking thalidomide, you should inform your • Severe skin reactions including rashes, which can cause infection. capsules are supplied in a wallet card Read all of this leaflet carefully before you • you do not understand the contraception containing 28 capsules (2 blisters of 14 advice given to you by your doctor or if you doctor immediately. which is a common side effect and blister- start taking this medicine. capsules each). Take special care with Thalidomide do not feel able to follow this advice. ing of the skin and mucosa (Stevens John- • Keep this leaflet. You may need to read it Additional side effects have been reported after This is a medicament Celgene: • you have high blood pressure from the Breast-feeding: son Syndrome and toxic epidermal necrol- again. this medicine was marketed. These include: – A medicament is a product which heart to the lungs. Do not breastfeed during Thalidomide ysis, which are rare side effects). You may • If you have further questions, please ask • Underactive thyroid (hypothyroidism). affects your health, and its consump- For females taking Thalidomide Celgene • you have or have ever had previous viral Celgene treatment, during dose interruptions have a high temperature (fever) at the • Bowel obstruction. tion contrary to instructions is danger- your doctor, pharmacist or nurse. Before starting the treatment, you should ask infection, particularly varicella, zona, and for 4 weeks after stopping treatment as it same time. • Sexual dysfunction, for example impotence. ous for you. • This medicine has been prescribed for you your doctor if you are able to become preg- hepatitis B infection, or HIV. If you are in is not known if thalidomide is passed into • A fall in the number of white blood cells − Follow strictly the doctor’s prescription, Do not pass it on to others. It may harm nant, even if you think this is unlikely. doubt, talk to your doctor. Treatment with human breast milk. Tell your doctor straight away if you notice • (neutropenia) accompanied by fever and them, even if their symptoms are the same If you are able to become pregnant: thalidomide may cause virus to become any of the following serious side effects: the method of use and the instructions infection as yours. • Your doctor will make sure that you have active again in patients who carry it, result- • Numbness, tingling, abnormal co-ordi- of the pharmacist who sold the medica- Driving and using machines: • Severe blood infection (sepsis) accompa- • If any of your side effects get serious, or if pregnancy tests ing in a recurrence of the infection. Your nation or pain in your hands and feet. ment to you Do not drive or use any tools or machines if nied by fever, chills and severe shaking, you notice any side effects not listed in this ◦ before treatment doctor should check whether you have This may be due to nerve damage (called – The doctor and the pharmacist are you experience side effects, such as dizzi- and possibly complicated by low blood leaflet, please tell your doctor or pharmacist. ◦ every 4 weeks during treatment ever had hepatitis B infection. ‘peripheral neuropathy’), which is a very experts in medicine, its benefits and ness, tiredness, sleepiness or blurred vision. pressure and confusion (septic shock). ◦ 4 weeks after stopping treatment risks. common side effect. It may become very • A fall in the number of red and white blood In this leaflet • You must use two effective methods of Donating Blood: − Do not, by yourself, interrupt the period severe, painful and disabling. If you expe- cells and platelets at the same time (pan- 1. What Thalidomide Celgene is and what it contraception at the same time: You must not donate blood during Thalido- of treatment prescribed for you. 3. HOW TO TAKE THALIDOMIDE rience such symptoms, speak to your cytopenia). is used for ◦ for 4 weeks before starting treatment mide Celgene treatment, during dose interrup- − Do not repeat the same prescription CELGENE doctor straight away, who may reduce the • Tumour Lysis Syndrome - metabolic 2. Before you take Thalidomide Celgene ◦ during treatment tions and for 4 weeks after stopping treatment. dose or discontinue the treatment. This without consulting your doctor. 3. How to take Thalidomide Celgene complications that can occur during the ◦ during dose interruptions Always take Thalidomide Celgene exactly as side effect usually happens after you have 4. Possible side effects If you are not sure if any of the above apply to treatment of cancer and sometimes even Keep Medicament out of the reach and sight ◦ until 4 weeks after stopping treatment your doctor has told you to. You should check been taking this medicine for several 5. How to store Thalidomide Celgene you, talk to your doctor before taking Thalido- without treatment. These complications of children and any other person not directly You should talk to your doctor about the with your doctor if you are not sure. months but can happen sooner than this. It are caused by the break-down products of 6. Further information mide Celgene. involved in the treatment following birth control methods. can also happen sometime after treatment dying cancer cells and may include the has stopped. It may not go away, or may following: changes to blood chemistry; Children and adolescents How much to take Manufactured by Celgene International Sarl, Examples of Effective Methods of Contra- The recommended dose is 200 mg (4 x 50 mg go away slowly. high potassium, phosphorus, uric acid, 1. WHAT THALIDOMIDE CELGENE Thalidomide Celgene is not recommended Switzerland ception capsules) a day for adults aged 75 years and • Sudden pain in your chest or difficulty and low calcium consequently leading to IS AND WHAT IT IS USED FOR for