PACKAGE LEAFLET: INFORMATION FOR Do not take Thalidomide • 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 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 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 . dioxide (E171). The printing ink is condition is called ). 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, 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. • , 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 • () 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. ‘’), 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 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 consequently leading to IS AND WHAT IT IS USED FOR for use in children and young people under in breathing. changes in kidney function, heart beat, 18 years. under or 100 mg (2 x 50 mg capsules) a day Marketing Authorization Holder: Celgene Highly Effective Methods: for adults aged over 75 years. However your This may be due to blood clots in the arter- seizures, and sometimes death. What Thalidomide Celgene is – Intra Uterine Device (IUD) Europe Ltd, UK Taking other medicines: doctor will choose the dose for you, monitor ies leading to your lungs (called ‘pulmo- • Allergic reactions such as a localised or Thalidomide Celgene contains an active – Hormonal (hormonal implants, nary embolism’), which is a common side generalised pruritic rash and angioedema substance called thalidomide. This belongs to Please tell your doctor or pharmacist if you your progress and may adjust your dose. This leaflet was last revised in -releasing intrauterine are taking or have recently taken any other effect. These can happen during treat- (types of allergic reaction that may be a group of medicines which affect how your Your doctor will tell you how to take Thalido- February 2017 system (IUS), medroxyprogesterone medicines since other medicines could inter- ment, or after treatment has stopped. manifested as hives, rashes, swelling of immune system works. mide Celgene and for how long you will need acetate depot injections, ovulation fere with the effect of thalidomide. This to take it (see section 2, “Before you take • Pain or swelling in your legs, especial- eyes, mouth or face, difficulty of breathing, inhibitory progesterone-only pills e.g. includes medicines obtained without a ly in your lower leg or calves. or itching). What Thalidomide Celgene is used for Thalidomide Celgene”). ) prescription, including herbal medicines. This may be due to blood clots in the veins • Hearing decreased or deafness. Thalidomide Celgene is used with two other – Tubal ligation Thalidomide Celgene is taken daily in treatment of your leg (deep vein ), which • Convulsions. medicines called ‘’ and ‘pred- – Partner’s vasectomy • Kidney disease (renal failure). Make sure you tell your doctor if you are cycles, each cycle lasting 6 weeks, in combina- is a common side effect. These can nisone’ to treat adults aged 65 years and over, • Injury to the (hepatic disorder) includ- taking any medicines which: tion with melphalan and which are happen during treatment, or after treat- with a type of cancer called . Effective Methods: ing abnormal liver test results. • cause sleepiness as thalidomide may taken on days 1 to 4 of each 6 week cycle. ment has stopped. It is used in people who have recently been – Male condom increase their effects. This includes seda- • Chest pain spreading to the arms, • Bleeding from the stomach or bowels diagnosed and who have not been prescribed –Diaphragm tives (such as anxiolytics, hypnotics, (gastrointestinal haemorrhage). Taking this medicine neck, jaw, back or stomach, feeling another medicine for their multiple myeloma –Cervical cap antipsychotics, H anti-histamines, opiate • Irregularities of the heartbeat (heart block 1 • Do not break, open or chew the capsules. sweaty and breathless, feeling sick or before, or who cannot be treated with high derivatives and ). or atrial fibrillation), feeling faint or fainting. If powder from a broken Thalidomide vomiting. dose , which can be very Because of the increased risk of venous • slow the heart rate (induce , such • Worsening of Parkinson’s disease symptoms Celgene capsule makes contact with the These may be symptoms of a heart attack/ difficult for the body to handle. thromboembolism in patients with multiple as anti-cholinesterases and beta blockers). (such as , depression or confusion). skin, wash the skin immediately and (which may be due myeloma, combined oral contraceptive pills • are used for heart problems and complica- • Pain in the upper abdomen and/or back, thoroughly with soap and water. to blood clots in the arteries of your heart). What is multiple myeloma are not recommended. If a patient is currently tions (such as digoxin), or for thinning the • Having difficulty in seeing or speaking, which may be severe and which remains • Take this medicine by mouth. for a few days, possibly accompanied by Multiple myeloma is a type of cancer which using combined oral contraception the patient blood (such as warfarin). which is temporary. • Swallow the capsules whole with a full nausea, vomiting, fever and a rapid pulse – affects a certain type of white blood cell, should switch to two of the effective methods • are other treatments for cancer. These may be symptoms of a stroke glass of water. these symptoms may be due to the inflam- called the plasma cell. These cells collect in listed above. The risk of venous thromboem- • are used for contraception. (which may be due to a clot in an artery in • Do not crush or chew. mation of the pancreas (pancreatitis). the bone marrow and divide out of control. bolism continues for 4−6 weeks after discon- your brain). Taking Thalidomide Celgene with food • Take the capsules as a single dose before • Increase in blood pressure within blood This can damage the bone and kidneys. tinuing combined oral contraception. • Fever, chills, sore throat, cough, and drink: going to bed. This will make you less likely vessels that supply the lungs which can Multiple myeloma generally cannot be cured. mouth ulcers or any other symptoms Thalidomide Celgene can be taken with or to feel sleepy at other times. lead to shortness of breath, tiredness, However, the signs and symptoms can be If you are able to become pregnant, your of infection. without food (see section 3, “How to take dizziness, pain in the chest, a faster heart- • greatly reduced or disappear for a period of doctor will record with each prescription that Thalidomide Celgene”). • Bleeding or bruising in the absence of beat, or swelling in the legs or ankles time. This is called a ‘remission’. the necessary measures, as outlined above, To remove the capsule from the blister, press injury. (). have been taken and will state that on the only one end of the capsule out to push it i-SECURE Do not drink alcohol while you are taking through the foil. Do not apply pressure on the • Viral infections, including herpes zoster How Thalidomide Celgene works relevant documents. Other side effects include: Thalidomide Celgene works by helping the Thalidomide Celgene. This is because centre of the capsule as this can cause it to (also known as ‘shingles’, a viral disease body’s immune system and directly attacking the alcohol can make you sleepy and Thalido- break. that causes a painful skin rash with For men taking Thalidomide Celgene mide Celgene can make you even sleepier. It is important to note that a small number of cancer. It works in a number of different ways: blisters) and recurrence of hepatitis B Thalidomide passes into . Therefore, patients with multiple myeloma may develop infection (which can cause yellowing of ■ by stopping the cancer cells developing do not have unprotected intercourse. Pregnancy and breast-feeding additional types of cancer, especially haema- the skin and eyes, dark brown-coloured ■ by stopping blood vessels growing in • Pregnancy and any exposure during preg- If you are pregnant or breast-feeding, think tological malignancies, and it is possible that urine, right-sided stomach pain, fever and the cancer nancy must be avoided. Always use a you may be pregnant or are planning to have this risk may be increased with Thalidomide feeling nauseous or being sick). ■ by stimulating part of the immune condom: a baby, ask your doctor or pharmacist for Celgene treatment; therefore your doctor system to attack the cancer cells. ◦ during treatment advice before taking this medicine. should carefully evaluate the benefit and risk If any of the side effects gets serious, or if ◦ during dose interruptions when you are prescribed Thalidomide you notice any side effects not listed in this ◦ for 4 weeks after stopping treatment Pregnancy Celgene. leaflet, please tell your doctor or pharmacist. 2. BEFORE YOU TAKE THALIDOMIDE • You must not donate semen: Thalidomide causes severe birth defects or CELGENE ◦ during treatment death to an unborn baby. Very common (may affect more than 1 in ◦ during dose interruptions • As little as one capsule taken by a preg- If you take more Thalidomide Celgene 10 people) 5. HOW TO STORE THALIDOMIDE You will have been given specific instructions ◦ for 4 weeks after stopping treatment nant woman can cause a baby to have than you should • Constipation. CELGENE by your doctor, particularly on the effects of serious birth defects. If you take more Thalidomide Celgene than • Feeling dizzy. thalidomide on unborn babies (outlined in the • These defects can include shortened For all patients taking Thalidomide Celgene you should, talk to a doctor or go to a hospital • Sleepiness, feeling tired. Keep out of the reach and sight of children i-SECURE program). arms or legs, malformed hands or feet, Check with your doctor before taking this straightaway. If possible, take the medicine • Shaking (tremor). and any other person not directly involved in medicine if eye or ear defects, and problems with the treatment. i-SE- pack and this leaflet with you. • Swelling of hands and feet. You will have been given a Thalidomide • you have had a heart attack, have ever internal organs. CURE • Low blood cell counts. This may mean that patient brochure by your doctor. Read had a blood clot in the past, or if you If you are pregnant, you must not take Thalido- Do not use after the expiry date stated on the If you forget to take Thalidomide Celgene you are more likely to develop infections. it carefully and follow the related instructions. smoke, have high blood pressure or high mide Celgene. In addition, you must not wallet card and the blister after EXP. The If you forget to take Thalidomide Celgene at Your doctor may monitor your blood cell cholesterol levels. During the treatment become pregnant while taking Thalidomide expiry date refers to the last day of that month. your regular time and counts during treatment with Thalidomide If you do not fully understand these instruc- with Thalidomide Celgene you have an Celgene. • less than 12 hours have passed: take your Celgene. tions, please ask your doctor to explain them increased risk of developing blood clots in Store below 30°C in the original package. You must use two effective methods of contra- capsules immediately. again before you take thalidomide. See also the veins and arteries. Common (may affect up to 1 in 10 people) ception at the same time every time you have • more than 12 hours have passed: do not further information in this section under “Take • you experienced or have existing slow At the end of your treatment you should return sex with a male if you are a woman who is able take your capsules. Take your next • Indigestion, feeling sick (nausea), being special care with Thalidomide Celgene” and heart rate (this may be symptoms of brad- all unused capsules to the pharmacist or to become pregnant (see section 2, “Take capsules at the usual time the next day. sick (vomiting), dry mouth. “Pregnancy and breast-feeding”. ycardia). doctor. These measures will prevent misuse. special care with Thalidomide Celgene”). • Rash, dryness of the skin.