TALIDOMIDE 50 mg Kapsułka Twarda

Treść ulotki

1. Talidomide BMS 50 mg hard capsules
   1. What is Talidomide BMS and what is it used for
   2. Cosa deve sapere prima di prendere Talidomide BMS
   3. How to take Talidomide BMS
   4. Possible side effects
   5. How to store Talidomide BMS
   6. Contents of the pack and other information

Talidomide BMS 50 mg hard capsules

talidomide

WARNING
Talidomide causes congenital defects and fetal death. Do not take talidomide if you are pregnant
or maybecome pregnant. You must follow the advice on contraceptive methods provided by your
doctor.
Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Talidomide BMS is and what it is used for
• 2. What you need to know before you take Talidomide BMS
• 3. How to take Talidomide BMS
• 4. Possible side effects
• 5. How to store Talidomide BMS
• 6. Contents of the pack and other information

1. What is Talidomide BMS and what is it used for

What is Talidomide BMS
Talidomide BMS contains an active substance called “talidomide”. It belongs to a group of
medicines that affect the functioning of the immune system.

What is Talidomide BMS used for
Talidomide BMS is used with two other medicines, called “melfalan” and “prednisone”, for the
treatment of adults affected by a type of cancer called multiple myeloma. It is used in people who have
recently been diagnosed and to whom other medicines for multiple myeloma have never been prescribed
with 65 years of age or more, or with less than 65 years of age who cannot be treated with
high-dose chemotherapy, which can be very difficult for the body to tolerate.

What is multiple myeloma
Multiple myeloma is a type of cancer that affects a certain type of white blood cells, called
plasma cells. These cells collect in the bone marrow and divide uncontrollably. This
can damage the bones and kidneys. Multiple myeloma is generally incurable. However, the signs and
symptoms can be significantly reduced or disappear for a certain period, defined as “remission”.

How does Talidomide BMS work
Talidomide BMS works by helping the body's immune system and directly attacking the
tumor. It works in a number of different ways:

• stopping the development of cancer cells
• stopping the growth of blood vessels inside the tumor
• stimulating part of the immune system to attack cancer cells.

2. Cosa deve sapere prima di prendere Talidomide BMS

The doctor will have given you specific information, particularly regarding the effects of thalidomide on the fetus
(described in the Pregnancy Prevention Program for Talidomide BMS).
The doctor will have given you informational material for patients. Read the material carefully and
follow the related instructions.
If you do not fully understand these instructions, ask your doctor for further explanation before
taking thalidomide. Reference is also made to the additional information in this paragraph under the headings
“Warnings and precautions” and “Pregnancy and breastfeeding”.

Do not take Talidomide BMS

• if you are pregnant or think you might be, or are planning a pregnancy, becauseTalidomide BMS causes birth defects and fetal death
• if you are of childbearing potential, unless you are able to follow or adhere to the required contraceptive measures to prevent pregnancy (see section 2 “Warnings and precautions” and “Pregnancy and breastfeeding”)
• if you are of childbearing potential, with each prescription the doctor will note that the necessary measures have been taken and will provide you with this confirmation
• if you are allergic to thalidomide or to any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”).

Do not take Talidomide BMS if any of these conditions apply to you. If you have
any doubts, ask your doctor or pharmacist before taking Talidomide BMS.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking this medicine in the
following situations:

For womentaking Talidomide BMS
Before starting treatment, you must ask your doctor if there is a possibility for you to become
pregnant, even if you think it is unlikely. Even if you do not have a menstrual period after cancer treatment, you may become pregnant.
If you are of childbearing potential:

• The doctor will verify that pregnancy tests are performed: either before treatment or every 4 weeks during treatment or 4 weeks after the end of treatment
• You must use an effective method of contraception: either for at least 4 weeks before the start of treatment or during treatment or for at least 4 weeks after the end of treatment. The doctor will suggest which method of contraception to use.

If you are of childbearing potential, with each prescription of thalidomide the doctor must record that the necessary contraceptive measures, described above, have been taken.

For mentaking Talidomide BMS
Thalidomide penetrates into semen. Therefore, you must not have unprotected sexual intercourse, even
if you have had a vasectomy.

• It is necessary to avoid pregnancy and any exposure to the drug during pregnancy. Always use a condom: either during treatment or for at least 7 days after the end of treatment
• You must not donate semen: either during treatment or for at least 7 days after the end of treatment

For all patients
Talk to your doctor before taking Talidomide BMS if

• you do not understand what the doctor has advised you about contraceptive measures or if you do not feel able to follow this advice
• you have had a heart attack, have had a blood clot in the past, or if you smoke, have high blood pressure or high cholesterol levels. During treatment with Talidomide BMS, the risk of blood clots (thrombi) in the veins and arteries increases (see also section 4 “Possible side effects”)
• you have or have had neuropathy, i.e. nerve damage that causes tingling, coordination abnormalities or pain in your hands or feet (see also section 4 “Possible side effects”)
• you have or have had a slow heart rate (which may be a symptom of bradycardia)
• you have high blood pressure in the arteries of the lungs (see also section 4 “Possible side effects”)
• you have a decrease in the number of white blood cells (neutropenia) accompanied by fever and infection.
• you have a decrease in the number of platelets. You will be more prone to bleeding and bruising
• you have or have had liver damage (hepatic disorders) including abnormal liver function test results
• you have or have had severe skin reactions called Stevens-Johnson syndrome, toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms (also known as DRESS or drug hypersensitivity syndrome). (For a description of the symptoms, see section 4 “Possible side effects”)
• you have had an allergic reaction during treatment with Talidomide BMS, such as rash, itching, swelling, dizziness or difficulty breathing
• you have had drowsiness
• you have had fever, chills and severe shivering, possibly complicated by low blood pressure and confusion (which may be symptoms of serious infections)
• you have or have had a viral infection, in particular chickenpox, hepatitis B virus or HIV infection. If you have doubts, consult your doctor. Treatment with Talidomide BMS may cause reactivation of the virus in patients who are carriers, resulting in recurrence of the infection. The doctor should check if you have ever had a hepatitis B virus infection.
• you have kidney or liver problems (see also section 4 “Possible side effects”)

Before taking thalidomide, your thyroid function may be checked and monitored during treatment.
At any time during or after treatment, immediately inform your doctor or nurse
if you experience blurred vision, loss of vision or double vision, difficulty speaking, weakness in an
arm or leg, changes in the way you walk or problems with balance, persistent numbness, reduced sensation or loss of sensation, memory loss or confusion. These may
be symptoms of a serious brain disease that can be fatal, known as
progressive multifocal leukoencephalopathy (PML). If you had these symptoms before treatment
with Talidomide BMS, inform your doctor of any changes in these symptoms.
The doctor may check if you have a high tumor burden throughout your body, including the bone
marrow. This can cause a disease in which tumors break down and cause the presence of unusual levels of chemicals in the body, which can lead to kidney failure (this
disease is called tumor lysis syndrome) (see also section 4 “Possible side
effects”).
The doctor should assess whether you develop other types of blood cancers (called acute myeloid
leukemia and myelodysplastic syndromes) during treatment with Talidomide BMS (see also
section 4 “Possible side effects”).
You must not donate blood during treatment with Talidomide BMS and for at least 7 days after the
end of treatment.
If you are not sure whether any of the above circumstances apply to your case, ask
your doctor before taking Talidomide BMS.

Children and adolescents
The use of Talidomide BMS is not recommended in children and adolescents under 18 years of age.

Other medicines and Talidomide BMS
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including over-the-counter medicines and herbal products.
Make sure you tell your doctor if you are taking other medicines that:

• cause drowsiness, as thalidomide may increase their effects. These include sedatives (such as anxiolytics, hypnotics, antipsychotics, antihistamines H , opioid derivatives and barbiturates)
• reduce heart rate (induce bradycardia, such as anticholinesterases and beta-blockers)
• are used for heart problems and complications (such as digoxin) or to thin the blood (such as warfarin)
• are associated with neuropathy, such as other cancer treatments
• are used for contraception.

Talidomide BMS with food, drinks and alcohol
Do not drink alcohol during treatment with Talidomide BMS, as alcohol can cause
drowsiness, which may be potentiated by Talidomide BMS.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant, if you suspect or are planning a pregnancy, or if you are breastfeeding.
Pregnancy
Thalidomide causes serious birth defects or fetal death.

• It is sufficient for a pregnant woman to take only one capsule to cause serious birth defects in the newborn.
• These defects may include shortened arms or legs, malformation of the hands or feet, eye or ear defects, and problems with internal organs. If you are pregnant, you must not take Talidomide BMS. Also, if you take Talidomide BMS, you must avoid becoming pregnant.

If you are a woman of childbearing potential, you must use an effective method of contraception (see section 2 “What
you need to know before taking Talidomide BMS”).

You must stop treatment and immediately inform your doctor if:

• You miss a period or think you have missed it, or if you notice unusual menstrual bleeding, or if you suspect you are pregnant.
• You are sexually active without using an effective method of contraception. If you become pregnant during treatment with thalidomide, you must stop treatment and immediately inform your doctor.

For men taking Talidomide BMS, whose partner is of childbearing potential, see section 2 “What
you need to know before taking Talidomide BMS”. If your partner becomes pregnant while you
are taking thalidomide, you must immediately inform your doctor.
Breastfeeding
Do not breastfeed during the intake of Talidomide BMS, because it has not been determined whether
thalidomide passes into breast milk.

Driving and operating machinery
Do not drive or operate tools or machinery if you experience side effects such as dizziness,
fatigue, drowsiness or blurred vision.

3. How to take Talidomide BMS

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

How much medicine to take
The recommended dose is 200 mg (4 capsules x 50 mg) per day for adults aged 75 years and under,
while it is 100 mg (2 capsules x 50 mg) per day for adults over 75 years of age. However, your
doctor will choose your dose, monitor your progress, and may modify the dose. Your doctor will
tell you how to take Talidomide BMS and for how long you should take it (see section 2
“What you need to know before you take Talidomide BMS”).
Talidomide BMS is taken every day in treatment cycles each of 6 weeks, in
association with melfalan and prednisone (taken on day 1 and day 4 of each 6-week
cycle).

How to take this medicine

• Do not break, open or chew the capsules. If the powder from a broken Talidomide BMS capsule comes into contact with the skin, wash the skin immediately and thoroughly with water and soap.
• Healthcare professionals, those providing assistance to the patient, and family members must wear disposable gloves when handling the blister or the capsule. The gloves should then be removed carefully to avoid skin exposure, placed in a sealable polyethylene bag and disposed of in accordance with local regulations. Then wash your hands thoroughly with water and soap. Women who are pregnant or suspect they may be pregnant should not handle the blister or capsule.
• Take this medicine by mouth.
• Swallow the capsules whole with a full glass of water.
• Do not break or chew the capsule.
• Take the capsule in a single dose before bedtime. This is to make drowsiness at other times less likely.

To remove the capsule from the blister, press on one side of the capsule only, pushing it through the
aluminum foil. Do not press on the center of the capsule, otherwise there is a risk of breaking it.

If you take more Talidomide BMS than you should
If you take more Talidomide BMS than you should, contact your doctor or go to hospital

If you forget to take Talidomide BMS
If you forget to take Talidomide BMS at the usual time and

• less than 12 hours have passed: take the capsules immediately.
• more than 12 hours have passed: do not take the capsules. Take the next capsules at the usual time the following day.

If you have any questions about 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 everyone will experience them.
The use of this medicine may induce the following side effects:

Stop taking Talidomide BMS and consult your doctor immediately if you notice the onset of
the following serious side effects. Youmay need urgent medical attention:

• Extremely intense and severe skin reactions. The adverse skin reaction can appear as a rash with or without blisters. Skin irritation, ulcers or swelling may occur in the mouth, throat, eyes, nose and genital area, edema and fever, and flu-like symptoms. These symptoms may be signs of rare and serious skin reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis or DRESS syndrome.
• Allergic reactions, such as localized or generalized rash with itching, angioedema and anaphylactic reaction (types of severe allergic reactions that can manifest as hives, rash, swelling of the eyes, mouth or face, difficulty breathing or itching).

If you notice the onset of any of the following serious side effects, inform your
doctor immediately:

• Numbness, tingling, coordination disorders or pain in the hands and feet.These may be caused by nerve damage (“peripheral neuropathy”), a very common side effect. It can become very severe, painful and disabling. If you experience these symptoms, contact your doctor immediately, who may reduce the dose or stop treatment. This side effect usually occurs when taking this medicine for many months, but can also occur after shorter periods. It can also occur some time after stopping treatment. It may not resolve or may resolve slowly.
• Sudden chest pain or difficulty breathing.This may be caused by the presence of blood clots in the arteries that carry blood to the lungs (“pulmonary embolism”), a common side effect. Blood clots can form during therapy or after the end of treatment.
• Pain or swelling in the legs, especially in the lower legs or calves.This may be caused by the presence of blood clots in the veins of the lower limbs (“deep vein thrombosis”), a common side effect. Blood clots can form during therapy or after the end of treatment.
• Chest pain that radiates to the arms, neck, jaw, back orstomach, with a feeling of sweating and shortness of breath, with a feeling ofdiscomfort or vomiting.These may be symptoms of a heart attack/myocardial infarction (which may be caused by blood clots in the arteries of the heart).
• Temporary difficulty seeing or speaking.

These may be symptoms of a stroke (which may be caused by a blood clot in a cerebral artery).

• Fever, chills, sore throat, cough, ulcers in the mouth or any other symptom of infection.
• Bleeding or bruising without injury.

Other side effects are listed below:
It should be noted that a small number of patients with multiple myeloma may develop other types of
cancer, especially blood cancers, and it is possible that this risk may increase with
treatment with Talidomide BMS; therefore, the doctor must carefully assess the benefit and the
risk when prescribing Talidomide BMS.

Very common(may affect more than 1 in 10 people)

• Constipation.
• Feeling dizzy.
• Sleepiness, feeling tired.
• Tremor.
• Reduced or abnormal sensitivity (dysesthesia).
• Swelling of the hands and feet.
• Reduced blood counts. This may mean that you are more likely to develop infections. During treatment with Talidomide BMS, your doctor may monitor your blood cell counts.

Common(may affect up to 1 in 10 people)

• Indigestion, feeling unwell (nausea), feeling sick (vomiting), dry mouth.
• Redness, dry skin.
• A decrease in the number of white blood cells (neutropenia) accompanied by fever and infection.
• A decrease in the number of red blood cells, white blood cells and platelets simultaneously (pancytopenia).
• Feeling weak, fainting or unstable, lack of energy or strength, low blood pressure.
• Fever, feeling generally unwell.
• Convulsions.
• Dizziness, making it difficult to stand and move normally.
• Blurred vision.
• Chest infection (pneumonia), lung disease.
• Low heart rate, heart failure.
• Depression, confusion, mood changes, anxiety.
• Hearing loss or deafness.
• Kidney disease (renal failure).

Uncommon(may affect up to 1 in 100 people)

• Inflammation and swelling of the airways (bronchitis).
• Inflammation of the cells lining the stomach wall.
• Perforation of a part of the large intestine (colon) which can cause infection.
• Bowel obstruction.
• Decrease in blood pressure when standing up, which can lead to fainting.
• Irregular heartbeat (heart block or atrial fibrillation), feeling faint or fainting.

Not known(frequency cannot be estimated from available data)

• Hypothyroidism (underactive thyroid).
• Sexual dysfunction, for example impotence.
• Severe blood infection (sepsis), accompanied by fever, chills and severe shivering, with possible complication due to low blood pressure and confusion (septic shock).
• Tumor lysis syndrome - metabolic complications that can occur during cancer treatment and, sometimes, even in the absence of treatment. These complications are caused by the products of the decomposition of cancer cells that are dying and can include the following: changes in blood chemistry parameters; high levels of potassium, phosphorus and uric acid; and low levels of calcium leading, consequently, to changes in kidney function, heartbeat, seizures and, sometimes, death.
• Liver damage (hepatic disorders), including changes in liver function tests.
• Bleeding from the stomach or intestines (gastrointestinal hemorrhage).
• Worsening of the symptoms of Parkinson's disease (such as tremor, depression or confusion).
• Pain in the upper abdomen and/or back, which may be severe and persist for several days and may be accompanied by nausea, vomiting, fever and rapid pulse: these symptoms may be due to inflammation of the pancreas (pancreatitis).
• Increased pressure in the blood vessels that supply the lungs, which can cause shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat or swelling of the legs or ankles (pulmonary hypertension).
• Viral infections, including herpes zoster (also known as “shingles”, a viral disease that causes painful blistering rash) and recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark brown urine, pain in the stomach on the right side, fever and feeling nauseous or sick).
• A brain condition with symptoms including changes in vision, headache, seizures and confusion with or without high blood pressure (reversible posterior encephalopathy syndrome or PRES).
• A condition affecting the skin, caused by inflammation of the small blood vessels, with joint pain and fever (leucocytoclastic vasculitis).

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system
listed in Annex V. By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Talidomide BMS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package insert and on the
blister after Scad./EXP. The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the packaging has been damaged or shows signs of
tampering.
This medicine does not require any special storage conditions.
At the end of treatment, return all unused capsules to the pharmacist or doctor. These
measures prevent misuse.

6. Contents of the pack and other information

What Talidomide BMS contains

• The active ingredient is talidomide. Each capsule contains 50 mg of talidomide
• The other ingredients are: o The inside of the capsule contains pregelatinized starch and magnesium stearate. o The capsule shell contains gelatin and titanium dioxide (E171).

o The printing ink is composed of shellac, black iron oxide (E172) and propylene glycol.

Description of the appearance of Talidomide BMS and contents of the pack
Talidomide BMS is presented as hard capsules, white in colour, marked with the inscription
“Thalidomide BMS 50 mg”. The capsules are supplied in wallet packs containing 28 capsules
(2 blisters of 14 capsules each).

Marketing Authorisation Holder
Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland

Manufacturer
Celgene Distribution B.V.
Orteliuslaan 1000
3528 BD Utrecht
Netherlands

Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency, http://www.ema.europa.eu . Furthermore, links to other websites are provided