TALIDOMIDE 50 mg Капсулы Твердые

Содержание инструкции

1. Talidomide Koanaa 50 mg hard capsules
   1. What is Talidomide Koanaa and what is it used for
   2. What you need to know before taking Talidomide Koanaa
   3. How to take Talidomide Koanaa
   4. Possible side effects
   5. How to store Talidomide Koanaa
   6. Package contents and other information

Talidomide Koanaa 50 mg hard capsules

talidomide

Generic medicine

WARNING
Talidomide causes congenital defects and fetal death. Do not take talidomide if you are pregnant or
may become 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 their symptoms are the same as yours, as it could 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 Koanaa is and what it is used for
• 2. What you need to know before you take Talidomide Koanaa
• 3. How to take Talidomide Koanaa
• 4. Possible side effects
• 5. How to store Talidomide Koanaa
• 6. Contents of the pack and other information

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

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

What is Talidomide Koanaa used for
Talidomide Koanaa is used with two other medicines, called “melfalan” and “prednisone”, for the
treatment of adults with a type of cancer called multiple myeloma. It is used in people who have been
recently diagnosed and have never been prescribed other medicines for multiple myeloma with 65 or more years of age, or 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 Koanaa work
Talidomide Koanaa works by helping the body's immune system and directly attacking the
tumour. It works in a number of different ways:

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

2. What you need to know before taking Talidomide Koanaa

Your doctor will have given you specific information, particularly about the effects of thalidomide on the fetus
(described in the Pregnancy Prevention Program for Talidomide Koanaa).
Your 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 Koanaa

• if you are allergic to thalidomide or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or think you might be pregnant or are planning a pregnancy, because Talidomide Koanaa 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

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

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

For womentaking Talidomide Koanaa
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:
• before treatment
• every 4 weeks during treatment
• 4 weeks after the end of treatment
• You must use an effective method of contraception:
• for at least 4 weeks before starting treatment
• during treatment
• 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 Koanaa
Thalidomide penetrates into the seminal fluid. Therefore, you should 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:
• during treatment
• for at least 7 days after the end of treatment
• You should not donate semen:
• during treatment
• for at least 7 days after the end of treatment

For all patients
Consult your doctor before taking Talidomide Koanaa if

• you do not understand what your 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 Koanaa 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 the hands or feet (see also section 4 “Possible side effects”)
• you have or have had a slow heart rate in the past (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 Koanaa, 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 or HIV infection. If you have doubts, consult your doctor. Treatment with Talidomide Koanaa 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 Koanaa, inform your doctor of any changes in these symptoms.
The doctor may check if you have a high tumor burden throughout the 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 Koanaa (see also
section 4 “Possible side effects”).
You should not donate blood during treatment with Talidomide Koanaa and for at least 7 days after
the end of treatment.
If you are not sure whether any of the above circumstances are relevant to your case, consult
your doctor before taking Talidomide Koanaa.

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

Other medicines and Talidomide Koanaa
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription, including 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, H1 antihistamines, opioid derivatives and barbiturates)
• reduce heart rate (induce bradycardia, such as cholinesterase inhibitors 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 Koanaa with food, drinks and alcohol
Do not drink alcohol during treatment with Talidomide Koanaa, as alcohol can cause
drowsiness, which may be enhanced by Talidomide Koanaa.

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

• Just one capsule taken by a pregnant woman is enough to cause serious birth defects in the newborn.
• These defects can include shortened arms or legs, malformation of the hands or feet, defects in the eyes or ears, and problems with internal organs. If you are pregnant, you should not take Talidomide Koanaa. Also, if you take Talidomide Koanaa, 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 Koanaa”).
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 Koanaa, whose partner is of childbearing potential, see section 2 “What
you need to know before taking Talidomide Koanaa”. If your partner becomes pregnant while you
are taking thalidomide, you must immediately inform your doctor.
Breastfeeding
Do not breastfeed while taking Talidomide Koanaa, because it has not been determined whether
thalidomide passes into breast milk.

Driving and using machines
Do not drive or use tools or machines if you experience side effects such as dizziness,
fatigue, drowsiness or blurred vision.

Talidomide Koanaa contains lactose
The medicine contains lactose. Patients with rare hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this
medicine.

3. How to take Talidomide Koanaa

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 adjust the dose. Your doctor will
tell you how to take Talidomide Koanaa and for how long you should take it (see
paragraph 2 “What you need to know before you take Talidomide Koanaa”).
Talidomide Koanaa is taken every day in treatment cycles each of 6 weeks, in
association with melphalan 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 Koanaa 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. Pregnant or suspected pregnant women should not handle the blister or the 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 as a single dose before bedtime. This is to make drowsiness less likely at other times.

To remove the capsule from the blister, press on only one side of the capsule, 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 Koanaa than you should
If you take more Talidomide Koanaa than you should, contact your doctor or go to hospital

If you forget to take Talidomide Koanaa
If you forget to take Talidomide Koanaa 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.

Do not take a double dose to make up for a missed dose.
If you have any questions about using 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 Koanaa and consult your doctor immediately if you notice the
appearance of the following serious side effects. You may need urgent medical attention:
Extremely intense and severe skin reactions. The skin adverse reaction may appear as
skin rashes 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 serious allergic reactions that can manifest as hives, skin rashes, swelling of the eyes, mouth or face, difficulty breathing or itching).

If you notice the appearance 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 may become very severe, painful and disabling. If you experience these symptoms, consult your doctor immediately, who may reduce the dose or stop treatment. This side effect usually occurs when taking this medicine for many months, but may also occur after shorter periods. It may also occur some time after stopping treatment. It is possible that it will not resolve or will 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 may form during
therapy or after the end of treatment.

• Pain or swelling in the legs, especially in the lower part of the 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 may form during therapy or after the end of treatment.
• Chest pain that radiates to the arms, neck, jaw, back or stomach, 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 the presence of 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 Koanaa; therefore, the doctor must carefully assess the benefit and the
risk when prescribing Talidomide Koanaa.

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

• Constipation.
• Dizziness.
• 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 Koanaa, 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.
• Erythema, 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.
• Vertigo, making it difficult to stay upright 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.
• Intestinal 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 dying tumor cells and may 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 persistent for a few 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
adverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Talidomide Koanaa

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 outer packaging and on the blister
after Exp. The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the packaging is 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 your pharmacist or doctor. These
measures prevent misuse.

6. Package contents and other information

What Talidomide Koanaa contains

• The active substance is talidomide. Each capsule contains 50 mg of talidomide.
• The other excipients are Capsule content:Microcrystalline cellulose, lactose monohydrate, Pregelatinized starch, Colloidal silicon dioxide, Magnesium stearate Capsule shell:Gelatin, Titanium dioxide (E171) Ink:Lacquer, Propylene glycol, Black iron oxide (E172), Ammonia solution, concentrated, Potassium hydroxide

Description of the appearance of Talidomide Koanaa and package contents
Talidomide Koanaa Capsules are hard gelatin capsules (size ‘4’) with an opaque white cap
and an opaque white body, with “SML” inscribed on the cap and “28” on the body in black ink
containing white/off-white granular powder. Each capsule measures approximately 14 mm in length.
Talidomide Koanaa hard capsules are available in PVC/Aclar (PCTFE)-aluminum blisters containing
7 capsules.
Package size: 28 capsules

Marketing authorization holder and manufacturer
Marketing authorization holder
Koanaa Healthcare Spain, S.L,
Parque Empresarial Vallsolana Garden
Cami de Can Camps, 17-19
Kibo Building, 2H
08174 Sant Cugat del Valles
Spain.

Manufacturer
apis labor GmbH
Resslstraβe 9
9065 Ebenthal in Kärnten,
Austria

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
France THALIDOMIDE KOANAA 50 mg, capsule
Germany Thalidomid Koanaa 50 mg hard capsules
Italy Talidomide Koanaa 50 mg hard capsules
Portugal Thalidomide Koanaa 50 mg capsules
Sweden Thalidomide Zentiva