PIRFENIDONE 267 mg Film-Coated Tablets

Содержание инструкции

1. What is Talidomide Aurobindo and what is it used for
2. Cosa deve sapere prima di prendere Talidomide Aurobindo
3. How to take Talidomide Aurobindo
4. Possible side effects
5. How to store Talidomide Aurobindo
6. Package Contents and Other Information

Talidomide Aurobindo 50 mg hard capsules
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 or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

What is Talidomide Aurobindo used for
Talidomide Aurobindo 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 recently
been 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 Aurobindo work
Talidomide Aurobindo 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 Aurobindo

The doctor will have given you specific information, in particular about the effects of Talidomide Aurobindo on the fetus
(described in the Talidomide Aurobindo Pregnancy Prevention Program).
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
Talidomide Aurobindo. Please also refer to the additional information in this paragraph under the headings “Warnings and
precautions” and “Pregnancy and breastfeeding”.

Do not take Talidomide Aurobindo

• if you are pregnant or think you may be pregnant or are planning a pregnancy, as Talidomide Aurobindo 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 talidomide 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 Aurobindo if any of these conditions apply to you. If you have any
doubts, ask your doctor or pharmacist before taking Talidomide Aurobindo.

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

For womentaking Talidomide Aurobindo
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 therapy, 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 talidomide the doctor must record that the
necessary contraceptive measures, as described above, have been taken.

For mentaking Talidomide Aurobindo
Talidomide Aurobindo penetrates into 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: either during treatment or for at least 7 days after the end of treatment.
• You should 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 Aurobindo 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 Aurobindo, 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 Aurobindo, such as rash, itching, swelling, dizziness or difficulty breathing;
• you have had drowsiness;
• you have had fever, chills and 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 Aurobindo 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 Talidomide Aurobindo, 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 one arm or one
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 Aurobindo, inform your doctor of any
change in these symptoms.
The doctor may check if you have a high tumor load 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 Aurobindo (see also section 4
“Possible side effects”).
You should not donate blood during treatment with Talidomide Aurobindo 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 Aurobindo.

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

Other medicines and Talidomide Aurobindo
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
those available without a prescription, including herbal products.
Make sure to tell your doctor if you are taking other medicines that:

• cause drowsiness, as talidomide may increase their effects. These include sedatives (such as anxiolytics, hypnotics, antipsychotics, H1 antihistamines, opioid derivatives and barbiturates)
• reduce the 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 Aurobindo with food, drinks and alcohol
Do not drink alcohol during treatment with Talidomide Aurobindo, as alcohol can cause
drowsiness, which may be potentiated by Talidomide Aurobindo.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Talidomide Aurobindo 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 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 Aurobindo. Also, if you are taking Talidomide Aurobindo, 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 Aurobindo”).

You must stop treatment and immediately inform your doctor if:

• You miss a period or think you have missed a period or if you notice unusual vaginal 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 talidomide, you must stop treatment and inform
your doctor immediately.
For men taking Talidomide Aurobindo, whose partner is of childbearing potential, see section 2 “What you must
know before taking Talidomide Aurobindo”. If your partner becomes pregnant while you are
taking Talidomide Aurobindo, you must inform your doctor immediately.
Breastfeeding
Do not breastfeed while taking Talidomide Aurobindo, because it has not been determined whether talidomide
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.

Talidomide Aurobindo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is essentially ‘sodium-free’.

Talidomide Aurobindo contains isomalt
If you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking this
medicine.

3. How to take Talidomide Aurobindo

Take Talidomide Aurobindo 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 Aurobindo and for how long you should take it (see section 2 “What you need to know
before taking Talidomide Aurobindo”).
Talidomide Aurobindo 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 BMS capsule comes into contact with the skin, wash the skin immediately and thoroughly with water and soap.
• Healthcare professionals, those providing care to the patient, and family members must wear disposable gloves when handling the blister or 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 suspected of being pregnant must 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 as 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, pushing it through the
aluminum foil. Do not press on the center of the capsule, otherwise it may break.

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

If you forget to take Talidomide Aurobindo
If you forget to take Talidomide Aurobindo 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 next 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 gets them.
Use of this medicine may induce the following side effects:

Stop taking Talidomide Aurobindo and immediately consult your doctor if you notice the appearance of the
following serious side effects. You may need urgent medical attention:

• Extremely intense and severe skin reactions. The adverse skin reaction may 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 serious allergic reactions that can manifest as hives, rash, 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, see 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, withsweating and shortness of breath, with a feeling of malaise 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 Aurobindo; therefore, the doctor must carefully assess the benefit and risk when
prescribing Talidomide Aurobindo.

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 Aurobindo, your doctor may monitor your blood cell counts.

Common(may affect up to 1 in 10 people)

• Indigestion, feeling sick (nausea), feeling unwell (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 at the same time (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 may 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 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 intestine (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 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 sick or unwell).
• 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, even if not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the
national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this
medicine.

5. How to store Talidomide Aurobindo

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 packaging and on the blister after SCAD.
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.

Blister packs made of transparent PVC/Aclar (PCTFE)-aluminium foil:This medicine does not require
any special storage conditions.

Blister packs made of transparent PVC/PVdC-aluminium foil:Store at a temperature below 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to eliminate the
medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Talidomide Aurobindo contains
The active ingredient is talidomide.
Each hard capsule contains 50 mg of talidomide.
The other ingredients are:
Isomalt, sodium croscarmellose, talc, sodium stearyl fumarate.

Capsule Cap
Titanium dioxide (E171), gelatin.

Capsule Body
Titanium dioxide (E171), gelatin.

Printing Ink (black)
Shellac, black iron oxide (E172), potassium hydroxide.

Description of the appearance of Talidomide Aurobindo and package contents
Hard capsule.
White powder contained in a size “4” hard gelatin capsule, with an opaque white cap printed with “TLM” in black ink and an opaque white body printed with “50” in black ink.
It must be free from physical defects. Each capsule measures approximately 14.00 mm x 5.30 mm.

Talidomide Aurobindo 50 mg hard capsules:
Talidomide Aurobindo 50 mg hard capsules are available in transparent blister packs (PVC/Aclar
(PCTFE)-aluminum foil and PVC/PVdC-aluminum foil) containing 28 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Eugia Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront,
Floriana FRN 1914, Malta

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
Generis Farmacȇutica, S.A.
Rua Joao De Deus, no 19,
Venda Nova, 2700-487 Amadora
Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Italy: Talidomide Aurobindo
Portugal: Talidomida Generis