Thalidomide Accord 50 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Thalidomide Accord 50 mg hard capsules EFG

WARNING

Thalidomide causes congenital malformations and fetal death. Do not take thalidomide if you are or may become pregnant. You must follow your doctor's advice regarding contraception.

Read the entire leaflet carefully before starting to take this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Talidomida Accord is and what it is used for

What Talidomida Accord is

Talidomida Accord contains an active substance called talidomide, which belongs to a group of medicines that affect the way your immune system works.

What Talidomida Accord is used for

Talidomide is used in combination with two other medicines called "melphalan" and "prednisone" to treat adults with a type of cancer called multiple myeloma. It is used in people aged 65 years or older who have recently been diagnosed and who have not previously been treated with any medicine for multiple myeloma, or in people under 65 years of age who cannot be treated with high-dose chemotherapy, as this may be difficult for the body to tolerate.

What multiple myeloma is

Multiple myeloma is a type of cancer that affects a type of white blood cells called plasma cells. These cells are produced in the bone marrow and divide uncontrollably. This can damage the bones and kidneys. Multiple myeloma usually cannot be cured. However, signs and symptoms may greatly diminish or disappear for a period of time. This is called "remission".

How Talidomida Accord works

Talidomide works by helping the body's immune system and by directly attacking the cancer. It works in several different ways:

• Slows down the growth of cancer cells.
• Inhibits the growth of blood vessels in the cancer.
• Stimulates part of the immune system to attack cancer cells.

2. What you need to know before starting to take Thalidomide Accord

You must receive specific instructions from your doctor, particularly regarding the effects of thalidomide on the fetus (as explained in the Thalidomide Pregnancy Prevention Programme).

You will receive a patient information leaflet from your doctor. You must read it carefully and follow the instructions provided.

If you do not fully understand these instructions, ask your doctor to explain them again before taking thalidomide. Further information can be found in this section under "Warnings and precautions" and "Pregnancy and breastfeeding".

Do not take Thalidomide Accord

• If you are pregnant, think you may be pregnant, or intend to become pregnant, because thalidomide causes birth defects and fetal death.
• If you are capable of becoming pregnant unless you are able to follow and comply with the required contraceptive measures to prevent pregnancy (see section 2 "Warnings and precautions" and "Pregnancy and breastfeeding").
• If you are capable of becoming pregnant, your doctor will document with each prescription 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 components of this medicine listed in section 6 "Contents in the pack and other information".

Do not take thalidomide if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before starting to take thalidomide.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take this medicine if:

For women taking thalidomide

Before starting treatment, you must discuss with your doctor whether you could become pregnant, even if you think this is unlikely. Even if you have not had menstrual bleeding after cancer treatment, you may still become pregnant.

If you are capable of becoming pregnant:

• Your doctor will ensure that you undergo pregnancy testing

• Before treatment begins.

• Every 4 weeks during treatment.

• 4 weeks after treatment ends.

• You must use an effective method of contraception:

• For at least 4 weeks before starting treatment.

• During treatment.

• For at least 4 weeks after treatment ends.

Your doctor will advise you on which contraceptive method to use.

If you are capable of becoming pregnant, your doctor will document with each prescription that the necessary measures described above have been taken.

For men taking thalidomide

Thalidomide is present in semen. Therefore, do not have unprotected sexual intercourse, even if you have had a vasectomy.

• You must avoid pregnancy and any fetal exposure. Always use a condom:

• During treatment.

• For at least 7 days after stopping treatment.

• You must not donate semen:

• During treatment.

• For at least 7 days after stopping treatment.

For all patients

Before taking thalidomide, consult your doctor if:

• You do not understand the contraceptive instructions given by your doctor or do not believe you can follow them.
• You have had a heart attack, previously had a blood clot, smoke, or have high blood pressure or high cholesterol levels. During treatment with thalidomide, you have an increased risk of developing blood clots in veins and arteries (see also section 4 "Possible side effects").
• You have had or currently have neuropathy (nerve damage causing tingling, abnormal coordination, or pain in hands or feet) (see also section 4 "Possible side effects").
• You have had or currently have a slow heart rate (which may be a sign of bradycardia).
• You have high blood pressure in the arteries leading from the lungs (pulmonary hypertension) (see also section 4 "Possible side effects").
• You have experienced a decrease in white blood cell count (neutropenia) accompanied by fever and infection.
• You have a low platelet count. You will be more prone to bleeding and bruising.
• You have or have had liver problems (hepatic disorders), such as abnormal liver function test results.
• You have had severe skin rashes that may start in one area but spread with blisters on the skin and mucous membranes (Stevens-Johnson syndrome and toxic epidermal necrolysis). You may also have fever at the same time.
• You have had an allergic reaction while taking thalidomide, such as rash, itching, swelling, dizziness, or breathing difficulties.
• You have experienced drowsiness.
• You have had fever, chills, and severe shivering, possibly complicated by low blood pressure and confusion (these may be signs of serious infections).
• You have or have previously had a viral infection, particularly varicella zoster, hepatitis B, or HIV. If in doubt, consult your doctor. Treatment with thalidomide may reactivate the virus in carriers, leading to recurrence of the infection. Your doctor should check whether you have ever had hepatitis B infection.
• You have kidney or liver problems (see also section 4 "Possible side effects").

Your doctor may assess whether you have a high overall tumor burden, including in the bone marrow. This could lead to a condition where tumors break down and release abnormal levels of chemicals into the blood, potentially causing kidney failure (this condition is called tumor lysis syndrome) (see also section 4 "Possible side effects").

Your doctor should evaluate whether you develop other types of malignant hematological neoplasms (called acute myeloid leukemia and myelodysplastic syndromes) during treatment with thalidomide (see also section 4 "Possible side effects").

You must not donate blood during treatment with thalidomide or for at least 7 days after stopping treatment.

If you are unsure whether any of the above apply to you, consult your doctor before starting to take thalidomide.

Children and adolescents

The use of thalidomide is not recommended in children and adolescents under 18 years of age.

Taking Thalidomide Accord with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription and herbal preparations.

Be sure to inform your doctor if you are taking any medicine that:

• Causes drowsiness, as thalidomide may increase this effect. These include sedatives (such as anxiolytics, hypnotics, antipsychotics, H1 antihistamines, opioids, and barbiturates).
• Slows heart rate (induces bradycardia), such as anticholinesterases and beta-blockers.
• Is used for heart problems or complications (such as digoxin) or to thin the blood (such as warfarin).
• Is associated with neuropathy, such as other cancer treatments.
• Is used for contraception.

Taking Thalidomide Accord with food, drinks, and alcohol

Do not drink alcohol while taking thalidomide. This is because alcohol causes drowsiness, and thalidomide may increase this effect.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Thalidomide causes severe birth defects and fetal death.

• If a pregnant woman takes even a single small dose, such as one capsule, the baby may be born with severe congenital malformations.
• These defects may include shortened arms or legs, deformities of hands or feet, and problems with eyes, ears, or internal organs.

You must not take thalidomide if you are pregnant. Also, you must not become pregnant while taking thalidomide.

Women who are capable of becoming pregnant must use an effective method of contraception (see section 2 "What you need to know before starting to take Thalidomide Accord").

You must stop treatment and inform your doctor immediately if:

• You miss a period or think you may have missed a period, have unusual menstrual bleeding, or suspect you may be pregnant.
• You have heterosexual intercourse without using an effective contraceptive method.

If you become pregnant during treatment with thalidomide, you must stop treatment and inform your doctor immediately.

Men taking thalidomide who have a partner capable of becoming pregnant should read section 2 "What you need to know before starting to take Thalidomide Accord". If your partner becomes pregnant while you are taking thalidomide, you must inform your doctor immediately.

Breastfeeding

You must not breastfeed while taking thalidomide, as it is unknown whether thalidomide passes into human breast milk.

Driving and using machines

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

This medicine contains Isomalt.

If your doctor has informed you that you have an intolerance to certain sugars, consult them before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per capsule, i.e., essentially "sodium-free".

3. How to take Talidomida Accord

Follow exactly the instructions for taking thalidomide as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to take

The recommended dose is 200 mg (4 capsules of 50 mg) per day in adults aged 75 years or younger, or 100 mg (2 capsules of 50 mg) per day in adults over 75 years of age. However, your doctor will choose the most appropriate dose for your individual case, monitor your progress, and may adjust the dose accordingly. Your doctor will inform you how you should take thalidomide and for how long you will need to take it (see section 2, “What you need to know before starting to take Talidomida Accord”).

Thalidomide is taken daily in treatment cycles, each lasting 6 weeks, in combination with melphalan and prednisone, which are taken on days 1 to 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 thalidomide capsule comes into contact with the skin, wash the skin immediately and thoroughly with water and soap.
• Take this medicine by mouth.
• Swallow the capsules whole with a full glass of water.
• Do not crush or chew them.
• Take the capsules as a single dose before going to bed. This will help reduce drowsiness at other times.

To remove the capsule from the blister pack, press only on one end of the capsule to push it through the foil. Do not press in the center of the capsule, as this may break it.

If you take more Talidomida Accord than you should

If you take more thalidomide than prescribed, contact a doctor or go immediately to a hospital. If possible, bring the medicine packaging and this leaflet with you. In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately at 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Talidomida Accord

If you forget to take thalidomide at your usual time:

• Less than 12 hours have passed: take the missed dose immediately.
• More than 12 hours have passed: do not take the missed dose. Take the next dose at your usual time the following day.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

This medicine may cause the following adverse effects:

Stop taking thalidomide and consult your doctor immediately if you notice any of the following serious adverse effects – you may need urgent medical treatment:

• Severe skin reactions, such as skin rashes, which is a common adverse effect, and blisters on the skin and mucous membranes (Stevens-Johnson syndrome and toxic epidermal necrolysis, which are rare adverse effects). You may also have a high temperature (fever) at the same time.

Contact your doctor immediately if you notice any of the following serious adverse effects:

• Numbness, tingling, abnormal coordination, or pain in the hands and feet.

This may be due to nerve damage (peripheral neuropathy), which is a very common adverse effect. It can become severe, painful, and disabling. If you experience these symptoms, contact your doctor immediately; your doctor may reduce the dose or stop treatment. This adverse effect usually occurs after taking this medicine for several months, but it may occur earlier. It may also occur some time after treatment has ended. It may not go away or may resolve slowly.

• Sudden pain in the chest or difficulty breathing.

This may be due to blood clots in the arteries leading to the lungs (pulmonary embolism), which is a common adverse effect. It may occur during treatment or after treatment has ended.

• Pain or swelling in the legs, particularly in the lower part or calves.

This may be due to blood clots in the veins of the legs (deep vein thrombosis), which is a common adverse effect. It may occur during treatment or after treatment has ended.

• Chest pain spreading to the arms, neck, jaw, back, or stomach, sweating, shortness of breath, nausea, or vomiting.

These may be symptoms of a heart attack/myocardial infarction (which may be due to blood clots in the arteries of the heart).

• Temporary difficulty seeing or speaking.

These may be symptoms of a stroke (cerebral infarction) (which may be due to a blood clot in an artery of the brain).

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

Other adverse effects include:

It is important to note that a small number of patients with multiple myeloma may develop other types of cancer, particularly malignant hematological neoplasms, and this risk may be increased with thalidomide treatment; therefore, your doctor must carefully evaluate the benefits and risks before prescribing thalidomide.

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

• Constipation.
• Dizziness.
• Drowsiness, fatigue.
• Tremors.
• Decreased or abnormal sensations (dysesthesia).
• Swelling of hands and feet.
• Low blood cell counts, which could mean a higher chance of developing infections. Your doctor may monitor your blood cell counts during treatment with thalidomide.

Common (may affect up to 1 in 10 people)

• Indigestion, nausea, vomiting, dry mouth.
• Rash, dry skin.
• Decreased number of white blood cells (neutropenia) accompanied by fever and infection.
• Decreased number of red blood cells, white blood cells, and platelets at the same time (pancytopenia).
• Weakness, fainting or instability, lack of energy or strength, low blood pressure.
• Fever, general malaise.
• Seizures.
• Sensation of dizziness, making it difficult to stand and move normally.
• Blurred vision.
• Pneumonia, lung disease.
• Slow heart rate, heart failure.
• Depression, confusion, mood changes, anxiety.
• Decreased hearing or deafness.
• Kidney disease (renal failure).

Uncommon (may affect up to 1 in 100 people)

• Inflammation and swelling of the lung tubes (bronchitis).
• Inflammation of the stomach wall.
• Perforation of the large intestine (colon), which may cause infection.
• Bowel obstruction.
• Decreased blood pressure when standing up, which may cause fainting.
• Irregular heartbeat (heart block or atrial fibrillation), feeling of loss of consciousness or fainting.

Frequency not known (cannot be estimated from available data):

• Underactive thyroid (hypothyroidism).
• Bowel obstruction.
• Sexual dysfunction, for example, impotence.
• Serious blood infection (septicemia) accompanied by fever, chills, and severe shivering, and possibly complicated by low blood pressure and confusion (septic shock).
• Tumor lysis syndrome – metabolic complications that may occur during cancer treatment and sometimes even without treatment. These complications are due to the breakdown products of dying cancer cells and may include the following: changes in blood biochemistry; high levels of potassium, phosphate, uric acid, and low levels of calcium, which consequently lead to changes in kidney function, heartbeat, seizures, and sometimes death.
• Allergic reactions such as localized or generalized itchy rash and angioedema (types of allergic reactions that may present as hives, skin rashes, swelling of the eyes, mouth, or face, difficulty breathing, or itching).
• Liver injury (liver disorder), including abnormal results in liver function tests.
• Bleeding in the stomach or intestines (gastrointestinal bleeding).
• Worsening of symptoms of Parkinson's disease (such as tremors, depression, or confusion).
• Pain in the upper abdomen and/or back, which may be severe and last several days, possibly accompanied by nausea, vomiting, fever, and rapid pulse – these symptoms may be due to inflammation of the pancreas (pancreatitis).
• Increased blood pressure in the blood vessels supplying blood to the lungs, which may lead to difficulty breathing, fatigue, dizziness, chest pain, faster heartbeat, or swelling of legs or ankles (pulmonary hypertension).
• Viral infections, including herpes zoster (also known as "shingles," a viral disease causing a painful blistering rash) and recurrence of hepatitis B infection (which may cause yellowing of the skin and eyes, dark brown urine, stomach pain on the right side, fever, nausea, or vomiting).
• A brain disorder with symptoms such as changes in vision, headache, seizures, and confusion, with or without high blood pressure (reversible posterior encephalopathy syndrome or PRES).
• A skin condition caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis).

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Thalidomide Accord

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister, after EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if deterioration or signs of tampering with the safety seal are observed.

Do not store above 30°C.

At the end of your treatment, return all unused capsules to your pharmacist or doctor to prevent misuse.

6. Contents of the pack and other information

Composition of Talidomide Accord:

• The active substance is thalidomide. Each capsule contains 50 mg of thalidomide.
• The other excipients are isomalt (E953), sodium croscarmellose, and stearil fumarate and sodium. The capsule shell contains gelatin and titanium dioxide (E171).

Appearance of the medicine and contents of the pack

Talidomide Accord hard capsules are opaque white, size number 4. The capsules are filled with white powder.

PVC/PCTFE/aluminum blister pack containing 14 capsules. Pack size: Carton with 28 capsules (2 blisters).

Unit-dose PVC/PCTFE/aluminum blister pack containing 7 capsules. Pack size: 28 capsules (4 blisters) in cartons.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Accord Healthcare, S.L.U.

World Trade Center,

Moll de Barcelona, s/n,

Edifici Est, 6th floor,

08039 Barcelona

Spain

Manufacturer

Ardena Pamplona, S.L.

Pol Mocholi, Calle Noáin 1

31110 Noáin, Navarra

Spain

Or

Medichem S.A.

Narcis Monturiol, 41A

08970 Sant Joan Despí - Barcelona

Spain

Or

Bluepharma – Indústria Farmacêutica, S.A.

Eiras, Rua Adriano Lucas

Coimbra, 3020-430

Portugal

Or

Bluepharma – Indústria Farmacêutica, S.A.

• Martíns do Bispo

Coimbra, 3045-016

Portugal

This medicine is authorized in the European Economic Area member states under the following names:

Cyprus Thalidomide Accord 50mg σκληρ? καψ?κια

Denmark Thalidomide Accord

Slovenia Talidomid Accord 50mg trde kapsule

Spain Talidomida Accord 50 mg cápsulas duras EFG

France Thalidomide Accord 50mg gélule

Hungary Thalidomide Accord 50mg kemény kapszula

Italy Talidomide Accord

Malta Thalidomide Accord 50mg hard capsules

Poland Thalidomide Accord

Portugal Thalidomide Accord 50mg cápsulas

Romania Talidomida Accord 50 mg capsule

Date of the most recent review of this leaflet: 02/2022

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products: http://www.aemps.gob.es.