Prospect: information for the patient

Talidomida Accord 50 mg hard capsules EFG

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

What is Talidomida Accord

Talidomida Accord contains an active ingredient called talidomida, which belongs to a group of medications that affect how your immune system works.

What is Talidomida Accord used for

Talidomida is used with two other medications called “melfalán” and “prednisona” to treat adults with a type of cancer called multiple myeloma. It is used in people aged 65 or older who have recently been diagnosed and have not used any medication for multiple myeloma before, or in people under 65 who cannot be treated with high-dose chemotherapy as it may be difficult for the body to absorb.

What is multiple myeloma

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 bones and kidneys. Multiple myeloma is generally not curable. However, symptoms and signs can decrease significantly or disappear for a period of time. This is called “remission”.

How Talidomida Accord works

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

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

.

You should receive specific instructions from your doctor, particularly about the effects of thalidomide on the fetus (which are explained in the Accord Thalidomide Pregnancy Prevention Program).

You should receive a patient information leaflet from your doctor. You should read it carefully and follow their instructions.

If you do not fully understand these instructions, ask your doctor to explain them again before taking thalidomide. You can find more information in this section in the "Warnings and Precautions" and "Pregnancy and Breastfeeding" sections.

Do not take Thalidomide Accord

• If you are pregnant, think you may be pregnant, or intend to become pregnant, as thalidomide causes congenital defects and fetal death.Thalidomide causes congenital defects and fetal death..
• If you have the possibility of becoming pregnant unless you are able to follow or comply with the contraceptive measures required to avoid becoming pregnant (see section 2 "Warnings and Precautions" and "Pregnancy and Breastfeeding").
• If you have the possibility of becoming pregnant, your doctor will record 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 medication included in section 6 "Packaging and additional information".

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

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication in the following cases:

For women taking thalidomidewho take thalidomide

Before starting treatment, you must consult your doctor if there is a possibility that you may become pregnant, even if you think this is unlikely. Even if you do not have menstrual bleeding after cancer treatment, you may become pregnant.

If you have the possibility of becoming pregnant:

• Your doctor will ensure that you have pregnancy tests.

• Before treatment.
• Every 4 weeks during treatment.
• 4 weeks after completing treatment.

• You must use an effective contraceptive method:

• For at least 4 weeks before starting treatment.
• During treatment.
• Until at least 4 weeks after completing treatment.

Your doctor will tell you which contraceptive method to use.

If you have the possibility of becoming pregnant, your doctor will record with each prescription that the necessary measures have been taken, as described above.

For men taking thalidomidewho take thalidomide

Thalidomide passes into semen. Therefore, do not have unprotected sex, even if you have undergone a vasectomy.

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

• During treatment.
• For at least 7 days after completing treatment.

• You must not donate semen:

• During treatment.
• For at least 7 days after completing treatment.

For all patients

Before taking thalidomide, consult your doctor if:

• You do not understand the instructions on contraception that your doctor has given you or do not believe you are able to follow them.
• You have had a heart attack, have ever had a blood clot, or if you smoke, or have high blood pressure or high cholesterol. During treatment with thalidomide, you have a higher risk of developing blood clots in veins and arteries (see also section 4 "Possible side effects");
• You have had or have neuropathy, i.e., nerve damage that causes tingling, abnormal coordination, or pain in your hands or feet (see also section 4 "Possible side effects").
• You have had or have a slow heart rate (it may be a symptom of bradycardia).
• You have high blood pressure in the arteries that leave 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 (liver disorders), such as abnormal liver test results.
• You have had severe skin eruptions that can start as a skin eruption in an 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 a rash, itching, swelling, dizziness, or respiratory problems.
• You have had drowsiness.
• You have had fever, chills, and intense shivering, and possibly complicated with low blood pressure and confusion (they may be symptoms of severe infections).
• You have or have had a viral infection, specifically chickenpox, shingles, hepatitis B infection, or HIV. In doubt, consult your doctor. Thalidomide treatment can make the virus reappear in patients who carry it, leading to the reappearance of the infection. Your doctor should check if you have ever had a hepatitis B infection;
• You have kidney or liver problems (see also section 4 "Possible side effects");

Your doctor may check if you have a high total tumor burden throughout your body, including bone marrow. This could lead to a disease in which tumors break down and produce abnormal levels of chemicals in the blood that can cause kidney failure (this disease is called tumor lysis syndrome) (see also section 4 "Possible side effects").

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

You must not donate blood during treatment with thalidomide, nor at least 7 days after completing treatment.

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

Children and adolescents

Thalidomide is not recommended for use in children and adolescents under 18 years old.

Use of Thalidomide Accord with other medications

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription and herbal preparations.

Make sure to inform your doctor if you are taking any medication that:

• Causes drowsiness, as thalidomide may increase this effect. These medications include sedatives (such as anxiolytics, hypnotics, antipsychotics, antihistamines H1, opioid derivatives, and barbiturates).
• Slows down heart rate (induces bradycardia, such as anticholinesterases and beta-blockers).
• Is used for heart problems and 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. The reason is that alcohol will make you drowsy and thalidomide will make you even drowsier.

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 medication.

Pregnancy

Thalidomide causes severe congenital defects and fetal death.

• Even taking a very small dose, such as one capsule, can cause the baby to be born with severe congenital defects.
• These defects can include shorter arms or legs, hand or foot deformities, eye problems, ear problems, or internal organ problems.

Do not take thalidomide if you are pregnant. Also, do not become pregnant while taking thalidomide.

Women who may become pregnant must use an effective contraceptive method (see section 2, "What you need to know before starting to take Thalidomide Accord").

You must interrupt treatment and inform your doctor immediately if:

• You do not have a period or think you have not had a period, in case of abnormal menstrual bleeding or if you suspect you may be pregnant.
• You have unprotected heterosexual sex.

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

Men who take thalidomide and have a partner who may become pregnant must 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

Do not breastfeed while taking thalidomide, as it is not known if thalidomide passes into human 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.

This medication contains Isomalta.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1mmol) per capsule, which is essentially "sodium-free".

Follow exactly the administration instructions for talidomida as indicated by your doctor or pharmacist. In case of 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 75 years or less, or 100 mg (2 capsules of 50 mg) per day in adults over 75 years. However, your doctor will choose the most suitable dose for your case, monitor your progress, and may adjust the dose. Your doctor will tell you how to take talidomida and for how long you will need to take it (see section 2, "What you need to know before starting to take Talidomida Accord").

Talidomida is taken every day in treatment cycles, each lasting 6 weeks, in combination with melfalán and prednisona, which are taken on days 1 to 4 of each 6-week cycle.

How to take thismedicine

• Do not break, open, or chew the capsules. If the powder from a broken talidomida capsule comes into contact with the skin, wash the skin immediately and carefully with water and soap.
• Take this medicine orally.
• Swallow the capsules whole with a full glass of water.
• Do not crush or chew the capsules.
• Take the capsules as a single dose before going to sleep. This will make you feel less drowsy at other times.

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

If you take more Talidomida Accord than you should

If you take a larger amount of talidomida than indicated, consult a doctor or go directly to a hospital. If possible, bring the medication packaging and this leaflet with you. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Talidomida Accord

If you forget to take talidomida at your 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 your usual time the following day.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

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

This medicine may cause the following side effects:

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

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

Consult your doctor immediately if you notice any of the following serious side 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 side effect. It can be very severe, painful and debilitating. If you experience these symptoms, consult your doctor immediately, who may reduce the dose or discontinue treatment. This side effect usually occurs after taking this medicine for several months, but it can occur earlier. It may also occur some time after treatment has stopped. It may not go away or may take a long time to do so.

• Sudden chest pain or difficulty breathing.

This may be due to blood clots in the arteries that lead to the lungs (pulmonary embolism), which is a common side effect. It can occur during treatment or after treatment has stopped.

• Pain or inflammation in the legs, especially in the lower part or in the shins.

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

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

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

• Temporary difficulty seeing or speaking.

This may be a symptom of a stroke (cerebral infarction) (which may be due to a blood clot in a cerebral artery).

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

Other side effects include:

It is worth noting that a small number of patients with multiple myeloma may develop other types of cancer, especially malignant hematological neoplasms, and it is possible that this risk may increase with talidomide treatment; therefore, your doctor should carefully evaluate the benefits and risks of prescribing talidomide to you.

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

• Constipation.
• Dizziness.
• Somnolence, fatigue.
• Tremors.
• Decreased sensations or abnormal sensations (dysesthesia).
• Inflammation of hands and feet.
• Low white blood cell count, which may increase the risk of developing infections. Your doctor may monitor your white blood cell count during talidomide treatment.

Common(may affect up to 1 in 10 people)

• Indigestion, nausea, vomiting, dry mouth.
• Rash, dry skin.
• Decreased white blood cell count (neutropenia) accompanied by fever and infection.
• Decreased red and white blood cell count and platelet count at the same time (pancytopenia).
• Weakness, dizziness or instability, lack of energy or strength, low blood pressure.
• Fever, general malaise.
• Seizures.
• Sensation of spinning, 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).

Rare(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 an infection.
• Intestinal obstruction.
• Decreased blood pressure in an upright position, which may cause dizziness.
• Irregular heartbeat (cardiac block or atrial fibrillation), sensation of loss of consciousness or dizziness.

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

• Subclinical hypothyroidism.
• Intestinal obstruction.
• Sexual dysfunction, for example, impotence.
• Severe blood infection (septicemia) accompanied by fever, chills and severe tremors, 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 cancer cells that die and may include the following: changes in blood biochemistry; high levels of potassium, phosphorus, uric acid and low levels of calcium, which as a result, produce changes in kidney function, heart rate, seizures and sometimes death.
• Allergic reactions such as localized or generalized pruritic exanthema and angioedema (types of allergic reactions that may manifest as urticaria, skin rashes, eye, mouth or face inflammation, difficulty breathing or itching).
• Liver damage (hepatic disorder) including abnormal results in liver function tests.
• Gastrointestinal bleeding (gastrointestinal hemorrhage).
• Worsening of Parkinson's disease symptoms (such as tremors, depression or confusion).
• Abdominal pain and/or back pain, which may be severe and last for several days, possibly accompanied by nausea, vomiting, fever and rapid pulse – these symptoms may be due to pancreatitis (inflammation of the pancreas).
• Increased blood pressure in the blood vessels that supply blood to the lungs, which may cause shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat or swelling of the legs or ankles (pulmonary hypertension).
• Viral infections, including shingles (also known as "herpes", a viral disease that causes a painful rash with blisters) and recurrence of hepatitis B infection (which may cause yellowing of the skin and eyes, dark brown urine, right-sided abdominal pain, fever, nausea or vomiting).
• A brain disease with symptoms such as changes in vision, headache, seizures and confusion, with or without high blood pressure (posterior reversible encephalopathy syndrome or PRES).
• A skin disease caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and in the blister pack, after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe deterioration or signs of tampering with the safety seal.

Do not store at a temperature above 30°C

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

Composition of Thalidomide Accord:

• The active ingredient is thalidomide. Each capsule contains 50 mg of thalidomide.
• The other excipients are isomalta (E953), sodium croscarmellose, and stearate and sodium fumarate. The capsule coating contains gelatin and titanium dioxide (E171).

Appearance of the product and contents of the pack

Thalidomide Accord hard capsules are white and opaque, size 4. The capsules are filled with a white powder.

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

Single-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

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

CyprusThalidomide Accord 50mg σκληρ? καψ?κια

DenmarkThalidomide Accord

SloveniaTalidomid Accord 50mg trde kapsule

SpainTalidomida Accord 50 mg hard capsules EFG

FranceThalidomide Accord 50mg gélule

HungaryThalidomide Accord 50mg kemény kapszula

ItalyTalidomide Accord

MaltaThalidomide Accord 50mg hard capsules

PolandThalidomide Accord

PortugalThalidomide Accord 50mg capsules

RomaniaTalidomida Accord 50 mg capsule

Last review date of this leaflet: 02/2022

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices: http://www.aemps.gob.es.