Lenalidomide Tarbis 15 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lenalidomida Tarbis 15 mg hard capsules EFG

lenalidomide

Read all of this leaflet carefully before you start taking this medicine, because 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 for you only. Do not pass it on to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Lenalidomida Tarbis is and what it is used for

What Lenalidomida Tarbis is

Lenalidomida Tarbis contains the active substance “lenalidomide”. This medicine belongs to a group of medicines that affect how the immune system works.

What Lenalidomida Tarbis is used for

Lenalidomida Tarbis is used in adults for:

• Multiple myeloma
• Myelodysplastic syndromes (MDS)
• Follicular lymphoma

Multiple myeloma

Multiple myeloma is a type of cancer that affects a specific type of white blood cells called plasma cells. These cells accumulate in the bone marrow and multiply uncontrollably. This can damage bones and kidneys.

Multiple myeloma is generally incurable. However, signs and symptoms can be greatly reduced or disappear for a period of time. This is called “remission”.

Newly diagnosed multiple myeloma: in patients who have undergone a bone marrow transplant, lenalidomide is used as maintenance treatment after adequate recovery from the bone marrow transplant.

Newly diagnosed multiple myeloma: in patients who cannot receive a bone marrow transplant

Lenalidomide is taken with other medicines, including:

• a chemotherapy medicine called “bortezomib”;
• an anti-inflammatory medicine called “dexamethasone”;
• a chemotherapy medicine called “melphalan”; and
• an immunosuppressant called “prednisone”.

You will take these medicines at the beginning of treatment and then continue taking lenalidomide alone.

If you are 75 years of age or older or have moderate to severe kidney problems, your doctor will monitor you carefully before starting treatment.

Multiple myeloma: in previously treated patients

Lenalidomide is taken together with an anti-inflammatory medicine called “dexamethasone”.

Lenalidomide may slow the worsening of signs and symptoms of multiple myeloma. It has also been shown to delay the return of multiple myeloma after treatment.

Myelodysplastic syndromes (MDS)

MDS are a group of different blood and bone marrow diseases. Blood cells become abnormal and do not function properly. Patients may experience a variety of signs and symptoms, including low red blood cell count (anaemia), need for blood transfusions, and risk of infection.

Lenalidomide is used to treat adult patients diagnosed with MDS when all of the following apply:

• you require regular blood transfusions to treat low red blood cell levels (“transfusion-dependent anaemia”)
• you have an abnormality in bone marrow cells called “isolated 5q cytogenetic abnormality”. This means your body does not produce enough healthy blood cells
• previous treatments you have used are not suitable or have not worked well enough.

Lenalidomide can increase the number of healthy red blood cells your body produces by reducing the number of abnormal cells:

• this may reduce the number of blood transfusions needed. Blood transfusions may no longer be required.

Follicular lymphoma (FL)

FL is a slow-growing cancer that affects B-lymphocytes. These are a type of white blood cell that helps the body fight infections. In patients with FL, too many of these B-lymphocytes may accumulate in the blood, bone marrow, lymph nodes, and spleen.

Lenalidomide is used in combination with another medicine called “rituximab” for the treatment of adult patients who have received prior treatment for follicular lymphoma.

How Lenalidomida Tarbis works

Lenalidomide works by affecting the body's immune system and directly attacking cancer cells.

It acts in several ways:

• stops the development of cancer cells;
• inhibits the growth of blood vessels in cancer;
• stimulates part of the immune system to attack cancer cells

2. What you need to know before starting Lenalidomida Tarbis

You must read the package leaflet of all medicines you are going to take in combination with Lenalidomida Tarbis before starting treatment with Lenalidomida Tarbis.

Do not take Lenalidomida Tarbis:

• if you are pregnant, think you might be pregnant, or intend to become pregnant, as Lenalidomide is expected to be harmful to the fetus (see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”);
• if you are capable of becoming pregnant, unless you follow all necessary measures to prevent pregnancy (see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”). If you are capable of becoming pregnant, your doctor will document with each prescription that all necessary precautions have been taken and will provide you with this confirmation;
• if you are allergic to lenalidomide or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor.

If any of these conditions apply to you, do not take Lenalidomida. If in doubt, consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting Lenalidomida Tarbis if:

• you have ever had blood clots; during treatment, you have an increased risk of developing blood clots in veins and arteries;
• you have any signs of infection, such as cough or fever;
• you have or have previously had a viral infection, especially hepatitis B, varicella zoster, or HIV. If in doubt, consult your doctor. Treatment with Lenalidomide may reactivate the virus in patients who are carriers, leading to recurrence of the infection. Your doctor should check whether you have ever had hepatitis B infection;
• you have kidney problems; your doctor may adjust your dose of Lenalidomide;
• you have had a heart attack, have ever had a blood clot, or if you smoke, have high blood pressure, or high cholesterol levels;
• you have had an allergic reaction while using thalidomide (another medicine used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or breathing problems;
• you have previously experienced a combination of any of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes (signs of a serious skin reaction called drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or drug hypersensitivity syndrome) (see also section 4 “Possible side effects”).

If any of the above conditions apply to you, inform your doctor, pharmacist, or nurse before starting treatment.

At any time, during or after treatment, inform your doctor or nurse immediately if you experience:

• blurred vision, loss of vision, double vision, difficulty speaking, weakness in one arm or leg, change in walking pattern or balance problems, persistent numbness, reduced sensation, or loss of sensation, memory loss, or confusion. These may be symptoms of a serious and potentially fatal brain disease known as progressive multifocal leukoencephalopathy (PML). If you have any of these symptoms before starting treatment with Lenalidomida, inform your doctor if you notice any changes in these symptoms.
• shortness of breath, fatigue, dizziness, chest pain, faster heartbeat, or swelling in the legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Tests and monitoring

Before starting treatment with Lenalidomide and during treatment, you will have regular blood tests. This is because Lenalidomide can cause a decrease in blood cells that help fight infections (white blood cells) and those involved in blood clotting (platelets).

Your doctor will request that you have blood tests:

• before treatment begins;
• every week during the first 8 weeks of treatment;
• thereafter, at least once a month.

You may be evaluated for signs of cardiopulmonary problems before and during treatment with lenalidomide.

For patients with MDS taking lenalidomide:

If you have MDS, you may be more likely to develop a more advanced disease called acute myeloid leukemia (AML). In addition, it is unknown how lenalidomide affects the likelihood of developing AML. Therefore, your doctor may perform blood tests to detect signs that could better predict the likelihood of developing AML during your treatment with lenalidomide.

For patients with FL taking Lenalidomida

Your doctor will request that you have blood tests:

• before treatment;
• every week during the first 3 weeks (1 cycle) of treatment;
• then every 2 weeks during cycles 2 to 4 (see section 3 “Treatment cycle” for more information);
• after this, at the beginning of each cycle and
• at least once a month.

Your doctor may check whether you have a high total tumor burden in the body, including in the bone marrow. This could lead to a condition in which tumors break down and release unusual levels of chemicals into the blood, which in turn may cause kidney failure (this condition is called “tumor lysis syndrome”).

Your doctor may examine you to check for skin changes such as red spots or rashes.

Your doctor may adjust the dose of Lenalidomide or interrupt your treatment, depending on the results of your blood tests and your general condition. If you are a newly diagnosed patient, your doctor may also evaluate your treatment based on your age and other pre-existing conditions.

Blood donation

You must not donate blood during treatment or for at least 7 days after treatment ends.

Children and adolescents

Lenalidomide is not recommended for use in children and adolescents under 18 years of age.

Elderly patients and patients with kidney problems

If you are 75 years of age or older or have moderate to severe kidney problems, your doctor will carefully evaluate you before starting treatment.

Other medicines and Lenalidomida Tarbis

Inform your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines. This is because Lenalidomide may affect how other medicines work. In addition, some medicines may affect how Lenalidomide works.

Specifically, inform your doctor or nurse if you are taking any of the following medicines:

• certain medicines used to prevent pregnancy, such as oral contraceptives, as they may stop working;
• certain medicines used for heart problems, such as digoxin;
• certain medicines used to thin the blood, such as warfarin.

Pregnancy, breastfeeding and contraception: information for women and men

Pregnancy

Women taking Lenalidomida

• You must not take Lenalidomida if you are pregnant, as it is expected to be harmful to the fetus.
• You must not become pregnant while taking Lenalidomida. Therefore, you must use effective contraceptive methods if there is any possibility you could become pregnant (see “Contraception”).
• If you become pregnant during treatment with Lenalidomida, you must stop treatment and inform your doctor immediately.

Men taking Lenalidomida

• If your partner becomes pregnant while you are taking Lenalidomida, you must inform your doctor immediately. It is advisable that your partner seeks medical advice.
• You must also use effective contraceptive methods (see “Contraception”).

Breastfeeding

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

Contraception

For women taking Lenalidomida

Before starting treatment, ask your doctor whether you are capable of becoming pregnant, even if you think this is unlikely.

If you are capable of becoming pregnant:

• you will undergo pregnancy tests under medical supervision (before each treatment cycle, at least every 4 weeks during treatment, and for at least 4 weeks after treatment ends), unless it has been confirmed that your fallopian tubes are closed so that eggs cannot reach the uterus (tubal ligation);

And

• you must use effective contraceptive methods starting at least 4 weeks before beginning treatment, throughout treatment, and for at least 4 weeks after treatment ends. Your doctor will advise you on the most appropriate contraceptive methods.

For men taking Lenalidomida

Lenalidomide is present in human semen. If your partner is pregnant or could become pregnant and is not using an effective contraceptive method, you must use condoms during treatment and for at least 7 days after treatment ends, even if you have had a vasectomy. You must not donate semen or sperm during treatment and for at least 7 days after treatment ends.

Driving and use of machines

Do not drive or operate machinery if you feel dizzy, tired, drowsy, have vertigo, or blurred vision after taking Lenalidomida.

Lenalidomida Tarbis contains lactose

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

Lenalidomida Tarbis contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule; this is, essentially “sodium-free”.

3. How to take Lenalidomide Tarbis

Lenalidomide must be prescribed and administered by a healthcare professional experienced in the treatment of multiple myeloma, MDS, or FL.

• When lenalidomide is used for the treatment of multiple myeloma in patients who are not eligible for bone marrow transplant or who have received prior therapies, it is taken in combination with other medicines (see section 1 “What Lenalidomide Tarbis is used for”).
• When lenalidomide is used for the treatment of multiple myeloma in patients who have undergone bone marrow transplant or for the treatment of patients with MDS, it is taken alone.
• When lenalidomide is used for the treatment of follicular lymphoma, it is taken together with another medicine called “rituximab”.

Always follow exactly the instructions provided by your doctor regarding the administration of lenalidomide. If in doubt, consult your doctor or pharmacist.

If you are taking lenalidomide together with other medicines, please refer to the package leaflet of those other medicines for additional information about their use and effects.

Treatment cycle

Lenalidomide is taken on certain days within a 3-week period (21 days).

• A "treatment cycle" consists of 21 days.
• Depending on the day of the cycle, you will take one or more medicines. However, on some days you will not take any medicine.
• After completing each 21-day cycle, you must start a new "cycle" for the following 21 days.

Or

Lenalidomide is taken on certain days within a 4-week period (28 days).

• A "treatment cycle" consists of 28 days.
• Depending on the day of the cycle, you will take one or more medicines. However, on some days you will not take any medicine.
• After completing each 28-day cycle, you must start a new "cycle" for the following 28 days.

How much Lenalidomide Tarbis to take

Before starting treatment, your doctor will inform you:

• of the dose of lenalidomide you should take;
• of the dose of any other medicines you should take together with this medicine, if applicable;
• on which days of the treatment cycle you should take each medicine.

How and when to take Lenalidomide Tarbis

• Swallow the capsules whole, preferably with water.
• Do not break, open, or chew the capsules. If the powder from a broken lenalidomide capsule comes into contact with the skin, wash the affected skin area immediately and thoroughly with water and soap.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Afterwards, gloves should be carefully removed to avoid skin exposure, placed into a sealed polyethylene plastic bag, and disposed of according to local requirements. Hands should then be thoroughly washed with water and soap. Pregnant women or women who suspect they may be pregnant must not handle the blister pack or capsule.
• Capsules may be taken with or without food.
• You should take lenalidomide at approximately the same time each day on the scheduled days.

How to take this medicine

To remove the capsule from the blister:

• Press only on one end of the capsule so that it comes through the foil.
• Do not press in the center of the capsule, as this may break it.

Duration of treatment with Lenalidomide Tarbis

Lenalidomide is taken in treatment cycles, each lasting 21 or 28 days (see “Treatment cycle” above). You must continue the treatment cycles until your doctor instructs you to stop treatment.

If you take more Lenalidomide Tarbis than you should

If you take more lenalidomide than prescribed, inform your doctor immediately.

If you forget to take Lenalidomide Tarbis

If you forget to take lenalidomide at your usual time and:

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

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

4. Possible adverse effects

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

If you experience any of the following serious adverse effects, stop treatment with Lenalidomida Tarbis and seek medical attention immediately, as you may require urgent medical treatment:

• Hives, rashes, swelling of the eyes, mouth or face, difficulty breathing or itching, which may be symptoms of severe types of allergic reactions called angioedema and anaphylactic reaction.
• Severe allergic reaction that may start as a rash in one area but spreads, causing extensive skin loss throughout the body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
• Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and effects on other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or drug hypersensitivity syndrome). See also section 2.

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

• Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection, including in the bloodstream (sepsis).
• Bleeding or bruising not due to injury.
• Chest (thoracic) pain or leg pain.
• Difficulty breathing.
• Bone pain, muscle pain, confusion, or fatigue, which may be due to high levels of calcium in the blood.

Lenalidomide may reduce the number of white blood cells that fight infections and also the number of blood cells involved in blood clotting (platelets), which may lead to bleeding disorders such as nosebleeds and bruising. Lenalidomide may also cause blood clots in the veins (thrombosis).

Other adverse effects

It is important to note that a small number of patients may develop other types of cancer, and this risk may increase with treatment with Lenalidomide. Therefore, your doctor must carefully evaluate the benefits and risks before prescribing Lenalidomide.

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

• A decrease in the number of red blood cells, which may lead to anemia causing fatigue and weakness.
• Skin rash, itching.
• Muscle cramps, muscle weakness, muscle pain, muscle discomfort, bone pain, joint pain, back pain, limb pain.
• Generalized swelling, including swelling of arms and legs.
• Weakness, fatigue.
• Fever and flu-like symptoms including fever, muscle pain, headache, earache, cough, and chills.
• Numbness, tingling, or burning sensation in the skin, pain in hands or feet, dizziness, tremor.
• Decreased appetite, changes in taste.
• Increased pain, size of tumor, or redness around the tumor.
• Weight loss.
• Constipation, diarrhea, nausea, vomiting, stomach pain, heartburn.
• Low levels of potassium, calcium, and/or sodium in the blood.
• Underactive thyroid function.
• Leg pain (which could be a symptom of thrombosis), chest pain, or difficulty breathing (which could be symptoms of blood clots in the lungs, called pulmonary embolism).
• Infections of all types, including infection of the sinuses around the nose (sinusitis), lung infection, and upper respiratory tract infections.
• Difficulty breathing.
• Blurred vision.
• Clouding of the eye (cataracts).
• Kidney problems, including kidneys that do not function properly or are unable to maintain normal function.
• Abnormal results in liver function tests.
• High values in liver function tests.
• Changes in a blood protein that may cause swelling of the arteries (vasculitis).
• Increased blood sugar levels (diabetes).
• Decreased blood sugar levels.
• Decrease in blood sugar levels.
• Headache.
• Nosebleeds.
• Dry skin.
• Depression, mood changes, difficulty sleeping.
• Cough.
• Low blood pressure.
• General feeling of discomfort or malaise.
• Painful inflammation of the mouth, dry mouth.
• Dehydration.

Common adverse effects (may affect up to 1 in 10 people):

• Destruction of red blood cells (hemolytic anemia).
• Certain types of skin tumors.
• Bleeding from gums, stomach, or intestines.
• Increased blood pressure, slow, fast, or irregular heartbeat.
• Increased levels of a substance released after normal or abnormal destruction of red blood cells.
• Increased levels of a protein indicating inflammation in the body.
• Darkening of skin color; skin discoloration due to internal bleeding, usually caused by bruising; skin inflammation due to blood accumulation; bruising.
• Increased uric acid levels in the blood.
• Skin rashes, redness of the skin, cracked skin, peeling or flaking skin, hives.
• Increased sweating, night sweats.
• Difficulty swallowing, sore throat, difficulty maintaining voice quality or voice changes.
• Runny nose.
• Marked increase or decrease in urine output compared to normal, or inability to control urination.
• Blood in the urine.
• Difficulty breathing, especially when lying down (which could be a symptom of heart failure).
• Difficulty achieving an erection.
• Stroke, fainting, dizziness (a disorder of the inner ear causing a sensation of spinning), temporary loss of consciousness.
• Chest pain spreading to arms, neck, jaw, back, or stomach, accompanied by sweating and shortness of breath, nausea or vomiting, which may be symptoms of a heart attack (myocardial infarction).
• Muscle weakness, lack of energy.
• Neck pain, chest pain.
• Chills.
• Swelling of joints.
• Slowed or blocked bile flow from the liver.
• Low levels of phosphate or magnesium in the blood.
• Difficulty speaking.
• Liver damage.
• Loss of balance, movement difficulties.
• Deafness, ringing in the ears (tinnitus).
• Nerve pain, abnormal and unpleasant sensation, especially upon touch.
• Excess iron in the body.
• Thirst.
• Confusion.
• Toothache.
• Falls that may result in injury.

Uncommon adverse effects (may affect up to 1 in 100 people):

• Bleeding inside the skull.
• Circulatory problems.
• Loss of vision.
• Loss of sexual desire (libido).
• Excretion of large amounts of urine with bone pain and weakness, which may be symptoms of a kidney disorder (Fanconi syndrome).
• Yellow pigmentation of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itchy skin, skin rash, stomach pain or swelling; these may be symptoms of liver damage (liver failure).
• Stomach pain, abdominal swelling, or diarrhea, which may be symptoms of inflammation of the large intestine (called colitis or typhlitis).
• Damage to kidney cells (called renal tubular necrosis).
• Changes in skin color, sensitivity to sunlight.
• Tumor lysis syndrome – metabolic complications may occur during cancer treatment and sometimes even without treatment. These complications arise from the breakdown products of dying tumor cells and may include: changes in blood chemistry, high levels of potassium, phosphorus, uric acid, and low calcium levels, leading to changes in kidney function and heart rhythm, seizures, and sometimes death.
• Increased blood pressure in the blood vessels supplying the lungs (pulmonary hypertension).

Adverse effects of unknown frequency (cannot be estimated from available data):

• Sudden or mild pain in the upper abdomen and/or back that worsens and lasts for several days, possibly accompanied by nausea, vomiting, fever, and rapid pulse. These symptoms may be due to inflammation of the pancreas.
• Wheezing or whistling sounds when breathing, difficulty breathing, or dry cough, which may be symptoms caused by inflammation of lung tissue.
• Rare cases of muscle breakdown (muscle pain, weakness, or swelling) have been observed, which may lead to kidney problems (rhabdomyolysis), some of them occurring when lenalidomide is administered with a statin (a type of medicine used to lower cholesterol).
• A skin disease caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis).
• Perforation of the stomach or intestinal wall. This may lead to a severe infection. Inform your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in stools, or changes in bowel habits.
• Viral infections, including herpes zoster (also known as shingles, a viral disease causing a painful skin rash with blisters) and reactivation of hepatitis B infection (which may cause yellowing of the skin and eyes, dark brown urine, stomach pain on the right side, fever, and nausea or feeling unwell).
• Rejection of solid organ transplants (such as kidney, heart).

Reporting of adverse effects

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

5. Storage of Lenalidomida Tarbis

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

Do not use this medicine after the expiry date stated on the blister and carton after "CAD"/"EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice any visible signs of deterioration or evidence of improper handling.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lenalidomide

The active substance is lenalidomide. Each capsule contains 15 mg of lenalidomide.

The other components are:

Capsule contents: Anhydrous lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.

Capsule shell: Gelatin, titanium dioxide (E171), and red iron oxide (E172).

Printing ink: Shellac, black iron oxide (E172), and potassium hydroxide.

Description of the product and contents of the pack

Lenalidomide Tarbis 15 mg hard capsules have an opaque red cap and an opaque white body. They are size “0” hard gelatin capsules printed with 'H' on the cap and 'L5' on the body, filled with a whitish to pale yellow powder.

The capsules are supplied in blisters containing 7 and 21 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Tarbis Farma S.L.
Gran Vía Carlos III, 94
08028 Barcelona
Spain

Manufacturer:

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta

or

Amarox Pharma B.V.
Rouboslaan 32
2252 TR Voorschoten
The Netherlands

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

The Netherlands: Lenalidomide Amarox 15 mg harde capsules
Spain: Lenalidomida Tarbis 15 mg cápsulas duras EFG

Date of the most recent review of this leaflet: March 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/