LENALIDOMIDE COMBIX 15 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Lenalidomide Combix 5 mg hard capsules EFG

Lenalidomide Combix 10 mg hard capsules EFG

Lenalidomide Combix 15 mg hard capsules EFG

Lenalidomide Combix 20 mg hard capsules EFG

Lenalidomide Combix 25 mg hard capsules EFG

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Lenalidomide Combix and what is it used for

What is Lenalidomide Combix

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

What Lenalidomide Combix is used for

Lenalidomide is used in adults to:

• Multiple myeloma
• Myelodysplastic syndromes (MDS)
• Mantle cell lymphoma (MCL)
• Follicular lymphoma

Multiple myeloma

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

Multiple myeloma usually has no cure. However, the signs and symptoms can be greatly reduced or may 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 recovering adequately from a bone marrow transplant.

Newly diagnosed multiple myeloma: in patients who cannot be treated with a bone marrow transplant

Lenalidomide is taken with other medicines, including:

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

You will take these medicines when you start treatment and then continue taking lenalidomide alone.

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

Multiple myeloma: in previously treated patients

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

Lenalidomide can slow down the worsening of multiple myeloma symptoms. It has also been shown to delay the return of multiple myeloma after treatment.

Myelodysplastic syndromes (MDS)

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

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

• need regular blood transfusions to treat low red blood cell counts (“transfusion-dependent anemia”)
• have a bone marrow cell abnormality called “isolated deletion 5q cytogenetic anomaly”. This means your body does not produce enough healthy blood cells
• other treatments you have used before are not suitable or do not work well enough.

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

• this can reduce the number of blood transfusions needed. You may not need transfusions at all.

Mantle cell lymphoma (MCL)

MCL is a cancer of part of the immune system (lymphatic tissue). It affects a type of white blood cell called “B lymphocytes” or B cells. MCL is a disease in which B cells grow out of control and accumulate in lymphatic tissue, bone marrow, or blood.

Lenalidomide is used alone to treat adult patients who have received previous treatment with other medicines.

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. When someone has FL, they may store too many of these B lymphocytes in the blood, bone marrow, lymph nodes, and spleen.

Lenalidomide is used with another medicine called “rituximab” to treat adult patients who have received previous treatment for follicular lymphoma.

How Lenalidomide Combix works

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

It works in several ways:

• stops the growth of cancer cells
• stops 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 you take Lenalidomide Combix

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

Do not take Lenalidomide Combix

• if you are pregnant, think you may be pregnant or plan 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 can become pregnant, unless you follow all the necessary measures to prevent it (see section 2, “Pregnancy, breastfeeding and contraception: information for women and men”). If you can become pregnant, your doctor will record with each prescription that all necessary measures have been taken and will provide you with this confirmation
• if you are allergic to lenalidomide or 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 lenalidomide. If in doubt, consult your doctor.

Warnings and precautions

Tell your doctor, pharmacist or nurse before you start taking Lenalidomide Combix if:

• you have ever had blood clots; during treatment, you have a higher risk of developing blood clots in the 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 cause the virus to become active again in patients who carry the virus. This can lead to the recurrence of the infection. Your doctor should check if you have ever had a hepatitis B infection
• you have kidney problems; your doctor may adjust your lenalidomide dose
• 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 skin rash, itching, swelling, dizziness or breathing problems
• you have experienced in the past 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 (these are signs of a severe skin reaction called Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS syndrome)

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, tell your doctor or nurse immediately if you:

• have blurred vision, loss of vision or double vision, difficulty speaking, weakness in an arm or leg, a change in the way you walk or balance problems, persistent numbness, decreased or lost sensation, memory loss or confusion. These can be symptoms of a serious and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If you have any of these symptoms before starting treatment with lenalidomide, tell your doctor if you notice any change in these symptoms
• have shortness of breath, tiredness, dizziness, chest pain, faster heart rate or swelling in the legs or ankles. These can be symptoms of a serious condition called pulmonary hypertension (see section 4).

Tests and examinations

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

Your doctor will ask you to have a blood test:

• before treatment
• every week, during the first 8 weeks of treatment
• then, at least every month.

You may be evaluated for signs of heart and lung 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). Additionally, it is not known how lenalidomide affects the chances of developing AML. Your doctor may therefore have you undergo tests to detect signs that may predict a higher likelihood of developing AML during treatment with lenalidomide.

For patients with MCL taking lenalidomide

Your doctor will ask you to have a blood test:

• before treatment
• every week during the first 8 weeks (2 cycles) of treatment
• then, every 2 weeks in cycles 3 and 4 (see section 3 “Treatment cycle” for more information)
• after that, at the start of each cycle
• at least once a month.

For patients with FL taking lenalidomide

Your doctor will ask you to have a blood test:

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

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

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

Your doctor may adjust your lenalidomide dose or interrupt your treatment, depending on the results of your blood tests and your overall condition. If you are a newly diagnosed patient, your doctor may also evaluate your treatment based on your age and other conditions you already have.

Blood donation

You must not donate blood during treatment or for at least 7 days after the end of treatment.

Children and adolescents

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

Elderly and patients with kidney problems

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

Other medicines and Lenalidomide Combix

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This is because lenalidomide can affect how other medicines work. Additionally, some medicines can affect how lenalidomide works.

In particular, tell your doctor or nurse if you are taking any of the following medicines:

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

Pregnancy, breastfeeding and contraception: information for women and men

Pregnancy

Women taking lenalidomide

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

Men taking lenalidomide

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

Breastfeeding

Do not breastfeed while taking lenalidomide, as it is not known whether lenalidomide passes into breast milk.

Contraception

For women taking lenalidomide

Before starting treatment, ask your doctor if you are able to become pregnant, even if you think this is unlikely.

If you can become pregnant:

• you will have pregnancy tests under medical supervision (before each treatment, at least every 4 weeks during treatment and for at least 4 weeks after the end of treatment) unless it has been confirmed that your fallopian tubes have been blocked (tubal ligation)

And

• you must use effective contraceptive methods from at least 4 weeks before starting treatment, during treatment and for at least 4 weeks after the end of treatment. Your doctor will advise you on the most suitable contraceptive methods.

For men taking lenalidomide

Lenalidomide passes into human semen. If your partner is pregnant or may become pregnant and does not use any effective contraceptive method, you must use condoms during treatment and for at least 7 days after the end of treatment, even if you have had a vasectomy. Do not donate semen or sperm during treatment or for at least 7 days after the end of treatment.

Driving and using machines

Do not drive or use machines if you feel dizzy, tired, drowsy, have vertigo or blurred vision after taking Lenalidomide Combix.

Lenalidomide Combix contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Lenalidomide Combix contains sodium

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

3. How to take Lenalidomida Combix

Lenalidomida should be administered by a healthcare professional with experience in the treatment of multiple myeloma, MDS, CMML, or MF.

• When lenalidomida is used to treat multiple myeloma in patients who cannot undergo a bone marrow transplant or have undergone other treatments before, it is taken with other medications (see section 1 "What Lenalidomida Combix is used for").
• When lenalidomida is used to treat multiple myeloma in patients who have undergone a bone marrow transplant or to treat patients with MDS or CMML, it is taken alone.
• When lenalidomida is used to treat follicular lymphoma, it is taken with another medication called "rituximab".

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist.

If you are taking lenalidomida with other medications, you should consult the package insert of those other medications for additional information on their use and effects.

Treatment cycle

Lenalidomida is taken on certain days during a period of 3 weeks (21 days).

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

Or

Lenalidomida is taken on certain days during a period of 4 weeks (28 days).

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

How much Lenalidomida Combix to take

Before starting treatment, your doctor will indicate:

• what quantity of lenalidomida you should take;
• what quantity of other medications you should take with lenalidomida, if applicable;
• which days of the treatment cycle you should take each medication.

How and when to take Lenalidomida Combix

• Swallow the capsules whole, preferably with water.
• Do not break, open, or chew the capsules. In the event that the powder from a broken lenalidomida capsule comes into contact with the skin, wash the skin immediately and carefully with water and soap.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister or capsule. Afterwards, they should carefully remove the gloves to avoid skin exposure, place them in a sealable polyethylene plastic bag, and dispose of them according to local requirements. Then, they should wash their hands well with water and soap. Pregnant women or those who suspect they may be pregnant should not handle the blister or capsule.
• The capsules can be taken with or without food.
• You should take lenalidomida approximately at the same time on the scheduled days.

Taking this medication

To remove the capsule from the blister:

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

Duration of treatment with Lenalidomida Combix

Lenalidomida is taken in treatment cycles, each cycle lasting 21 or 28 days (see "Treatment cycle" above). You should continue the treatment cycles until your doctor tells you to stop the treatment.

If you take more Lenalidomida Combix than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Lenalidomida Combix

If you forget to take lenalidomida at its usual time and:

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If you experience any of the following serious side effects, stop treatment with lenalidomida and go to a doctor immediately, as you may need urgent medical treatment:

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

Consult your doctor immediately if you notice any of the following serious side effects:

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

Lenalidomida may reduce the number of white blood cells that fight infections and also the cells in the blood that help blood to clot (platelets), which can cause bleeding disorders such as nosebleeds and bruising. Lenalidomida can also cause blood clots in the veins (thrombosis).

Other side effects

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

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

• A decrease in the number of red blood cells, which can cause anemia, leading to fatigue and weakness.
• Skin rash, itching.
• Muscle cramps, muscle weakness, muscle pain, muscle discomfort, bone pain, joint pain, back pain, pain in the limbs.
• Generalized swelling, including swelling of the arms and legs.
• Weakness, fatigue.
• Fever and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough, and chills.
• Numbness, tingling, or a prickling sensation on the skin, pain in the hands or feet, dizziness, tremors.
• Decreased appetite, changes in taste.
• Increased pain, tumor size, or redness around the tumor.
• Weight loss.
• Constipation, diarrhea, nausea, vomiting, stomach pain, stomach acid.
• Low levels of potassium, calcium, 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 a symptom of blood clots in the lungs, called pulmonary embolism).
• Infections of all kinds, including sinusitis, lung infection, and upper respiratory tract infection.
• Difficulty breathing.
• Blurred vision.
• Eye opacity (cataracts).
• Kidney problems, including kidneys that do not function properly or are unable to maintain normal function.
• Abnormal results in liver tests.
• High values in liver test results.
• Changes in a blood protein that can cause artery swelling (vasculitis).
• Increased blood sugar levels (diabetes).
• Decreased blood sugar levels.
• Headache.
• Nosebleeds.
• Dry skin.
• Depression, mood changes, difficulty sleeping.
• Cough.
• Low blood pressure.
• A vague feeling of discomfort in the body, feeling unwell.
• Painful inflammation of the mouth, dry mouth.
• Dehydration.

Frequent side effects(may affect up to 1 in 10 people):

• Destruction of red blood cells (hemolytic anemia).
• Certain types of skin tumors.
• Bleeding from the gums, stomach, or intestines.
• Increased blood pressure, slow, fast, or irregular heartbeat.
• Increased levels of a substance released after normal or abnormal red blood cell destruction.
• Increased levels of a protein that indicates inflammation in the body.
• Darkening of skin color; skin color change due to internal bleeding, usually caused by bruising; skin inflammation caused by blood accumulation; bruising.
• Increased uric acid levels in the blood.
• Skin rash, skin redness, cracked skin, skin peeling or flaking, hives.
• Increased sweating, night sweats.
• Difficulty swallowing, sore throat, difficulty maintaining voice quality or changes in voice.
• Rhinorrhea.
• Strong increase or decrease in urine output compared to usual or inability to control urination.
• Blood in the urine.
• Difficulty breathing, especially when lying down (which could be a symptom of heart failure).
• Difficulty having an erection.
• Stroke, fainting, dizziness (a disorder of the inner ear that causes a sensation of spinning), temporary loss of consciousness.
• Chest pain that spreads to the arms, neck, jaw, back, or stomach, a feeling of sweating and shortness of breath, nausea or vomiting, which can be symptoms of a heart attack (myocardial infarction).
• Muscle weakness, lack of energy.
• Cervical pain, chest pain.
• Chills.
• Joint swelling.
• Slower or blocked bile flow from the liver.
• Low levels of phosphate or magnesium in the blood.
• Difficulty speaking.
• Liver damage.
• Balance disturbance, movement difficulty.
• Deafness, ringing in the ears (tinnitus).
• Nerve pain, abnormal and unpleasant sensation, especially when touched.
• Excess iron in the body.
• Thirst.
• Confusion.
• Toothache.
• Falling that can cause injuries.

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

• Bleeding inside the skull.
• Circulatory problems.
• Vision loss.
• Loss of sexual desire (libido).
• Excretion of large amounts of urine with bone pain and weakness, which can be symptoms of a kidney disorder (Fanconi syndrome).
• Yellowing of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching, skin rash, stomach pain or swelling; these can be symptoms of liver damage (liver failure).
• Stomach pain, abdominal swelling, or diarrhea, which can be symptoms of inflammation of the large intestine (called colitis or typhlitis).
• Kidney cell damage (called tubular necrosis).
• Changes in skin color, sensitivity to sunlight.
• Tumor lysis syndrome - metabolic complications can occur during cancer treatment and sometimes even without treatment. These complications occur as a result of the breakdown products of dying cancer cells and can include: changes in blood biochemistry, high levels of potassium, phosphorus, uric acid, and low levels of calcium, which can cause changes in kidney function and heart rhythm, seizures, and sometimes death.
• Increased blood pressure in the blood vessels that supply the lungs (pulmonary hypertension).

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

• Sudden, mild, or worsening pain in the upper abdomen and/or back, lasting several days, possibly accompanied by nausea, vomiting, fever, and rapid pulse. These symptoms can be due to pancreatitis.
• Wheezing or whistling when breathing, difficulty breathing, or dry cough, which can be symptoms caused by inflammation of lung tissue.
• Rare cases of muscle breakdown (pain, weakness, or swelling) have been observed, which can lead to kidney problems (rhabdomyolysis), some of which occur when lenalidomida is administered with a statin (a type of cholesterol-lowering medication).
• A disease that affects the skin, caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis).
• Rupture of the stomach or intestine wall. This can lead to a severe infection. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel habits.
• Viral infections, including herpes zoster (also known as shingles, a viral disease that causes a painful rash with blisters) and the recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark urine, stomach pain on the right side, fever, and nausea or feeling sick).
• Rejection of solid organ transplants (such as kidney, heart).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package insert. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Lenalidomida Combix

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Return any unused medication to your pharmacist, and you will help protect the environment.

6. Package contents and additional information

Composition of Lenalidomida Combix

• The active ingredient is lenalidomida.

Each hard capsule contains 5 mg of lenalidomida.

Each hard capsule contains 10 mg of lenalidomida.

Each hard capsule contains 15 mg of lenalidomida.

Each hard capsule contains 20 mg of lenalidomida.

Each hard capsule contains 25 mg of lenalidomida.

• The other ingredients are:

Capsule content: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.

Capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132) (only for 10 mg, 15 mg, and 20 mg), and yellow iron oxide (E172) (only for 10 mg and 20 mg).

Printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).

Appearance of the product and package contents

Lenalidomida Combix 5 mg hard capsules EFG

Capsules with white body and cap, approximately 18 mm in size, and marked with "LLM 5".

Lenalidomida Combix 10 mg hard capsules EFG

Capsules with ivory body and green cap, approximately 21.7 mm in size, and marked with "LLM 10".

Lenalidomida Combix 15 mg hard capsules EFG

Capsules with white body and blue cap, approximately 21.7 mm in size, and marked with "LLM 15".

Lenalidomida Combix 20 mg hard capsules EFG

Capsules with blue body and green cap, approximately 23.3 mm in size, and marked with "LLM 20".

Lenalidomida Combix 25 mg hard capsules EFG

Capsules with white body and cap, approximately 23.3 mm in size, and marked with "LLM 25".

The capsules are presented in single-dose blisters, in packages of 7 and 21 hard capsules.

Only some package sizes may be marketed.

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Ardena Pamplona, S.L.

Polígono Mocholí, C/ Noáin, Nº 1,

Noáin, 31110 Navarra

Spain

Date of the last revision of this package insert:July 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).