Pomalidomide Sala 3 mg hard capsules EFG: detailed information

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Pomalidomide Sala 3 mg hard capsules EFG

Pomalidomide Sala 4 mg hard capsules EFG

Pomalidomide Sandoz is expected to cause severe birth defects and may result in fetal death.

Do not take this medicine if you are pregnant or may be pregnant.
You must follow the contraception measures described in this leaflet.

Read the entire leaflet carefully before you start taking this medicine, as 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 may harm them.
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

What Pomalidomide Sala is and what it is used for
What you need to know before taking Pomalidomide Sala
How to take Pomalidomide Sala
Possible adverse effects
How to store Pomalidomide Sala
Contents of the pack and other information

1. What Pomalidomide Sala is and what it is used for

What Pomalidomide Sala is

Pomalidomide Sala contains the active substance “pomalidomide”. This medicine is related to thalidomide and belongs to a group of medicines that affect the immune system (the body’s natural defenses).

What Pomalidomide Sala is used for

Pomalidomide is used to treat adults with a type of cancer called “multiple myeloma”.

Pomalidomide is used in combination with:

Two other medicines called “bortezomib” (a type of chemotherapy medicine) and “dexamethasone” (an anti-inflammatory medicine) in people who have received at least one other treatment, including lenalidomide.

Another medicine called “dexamethasone” in people whose myeloma has worsened despite having received at least two other types of treatments, including the medicines lenalidomide and bortezomib.

What is multiple myeloma

Multiple myeloma is a type of cancer that affects a specific type of white blood cells (called “plasma cells”). These cells grow uncontrollably and accumulate in the bone marrow, damaging bones and kidneys.

Multiple myeloma is generally incurable. However, treatment can reduce or eliminate the signs and symptoms of the disease for a period of time. When this occurs, it is called a “response”.

How Pomalidomide Sala works

Pomalidomide works in several ways:

It stops the growth of myeloma cells;
It stimulates the immune system to attack cancer cells;
It inhibits the formation of blood vessels that supply nutrients to cancer cells.

Benefit of using Pomalidomide Sala with bortezomib and dexamethasone

When pomalidomide is used with bortezomib and dexamethasone in people who have received at least one other treatment, it can delay the progression of multiple myeloma:

On average, the combination of pomalidomide with bortezomib and dexamethasone prevented the recurrence of multiple myeloma for up to 11 months, compared with 7 months in patients receiving only bortezomib and dexamethasone.

Benefit of using Pomalidomide Sala with dexamethasone

When pomalidomide is used with dexamethasone in people who have received at least two other treatments, it can delay the progression of multiple myeloma:

On average, the combination of pomalidomide and dexamethasone prevented the recurrence of multiple myeloma for up to 4 months, compared with 2 months in patients receiving dexamethasone alone.

2. What you need to know before starting to take Pomalidomida Sala

Do not take Pomalidomida Sala

if you are allergic to pomalidomide or to any of the other ingredients of this medicine (listed in section 6). If you think you might be allergic, consult your doctor.
if you are pregnant, think you might be pregnant, or intend to become pregnant, as Pomalidomida Sala is expected to be harmful to the fetus. (Men and women taking this medicine must read the section “Pregnancy, contraception and breastfeeding – information for women and men” below);
if you could become pregnant, unless you are taking all necessary measures to prevent pregnancy (see “Pregnancy, contraception and breastfeeding – information for women and men”). If you could 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 unsure whether any of these situations apply to you, consult your doctor, pharmacist, or nurse before taking Pomalidomida Sala.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Pomalidomida Sala if:

you have ever had blood clots in the past. During treatment with Pomalidomida Sala, you have an increased risk of developing blood clots in your veins or arteries. Your doctor may recommend additional treatments (e.g., warfarin) or reducing your dose of Pomalidomida Sala to lower the risk of developing blood clots;
you have previously experienced an allergic reaction, such as rash, itching, swelling, dizziness, or breathing problems while taking related medicines called “thalidomide” or “lenalidomide”;
you have had a heart attack, have heart failure, have difficulty breathing, or if you are a smoker, have high blood pressure or high cholesterol levels;
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. You may also experience irregular heartbeats. This condition is called tumor lysis syndrome;
you suffer from or have previously had neuropathy (nerve damage causing tingling or pain in your feet or hands);
you have or have previously had hepatitis B virus infection. Treatment with Pomalidomida Sala may reactivate the hepatitis B virus in patients who carry the virus, leading to the infection returning (recurrence). Your doctor must check whether you have ever had a hepatitis B virus infection.
you are experiencing or have previously experienced a combination of any of the following symptoms: facial or widespread rash, redness of the skin, high fever, flu-like symptoms, enlarged lymph nodes (symptoms of a serious skin reaction called drug reaction with eosinophilia and systemic symptoms, or DRESS syndrome, or drug hypersensitivity syndrome, toxic epidermal necrolysis [TEN], or Stevens-Johnson syndrome [SJS]. See also section 4 “Possible side effects”).

It is important to note that patients with multiple myeloma treated with pomalidomide may develop other types of cancer, so your doctor must carefully evaluate the benefits and risks when prescribing this medicine.

At any time during or after treatment, inform your doctor or nurse immediately if you experience: blurred vision, loss of vision or double vision, difficulty speaking, weakness in one arm or leg, a change in the way you walk or problems with balance, persistent numbness, reduced sensation or loss of sensation, memory loss or confusion. All of these may be symptoms of a serious and potentially fatal brain disease known as progressive multifocal leukoencephalopathy (PML). If you had any of these symptoms before starting treatment with Pomalidomida Sala, inform your doctor if you notice any changes in these symptoms.

At the end of treatment, you must return all unused capsules to the pharmacist.

Children and adolescents

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

Other medicines and Pomalidomida Sala

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

In particular, inform your doctor, pharmacist, or nurse before taking pomalidomide if you are taking any of the following medicines:

certain antifungal medicines such as ketoconazole
certain antibiotics (e.g., ciprofloxacin, enoxacin)
certain antidepressants such as fluvoxamine

Pregnancy, contraception and breastfeeding: information for men and women

You must follow the instructions outlined in the Pomalidomida Sala Pregnancy Prevention Programme.

Men and women taking Pomalidomida Sala must not father children or become pregnant. This is because pomalidomide is expected to be harmful to the fetus. You and your partner must use effective contraceptive methods while taking this medicine.

Women

Do not take Pomalidomida Sala if you are pregnant, think you might be pregnant, or intend to become pregnant. This is because this medicine is expected to be harmful to the fetus. Before starting treatment, you must inform your doctor if there is any possibility that you could become pregnant, even if you think this is unlikely.

If you could become pregnant:

you must use effective contraceptive methods starting at least 4 weeks before beginning treatment, throughout the time you are taking the medicine, and for at least 4 weeks after stopping treatment. Your doctor will advise you on the most appropriate contraceptive methods;
each time your doctor prescribes a new prescription, they will ensure you understand the necessary measures to prevent pregnancy;
your doctor will schedule pregnancy tests before treatment, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends.

If you become pregnant despite preventive measures:

you must stop treatment immediately and inform your doctor immediately.

Breastfeeding

It is unknown whether Pomalidomida Sala passes into human breast milk. Inform your doctor if you are breastfeeding or intend to breastfeed. Your doctor will advise you whether you can continue or should stop breastfeeding.

Men

Pomalidomida Sala passes into human semen.

If your partner is pregnant or could become pregnant, you must use condoms throughout the entire time you are taking the treatment and for 7 days after stopping it.
If your partner becomes pregnant while you are taking Pomalidomida Sala, inform your doctor immediately. Your partner must also inform her doctor immediately.

You must not donate semen or sperm during treatment and for 7 days after stopping treatment.

Blood donation and blood tests

You must not donate blood during treatment and for 7 days after stopping treatment.

Before starting treatment with Pomalidomida Sala and during treatment, you will have periodic blood tests. This is because your medicine may cause a decrease in the number of blood cells that help fight infections (white blood cells) and in the number of cells that help stop bleeding (platelets).

Your doctor will request that you have a blood test:

before starting treatment;
weekly during the first 8 weeks of treatment;
at least once a month while continuing to take Pomalidomida Sala.

Your doctor may adjust the dose of Pomalidomida Sala or interrupt your treatment, depending on the results of these tests. Your doctor may also adjust the dose or interrupt this medicine due to your overall health status.

Driving and use of machines

Some people experience fatigue, fainting, confusion, or reduced level of consciousness while taking Pomalidomida Sala. If this happens to you, do not drive or operate tools or machinery.

Pomalidomida Sala contains sodium

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

Pomalidomida Sala contains isomalt

This medicine contains isomalt. If your doctor has diagnosed you with an intolerance to certain sugars, consult with your doctor before taking this medicine.

3. How to take Pomalidomida Sala

Pomalidomida must be prescribed and administered by a physician experienced in the treatment of multiple myeloma.

Follow exactly the dosing instructions provided by your doctor. If you have any doubts, consult your doctor, pharmacist, or nurse.

For markets where Pomalidomida Sala is not available in 1 mg or 2 mg strengths:

If doses are required that cannot be achieved using Pomalidomida Sala 3 mg and Pomalidomida Sala 4 mg capsules, another available medication containing pomalidomide as the active substance in the appropriate strength and form should be used.

When to take Pomalidomida Sala with other medicines

Pomalidomida Sala in combination with bortezomib and dexamethasone

Refer to the package leaflet provided with bortezomib and dexamethasone for additional information on their use and effects.
Pomalidomida, bortezomib, and dexamethasone are administered in treatment cycles. Each cycle lasts 21 days (3 weeks).
Follow the schedule below to see which medicines you should take each day during the 3-week cycle:
Each day, check the schedule and identify the correct day to determine which medicines to take.
On some days, you will take all three medicines; on other days, only one or two of them; and on some days, none of them.
POM: Pomalidomida Sala; BOR: bortezomib; DEX: dexamethasone

Cycles 1 to 8		Cycle 9 onwards
	Drug name			Drug name
Day	POM	BOR	DEX		Day	POM	BOR	DEX
1	√	√	√		1	√	√	√
2	√		√		2	√		√
3	√				3	√
4	√	√	√		4	√
5	√		√		5	√
6	√				6	√
7	√				7	√
8	√	√	√		8	√	√	√
9	√		√		9	√		√
10	√				10	√
11	√	√	√		11	√
12	√		√		12	√
13	√				13	√
14	√				14	√
15					15
16					16
17					17
18					18
19					19
20					20
21					21

After completing each 3-week cycle, start a new one.

Pomalidomida Sala with dexamethasone

Refer to the package leaflet provided with dexamethasone for additional information about its use and effects.

Pomalidomida Sala and dexamethasone are taken in treatment cycles. Each cycle lasts 28 days (4 weeks).
Follow the schedule in the chart below to see which medications you should take each day during the 4-week cycle:
Each day, consult the chart and identify the correct day to determine which medications to take.
On some days you will take both medications, on other days only one medication, and on some days neither.
POM: Pomalidomida Sala; DEX: dexamethasone

	Name of the medication
Day	POM	DEX
1	√	√
2	√
3	√
4	√
5	√
6	√
7	√
8	√	√
9	√
10	√
11	√
12	√
13	√
14	√
15	√	√
16	√
17	√
18	√
19	√
20	√
21	√
22		√
23
24
25
26
27
28

After completing each 4-week cycle, start a new one.

Pomalidomide Sandoz with other medicines

Pomalidomide Sandoz with bortezomib and dexamethasone

The recommended starting dose of Pomalidomide Sandoz is 4 mg once daily.
The recommended starting dose of bortezomib will be calculated by your doctor based on your height and weight (1.3 mg/m² body surface area).
The recommended starting dose of dexamethasone is 20 mg per day. However, if you are over 75 years of age, the recommended starting dose is 10 mg per day.

Pomalidomide Sandoz alone with dexamethasone

The recommended dose of Pomalidomide Sandoz is 4 mg once daily.
The recommended starting dose of dexamethasone is 40 mg per day. However, if you are over 75 years of age, the recommended starting dose is 20 mg per day.

Your doctor may need to reduce the dose of pomalidomide, bortezomib, or dexamethasone, or interrupt one or more of these medicines based on your blood test results and overall condition, whether you are taking other medicines (e.g., ciprofloxacin, enoxacin, and fluvoxamine), and if you experience adverse effects (especially rash or swelling) as a result of treatment.

If you have liver or kidney problems, your doctor will carefully monitor your condition while you receive this medicine.

How to take Pomalidomide Sandoz

Do not break, open, or chew the capsules. If the powder from a broken capsule comes into contact with the skin, wash the skin immediately and thoroughly with soap and water.
Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Gloves should then 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 soap and water. Pregnant women or women who suspect they may be pregnant must not handle the blister pack or capsule.
Swallow the capsules whole, preferably with water.
You may take the capsules with or without food.
You should take the capsules at approximately the same time each day.

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

Schematic drawing showing hands removing a tablet from a container using tweezers or a holder to avoid direct contact

Your doctor will advise you on how and when to take Pomalidomide Sandoz if you have kidney problems and are undergoing dialysis treatment.

Duration of treatment with Pomalidomide Sandoz

You should continue treatment cycles until your doctor tells you to stop.

If you take more Pomalidomide Sandoz than you should

If you take more Pomalidomide Sandoz than you should, inform your doctor or go to hospital immediately. Take the medicine packaging with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Pomalidomide Sandoz

If you forget to take Pomalidomide Sandoz on the day you were supposed to, take the next capsule the following day at your usual time.

Do not take extra capsules to make up for the dose of Pomalidomide Sandoz you missed the previous 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.

Serious adverse effects

If you experience any of the following serious adverse effects, stop taking Pomalidomida Sula and contact a doctor immediately, as you may require urgent medical treatment:

Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection (due to a decrease in white blood cells that fight infection).
Bleeding or bruising without apparent cause, including nosebleeds and intestinal or stomach bleeding (due to effects on blood cells called "platelets").
Rapid breathing, fast pulse, fever and chills, little or no ability to urinate, nausea and vomiting, confusion, unconsciousness (due to a blood infection called sepsis or septic shock).
Severe, persistent, or bloody diarrhea (possibly accompanied by stomach pain or fever) caused by the bacterium Clostridium difficile.
Chest or leg pain and swelling, especially in the lower leg or calves (caused by blood clots).
Difficulty breathing (due to a severe chest infection, lung inflammation, heart failure, or blood clots).
Swelling of the face, lips, tongue, and throat, which may cause difficulty breathing (due to severe allergic reactions called angioedema and anaphylactic reaction).
Certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which may cause changes in the appearance of the skin or lumps on the skin. If you notice any skin changes while taking Pomalidomida Sula, inform your doctor as soon as possible.
Reactivation of hepatitis B virus infection, which may cause yellowing of the skin and eyes, dark brown urine, abdominal pain on the right side, fever, nausea, or malaise. Inform your doctor immediately if you notice any of these symptoms.
Widespread rash, high body temperature, swollen lymph nodes, and effects on other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or drug hypersensitivity syndrome, toxic epidermal necrolysis, or Stevens-Johnson syndrome). Stop taking pomalidomide if you experience these symptoms and contact your doctor or seek immediate medical attention. See also section 2.

If you experience any of the following serious adverse effects, stop taking Pomalidomida Sula and contact a doctor immediately, as you may require urgent medical treatment.

Other adverse effects

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

Difficulty breathing (dyspnea).
Lung infection (pneumonia and bronchitis).
Infections of the nose, sinuses, and throat caused by bacteria or viruses.
Flu-like symptoms (influenza).
Low red blood cell count, which may cause anemia leading to fatigue and weakness.
Low levels of potassium in the blood (hypokalemia), which may cause weakness, cramps and muscle pain, palpitations, tingling or numbness, dyspnea, and mood changes.
High blood sugar levels.
Fast and irregular heartbeat (atrial fibrillation).
Loss of appetite.
Constipation, diarrhea, or nausea.
Vomiting.
Abdominal pain.
Lack of energy.
Difficulty falling or staying asleep.
Dizziness, tremor.
Muscle spasms, muscle weakness.
Bone pain, back pain.
Numbness, tingling, or burning sensation in the skin, pain in hands or feet (peripheral sensory neuropathy).
Generalized swelling, including swelling of arms and legs.
Skin rashes.
Urinary tract infection, which may cause a burning sensation when urinating or the need to urinate more frequently.

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

Fall.
Bleeding inside the skull.
Reduced ability to move or feel (sensation) in the hands, feet, and legs due to neurological damage (peripheral sensorimotor neuropathy).
Numbness, itching, or tingling in the skin (paresthesia).
Sensation of dizziness, making it difficult to stand and move normally.
Swelling due to fluid retention.
Hives (urticaria).
Itching of the skin.
Shingles (herpes zoster).
Heart attack (chest pain spreading to arms, neck, and jaw, sweating, difficulty breathing, nausea or vomiting).
Chest pain, chest infection.
Increased blood pressure.
Reduction in the number of red blood cells, white blood cells, and platelets simultaneously (pancytopenia), making you more prone to bleeding and bruising. You may feel tired and weak and have difficulty breathing. You will also be more susceptible to infections.
Decreased number of lymphocytes (a type of white blood cell), often caused by infection (lymphopenia).
Low levels of magnesium in the blood (hypomagnesemia), which may cause fatigue, general weakness, muscle cramps, and irritability, and may lead to low levels of calcium in the blood (hypocalcemia), causing numbness or tingling in hands, feet, or lips, muscle cramps, muscle weakness, dizziness, confusion.
Low levels of phosphate in the blood (hypophosphatemia), which may cause muscle weakness, irritability, or confusion.
High levels of calcium in the blood (hypercalcemia), which may slow reflexes and cause skeletal muscle weakness.
High levels of potassium in the blood, which may cause an abnormal heart rhythm.
Low levels of sodium in the blood, which may cause fatigue and confusion, muscle twitching, seizures (epileptic convulsions), or coma.
High levels of uric acid in the blood, which may cause a type of arthritis called gout.
Low blood pressure, which may cause dizziness or fainting.
Pain or dryness in the mouth.
Changes in taste.
Abdominal bloating.
Confusion.
Feeling low (depressed mood).
Loss of consciousness, fainting.
Cloudiness in the eye (cataract).
Kidney damage.
Inability to urinate.
Abnormal results in liver function tests.
Pelvic pain.
Weight loss.

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

Stroke.
Inflammation of the liver (hepatitis), which may cause itchy skin, yellowing of the skin and whites of the eyes (jaundice), pale stools, dark urine, and abdominal pain.
Breakdown of tumor cells resulting in the release of toxic substances into the bloodstream (tumor lysis syndrome). This may lead to kidney problems.
Underactive thyroid gland, which may cause symptoms such as fatigue, sluggishness, muscle weakness, slow heart rate, and weight gain.

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

Rejection of solid organ transplants (such as heart or liver).

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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pomalidomida Sala

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

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

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the pharmacy's Punto Sigre collection point. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pomalidomida Sala

The active substance is pomalidomide.
The other components are isomalt 801, isomalt 721, pregelatinized corn starch, and stearoyl fumarate sodium.

Pomalidomida Sala 3 mg hard capsules EFG:

Each hard capsule contains 3 mg of pomalidomide.
The capsule shell contains: gelatin, titanium dioxide (E171), brilliant blue FCF (E133), and black printing ink.

Pomalidomida Sala 4 mg hard capsules EFG:

Each hard capsule contains 4 mg of pomalidomide.
The capsule shell contains: gelatin, brilliant blue FCF (E133), titanium dioxide (E171), erythrosine (E127), and black printing ink.

The printing ink contains: shellac (E904), concentrated ammonia solution, potassium hydroxide, and black iron oxide (E172).

Appearance of the product and contents of the pack

Pomalidomida Sala 3 mg hard capsules EFG

Opaque blue cap and opaque blue body, size 2 hard capsule (approximately 18 mm x 6 mm), printed in black ink with “LP” on the cap and “690” on the body, containing yellow granular powder.

Pomalidomida Sala 4 mg hard capsules EFG

Opaque blue cap and opaque blue body, size 2 hard capsule (approximately 18 mm x 6 mm), printed in black ink with “LP” on the cap and “667” on the body, containing yellow granular powder.

Pack sizes:

PVC/PCTFE (Aclar) – Aluminium or OPA/Al/PVC – Aluminium blister packs:

14 hard capsules (blister packs)
14 hard capsules (perforated unit dose blister)
21 hard capsules (blister packs)
21 hard capsules (perforated unit dose blister)

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio Reig Jofre S.A.
Gran Capitan, 10
08970 Sant Joan Despí (Barcelona)
Spain

Manufacturer

Qualimetrix S.A.
579 Mesogeion Avenue
Agia Paraskevi
15343 Athens, Greece

Adalvo Limited
Malta Life Sciences Park,
Building 1, Level 4, Sir Temi Zammit Buildings,
San Gwann, SGN 3000 Malta

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

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

Denmark: Pomalidomide Bioglan
Spain: Pomalidomida Sala 3 mg and 4 mg hard capsules EFG
Finland: Pomalidomide Bioglan
France: Pomalidomide Reig Jofre 1 mg, 2 mg, 3 mg et 4 mg gélule
Netherlands: Pomalidomide Reig Jofre 1 mg, 2 mg, 3 mg en 4 mg harde capsule
Italy: Pomalidomide Reig Jofre
Poland: Pomalidomid Reig Jofre
Sweden: Pomalidomide Bioglan

Date of the most recent review of this leaflet: 12/2024.

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