Pomalidomide Sandoz 4 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pomalidomida Sandoz 1 mg hard capsules EFG

Pomalidomida Sandoz 2 mg hard capsules EFG

Pomalidomida Sandoz 3 mg hard capsules EFG

Pomalidomida Sandoz 4 mg hard capsules EFG

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

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

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of the leaflet

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

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

What Pomalidomide Sandoz is

Pomalidomide Sandoz 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 Sandoz is used for

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

Pomalidomide is used 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.

or

• another medicine called "dexamethasone" in people whose myeloma has worsened despite having received at least two other types of treatment, 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 the signs and symptoms of the disease or make them disappear for a period of time. When this occurs, it is called a "response".

How Pomalidomide Sandoz 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 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:

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

Benefit of using pomalidomide 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:

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

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

Do not take Pomalidomida Sandoz:

• if you are pregnant, think you might be pregnant, or intend to become pregnant, since pomalidomide is expected to be harmful to the fetus. (Men and women taking this medicine should read the section “Pregnancy, contraception, and breastfeeding – information for women and men” below),
• if you are capable of becoming pregnant, unless you are taking all necessary measures to prevent pregnancy (see “Pregnancy, contraception, and breastfeeding – 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 pomalidomide 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 you are unsure whether any of the above situations apply to you, consult your doctor, pharmacist, or nurse before taking pomalidomide.

Warnings and precautions

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

• you have ever had blood clots in the past. During treatment with pomalidomide, 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 pomalidomide to lower the risk of blood clots,
• you have previously experienced an allergic reaction, such as rash, itching, swelling, dizziness, or breathing difficulties while taking related medications 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 currently have 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 pomalidomide may reactivate the hepatitis B virus in patients who carry the virus, leading to a recurrence of the infection. Your doctor should 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 generalized rash, skin redness, high fever, flu-like symptoms, enlarged lymph nodes (symptoms of a severe 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 before 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, change in the way you walk or problems with balance, 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 had any of these symptoms before starting treatment with pomalidomide, 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.

Pregnancy, contraception, and breastfeeding: information for men and women

You must follow the instructions outlined in the Pomalidomide Pregnancy Prevention Program.

Men and women taking pomalidomide must not father children or become pregnant.

The reason is that 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 pomalidomide if you are pregnant, think you might be pregnant, or intend to become pregnant. The reason is that 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 are capable of becoming pregnant:

• you must use effective contraceptive methods starting at least 4 weeks before beginning treatment, throughout the entire treatment period, 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 completing treatment.

If you become pregnant despite preventive measures:

• you must stop treatment immediately and inform your doctor immediately.

Breastfeeding

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

Men

Pomalidomide passes into human semen.

• If your partner is pregnant or could become pregnant, you must use condoms throughout the entire treatment period and for 7 days after stopping treatment.
• If your partner becomes pregnant while you are taking pomalidomide, 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 pomalidomide 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 ask you to have blood tests:

• before starting treatment,
• weekly during the first 8 weeks of treatment,
• at least once a month while continuing to take pomalidomide.

Your doctor may adjust the dose of pomalidomide 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.

Children and adolescents

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

Other medicines and Pomalidomida Sandoz

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 antifungals such as ketoconazole,
• certain antibiotics (e.g., ciprofloxacin, enoxacin),
• certain antidepressants such as fluvoxamine.

Driving and use of machines

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

Pomalidomida Sandoz contains sodium

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

3. How to take Pomalidomide Sandoz

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

Always follow exactly the instructions provided by your doctor regarding the administration of the medication. If you have any doubts, consult your doctor, pharmacist, or nurse.

When to take pomalidomide with other medicines

Pomalidomide in combination with bortezomib and dexamethasone

• Refer to the package leaflet provided with bortezomib and dexamethasone for additional information on their use and effects.

• Pomalidomide, bortezomib, and dexamethasone are taken in treatment cycles.

• Each cycle lasts 21 days (3 weeks).

• Refer to the following chart to see which medicines you should take each day of the 3-week cycle:

• Each day, check the chart and identify the correct day to determine which medicines you should take.

• On some days you will take all three medicines, on other days only one or two medicines, and on some days none of them.

POM: Pomalidomide; BOR: Bortezomib; DEX: Dexamethasone

Cycle 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.

Pomalidomide with dexamethasone only

Refer to the package leaflet supplied with dexamethasone for additional information on its use and effects.

• Pomalidomide 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 to take each day of the 4-week cycle:

• Each day, consult the chart to identify the correct day and see which medications you should take.

• On some days you will take both medications, on other days only one medication, and on some days neither medication.

POM: Pomalidomide; DEX: Dexamethasone

	Medication Name
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, begin a new cycle.

How much pomalidomide to take with other medicines

Pomalidomide with bortezomib and dexamethasone

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

Pomalidomide with dexamethasone only

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

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 general 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 are receiving 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. Afterwards, gloves should be carefully removed to avoid skin exposure, placed into a sealable polyethylene plastic bag, and disposed of according to local requirements. Hands should then be washed thoroughly 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 pack, 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.

Your doctor will advise you on how and when to take pomalidomide 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 treatment.

If you take more Pomalidomide Sandoz than you should

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

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

If you forget to take Pomalidomide Sandoz

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

Do not take a double dose to make up for forgotten doses.

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 treatment with pomalidomide and seek immediate medical attention, as you may require urgent medical treatment:

• Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection (due to reduced white blood cells responsible for fighting 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 urine output, nausea and vomiting, confusion, unconsciousness (due to a blood infection called sepsis or septic shock),
• Severe, persistent, or bloody diarrhoea (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 known as angioedema and anaphylactic reaction),
• Certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which may cause changes in the skin's appearance or lumps on the skin. If you notice any skin changes while taking pomalidomide, 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 treatment with pomalidomide and seek immediate medical attention, as you may require urgent medical treatment.

Other adverse effects

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

• Difficulty breathing (dyspnoea),
• 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 lead to anaemia causing fatigue and weakness,
• Low blood potassium levels (hypokalaemia), which may cause weakness, muscle cramps and pain, palpitations, tingling or numbness, dyspnoea, and mood changes,
• High blood sugar levels,
• Fast and irregular heartbeat (atrial fibrillation),
• Loss of appetite,
• Constipation, diarrhoea, 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),
• Generalised swelling, including swelling of arms and legs,
• Skin rashes,
• Urinary tract infection, which may cause a burning sensation when urinating or increased need to urinate.

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

• Falls,
• Bleeding within the skull,
• Reduced ability to move or feel (sensation) in the hands, feet, and legs due to neurological damage (peripheral sensory-motor neuropathy),
• Numbness, itching, or tingling in the skin (paraesthesia),
• Sensation of dizziness, making it difficult to stand or 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),
• Sensation of sweating and difficulty breathing, feeling nauseous 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 blood magnesium levels (hypomagnesaemia), which may cause fatigue, generalised weakness, muscle cramps, and irritability, and may lead to low blood calcium levels (hypocalcaemia), causing numbness or tingling in hands, feet, or lips, muscle cramps, muscle weakness, dizziness, confusion,
• Low blood phosphate levels (hypophosphataemia), which may cause muscle weakness, irritability, or confusion,
• High blood calcium levels (hypercalcaemia), which may slow reflexes and cause skeletal muscle weakness,
• High blood potassium levels, which may cause abnormal heart rhythm,
• Low blood sodium levels, which may cause fatigue and confusion, muscle twitching, seizures (epileptic convulsions), or coma,
• High blood uric acid levels, 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,
• Swollen abdomen,
• Feeling confused,
• Feeling low in mood (depressive 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 adverse effects (may affect up to 1 in 100 people):

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

Adverse effects of unknown frequency (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, consult 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 Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Pomalidomida Sandoz

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 the outer 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 tampering.

Medicines should not be disposed of via wastewater or household waste. If you are unsure how to dispose of unused medicines or packaging, please consult your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pomalidomide Sandoz

• The active substance is pomalidomide.
• The other excipients are microcrystalline cellulose (E460), maltodextrin, and stearic acid and sodium fumarate.

Pomalidomide Sandoz 1 mg hard capsules:

• Each capsule contains 1 mg of pomalidomide.
• The other excipients are:
• Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), and white ink.
• Printing ink: shellac, titanium dioxide (E171), propylene glycol.

Pomalidomide Sandoz 2 mg hard capsules:

• Each capsule contains 2 mg of pomalidomide.
• The other excipients are:
• Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), and white ink.
• Printing ink: shellac, titanium dioxide (E171), propylene glycol.

Pomalidomide Sandoz 3 mg hard capsules:

• Each capsule contains 3 mg of pomalidomide.
• The other excipients are:
• Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), indigo carmine (E132), and white ink.
• Printing ink: shellac, titanium dioxide (E171), propylene glycol.

Pomalidomide Sandoz 4 mg hard capsules:

• Each capsule contains 4 mg of pomalidomide.
• The other excipients are:
• Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), indigo carmine (E132), and white ink.
• Printing ink: shellac, titanium dioxide (E171), propylene glycol.

Appearance of the product and contents of the pack

Pomalidomide Sandoz 1 mg hard capsules:

Hard gelatin capsule with a yellow body and red cap, marked with "PLM 1" printed in white ink in rectified axial printing on the body.

Pomalidomide Sandoz 2 mg hard capsules:

Hard gelatin capsule with an orange body and red cap, marked with "PLM 2" printed in white ink in rectified axial printing on the body.

Pomalidomide Sandoz 3 mg hard capsules:

Hard gelatin capsule with a turquoise body and red cap, marked with "PLM 3" printed in white ink in rectified axial printing on the body.

Pomalidomide Sandoz 4 mg hard capsules:

Hard gelatin capsule with a dark blue body and red cap, marked with "PLM 4" printed in white ink in rectified axial printing on the body.

Pack sizes:

Pomalidomide Sandoz is packaged in blisters or in perforated unit-dose blisters. Each pack contains 14, 21, 56, 63, 14x1, or 21x1 capsules.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Synthon B.V.

Microweg 22

6545 CM

Nijmegen

The Netherlands

or

Synthon Hispania, S.L.

C/ Castelló, nº 1

Sant Boi de Llobregat

08830 Barcelona

Spain

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

Date of the most recent revision of this leaflet: June 2024.

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