Aspifox 10 mg/100 mg hard capsules

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Aspifox 5 mg/100 mg hard capsules

Aspifox 10 mg/100 mg hard capsules

Aspifox 20 mg/100 mg hard capsules

Rosuvastatin/ Acetylsalicylic acid

Read the entire 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 or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Aspifox is and what it is used for

Aspifox contains two active substances – rosuvastatin and acetylsalicylic acid.

• Rosuvastatin belongs to a group of substances called statins, which are medicines that regulate lipid (fat) levels by lowering cholesterol and triglyceride levels in the blood when a low-fat diet and lifestyle changes alone have failed. Cholesterol is a fatty substance (lipid) that can cause narrowing of the blood vessels in the heart, leading to coronary heart disease. If you are at risk of having a heart attack, rosuvastatin may also be used to reduce this risk even if your cholesterol levels are normal. You should maintain a cholesterol-lowering diet during treatment.

• Acetylsalicylic acid, at low doses, belongs to a group of medicines called antiplatelet agents. Platelets are small blood cells involved in blood clotting and in thrombosis. When a blood clot forms in an artery, it blocks blood flow and cuts off the supply of oxygen. When this occurs in the heart, it can cause a heart attack or angina.

These two active substances, taken together, reduce the likelihood of having another heart attack if you have previously had one, or if you suffer from chest pain attacks (unstable angina).

Aspifox is indicated for patients who are already taking rosuvastatin and acetylsalicylic acid at these doses. Instead of taking rosuvastatin and acetylsalicylic acid as separate tablets, you will receive one Aspifox capsule containing both components at the same doses as before.

2. What you need to know before taking Aspifox

Do not take Aspifox

• If you are allergic to rosuvastatin, acetylsalicylic acid, or any other salicylate or non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breastfeeding, or if you become pregnant while taking Aspifox, stop taking this medicine immediately and inform your doctor. Women should avoid becoming pregnant while taking Aspifox by using appropriate contraceptive methods.
• If you have liver disease.
• If you have severe kidney problems.
• If you have recurrent or unexplained muscle pain.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used for the viral liver infection called hepatitis C).
• If you are taking a medicine called cyclosporine (used, for example, after organ transplantation).
• If you have previously experienced an asthma attack or swelling of certain parts of the body, such as face, lips, throat, or tongue (angioedema), after taking salicylates or NSAIDs.
• If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking rosuvastatin or other related medicines.
• If you currently have or have ever had a stomach or small intestine ulcer or any other type of bleeding, such as a cerebral hemorrhage.
• If you have ever had problems with your blood not clotting properly.
• If you suffer from gout.
• If you have uncompensated heart failure.
• If you are taking a medicine called methotrexate (for example, for cancer or rheumatoid arthritis) at doses exceeding 15 mg per week.
• If you are allergic to peanuts or soy

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Aspifox

• If you have kidney problems.
• If you have liver problems.
• If you have had recurrent or unexplained muscle pain or discomfort, personal or family history of muscle disorders, or previous muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or discomfort, especially if you feel unwell or have a fever. Also inform your doctor or pharmacist if you have persistent muscle weakness.
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).
• If you regularly drink large amounts of alcohol.
• If your thyroid gland is not functioning properly.
• If you are taking other medicines called fibrates to lower cholesterol. Read this leaflet carefully, even if you have previously taken other medicines for high cholesterol.
• If you are taking medicines used against HIV infection, for example ritonavir with lopinavir and/or atazanavir, see "Other medicines and Aspifox".
• If you are taking or have taken within the last 7 days medicines containing fusidic acid (used to treat bacterial infections) taken orally or by injection; taking Aspifox with fusidic acid may cause severe muscle problems (rhabdomyolysis); see "Other medicines and Aspifox".
• If you have severe respiratory insufficiency.
• If you are over 70 years old.
• If you are of Asian origin, i.e., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. Your doctor should choose the appropriate starting dose of Aspifox suitable for you.
• If you have or have had stomach or small intestine problems (ulcers or gastrointestinal bleeding).
• If you have high blood pressure.
• If you are asthmatic, have hay fever, nasal polyps, or other chronic respiratory diseases; acetylsalicylic acid may trigger an asthma attack.
• In case of hypersensitivity (allergy) to other painkillers and anti-inflammatory medicines, other medicines for rheumatism, or other allergy-causing factors.
• If you have other allergies (e.g., skin reactions, itching).
• If you are taking other medicines called anticoagulants (e.g., coumarin derivatives, heparin, except for low-dose heparin treatment).
• With renal insufficiency or reduced cardiac and vascular blood flow (e.g., kidney vascular disease, cardiac muscle weakness, reduced blood volume, major surgery, blood poisoning, or increased bleeding): acetylsalicylic acid may further increase the risk of renal dysfunction and acute renal failure.
• If you have heavy menstrual periods.

You should seek immediate medical attention if your symptoms worsen or if you experience serious or unexpected side effects, such as unusual bleeding symptoms, severe skin reactions, or any other signs of severe allergy (see section "Possible side effects").

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin treatment. Stop using Aspifox and seek immediate medical attention if you notice any of the symptoms described in section 4.

In a small number of people, statins may affect the liver. This is detected by a simple test showing elevated liver enzyme levels in the blood. For this reason, your doctor will usually perform this blood test (liver function test) before and during treatment with Aspifox.

While taking this medicine, your doctor will monitor you for diabetes or risk of developing it. You are likely to be at risk of developing diabetes if you have high levels of sugar and fats in your blood, are overweight, or have high blood pressure.

You should be careful not to become dehydrated (you may feel thirsty with a dry mouth), as the use of acetylsalicylic acid at the same time may lead to worsening of kidney function.

Inform your doctor if you are planning to undergo surgery (even minor procedures, such as tooth extraction), as acetylsalicylic acid thins the blood and may therefore increase the risk of bleeding.

Acetylsalicylic acid may cause Reye's syndrome when given to children. Reye's syndrome is a very rare disease affecting the brain and liver and can be potentially fatal. For this reason, Aspifox must not be given to children and adolescents under 18 years of age.

In patients with severe glucose-6-phosphate dehydrogenase deficiency: acetylsalicylic acid may cause accelerated breakdown, collapse of red blood cells, or a certain form of anemia. This risk may be triggered by factors such as high doses, fever, or acute infections.

Acetylsalicylic acid reduces uric acid excretion at low doses. This may trigger a gout attack in at-risk patients.

If you are cut or injured, bleeding may take slightly longer than normal. This is related to the effect of acetylsalicylic acid. Small cuts and injuries (e.g., while shaving) are usually not significant. If you experience unusual bleeding (in an unusual location or of unusual duration), contact your doctor.

Children and adolescents

Aspifox must not be used in children or adolescents.

Other medicines and Aspifox

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Aspifox may interact with or be affected by other medicines, such as:

• fibrates (e.g., gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (e.g., ezetimibe)
• treatments for indigestion (used to neutralize stomach acid)
• oral contraceptives (the pill)
• hormone replacement therapy
• regorafenib, darolutamide, capmatinib (used to treat cancer)
• fostamatinib (used to treat low platelet counts)
• febuxostat (used to treat and prevent high uric acid levels in blood)
• teriflunomide (used to treat multiple sclerosis)
• any of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see "Warnings and precautions"):

ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir

• ketoconazole, itraconazole (antifungal medicines)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• blood-thinning/clot-preventing treatments (e.g., warfarin, heparin, coumarin, clopidogrel, ticlopidine, ticagrelor): acetylsalicylic acid may increase the risk of bleeding if taken before clot dissolution or blood-thinning treatment. Therefore, if undergoing such treatment, pay attention to signs of external or internal bleeding (e.g., bruising)
• treatments to prevent organ rejection after transplantation (cyclosporine, tacrolimus)
• treatments for high blood pressure (e.g., diuretics and ACE inhibitors)
• treatments to regulate heart rhythm (digoxin)
• treatments for manic-depressive disorder (lithium)
• treatments for pain and inflammation (e.g., NSAIDs such as ibuprofen, naproxen, or steroids)
• treatments for gout (e.g., probenecid, benzbromarone)
• treatments for glaucoma (acetazolamide)
• cancer or rheumatoid arthritis medicines (methotrexate; at doses below 15 mg per week)
• medicines to lower blood sugar (antidiabetic medicines) (e.g., glibenclamide): blood sugar levels may decrease
• treatments for depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine)
• treatments such as hormone replacement therapy when adrenal or pituitary glands have been destroyed or removed (except for skin-applied products or cortisone replacement therapy for Addison's disease), or to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids). Concomitant use increases the risk of gastrointestinal side effects.
• brain anti-convulsant treatments [epilepsy] (valproic acid)
• medicines that increase urinary excretion (diuretics: aldosterone antagonists such as spironolactone and canrenoate, loop diuretics, e.g., furosemide)
• metamizole (a substance to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells stick together and form a blood clot) when taken concomitantly. Therefore, this combination should be used with caution in patients taking low-dose acetylsalicylic acid for cardioprotection.
• alcohol: the risk of gastrointestinal ulcers and bleeding is increased.

If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop using Aspifox. Your doctor will tell you when it is safe to restart treatment with this medicine. Taking Aspifox with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.

Aspifox may further lower your blood pressure if you are already taking other medicines to treat high blood pressure.

Taking Aspifox with food and drinks

You should take Aspifox with food. Do not drink grapefruit juice during treatment with Aspifox.

Alcohol intake may increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy and breastfeeding

Do not take Aspifox if you are pregnant or breastfeeding. If you become pregnant while taking Aspifox, stop taking the medicine immediately and consult your doctor. Women should avoid becoming pregnant by using appropriate contraceptive methods.

Driving and using machines

Most people can drive a car and operate machinery while being treated with Aspifox; this will not affect your ability. However, some people may feel dizzy during treatment with Aspifox. If you feel unwell, dizzy, tired, or have a headache during treatment, do not drive or operate machinery and contact your doctor immediately.

Aspifox contains lactose

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

Aspifox contains soy lecithin

This medicine contains traces of soy lecithin, which may contain soybean oil. It must not be used in case of allergy to peanuts or soy.

3. How to take Aspifox

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults

Your doctor will determine the appropriate dose for you depending on your condition, your current treatment, and your level of risk.

This medicine is not suitable for initiating treatment. Treatment initiation should only be done by administering the active substances separately. After appropriate doses have been established, switching to Aspifox with the suitable concentration may be considered.

The recommended dose is one capsule per day.

This medicine should be taken with food. You must take your medicine at the same time each day. The capsules must be swallowed with plenty of liquid and must not be crushed or chewed.

Do not take Aspifox with grapefruit juice.

If you are admitted to hospital or receive treatment for another illness, inform the medical staff that you are taking Aspifox.

Use in elderly patients

Dose adjustment is not necessary in elderly patients.

Use in children and adolescents

Aspifox must not be used in children and adolescents.

Patients with renal impairment

Dose adjustment is not required in patients with mild or moderate renal impairment.

The use of Aspifox in patients with severe renal impairment is contraindicated.

Patients with hepatic impairment

Dose adjustment is not required in patients with mild or moderate hepatic impairment.

The use of Aspifox in patients with severe hepatic impairment is contraindicated.

If you take more Aspifox than you should

Contact your doctor or nearest hospital for advice.

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, stating the medicine and the amount ingested.

If you forget to take Aspifox

Do not worry. If you forget to take a capsule, skip that dose completely. Take your next dose at the usual time. Do not take a double dose to make up for missed doses.

If you stop taking Aspifox

Your doctor will advise you on how long you should take this medicine. Your cholesterol levels may rise again if you stop taking Aspifox. Your condition may recur if you stop taking the medicine before being instructed to do so.

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 experiences them.

Stop taking Aspifox and seek medical attention immediately if you experience any of the following very rare and serious adverse effects after taking this medicine:

• Sudden wheezing, chest pain, shortness of breath or difficulty breathing.
• Swelling of the eyelids, face or lips.
• Swelling of the tongue and throat causing severe difficulty breathing and/or swallowing.
• Intense itching of the skin (with raised lumps).
• Reddish, non-elevated spots on the trunk, target-shaped or circular, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• If you have black stools or vomit blood (signs of significant stomach bleeding).

Also, stop taking Aspifox and contact your doctor immediately

• if you have unexplained muscle pain or discomfort lasting longer than expected. As with other statins, a very small number of people have experienced unpleasant muscle effects, and rarely these have progressed to potentially life-threatening muscle damage known as rhabdomyolysis.
• If you experience muscle rupture
• If you develop a lupus-like syndrome (including skin rash, joint disorders and blood cell abnormalities).

The following side effects have been reported. If any of them cause you problems or last longer than one week, you should contact your doctor.

ROSUVASTATIN

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

• Headache.
• Stomach pain.
• Constipation.
• Feeling sick.
• Muscle pain.
• Feeling weak.
• Dizziness.
• Diabetes. This is more likely to occur if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

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

• Rash, itching, hives or other skin reactions.
• Increase in the amount of protein in the urine: this usually returns to normal on its own without needing to stop taking your Aspifox capsules (only at the 5–20 mg dose).

Rare (may affect up to 1 in 1,000 people):

• Severe allergic reaction: signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe itching of the skin (with raised bumps). If you think you are having an allergic reaction, stop taking Aspifox and seek medical help immediately.
• Muscle damage in adults: as a precaution, stop taking Aspifox and contact your doctor immediately if you have unusual muscle pain or discomfort lasting longer than expected.
• Severe stomach pain (inflamed pancreas).
• Increase in liver enzymes in the blood.
• Reduction in platelets, increasing the risk of bleeding or bruising (thrombocytopenia).
• A lupus-like syndrome (includes rash, joint disorders and blood cell abnormalities).

Very rare (may affect up to 1 in 10,000 people):

• Jaundice (yellowing of the skin and eyes).
• Hepatitis (liver inflammation).
• Traces of blood in the urine.
• Nerve damage in the arms and legs (such as numbness).
• Joint pain.
• Memory loss.
• Gynecomastia (breast enlargement in men).

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

• Diarrhea (loose stools).
• Cough.
• Difficulty breathing.
• Edema (swelling).
• Sleep disorders, including insomnia and nightmares.
• Sexual difficulties.
• Depression.
• Respiratory problems, including persistent cough and/or shortness of breath or fever.
• Tendon injury.
• A nerve disorder that may cause weakness, tingling or numbness.
• Persistent muscle weakness.
• Myasthenia gravis (a condition causing generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Ocular myasthenia (a condition causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

ACETYLSALICYLIC ACID

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

• Gastrointestinal discomfort such as heartburn, nausea, vomiting, abdominal pain and diarrhea.
• Minor bleeding from the gastrointestinal tract (micro-bleeding).
• Bleeding such as nosebleeds, bleeding gums, skin bleeding or bleeding from the urinary tract and genital organs, possibly with prolonged bleeding time. This effect may last 4 to 8 days after ingestion.

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

• Bleeding from the stomach or intestines. After long-term use of acetylsalicylic acid, anemia (iron deficiency anemia) may occur due to hidden blood loss from the stomach or intestines.
• Intracranial bleeding, blood in the urine.
• Stomach or intestinal ulcers, which very rarely may lead to perforation.
• Gastrointestinal inflammation.
• Skin reactions.

Rare (may affect up to 1 in 1,000 people):

• Hypersensitivity reactions affecting the skin, respiratory tract, gastrointestinal system and cardiovascular system, especially in asthmatics. The following symptoms may occur: drop in blood pressure, shortness of breath attacks, nasal mucosa inflammation, nasal congestion, allergic shock, swelling of the face, tongue and larynx (Quincke's edema).
• Severe bleeding, such as cerebral hemorrhage, especially in patients with uncontrolled high blood pressure and/or concomitant treatment with anticoagulants (blood-thinning medicines), which may be life-threatening in individual cases.
• Confusion.
• Headache, dizziness.
• Hearing impairment or ringing in the ears (tinnitus), especially in children and elderly people, which may be signs of overdose (see also “If you take more Aspifox than you should”).

Very rare (may affect up to 1 in 10,000 people):

• Abnormal liver function tests.
• Kidney dysfunction and acute kidney failure.
• Decrease in blood sugar (hypoglycemia).
• Acetylsalicylic acid reduces uric acid excretion at low doses. This may trigger a gout attack in at-risk patients.
• Febrile skin eruptions with mucous membrane involvement (multiforme erythema).

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

• Accelerated breakdown or destruction of red blood cells and a certain form of anemia in patients with severe glucose-6-phosphate dehydrogenase deficiency.

If any of the side effects worsen or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Aspifox

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

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

Store below 30 °C. Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any questions (Not applicable for Hospital Use), ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Aspifox

The active substances are rosuvastatin (as rosuvastatin calcium) and acetylsalicylic acid.

Aspifox 5 mg/100 mg hard capsules

Each hard capsule contains 5 mg of rosuvastatin (as rosuvastatin calcium) and 100 mg of acetylsalicylic acid.

Aspifox 10 mg/100 mg hard capsules

Each hard capsule contains 10 mg of rosuvastatin (as rosuvastatin calcium) and 100 mg of acetylsalicylic acid.

Aspifox 20 mg/100 mg hard capsules

Each hard capsule contains 20 mg of rosuvastatin (as rosuvastatin calcium) and 100 mg of acetylsalicylic acid.

The other components are:

Tablet coated with rosuvastatin

Tablet core

Monohydrate lactose (see section 2 “Aspifox contains lactose”)

Microcrystalline cellulose

Heavy magnesium oxide

Crospovidone (type IA)

Anhydrous colloidal silica

Magnesium stearate

Coating system

Polyvinyl alcohol

Titanium dioxide (E171)

Talc

Yellow iron oxide (E172)

Soybean lecithin (see section 2 “Aspifox contains soybean lecithin”)

Red iron oxide (E172)

Xanthan gum

Black iron oxide (E172)

Tablet with acetylsalicylic acid

Microcrystalline cellulose

Corn starch

Anhydrous colloidal silica

Stearic acid

Capsule shell:

Gelatin

Titanium dioxide (E171)

Indigotine (E132)

Yellow iron oxide (E172)

Black ink:

Shellac

Propylene glycol

Strong ammonia solution

Black iron oxide (E172)

Potassium hydroxide

Appearance of the product and contents of the pack

Aspifox 5 mg/100 mg hard capsules: size 2 hard gelatin capsules with an opaque white body and a dark green opaque cap. Each capsule contains one white or almost white, biconvex, oval uncoated tablet of acetylsalicylic acid and one brown, biconvex, round coated tablet containing 5 mg of rosuvastatin.

Aspifox 10 mg/100 mg hard capsules: size 1 hard gelatin capsules with an opaque white body printed in black with "ASA 100" and a light green opaque cap printed with "RSV 10". Each capsule contains one white or almost white, biconvex, oval uncoated tablet of acetylsalicylic acid and one brown, biconvex, round film-coated tablet containing 10 mg of rosuvastatin.

Aspifox 20 mg/100 mg hard capsules: size 0 hard gelatin capsules with an opaque white body printed in black with "ASA 100" and a green opaque cap printed with "RSV 20". Each capsule contains one white or almost white, biconvex, oval uncoated tablet of acetylsalicylic acid and two brown, biconvex, round film-coated tablets, each containing 10 mg of rosuvastatin (total 20 mg).

Aspifox is available in blisters containing 20, 28, 30, 56, 60, 90 and 100 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

Manufacturer

Adamed Pharma S.A.

Pienków, ul. M. Adamkiewicza 6A

05-152 Czosnów

Poland

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108, Madrid (Spain)

Date of the most recent review of this leaflet: February 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es