Ezetimibe/atorvastatin Stada 10 mg/20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ezetimibe/Atorvastatin Stada 10 mg/10 mg film-coated tablets EFG

Ezetimibe/Atorvastatin Stada 10 mg/20 mg film-coated tablets EFG

Ezetimibe/Atorvastatin Stada 10 mg/40 mg film-coated tablets EFG

Ezetimibe/Atorvastatin Stada 10 mg/80 mg film-coated tablets EFG

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

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

Leaflet contents

1. What Ezetimibe/Atorvastatin Stada is and what it is used for

2. What you need to know before taking Ezetimibe/Atorvastatin Stada

3. How to take Ezetimibe/Atorvastatin Stada

4. Possible side effects

5. How to store Ezetimibe/Atorvastatin Stada

6. Contents of the pack and other information

1. What Ezetimiba/Atorvastatina Stada is and what it is used for

Ezetimiba/Atorvastatina Stada is a medicine that lowers high cholesterol levels. This medicine contains ezetimibe and atorvastatin.

Ezetimibe/atorvastatin is used in adults to lower total cholesterol levels, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides circulating in the blood. In addition, ezetimibe/atorvastatin increases levels of "good" cholesterol (HDL cholesterol).

Ezetimibe/atorvastatin works by reducing cholesterol in two ways: by decreasing cholesterol absorbed from the gastrointestinal tract and by reducing cholesterol produced by your body.

This medicine is used in patients who cannot control their cholesterol levels with diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet.

What is cholesterol?

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol consists mainly of LDL and HDL cholesterol.

• LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of your arteries, forming plaques. Over time, this plaque buildup can cause narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. Such blockage may trigger a heart attack or stroke.

• HDL cholesterol is often called "good" cholesterol because it helps prevent bad cholesterol from building up in the arteries and protects against heart disease.

Triglycerides are another type of fat present in your blood that may increase the risk of heart disease.

Conditions for which it is used

Ezetimibe/atorvastatin is used together with a cholesterol-lowering diet if you have:

• high blood cholesterol levels (primary hypercholesterolemia [heterozygous familial and non-familial]) or high blood fat levels (mixed hyperlipidemia)

  • that are not well controlled by a statin alone
  • for whom treatment with a statin and ezetimibe in separate tablets has been used

• a hereditary condition (homozygous familial hypercholesterolemia), which increases blood cholesterol levels. You may also receive other treatments.

• heart disease. Ezetimibe/atorvastatin reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

Ezetimibe/atorvastatin does not help you lose weight.

2. What you need to know before taking Ezetimiba/Atorvastatina Stada

DO NOT take Ezetimiba/Atorvastatina Stada if:

• you are allergic to ezetimibe, atorvastatin, or any of the other ingredients of this medicine (listed in section 6).
• you have or have ever had a liver disease
• you have had unexplained abnormal results in liver function blood tests
• you are a woman who could become pregnant and are not using reliable contraceptive methods
• you are pregnant, trying to become pregnant, or breastfeeding
• you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C

Warnings and precautions

Talk to your doctor or pharmacist before starting ezetimiba/atorvastatina if:

• you have previously had a stroke with intracranial haemorrhage, or have small accumulations of fluid in the brain due to previous strokes
• you have kidney problems
• your thyroid gland is underactive (hypothyroidism)
• you have had recurrent or unexplained muscle pain or weakness, or have a personal or family history of muscle disorders
• you have previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g., other medicines containing "statins" or "fibrates")
• you regularly consume large amounts of alcohol
• you have a history of liver disease
• you are over 70 years old
• you have severe respiratory failure
• you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (used to treat bacterial infection). The combination of fusidic acid and ezetimiba/atorvastatina may cause serious muscle problems (rhabdomyolysis)
• you have or have had myasthenia (a disease causing generalized muscle weakness, which 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).

Muscle problems

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness while taking ezetimiba/atorvastatina. This is because, although rarely, muscle problems can be serious, including muscle breakdown leading to kidney damage. Atorvastatin is known to cause muscle problems, and cases of muscle problems have also been reported with ezetimibe.

Also speak to your doctor or pharmacist if you have persistent muscle weakness. You may need additional tests and treatment.

If any of the above apply to you (or you are unsure), consult your doctor or pharmacist before starting ezetimiba/atorvastatina, as your doctor may need to perform a blood test before starting and possibly during treatment to assess your risk of experiencing muscle-related adverse effects. The risk of muscle adverse effects, e.g., rhabdomyolysis (breakdown of damaged skeletal muscle), is known to increase when certain medicines are taken concomitantly (see section 2 “Other medicines and Ezetimiba/Atorvastatina Stada”).

While taking this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. This risk increases if you have high levels of blood sugar and fats, are overweight, or have high blood pressure.

Inform your doctor of all your medical conditions, including allergies.

Children and adolescents

Ezetimiba/atorvastatina is not recommended for use in children and adolescents.

Other medicines and Ezetimiba/Atorvastatina Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Fusidic acid

If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will advise you when you can restart treatment with ezetimiba/atorvastatina. Taking this medicine with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Some medicines may affect the action of ezetimiba/atorvastatina or may be affected by it (see section 3). Such interactions could reduce the effectiveness of one or both medicines. They could also increase the risk or severity of adverse effects, including a serious condition involving muscle breakdown known as "rhabdomyolysis", described in section 4:

• cyclosporine (a medicine often used in transplant patients)

• fibrates (cholesterol-lowering medicines) should be avoided as the combined use of ezetimiba/atorvastatina with fibrates has not been studied

• erythromycin, clarithromycin, telithromycin, fusidic acid, rifampicin (medicines used to treat bacterial infections)

• ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medicines used to treat fungal infections)

• gemfibrozil, nicotinic acid, derivatives, colestipol, cholestyramine (medicines used to regulate lipid levels)

• certain calcium channel blockers used to treat angina or high blood pressure, e.g., amlodipine, diltiazem

• digoxin, verapamil, amiodarone (medicines that regulate heart rhythm)

• medicines used in the treatment of HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (used to treat AIDS)

• some medicines used in the treatment of hepatitis C, e.g., telaprevir, boceprevir, and the combination elbasvir/grazoprevir, ledipasvir/sofosbuvir

• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia)

• Other medicines known to interact with the combination ezetimiba/atorvastatina:

  • oral contraceptives (medicines that prevent pregnancy)
  • stiripentol (an anticonvulsant medicine used to treat epilepsy)
  • cimetidine (a medicine used for stomach acidity and peptic ulcers)
  • phenazone (a painkiller)
  • antacids (medicines for indigestion containing aluminium or magnesium)
  • warfarin, phenprocoumon, acenocoumarol or fluindione (medicines that prevent blood clotting)
  • colchicine (used to treat gout)
  • St. John's wort (a herbal medicine used to treat depression)

Taking Ezetimiba/Atorvastatina Stada with food, drinks, and alcohol

See section 3 for instructions on how to take ezetimiba/atorvastatina. Please note the following:

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large quantities may alter the effects of ezetimiba/atorvastatina.

Alcohol

Avoid excessive alcohol consumption while taking this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

The safety of ezetimiba/atorvastatina during pregnancy and breastfeeding has not been established.

Do not take ezetimiba/atorvastatina if you are pregnant, planning to become pregnant, or think you may be pregnant.

Do not take ezetimiba/atorvastatina if you could become pregnant unless you are using reliable contraceptive methods. If you become pregnant while taking this medicine, stop taking it immediately and inform your doctor.

Do not take ezetimiba/atorvastatina if you are breastfeeding.

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Ezetimiba/atorvastatina is not expected to affect your ability to drive or use machines. However, bear in mind that some people may experience dizziness after taking ezetimiba/atorvastatina. If you feel dizzy after taking this medicine, do not drive or operate machinery.

Ezetimiba/Atorvastatina Stada 10 mg/10 mg, 10 mg/20 mg, and 10 mg/40 mg contains lactose

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

Ezetimiba/Atorvastatina Stada contains sodium

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

3. How to take Ezetimibe/Atorvastatin Stada

Follow exactly the instructions for use of this medicine given by your doctor. Your doctor will determine the appropriate tablet dose for you, depending on your current treatment and your personal risk situation.

If in doubt, consult your doctor or pharmacist again.

• Before starting to take ezetimibe/atorvastatin, you should already be following a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking ezetimibe/atorvastatin.

How much should you take

The recommended dose is one ezetimibe/atorvastatin tablet taken once daily by mouth.

Method of administration

Take ezetimibe/atorvastatin at any time of day. You may take it with or without food.

The tablet should be taken with a sufficient amount of liquid (e.g., a glass of water).

If your doctor has prescribed ezetimibe/atorvastatin together with cholestyramine or any other bile acid sequestrant (medicines that reduce cholesterol levels), you must take ezetimibe/atorvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe/Atorvastatin Stada than you should

Consult your doctor or pharmacist.

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 medication and the amount ingested.

If you forget to take Ezetimibe/Atorvastatin Stada

Do not take a double dose to make up for missed doses. Take the next dose at the usual time on the following day.

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

4. Possible adverse effects

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

If you experience any of the following serious adverse effects or symptoms, stop taking your tablets immediately and contact your doctor or go to the nearest hospital emergency department, taking the tablets with you.

• severe allergic reactions causing swelling of the face, tongue, and throat, which may cause severe difficulty breathing
• a serious illness characterized by severe skin peeling and inflammation, blistering of the skin, mouth, eyes, genitals, and fever; skin rash with pink or red spots, particularly on the palms of the hands or soles of the feet, which may progress to blisters
• muscle weakness, sensitivity, tearing, or pain, change in urine color to red-brown, and especially if occurring together with feeling unwell or high temperature, which may be due to abnormal muscle breakdown (rhabdomyolysis) that can be potentially life-threatening and lead to kidney problems
• lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells)

Consult your doctor as soon as possible if you experience unexpected or unusual bleeding or bruising, as this may indicate liver disease.

Other possible adverse effects with ezetimiba/atorvastatina:

Frequent (may affect up to 1 in 10 people)

• diarrhea
• muscle pain

Uncommon (may affect up to 1 in 100 people)

• flu-like illness
• depression, trouble sleeping, sleep disorders
• dizziness, headache, tingling sensation
• slow heart rate
• hot flushes
• breathing difficulty
• abdominal pain, bloating, constipation, indigestion, flatulence, frequent bowel movements, stomach inflammation, nausea, stomach discomfort, gastrointestinal discomfort
• acne, pimples
• joint pain, back pain, leg muscle cramps
• muscle fatigue, spasms, or muscle weakness
• pain in arms and legs
• unusual weakness, tiredness, or malaise
• swelling, especially in the ankles (edema)
• increased liver or muscle function tests (CK) in laboratory blood tests
• weight gain

The following adverse effects have been reported with unknown frequency (frequency cannot be estimated from available data):

• myasthenia gravis (a disease causing generalized muscle weakness that, in some cases, affects muscles used for breathing),
• ocular myasthenia (a disease causing weakness of the eye muscles).

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

Additionally, the following adverse effects have been reported in patients taking ezetimiba/atorvastatina, ezetimiba, or atorvastatina tablets:

• allergic reactions including swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (requiring immediate medical treatment)
• red skin rash, sometimes target-shaped
• liver problems
• cough
• heartburn
• decreased appetite, loss of appetite
• high blood pressure
• skin rash and itching, allergic reactions including skin rash and hives
• tendon injury
• gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, or vomiting)
• inflammation of the pancreas, often accompanied by severe abdominal pain
• decreased blood cell count, which may lead to bruising/bleeding (thrombocytopenia)
• nasal inflammation; nosebleeds
• neck pain, pain, chest pain, sore throat
• increased or decreased blood sugar levels (if you have diabetes, you should closely monitor your blood glucose levels)
• nightmares
• numbness or tingling in fingers and toes
• decreased sensitivity to pain or touch
• altered sense of taste, dry mouth
• memory loss
• ringing in the ears and/or head, hearing loss
• vomiting
• belching
• hair loss
• high temperature
• presence of white blood cells in urine tests
• blurred vision, visual disturbances
• gynecomastia (breast enlargement in men)

Possible adverse effects reported with some statins

• sexual dysfunction
• respiratory problems, including persistent cough and/or choking or fever
• diabetes. This is more likely if you have high levels of blood sugar and fats, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• persistent muscle pain, tenderness, or weakness, and especially if occurring together with feeling unwell or high temperature, which may not resolve after stopping treatment with ezetimiba/atorvastatina (frequency not known – frequency cannot be estimated from available data)

Reporting of adverse effects

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

5. Storage of Ezetimibe/Atorvastatin Stada

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

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. Ask your pharmacist how to properly 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 Ezetimibe/Atorvastatin STADA

• The active substances are ezetimibe and atorvastatin.

10 mg/10 mg: Each tablet contains 10 mg of ezetimibe and 10 mg of atorvastatin (as atorvastatin calcium trihydrate).

10 mg/20 mg: Each tablet contains 10 mg of ezetimibe and 20 mg of atorvastatin (as atorvastatin calcium trihydrate).

10 mg/40 mg: Each tablet contains 10 mg of ezetimibe and 40 mg of atorvastatin (as atorvastatin calcium trihydrate).

10 mg/80 mg: Each tablet contains 10 mg of ezetimibe and 80 mg of atorvastatin (as atorvastatin calcium trihydrate).

• The other components are:

Tablet core

Microcrystalline cellulose 101, mannitol, calcium carbonate, sodium croscarmellose, hydroxypropylcellulose, polysorbate 80, yellow iron oxide (E172), magnesium stearate, povidone K-29/32, sodium lauryl sulfate.

Tablet coating

10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg – Opadry White OY-L-28900 containing: lactose monohydrate, hypromellose 2910 (E464), titanium dioxide (E171), macrogol 4000 (E1521)

10 mg/80 mg – DrCoat FCU containing: hypromellose 2910, titanium dioxide (E171), talc (E553b), macrogol 400, yellow iron oxide (E172)

Appearance of the product and contents of the pack

10 mg/10 mg tablet: white, round, biconvex, film-coated tablet with a diameter of approximately 8.1 mm

10 mg/20 mg tablet: white, oval, biconvex, film-coated tablet with a size of approximately 11.6 x 7.1 mm

10 mg/40 mg tablet: white, capsule-shaped, biconvex, film-coated tablet with a size of approximately 16.1 x 6.1 mm

10 mg/80 mg tablet: yellow, oblong, biconvex, film-coated tablet with a size of approximately 19.1 x 7.6 mm

Blister packs (single-dose and non-single-dose) made of OPA/AL/PVC//Al, packed in cardboard cartons.

Packs containing 10, 20, 30, 50, 60, 90, or 100 film-coated tablets.

Single-dose packs containing 10, 20, 30, 50, 60, 90, or 100 film-coated tablets.

10 mg/80 mg:

Multiple packs contain 90 (2 packs of 45) and 100 (2 packs of 50) film-coated tablets.

Multiple single-dose packs contain 90 (2 packs of 45) and 100 (2 packs of 50) film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

ELPEN Pharmaceutical Co. Inc.

Marathonos Ave. 95, Pikermi Attiki, 19009

Greece

or

ELPEN Pharmaceutical Co. Inc.

Zapani, Block 1048,

Keratea, 190 01

Greece

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

or

Laboratori Fundació Dau

Calle Lletra C de la Zona Franca 12-14,

Polígono Industrial de la Zona Franca de Barcelona

08040 Barcelona

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Iceland: Ezetimibe/Atorvastatin STADA 10 mg/10 mg filmuhúðuð tafla
Ezetimibe/Atorvastatin STADA 10 mg/20 mg filmuhúðuð tafla
Ezetimibe/Atorvastatin STADA 10 mg/40 mg filmuhúðuð tafla
Ezetimibe/Atorvastatin STADA 10 mg/80 mg filmuhúðuð tafla

Austria: Ezetimib/Atorvastatin STADA 10 mg/10 mg Filmtabletten
Ezetimib/Atorvastatin STADA 10 mg/20 mg Filmtabletten
Ezetimib/Atorvastatin STADA 10 mg/40 mg Filmtabletten
Ezetimib/Atorvastatin STADA 10 mg/80 mg Filmtabletten

Belgium: Ezetimibe/Atorvastatine EG 10 mg/10 mg Filmomhulde tabletten/comprimés pelliculés/Filmtabletten
Ezetimibe/Atorvastatine EG 10 mg/20 mg Filmomhulde tabletten/comprimés pelliculés/Filmtabletten
Ezetimibe/Atorvastatine EG 10 mg/40 mg Filmomhulde tabletten/comprimés pelliculés/Filmtabletten
Ezetimibe/Atorvastatine EG 10 mg/80 mg Filmomhulde tabletten/comprimés pelliculés/Filmtabletten

Czech Republic: Ezetimib/Atorvastatin STADA

Germany: Ezetimib/Atorvastatin STADA 10 mg/10 mg Filmtabletten
Ezetimib/Atorvastatin STADA 10 mg/20 mg Filmtabletten
Ezetimib/Atorvastatin STADA 10 mg/40 mg Filmtabletten
Ezetimib/Atorvastatin STADA 10 mg/80 mg Filmtabletten

Estonia: Ezetimibe/Atorvastatin STADA

Greece: Ezetimib/Atorvastatin STADA 10 mg/10 mg
Ezetimib/Atorvastatin STADA 10 mg/20 mg
Ezetimib/Atorvastatin STADA 10 mg/40 mg
Ezetimib/Atorvastatin STADA 10 mg/80 mg

Spain: Ezetimiba/Atorvastatina STADA 10 mg/10 mg comprimidos recubiertos con película EFG
Ezetimiba/Atorvastatina STADA 10 mg/20 mg comprimidos recubiertos con película EFG
Ezetimiba/Atorvastatina STADA 10 mg/40 mg comprimidos recubiertos con película EFG
Ezetimiba/Atorvastatina STADA 10 mg/80 mg comprimidos recubiertos con película EFG

France: EZETIMIBE/ATORVASTATINE EG 10 mg/10 mg comprimé pelliculé
EZETIMIBE/ATORVASTATINE EG 10 mg/20 mg comprimé pelliculé
EZETIMIBE/ATORVASTATINE EG 10 mg/40 mg comprimé pelliculé
EZETIMIBE/ATORVASTATINE EG 10 mg/80 mg comprimé pelliculé

Italy: Ezetimibe/Atorvastatina EG STADA 10 mg/10 mg
Ezetimibe/Atorvastatina EG STADA 10 mg/20 mg
Ezetimibe/Atorvastatina EG STADA 10 mg/40 mg
Ezetimibe/Atorvastatina EG STADA 10 mg/80 mg

Lithuania: Ezetimibe/Atorvastatin STADA 10 mg/10 mg plevele dengtos tabletes
Ezetimibe/Atorvastatin STADA 10 mg/20 mg plevele dengtos tabletes
Ezetimibe/Atorvastatin STADA 10 mg/40 mg plevele dengtos tabletes
Ezetimibe/Atorvastatin STADA 10 mg/80 mg plevele dengtos tabletes

Luxembourg: Ezetimibe/Atorvastatine EG 10 mg/10 mg comprimés pelliculés
Ezetimibe/Atorvastatine EG 10 mg/20 mg, comprimés pelliculés
Ezetimibe/Atorvastatine EG 10 mg/40 mg comprimés pelliculés
Ezetimibe/Atorvastatine EG 10 mg/80 mg comprimés pelliculés

Latvia: Ezetimibe/Atorvastatin STADA 10 mg/10 mg apvalkotas tabletes
Ezetimibe/Atorvastatin STADA 10 mg/20 mg apvalkotas tabletes
Ezetimibe/Atorvastatin STADA 10 mg/40 mg apvalkotas tabletes
Ezetimibe/Atorvastatin STADA 10 mg/80 mg apvalkotas tabletes

Slovakia: Ezetimibe/Atorvastatin STADA 10 mg/10 mg filmom obalené tablety
Ezetimibe/Atorvastatin STADA 10 mg/20 mg filmom obalené tablety
Ezetimibe/Atorvastatin STADA 10 mg/40 mg filmom obalené tablety
Ezetimibe/Atorvastatin STADA 10 mg/80 mg filmom obalené tablety

Date of the most recent revision of this leaflet: December 2023

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/