Levofloxacin Viatris 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levofloxacin Viatris 500 mg film-coated tablets EFG

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

• Keep this leaflet. You may need to read it again.
• If you have any 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. 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.

Leaflet contents

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

1. What Levofloxacino Viatris is and what it is used for

Levofloxacin belongs to a group of medicines called antibiotics. Levofloxacin is a type of antibiotic known as a quinolone and works by killing the bacteria that cause infections in your body.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Levofloxacino Viatris can be used to treat infections in:

• The paranasal sinuses.
• The lungs, in people with long-term respiratory problems or pneumonia.
• The urinary tract, including the kidneys or bladder.
• The prostate.
• The skin and beneath the skin, including muscles. This is sometimes referred to as "soft tissues."

In certain special situations, levofloxacin may be used to reduce the risk of developing or worsening a lung infection called anthrax after exposure to the bacterium that causes anthrax.

2. What you need to know before taking Levofloxacino Viatris

Do not take Levofloxacino Viatris if:

• You are allergic to levofloxacin, to other antibiotics of the quinolone type such as moxifloxacin, ciprofloxacin or ofloxacin, or to any of the other components of this medicine (listed in section 6).

Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat or tongue.

• You suffer from or have had epilepsy.
• You have previously experienced tendon problems such as tendinitis related to taking quinolone-type medications. Tendons are the tissues connecting your muscles to your skeleton.
• You are a child or adolescent who is still growing.
• You are pregnant, could become pregnant, or think you might be pregnant.
• You are breastfeeding.

Do not take this medicine if any of the above conditions apply to you. If in doubt, consult your doctor or pharmacist before taking levofloxacin.

Warnings and precautions

Before starting this medicine

You should not take antibacterial medicines containing fluoroquinolones or quinolones, including levofloxacin, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible.

Consult your doctor or pharmacist before starting Levofloxacino Viatris:

• If you are 60 years of age or older.
• If you have been diagnosed with an enlarged or "bulging" large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
• If you have previously experienced aortic dissection (a tear in the wall of the aorta).
• If you have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• If you have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome (an inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• You are taking corticosteroids, sometimes called steroids (see section “Other medicines and Levofloxacino Viatris”).
• You have received an organ transplant.
• You have ever had a seizure (epileptic fit).
• You have suffered brain damage due to stroke or other brain injury.
• You have kidney problems.
• You have what is known as “glucose-6-phosphate dehydrogenase deficiency”, as you may be prone to serious blood problems while taking this medicine.
• You have ever had mental health problems.
• You have ever had heart problems: caution is advised when using this type of medicine if you were born with, or have a family history of, prolonged QT interval (seen on electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have an imbalance in blood electrolyte levels (especially low potassium or magnesium levels), have a slow heart rate (called “bradycardia”), have heart failure, have a history of heart attack (myocardial infarction), if you are female or elderly, or if you are taking other medicines that may cause abnormal changes in the ECG (see section “Other medicines and Levofloxacino Viatris”).
• You are diabetic.
• You have ever had liver problems.
• You suffer from myasthenia gravis.
• You have previously developed a severe skin rash, skin peeling, blisters and/or mouth sores after taking levofloxacin.

Inform your doctor or pharmacist before taking levofloxacin if you are unsure whether any of the above conditions apply to you.

During treatment with this medicine

Rarely, joint pain and swelling, and tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even several months after stopping levofloxacin treatment. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder or knee), stop taking levofloxacin, contact your doctor and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.

Rarely, you may experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, prickling, numbness and/or weakness, especially in the feet and legs or hands and arms. If this occurs, stop taking levofloxacin and inform your doctor immediately to prevent the development of a potentially irreversible condition.

Avoid direct exposure to sunlight and ultraviolet lamps during treatment and for 2 days after stopping treatment with levofloxacin (see also section 3, “Protect your skin from sunlight”).

Serious, long-lasting, disabling and potentially irreversible adverse effects

Antibacterial medicines containing fluoroquinolones or quinolones, including levofloxacin, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting for months or years), disabling or potentially irreversible. These include tendon, muscle and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, burning or stinging (paresthesia), sensory disturbances such as reduced vision, taste, smell and hearing, depression, memory impairment, severe fatigue and serious sleep disorders.

If you experience any of these adverse effects after taking levofloxacin, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, possibly considering the use of an antibiotic from another class.

Severe skin reactions

Severe skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of levofloxacin.

• SJS/TEN may initially appear on the trunk as reddish, target-like spots or circular lesions, often with blisters in the center. Ulcers may also develop in the mouth, throat, nose, genitals and eyes (red, swollen eyes). These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and life-threatening or fatal complications.
• DRESS initially presents with flu-like symptoms and a facial rash, followed by a more widespread rash, elevated body temperature, increased liver enzymes in blood tests, elevated levels of a type of white blood cell (eosinophilia) and swollen lymph nodes.

If you develop a severe rash or any of these skin symptoms, stop taking levofloxacin and contact your doctor or seek immediate medical attention.

• If you experience sudden, severe abdominal, chest or back pain, which may be symptoms of aortic dissection or aneurysm, go immediately to the emergency department. The risk may be increased if you are receiving systemic corticosteroid treatment.
• If you begin to experience sudden onset of shortness of breath, especially when lying down, or notice swelling in your ankles, feet or abdomen, or develop palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.
• If you begin to experience sudden, involuntary jerking movements, muscle spasms or contractions – consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to discontinue levofloxacin treatment and initiate appropriate therapy.
• If you have nausea, malaise, severe discomfort, persistent or worsening stomach pain or vomiting, seek immediate medical attention, as this could be a sign of pancreas inflammation (acute pancreatitis).
• If you experience fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat and a significant worsening of your general condition, or a feeling that your resistance to infections may be reduced – consult a doctor immediately, as these could be signs of blood disorders. Your doctor should monitor your blood with blood counts. If blood counts are abnormal, your doctor may need to discontinue treatment.

Other medicines and Levofloxacino Viatris

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

In particular, inform your doctor if you are taking any of the following medicines, as they may increase the risk of adverse effects when taken with levofloxacin:

• Corticosteroids, sometimes called steroids, used for inflammation. You may be more likely to experience tendon inflammation and/or rupture.
• Warfarin, used to thin the blood. You may have an increased risk of bleeding. Your doctor may require periodic blood tests to check your blood clotting.
• Theophylline, used for respiratory problems. You may have an increased risk of seizures when taken with levofloxacin.
• Non-steroidal anti-inflammatory drugs (NSAIDs), used for pain and inflammation such as acetylsalicylic acid (aspirin), ibuprofen, fenbufen, ketoprofen, indomethacin. You may have an increased risk of seizures when taken with levofloxacin.
• Cyclosporine, used after organ transplants. You may be more likely to experience adverse effects of cyclosporine.
• Medicines known to affect your heart rhythm. These include medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide and amiodarone), for depression (tricyclic antidepressants such as amitriptiline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as erythromycin, azithromycin and clarithromycin).
• Probenecid, used for gout. If you have kidney problems, your doctor may wish to prescribe a lower dose.
• Cimetidine, used for ulcers and heartburn. If you have kidney problems, your doctor may wish to prescribe a lower dose.

Do not take levofloxacin at the same time as the following medicines, as they may affect the action of levofloxacin:

• Iron tablets (for anemia), zinc supplements, antacids containing aluminium or magnesium (for acidity or heartburn), didanosine, or sucralfate (for stomach ulcers). See section 3 “If you are already taking iron tablets, zinc supplements, antacids, didanosine or sucralfate” below.

Urine opiate tests

Urine tests may show "false positive" results for strong painkillers called "opiates" in patients taking levofloxacin. Inform your doctor that you are taking levofloxacin if you are prescribed a urine test.

Tuberculosis testing

This medicine may cause a "false negative" result in some laboratory tests used to detect the bacteria causing tuberculosis.

Pregnancy and breastfeeding

Do not take this medicine if:

• You are pregnant, could be pregnant, or plan to become pregnant.
• You are breastfeeding or plan to breastfeed.

Driving and using machines

Some adverse effects such as dizziness, drowsiness, loss of balance (vertigo) or visual disturbances may occur. Some of these adverse effects may affect your ability to concentrate or reduce your reaction speed. If this occurs, do not drive or perform any work requiring a high level of attention.

3. How to take Levofloxacin Viatris

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

How to take this medicine

• Take this medicine by mouth.
• Swallow the tablets whole with some water.
• The tablets may be taken during or between meals.

Protect your skin from sunlight

Do not expose your skin directly to sunlight (even when cloudy) while taking this medicine and for two days after stopping it, as your skin will become much more sensitive to sunlight and may burn, sting, or even blister if you do not take the following precautions:

• Be sure to use sunscreen creams with a high protection factor.
• Always wear a hat and clothing that covers your arms and legs.
• Avoid ultraviolet (UVA) lamps.

If you are already taking iron tablets, zinc supplements, antacids, didanosine, or sucralfate

• Do not take these medicines at the same time as levofloxacin. You must take these medicines at least two hours before or two hours after taking levofloxacin.

What dose should you take

• Your doctor will decide how much levofloxacin you should take.
• The dose will depend on the type of infection you have and where in your body the infection is located.
• The duration of treatment will depend on the severity of your infection.
• If you think the effect of the medicine is too weak or too strong, do not change the dose yourself—ask your doctor.

Adults and elderly people

Sinus infection

• One 500 mg levofloxacin tablet once daily.

Lung infection in people with long-term breathing problems

• One 500 mg levofloxacin tablet once daily.

Pneumonia

• One 500 mg levofloxacin tablet once or twice daily.

Urinary tract infection, including kidneys or bladder

• Half or one 500 mg levofloxacin tablet daily.

Prostate infection

• One 500 mg levofloxacin tablet once daily.

Skin and soft tissue infection, including muscles

• One 500 mg levofloxacin tablet once or twice daily.

Adults and elderly people with kidney problems

Your doctor may give you a lower dose.

Children and adolescents

This medicine should not be given to children or adolescents.

If you take more Levofloxacin Viatris than you should

If you accidentally take more tablets than you should, inform your doctor or seek immediate medical help. Take the medicine with you so the doctor knows what you have taken. You may also call the Toxicology Information Service at telephone 91 562 04 20, indicating the medicine and the amount taken. Possible effects include epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disturbances that may cause irregular heartbeat, as well as feeling unwell (nausea) or heartburn.

If you forget to take Levofloxacin Viatris

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a missed dose.

If you stop taking Levofloxacin Viatris

Do not stop your treatment with levofloxacin, even if you feel better. It is important that you complete the treatment prescribed by your doctor. If you stop taking it too early, the infection may return, your condition may worsen, or the bacteria may become resistant to the medicine.

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. They are usually mild to moderate in intensity and tend to disappear in a short time.

Stop treatment with levofloxacin and contact a doctor or go to a hospital immediately if you experience the following adverse effects:

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

• If you have an allergic reaction. Signs may include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat or tongue, rapid drop in blood pressure (with symptoms such as shallow breathing, dizziness and weak pulse).

Stop treatment with levofloxacin and contact your doctor immediately if you notice the following serious adverse effects, as you may require urgent medical treatment:

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

• Pain and inflammation in tendons or ligaments, which could lead to rupture. The Achilles tendon is most frequently affected.
• Seizures (epileptic fits).
• Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
• Syndrome associated with impaired water excretion and low sodium levels (SIADH).
• Decreased blood sugar levels (hypoglycaemia) or decreased blood sugar levels leading to coma (hypoglycaemic coma). This is important for diabetic patients.

Frequency not known (cannot be estimated from available data)

• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red, target-like macules or circular spots, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes, and may be preceded by flu-like symptoms. See also section 2.
• Changes in thinking and thoughts, with risk of suicidal thoughts or actions.
• Loss of appetite, nausea, vomiting, yellowing of the skin and eyes, dark urine, fever, burning sensation or abdominal tenderness. These may be signs of liver problems, which could include fulminant liver failure.
• Watery diarrhoea, which may contain blood, possibly with stomach cramps and fever. These could be signs of a serious intestinal problem.
• Abnormally fast heartbeat, irregular heartbeat that may be life-threatening, including cardiac arrest, disturbances in heart rhythm (known as “prolongation of the QT interval”, observed on ECG, a graphical representation of the heart's electrical activity).
• Burning, tingling, pain or numbness. These may be signs of what is known as “neuropathy”.
• Nausea, general malaise, discomfort or pain in the stomach area or vomiting. These could be signs of an inflamed pancreas (acute pancreatitis). See section 2.

Seek immediate advice from an eye specialist if your vision deteriorates or you develop any other eye problems while taking levofloxacin.

Inform your doctor if any of the following adverse effects worsen or last longer than a few days:

Frequent (may affect up to 1 in 10 people)

• Sleep disturbances.
• Headache, dizziness.
• Nausea, vomiting and diarrhoea.
• Increased levels of certain liver enzymes in the blood.

Uncommon (may affect up to 1 in 100 people)

• Changes in the number of other bacteria or fungi, fungal infection caused by Candida, which may require treatment.
• Changes in the number of white blood cells, as shown in blood test results (leucopenia, eosinophilia).
• Stress (anxiety), confusion, nervousness, drowsiness, tremors, dizziness (vertigo).
• Difficulty breathing (dyspnoea).
• Changes in taste, loss of appetite, stomach upset or indigestion (dyspepsia), stomach pain, bloating (flatulence) or constipation.
• Itching and skin rash, intense pruritus or hives (urticaria), excessive sweating (hyperhidrosis).
• Joint pain or muscle pain.
• Abnormal blood test results due to liver problems (increased bilirubin) or kidney problems (increased creatinine).
• Generalized weakness.

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

• Appearance of bruises and easy bleeding, due to decreased number of platelets in the blood (thrombocytopenia).
• Decreased number of white blood cells in the blood (neutropenia).
• Exaggerated immune response (hypersensitivity).
• Mental disturbances, such as seeing or hearing things that are not real (hallucinations) or feeling threatened (paranoia).
• Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares.
• Tingling sensation in hands and feet (paraesthesiae).
• Ear disorders (tinnitus) or vision disorders (blurred vision).
• Abnormally fast heartbeat (tachycardia) or decreased blood pressure (hypotension).
• Muscle weakness. This is important in people with myasthenia gravis (a rare nervous system disorder).
• Changes in kidney function and, occasionally, kidney failure, which may result from an allergic-type reaction in the kidney, known as interstitial nephritis.
• Fever.
• Erythematous patches, clearly defined with or without blisters, developing within hours of levofloxacin administration and healing with post-inflammatory residual hyperpigmentation; usually recurring at the same skin or mucosal site after subsequent exposure to levofloxacin.
• Memory impairment.

Frequency not known (cannot be estimated from available data)

• Decrease in red blood cells (anaemia): this may cause the skin to become pale or yellowish due to damage to red blood cells; decrease in all types of blood cells (pancytopenia).
• Bone marrow stops producing new blood cells, which may cause fatigue, reduced ability to fight infections and uncontrolled bleeding (bone marrow failure).
• Fever, sore throat and persistent general malaise. This may be due to a decreased number of white blood cells (agranulocytosis).
• Increased blood sugar levels (hyperglycaemia). This is important in people with diabetes.
• Changes in smell, loss of smell or taste (parosmia, anosmia, ageusia).
• Feeling very excited, euphoric, agitated or enthusiastic (mania).
• Movement and gait disorders (dyskinesia, extrapyramidal disorders).
• Temporary loss of consciousness or posture (syncope).
• Temporary loss of vision, eye inflammation.
• Hearing problems or loss.
• Difficulty breathing or wheezing (bronchospasm).
• Pulmonary allergic reactions.
• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity), darker areas of skin (hyperpigmentation).
• Inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis).
• Inflammation of the tissue inside the mouth (stomatitis).
• Muscle rupture and destruction of muscle (rhabdomyolysis).
• Redness and swelling of joints (arthritis).
• Pain, including back, chest and limb pain.
• Sudden, involuntary jerks, muscle spasms or muscle contractions (myoclonus).
• Acute attacks of porphyria in patients with porphyria (a very rare metabolic disorder).
• Persistent headache with or without blurred vision (benign intracranial hypertension).

Administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, burning, stinging, numbness or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression and suicidal ideation), as well as decreased hearing, vision, taste and smell, in some cases regardless of the presence of pre-existing risk factors.

Cases of increased size and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and potentially be fatal, and heart valve insufficiency have been reported in patients receiving fluoroquinolones. See also section 2.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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 Levofloxacin Viatris

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

This medicine does not require special storage conditions, but it is preferable to keep it in the original packaging in a dry place.

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

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levofloxacino Viatris

• The active substance is levofloxacin hemihydrate.

• One film-coated tablet contains 500 mg of levofloxacin (as levofloxacin hemihydrate).

• The other components are:

• Core: microcrystalline cellulose (E-460), crospovidone (E-1202), hydroxypropylcellulose (E-463), magnesium stearate (E-470b).

• Coating: hydroxypropylcellulose (E-463), macrogol 3350, macrogol 400, and titanium dioxide (E-171).

Nature of the product and pack contents

Levofloxacino Viatris are film-coated tablets. The tablet is white or almost white, capsule-shaped, biconvex, and film-coated, with the inscriptions “LVO” and “500” separated by a score line on one side, and the inscriptions “G” and “G” separated by another score line on the other side.

The packs contain blisters of 1, 2, 3, 5, 7, 8, 10, 14, 16, 50, and 200 tablets, and bottles containing 50 and 500 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

McDermott Laboratories Ltd. t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road, Dublin 13
Ireland

or

Mylan Hungary Kft.
H-2900 Komárom
Mylan utca 1
Hungary

or

Pharma Pack Hungary Kft.
Vasút utca 13, Budaörs, 2040
Hungary

or

Mylan Germany GmbH
Benzstrasse 1, Bad Homburg v. d.
Hoehe, Hessen, 61352
Germany

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

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

Belgium: Levofloxacine Viatris 500 mg filmomhulde tabletten
Spain: Levofloxacino Viatris 500 mg comprimidos recubiertos con película EFG
Ireland: Tavager 500 mg film-coated tablets
Portugal: Levofloxacina Mylan 500 mg comprimidos revestidos
Czech Republic: Levofloxacin Viatris 500 mg film-coated tablets
Sweden: Levofloxacine Viatris 500 mg film-coated tablets

This patient information leaflet does not contain all the information about your medicine. If you have any questions or are unsure about anything, consult your doctor or pharmacist.

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

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