Levofloxacin Pensa 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levofloxacino Pensa 500 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 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Levofloxacino Pensa tablets are and what they are used for
2. What you need to know before taking Levofloxacino Pensa tablets
3. How to take Levofloxacino Pensa tablets
4. Possible side effects
5. How to store Levofloxacino Pensa tablets
6. Contents of the pack and other information

1. What Levofloxacino Pensa tablets are and what they are used for

The name of this medicine is Levofloxacino Pensa film-coated tablets. Levofloxacino Pensa tablets contain an active substance called levofloxacin, which belongs to a group of medicines known as antibiotics. Levofloxacin is a fluoroquinolone-type antibiotic that works by killing the bacteria causing infections in your body.

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

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

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 Pensa tablets 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, when the infection is persistent
• the skin and beneath the skin, including muscles. This is sometimes referred to as "soft tissues"

In certain special situations, Levofloxacino Pensa tablets may be used to reduce the chance 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 Levofloxacin Pensa tablets

Do not take this medicine and consult your doctor 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 ingredients 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 or have suffered from epilepsy
• You have previously experienced tendon problems, such as tendinitis, related to taking quinolone-type medicines. The tendon is the tissue connecting your muscle to the skeleton
• You are a child or adolescent undergoing growth
• You are pregnant, could become pregnant, or think you may be pregnant
• You are breastfeeding

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

Warnings and precautions

Before starting to take this medicine

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

Consult your doctor or pharmacist before starting to take this medicine if:

• You are 60 years of age or older
• You are taking corticosteroids, sometimes called steroids (see section “Other medicines and Levofloxacin Pensa”)
• You have ever had a seizure (convulsions)
• 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 required 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 imbalances in blood electrolyte levels (especially low potassium or magnesium levels), have a slow heart rate (called “bradycardia”), have a weak heart (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 Levofloxacin Pensa”)
• You are diabetic
• You have ever had liver problems
• You suffer from myasthenia gravis
• You have a peripheral nerve disorder (peripheral neuropathy)
• You have been diagnosed with enlargement or a “lump” in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm)
• You have been diagnosed with heart valve insufficiency (heart valve regurgitation)
• You have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other predisposing risk factors or disorders (e.g., connective tissue disorders such as Marfan syndrome or Ehlers-Danlos vascular syndrome, Turner syndrome, or 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 have previously developed a severe skin rash or skin peeling, blisters and/or mouth sores after taking levofloxacin.

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

Consult an ophthalmologist immediately if you experience any changes in vision or any eye problems.

While taking this medicine

• If you experience sudden and severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency department. The risk may increase if you are receiving systemic corticosteroid treatment.

• If you begin to experience sudden 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.

• Rarely, joint pain and swelling, or 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 or even several months after stopping Levofloxacin Pensa. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacin Pensa, 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, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this occurs, stop taking Levofloxacin Pensa and inform your doctor immediately to prevent potentially irreversible damage.

• If you begin to experience sudden involuntary jerks, muscle spasms, or muscle 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, general discomfort, severe discomfort or persistent or worsening stomach pain, or vomiting—consult a doctor immediately, as this could be a sign of pancreas inflammation (acute pancreatitis).

• If you experience fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat, 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.

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

Antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacin Pensa, 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, or burning (paresthesia), sensory disturbances such as decreased vision, taste, smell, or hearing, depression, memory decline, severe fatigue, and serious sleep disorders.

If you experience any of these adverse effects after taking Levofloxacin Pensa, 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.

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

Severe skin reactions

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

• SJS/TEN may initially appear on the trunk as reddish, target-like spots or circular patches, often with blisters in the center. Ulcers may also develop in the mouth, throat, nose, genitals, and eyes (red and 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 rash on the face, 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 enlarged lymph nodes.
• Generalized, red, scaly rash with bumps under the skin (including skin folds, chest, abdomen (including stomach), back, and arms) and blisters, accompanied by fever. Symptoms typically appear early in treatment (acute generalized exanthematous pustulosis).

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 any of these adverse effects after taking Levofloxacin Pensa, 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.

Other medicines and Levofloxacin Pena

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

• 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 a higher risk of bleeding. Your doctor may need periodic blood tests to check that your blood clots properly
• Theophylline—used for respiratory problems. You may have a higher risk of seizures (convulsions) when taken with Levofloxacin Pensa
• Non-steroidal anti-inflammatory drugs (NSAIDs)—used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indometacin. You may have a higher risk of seizures (convulsions) when taken with Levofloxacin Pensa
• Cyclosporine—used after organ transplants. You may be more likely to experience adverse effects from cyclosporine
• Medicines known to affect heart rhythm. This includes medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin)
• Probenecid (used for gout) and cimetidine (used for ulcers and heartburn). Special caution is required when taking these medicines with Levofloxacin Pensa. If you have kidney problems, your doctor may want to prescribe a lower dose.
• Cimetidine—used for ulcers and heartburn. Your doctor may need to prescribe a lower dose if you have kidney problems.

Inform your doctor if any of the above apply to you.

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

• 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, zinc supplements, antacids, didanosine, or sucralfate” below.

Opiate testing in urine

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

Tuberculosis test

This medicine may cause a “false negative” result in certain laboratory tests used to detect the bacteria causing tuberculosis.

Pregnancy and breastfeeding

Do not take this medicine if:

• You are pregnant, could become pregnant, or think you may be pregnant
• You are breastfeeding or plan to breastfeed

Driving and using machines

Some adverse effects such as dizziness, drowsiness, balance disturbances (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 high attention.

3. How to take Levofloxacino Pensa tablets

Follow exactly the instructions for taking this medicine as given by your doctor. 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.

The tablet may be divided into equal doses.

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 covering 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 Levofloxacino Pensa. You must take these medicines at least two hours before or two hours after taking Levofloxacino Pensa tablets.

What dose should you take?

• Your doctor will decide how much Levofloxacino Pensa tablets 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 patients

Sinus infection

• one Levofloxacino Pensa 500 mg tablet once daily

Lung infection in people with long-term respiratory problems

• one Levofloxacino Pensa 500 mg tablet once daily

Pneumonia

• one Levofloxacino Pensa 500 mg tablet once or twice daily

Urinary tract infection, including kidneys or bladder

• half or one Levofloxacino Pensa 500 mg tablet daily

Prostate infection

• one Levofloxacino Pensa 500 mg tablet once daily

Skin and soft tissue infection, including muscles

• one Levofloxacino Pensa 500 mg tablet once or twice daily

Adults and elderly patients with kidney problems

Your doctor may give you a lower dose.

Children and adolescents

This medicine must not be given to children or adolescents.

If you take more Levofloxacino Pensa tablets 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 number 91 562 04 20, indicating the medicine and the amount ingested. Possible effects include: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disturbances that may cause irregular heartbeat, as well as nausea or stomach burning.

If you forget to take Levofloxacino Pensa tablets

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

If you stop taking Levofloxacino Pensa tablets

Do not stop your treatment with Levofloxacino Pensa 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 using this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Usually, these are mild to moderate effects and tend to disappear in a short time.

Stop treatment with Levofloxacino Pensa and contact a doctor or go to a hospital immediately if you notice the following adverse effects:

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

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

Stop treatment with Levofloxacino Pensa 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)

• Watery diarrhoea that may contain blood, possibly with stomach cramps and fever. These could be signs of a serious bowel problem
• Pain and inflammation in tendons or ligaments, which could lead to rupture. The Achilles tendon is most frequently affected
• Seizures (epileptic fits)
• Seeing or hearing things that are not real (hallucinations, paranoia)
• Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares
• 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 disturbances in water elimination and low sodium levels (SIADH)
• Decrease in blood sugar levels (hypoglycaemia) or decrease in blood sugar levels that may lead to coma (hypoglycaemic coma). This is important for diabetic patients

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

• Burning, tingling, pain or numbness. These may be signs of what is called "neuropathy"

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 reddish macules in target-like shapes or circular spots, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by fever and flu-like symptoms. See also section 2.
• Generalized, red, scaly skin rash, with bumps under the skin (including skin folds, chest, abdomen (including stomach), back and arms) and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). See section 2
• Loss of appetite, yellowing of skin and eyes, dark urine, stinging or painful abdomen on palpation. These may be signs of liver problems which may include fulminant liver failure
• Changes in thinking and thoughts (psychotic reactions) with risk of suicidal thoughts or actions and panic attacks
• 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
• Nerve-originating pain with burning or scalding sensation (neuralgia)

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

Tell 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 problems
• Headache, dizziness
• Nausea, vomiting and diarrhoea
• Increase in certain liver enzyme levels 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 white blood cell count in your blood tests (leucopenia, eosinophilia)
• Anxiety, confusion, nervousness, drowsiness, tremors, dizziness (vertigo)
• Difficulty breathing (dyspnoea)
• Changes in taste, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach area pain, bloating (flatulence) or constipation
• Itching and skin rash, intense pruritus or hives (urticaria), excessive sweating (hyperhidrosis)
• Joint pain or muscle pain
• Abnormal results in your blood tests due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
• Generalised weakness

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

• Appearance of bruises and easy bleeding due to reduced number of blood platelets (thrombocytopenia)
• Decrease in white blood cell count (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Tingling sensation in hands and feet (paraesthesia)
• Ear disorders (tinnitus) or vision disorders (blurred vision)
• Abnormally rapid 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 called interstitial nephritis
• Fever
• Well-defined erythematous spots with or without blisters appearing within hours of levofloxacin administration and associated with residual post-inflammatory 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 decrease in white blood cell count (agranulocytosis)
• Circulatory collapse (anaphylactic-type shock)
• Increase in blood sugar levels (hyperglycaemia) or decrease in blood sugar levels that may lead to coma (hypoglycaemic coma). 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
• Abnormally rapid heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, disturbance in heart rhythm (known as "QT interval prolongation", seen on ECG, a graphical representation of the heart's electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Pulmonary allergic reactions
• Inflammation of the pancreas (pancreatitis)
• Inflammation of the liver (hepatitis)
• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity), darkened 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)
• Red and swollen joints (arthritis)
• Pain, including back, chest and limb pain
• Sudden, involuntary jerks, muscle spasms or muscle contractions (myoclonia)
• Porphyria attacks in patients with porphyria (a very rare metabolic disorder)
• Persistent headache with or without blurred vision (benign intracranial hypertension)

The 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, numbness or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression and suicidal thoughts), as well as decreased hearing, vision, taste and smell, in some cases regardless of the presence of pre-existing risk factors.

Cases of enlargement and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and may 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 type of adverse effect, consult 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 national reporting system included in 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 Levofloxacino Pensa tablets

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

This medicine does not require special storage conditions, but it is preferable to store Levofloxacino Pensa tablets 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. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levofloxacino Pensa tablets

The active substance is levofloxacin. Each tablet contains 500 mg of levofloxacin.

The other components (excipients) are:

• Core: crospovidone, hypromellose, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, stearic acid, and talc.
• Coating: titanium dioxide (E-171), hypromellose, macrogol 6000, iron oxide red (E-172), and iron oxide yellow (E-172).

Appearance of the product and contents of the pack

Levofloxacino Pensa are film-coated tablets for oral use. The tablets are orange-colored, oblong, biconvex, and scored. They are supplied in packs of 1, 7, and 14 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios Liconsa, S.A.

Avenida Miralcampo 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

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 latest revision of this leaflet: February 2026

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