Patient Information Leaflet

Levofloxacino Teva 500 mg Film-Coated Tablets

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

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

Contents of the Leaflet:

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

This medicine is called Levofloxacino Teva tablets coated with a film. Levofloxacino Teva tablets contain an active ingredient called levofloxacino, which belongs to a group of medicines called antibiotics. Levofloxacino is an antibiotic of the quinolone type, and it works by killing the bacteria that cause infections in your body.

Levofloxacino Teva tablets can be used to treat infections in:

• the sinuses
• the lungs, in people with long-standing respiratory problems or pneumonia
• the urinary tract, including the kidneys or bladder
• the prostate, when the infection is persistent
• the skin and under the skin, including the muscles. This is sometimes referred to as "soft tissues"

In some special situations, Levofloxacino Teva tablets may be used to reduce the risk of acquiring a lung infection called anthrax or a worsening of the disease after exposure to the anthrax-causing bacteria.

Do not take Levofloxacino Teva tablets

The signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue

Do not take this medication if any of the above cases apply to you. If in doubt, consult your doctor or pharmacist before taking Levofloxacino Teva tablets.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Levofloxacino Teva

• if you are 60 years old or older
• if you are using corticosteroids, sometimes called steroids (see section “Other medications and Levofloxacino Teva tablets”)
• if you have received a transplant
• if you have ever had a seizure (convulsion)
• if you have had brain damage due to a stroke or other brain injury
• if you have kidney problems
• if you have what is known as “glucose-6-phosphate dehydrogenase deficiency”, as you may be prone to having severe blood problems when taking this medication
• if you have ever had mental problems
• if you have ever had heart problems:you should be cautious when using this type of medication, if you were born with, or have a family history of, prolonged QT interval (seen on the electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have an imbalance in blood salt levels (especially low levels of potassium or magnesium in the blood), have a slow heart rate (called “bradycardia”), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are a woman or an older person, or are taking other medications that may cause abnormal changes in the ECG (see section 2 “Other medications and Levofloxacino Teva tablets”)
• if you are diabetic
• if you have ever had liver problems
• if you have myasthenia gravis
• if you have nerve problems (peripheral neuropathy)
• if you have been diagnosed with an enlarged or a “bulge” of a large blood vessel (aortic aneurysm or a large peripheral vessel aneurysm).
• if you have had a previous episode of aortic dissection (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 aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., Marfan syndrome, Ehlers-Danlos vascular syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or atherosclerosis known, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).
• if you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking levofloxacino.

Inform your doctor or pharmacist before taking Levofloxacino Teva tablets, if you are unsure whether any of the above cases apply to you.

Do not take medications that contain fluoroquinolones or quinolones, including Levofloxacino Teva tablets, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. If this is the case, inform your doctor as soon as possible.

Consult your doctor or pharmacist during treatment with Levofloxacino Teva tablets

• if you experience a sudden, severe pain in the chest, abdomen, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency service. You may be at increased risk if you are receiving systemic corticosteroid treatment.

• if you start experiencing sudden, involuntary jerks, muscle spasms, or muscle contractions – consult a doctor immediately, as these may be signs of myoclonia. Your doctor may need to interrupt treatment with levofloxacino and start an appropriate treatment.

• in rare cases, you may experience pain and swelling in the joints and inflammation or rupture of tendons. The risk is higher if you are an older person (over 60 years old), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture can occur in the first 48 hours of treatment and even several months after stopping treatment with Levofloxacino Teva tablets. If you experience any pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino Teva tablets, contact your doctor, and keep the affected area at rest. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.

• in rare cases, 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 happens, stop taking Levofloxacino Teva tablets and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

• if your vision worsens or if you experience any other eye changes, consult an ophthalmologist immediately (see section 2 “Driving and operating machinery” and section 4).

• quinolone antibiotics can cause an increase in your blood sugar level above your normal level (hyperglycemia), or a decrease in your blood sugar level below normal levels, which in severe cases can cause a loss of consciousness (hypoglycemic coma) (see section 4). This is important for people with diabetes. If you have diabetes, you should monitor your blood sugar levels carefully.
• if you start experiencing sudden, involuntary jerks, muscle spasms, or muscle contractions – consult a doctor immediately, as these may be signs of myoclonia. Your doctor may need to interrupt treatment with levofloxacino and start an appropriate treatment.

• if you experience fatigue, pale skin, hematoma, uncontrolled bleeding, fever, sore throat, and a severe deterioration of your general condition, or a feeling that your resistance to infections may be decreased – consult a doctor immediately, as these may be signs of blood disorders. Your doctor should check your blood with blood counts. If your blood counts are abnormal, your doctor may need to interrupt treatment.

Severe skin reactions

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

-SJS/TEN may initially appear on the trunk as red, ring-shaped spots or circular patches often with blisters in the center. They may also appear as ulcers in the mouth, throat, nose, genitals, and eyes (red, swollen eyes). These severe skin reactions often precede a generalized skin peeling and potentially life-threatening or fatal complications.

- DRESS initially presents with symptoms similar to the flu and a rash on the face, followed by a more widespread rash with elevated body temperature, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell (eosinophilia) and swollen lymph nodes.

if you develop a severe skin rash or any of these symptoms, stop taking levofloxacino and contact your doctor or seek medical attention immediately.

Severe, long-lasting, and potentially irreversible adverse effects

Fluoroquinolone or quinolone-containing antibacterial medications, including Levofloxacino Teva tablets, have been associated with rare but severe adverse effects, some of which were long-lasting (persistent for months or years), incapacitating, or potentially irreversible. This includes pain in the tendons, muscles, and joints of the upper and lower extremities, difficulty walking, abnormal sensations such as pinpricks, tingling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

if you experience any of these adverse effects after taking Levofloxacino Teva tablets, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or discontinue treatment, considering also the use of an antibiotic of another class.

Children and adolescents

This medication should not be administered to children or adolescents.

Other medications and Levofloxacino Teva tablets

Inform your doctor or pharmacist if you are taking/using, have taken/used recently, or may need to take/use any other medication. This is because Levofloxacino Teva tablets may affect the functioning of other medications. Additionally, some medications may affect the functioning of Levofloxacino Teva tablets.

Particularly, inform your doctor if you are taking any of the following medications, as it increases the likelihood of experiencing adverse effects when taking them with Levofloxacino Teva tabletstablets:

• corticosteroids, sometimes called steroids - used for inflammation. You may be more likely to experience inflammation and/or tendon rupture
• warfarin - used to make the blood more liquid. You may be more likely to experience bleeding. Your doctor may need to perform regular blood tests to check if your blood clots properly
• theophylline - used for respiratory problems. You may be more likely to experience a seizure (convulsion) if you take it with Levofloxacino Teva tablets.
• nonsteroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as aspirin, ibuprofen, phenbufen, ketoprofen, indomethacin. You may be more likely to experience a seizure (convulsion) if you take them with Levofloxacino Teva tablets.
• ciclosporin - used after organ transplants. You may be more likely to experience the adverse effects of ciclosporin
• medications with a known effect on your heart rhythm. This includes medications 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)
• probencid - used for gout. Your doctor may want to give you a lower dose if you have kidney problems
• cimetidine – used for ulcers and heartburn. Your doctor may want to give you a lower dose if you have kidney problems

Consult your doctor if any of the above applies to you.

Do not take Levofloxacino Teva tablets at the same time as the following medications, as it may affectthe way Levofloxacino Teva tablets work:

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

Determination of opiates in urine

Urine tests may show “false positive” results for the presence of strong painkillers called “opioids” in patients taking Levofloxacino Teva tablets. Inform your doctor that you are taking Levofloxacino Teva tablets if they have prescribed a urine test.

Tuberculosis test

This medication may cause a “false negative” result in some laboratory tests used to search for the bacteria that causes tuberculosis.

Pregnancy and breastfeeding

Do not take this medication if:

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

Driving and operating machinery

You may experience some adverse effects such as dizziness, drowsiness, balance disturbances (vertigo), or visual changes. Some of these adverse effects may affect your ability to concentrate or decrease your reaction time. If this happens, do not drive or perform any work that requires a high level of attention.

Levofloxacino Teva contains sodium

This medication contains less than 23 mg of sodium (1mmol) per coated tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How to take this medication

• Take this medication by mouth
• Swallow the whole tablets with a little water
• The tablets can be taken during or between meals

Protect your skin from sunlight

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

• Make sure to use high-protection sunscreens
• Always wear a hat and clothing that covers your arms and legs
• Avoid ultraviolet A (UVA) lamps

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

• Do not take these medications at the same time as Levofloxacino Teva tablets. You must take these medications at least two hours before or two hours after taking Levofloxacino Teva tablets.

What dose should you take

• Your doctor will decide what amount of Levofloxacino Teva tablets you should take.
• The dose will depend on the type of infection you have and where the infection is located in your body.
• The duration of treatment will depend on the severity of your infection.
• If you think the effect of the medication is too weak or too strong, do not change the dose yourself, ask your doctor.

Adults and elderly patients

Paranasal sinus infection

• one Levofloxacino Teva 500 mg tablet, once a day

Pulmonary infection, in people with long-term respiratory problems

• one Levofloxacino Teva 500 mg tablet, once a day

Pneumonia

• one or two Levofloxacino Teva 500 mg tablets, once a day

Urinary tract infection, including kidneys or bladder

• half or one Levofloxacino Teva 500 mg tablet, once a day

Prostate infection

• one Levofloxacino Teva 500 mg tablet, once a day

Skin and subcutaneous tissue infection, including muscles

• one or two Levofloxacino Teva 500 mg tablets, once a day

Adults and elderly patients with kidney problems

Your doctor may possibly administer a lower dose.

If you take more Levofloxacino Teva tablets than you should

If you accidentally take more tablets than you should, inform your doctor or get immediate medical help. Bring the medication with you so that the doctor knows what you have taken. You can also call the Toxicological Information Service at phone 91 562 04 20, indicating the medication and the amount ingested. The effects that may appear are: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart rhythm disturbances that may cause irregular heartbeats as well as discomfort (nausea) or heartburn.

If you forget to take Levofloxacino Teva tablets

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 compensate for the missed doses.

If you interrupt treatment with Levofloxacino Teva tablets

Do not interrupt your treatment with Levofloxacino Teva even if you feel better. It is essential that you complete the treatment prescribed by your doctor. If you stop taking them too soon, the infection may recur, your condition may worsen, or the bacteria may become resistant to the medication.

If you have any other questions about the product, ask your doctor, pharmacist, or nurse.

Like all medicines,this medicinecan cause side effects, although not everyone will experience them. They are usually mild to moderate and usually disappear quickly.

Stop taking Levofloxacino Teva tablets and contact a doctor or go to a hospital immediately if you notice the following side effects:

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

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

Stop taking Levofloxacino Teva tablets and contact a doctor immediately if you notice the following serious side effects, as you may need 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 the most commonly affected
• Seizures (convulsions)
• Seeing or hearing things that are not real (hallucinations, paranoia)
• Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares
• Generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and other organs involved (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See section 2
• Syndrome associated with changes in water elimination and low sodium levels (SIADH)
• Low blood sugar (hypoglycemia) or low blood sugar that can lead to coma (hypoglycemic coma). This is particularly important for diabetic patients. See section 2.

Unknown(frequency cannot be estimated from available data):

• Severe skin eruptions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red macules in the shape of a bull's-eye or circular patches often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers, and may be preceded by symptoms similar to the flu. See section 2
• Loss of appetite, yellow skin and eyes, dark urine, burning or painful stomach (abdomen). These may be signs of liver problems that can include fulminant liver failure
• Watery diarrhea that may contain blood, possibly with stomach cramps and fever. These may be signs of a serious intestinal problem
• Burning, tingling, pain, or numbness. These may be signs of what is called "neuropathy"
• Changes in opinion and thought (psychotic reactions) with a risk of having suicidal thoughts or actions
• If your vision worsens or if you have any other eye changes during treatment, consult an ophthalmologist immediately (see section 2 "Consult your doctor or pharmacist during treatment with Levofloxacino Teva tablets" and "Driving and using machines").

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting or permanent adverse reactions (even months or years) or side effects, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinching, tingling, burning, numbness, or pain (neuropathy), depression, fatigue, sleep disorders, decreased memory, and 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) have been reported, which could lead to rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones. See also section 2.

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

Frequent(may affect up to 1 in 10 people)

• Sleep problems
• Headache, dizziness
• Discomfort (nausea, vomiting) and diarrhea
• Increased levels of some liver enzymes in the blood

Rare(may affect up to 1 in 100 people)

• Changes in the number of other bacteria or fungi, fungal infection by Candida, which may require treatment
• Changes in the number of white blood cells in blood test results (leucopenia, eosinophilia)
• Stress (anxiety), confusion, nervousness, drowsiness, tremors, feeling dizzy (vertigo)
• Difficulty breathing (dyspnea)
• Changes in the taste of things, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, feeling bloated (flatulence) or constipation
• Itching and rash on the skin, intense itching or hives (urticaria), excessive sweating (hyperhidrosis)
• Joint pain or muscle pain
• Abnormal values in 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 bleeding easily due to a decrease in the number of platelets in the blood (thrombocytopenia)
• Decrease in the number of white blood cells in the blood (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Feeling of tingling in hands and feet (paresthesias)
• Ear or vision disorders (tinnitus, blurred vision)
• Abnormally fast heart rate (tachycardia) or decreased blood pressure (hypotension)
• Muscle weakness. This is particularly important in people with myasthenia gravis (rare nervous system disease)
• Changes in kidney function and, occasionally, renal insufficiency that may be a consequence of an allergic reaction in the kidneys called interstitial nephritis
• Fever
• Clearly defined red patches with or without blisters that develop a few hours after levofloxacino administration and heal with residual post-inflammatory hyperpigmentation; usually, they repeat in the same skin or mucous membrane site after subsequent exposure to levofloxacino.
• Memory disorders

Unknown(frequency cannot be estimated from available data):

• Decrease in red blood cells in the blood (anemia): this may cause pale or yellow skin due to damage to red blood cells; decrease in the number of all types of blood cells (pancytopenia)
• The bone marrow stops producing new blood cells, which can cause fatigue, decreased ability to fight infections, and uncontrolled bleeding (bone marrow insufficiency)
• Fever, sore throat, and persistent general discomfort. This may be due to a decrease in the number of white blood cells (agranulocytosis)
• Cardiovascular collapse (anaphylactic shock)
• Increased blood sugar levels (hyperglycemia). This is particularly important in people with diabetes. See section 2.
• Changes in smell, loss of smell or taste (parosmia, anosmia, ageusia)
• Feeling extremely 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
• Ear or hearing problems
• Abnormally fast heart rate, irregular heart rhythm with life-threatening risk including heart stoppage, alteration of heart rhythm (denominated "prolongation of the QT interval", observed in the ECG, graphical representation of heart electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Allergic pulmonary reactions
• Pancreatitis (inflammation of the pancreas)
• Heptatitis (inflammation of the liver)
• Increased skin sensitivity to the sun and ultraviolet light (photosensitivity), darker skin patches (hyperpigmentation)
• Inflammation of the blood vessels due to an allergic reaction (vasculitis)
• Inflammation of the mucous membrane inside the mouth (stomatitis)
• Muscle rupture and muscle destruction (rhabdomyolysis)
• Red and swollen joints (arthritis)
• Pain, including back, chest, and limb pain
• Sudden, involuntary muscle contractions or spasms (myoclonia)
• Porphyria crisis in patients with porphyria (very rare metabolic disease)
• Persistent headache with or without blurred vision (benign intracranial hypertension)

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es.

By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of sight andout of reach of children.

Do not usethis medicationafter the expiration datethat appears on the packaging and theblister after CAD.The expiration date is the last day of the month indicated.

This medication does not require special storage conditions

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Levofloxacino Teva tablets

The active ingredient is levofloxacino. Each tablet contains 500 mg of levofloxacino.

The other components (excipients) are:

• Core: colloidal anhydrous silica, hydroxypropylcellulose, sodium carboxymethylcellulose type A (from potato), talc, croscarmellose sodium, magnesium stearate.
• Coating: hypromellose, titanium dioxide (E171), macrogol 400, polisorbate, iron oxide red (E172), iron oxide black and yellow (E172).

Appearance of the product and contents of the package

Levofloxacino Teva are film-coated oral tablets. The tablets are capsule-shaped, orange in color, with a notch, engraved with “LX” on the left side and “500” on the right side. The other side of the tablet is notched and smooth. The tablet can be divided into two equal halves.

They are presented in packs of 1, 2, 5, 7, 10, 14, 30, 50 (5x10) and 200 (20x10), 500 (50x10) tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

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

Alcobendas 28108 Spain

Responsible manufacturer

Pharmachemie B.V.

Swensweg 5, Postbus 552, 2003 RN Haarlem

Netherlands

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Merckle GmbH

Ludwig-Merckle-Str.3

89134 Blaubeuren

Germany

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

AustriaLevofloxacin ratiopharm 250 mg Filmtabletten

Levofloxacin ratiopharm 500 mg Filmtabletten

GermanyLevofloxacin-ratiopharm 250 mg Filmtabletten

Levofloxacin-ratiopharm 500 mg Filmtabletten

ItalyLevofloxacina Teva 250 compresse rivestite con film

Levofloxacina Teva 500 compresse rivestite con film

NetherlandsLevofloxacine 250 mg PCH, filmomhulde tabletten

Levofloxacine 500 mg PCH, filmomhulde tabletten

PortugalLevofloxacina Teva 250 mg comprimido revestido por película

Levofloxacina Teva 500 mg comprimido revestido por película

SpainLevofloxacino Teva 500 mg comprimidos recubiertos con película EFG

United Kingdom (Northern Ireland)Levofloxacin 500 mg Film-coated Tablets

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

Last review date of this leaflet:August 2024

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71603/P_71603.html