Label: information for the useruser

Levofloxacino Pharma Combix 500 mg film-coated tablets

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4

Levofloxacino Pharma Combix contains an active ingredient called levofloxacino, which belongs to a group of medicines called antibiotics. Levofloxacino is a type of antibiotic known as a quinolone, and it works by eliminating the bacteria that cause infections in your body.andit works by eliminating the bacteria that cause infections in your body.

Levofloxacino can be used to treat infections in:

In certain special situations, levofloxacino may be used to reduce the likelihood of acquiring a type of lung infection called anthrax or a worsening of the disease after exposure to the bacteria that cause anthrax.

Do not take this medicine and consult your doctor if:

• You are allergic to levofloxacin, other quinolone antibiotics such as moxifloxacin, ciprofloxacin, or ofloxacin, or any of the other components of this medicine (listed in section 6)
• The signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue
• You have or have had epilepsy
• You have had problems with tendons, such as tendinitis, that were related to taking quinolone medicines. The tendon is the tissue that connects your muscle to your skeleton
• You are a child or adolescent in a growth period
• You are pregnant, may become pregnant, or think you may be pregnant
• You are breastfeeding

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

Warnings and precautions

Before starting to take the medicine

Do not take fluoroquinolone or quinolone antibiotics, including Levofloxacino Pharma Combix, 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 before taking your medicine if:

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

During treatment with this medicine

• If you have a sudden, severe pain in your abdomen or back, which may be symptoms of aortic dissection or aneurysm, go to an emergency service immediately. The risk may be increased if you are receiving systemic corticosteroid treatment.
• If you start experiencing sudden onset of shortness of breath, especially when lying down, or if you notice swelling in your ankles, feet, or abdomen, or if you experience palpitations (a sensation of rapid or irregular heartbeat), inform your doctor immediately.
• If you start experiencing sudden, involuntary muscle contractions, muscle spasms, or muscle contractions, consult a doctor immediately, as these may be signs of myoclonia. Your doctor may need to interrupt treatment with levofloxacin 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 monitor your blood with blood counts. If abnormal blood counts are found, your doctor may need to interrupt treatment.

In rare cases, pain and swelling in the joints and inflammation or rupture of tendons may occur. 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 Pharma Combix. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino Pharma Combix, 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 your feet and legs or hands and arms. If this happens, stop taking Levofloxacino Pharma Combix and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

Severe, prolonged, and potentially irreversible adverse effects

Fluoroquinolone or quinolone antibiotics, including Levofloxacino Pharma Combix, have been associated with rare but severe adverse effects, some of which were of long duration (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, itching, 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 Pharma Combix, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not with the treatment, also considering the use of an antibiotic of another class.

Taking Levofloxacino Pharma Combix with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This is because levofloxacin may affect the functioning of other medicines. In addition, some medicines may affect the functioning of levofloxacin.

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

Do not take levofloxacin tablets at the same time as the following medicines, as it may affect the way levofloxacin works:

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 levofloxacin.

•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 and swollen eyes). These severe skin eruptions often precede fever and/or flu-like symptoms. The eruptions may progress to widespread skin peeling and potentially life-threatening or fatal complications.

•DRESS initially presents with flu-like symptoms 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 levofloxacin and contact your doctor or seek medical attention immediately.

Determination of opiates in urine

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

Tuberculosis test

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

Pregnancy, breastfeeding, and fertility

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

Do not takethis medicine if:

Driving and operating machinery

You may experience some adverse effects such as dizziness, drowsiness, balance disturbances (vertigo), or visual disturbances. 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.

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

How to take this medication

• Take this medication by mouth
• Swallow the tablets whole 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:

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

• Do not take these medications at the same time as levofloxacino. You should take these medications at least two hours before or two hours after taking levofloxacino.

What dose should you take

Adults and elderly patients

Upper respiratory tract infection

Pneumonia, in people with long-term respiratory problems

Pneumonia

Urinary tract infection, including kidneys or bladder

Prostate infection

Skin and subcutaneous tissue infection, including muscles

Adults and elderly patients with kidney problems

Your doctor may possibly administer a lower dose.

Children and adolescents

This medication should not be administered to children or adolescents.

If you take more Levofloxacino Pharma Combix than you should

If you accidentally take more tablets than you should, inform your doctor or seek immediate medical help. Bring the medication with you so that the doctor knows what you have taken.

The effects that may appear are: seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart rhythm disturbances that may cause irregular heartbeats as well as discomfort (nausea) or heartburn.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Levofloxacino Pharma Combix

If you forgot 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 the treatment with Levofloxacino Pharma Combix

Do not interrupt your treatment with levofloxacino 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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Usually, they are mild to moderate and tend to disappear quickly.

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

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

Stop taking levofloxacin 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)

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

Frequency not known(cannot be estimated from available data)

Others:

Consult an eye specialist immediately if your vision deteriorates or you have any other eye problems while taking levofloxacin.

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

Common(may affect up to 1 in 10 people)

Uncommon(may affect up to 1 in 100 people)

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

Other side effects include:

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.

Reporting of adverse reactions

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging and the blister pack after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Levofloxacino Pharma Combix

• The active ingredient is levofloxacin. Each tablet contains 500 mg of levofloxacin (as hemihydrate).

• The other components are:

Tablet core:Crospovidone (E468), hypromellose (E464), microcrystalline cellulose (E460i), stearate and sodium fumarate.

Tablet coating:Instacoat ICG-U-10236 pink: contains hypromellose (E464), polyethylene glycol 8000 (E1521), talc (E553b), titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).

Appearance of the product and content of the container

Levofloxacino Pharma Combixare pink film-coated tablets, capsule-shaped, biconvex and scored on both sides. The tablet can be divided into two equal halves.

It is presented in carton containers with PVC/PVDC-Aluminum blisters containing 7 and 14 film-coated tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Combix, S.L.U.

C/Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Last review date of this leaflet: September 2024

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