FLEXID 500mg x 7 tabs

FLEXID 500mg x 7 tabs

Leaflet : patient information

Flexid 5 0 0 mg film-coated tablets

Flexid 500 mg film-coated tablets

levofloxacin ( levofloxacin )

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• This medicine has been prescribed for you personally. Don't leave it to other people. It can harm them, even if their symptoms are the same as yours.

If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.

What this leaflet contains

1. What Flexid is and what it is used for

2. What you need to know before you take Flexid

3. How to take Flexid

4. Possible side effects

5. How to store Flexid

6. Contents of the package and additional information

1. What Flexid is and what it is used for

The name of your medicine is Flexid. Flexid film-coated tablets contain a medicine called levofloxacin. It belongs to a group of medicines called antibiotics. Levofloxacin is an antibacterial agent of the quinolone class. It works by killing the bacteria that have caused an infection in your body.

Levofloxacin can be used to treat infections of:

- The sinuses

- The lungs, in people with long-term breathing problems or pneumonia

- The urinary tract, including the kidneys and bladder

- The prostate gland, in case of prolonged infection

- The skin and underlying tissues, (including muscle), sometimes called "soft tissue"

In some special situations, Flexid film-coated tablets can be used to reduce the risk of developing a lung disease called anthrax or to make the disease worse in case of exposure to the bacteria that cause anthrax.

2. What you need to know before you take Flexid

Do not take this medicine and tell your doctor if :

- you are allergic to levofloxacin, other quinolone antibiotics such as moxifloxacin, ciprofloxacin or ofloxacin or any of the other ingredients of the medicine (listed in point 6)

Signs of an allergic reaction include: rash, trouble swallowing or breathing, swelling of the lips, face, neck, or tongue.

- you have ever had epilepsy

- if you have had tendon problems after using quinolone antibacterial agents. The tendon is the connection between the muscles and the skeleton.

- you are a child or adolescent in the growth period

- you are pregnant, become pregnant or think you are pregnant

- you are breastfeeding

Do not take this medicine if any of the above apply to you. If you are not sure, ask your doctor or pharmacist before taking Flexid.

Warnings and precautions

Before taking this medicine

You should not take antibacterial medicines containing fluoroquinolones/quinolones, including Flexid, if you have had any serious side effects in the past when you took quinolones or fluoroquinolones. In this case, you should inform your doctor as soon as possible.

Consult your doctor or pharmacist before taking Flexid if :

- you are 60 or older

- you are taking corticosteroids, sometimes called steroids (see section 'Taking other medicines and Flexid')

- you have had seizures (convulsions)

- you have had brain damage due to a stroke or other injury

- you have kidney problems

- you have glucose-6-phosphate dehydrogenase deficiency. You are more likely to have serious blood problems while taking this medicine.

- you have had mental health problems

- you have had heart disease. Caution is required when using this type of medicine if you are born with or have a family history of a prolonged QT-interval (seen on an ECG, electrical recording of the heart), you have impaired salt balance in the blood (in particular low levels of potassium or magnesium in the blood), you have a very slow heart rate (called "bradycardia"), you have a weak heart (heart failure), you have had a heart attack (myocardial infarction), if you are female or elderly, or if you are taking other drugs that lead to abnormal ECG changes (see the section "Taking other drugs and Flexid").

- you have diabetes

- you have had liver problems

- you have myasthenia gravis

- You have been diagnosed with an enlargement or 'bulging' of a large blood vessel (aortic aneurysm or large peripheral vessel aneurysm).

- you have experienced a previous episode of aortic dissection (tearing of the aortic wall)

- you have nerve problems (peripheral neuropathy)

- you have been diagnosed with leakage from the heart valves (heart valve regurgitation)

- if you have a family history of aortic aneurysm or aortic dissection congenital heart valve disease, or other risk factors or predisposing diseases (e.g. connective tissue disorders such as Marfan's syndrome or Ehlers-Danlos syndrome, Turner's syndrome, Sjögren's syndrome ( inflammatory autoimmune disease), or vascular disorders such as Takayasu's arteritis, giant cell arteritis, Behcet's disease, high blood pressure or known atherosclerosis, rheumatoid arthritis (joint disease), or endocarditis (heart infection).

- if you have ever had a severe skin rash or skin peeling, blistering and/or mouth ulcers after taking levofloxacin.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Flexid.

Quinolone antibiotics can cause blood sugar levels to rise above normal values (hyperglycaemia) or blood sugar levels to fall below normal values, potentially leading to loss of consciousness (hypoglycaemic coma) in severe cases (see section 4.4. ). This is important for people who have diabetes. If you suffer from diabetes, your blood sugar should be monitored carefully.

While taking this medicine

Rarely, joint pain and swelling and tendon inflammation or rupture occur. Your risk increases if you are elderly (over 60), have had an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and tears can occur within the first 48 hours of treatment and even up to several months after stopping Flexid therapy. At the first sign of tendon pain or inflammation (for example in the ankle, wrist, elbow, shoulder or knee), stop taking Flexid, contact your doctor and immobilize the painful area. Avoid unnecessary strain, as this can increase the risk of tearing the tendon.

Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness may occur, especially in the feet and legs or hands and palms. If this happens, stop taking Flexid and tell your doctor immediately to prevent the development of a potentially irreversible condition.

If you experience sudden, severe pain in your abdomen, chest, or back, which may be a symptom of an aortic aneurysm and dissection, go to the emergency room right away. The risk may be increased if you are treated with systemic corticosteroids.

If you start to experience shortness of breath, especially when you are lying in bed, or if you notice swelling in your ankles, feet or abdomen, or a new onset of palpitations (a feeling of a fast or irregular heartbeat), you should inform a doctor immediately.

Prolonged, debilitating and potentially irreversible serious side effects

The use of antibacterial drugs containing fluoroquinolones/quinolones, including Flexid, is associated with the occurrence of very rare but serious side effects, some of which are long-lasting (months or years), debilitating or potentially irreversible. This includes pain in the tendons, muscles and joints of the upper and lower limbs, difficulty walking, unusual sensations such as pricking, tingling, tickling, numbness or burning sensations (paresthesias), sensory disturbances including disturbances of sight, taste, smell and hearing , depression, memory impairment, severe fatigue and severe sleep disturbances.

If you experience any of these side effects after taking Flexid, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue the treatment, also discussing the possible use of another class of antibiotic.

Serious skin reactions

Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with levofloxacin.

• Stevens-Johnson syndrome/toxic epidermal necrolysis may appear initially as reddish, target-like patches on the body, or round patches often with blisters in the center. Ulcers in the mouth, throat, nose, genitals and eyes (red and swollen eyes) may also occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms. Rashes can progress to widespread skin peeling and life-threatening complications, or be fatal.

• DRESS manifests initially as flu-like symptoms and a rash on the face, then a widespread rash with a high body temperature, elevated levels of liver enzymes seen in blood tests, and an increase in a type of white blood cell (eosinophils) and enlarged lymph nodes.

If you develop a serious rash or any of these skin symptoms, stop taking levofloxacin and contact your doctor or get medical help right away.

Other medicines and Flexid

Check with your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is necessary because Flexid can affect the action of some medicines. As well as some medicines can affect the action of Flexid.

In particular, consult your doctor if you are taking any of the following medicines. This is necessary because taking them together with Flexid can increase the risk of side effects.

• Corticosteroids, sometimes called steroids (used for inflammation). You are more likely to get tendon inflammation and/or rupture
• Warfarin, used to thin the blood. You are more likely to bleed. It is necessary for your doctor to carry out regular blood tests to determine the ability of your blood to clot.
• Theophylline (to treat breathing problems). You are more likely to have a fit (convulsion) if you take it with Flexid
• Nonsteroidal anti-inflammatory drugs (NSAIDs) used for pain and inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen, and indomethacin. You are more likely to have a fit (convulsion) if you take them with Flexid
• Cyclosporine used after transplants. You are more likely to experience side effects from cyclosporine.
• Medicines known to affect heart rate. This includes medicines used for abnormal heart rhythms (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide and ibutilide), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for mental disorders (antipsychotics), for bacterial infections (macrolide antibiotics, such as erythromycin, azithromycin and clarithromycin)

• Probenecid (to treat gout) or cimetidine (to treat ulcers or heartburn). Special care should be taken when using any of the following medicines together with Flexid. If you have kidney problems, your doctor may recommend a lower dose.

Do not take Flexid film-coated tablets at the same time as the following medicines, as this may affect the action of Flexid:

• Iron supplements (for anemia), supplements containing zinc, antacids containing magnesium or aluminum (for heartburn), didanosine or sucralfate (for treating stomach ulcers). See point 3 "If you are already taking iron tablets, zinc supplements, antacids, didanosine or sucralfate" below.

Urine tests for opiates

Urine tests may show a false-positive result for strong pain relievers called opiates in people taking Flexid. If your doctor prescribes a urine test, inform him that you are taking Flexid.

Tuberculosis tests

This medicine can cause false-negative results in some laboratory tests to detect the bacteria that cause tuberculosis.

Pregnancy and breastfeeding

Do not take this medicine if:

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

Driving and using machines

You are likely to experience side effects after taking this medicine, which may include dizziness, lightheadedness, drowsiness or visual disturbances. Some of these side effects may affect your ability to concentrate and the speed of your reactions. If this happens, do not drive or do any activities that require caution.

Flexid contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Flexid contains sodium.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. practically no sodium.

3. How to take Flexid

Always take the medicine exactly as your doctor has recommended. Consult your doctor or pharmacist if you are not sure.

Taking the medicine

• take the medicine by mouth
• swallow the tablets whole with a sufficient amount of liquid
• tablets can be taken with or between meals

The tablet can be divided into two equal doses.

Protect your skin from the sun

Avoid exposure to direct sunlight while taking the medication and for up to 2 days after you stop taking it. This is necessary because your skin may become more sensitive to the sun and burns, tingling or severe blisters may occur if you do not take the following precautions:

• Make sure you use a high factor sunscreen
• Always wear a hat and clothing that covers your arms and legs
• Avoid sunbathing

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

• Do not take these medicines at the same time as Flexid. Take the required dose of these medicines at least 2 hours before or after taking Flexid tablets.

What amount to take

• Your doctor will decide how many tablets you should take
• The dose depends on the type of infection you have and the place in the body affected by the infection
• The length of your treatment depends on the severity of your infection
• If you feel that the effect of the medicine is too weak or too strong, do not change your dose yourself, but consult your doctor.

Adults and elderly patients

Adults and elderly patients with kidney problems :

Your doctor may recommend a lower dose.

Children and adolescents :

Flexid should not be used in children and adolescents in the growth stage.

If you have taken more than the required dose of Flexid tablets

If you accidentally take more tablets than you need, consult your doctor immediately. Take the package with you so the doctor knows what medicine you have taken. The following symptoms may occur: convulsive seizures (seizures), confusion, dizziness, impaired consciousness, tremors, heart problems - irregular heartbeat, as well as nausea or heartburn.

If you forget to take Flexid tablets

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

If you have stopped taking Flexid tablets

Do not stop taking Flexid tablets just because you feel better. It is important to complete the course of treatment prescribed by your doctor. If you stop taking the tablets prematurely, the infection may reappear, your condition may worsen, or the bacteria may become resistant to the drug.

If you have any further questions related to the use of this product, please ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this one can cause side effects, although not everybody gets them. These reactions are usually mild to moderate and often disappear in a short time.

Stop taking Flexid and consult a doctor immediately or go to a hospital immediately if you notice any of the following side effects:

Not known (frequency cannot be estimated from the available data) :

• You have an allergic reaction. Signs may include: rash, trouble swallowing or breathing, swelling of the lips, face, throat or tongue

Stop taking Flexid and consult a doctor immediately if you notice any of the following serious side effects - you may need emergency treatment:

Rare (may affect up to 1 in 1,000 patients) :

• Watery diarrhea that may also contain blood, which may be accompanied by stomach pain and high fever. This can be a symptom of severe intestinal inflammation.
• Pain and inflammation of a tendon or muscle ligament, which can lead to a tear. The Achilles tendon is most commonly affected.
• Seizures (convulsions).
• Seeing or hearing things that are not there (hallucinations, paranoia), changeable moods and thoughts (psychotic reactions) with a risk of suicidal thoughts and actions.
• Depression, mental problems, nervousness (anxiety), strange dreams or nightmares
• Widespread rash, high body temperature, increased liver enzymes, blood count abnormalities (eosinophilia), enlarged lymph nodes and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, which is also known as DRESS or drug hypersensitivity syndrome ). See also point 2.
• Syndrome associated with impaired water excretion and low sodium levels (SIADH)

With an unknown frequency ( an estimate cannot be made from the available data )

• Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. They may appear as reddish, target-like spots on the body or round spots often with blisters in the center, peeling skin, ulcers in the mouth, throat, nose, genitals and eyes, and may be preceded by fever and flu-like symptoms. See also point 2.
• lack of appetite, yellowing of the skin and eyes, darkening of the urine, itching, and stomach discomfort (in the abdominal area). These may be symptoms of liver problems, which may include a life-threatening condition related to the liver
• burning, tingling, pain or numbness. These may be symptoms of a condition called 'neuropathy'

If your vision is affected or you have other eye problems while taking Flexid tablets, consult an ophthalmologist immediately.

Tell your doctor if any of the following reactions become serious or last more than a few days:

Common side effects (may affect up to 1 in 10 patients) :

• sleep problems;
• headache, dizziness;
• general malaise (nausea, vomiting) and diarrhea;
• increase blood levels of liver enzymes.

Uncommon side effects (may affect up to 1 in 100 patients) :

• changes in the number of other bacteria or fungi, fungal infections called candida, which may need to be treated
• increase or decrease in the number of white blood cells (leukopenia, eosinophilia)
• feeling stressed (anxiety), confused, nervous, sleepy, tremors, dizzy (vertigo);
• shortness of breath (dyspnea)
• changes in taste, lack of appetite, stomach discomfort and indigestion (dyspepsia), abdominal pain; feeling bloated (gas) or constipated
• itching, rash, severe itching or hives, excessive sweating (hyperhidrosis);
• muscle pain, joint pain;
• changes in blood tests that are due to liver (increased bilirubin) or kidney (increased creatinine) problems;
• general weakness

Rare (may affect up to 1 in 1,000 patients) :

• easy bruising and bleeding due to a decrease in the number of platelets (thrombocytopenia);
• decrease in the number of white blood cells (neutropenia);
• strong immune system response (hypersensitivity);
• lowering of blood sugar values to low levels (hypoglycaemia), which may be of particular importance in patients undergoing treatment for diabetes;

• tingling in the hands and feet (paresthesia);
• hearing problems (eg 'ringing' or tinnitus) in the ears or vision problems (blurred vision);
• abnormally fast heart rate (tachycardia), abnormally low blood pressure (hypotension);
• muscle weakness, which may be of particular importance in patients with myasthenia gravis (a rare disease of the nervous system).
• changes in the way the kidneys work and rarely kidney failure, which may be the result of an allergic reaction on the part of the kidneys, which is called interstitial nephritis;
• fever
• sharply defined, erythematous plaques with/without blistering that develop within hours of levofloxacin administration and resolve with post-inflammatory residual hyperpigmentation; usually recur at the same site on the skin or mucous membranes with subsequent exposure to levofloxacin.

Not known (frequency cannot be estimated from the available data):

• reduction in the number of red blood cells (anaemia): this can be manifested by paleness or yellowing of the skin due to the breakdown of red blood cells; decrease in the number of all blood cells (pancytopenia)
• a very marked decrease in the number of white blood cells (agranulocytosis) leading to symptoms such as recurrent or persistent high fever, sore throat or repeated feeling of general unwellness
• circulatory disorder (anaphylactic-like shock)
• increased blood sugar levels (hyperglycaemia) or decreased blood sugar levels leading to coma (hypoglycaemic coma). This is important for people with diabetes
• olfactory disorders, lack of smell and taste (parosmia, anosmia, ageusia)
• motor and walking problems (dyskinesia, extrapyramidal disorders)
• stiffness of the limbs, trembling hands and other disorders of muscle coordination
• temporary loss of consciousness (syncope)
• transient vision loss
• reduction or loss of hearing
• abnormally fast heart rate, life-threatening irregular heart rhythm, changes in heart rhythm (called "prolongation of the QT interval" on the EKG, electrical activity of the heart)
• allergic inflammation of the lungs
• pancreatitis
• inflammation of the liver (hepatitis)
• increased sensitivity of the skin to the sun and ultraviolet rays (photosensitivity)
• allergic inflammation of small blood vessels (vasculitis)
• inflammation of the oral mucosa (stomatitis)
• muscle tears and muscle damage (rhabdomyolysis)
• swelling and redness of the joints (arthritis)
• pain, including in the back, chest and limbs
• this drug may trigger a porphyria attack in patients with porphyria (a very rare metabolic disease)
• persistent headache with or without blurred vision (benign intracranial hypertension)

Very rare cases of long-lasting (up to months or years) or permanent side effects such as tendonitis, tendon rupture, joint pain, limb pain, difficulty walking, unusual sensations such as pricking, tingling, tickling, burning sensation, numbness or pain (neuropathy), depression, fatigue, sleep disturbances, memory impairment, as well as impairment of hearing, sight, taste and smell, are associated with the administration of antibiotics containing quinolones and fluoroquinolones, in some cases regardless of pre-existing risk factors.

Aortic wall enlargement and weakening or aortic wall rupture (aneurysms and dissections), which can rupture and be fatal, and leaky heart valves have been reported in patients receiving fluoroquinolones. See also point 2.

Reporting adverse reactions

If you get any side effects, tell your doctor, pharmacist or nurse. This includes all possible side effects not described in this leaflet. You can also report adverse reactions directly through the national reporting system to the Medicines Executive Agency, Sofia 1303, 8 Damyan Gruev Street, phone: +35928903555; fax: +35928903434; e-mail: bda@bda.bg . By reporting side effects, you can contribute to getting more information about the safety of this medicine.

5. How to store Flexid

Store in a place out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiration date corresponds to the last day of the specified month.

This medicinal product does not require special storage conditions.

Do not dispose of any medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Flexid contains

• The active substance is levofloxacin. Each tablet contains 500 mg of levofloxacin (in the form of hemihydrate).

• The other ingredients are:

Tablet core :

lactose monohydrate

povidone K30

sodium starch glycolate (type A)

talc

silica, colloidal, anhydrous

croscarmellose sodium

glycerol dibehenate

Tablet coating :

hypromellose

hydroxypropyl cellulose

macrogol 6000

titanium dioxide (E 171)

yellow iron oxide (E 172)

red iron oxide (E 172)

talc

What Flexid looks like and contents of the pack

Film-coated tablets are pale orange-pink, octagonal, biconvex, scored on one side.

The film-coated tablets are packed in aluminum/PVC/TE/PVDC blisters and placed in a cardboard box.

Blisters: 1, 3, 4, 5, 7, 8, 10, 14, 20, 28, 30, 50, 60, 90, 100, 200 and 500 film-coated tablets.

Not all types of packaging can be put on sale.

License holder

Sandoz dd

Verovskova 57, 1000 Ljubljana, Slovenia

Manufacturers

Lek Pharmaceuticals dd

Verovškova 57, 1526 Ljubljana, Slovenia

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

This medicinal product is authorized for use in the EEC member countries under the following names :

Austria: Levofloxacin Sandoz 500 mg - Filmtabletten

Belgium: Levofloxacine Sandoz 500 mg – filmomhulde tabletten

Bulgaria: Flexid 500 mg film-coated tablets

Finland: Levofloxacin Sandoz 500 mg tabletti, kalvovärvementinen

France: Levofloxacine Sandoz 500 mg, comprimé pelliculé sécable

Germany: Levofloxacin Sandoz 500 mg Filmtabletten

Hungary: Levofloxacin Sandoz 500 mg filmtabletta

Italy: Levofloacina Sandoz 500 mg compresse rivestite con film

Malta: Levofloxacin 500 mg Film-coated Tablets

The Netherlands: Levofloxacine Sandoz 500 mg - filmomhulde tabletten

Portugal: Levofloxacina Sandoz

Slovakia: Levofloxacin Sandoz 500 mg filmom obalené tablety

Slovenia: Levofloxacin Lek 500 mg filmsko obložene tablete

Spain: Levofloxacino Sandoz 500 mg comprimidos recubiertos con pelicula EFG

United Kingdom: Levofloxacin 500 mg Film-coated Tablets

Date of last revision of leaflet

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