400 mg film-coated tablets. For use by adults. 
moxifloxacin

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Avelox is and what it is used for 
2. What you need to know before you use Avelox 
3. How to take Avelox 
4. Possible side effects 
5. How to store Avelox 
6. Contents of the packaging and other information 

1. What Avelox is and what it is used for

Avelox contains the active substance moxifloxacin, which belongs to a group of antibiotics called fluoroquinolones. Avelox works by killing bacteria that cause infection.

Avelox is used in patients aged 18 years and older to treat the following bacterial infections caused by bacteria that moxifloxacin is effective against. Avelox should only be used to treat these infections when standard antibiotics cannot be used or have not worked:

Sinus infection, sudden worsening of long-term inflammation of the airways ( chronic bronchitis ), or pneumonia ( pneumonia ) that has been received outside of the hospital (does not apply to serious cases).

Mild to moderate infection in the upper parts of the woman’s abdomen ( inflammation of the small pelvis), including infection in the fallopian tubes and infection in the lining of the uterus. It is not enough to treat these types of infections with Avelox tablets alone, but your doctor will prescribe an additional antibiotic in addition to Avelox tablets to treat infections in the upper parts of the woman’s genitals (see section 2: What you need to know before you are taking Avelox, Warnings, and Precautions, Talk to your doctor before taking Avelox).

If the following bacterial infection you have improved in initial treatment with Avelox solution for infusion solution can Avelox tablets prescribed by your doctor to complete the treatment: pneumonia ( pneumonia ) acquired outside the hospital, skin and soft tissue infections. Avelox tablets should not be used for the initial treatment of any type of skin or soft tissue infection or pneumonia.

2. What you need to know before you use Avelox

Contact your doctor if you are not sure if you belong to any of the patient groups described below.

Do not take Avelox

  • If you are allergic to the active substance moxifloxacin, any other quinolone antibiotic,s or any of the other ingredients of this medicine (listed in section 6).
  • If you are pregnant or breastfeeding.
  • If you are younger than 18 years.
  • If you have a history of tendon disease or disorder that was related to treatment with quinolone antibiotics (see sections warnings and precautions, and Possible side effect s ).
  • If you were born with or have ever experienced abnormal heart rhythms (visible on ECG, heart examination using electrodes), have an imbalance in the blood salts (especially low levels of potassium or magnesium in the blood), have a very slow heart rhythm (called bradycardia ), have a weak heart ( heart failure ), have previously had an abnormal heart rhythm or if you are being treated with other medicines that may cause abnormal ECG changes (see section Other medicines and Avelox ). 
    This is because Avelox can cause ECG changes that are an extension of the QT interval and e.g. delayed transmission of electrical signals.
  • If you have severe liver disease (elevated liver enzymes ( transaminases ) higher than 5 times the upper limit of normal).

Warnings and cautions

Before taking this medicine

You should not take antibacterial fluoroquinolone/quinolone medicines, including Avelox if you have previously had any serious side effects from taking any quinolone or fluoroquinolone medicines. If this is the case, contact your doctor as soon as possible.

Talk to your doctor before taking Avelox

  • Avelox can change your ECG, especially if you are a woman or if you are older. If you are currently taking any medicine that lowers the levels of potassium in your blood, consult your doctor before taking Avelox (see also Do not take Avelox and Other medicines and Avelox ).
  • If you have ever developed a severe rash or scaly skin, blisters, and/or sores in your mouth after taking moxifloxacin.
  • If you have epilepsy or any other condition that can cause seizures, talk to your doctor before taking Avelox.
  • If you have or have had problems with your mental health, talk to your doctor before taking Avelox.
  • If you have myasthenia gravis, Avelox may make your symptoms worse. Contact a doctor immediately if you think this applies to you.
  • If you have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or peripheral aneurysm in a large blood vessel).
  • If you have had an aortic dissection (a rupture in the aortic wall).
  • If someone in your family has or has had an aortic aneurysm or aortic dissection or has other risk factors or conditions that increase the risk of this (eg connective tissue diseases such as Marfan’s syndrome, or vascular Ehlers-Danlos syndrome , or vascular diseases such as Takayasu’s arteritis, giant cell arteritis, Behçet’s disease, high blood pressure, or known atherosclerosis).
  • If you are diabetic because there is a risk of you getting altered blood sugar levels of moxifloxacin.
  • If you or someone in your family has glucose -6-phosphate dehydrogenase deficiency (an uncommon inherited disease), tell your doctor, who will tell you if Avelox is suitable for you.
  • If you as a woman have a complicated infection in the abdomen (eg at the same time as varicose veins in the fallopian tubes and ovaries or in the pelvis), for which your doctor considers an intravenous treatment is necessary, treatment with Avelox tablets is not suitable.
  • For the treatment of mild to moderate infections in the woman’s abdomen, your doctor may also prescribe another antibiotic in addition to Avelox. If no improvement in symptoms is seen after 3 days of treatment, consult your doctor.

During treatment with Avelox

  • If you experience palpitations or irregular heartbeats during the treatment period, tell your doctor immediately. He/she may want to do an ECG to measure your heart rate.
  • The risk of heart problems may increase if the dose is increased. Therefore, the recommended dosing instructions must be followed.
  • There is a small risk that you may have a severe, sudden allergic reaction (an anaphylactic reaction/shock), already at the first dose one, with the following symptoms: pressure over the chest, that you feel dizzy, feel unwell, feel faint or dizzy when you get up. If this happens, stop taking Avelox and seek medical attention immediately.
  • Avelox may cause a rapid and severe inflammation of the liver which can lead to life-threatening liver failure (including fatal cases, see section 4. Possible side effects s ). Contact your doctor before continuing treatment if you develop signs such as sudden malaise and/or nausea in combination with yellowing of the whites of the eyes, dark urine, itchy skin, bleeding tendencies, or brain disease caused by the liver (symptoms of hepatic impairment or a sudden and severe inflammation of the liver ).
  • Severe skin reactionsSevere skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis (AGEP) have been reported with moxifloxacin.
    • Stevens-Johnson syndrome and toxic epidermal necrolysis may first appear as red, target-like spots or round spots, often with blisters in the center, on the torso. In addition, sores in the mouth, throat, nose, genitals, and eyes (red and swollen eyes) may occur. These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rash can develop into widespread peeling and complications that can be life-threatening or fatal.
    • Acute generalized exanthematous pustulosis (AGEP) occurs at the beginning of treatment as a red, widespread, and flaky rash with lumps under the skin and blisters along with fever. Most often located in skin folds, on the upper body, and on the arms. If you develop a severe skin rash or any of these other skin symptoms, stop taking moxifloxacin and consult a doctor or seek medical attention immediately.
  • Antibiotics of the quinolone type, including Avelox, may cause convulsions. If this happens, stop taking Avelox and contact your doctor immediately.
  • Long-term, debilitating, and potentially lasting serious side effects antibacterial fluoroquinolone/quinolone drugs, including Avelox have been linked to very rare but serious side effects. Some of these have been long-lasting (up to months or years), disabling, and possibly permanent. This includes pain in tendons, muscles, and joints in arms and legs, difficulty walking, abnormal sensations such as ant crawling, tingling, tingling, numbness or a burning sensation ( paresthesia ), sensory disturbances in the form of impaired vision, taste, smell, and hearing, depression, impaired memory, extreme fatigue, and severe sleep problems. If you get any of these side effects after taking Avelox, talk to a doctor immediately before continuing treatment. You and your doctor will decide if you should continue treatment or consider using another type of antibiotic.
  • In rare cases, you may experience symptoms of nerve damage ( neuropathy )such as pain, a burning sensation, tingling, numbness, and/or weakness, especially in the feet and legs or in the hands and arms. If this happens, stop taking Avelox and contact your doctor immediately to prevent the development of a possible permanent condition.
  • You may experience problems with your mental health when taking antibiotics for the quinolone type, including Avelox, for the first time. In very rare cases, depression and problems with mental health led to suicidal thoughts and self-injurious behavior such as suicide attempts (see section 4. Possible side effects s ). If you develop such reactions, stop taking Avelox and tell your doctor immediately.
  • You may experience diarrhea during or after taking antibiotics, including Avelox. If this becomes severe or long-lasting or if you notice that the stool contains blood or mucus, stop Avelox treatment immediately and contact your doctor. In this situation, do not take any medicine that stops or reduces bowel motility.
  • In rare cases, pain and swelling in the joints and inflammation, or rupture of tendons occur (see sections Do not take Avelox and 4. Possible side effects s ). The risk is greater if you are older (over 60 years), have undergone an organ transplant, have kidney problems, or if you are being treated with cortisone ( corticosteroids ). Inflammation and tendon rupture can occur within the first 48 hours after starting treatment but also up to several months after stopping treatment with Avelox. At the first sign of pain or inflammation in a tendon (eg in the ankle, wrist, elbow, shoulder, or knee), stop taking Avelox, consult a doctor, and rest the painful area. Avoid unnecessary effort as it may increase the risk of a tendon rupture.
  • If you feel a sudden, severe pain in your stomach, chest, or back, you should immediately go to an emergency room.
  • If you are older and have kidney problems, be sure to drink enough as dehydration can increase the risk of kidney failure.
  • If your vision is impaired or if your eyes are affected in other ways, contact an eye specialist immediately (see sections Driving and using machines and 4. Possible side effects s ).
  • Fluoroquinolone -type antibiotics may cause your blood sugar level to rise above normal (hyperglycemia) or decrease your blood sugar level below normal (hypoglycemia), which may lead to loss of consciousness (hypoglycaemic coma ) in severe cases (see section 4. Possible side effects ). If you have diabetes, your blood sugar should be monitored carefully.
  • Quinolone can make your skin more sensitive to sunlight or UV rays. You should avoid prolonged exposure to sunlight or strong sunlight and do not sunbathe in a solarium or use any other UV light lamp during Avelox treatment.
  • The effect of Avelox infusion has not been established in the treatment of serious burns, infection s deep in tissue one or foot infections with osteomyelitis ( infection s in the bone marrow a) in diabetics.

Children and young people

Do not give this medicine to children and adolescents under 18 years of age as efficacy and safety have not been established for this age group (see section Do not use Avelox ).

Other medicines and Avelox

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines other than Avelox.

For Avelox, you should know the following:

  • If you are taking Avelox and other medicines that may affect your heart, there is an increased risk of heart rhythm changes. Therefore, do not take Avelox with the following medicines: 
    Medicines belonging to the antiarrhythmic group (eg quinidine, hydroquinone, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), antipsychotics (eg phenothiazines, pimozide, sertindole, haloperidol, sultoprid), tricyclic antidepressants, certain antimicrobials (eg saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, especially halofantrine), certain antihistamines(eg terfenadine, astemizole, mizolastine) and other medicines (eg cisapride, intravenous vincamine, bepridil, difemanil).
  • You must tell your doctor if you are taking other medicines that may lower your blood potassium levels (eg certain diuretics, certain laxatives and enemas (in high doses ) or corticosteroids (anti-inflammatory drugs), amphotericin B) or cause slower heartbeats as this may increase the risk of severe heart rhythm disturbances while you are taking Avelox.
  • Drug-containing magnesium or aluminum such as antacids for indigestion, or any other medicine containing iron or zinc, a medicine containing didanosine, or medicine containing sucralfate for the treatment of gastrointestinal problems may reduce the effect of Avelox. Therefore, take Avelox 6 hours before or after taking these other medicines.
  • Taking medical carbon orally at the same time as Avelox reduces the effect of Avelox. Therefore, it is recommended that these medications not be taken at the same time.
  • If you are being treated with oral anticoagulants (eg warfarin ) at the same time, your doctor may need to check your coagulation time.

Avelox with food and drink

The effect of Avelox is not affected by food or dairy products.

Pregnancy, breastfeeding, and fertility

Do not take Avelox if you are pregnant or breast-feeding. 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Animal studies do not suggest that your fertility will be impaired when using this medicine.

Driving and using machines

Avelox may make you feel dizzy and faint, you may experience a sudden transient loss of vision or you may faint for a short time. If you feel this, do not drive or operate machinery. 
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Avelox contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Avelox.

This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘sodium-free’.

3. How to take Avelox

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose for adults is one 400 mg tablet once a day.

Avelox tablets should be taken orally. Swallow the tablet whole (so as not to feel the bitter taste) and together with plenty of liquid. You can take Avelox with or without food. It is recommended to take the tablet at about the same time each day.

There is no need to change the dose to elderly patients, patients with low body weight, or patients with kidney problems.

The duration of treatment with Avelox film-coated tablets depends on the type of infection. Unless your doctor prescribes otherwise, the following treatment times are recommended:

– Sudden exacerbation of chronic bronchitis ( acuteexacerbation of chronic obstructive pulmonary diseaseincluding bronchitis ) 5-10 days
– Pneumonia ( pneumonia ) that has been received outside of a hospital, does not apply to serious cases Ten days
– Acute sinus infection ( acute bacterial sinusitis ) 7 days
Mild to moderate infection in the upper parts of the woman’s abdomen ( inflammation of the small pelvis), including infection in the fallopian tubes and infection in the lining of the uterus). 14 days

When Avelox film-coated tablets are used to terminate a treatment started with Avelox solution for infusion, the recommended treatment time is:

– Pneumonia ( pneumonia ) that has been received outside of hospital most patients with pneumonia switched to oral treatment with Avelox film-coated tablets within 4 days. 7-14 days
– Infection in the skin and soft tissuesMost patients with infection you in the skin and soft tissue switched to oral treatment with Avelox film-coated tablets within 6 days. 7-21 days

It is important that you complete the entire course, even if you feel better after a few days. If you stop taking this medicine too soon, the infection may not be adequately treated, the infection may return or your general condition may worsen and you may even develop bacterial resistance to antibiotics.

The recommended dose and duration of treatment should not be exceeded (see 2. What you need to know before taking Avelox, Warnings, and Precautions ).

If you take more Avelox than you should

If you take more than one prescribed dose (1 tablet per day), seek medical advice immediately and, if possible, take any remaining tablet or package or this leaflet and show your doctor or pharmacist which medicine you have taken.

If you forget to take Avelox

If you forget to take your tablet, take it as soon as you remember on the same day. If you do not take a tablet for one day, take your normal dose (one tablet) the next day. Do not take a double dose to make up for a forgotten dose.

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

If you stop taking Avelox

If you stop taking this medicine too soon, your infection may not be adequately treated. Contact your doctor if you wish to stop taking your tablets before the end of the treatment period.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most serious adverse reactions were observed in connection with Aveloxbehandling are listed below.

If you experience:

  • an abnormally fast heartbeat (rare side effect)
  • if you suddenly start to feel unwell or discover yellowing whites of the eyes, dark urine, itching of the skin, bleeding tendencies or thought disorders, and altered alertness (these may be signs or symptoms of a sudden inflammation of the liver which can lead to life-threatening liver failure (very rare side effect, death has been observed ))
  • severe skin rash including Steven-Johnson syndrome and toxic epidermal necrolysis. These rashes can appear as red, target-like spots or round spots, often with blisters in the middle, trunk, skin rash, sores in the mouth, throat, nose, genitals, and eyes and may be preceded by fever and flu-like symptoms (very rare side effects, maybe life-threatening).
  • a red, widespread, flaky rash with bumps under the skin and blisters together with fever at the beginning of treatment ( acute generalized exanthematous pustulosis) (the frequency of this side effect is “unknown”)
  • syndrome associated with decreased water excretion and low sodium levels (SIADH) (very rare side effect )
  • loss of consciousness due to severe hypoglycemia (hypoglycaemic coma ) (very rare side effect )
  • inflammation of blood vessels (signs may be red marks on the skin, usually on the shins, or symptoms such as joint pain) (very rare side effect)
  • severe, sudden generalized allergic reaction incl. very rarely life-threatening shock (eg difficulty breathing, drop in blood pressure and fast pulse ) (rare side effect)
  • swelling (rare side effect, including potentially life-threatening airway swelling)
  • seizures (rare side effect)
  • disorders related to the nervous system such as pain, burning sensation, tingling, numbness, and/or weakness in the arms and legs (rare side effect)
  • depression (can in very rare cases lead to self-harming behavior, such as suicidal ideation / thoughts or suicide attempts) (rare side effect)
  • mental illness (may lead to self-harming behavior, such as suicidal ideation/thoughts or suicide attempts) (very rare side effect)
  • severe diarrhea containing blood and / or mucus ( colitis caused by antibiotics, including pseudomembranous colitis ), which in some very rare cases can lead to life-threatening complications (rare side effect)
  • tendon pain and swelling (tendinitis) (rare side effect), muscle cramps, muscle twitching, muscle weakness (very rare side effect)
  • muscle weakness, tenderness, or pain, and especially if you also feel sick, have a high body temperature or have dark urine. This can be caused by abnormal muscle breakdown which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis ) (the frequency of this side effect is “unknown”)

stop taking Avelox and contact a doctor immediately as you may need urgent medical attention.

In addition, if you experience:

  • transient vision loss (very rare side effect)
  • discomfort or pain in the eyes, especially when exposed to light (very rare to rare side effect)

contact an ophthalmologist immediately.

If you have experienced life-threatening, irregular heartbeats ( torsade de pointes ) or your heart has stopped beating during treatment with Avelox (a very rare side effect), tell your treating doctor immediately that you have taken Avelox and do not resume treatment.

Deterioration of myasthenia gravis symptoms has been observed in very rare cases. If this happens, consult a doctor immediately.

If you have diabetes and notice that your blood sugar level increases or decreases (rare or very rare side effect), tell your doctor immediately.

If you are elderly, have kidney problems and notice a decrease in urine levels, swelling in the legs, ankles, fatigue, nausea, drowsiness, difficulty breathing, or confusion (these may be signs and symptoms of kidney failure, a rare side effect), contact your doctor immediately.

Other side effects are observed during treatment with Avelox are listed below according to how common they are:

Common  (may affect up to 1 in 10 users)

  • nausea
  • diarrhea
  • dizziness
  • abdominal and abdominal pain
  • vomiting
  • headache
  • increase in special liver enzymes ( transaminases ) in the blood
  • infection is caused by resistant bacteria or fungi e.g. Oral or vaginal infection is caused by Candida
  • change in heart rate ( ECG ) in patients with low potassium levels in the blood

Uncommon  (may affect up to 1 in 100 people)

  • rash
  • upset stomach (indigestion / heartburn)
  • sleep disorders (mainly insomnia)
  • increase in specific liver enzymes (gamma-glutamyltransferase and/or alkaline phosphatase) in the blood
  • the low number of special white blood cells ( leukocytes, neutrophils )
  • constipation
  • itching
  • a feeling of dizziness (instability or risk of falling)
  • somnolence
  • gas in the stomach
  • change in heart rate ( ECG )
  • Impaired liver function (including an increase in specific liver enzymes (LDH) in the blood)
  • decreased appetite and decreased food intake
  • low white blood cell count
  • aches and pains in e.g. back, chest, pelvic and extremity are
  • increase of special blood cell is necessary for coagulation one
  • sweating
  • increased number of special white blood cells ( eosinophils )
  • anxiety
  • feeling sick (mainly feeling weak or tired)
  • shaking
  • joint pain
  • palpitation
  • irregular and rapid heartbeat
  • difficulty breathing including asthmatic conditions
  • increase in special digestive enzymes (amylase) in the blood  
  • restlessness / agitation
  • creeping sensation (tingling) and/or numbness
  • hives
  • dilation of blood vessels
  • confusion and disorientation
  • reduction of special blood cells are necessary for coagulation one
  • visual disturbances including double vision and blurred vision
  • decreased blood coagulation
  • the increased amount of lipids (fats) in the blood
  • low red blood cell count
  • muscle pain
  • allergic reaction
  • increase in bilirubin in the blood
  • inflammation of the stomach
  • dehydration
  • severe abnormal heart rhythm
  • dry skin
  • angina

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

  • muscle twitching
  • muscle cramps
  • hallucination
  • high blood pressure
  • swelling (hands, feet, ankles, lips, mouth, throat)
  • low blood pressure
  • renal impairment (including elevated laboratory values ​​with respect to the kidneys, such as urea and creatinine )
  • inflammation of the liver
  • inflammation of the oral mucosa
  • ringing/noise in the ears
  • jaundice (whites of the eyes or skin yellowing)
  • decreased sensitivity of the skin
  • abnormal dreams
  • impaired concentration
  • difficulty swallowing
  • changes in the sense of smell (including the lost sense of smell)
  • imbalance and poor coordination (due to fraud)
  • partially or completely lost memory
  • hearing loss incl. deafness (usually transient)
  • elevated uric acid levels in the blood
  • emotional instability
  • impaired speech
  • fainting
  • muscle weakness

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

  • decreased number of red and white blood cells and platelets (pancytopenia)
  • inflammation in the joints
  • abnormal heart rhythm
  • increased sensitivity of the skin
  • the feeling of seclusion (not being yourself)
  • increased blood coagulation
  • muscle stiffness
  • clear reduction in the number of special white blood cells ( agranulocytosis )

In very rare cases, long-term (up to several months or years) or lasting side effects, such as tendinitis, tendonitis, joint pain, pain in arms and legs, difficulty walking, abnormal sensations such as ant crawling, tingling, tingling, a burning sensation, numbness or pain ( neuropathy ), depression, fatigue, sleep disturbances, impaired memory and impaired hearing, vision and taste and odor associated with treatment with quinolone and fluoroquinolone antibiotics, in some cases regardless of existing risk factors.

Furthermore, in very rare cases, the following side effects have been reported during treatment with other quinolones, which may also occur during treatment with Avelox: increased pressure in the skull (symptoms include headache, vision problems including blurred vision, blind spots, double vision, loss of vision), increased sodium levels in the blood, increased calcium levels in the blood, decreased level of a special type of red blood cells ( hemolytic anemia ), the skin becomes more sensitive to sunlight or UV light.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Avelox

Keep this medicine 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 and EXP respectively. date. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Store in the original package. Moisture sensitive.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is moxifloxacin. Each film-coated tablet contains 400 milligrams of moxifloxacin as moxifloxacin hydrochloride.
  • The other ingredients are: The 
    core: Microcrystalline cellulose, croscarmellose sodium, lactose monohydrate (see section 2: Avelox contains lactose ), magnesium stearate. 
    Coating: Hypromellose, Macrogol 4000, iron oxide (E 172), and titanium dioxide (E 171).

What the medicine looks like and the contents of the pack

Each film-coated, pale red, oblong, slightly rounded tablet, measuring 17 x 7 mm, is marked “M400” on one side and “BAYER” on the other side.

Avelox is packaged in cartons containing colorless, transparent, or white opaque polypropylene/aluminum blisters or colorless transparent polyvinyl chloride/polyvinylidene chloride/aluminum blisters.

Avelox is available in packs containing 5, 7, and 10 film-coated tablets, in

hospital packs containing 25, 50, or 70 film-coated tablets and in multipacks for hospitals consisting of 5 cartons, each carton containing 16 film-coated tablets, or 10 cartons, each carton containing 10 film-coated tablets.

Avelox is also available in drug test packs of 1 film-coated tablet in a carton containing aluminum/aluminum blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bayer AB 
Box 606

SE-169 26 Solna

Manufacturer

The manufacturer can be identified by the batch number printed on the side flap of the carton and on each blister:

  • If the first and second characters are BX, the manufacturer

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

  • If the first and second signs are IT, it is the manufacturer

Bayer HealthCare Manufacturing Srl 
Via Delle Groaned, 126 
20024 Garbagnate Milanese 
Italien

This medicinal product is authorized under the European Economic Area under the names:

Belgium, Cyprus, Denmark, Estonia, Finland, Greece, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Czech Republic, Portugal, Slovenia, United Kingdom, , Hungary, Austria: Avelox
France: Izilox
Italy, Germany: Avalox

Muhammad Nadeem

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