400 mg film-coated tablets
moxifloxacin
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What Moxifloxacin Orion is and what it is used for
Moxifloxacin Orion contains the active substance moxifloxacin, which belongs to a group of antibiotics called fluoroquinolones. Moxifloxacin Orion works by killing bacteria that cause you infections.
Moxifloxacin Orion is used in patients aged 18 years and older to treat the following bacterial infections caused by bacteria that moxifloxacin is effective against. Moxifloxacin Orion should only be used to treat these infections when standard antibiotics cannot be used or have not worked:
- infection of the sinuses
- sudden worsening of prolonged inflammation of the airways
- pneumonia contracted outside of 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 moxifloxacin alone, but your doctor will prescribe an additional antibiotic in addition to Moxifloxacin Orion to treat infections in the upper parts of the woman’s genitals (see section 2. What you need to know before you tar Moxifloxacin Orion).
If the following bacterial infection has improved during initial treatment with Moxifloxacin Orion solution for infusion, Moxifloxacin Orion tablets may be prescribed by your doctor to complete the treatment:
- pneumonia contracted outside of hospital
- skin and soft tissue infections.
Moxifloxacin Orion tablets should not be used for the initial treatment of any type of skin or soft tissue infection or pneumonia.
Moxifloxacin contained in Moxifloxacin Orion may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Moxifloxacin Orion
Do not take Moxifloxacin Orion
- if you are allergic to moxifloxacin, any other quinolone antibiotic 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 tinnitus or tendon problems related to quinolone antibiotics (see sections Warnings and precautions and 4. Possible side effects ).
- if you have severe liver disease or elevated liver enzymes ( transaminases ) higher than 5 times the upper limit of normal
- if you were born with or have ever experienced an abnormal heart rhythm (visible on ECG , heart examination using electrodes)
- if you have an imbalance in your blood salts (especially low levels of potassium or magnesium in your blood)
- if you have a very slow heartbeat (called bradycardia )
- if you have a weak heart ( heart failure )
- if you have previously had an abnormal heart rhythm
- if you are being treated with other medicines that may cause abnormal ECG changes (see section Other medicines and Moxifloxacin Orion). This is because moxifloxacin can cause changes in the ECG which is an extension of the QT interval (the time between electrical impulses in the heart) e.g. delayed transmission of electrical signals.
Warnings and cautions
Talk to your doctor or pharmacist before taking Moxifloxacin Orion
- You should not take antibacterial fluoroquinolone / quinolone medicines, including Moxifloxacin Orion, 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.
- if you are diabetic because there is a risk of you getting altered blood sugar levels of moxifloxacin
- if you have ever developed severe rash or scaly skin, blisters and / or sores in your mouth after taking moxifloxacin
- moxifloxacin may alter your ECG , especially if you are a woman or older. If you are currently taking any medicine that lowers your blood potassium levels, talk to your doctor before taking Moxifloxacin Orion.
- if you have been diagnosed with an enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm in a large blood vessel), consult your doctor before taking Moxifloxacin Orion
- if you have had an aortic dissection (a rupture of the aortic wall), consult your doctor before taking Moxifloxacin Orion
- if you have been diagnosed with leaking heart valves (regurgitation of heart valves)
- if someone in your family has or has had an aortic aneurysm, aortic dissection or congenital heart valve disease, or has other risk factors or conditions that increase the risk of this (eg connective tissue diseases such as Marfan syndrome, Ehlers-Danlos syndrome , Turner syndrome , Sjögren’s syndrome [an inflammatory autoimmune disease] or vascular diseases such as Takayasus arteritis, giant cell arteritis, Behçet’s disease, high blood pressure , or known atherosclerosis, rheumatoid arthritis [a joint disease] or endocarditis [an infection of the heart]), consult your doctor before taking Moxifloxacin Orion
- if you suffer from epilepsy or any other condition that can cause seizures, consult your doctor before taking Moxifloxacin Orion
- if you have, or have had, problems with your mental health, talk to your doctor before taking Moxifloxacin Orion
- if you have myasthenia gravis (abnormal muscle fatigue leading to weakness and, in severe cases, paralysis), Moxifloxacin Orion may make your symptoms worse. Contact a doctor immediately if you think this applies to you.
- 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 Moxifloxacin Orion 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 Moxifloxacin Orion 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 Moxifloxacin Orion. If no improvement in symptoms is seen after 3 days of treatment, consult your doctor.
During treatment with Moxifloxacin Orion
Be aware of this important information while taking this medicine:
- if you feel a sudden, severe pain in the abdomen, chest or back, you should immediately go to an emergency room as this may be a symptom of aortic aneurysm and aortic dissection. The risk of developing this may be increased if you are being treated with systemic corticosteroids (“cortisone”).
- if you experience sudden shortness of breath, especially when lying down in bed, or notice swelling in the ankles, feet or abdomen, or have a new heartbeat (feeling of rapid or irregular heartbeat), contact a doctor immediately
- 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 Moxifloxacin Orion and seek medical attention immediately.
- moxifloxacin can cause sudden and severe inflammation of the liver which can lead to life-threatening liver failure (including fatal cases, see section 4. Possible side effects ). 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 reactions
Severe 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 skin peeling and complications that can be life-threatening or have a fatal outcome.
- Acute generalized exanthematous pustulosis (AGEP) occurs at the beginning of treatment as red, widespread and flaky rash with bumps 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 skin symptoms, stop taking moxifloxacin and consult a doctor or seek medical attention immediately.
- Quinolone – type antibiotics , including Moxifloxacin Orion, can cause seizures. If this happens, stop taking Moxifloxacin Orion and contact your doctor immediately.
- you may in rare cases 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 Moxifloxacin Orion and contact your doctor immediately to prevent the development of a possible permanent condition.
- You may experience mental health problems when taking quinolone- type antibiotics , including moxifloxacin, for the first time. In very rare cases, depression and mental health problems have led to suicidal thoughts and behaviors such as suicide attempts (see section 4. Possible side effects ). If you develop such reactions, stop taking Moxifloxacin Orion and tell your doctor immediately.
- you may experience diarrhea during or after taking antibiotics , including moxifloxacin. If this becomes severe or long-lasting or if you notice that the stool contains blood or mucus, stop taking Moxifloxacin Orion immediately and consult your doctor. In this situation, do not take any medicine that stops or reduces bowel movement.
- in rare cases, pain and swelling in the joints and inflammation or rupture of tendons may occur. 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 Moxifloxacin Orion. At the first sign of pain or inflammationin a tendon (eg in the ankle, wrist, elbow, shoulder or knee), stop taking Moxifloxacin Orion, consult a doctor and rest the painful area. Avoid unnecessary exertion as it may increase the risk of a tendon rupture (see sections Do not take Moxifloxacin Orion and 4. Possible side effects ).
- long-term, impaired and possibly lasting serious side effects: Antibacterial fluoroquinolone / quinolone medicines, including Moxifloxacin Orion 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 the tendons, muscles and joints of the arms and legs, difficulty walking, abnormal sensations such as ant crawling, tingling, tingling, numbness or a burning sensation ( paresthesia ), sensory disorders in the form of impaired vision, taste, smell and hearing, depression, memory loss, extreme fatigue and severe sleep disorders. If you suffer from any of these side effectsAfter taking Moxifloxacin Orion, you should contact your doctor immediately before continuing treatment. You and your doctor will decide if you should continue treatment or consider using another type of antibiotic .
- If you are older and have kidney problems then be sure to drink enough as dehydration can increase the risk of kidney failure .
- if you experience impaired vision or if you experience any other eye problems while taking Moxifloxacin Orion, contact an eye specialist immediately (see sections Driving and using machines and 4. Possible side effects ).
- Fluoroquinolone -type antibiotics can cause an increase in your blood sugar level above normal ( hyperglycaemia ), or decrease your blood sugar level below normal ( hypoglycaemia ), which can 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.
- quinolones 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 Moxifloxacin Orion treatment.
- The effect of moxifloxacin has not been established in the treatment of severe burns, deep tissue infections or osteomyelitis foot infections ( bone marrow infections) 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 Moxifloxacin Orion).
Other medicines and Moxifloxacin Orion
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
For Moxifloxacin Orion you should know the following:
- if you are taking Moxifloxacin Orion and other medicines that may affect your heart, there is an increased risk of changes in your heart rhythm. Therefore, do not take Moxifloxacin Orion with the following medicines:
medicines belonging to the group antiarrhythmics (medicines for arrhythmias) (eg quinidine , hydroquinidine, disopyramide , amiodarone , sotalol, dofetilide, ibutilide), antipsychotics (medicines for psychosis ) (eg phentiazines, pimozide, sertindole, haloperidol , sultopride), tricyclic antidepressants (medicines for depression), certain antimicrobials (medicines for bacteria, fungi, parasites or other micro-organisms(eg saquvinavir, sparfloxacin, intravenous erythromycin, pentamidine, anti- malarial agents, especially halofantrine), certain antihistamines (eg terfenadine, astemizole, mizolastine) and other medicines (eg cisapride, vincamine given as injection , bepridil and difemanil). - you need to tell your doctor if you are taking other medicines that can 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 serious heart rhythm disturbances while you are taking moxifloxacin.
- a medicine containing magnesium or aluminum (such as antacids for indigestion), iron, zinc or didanosine or medicines containing sucralfate (for the treatment of gastrointestinal disorders) may reduce the effect of Moxifloxacin Orion tablets. Therefore, take Moxifloxacin Orion 6 hours before or after taking these other medicines.
- if you take medical carbon orally at the same time as Moxifloxacin Orion, the effect of moxifloxacin is reduced. Therefore, it is recommended that these medications not be taken at the same time.
- If you are being treated with oral anticoagulants (medicines used to make your blood coagulate more slowly) (eg warfarin ) at the same time, your doctor may need to check your coagulation time.
Moxifloxacin Orion with food, drink and alcohol
Moxifloxacin Orion can be taken with or without food (dairy products included).
Pregnancy, breastfeeding and fertility
Do not take Moxifloxacin Orion if you are pregnant or breastfeeding. If you are pregnant or breastfeeding, 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
Moxifloxacin Orion may make you feel dizzy and faint, you may experience a sudden transient loss of vision or you may faint for a short while. 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 sharpened attention. 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.
Moxifloxacin Orion contains excipients
Excipients
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to take Moxifloxacin Orion
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose for adults is one 400 mg film-coated tablet once daily.
Moxifloxacin Orion tablets should be swallowed. Swallow the tablet whole (so as not to feel the bitter taste) and together with plenty of liquid. You can take Moxifloxacin Orion with or without food. Try to take the tablet at about the same time each day. Dose one does not need to be changed in elderly patients, in patients with low body weight, or in patients with kidney problems.
The duration of treatment with Moxifloxacin Orion depends on the type of infection. Unless your doctor prescribes otherwise, the following treatment times are recommended:
- sudden worsening of chronic obstructive pulmonary disease including bronchitis ( inflammation of the airways) ( acute exacerbation of chronic obstructive pulmonary disease including bronchitis ) 5-10 days
- pneumonia ( pneumonia ) that has been received outside of hospital, does not apply to serious cases, 10 days
- acute infection of the sinuses ( 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 Moxifloxacin Orion film-coated tablets are used to end a treatment started with Moxifloxacin Orion solution for infusion, the recommended treatment time is:
- Pneumonia ( pneumonia ) that has been received outside the hospital for 7-14 days
Most patients with pneumonia switch to oral treatment with Moxifloxacin Orion film-coated tablets within 4 days.
- Infection in the skin and soft tissues 7-21 days
Most patients with skin and soft tissue infections switch to oral treatment with Moxifloxacin Orion film-coated tablets within 6 days.
You must 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 and may come back or your general condition may worsen and you may also develop bacterial resistance (resistance) to moxifloxacin.
The recommended dose and duration of treatment should not be exceeded (see Warnings and Precautions).
If you take more Moxifloxacin Orion than you should
If you take more than the prescribed dose of 1 tablet a day, seek medical advice immediately and, if possible, take any remaining tablet or package or this leaflet with your doctor or pharmacist.
If you forget to take Moxifloxacin Orion
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 in 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 Moxifloxacin Orion
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.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The most serious adverse reactions observed during treatment with moxifloxacin are listed below.
If you experience:
- an abnormally fast heartbeat (rare side effect)
- that you suddenly start to feel unwell or discover yellowing whites of the eyes, dark urine, itchy skin, bleeding tendencies, thought disorders or altered alertness (this may be a sign or symptom of sudden inflammation in the liver which can lead to very 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 , may be life threatening)
- a red, widespread, flaky rash with lumps 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 hypoglycaemia (hypoglycaemic coma ) (very rare side effect )
- inflammation of blood vessels (signs may be red marks on the skin, usually on the narrow legs or symptoms such as joint pain) (very rare side effect)
- severe, sudden generalized allergic reaction incl. very rare life-threatening shock (eg difficulty breathing, drop in blood pressure and rapid pulse ) (rare side effect)
- swelling incl. airway swelling (rare side effect, possibly life-threatening)
- 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) or tendon rupture (muscle strain) (very rare side effect)
- muscle weakness, soreness 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 Moxifloxacin Orion and contact a doctor immediately as you may need urgent medical attention.
Cases of enlargement and weakening of an aortic wall or rupture of an aortic wall ( aneurysms and dissections), which can rupture and be life-threatening, as well as cases of leaking heart valves, have been reported in patients receiving fluoroquinolones. See also section 2.
Also if you experience
- transient vision loss (very rare side effect)
- discomfort or pain in the eyes, especially due to light exposure (very rare or rare side effect )
contact an eye specialist immediately.
If you have experienced life-threatening, irregular heartbeats ( torsade de pointes ) or your heart has stopped beating during treatment with Moxifloxacin Orion (a very rare side effect), tell your treating doctor immediately that you have taken Moxifloxacin Orion 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, or feet, fatigue, nausea, drowsiness, difficulty breathing, or confusion (there may be signs and symptoms of kidney failure, a rare side effect), contact immediately your doctor.
Other side effects that have been observed during treatment with moxifloxacin are listed below according to how common they are:
Common (may affect up to 1 in 10 people):
- nausea
- diarrhea
- dizziness
- abdominal and abdominal pain
- vomiting
- headache
- increase in special liver enzymes ( transaminases ) in the blood
- infection is caused by resistant (resistant) bacteria or fungi e.g. oral or vaginal infection er caused by Candida (cod)
- 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)
- taste changes (in very rare cases lost sense of taste)
- sleep disorders (mainly insomnia)
- increases in specific liver enzymes (gamma-glutamyltransferase and / or alkaline phosphatase) in the blood
- low number of special white blood cells ( leukocytes , neutrophils )
- constipation
- itching
- feeling of dizziness (instability or risk of falling)
- somnolence
- gas in the stomach
- change in heart rate ( ECG )
- impaired liver function (incl. increase in special 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, pain in the pelvis and in the extremities
- increase in special blood cells necessary for coagulation
- 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 incl. asthmatic conditions
- increase of special digestive enzymes (amylase) in the blood
- restlessness / agitation
- creeping sensation (tingling) and / or numbness
- hives
- dilation of blood vessels
- confusion or disorientation
- reduction of special blood cells that are necessary for coagulation
- visual disturbances incl. double vision and blurred vision
- decreased blood coagulation
- increased amount of lipids (fats) in the blood
- low number of red blood cells
- 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 people):
- 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 mouth
- 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 (incl. 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 people):
- inflammation in the joints
- abnormal heart rhythm
- increased sensitivity of the skin
- sense of unreality of oneself or the environment
- increased blood coagulation
- muscle stiffness
- clear decrease in the number of special white blood cells ( agranulocytosis )
- decreased number of red and white blood cells and platelets (pancytopenia).
Furthermore, in very rare cases, the following side effects have been reported during treatment with other quinolones, which may also occur during treatment with moxifloxacin:
- increased pressure in the skull (symptoms are headache, visual disturbances such as blurred vision, “blind” spots, double vision, loss of vision)
- increased sodium levels in the blood
- increased calcium levels in the blood
- decreased level of special type of red blood cells ( hemolytic anemia )
- the skin becomes more sensitive to sunlight or UV light.Reporting of side effects ar
In very rare cases, long-term (up to several months or years) or permanent 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 hearing loss, vision and taste and odor associated with treatment with quinolone and fluoroquinolone antibiotics, in some cases regardless of existing risk factors.
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase the safety of your medicine.
How to store Moxifloxacin Orion
Keep this medicine out of the sight and reach of children.
Store in the original package. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the blister and carton. The expiration date is the last day of the specified month.
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.
Contents of the pack and other information
Content declaration
- The active substance is moxifloxacin. Each film-coated tablet contains 400 mg moxifloxacin equivalent to 436.37 mg moxifloxacin hydrochloride.
- Other ingredients are:Tablet core: Microcrystalline cellulose, mannitol (E421), colloidal anhydrous silica, sodium starch glycolate (type A), hydroxypropylcellulose, talc and magnesium stearate.Coating: Partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E 171), macrogol 3350 / PEG (E1521), talc (E553b), yellow iron oxide (E 172), red iron oxide (E 172).
What the medicine looks like and contents of the pack
Each tablet is a pink, oblong, biconvex film-coated tablet with a diameter of 19.4 x 7.8 mm and a thickness of 5.8 mm.
Moxifloxacin Orion tablets are packaged in cartons containing aluminum/aluminum blisters.
Moxifloxacin Orion is available in packs containing 5, 7, and 10 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
Pharmathen SA
Dervenakion 6
Pallini 15351, Attikis
Greece
Pharmathen International SA
Industrial Park Sapes, Rodopi Prefecture
Block No 5
69300 Ellas
Greece
For further information on this medicine, please contact your local representative:
Orion Pharma AB, Danderyd
medinfo@orionpharma.com