400 mg film-coated tablets
moxifloxacin
What Moxifloxacin Krka is and what it is used for
Moxifloxacin Krka contains the active substance moxifloxacin, which belongs to a group of antibiotics called fluoroquinolones. Moxifloxacin Krka works by killing bacteria that cause you infections.
Moxifloxacin Krka is used in patients aged 18 years and older to treat the following bacterial infections caused by bacteria that moxifloxacin is effective against. Moxifloxacin Krka 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 long-term inflammation of the airways, 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 only Moxifloxacin Krka tablets, but your doctor will prescribe an additional antibiotic in addition to Moxifloxacin Krka tablets to treat infections in the upper parts of the woman’s genitals (see section 2. What you need know before using Moxifloxacin Krka, Warnings and Precautions, Talk to your doctor before using Moxifloxacin Krka ).
If the following bacterial infection has improved during initial treatment with infusion of moxifloxacin, Moxifloxacin Krka tablets may be prescribed by your doctor to complete the treatment: pneumonia ( out-of-hospital pneumonia ), skin and soft tissue infections. Moxifloxacin Krka tablets should not be used for the initial treatment of any type of skin or soft tissue infection or pneumonia.
Moxifloxacin contained in Moxifloxacin Krka may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Moxifloxacin Krka
Do not use Moxifloxacin Krka
Contact your doctor if you are not sure if you belong to any of the patient groups described below.
Do not use Moxifloxacin Krka
- if you are allergic to moxifloxacin 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 tendon problems related to quinolone antibiotics (see section 2. What you need to know before using Moxifloxacin Krka, Warnings and precautions and section 4. Possible side effects ) .
- if you were born with or have:
- normal heart rhythm (visible on ECG , heart examination using electrodes)
- imbalance in blood salts (especially low levels of potassium or magnesium in the blood)
- a very slow heart rhythm (called bradycardia )
- a weak heart ( heart failure )
- previously had an abnormal heart rhythm or if you are being treated with other medicines that may cause abnormal ECG changes (see section 2. What you need to know before you use Moxifloxacin Krka, Other medicines and Moxifloxacin Krka). This is because Moxifloxacin Krka can cause changes in the ECG which is an extension of the QT interval et 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 Moxifloxacin Krka 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 or pharmacist before using Moxifloxacin Krka.
- Moxifloxacin Krka can alter your ECG , especially if you are a woman or older. If you are currently taking any medicine that lowers potassium levels in your blood, consult your doctor before taking Moxifloxacin Krka (see also section 2. What you need to know before using Moxifloxacin Krka, Do not use Moxifloxacin Krka and Other medicines and Moxifloxacin Krka ).
- 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 you have been diagnosed with leaky heart valves.
- If anyone in your family has or has had an aortic aneurysm or aortic dissectionor congenital heart valve disease, or have other risk factors or conditions that increase the risk of it (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, Behçets disease, high blood pressure , or known atherosclerosis, rheumatoid arthritis (a joint disease) or endocarditis (an infection of the heart)).
- If you suffer from epilepsy or any other condition that can cause seizures, consult your doctor before taking Moxifloxacin Krka ..
- If you have, or have had, problems with your mental health , talk to your doctor before taking Moxifloxacin Krka.
- If you have myasthenia gravis (abnormal muscle fatigue leading to weakness and, in the worst case, paralysis), Moxifloxacin Krka may worsen your symptoms. 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 Krka 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 that intravenous treatment is necessary, treatment with Moxifloxacin Krka tablets is not suitable.
- For the treatment of mild to moderate infection in the woman’s abdomen, your doctor may also prescribe another antibiotic in addition to Moxifloxacin Krka. If no improvement in symptoms is seen after 3 days of treatment, consult your doctor.
- 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.
During treatment with Moxifloxacin Krka
- 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 Moxifloxacin Krka and seek medical attention immediately.
- Moxifloxacin Krka can cause sudden and severe inflammation in 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 ).
- Quinolone – type antibiotics , including Moxifloxacin Krka, may cause seizures . If this happens, stop taking Moxifloxacin Krka and contact your doctor immediately.
- Long-term, disabling and possibly lasting serious side effectsAntibacterial fluoroquinolone / quinolone drugs, including Moxifloxacin Krka 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 get any of these side effects after taking Moxifloxacin Krka, 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, 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 Krka and contact your doctor immediately to prevent the development of a possible permanent condition.
- You may experience problems with your mental health when taking quinolone- type antibiotics , including Moxifloxacin Krka, 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 Krka and tell your doctor immediately.
- You may experience diarrhea during or after taking antibiotics , including Moxifloxacin Krka. If this becomes severe or long-lasting or if you notice that the stool contains blood or mucus, stop taking Moxifloxacin Krka immediately and contact your doctor . In this situation, do not take any medicine that stops or reduces bowel movement.
- In rare cases, joint pain and swelling and inflammation or tendon rupture 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 rupture of tendons can occur within the first 48 hours after starting treatment but also up to several months after treatment with Moxifloxacin Krka has ended. At the first sign of pain or inflammationin a tendon (eg in the ankle, wrist, elbow, shoulder or knee), stop taking Moxifloxacin Krka, consult a doctor and rest the painful area. Avoid unnecessary exertion as it may increase the risk of tendon rupture (see section 2. What you need to know before using Moxifloxacin Krka , Do not use Moxifloxacin Krka and section 4. Possible side effects ) .
- If you experience a sudden, severe pain in the abdomen, chest or back, visit an emergency room immediately 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 you lie down in bed, or notice swelling in your ankles, feet or stomach, or have a new heartbeat (feeling of rapid or irregular heartbeat), contact a doctor immediately.
- Fluoroquinolone -type antibiotics can cause an increase above your normal blood sugar level ( hyperglycaemia ) or a decrease below your normal blood sugar level ( hypoglycaemia ) which in severe cases can lead to loss of consciousness (hypoglycaemic coma ) (see section 4. Possible side effects ) . If you have diabetes , your blood sugar should be monitored carefully.
- If you are older and have kidney problems , be sure to drink enough as dehydration can increase the risk of kidney failure .
- If you experience impaired vision or any other eye problems while taking Moxifloxacin Krka, contact an ophthalmologist immediately (see section 3. How to use Moxifloxacin Krka, Driving and using machines and section 4. Possible side effects ) .
- 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 treatment with Moxifloxacin Krka.
- The efficacy of moxifloxacin infusion fluid has not been established in the treatment of severe burns, deep tissue infections or osteomyelitis foot infections ( bone marrow infections) in diabetics.
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.
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 2. What you need to know before using Moxifloxacin Krka, Do not use Moxifloxacin Krka ).
Other medicines and Moxifloxacin Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines other than Moxifloxacin Krka.
For Moxifloxacin Krka you should know the following:
- If you are taking Moxifloxacin Krka and other medicines that may affect your heart , there is an increased risk of heart rhythm changes. Therefore, do not take Moxifloxacin Krka with the following medicines:
- medicines belonging to the antiarrhythmic group (eg quinidine , hydroquinidine, disopyramide , amiodarone , sotalol, dofetilide, ibutilide)
- antipsychotics (eg phentiazines, pimozide, sertindole, haloperidol , sultopride)
- tricyclic antidepressants
- certain antimicrobials (eg saquvinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, especially halofantrine)
- some antihistamines (eg terfenadine, astemizole, mizolastine)
- certain other medicines (eg cisapride, intravenous vincamine, bepridil, difemanil)
- you need to 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 heartbeat as this may increase the risk of severe heart rhythm disturbances while you are taking Moxifloxacin Krka.
- A medicine containing magnesium or aluminum (such as antacids for indigestion) or any other medicine containing iron or zinc, medicine containing didanosine or medicine containing sucralfate for the treatment of gastrointestinal problems may reduce the effect of Moxifloxacin Krka. Therefore, take Moxifloxacin Krka 6 hours before or after taking these other medicines.
- if you take medical carbon orally at the same time as Moxifloxacin Krka, the effect of Moxifloxacin Krka is reduced. 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, it may be necessary for your doctor to check your coagulation time.
Moxifloxacin Krka with food, drink and alcohol
The effect of Moxifloxacin Krka is not affected by food or dairy products.
Pregnancy, breastfeeding and fertility
Do not take Moxifloxacin Krka 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 Krka 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 sharpened 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.
Moxifloxacin Krka contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Moxifloxacin Krka
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.
Moxifloxacin Krka 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 Moxifloxacin Krka 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 Moxifloxacin Krka depends on the type of infection. Unless your doctor prescribes otherwise, the following treatment times are recommended:
| Sudden exacerbation of chronic bronchitis ( acute exacerbation of chronic bronchitis ) | 5-10 days |
| Pneumonia ( pneumonia ) that has been received outside of the hospital does not apply to serious cases | 10 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 Moxifloxacin Krka film-coated tablets are used to terminate a treatment started with moxifloxacin solution for infusion, the recommended treatment time is:
| Pneumonia ( pneumonia ) that has been received outside of a hospital. Most patients with pneumonia switched to oral treatment with Moxifloxacin Krka film-coated tablets within 4 days. | 7-14 days |
| Infection in the skin and soft tissues. Most patients with skin and soft tissue infections switched to oral treatment with Moxifloxacin Krka film-coated tablets within 6 days. | 7-21 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, the infection may come back 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 section 2. What you need to know before using Moxifloxacin Krka, Warnings and Precautions )
If you forget to use Moxifloxacin Krka
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 using Moxifloxacin Krka
If you stop taking this medicine too soon, the 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 side effects that have been observed with moxifloxacin treatment 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, itchy skin, bleeding tendencies or thought disorders and altered alertness (this may be a sign or symptom of sudden inflammation in 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 , 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, including swelling of the airways (rare side effect, may be 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)
- pain and swelling of tendons (tendinitis) (rare side effect) or a tendon rupture (tendon rupture) (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 Krka 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 eye specialist immediately.
If you have experienced life-threatening, irregular heartbeats ( torsade de pointes ) or your heart has stopped beating during treatment with Moxifloxacin Krka (a very rare side effect), tell your treating doctor immediately that you have taken Moxifloxacin Krka 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: affects 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 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: affects up to 1 in 100 people
- rash
- upset stomach (indigestion / heartburn)
- taste changes (in very rare cases loss of taste)
- sleep disorders (mainly insomnia)
- increase in special 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 (including 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, pain in the pelvis and in the extremities
- 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 of 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
- 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: affects 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 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 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: affects up to 1 in 10,000 people
- inflammation in the joints
- abnormal heart rhythm
- increased sensitivity of the skin
- feeling of seclusion (not being yourself)
- 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)
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.
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.
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 Krka:
- Increased pressure in the skull (symptoms are headache, vision problems including blurred vision, blind spots, double vision, loss of vision)
- Increased sodium levels in the blood
- Increased pressure in the skull (symptoms are headache, vision problems including blurred vision, blind spots, double vision, loss of vision)
- 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.
How to store Moxifloxacin Krka
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 carton after EXP. The expiration date is the last day of the specified month.
Store in the original package. Moisture sensitive.
No special temperature instructions.
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 moxifloxacin hydrochloride equivalent to 400 mg moxifloxacin.
- The other ingredients are microcrystalline cellulose, croscarmellose sodium and magnesium stearate in the tablet core, hypromellose 6 mPa • s, macrogol 4000, titanium dioxide (E171) and red iron oxide (E172) in the film coating. See section 2 “Moxifloxacin Krka contains sodium”.
What the medicine looks like and contents of the pack
The film-coated tablets are dark pink, biconvex, capsule-shaped tablets with the dimensions: length 15.9 mm – 16.6 mm and thickness 5.8 mm – 7.0 mm.
Moxifloxacin Krka is available in blister packs (OPA / Al / PVC-Al foil blister) with 5, 7, 10, 14, 25, 28, 30, 50, 70, 80, 100 or 120 film-coated tablets in a carton.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
KRKA – FARMA doo, V. Holjevca 20 / E 10450 Jastrebarsko, Croatia