400 mg film-coated tablets (Adults)
moxifloxacin
What Rivomoxi is and what it is used for
Rivomoxi contains the active substance moxifloxacin, which belongs to a group of antibiotics called fluoroquinolones. Rivomoxi works by killing bacteria that cause you infections.
Rivomoxi is used in patients aged 18 years and older to treat bacterial infections caused by bacteria that moxifloxacin is effective against. Rivomoxic is only used to treat these infections when standard antibiotics can not 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 severe 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 Rivomoxi alone. Therefore, your doctor will prescribe an additional antibiotic in addition to Rivomoxi to treat infections in the upper parts of the woman’s abdomen (see section 2. What you need to know before taking Rivomoxi, Warnings, and Precautions, Talk to your doctor before taking Rivomoxi).
If the following bacterial infection has improved during initial treatment with moxifloxacin solution for infusion, your doctor may prescribe Rivomoxy tablets to complete the treatment:
pneumonia outside of hospital, skin and soft tissue infections.
Rivomoxi should not be used for the initial treatment of any type of skin or soft tissue infection or severe pneumonia.
What you need to know before you use Rivomoxi
Before taking this medicine
You should not take antibacterial fluoroquinolone/quinolone medicines, including Rivomoxi 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.
Contact a physician if you are not sure if you belong to any of the patient groups described below.
Do not take Rivomoxi
– if you are allergic to the active substance moxifloxacin, any other quinolone antibiotics, or any of the other ingredients of this medicine (listed in section 6. Contents of the pack and other information)
– if you are pregnant or breast-feeding
– if you are younger than 18 years
– if you have a history of late-onset problems with quinolone antibiotics (see section Warnings and precautions and section 4. Possible side effects )
– if you were born with or have
- a condition associated with abnormal 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 taking other medicines that may cause abnormal ECG changes (see section Other medicines and Rivomoxi). This is because Rivomoxi can cause ECG changes that are an extension of the QT interval, e.g. delayed transmission of electrical signals.
– if you have severe liver disease or elevated liver enzymes ( transaminases ) higher than 5 times the upper limit of normal.
Warnings and cautions
Talk to your doctor before taking Rivomoxi
- Rivomoxi may alter your ECG (changes in electrocardiography), especially if you are a woman or older. If you are currently taking a medicine that lowers your blood potassium levels, consult your doctor before taking Rivomoxi (see also section Do not take Rivomoxi and Other medicines and Rivomoxi).
- 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 of the aortic wall).
- if you have been diagnosed with leaky heart valves.
- if someone in your family has or has had an aortic aneurysm or 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 Takayasu’s 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)).
- If you have epilepsy or any other condition that can cause seizures, consult your doctor before taking Rivomoxi.
- If you have or have had mental health problems, talk to your doctor before taking Rivomoxi.
- If you or someone in your family has glucose ‑6 ‑ phosphate dehydrogenase deficiency (a rare inherited disease), tell your doctor, who will tell you if Rivomoxi is suitable for you.
- If you have myasthenia gravis (abnormal muscle fatigue leading to weakness and, in severe cases, paralysis), Rivomoxi may worsen your symptoms. Contact a doctor immediately if you think this applies to you.
- If you as a woman have a complicated infection in the upper abdomen (eg at the same time as varicose veins in the fallopian tubes and ovaries or the pelvis) for which the doctor considers an intravenous treatment is necessary, treatment with Rivomoxi is not suitable.
- For the treatment of mild to moderate infection in the upper parts of the woman’s abdomen, the doctor must also prescribe another antibiotic in addition to Rivomoxi. If no improvement in symptoms is seen after 3 days of treatment, consult a doctor.
- If you are diabetic because there is a risk of you getting altered blood sugar levels of moxifloxacin.
- If you have ever developed a severe rash or scaly skin, blisters, and/or sores in your mouth after taking moxifloxacin.
During treatment with Rivomoxi
- If you experience palpitations or irregular heartbeats during treatment, contact a doctor immediately. He/she may want to do an ECG examination (electrocardiography) to check your heart rhythm.
- 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 get a severe, sudden allergic reaction (an anaphylactic reaction/shock), already at the first dose. The symptoms are pressure over the chest, that you feel dizzy, feel unwell, feel dizzy, or dizzy when you get up. If this happens, stop taking Rivomoxi and seek medical attention immediately.
- Rivomoxi 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 a doctor before continuing to take the medicine if the following signs occur: sudden malaise and/or nausea in combination with yellowing of the whites of the eyes, dark urine, itchy skin, the tendency to bleed, or brain disease caused by the liver (symptoms of hepatic impairment or a sudden and severe inflammation of the liver).
- 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 a 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 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.
- Quinolone antibiotics, including Rivomoxi, can cause seizures. If this happens, stop taking Rivomoxi and contact your doctor immediately.
- You may experience mental health problems the first time you take quinolone antibiotics, including Rivomoxi. 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 Rivomoxi and tell your doctor immediately.
- You may have diarrhea during or after taking antibiotics, including Rivomoxi. If this becomes severe or long-lasting or if you notice that the stool contains blood or mucus, stop taking Rivomoxi immediately and consult a doctor. You should not take any medicine that stops or reduces bowel movement.
- If you are elderly and have kidney problems, be sure to drink plenty of fluids during treatment with Rivomoxi. Dehydration can increase the risk of kidney failure.
- If your vision is impaired or you experience any other eye problems during treatment with Rivomoxi, contact an eye specialist immediately (see sections Driving and using machines and section 4. Possible side effects ).
- Quinolone antibiotics can make the 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 Rivomoxi.
- The efficacy of Rivomoxi in the treatment of severe burns, deep tissue infection, or osteomyelitis foot infections ( bone marrow infection) in diabetics has not been established.
- Suppose you feel a sudden, severe pain in the abdomen, chest, or back. In that case, you should immediately go to an emergency room as this may be a symptom of an 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, 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 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 ) have been reported. If you have diabetes, your blood sugar should be monitored carefully.
Long-term, disabling, and possibly lasting serious side effects
Antibacterial fluoroquinolone/quinolone drugs, including Rivomoxi, 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 difficulty sleeping.
If you get any of these side effects after taking Rivomoxi, 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.
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 take Rivomoxi).
Other medicines and Rivomoxi
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
For Rivomoxi, be aware of the following:
- If you are taking Rivomoxi and other medicines that may affect your heart, there is an increased risk of heart rhythm changes. Therefore, do not take Rivomoxi with the following medicines:
- medicines belonging to the antiarrhythmic group (eg quinidine, hydroquinone, disopyramide , amiodarone, sotalol, dofetilide, ibutilide)
- antipsychotics (eg phenothiazines, pimozide, sertindole, haloperidol, sultopride)
- tricyclic antidepressants
- certain antimicrobials (eg sparfloxacin, saquinavir, intravenous erythromycin, pentamidine, antimalarials, especially halofantrine)
- some antihistamines (eg terfenadine, astemizole, mizolastine)
- other medicines (eg cisapride, intravenous vincamine, bepridil and difemanil).
- You must 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 heartbeat, such as this may increase the risk of serious heart rhythm disturbances while you are taking moxifloxacin.
- Drug-containing magnesium or aluminum (such as antacids for indigestion), iron, zinc, or didanosine or drugs containing sucralfate (for the treatment of stomach upset) may reduce the effect of Rivomoxi. Therefore, moxifloxacin tablets should be taken 6 hours before or after taking these other medicines.
- Taking medicines containing medical carbon at the same time as Rivomoxi reduces the effect of Rivomoxi. Therefore, it is recommended that these drugs not be taken at the same time.
- If you are taking blood-thinning medicines at the same time (oral anticoagulants such as warfarin ), it may be necessary for your doctor to check your coagulation time.
Rivomoxi with food, drink, and alcohol
Rivomoxi can be taken with or without food (including dairy products).
Pregnancy, breastfeeding, and fertility
Do not take Rivomoxi 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 indicate that fertility will be impaired when using this medicine.
Driving and using machines
Rivomoxi 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.
Rivomoxi contains para-orange (E110)
Rivomoxi contains para-orange (E110) which is a dye that can cause allergic reactions.
How to use Rivomoxi
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 film-coated tablet once daily.
Swallow the tablet whole (so as not to feel the bitter taste) and together with plenty of liquid. You can take Rivomoxi with or without food. Try to take the tablet at about the same time each day.
The same dose can be taken by elderly patients, patients with low body weight, or by patients with kidney problems.
The duration of treatment with Rivomoxi depends on your infection. Unless your doctor prescribes otherwise, your treatment will be as follows:
- for the treatment of sudden exacerbation of chronic bronchitis: 5-10 days
- for the treatment of pneumonia ( pneumonia ) obtained outside the hospital: 10 days
- for the treatment of acute sinus infection ( acute bacterial sinusitis ): 7 days
- for the treatment of mild to moderate infection of the upper abdomen ( inflammation of the small pelvis), including infection of the fallopian tubes and infection of the lining of the uterus: 14 days.
When Rivomoxi is used to end a treatment started with moxifloxacin solution for infusion, the recommended treatment times are:
- Pneumonia ( pneumonia ) received outside hospital: 7–14 days. Most patients with pneumonia usually switch to oral treatment with moxifloxacin tablets within 4 days.
- Infection of the skin and soft tissues: 7-21 days. Most patients with skin and soft tissue infections switch to oral treatment with Rivomoxi within 6 days.
You must complete the entire course, even if you feel better after a few days. If you stop taking Rivomoxi prematurely, the infection may not be adequately treated and infection may return or your condition may worsen. The bacteria that cause infection can develop resistance to Rivomoxi.
The recommended dose and duration of treatment should not be exceeded (see section 2. What you need to know before taking Rivomoxi, Warnings, and Precautions).
If you use more Rivomoxi than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you have taken more than the prescribed dose (1 tablet per day), seek medical help immediately. If possible, take any remaining tablet or package or package leaflet with your doctor or pharmacist.
If you forget to use Rivomoxi
If you forget to take the 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 Rivomoxi
If you stop taking this medicine too soon, the infection may be inadequately treated. Talk to your doctor if you wish to stop taking the 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.
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.
The most serious side effects that have been observed with Rivomoxi are listed below.
If you notice any of the following side effects, stop using Rivomoxi and contact your doctor immediately. You may need urgent medical attention:
- Abnormally fast heartbeat (rare side effect )
- that you suddenly start to feel unwell or notice that your whites of the eyes turn yellow, your urine is dark, you have itching, you have a greater tendency to bleed or you have thought disorders or difficulty staying awake (these can be signs and symptoms of sudden hepatitis such as can even lead to life-threatening liver failure [very rare side effect, fatalities have 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 linked to 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 )
- severe, sudden generalized allergic reaction including a life-threatening shock (eg difficulty breathing, drop in blood pressure, and rapid heartbeat ) (rare side effect )
- swelling including swelling of the airways (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 extremities, eg. arms, and legs, (rare side effect )
- depression (may in very rare cases 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 is very rare cases can lead to life-threatening complications (rare side effect ) pain and swelling of tendons (tendinitis) (rare side effect ), or tendon rupture (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 )
- 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”).
If you notice further
- transient vision loss (a very rare side effect ) contact an eye specialist immediately.
If you have experienced life-threatening irregular heartbeat ( torsades de pointes ) or cardiac arrest while using Rivomoxi (very rare side effects ), tell your treating doctor immediately that you are using Rivomoxi. Do not start treatment again.
Deterioration of myasthenia gravis symptoms has been observed in very rare cases. If this happens, consult a doctor immediately.
If you have diabetes and you notice that your blood sugar levels increase or decrease (rare or very rare side effects), tell your doctor immediately.
If you are older with pre-existing kidney problems and you notice a decrease in urine levels, swelling of the legs, ankles, or feet, fatigue, nausea, drowsiness, shortness of breath, or confusion (these may be signs and symptoms of kidney failure, a rare side effect ), contact a doctor immediately.
Side effects can occur with the following frequencies:
Common, may affect up to 1 in 10 users:
- infection is caused by resistant bacteria or fungi, e.g. Oral or vaginal infection is caused by Candida
- headache
- dizziness
- nausea
- vomiting
- abdominal pain
- diarrhea
- increase in specific liver enzymes ( transaminases ) in the blood.
Uncommon, may affect up to 1 in 1,000 users:
- allergic reaction
- low red blood cell count ( anemia )
- low white blood cell count
- the low number of specific white blood cells ( neutrophils )
- decrease or increase in specific blood cells needed for blood coagulation
- increased number of specific white blood cells ( eosinophils )
- impaired blood coagulation
- elevated blood fat levels
- feelings of anxiety, restlessness, or upset
- creeping sensation (tingling) and/or numbness
- taste changes (in very rare cases lost sense of taste)
- confusion and disorientation
- sleep problems (eg, insomnia or drowsiness)
- shaking
- the feeling of dizziness (instability or risk of falling)
- vision problems (including double vision and blurred vision)
- dilation of blood vessels (hot flashes)
- difficulty breathing (including asthmatic conditions)
- decreased appetite and decreased food intake
- gas formation and constipation
- upset stomach (indigestion or heartburn)
- inflammation of the stomach
- increase of a particular digestive enzyme (amylase) in the blood
- impaired liver function (including an increase in a specific liver enzyme [LDH] in the blood), increase in bilirubin in the blood, increase in a specific liver enzyme (gamma-glutamyltransferase and/or alkaline phosphatase) in the blood
- itching, rash, hives, dry skin
- joint pain, muscle pain
- dehydration
- feeling sick (mainly feeling weak or tired), aches and pains in e.g. back, chest, pelvis, and extremities
- sweating.
Rare may affect up to 1 in 10,000 users:
- pain and swelling of tendons (tendinitis)
- elevated blood sugar
- elevated uric acid levels in the blood
- emotional instability
- hallucinations
- decreased sensitivity of the skin
- changes in the sense of smell (including a lost sense of smell)
- abnormal dreams
- problems with balance and coordination (due to dizziness)
- cramps
- impaired concentration
- impaired speech
- partially or completely lost memory
- disorders related to the nervous system such as pain, burning sensation, tingling, numbness, and/or weakness in the extremities
- ringing or ringing in the ears, hearing loss including deafness (usually transient)
- high or low blood pressure
- difficulty swallowing
- inflammation of the mouth
- muscle cramps or muscle twitching
- muscle weakness
- renal problems (including elevated laboratory values concerning the kidneys, such as urea and creatinine ), renal failure
- swelling (of hands, feet, ankles, lips, mouth or throat, edema ).
Very rare, may affect up to 1 in 10,000 users:
- changes in the skin and mucous membranes (painful blisters in the mouth/nose or on the penis/vagina)
- stretch marks
- increased blood coagulation, a clear decrease in the number of specific white blood cells ( agranulocytosis )
- the feeling of seclusion (not being yourself)
- transient vision loss
- increased sensitivity of the skin
- inflammation in the joints
- muscle stiffness
- aggravated symptoms of myasthenia gravis (abnormal muscle fatigue leading to weakness and, in severe cases, paralysis)
- decreased number of red and white blood cells and platelets (pancytopenia)
Furthermore, the following side effects have been reported in very rare cases during treatment with other quinolone antibiotics and this may also occur during treatment with Rivomoxi:
- increased sodium levels in the blood
- increased calcium levels in the blood
- decreased level of a specific type of red blood cell (hemolytic anemia )
- the skin becomes more sensitive to sunlight or UV light.
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 impaired hearing, 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 or pharmacist. This also applies to any side effects not mentioned in this information.
How to store Rivomoxi
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. 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 of moxifloxacin as hydrochloride.
- Other ingredients are:
Tablet core: Microcrystalline cellulose, croscarmellose sodium, povidone, and magnesium stearate.
Film coating: Macrogol, red iron oxide (E172), para-orange (E110), polyvinyl alcohol, titanium dioxide (E171), talc.
What the medicine looks like and the contents of the pack
Light orange, capsule-shaped, biconvex film-coated tablet with dimensions 18.0 x 8.0 mm. Rivomoxi is packaged in cartons containing aluminum / PVC-PVDC blisters.
They are available in packs of 5, 7, and 10 film-coated tablets and hospital packs of 25, 50, 70, 80, or 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Rivopharm Ltd.
17, Corrig Road, Sandyford
Dublin 18
Ireland
Manufacturer:
BTT Laboratories
ZI de Krafft
67150 Erstein
France