Moxiqol 400 mg film-coated tablets
Moxifloxacin
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their sings of illness are the same as yours. Do not reuse this medicine without a prescription even if you pretend to treat a similar dsease.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
- What Moxiqol is and what it is used for
- What you need to know before you take Moxiqol
- How to take Moxiqol
- Possible side effects
- How to store Moxiqol
- Contents of the pack and other information
- What Moxiqol is and what it is used for
Moxiqol contains the active substance moxifloxacin which belongs to a group of antibiotics called fluoroquinolones. Moxiqol works by killing bacteria that cause infections.
Moxifloxacin is used in patients aged 18 years and above, for treating the following bacterial infections when caused by bacteria against which moxifloxacin is active. Moxifloxacin should only be used to treat these infections when usual antibiotics cannot be used or have not worked:
- Infection of the sinuses, sudden worsening of long term inflammation of the airways or infection of the lungs (pneumonia) acquired outside the hospital (except severe cases).
- Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease), including: infections of the fallopian tubes and infections of the uterus mucous membrane.
Moxiqol tablets are not sufficient on their own for treating this kind of infection. Therefore, another antibiotic in addition to Moxiqol tablets should be prescribed by your doctor for the treatment of infections of the female upper genital tract (see section “2. What you need to know before you take Moxiqol”, “Warnings and precautions”, “When taking Moxiqol”).
If the following bacterial infections have shown improvement during initial treatment with moxifloxacin solution for infusion, Moxiqol film-coated tablets may also be prescribed by your doctor to complete the course of therapy:
- infection of the lungs (pneumonia) acquired outside the hospital,
- infections of the skin and soft tissue.
Moxiqol film-coated tablets should not be used to initiate therapy for any type of infections of the skin and soft tissue or in severe infections of the lungs.
- What you need to know before you take Moxiqol
Contact your doctor if you are not sure if you belong to a patient group described below.
Do not take Moxiqol:
- If you are allergic (hypersensitive) to the active substance moxifloxacin, any other quinolone antibiotics or any of the other ingredients of this medicine (listed in section 6).
- If you are pregnant or are breast-feeding.
- If you are under 18 years of age.
- If you have previously had problems with your tendons related to treatment with quinolone antibiotics (see section “Warnings and precautions” and section “ Possible side effects”).
- If you were born with or have:
- any condition with abnormal heart rhythm (seen on ECG, electrical recording of the heart);
- a salt imbalance in the blood (especially low levels of potassium or magnesium in the blood);
- a very slow heart rhythm (called ‘bradycardia’);
- a weak heart (heart failure);
- an history of abnormal heart rhythms, or
- if you are taking other medicines that result in abnormal ECG changes (see section “Other medicines and Moxiqol”). This is because Moxifoxacin can cause changes on the ECG, that is a prolongation of the QT-interval, i.e., delayed conduction of electrical signals.
- If you have a severe liver disease or increased liver enzymes (transaminases) higher than 5 times the upper normal limit.
Warnings and precautions
Talk to your doctor before taking Moxiqol.
Moxifloxacin can change your heart’s ECG, especially if you are female, or if you are elderly. If you are currently taking any medicine that decreases your blood potassium levels, consult your doctor before taking Moxiqol (see also sections “Do not take Moxiqol” and “Other medicines and Moxiqol”).
If you suffer from epilepsy or a condition which makes you likely to have convulsions talk to your doctor before taking Moxiqol.
If you have or have ever had any mental health problems, consult your doctor before taking Moxiqol.
If you suffer from myasthenia gravis (abnormal muscle fatigue leading to weakness and in serious cases paralysis), taking Moxifloxacin may worsen the symptoms of your disease. If you think you are affected consult your doctor immediately.
If you or any member of your family have glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease), tell your doctor, who will advise whether Moxiqol is suitable for you.
If you have a complicated infection of the female upper genital tract (e.g. associated with an abscess of the fallopian tubes and ovaries or of the pelvis), for which your doctor considers an intravenous treatment necessary, treatment with Moxiqol tablets is not appropriate.
For the treatment of mild to moderate infections of the female upper genital tract your doctor should prescribe another antibiotic in addition to Moxiqol. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.
When taking Moxiqol
If you experience palpitations or irregular heart beat during the period of treatment, you should inform your doctor immediately. He/she may wish to perform an ECG to measure your heart rhythm.
The risk of heart problems may increase with increase of the dose. Therefore, the recommended dosage should be followed.
There is a rare chance that you may experience a severe, sudden allergic reaction (an anaphylactic reaction/shock) even with the first dose. Symptoms include tightness in the chest, feeling dizzy, feeling sick or faint, or dizziness when standing up. If so, stop taking Moxiqol and seek medical advice immediately.
Moxifloxacin may cause a rapid and severe inflammation of the liver which could lead to life-threatening liver failure (including fatal cases, see section “4. Possible side effects”). If you suddenly feel unwell and/or are being sick and also have yellowing of the whites of the eyes, dark urine, itching of the skin, a tendency to bleed or liver induced disease of the brain (symptoms of a reduced liver function or a rapid and severe inflammation of the liver) please contact your doctor before continuing the treatment.
If you develop a skin reaction or blistering / peeling of the skin and/or mucosal reactions (see section “4. Possible side effects”), contact your doctor immediately before you continue treatment.
Quinolone antibiotics, including Moxiqol, may cause convulsions. If this happens, stop taking Moxifloxacin and contact your doctor immediately.
You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness. If this happens, inform your doctor immediately prior to continuing treatment with Moxiqol.
You may experience mental health problems even when taking quinolone antibiotics, including Moxifloxacin, for the first time. In very rare cases depression or mental health problems have led to suicidal thoughts and self-injurious behaviour such as suicide attempts (see section “4. Possible side effects”). If you develop such reactions, stop taking Moxiqol and inform your doctor immediately.
You may develop diarrhoea whilst or after taking antibiotics including Moxiqol. If this becomes severe or persistent or you notice that your stool contains blood or mucus you should stop taking Moxiqol immediately and consult your doctor. You should not take medicines that stop or slow down bowel movement.
Moxiqol may cause pain and inflammation of your tendons, even within 48 hours of starting treatment and up to several months after discontinuing Moxiqol therapy. The risk of inflammation and rupture of tendons is increased if you are elderly or if you are also taking corticosteroids. At the first sign of any pain or inflammation you should stop taking Moxiqol, rest the affected limb(s) and consult your doctor immediately. Avoid any unnecessary exercise, as this might increase the risk of a tendon rupture (see sections “Do not take Moxiqol” and “4. Possible side effects”).
If you are elderly and have kidney problems make sure that you drink plenty whilst taking Moxiqol. If you get dehydrated this may increase the risk of kidney failure.
If your eyesight becomes impaired or if your eyes seem to be otherwise affected whilst taking Moxiqol, consult an eye specialist immediately (see sections “Driving and using machines” and “4. Possible side effects”).
Fluoroquinolone antibiotics may cause disturbances in blood sugar, including both a decrease in blood sugar below normal levels (hypoglycemia) and an increase in blood sugar above normal levels (hyperglycemia). In patients treated with moxifloxacin, disturbances in blood sugar occurred predominantly in elderly patients receiving concomitant treatment with oral antidiabetic medicines that lower blood sugar (e. g. sulfonylurea) or with insulin. If you suffer from diabetes, your blood sugar should be carefully monitored (see section 4. Possible side effects).
Quinolone antibiotics may make your skin become more sensitive to sunlight or UV light. You should avoid prolonged exposure to sunlight or strong sunlight and should not use a sunbed or any other UV lamp while taking Moxiqol.
The efficacy of moxifloxacin (solution for infusion) in the treatment of severe burns, infections of deep tissue and diabetic foot infections with osteomyelitis (infections of the bone marrow) has not been established.
Children and adolescents
Do not give this medicine to children and adolescents under the age of 18 because efficacy and safety have not been established for this age group (see section “Do not take Moxiqol”)
Other medicines and Moxiqol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
For Moxiqol, be aware of the following:
– If you are taking Moxiqol and other medicines that affect your heart there is an increased risk for altering your heart rhythm. Therefore, do not take Moxiqol together with the following medicines:
- medicines that belong to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide)
- antipsychotics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride)
- tricyclic antidepressants
- some antimicrobials (e.g. saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials particularly halofantrine)
- some antihistamines (e.g. terfenadine, astemizole, mizolastine)
- other medicines (e.g. cisapride, intravenous vincamine, bepridil and diphemanil).
– You must tell your doctor if you are taking other medicines that can lower your blood potassium levels (e.g. some diuretics, some laxatives and enemas [high doses] or corticosteroids [anti-inflammatory drugs], amphotericin B) or cause a slow heart rate because these can also increase the risk of serious heart rhythm disturbances while taking Moxiqol.
– Any medicine containing magnesium or aluminium (such as antacids for indigestion), iron, zinc or didanosine or any medicine containing sucralfate (to treat stomach disorders) can reduce the action of Moxifloxacin tablets. Take your Moxiqol tablet 6 hours before or after taking the other medicine.
– Taking any medicine containing charcoal at the same time as Moxiqol tablets reduces the action of Moxiqol. It is recommended that these medicines are not used together.
– If you are currently taking drugs to thin your blood (oral anti-coagulants such as warfarin), it may be necessary for your doctor to monitor your blood clotting time.
Moxiqol with food and drink
Moxiqol can be taken with or without food (including dairy products).
Pregnancy, breast-feeding and fertility
Do not take Moxiqol 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 before taking this medicine.
Animal studies do not indicate that your fertility will be impaired by taking this medicine.
Driving and using machines
Moxiqol may make you feel dizzy or light-headed, you may experience a sudden, transient loss of vision, or you may faint for a short period. If you are affected do not drive or operate machinery.
Moxiqol contains Sunset yellow FCF aluminium lake (E110) and Ponceau 4R aluminium lake (E124).
These excipients may cause allergic reactions.
- How to take Moxiqol
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose for adults is one 400 mg film-coated tablet once daily.
Moxiqol tablets are for oral use. Swallow the tablet whole (to mask the bitter taste) and with plenty of liquid. You can take Moxifloxacin with or without food. Try to take the tablet at approximately the same time each day.
The same dose can be taken by elderly patients, patients with a low bodyweight or in patients with kidney problems.
The time you will take Moxiqol for depends on your infection. Unless your doctor tells you otherwise, your treatment will be as follows:
- for sudden worsening (acute exacerbation) of chronic bronchitis: 5 – 10 days.
- for infection of the lungs (pneumonia) acquired outside hospital, except severe cases: 10 days.
- for acute infection of the sinuses (acute bacterial sinusitis): 7 days.
- Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease), including infection of the fallopian tubes and infection of the uterus mucous membrane: 14 days.
When Moxiqol film-coated tablets are used to complete a course of therapy started with moxifloxacin solution for infusion, the recommended durations of use are:
- Infection of the lungs (pneumonia) acquired outside the hospital: 7 -14 days. Most patients with pneumonia were switched to oral treatment with Moxifloxacin film-coated tablets within 4 days.
- Infections of the skin and soft tissue: 7 -21 days. Most patients with infections of the skin and soft tissue were switched to oral treatment with Moxiqol film-coated tablets within 6 days.
It is important that you complete the course of treatment even if you begin to feel better after a few days. If you stop taking this medicine too soon your infection may not be completely cured and the infection may return or your condition may get worse. The bacteria causing your infection may become resistant to the antibiotic.
The recommended dose and duration of treatment should not be exceeded (see section “2. What you need to know before you take Moxiqol”, “Warnings and precautions”).
If you take more Moxiqol than you should
If you take more than the prescribed one tablet a day, get medical help immediately. Try to take any remaining tablets, the packaging or this leaflet with you to show the doctor or pharmacist what you have taken.
If you forget to take Moxiqol
If you forget to take your tablet you should take it as soon as you remember on the same day. If you do not remember on the same day, take your normal dose (one tablet) on the next day.
Do not take a double dose to make up for a forgotten dose. If you are unsure about what to do ask your doctor or pharmacist.
If you stop taking Moxiqol
If you stop taking this medicine too soon your infection may not be completely cured. Talk to your doctor if you wish to stop taking your tablets before the end of the course of treatment.
If you have any further questions about this medicine, ask your doctor, pharmacist or nurse.
- Possible side effects
Like all medicines, Moxiqol can cause side effects, although not everybody gets them.
The most serious side effects observed during treatment with moxifloxacin are listed below:
If you notice:
- an abnormal fast heart rhythm (rare side effect)
- that you suddenly start feeling unwell or notice yellowing of the whites of the eyes, dark urine, itching of the skin, a tendency to bleed or disturbances of thought or wakefulness (these can be signs and symptoms of fulminant inflammation of the liver potentially leading to life-threating liver failure (very rare side effect, fatal cases have been observed))
- alterations of the skin and mucous membranes like painful blisters in the mouth/nose or at the penis/vagina (Stevens-Johnson syndrome or toxic epidermal necrolysis) (very rare side effects, potentially life threatening)
- a severe, sudden generalised allergic reaction incl. very rarely a life-threatening shock (e.g. difficulty in breathing, drop of blood pressure, fast pulse) (rare side effect)
- swelling incl. swelling of the airway (rare side effect, potentially life-threatening)
- convulsions (rare side effect)
- troubles associated with the nervous system such as pain, burning, tingling, numbness and/or weakness in extremities (rare side effect)
- depression (in very rare cases leading to self-harm, such as suicidal ideations/thoughts, or suicide attempts) (rare side effect)
- insanity (potentially leading to self-harm, such as suicidal ideations/thoughts, or suicide attempts) (very rare side effect)
- severe diarrhoea containing blood and/or mucus (antibiotic associated colitis incl. pseudomembranous colitis), which in very rare circumstances, may develop into complications that are life-threatening (rare side effects)
- pain and swelling of the tendons (tendonitis) (rare side effect) or a tendon rupture (very rare side effect)
Stop taking Moxiqol and tell your doctor immediately as you may need urgent medical advice.
In addition, if you notice
- transient loss of vision (very rare side effect), contact an eye specialist immediately.
If you have experienced life-threatening irregular heart beat (Torsade de Pointes) or stopping of heart beat while taking Moxiqol (very rare side effects), tell your treating doctor immediately that you have taken Moxiqol and do not restart the treatment.
A worsening of the symptoms of myasthenia gravis has been observed in very rare cases. If this happens, consult your doctor immediately.
If you suffer from diabetes and you notice that your blood sugar is increased or decreased (rare or very rare side effect), inform your doctor immediately.
If you are elderly with existing kidney problems and you notice decrease in urine output, swelling in your legs, ankles or feet, fatigue, nausea, drowsiness, shortness of breath or confusion (these can be signs and symptoms of kidney failure, a rare side effect), consult your doctor immediately.
The following side effects have been observed during treatment with moxifloxacin. The evaluation of side effects was based on the following frequency data:
- Common: may affect up to 1 in 10 patients.
- Uncommon: may affect up to 1 in 100 patients.
- Rare: may affect up to 1 in 1000 patients.
- Very rare: may affect up to 1 in 10000 patients.
Infections
- Common: Infections caused by resistant bacteria or fungi e.g. vaginal or oral infection caused by Candida.
Blood and lymphatic system
- Uncommon: low count of red blood cells, low count of white blood cells, low number of special white blood cells (neutrophyils), decrease or increase of special blood cells necessary for blood clotting, increased specialised white blood cells (eosinophils), decreased blood clotting.
- Very Rare: increased blood clotting, significant decrease of special white blood cells (agranulocytosis).
Allergic reactions
- Uncommon: allergic reaction.
- Rare: severe, sudden generalised allergic reaction including, very rarely, life-threatening shock (e.g. difficulty in breathing, drop of blood pressure, fast pulse), swelling (including swelling of the airway, potentially life-threatening).
Alteration of laboratorial tests results
- Uncommon: increased blood lipids (fats).
- Rare: increased blood sugar, increased blood uric acid.
Psychiatric effects
- Uncommon: anxiety, restlessness/agitation
- Rare: emotional instability, depression (in very rare cases leading to self-harm, such as suicidal ideations/thoughts, or suicide attempts), hallucination.
- Very rare: a feeling of self-detachment (not being yourself), insanity (potentially leading to self-harm, such as suicidal ideations/thoughts, or suicide attempts).
Nervous system
- Common: headaches, dizziness.
- Uncommon: tingling sensation (pins and needles) and/or numbness, changes in taste (in very rare cases, loss of taste), confusion and disorientation, sleep problems (predominantly sleeplessness), shaking, sensation of dizziness (spinning or falling over), sleepiness.
- Rare: impairment of skin sensation, changes in smell (including loss of smell), abnormal dreams, balance disorders and poor co-ordination (due to dizziness), convulsions, disturbed concentration, impaired speech, partial or total loss of memory, problems associated with the nervous system such as pain, burning, tingling, numbness and/or weakness in the extremities.
- Very rare: increase of skin sensitivity.
Eye
- Uncommon: visual disturbances including double and blurred vision.
- Very rare: transient loss of vision.
Ear
- Rare: ringing/noise in the ears, hearing impairment including deafness (usually reversible).
Cardiac system (see section “2. What you need to know before you take Moxiqol”)
- Common: change of the heart rhythm (ECG) in patients with low blood potassium levels.
- Uncommon: change of the heart rhythm (ECG), palpitations, irregular and fast heartbeat, severe heart rhythm abnormalities, angina pectoris.
- Rare: abnormal fast heart rhythm, fainting.
- Very rare: abnormal heart rhythms, life-threatening irregular heartbeat, stopping of heartbeat.
Vascular system
- Uncommon: widening of blood vessels.
- Rare: high blood pressure, low blood pressure.
Respiratory system
- Uncommon: difficulty in breathing including asthmatic conditions.
Gastrointestinal system
- Common: Nausea, vomiting, stomach and abdominal ache, diarrhoea.
- Uncommon: decreased appetite and food intake, wind and constipation, stomach upset.
- Rare: difficulty in swallowing, inflammation of the mouth, severe diarrhoea containing blood and/or mucus (antibiotic associated colitis including pseudomembranous colitis), which in very rare circumstances, may develop into complications that are life-threatenin
Liver
- Common: increase of a special liver enzyme in the blood (transaminases).
- Uncommon: impaired liver function (incl. increase of a special liver enzyme in the blood (LDH)), increase of bilirubin in the blood, increase of a special liver enzyme in the blood (gamma-glutamyl-transferase and/or alkaline phosphatase).
- Rare: jaundice (yellowing of the whites of the eyes or skin), inflammation of the liver.
- Very rare: fulminant inflammation of the liver potentially leading to life-threating liver failure (including fatal cases).
Skin
- Uncommon: itching, rash, skin hives, dry skin.
- Very rare: alterations of the skin and mucous membranes (painful blisters in the mouth/nose or at the penis/vagina) potentially life-threatening (Stevens-Johnson syndrome or toxic epidermal necrolysis).
Joint and muscular system:
- Uncommon: joint pain, muscle pain.
- Rare: pain and swelling of the tendons (tendonitis), muscle cramp, muscle twitching, muscle weakness.
- Very rare: tendon rupture, inflammation of joints, muscle rigidity, worsening of the symptoms of myasthenia gravis.
Kidney
- Uncommon: dehydration.
- Rare: kidney impairment (including increase in special kidney laboratory test results like urea and creatinine), kidney failure.
General side effects
- Uncommon: feeling unwell (predominantly weakness or tiredness), aches and pains such as back, chest, pelvic and extremities pains, sweating.
- Rare: swelling (of the hands, feet, ankles, lips, mouth, throat…).
Also, there have been very rare cases of the following side effects reported following treatment with other quinolone antibiotics, which might possibly also occur during treatment with Moxiqol:
- Increased blood sodium levels
- Increased blood calcium levels
- A special type of reduced red blood cell count (haemolytic anaemia)
- Muscle reactions with muscle cell damage
- Increased sensitivity of the skin 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.
By reporting side effects, you can help provide more information on the safety of this medicine.
- How to store Moxiqol
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 on the carton, after “EXP”. The expiry date refers to the last day of that month.
The medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
- Contents of the pack and other information
What Moxiqol contains
- The active substance is moxifloxacin as hydrochloride. Each film-coated tablet contains 436,8 mg of moxifloxacin hydrochloride, equivalent to 400 mg of moxifloxacin.
- The other ingredients are:
- Tablet core: Mannitol (E421), Microcrystalline cellulose, Croscarmellose sodium, Sillica colloidal anhydrous, Magnesium stearate.
- Film-coat: Polyvinyl alcohol (E1203), Macrogol 4000 (E1521), Talc (E553b), Titanium Dioxide (E171), Sunset Yellow FCF Aluminum Lake (E110), Ponceau 4R Aluminum Lake (E124), Indigo Camine Aluminum Lake (E132).
What Moxiqol looks like and contents of the pack
Film-coated tablet, oblong, convex-shaped, dark red, engraved “MOXI” on one side and “400”on the other.
The film-coated tablets are available in PVC/PVDC/Aluminum blisters, with 5 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
- Marketing Authorisation Holder:
New Pharm Group Ltd
18 Evdoshvili Str., 0154, Tbilisi, Georgia.
- Manufacturer:
Bluepharma – Indústria Farmacêutica, S.A.
- Martinho do Bispo
3045-016 Coimbra
Portugal (EU)
