Patient leaflet - Moxifloxacin 400 mg film-coated tablets

1. What Moxifloxacin is and what it is used for

Moxifloxacin contains the active substance moxifloxacin which belongs to a group of antibiotics called fluoroquinolones. Moxifloxacin works by killing bacteria that cause infections. Moxifloxacin is used in patients 18 years of age and older 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.

Moxifloxacin is not sufficient on their own for treating this kind of infection. Therefore, another antibiotic in addition to Moxifloxacin 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 Moxifloxacin tablet, Warnings and precautions, Talk to your doctor before taking Moxifloxacin tablet). If the following bacterial infections have shown improvement during initial treatment with Moxifloxacin solution for infusion, Moxifloxacin 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.

Moxifloxacin 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.

2. What you need to know before you take Moxifloxacin

Contact your doctor if you are not sure if you belong to a patient group described below.

Do not take Moxifloxacin

If you are allergic to 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 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 ‘Warnings and Precautions’ and section ‘4. 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)
- a history of abnormal heart rhythms

or• if you are taking other medicines that result in abnormal ECG changes (see section Other medicines and Moxifloxacin tablets). This is because Moxifloxacin tablets can cause changes on the ECG, called prolongation of the QT-interval, indicating 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. Warning & Precautions

Before taking this medicine

You should not take fluoroquinolone/quinolone antibacterial medicines, including Moxifloxacin tablets, if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone. In this situation, you should inform your doctor as soon as possible.

Talk to your doctor before taking moxifloxacin

If you are diabetic because you may experience a risk of change in blood sugar levels with moxifloxacin.
If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking moxifloxacin.
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 Moxifloxacin (see also sections Do not take Moxifloxacin and Other medicines and Moxifloxacin)
If you suffer from epilepsy or a condition which makes you likely to have convulsions, tell your doctor before taking Moxifloxacin.
If you have or have ever had any mental health problems, consult your doctor before taking Moxifloxacin.
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 Moxifloxacin tablets are suitable for you.
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 have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm).
If you have experienced a previous episode of aortic dissection (a tear in the aorta wall).
If you have been diagnosed with leaking heart valves (heart valve regurgitation).
If you have a family history of aortic aneurysm or aortic dissection or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Sjögren’s syndrome (an inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet’s disease, high blood pressure, or known atherosclerosis, rheumatoid arthritis (a disease of the joints) or endocarditis (an infection of the heart).
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 Moxifloxacin 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 Moxifloxacin tablets. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor. When taking Moxifloxacin:

Tell your doctor immediately, if any of the following occurs while taking Moxifloxacin. Your doctor will decide whether treatment with Moxifloxacin needs to be stopped.

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, angio-oedema) even with the first dose. Symptoms include tightness in the chest, chest pain, shortness of breath, feeling dizzy, feeling sick or faint, or dizziness when standing up. If so, stop taking Moxifloxacin and contact your doctor or medical emergencies immediately.
Prolonged, disabling and potentially irreversible serious side effects. Fluoroquinolone/quinolone antibacterial medicines, including Moxifloxacin tablets, have been associated with rare but serious side effects, some of them being long lasting (continuing for months or years), disabling or potentially irreversible. This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning (paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, mental health effects which may include, but are not necessarily limited to, anxiety, panic attacks, confusion, or depression, memory impairment, severe fatigue, and severe sleep disorders. There are no medicines that have been established as being effective treatments for the symptoms of long lasting or disabling side effects associated with fluoroquinolones. If you experience any of these side effects after taking Moxifloxacin tablets, then do not take any further doses and contact your doctor immediately. You and your doctor will decide on whether to continue treatment, considering alternative options.
You may experience psychiatric reactions when taking
Moxifloxacin tablets, including when taking it for the first time. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Moxifloxacin tablets. In rare cases, depression or psychosis can progress to thoughts of suicide or suicide attempts. If this happens, stop taking Moxifloxacin tablets and contact your doctor immediately. You may not notice some changes in your mood and behaviour so it is very important to tell your friends and family that you are taking Moxifloxacin tablets, and that there may be rare psychiatric side effects. Others may notice changes and help you quickly identify any symptoms that you need to talk to your doctor about.
- 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 taking any more tablets.
- Serious skin reactions
  Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalised exanthematous pustulosis (AGEP) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported with the use of moxifloxacin.
  - Stevens-Johnson syndrome (SJS) / toxic epidermal necrolysis (TEN) can appear initially as reddish target-like spots or circular patches often with central blisters on the trunk. Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever and/ or flu-like symptoms. The rashes may progress to widespread peeling of the skin and life-threatening complications or be fatal.
  - AGEP appears at the initiation of treatment as a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The most common location: mainly localized on the skin folds, trunk, and upper extremities.
  - DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

If you develop a serious rash or another of these skin symptoms, stop taking moxifloxacin and contact your doctor or seek medical attention immediately.

Quinolone antibiotics, including Moxifloxacin tablets, may cause convulsions. If this happens, stop taking Moxifloxacin tablets and contact your doctor immediately.
You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness especially in the feet and legs or hands and arms. If this happens, stop taking Moxifloxacin tablets and inform your doctor immediately in order to prevent the development of a potentially irreversible condition.
You may experience mental health problems even when taking quinolone antibiotics, including Moxifloxacin tablets, 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 Moxifloxacin tablets and inform your doctor immediately.
You may develop diarrhoea whilst or after taking antibiotics including Moxifloxacin tablets. If this becomes severe or persistent or you notice that your stool contains blood or mucus you should stop taking Moxifloxacin tablets immediately and consult your doctor. You should not take medicines that stop or slow down bowel movement.
Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely. (see sections Do not take Moxifloxacin and 4. Possible Side Effects). Your risk is increased if you are elderly (above 60 years of age), have received an organ transplant, have kidney problems or if you are also taking corticosteroids. Inflammation and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after stopping of Moxifloxacin Tablets therapy. At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder, or knee), stop taking Moxifloxacin Tablets, contact your doctor and rest the painful area. Avoid any unnecessary exercise as this might increase the risk of a tendon rupture.
If you feel sudden, severe pain in your abdomen, chest or back, which can be symptoms of aortic aneurysm and dissection, go immediately to an emergency room. Your risk may be increased if you are being treated with systemic corticosteroids.
If you start experiencing a rapid onset of shortness of breath, especially when you lie down flat in your bed, or you notice swelling of your ankles, feet or abdomen, or a new onset of heart palpitations (sensation of rapid or irregular heartbeat), you should inform a doctor immediately.
If you are elderly and have kidney problems make sure that you drink plenty whilst taking Moxifloxacin tablets. 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, consult an eye specialist immediately (see sections Driving and using machines and 4. Possible side effects).
Fluoroquinolone antibiotics may cause an increase of your blood sugar level above normal levels (hyperglycemia), or lowering of your blood sugar levels below normal levels (hypoglycemia), potentially leading to loss of consciousness (hypoglycemic coma) in severe cases (see section 4. Possible side effects). If you suffer from diabetes, your blood sugar should be carefully monitored.
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 Moxifloxacin tablets (see section 4. Possible side effects).
The efficacy of Moxifloxacin tablets 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 Moxifloxacin tablets). Other medicines and Moxifloxacin tablets

Tell your doctor or pharmacist about any other medicines that you are taking, took recently or might take.

For Moxifloxacin tablets, be aware of the following:

If you are taking Moxifloxacin tablets and other medicines that affect your heart there is an increased risk for altering your heart rhythm. Therefore, do not take Moxifloxacin tablets 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 Moxifloxacin.
- Any medicine containing magnesium or aluminum (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 Moxifloxacin tablet 6 hours before or after taking the other medicine.
- Taking any medicine containing charcoal at the same time as Moxifloxacin tablets reduces the action of Moxifloxacin tablets. 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.

Moxifloxacin with food and drink

Moxifloxacin can be taken with or without food (including dairy products).

Pregnancy, breast-feeding and fertility

Do not take Moxifloxacin if you are pregnant or breastfeeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.

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3. How to take Moxifloxacin

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose for adults is one 400mg film coated tablet once daily.

Moxifloxacin 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 Moxifloxacin for depends on your infection. Unless your doctor tells you otherwise, your treatment will be as follows:

for sudden worsening of chronic bronchitis (acute exacerbation of chronic obstructive pulmonary disease including bronchitis): 5 - 10 days
for infection of the lungs (pneumonia) except for pneumonia which starts during a stay in hospital: 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 Moxifloxacin 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 Moxifloxacin 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 Moxifloxacin 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 Moxifloxacin. The recommended dose and duration of treatment should not be exceeded (see section 2 What you need to know before you take Moxifloxacin tablets, Warnings and precautions). If you take more Moxifloxacin 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 Moxifloxacin

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 Moxifloxacin

If you stop taking this medicine to 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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The most serious side effects observed during treatment with Moxifloxacin are listed below.

If you notice the following, stop taking Moxifloxacin and tell your doctor immediately (as you may need urgent medical advice)

An abnormal fast heart rhythm (rare side effect)
Alterations of the skin and mucous membranes like painful blisters in the mouth/nose/eye/throat or at the penis/vagina (Stevens-Johnson syndrome or toxic epidermal necrolysis) (very rare side effects, potentially life threatening)
Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. (very rare side effects, potentially life-threatening)
Inflammation of blood vessels (signs could be red spots on your skin, usually on your lower legs or effects like joint pain) (very rare side effect)
Pain and swelling of the tendons (tendonitis) (rare side effect) or a tendon rupture (very rare side effect)
Rupture of tendons (very rare side effect)
Severe diarrhoea containing blood and/or mucus (antibiotic associated colitis including pseudomembranous colitis), which very rarely, may develop into complications that are life threatening (rare side effects)
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-threatening liver failure (including fatal cases) (very rare side effect)
A severe, sudden generalized allergic reaction including very rarely life-threatening shock (e.g. difficulty in breathing, drop of blood pressure, fast pulse) (rare side effect)
Swelling including 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)
Syndrome associated with impaired water excretion and low levels of sodium (SIADH) (very rare side effect)
Loss of consciousness due to severe decrease in blood sugar levels (hypoglycaemic coma) (very rare side effect)
A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis”) (Frequency of this side effect is “not known”)
Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (drug reaction with eosinophilia and systemic symptoms which is also known as DRESS or drug hypersensitivity syndrome) (frequency of this side effect is ‘not known’).
Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have a high temperature or have dark urine. They may be caused by an abnormal muscle breakdown which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis) (Frequency of this side effect is “not known”) Stop taking Moxifloxacin and contact an eye specialist immediately if you notice:
Transient loss of vision (very rare side effect)
Discomfort or pain to the eyes, especially due to light exposure (very rare to rare side effect)

If you have experienced life-threatening irregular heart beat (Torsade de Pointes) or stopping of heart beat while taking Moxifloxacin tablets (very rare side effects), tell your treating doctor immediately that you have taken Moxifloxacin tablets 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.

Other side effects which have been observed during treatment of Moxifloxacin tablets are listed below by how likely they are: Common (may affect up to 1 in 10 people):

Infections caused by resistant bacteria or fungi, e.g. oral and vaginal infections caused by Candida
Headache
Dizziness
Nausea
Vomiting
Stomach and abdominal ache
Diarrhoea
Increase of a special liver enzyme in the blood (transaminases)
Change of the heart rhythm (ECG) in patients with low blood potassium level
Uncommon (may affect up to 1 in 100 people):
- Allergic reaction
- Low red blood cell count
- Low white blood cells count
- Low numbers of special white blood cells (leukocytes, neutrophils)
- Decrease or increase of special blood cells necessary for blood clotting
- Increased specialised white blood cells (eosinophils)
- Decreased blood clotting
- Increased blood lipids (fats)
- Feeling anxious, restless, or agitated
- Tingling sensation (pins and needles) and/or numbness
- Changes in taste (in very rare cases loss of taste)
- Feeling confused and disorientated
- Sleep problems (e.g. sleeplessness or sleepiness)
- Shaking
- Sensation of dizziness (spinning or falling over)
- Problems with vision (including double or blurred vision)
- Widening of the blood vessels
- Difficulty in breathing (including asthmatic conditions)
- Decreased appetite and food intake
- Wind and constipation
- Stomach upset (indigestion or heartburn)
- Inflammation of the stomach
- Increase of a special digestive enzyme in the blood (amylase)
- Impaired liver function (including 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)
- Itching, rash, skin hives, dry skin
- Joint pain, muscle pain
- Dehydration
- Feeling unwell (predominantly weakness or tiredness), aches and pains such as back, chest, pelvic pains and pains in the extremities
- Sweating
- Change of the heart rhythm (ECG)
- Palpitations
- Irregular and fast heartbeat
- Severe heart rhythm abnormalities
- Chest pain (angina pectoris)

Rare (may affect up to 1 in 1,000 people):

Jaundice (yellowing of the whites of the eyes or skin), inflammation of the liver
Increased blood uric acid
emotional instability
Hallucination
Impairment of skin sensations
Changes in smell (including loss of smell)
Unusual dreams
Problems with balance and co-ordination (due to dizziness)
Disturbed concentration
Impaired speech
Partial or total loss of memory
Ringing or noise in the ears, hearing impairment including deafness (usually reversible)
High or low blood pressure
Difficulty in swallowing
Inflammation of the mouth
Muscle cramps or twitching
Muscle weakness
Kidney problems (including an increase in special kidney laboratory test results like urea and creatinine)
Swelling (of the hands, feet, ankles, lips, mouth or throat)
Fainting

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

Very Rare cases of long lasting (up to months or years) or permanent adverse drug reactions ,such as tendon inflammation, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, mental health effects (which may include sleep disorders, anxiety, panic attacks, depression and suicidal ideation), as well as impairment of hearing, vision, and taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics, in some cases irrespective of pre-existing risk factors.
Increased blood clotting, significant decrease of special white blood cells (agranulocytosis)
A feeling of self-detachment (not being yourself)
Increase of skin sensitivity
Inflammation of joints
Muscles feeling stiff (Muscle rigidity)
A drop in the number of red and white blood cells and platelets (pancytopenia)
Abnormal heart rhythms

Not known (frequency cannot be estimated from the available data)

Increased sensitivity of the skin to sunlight or UV light (see also section 2, Warnings and precautions).
Sharply demarcated, erythematous patches with/without blistering that develop within hours of administration of moxifloxacin and heals with post inflammatory residual hyperpigmentation; it usually recurs at the same site of the skin or mucous membrane upon subsequent exposure to moxifloxacin.
Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

These are very serious side-effects requiring immediate attention which are potentially life threatening.

Furthermore, 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 Moxifloxacin:

Raised pressure in the skull (symptoms include headache, visual problems including blurred vision, “blind” spots, double vision, loss of vision)
Increased blood sodium levels
Increased blood calcium levels
A special type of reduced red blood cell count (haemolytic anaemia) Cases of an enlargement and weakening of the aortic wall or a tear in the aortic wall (aneurysms and dissections), which may rupture and may be fatal, and of leaking heart valves have been reported in patients receiving fluoroquinolones. See also section 2, Warnings & Precautions)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system Yellow Card Scheme, website:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

P3946T Ask your doctor or pharmacist for advice before taking this medicine. Animal studies do not indicate that your fertility will be impaired by taking this medicine.

Driving and using machines

Moxifloxacin 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. Moxifloxacin tablets contain lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, speak to your doctor before taking Moxifloxacin tablets. This medicine contains less than 1 millimol sodium (23 milligram) per film-coated tablet, that is to say essentially “sodium-free”.

5. How to store Moxifloxacin

Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage conditions. Do not use Moxifloxacin film-coated tablets after the expiry date {EXP} stated on the pack and blister. The expiry date refers to the last day of that month.

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.

6. Contents of the pack and other information

What Moxifloxacin contains

The active substance is moxifloxacin. Each film-coated tablet contains 400mg moxifloxacin, corresponding to 436.37mg moxifloxacin hydrochloride.
The other ingredients are:
Tablet core: Ludipress (Lactose monohydrate, Povidone and Crospovidone), Crospovidine, Povidone, Microcrystalline Cellulose, Croscarmellose sodium, colloidal anhydrous silica, Magnesium stearate.
Film coat: Opadry Yellow II (31K32701) composed of Lactose Monohydrate (see section Moxifloxacin contains lactose), HPMC 2910/Hypromellose (E 464), Titanium Dioxide (E171), Triacetin (E 1518), Quinoline Yellow Aluminum Lake (E 104) and Iron Oxide Yellow (E 172)

What Moxifloxacin tablets looks like and contents of the pack

Each tablet is presented as Oblong yellow film coated tablets with pale yellow core, plain from both sides. Moxifloxacin tablets are packaged in cartons containing Aluminium/Aluminium blisters.

Moxifloxacin 400mg film coated tablets are available in commercial packs containing 5 film coated tablets

Marketing Authorisation Holder & Manufacturer

Crescent Pharma Ltd., Key House,

Sarum Hill, Basingstoke, RG21 8SR, UK.

PL 20416/0768

This leaflet was last revised in 06/2026.