Moxifloxacin 400Mg Film-Coated Tablets

Package leaflet: Information for the user

Moxifloxacin 400mg Film-coated Tablets

Read all of this leaflet carefully before you • If you start experiencing a rapid onset of shortness of start taking this medicine because it contains breath, especially when you lie down flat in your bed, important information for you. or you notice swelling of your ankles, feet or abdomen, or a new onset of heart palpitations (sensation of rapid • Keep this leaflet. You may need to read it again. or irregular heartbeat), you should inform a doctor • If you have any further questions, ask your doctor immediately. or pharmacist. • The risk of heart problems may increase with increase of • This medicine has been prescribed for you only. the dose. Therefore, the recommended dosage should be Do not pass it on to others. It may harm them, followed. even if their signs of illness are the same as yours. • There is a rare chance that you may experience a severe, sudden allergic reaction (an anaphylactic reaction/shock) • If you get any side effects, talk to your doctor or even with the first dose. Symptoms include tightness in pharmacist. This includes any possible side effects the chest, feeling dizzy, feeling sick or faint, or dizziness not listed in this leaflet. See section 4. when standing up. If so, stop taking Moxifloxacin and seek medical advice immediately. • Moxifloxacin may cause a rapid and severe inflammation What is in this leaflet of the liver which could lead to life-threatening liver failure 1 What Moxifloxacin is and what it is used for (including fatal cases, see section 4). If you suddenly feel unwell and/or are being sick and also have yellowing of 2 What you need to know before you take the whites of the eyes, dark urine, itching of the skin, a Moxifloxacin tendency to bleed or liver induced disease of the brain 3 How to take Moxifloxacin (symptoms of a reduced liver function or a rapid and severe inflammation of the liver) please contact your doctor 4 Possible side effects before taking any more tablets. 5 How to store Moxifloxacin • Quinolone antibiotics, including Moxifloxacin, may cause 6 Contents of the pack and other information convulsions. If this happens, stop taking Moxifloxacin and contact your doctor immediately. • You may rarely experience symptoms of nerve damage 1 What Moxifloxacin is and what it is used for (neuropathy) such as pain, burning, tingling, numbness and/or weakness especially in the feet and legs or hands Moxifloxacin contains the active substance moxifloxacin and arms. If this happens, stop taking Moxifloxacin and which belongs to a group of antibiotics called inform your doctor immediately in order to prevent the fluoroquinolones. Moxifloxacin works by killing bacteria that development of a potentially irreversible condition. cause infections. • You may experience mental health problems even when Moxifloxacin is used in patients 18 years of age and older for taking quinolone antibiotics, including Moxifloxacin, for treating the following bacterial infections when caused by the first time. In very rare cases depression or mental health bacteria against which Moxifloxacin is active. Moxifloxacin problems have led to suicidal thoughts and self-injurious should only be used to treat these infections when usual behaviour such as suicide attempts (see section 4). If you antibiotics cannot be used or have not worked: develop such reactions, stop taking Moxifloxacin and • Infection of the sinuses inform your doctor immediately. • Sudden worsening of long term inflammation of the • You may develop diarrhoea whilst or after taking airways antibiotics including Moxifloxacin. If this becomes severe • Infection of the lungs (pneumonia) acquired outside the or persistent or you notice that your stool contains blood hospital (except severe cases) or mucus you should stop taking Moxifloxacin immediately • Mild to moderate infections of the female upper genital and consult your doctor. You should not take medicines tract (pelvic inflammatory disease), including infections of that stop or slow down bowel movement. the fallopian tubes and infections of the uterus mucous • Pain and swelling in the joints and inflammation or membrane. Moxifloxacin is not sufficient on its own for rupture of tendons may occur rarely. Your risk is increased treating this kind of infection. Therefore, another antibiotic if you are elderly (above 60 years of age), have received an in addition to Moxifloxacin should be prescribed by your organ transplant, have kidney problems or if you are being doctor for the treatment of infections of the female upper treated with corticosteroids. Inflammation and ruptures of genital tract (see section 2). tendons may occur within the first 48 hours of treatment and even up to several months after stopping Moxifloxacin If the following bacterial infections have shown improvement therapy. At the first sign of pain or inflammation of a during initial treatment with Moxifloxacin solution for infusion, tendon (for example in your ankle, wrist, elbow, shoulder Moxifloxacin tablets may also be prescribed by your doctor to or knee), stop taking Moxifloxacin, contact your doctor and complete the course of therapy: rest the painful area. Avoid any unnecessary exercise as this • Infection of the lungs (pneumonia) acquired outside the might increase the risk of a tendon rupture. hospital • If you are elderly and have kidney problems make sure • Infections of the skin and soft tissue. that you drink plenty whilst taking Moxifloxacin. If you get dehydrated this may increase the risk of kidney failure. Moxifloxacin tablets should not be used to initiate therapy for • If your eyesight becomes impaired or if your eyes any type of infections of the skin and soft tissue or in severe seem to be otherwise affected, consult an eye specialist infections of the lungs. immediately (see sections ‘Driving and using machines’ and 4 Possible side effects). 2 What you need to know before you take • Fluoroquinolone antibiotics may cause an increase of your Moxifloxacin blood sugar levels above normal levels (hyperglycaemia), Do not take Moxifloxacin or lowering of your blood sugar levels below normal • If you are allergic to moxifloxacin, any other quinolone levels (hypoglycaemia), potentially leading to loss of antibiotics or any of the other ingredients of this medicine consciousness (hypoglycaemic coma) in severe cases (see (listed in section 6). section 4 Possible side effects). If you suffer from diabetes, • If you are pregnant or breast-feeding. your blood sugar should be carefully monitored. • If you are younger than 18 years of age. • Quinolone antibiotics may make your skin become more • If you have previously had problems with your tendons sensitive to sunlight or UV light. You should avoid related to treatment with quinolone antibiotics (see prolonged exposure to sunlight or strong sunlight and ‘Warnings and Precautions’ and section 4 ‘Possible side should not use a sunbed or any other UV lamp while taking effects’). Moxifloxacin. • If you have a severe liver disease or increased liver • Prolonged, disabling and potentially irreversible enzymes (transaminases) higher than 5 times the upper serious side effects normal limit. Fluoroquinolone/quinolone antibacterial medicines, • If you were born with or have any condition with including Moxifloxacin, have been associated with very rare abnormal heart rhythm (seen on ECG, electrical recording but serious side effects, some of them being long lasting of the heart). (continuing months or years), disabling or potentially • If you have a salt imbalance in the blood (especially low irreversible. This includes tendon, muscle and joint pain of levels of potassium or magnesium in the blood). the upper and lower limbs, difficulty in walking, abnormal • If you have a very slow heart rhythm (called ‘bradycardia’). sensations such as pins and needles, tingling, tickling, • If you have a weak heart (heart failure). numbness or burning (paraesthesia), sensory disorders • If you have a history of abnormal heart rhythms. including impairment of vision, taste and smell, and • If you are taking other medicines that result in abnormal hearing, depression, memory impairment, severe fatigue, ECG changes (see ‘Other medicines and Moxifloxacin’). and severe sleep disorders. This is because Moxifloxacin can cause changes on the If you experience any of these side effects after taking ECG, that is a prolongation of the QT-interval, i.e. delayed Moxifloxacin, contact your doctor immediately prior to conduction of electrical signals. continuing treatment. You and your doctor will decide on continuing the treatment considering also an antibiotic Warnings and precautions from another class. • The efficacy of Moxifloxacin in the treatment of severe Talk to your doctor, pharmacist or nurse before burns, infections of deep tissue and diabetic foot infections taking Moxifloxacin with osteomyelitis (infections of the bone marrow) has not • Moxifloxacin can change your heart’s ECG, especially if been established. you are female, or if you are elderly. If you are currently • Serious skin reactions including Stevens-Johnson taking any medicine that decreases your blood potassium syndrome, toxic epidermal necrolysis, and acute levels, consult your doctor before taking Moxifloxacin. generalised exanthemous pustulosis (AGEP) have been • If you suffer from epilepsy or a condition which makes you reported with the use of moxifloxacin. likely to have convulsions. - SJS/TEN can appear initially as reddish target-like spots • If you have or have ever had any mental health problems. or circular patches often with central blisters on the • If you suffer from myasthenia gravis (abnormal muscle trunk. Also, ulcers of mouth, throat, nose, genitals and fatigue leading to weakness and in serious cases paralysis), eyes (red and swollen eyes) can occur. These serious taking Moxifloxacin may worsen the symptoms of your skin rashes are often preceded by fever and/or flu-like disease. If you think you are affected consult your doctor symptoms. The rashes may progress to widespread immediately. peeling of the skin and life-threatening complications or • If you or any member of your family have glucose-6- be fatal. phosphate dehydrogenase deficiency (a rare hereditary - AGEP appears at the initiation of treatment as a red, disease), tell your doctor, who will advise whether scaly widespread rash with bumps under the skin and Moxifloxacin is suitable for you. blisters accompanied by fever. The most common • If you have a complicated infection of the female location: mainly localised on the skin folds, trunk, and upper genital tract (e.g. associated with an abscess of upper extremities. the fallopian tubes and ovaries or of the pelvis), for which If you develop a serious rash or another of these skin your doctor considers an intravenous treatment necessary, symptoms, stop taking moxifloxacin and contact your treatment with Moxifloxacin tablets is not appropriate. doctor or seek medical attention immediately. • For the treatment of mild to moderate infections of the female upper genital tract your doctor should prescribe Children and adolescents another antibiotic in addition to Moxifloxacin. If there is Do not give this medicine to children and adolescents under no improvement in symptoms after 3 days of treatment, the age of 18 because efficacy and safety have not been please consult your doctor. established for this age group (see section 2). • If you have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or large vessel Other medicines and Moxifloxacin peripheral aneurysm). Tell your doctor or pharmacist if you are taking, have recently • If you have experienced a previous episode of aortic taken or might take other medicines. dissection (a tear in the aorta wall). In particular, when taking Moxifloxacin, be aware of the • If you have been diagnosed with leaking heart valves (heart valve regurgitation). following: • If you are taking Moxifloxacin and other medicines that • If you have a family history of aortic aneurysm or aortic dissection or congenital heart valve disease, affect your heart there is an increased risk for altering your or other risk factors or predisposing conditions (e.g. heart rhythm. Therefore, do not take Moxifloxacin together connective tissue disorders such as Marfan syndrome, with the following medicines: medicines that belong to the or Ehlers- Danlos syndrome, Turner syndrome, Sjögren’s group of anti-arrhythmics (e.g. quinidine, hydroquinidine, syndrome (an inflammatory autoimmune disease), or disopyramide, amiodarone, sotalol, dofetilide, ibutilide), vascular disorders such as Takayasu arteritis, giant cell antipsychotics (e.g. phenothiazines, pimozide, sertindole, arteritis, Behçet’s disease, high blood pressure, or known haloperidol, sultopride), tricyclic antidepressants, some atherosclerosis, rheumatoid arthritis (a disease of the antimicrobials (e.g. saquinavir, sparfloxacin, intravenous joints) or endocarditis (an infection of the heart)). erythromycin, pentamidine), antimalarials (particularly halofantrine), some antihistamines (e.g. terfenadine, • If you are diabetic because you may experience a risk of astemizole, mizolastine), other medicines (e.g. cisapride, change in blood sugar levels with moxifloxacin. intravenous vincamine, bepridil and diphemanil). • If you have ever developed a severe skin rash or skin • You must tell your doctor if you are taking other medicines peeling, blistering and/or mouth sores after taking that can lower your blood potassium levels (e.g. some moxifloxacin. diuretics, some laxatives and enemas (high doses) or Before taking this medicine corticosteroids (anti-inflammatory drugs), amphotericin B) You should not take fluoroquinolone/quinolone antibacterial or cause a slow heart rate because these can also increase medicines, including Moxifloxacin, if you have experienced the risk of serious heart rhythm disturbances while taking any serious adverse reaction in the past when taking a Moxifloxacin. quinolone or fluoroquinolone. In this situation, you should • Any medicine containing magnesium or aluminium (such inform your doctor as soon as possible. as antacids for indigestion), iron, zinc or didanosine or any medicine containing sucralfate (to treat stomach disorders) While taking Moxifloxacin can reduce the action of Moxifloxacin tablets. Take your Be aware of this important information while taking this Moxifloxacin tablet 6 hours before or after taking the other medicine: medicine. • If you experience palpitations or irregular heart beat • Taking any medicine containing charcoal at the same time during the period of treatment, you should inform your as Moxifloxacin tablets reduces the action of Moxifloxacin. doctor immediately. They may wish to perform an ECG to It is recommended that these medicines are not used measure your heart rhythm. together. • If you feel sudden, severe pain in your abdomen, chest • If you are currently taking medicines to thin your blood or back, which can be symptoms of aortic aneurysm and (oral anti-coagulants such as warfarin), it may be necessary dissection, go immediately to an emergency room. Your for your doctor to monitor your blood clotting time. risk may be increased if you are being treated with systemic corticosteroids. Moxifloxacin with food and drink Moxifloxacin may be taken with or without food (including dairy products).

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Moxifloxacin 400mg Film-coated Tablets PIL - UK

approved for print/date Item number: BBBA9606 Colours Non Printing Colours 1. Black 1. Originator: S.Anson Dimensions: 170x600 Origination Date: 29.10.2020 Min Body Text Size: 8pt 2. 2. Revision Date: Supplier: Pharmathen 3. 3. Revised By: 4. 5. Proof Round 29.10.2020 Technical Date sent: 6. 1 Approval Date received: 29.10.2020 [email protected]

Cartons and label leaflets only (labels only when specified) German GTIN 14 (incorporating PZN): * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 7 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 12.02.2020 Pregnancy, breast-feeding and fertility • Diarrhoea Do not take Moxifloxacin if you are pregnant or breast- • Increase of a special liver enzyme in the blood feeding. If you are pregnant or breast-feeding, think you may (transaminases) be pregnant or are planning to have a baby, ask your doctor or • Change of the heart rhythm (ECG) in patients with low pharmacist for advice before taking this medicine. blood potassium level. Animal studies do not indicate that your fertility will be impaired by taking this medicine. Uncommon (may affect up to 1 in 100 people): • Allergic reaction Driving and using machines • Low red blood cell count (anaemia) Moxifloxacin may make you feel dizzy or light-headed, you • Low white blood cells count may experience a sudden, transient loss of vision, or you may • Low numbers of special white blood cells (neutrophils) faint for a short period. If you are affected do not drive or • Decrease or increase of special blood cells necessary for operate machinery. blood clotting • Increased specialised white blood cells (eosinophils) This medicine contains less than 1 mmol sodium (23mg) • Decreased blood clotting per tablet, that is to say essentially ‘sodium-free’. • Increased blood lipids (fats) • Feeling anxious, restless, or agitated 3 How to take Moxifloxacin • Tingling sensation (pins and needles) and/or numbness Always take this medicine exactly as your doctor has told you. • Changes in taste (in very rare cases loss of taste) Check with your doctor or pharmacist if you are not sure. • Feeling confused and disorientated • Sleep problems (e.g. sleeplessness or sleepiness) The recommended dose for adults is one 400mg film-coated • Shaking tablet once daily. • Sensation of dizziness (spinning or falling over) • Problems with vision (including double or blurred vision) Moxifloxacin tablets are for oral use. Swallow the tablet whole • Widening of the blood vessels (flushing) (to mask the bitter taste) and with plenty of liquid. You can • Difficulty in breathing (including asthmatic conditions) take Moxifloxacin with or without food. Try to take the tablet • Decreased appetite and food intake at approximately the same time each day. • Wind and constipation The same dose can be taken by elderly patients, patients with • Stomach upset (indigestion or heartburn) a low bodyweight or in patients with kidney problems. • Inflammation of the stomach • Increase of a special digestive enzyme in the blood The length of time you will take Moxifloxacin for depends on (amylase) your infection. Unless your doctor tells you otherwise, your • Problems with liver function (including increase of a special treatment will be as follows: liver enzyme in the blood (LDH)), increase of bilirubin in • for sudden worsening (acute exacerbation) of chronic the blood, increase of a special liver enzyme in the blood bronchitis: 5 - 10 days (gamma-glutamyltransferase and/or alkaline phosphatase) • for infection of the lungs (pneumonia) acquired outside the • Itching, rash, skin hives, dry skin hospital except severe cases: 10 days • Joint pain, muscle pain • for acute infection of the sinuses (acute bacterial sinusitis): • Dehydration 7 days • Feeling unwell (usually weakness or tiredness), aches and • Mild to moderate infections of the female upper genital pains such as back, chest, pelvic pains and pains in the tract (pelvic inflammatory disease), including infection of extremities the fallopian tubes and infection of the uterus mucous • Sweating membrane: 14 days. • Change of the heart rhythm (ECG) • Palpitations When Moxifloxacin film-coated tablets are used to complete • Irregular and fast heartbeat a course of therapy started with Moxifloxacin solution for • Severe heart rhythm abnormalities infusion, the recommended durations of use are: • Chest pain (angina pectoris). • Infection of the lungs (pneumonia) acquired outside the hospital: 7 - 14 days Rare (may affect up to 1 in 1,000 people): Most patients with pneumonia were switched to oral • Jaundice (yellowing of the whites of the eyes or skin), treatment with (Moxifloxacin) film-coated tablets within 4 inflammation of the liver days. • Increased blood uric acid • Infections of the skin and soft tissue: 7 - 21 days • Feeling particularly emotional Most patients with infections of the skin and soft tissue • Hallucination were switched to oral treatment with Moxifloxacin film- • Problems with skin sensations coated tablets within 6 days. • Changes in smell (including loss of smell) • Unusual dreams It is important that you complete the course of treatment • Problems with balance and co-ordination (due to dizziness) even if you begin to feel better after a few days. If you stop • Disturbed concentration taking Moxifloxacin too soon your infection may not be • Problems with speech completely cured and the infection may return or your • Partial or total loss of memory condition may get worse. The bacteria causing your infection • Ringing or noise in the ears, hearing impairment including may become resistant to Moxifloxacin. deafness (usually reversible) • High or low blood pressure The recommended dose and duration of treatment should • Difficulty in swallowing not be exceeded (see section 2). • Inflammation of the mouth If you take more Moxifloxacin than you should • Muscle cramps or twitching If you take more than the prescribed one tablet a day, get • Muscle weakness medical help immediately. Take any remaining tablets, the • Kidney problems (including an increase in special kidney packaging or this leaflet with you to show the doctor or laboratory test results like urea and creatinine) pharmacist what you have taken. • Swelling (of the hands, feet, ankles, lips, mouth or throat) • Fainting. If you forget to take Moxifloxacin If you forget to take your tablet, you should take it as soon as Very rare (may affect up to 1 in 10,000 people): you remember on the same day. If you do not remember on • Increased blood clotting, significant decrease of special the same day, take your normal dose (one tablet) on the next white blood cells (agranulocytosis) day. Do not take a double dose to make up for a forgotten • A drop in the number of red and white blood cells and dose. platelets (pancytopenia) If you are unsure about what to do, ask your doctor or • A feeling of self-detachment (not being yourself) pharmacist. • Skin feeling more sensitive • Inflammation of joints If you stop taking Moxifloxacin • Muscles feeling stiff. If you stop taking this medicine before your prescription is finished your infection may not be completely cured. Talk to Also, there have been very rare cases of the following side your doctor if you wish to stop taking your tablets before the effects reported following treatment with other quinolone end of the course of treatment. antibiotics, which might possibly also occur during treatment with Moxifloxacin: If you have any further questions on the use of this medicine, • Raised pressure in the skull (symptoms include headache, ask your doctor or pharmacist. visual problems including blurred vision, “blind” spots, double vision, loss of vision) 4 Possible side effects • Increased blood sodium levels Like all medicines, this medicine can cause side effects, • Increased blood calcium levels although not everybody gets them. The following side effects • A special type of reduced red blood cell count (haemolytic have been observed during treatment with Moxifloxacin. anaemia) • Increased sensitivity of the skin to sunlight or UV light. Stop taking Moxifloxacin and tell your doctor immediately if you notice the following (as you may need Very rare cases of long lasting (up to months or years) urgent medical advice): or permanent adverse drug reactions, such as tendon • Serious skin rashes including Stevens-Johnson syndrome inflammations, tendon rupture, joint pain, pain in the limbs, and toxic epidermal necrolysis. These can appear as reddish difficulty in walking, abnormal sensations such as pins target-like macules or circular patches often with central and needles, tingling, tickling, burning, numbness or pain blisters on the trunk, skin peeling, ulcers of mouth, throat, (neuropathy), depression, fatigue, sleep disorders, memory nose, genitals and eyes and can be preceded by fever and impairment, as well as impairment of hearing, vision, and flu-like symptoms (very rare side effects, potentially life taste and smell have been associated with administration of threatening) quinolone and fluoroquinolone antibiotics, in some cases • A red, scaly widespread rash with bumps under the skin irrespective of pre-existing risk factors. and blisters accompanied by fever at the initiation of Cases of an enlargement and weakening of the aortic wall or a treatment (acute generalised exanthematous pustulosis) tear in the aortic wall (aneurysms and dissections), which may (frequency of this side effect is not known) rupture and may be fatal, and of leaking heart valves have • Syndrome associated with impaired water excretion and been reported in patients receiving fluoroquinolones. See also low levels of sodium (SIADH) (very rare side effect) section 2. • Loss of consciousness due to severe decrease in blood If you feel you are suffering from a side effect, especially if sugar levels (hypoglycaemic coma) (very rare side effect) any of the side effects get serious, or if you notice any side • Inflammation of blood vessels (signs could be red spots effects not listed in this leaflet, please tell your doctor or on your skin, usually on your lower legs or effects like joint pharmacist immediately to get advice before taking the pain) (very rare side effect) next dose. • Abnormal fast heart rhythm (rare side effect) • Pain and swelling of the tendons (tendonitis) (rare side Reporting of side effects effect) If you get any side effects, talk to your doctor, pharmacist or • Rupture of tendons (very rare side effect) nurse. This includes any possible side effects not listed in this • Muscle weakness, tenderness or pain and particularly, if at leaflet. You can also report side effects directly via Yellow Card the same time, you feel unwell, have a high temperature Scheme Website: www.mhra.gov.uk/yellowcard or search for or have dark urine. They may be caused by an abnormal MHRA Yellow Card in the Google Play or Apple App Store. muscle breakdown which can be life threatening and lead By reporting side effects you can help provide more to kidney problems (a condition called rhabdomyolysis) information on the safety of this medicine. (frequency of this side effect is not known) • Severe diarrhoea containing blood and/or mucus 5 How to store Moxifloxacin (antibiotic associated colitis including pseudomembranous Keep this medicine out of the sight and reach of children. colitis), which very rarely, may develop into complications This medicine does not require any special temperature that are life-threatening (rare side effects) storage conditions. Store in the original package in order to • That you suddenly start feeling unwell or notice yellowing protect from moisture. of the whites of the eyes, dark urine, itching of the Do not use Moxifloxacin film-coated tablets after the expiry skin, a tendency to bleed or disturbances of thought date {EXP} stated on the pack and blister. The expiry date or wakefulness (these can be signs and symptoms of refers to the last day of that month. fulminant inflammation of the liver, potentially leading to life-threatening liver failure (including fatal cases)) (very Do not throw away any medicines via wastewater or rare side effect) household waste. Ask your pharmacist how to throw away • Severe, sudden allergic reaction including very rarely medicines you no longer use. These measures will help life-threatening shock (e.g. difficulty in breathing, drop of protect the environment. blood pressure, fast pulse) (rare side effect) • Swelling (including potentially life-threatening swelling of 6 Contents of the pack and other information the airway) (rare side effect) • Convulsions (rare side effect) What Moxifloxacin contains • Troubles associated with the nervous system such as • The active substance is moxifloxacin. Each film-coated pain, burning, tingling, numbness and/or weakness in tablet contains 400mg moxifloxacin, corresponding to extremities (rare side effect) 436.37 mg moxifloxacin hydrochloride. • Depression (which in very rare cases may lead to self-harm, • The other ingredients are: Tablet core: Microcrystalline such as suicidal ideations/thoughts, or suicide attempts) Cellulose, Mannitol (E421), Colloidal anhydrous silica, (rare side effect) Sodium Starch Glycolate (Type A), Hydroxypropyl Cellulose, • Abnormal heart rhythms, life-threatening irregular Talc and Magnesium stearate. Film coating: Polyvinyl heartbeat, stopping of heartbeat (very rare side effects) alcohol part hydrolysed (E1203), Titanium dioxide (E171), • Worsening of the symptoms of myasthenia gravis Macrogol 3350/PEG (E1521), Talc (E553b), Iron oxide yellow (abnormal muscle fatigue leading to weakness and in (E172), Iron oxide red (E172). serious cases paralysis) (very rare side effect) What Moxifloxacin tablets look like and contents of • If you are elderly with existing kidney problems and you notice a decrease in urine output, swelling in your legs, the pack ankles or feet, fatigue, nausea, drowsiness, shortness of Each tablet is presented as a pink oblong biconvex film coated breath or confusion (these can be signs and symptoms of tablet with a diameter 19.4 x 7.8 mm and thickness 5.8 mm. kidney failure) (rare side effect) Moxifloxacin tablets are packaged in cartons containing • Feeling mentally unwell (potentially leading to self-harm, Aluminium/Aluminium blisters. such as suicidal ideations/thoughts, or suicide attempts) Marketing Authorisation Holder (very rare side effect) Accord Healthcare Limited • You suffer from diabetes and you notice that your blood Sage House sugar is increased or decreased (rare or very rare side 319 Pinner Road effect). North Harrow Stop taking Moxifloxacin and contact an eye specialist Middlesex immediately if you notice: HA1 4HF • Transient loss of vision United Kingdom • Discomfort or pain to the eyes, especially due to light Manufacturer exposure (very rare to rare side effect). Pharmathen S.A, 6, Dervenakion str.,153 51, Pallini Other side effects Attiki, Greece Common (may affect up to 1 in 10 people): This leaflet was last revised in November 2020. • Infections caused by resistant bacteria or fungi, e.g. oral and vaginal infections caused by Candida (thrush) • Headache • Dizziness If you would like a leaflet with • Feeling sick (nausea) • Being sick (vomiting) larger text, please contact • Stomach and abdominal ache 01271 385257.

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Moxifloxacin 400mg Film-coated Tablets PIL - UK