Biotech Ciprofloxacin Film-Coated Tablets

BIOTECH CIPROFLOXACIN belongs to a group of antibiotics called the fluoroquinolones. It kills the bacteria by inhibiting certain bacterial enzymes responsible for the replication of the bacteria. BIOTECH CIPROFLOXACIN is used in adults to treat severe and/or complicated bacterial infection of the lungs, bladder, gut (diarrhoea), bone, or skin and soft tissues where other antimicrobials used for similar infections were considered not to be an appropriate treatment option, have failed, cannot be used or are not tolerated. It is also used to prevent you getting an infection caused by a bacterium called Neisseria meningitidis.

Do not take BIOTECH CIPROFLOXACIN tablets:

• if you are hypersensitive (allergic) to ciprofloxacin or any of the other ingredients of BIOTECH CIPROFLOXACIN (listed in section 6).
• if you are pregnant or breastfeeding your baby
• BIOTECH CIPROFLOXACIN should not be used in children under the age of 18 years and in growing adolescents
• if you have previously experienced side effects with the use of quinolone/fluoroquinolone antibiotics relating to your joints, muscles, ligaments, nerves, central nervous system (brain), epilepsy or mental health (psychiatric disorder)
• if you were born with or have any condition with abnormal heart rhythm whether related to QT time prolongation or not (seen on ECG, electrical recording of the heart)
• if you are taking other medicines that result in an abnormal heart rate and/or rhythm tracing (ECG) e.g. (prolongation of the "QT time")
• if you have an enlargement or "bulge" of a large blood vessel (aortic aneurysm) or a previous episode of aortic dissection (a tear in the aortic wall) or a family history of aortic aneurysm/dissection or other risk factors or existing predisposing conditions)
• if you have mitral valve and/or aortic valve regurgitation (a heart condition where the mitral and/or aortic valve does not close properly)
• if you have myasthenia gravis (abnormal muscle fatigue leading to weakness and, in serious cases, paralysis)
• if you are on treatment for high blood pressure with medicines called ACE inhibitors/angiotensin receptor blockers in patients with moderate to severe renal impairment and in the elderly
• if you are taking tizanidine (for muscle spasticity in multiple sclerosis).

Warnings and precautions

Take special care with BIOTECH CIPROFLOXACIN:

• if you have a history of seizures or convulsive disorders
• if you are using medicines that will cause your urine to become alkaline or if you experience crystals in your urine which causes kidney pain or discomfort when passing urine. You should be well hydrated and avoid excessive alkalinity of the urine when taking BIOTECH CIPROFLOXACIN
• if you are currently taking other medicines that can reduce your blood potassium levels
• if you have heart problems. Caution should be taken when using BIOTECH CIPROFLOXACIN, if you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called ‘bradycardia’), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section 2: Other medicines and BIOTECH CIPROFLOXACIN).
• 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 other risk factors or existing predisposing conditions (e.g., connective tissue disorders such as Marfan Syndrome, Vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure or known atherosclerosis (see Do Not Take BIOTECH CIPROFLOXACIN)
• if you are taking ACE inhibitors/renin-angiotensin receptor blockers (treating high blood pressure) and especially if your kidney function is impaired. The concomitant use of BIOTECH CIPROFLOXACIN and the abovementioned medicine can cause acute kidney injury. Your doctor should monitor your kidney function before and during treatment (see Do Not Use BIOTECH CIPROFLOXACIN)
• if you have an infection of the urinary tract, your doctor will prescribe BIOTECH CIPROFLOXACIN based on the laboratory results
• if your doctor is treating you for Travellers’ diarrhoea, your doctor must take the information on the resistance of the pathogens of the countries you visited into account
• if you are being treated for an infection of your bones or joints, your doctor will prescribe another antibiotic as combination to BIOTECH CIPROFLOXACIN depending on laboratory results
• you should not take fluoroquinolone/quinolone antibacterial medicines, including BIOTECH CIPROFLOXACIN, 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
• if you experience painful swelling of your tendons, particularly the Achilles (heel) tendon, you should avoid any physical exercise and your doctor should be consulted. BIOTECH CIPROFLOXACIN may cause these side effects. Inflammation and ruptures of tendons may occur even within the first 48 hours of treatment or up to several months after discontinuation of BIOTECH CIPROFLOXACIN therapy. Avoid any unnecessary exercise as this might increase the risk of tendon rupture
• if you experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness. If this happens stop taking BIOTECH CIPROFLOXACIN and contact your doctor immediately (see Do Not Take BIOTECH CIPROFLOXACIN)
• if you feel sudden, severe pain in your abdomen, chest or back, immediately go to an emergency room
• if your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately
• avoid direct exposure to excessive sunlight and UV-light
• if you notice an atypical, widespread rash, which may occur in conjunction with high body temperature and enlarged lymph nodes, you should seek medical attention immediately
• if you experience any psychiatric reactions such as depression or psychosis or thoughts about suicide or self-harm, after taking BIOTECH CIPROFLOXACIN, consult with your doctor immediately (see Do Not Take BIOTECH CIPROFLOXACIN)
• if you are a diabetic patient receiving concurrent treatment with an oral medicine to lower your blood glucose or insulin. Disturbances in blood glucose including too high and too low blood glucose levels have been reported. Your doctor will carefully monitor your blood glucose level
• if you experience severe and persistent diarrhoea during or after your treatment, you should consult your doctor as soon as possible
• BIOTECH CIPROFLOXACIN may cause liver damage: If you notice any symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching or tenderness of the stomach, stop taking BIOTECH CIPROFLOXACIN and contact your doctor immediately
• if you or a member of your family is known to have a deficiency in glucose-6-phosphate dehydrogenase (G6PD) (disease of the red blood cells based on a hereditary enzyme deficiency) because taking BIOTECH CIPROFLOXACIN may lead to a destruction of red blood cells causing anaemia. Signs of anaemia are a feeling of weakness and in more severe cases, breathlessness and pale skin
• tell your doctor if you are chronically using theophylline (usually used for asthma) clozapine, olanzapine, ropinirole, tizanidine, duloxetine or agomelatine
• tell your doctor if you have impaired liver or kidney function. Your doctor will have to adjust your dosage
• if you have myasthenia gravis (a type of muscle weakness) because symptoms can be exacerbated (see Do not take BIOTECH CIPROFLOXACIN)
• if you are epileptic or suffer from other neurological conditions, you might experience side effects associated with the central nervous system. If this happens, stop taking BIOTECH CIPROFLOXACIN immediately, and contact your doctor
• BIOTECH CIPROFLOXACIN may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as a sore throat/pharynx/mouth or urinary problems, inform your doctor immediately
• BIOTECH CIPROFLOXACIN may interfere with the interpretation of diagnostic culture tests for tuberculosis
• if you are taking blood or urinary samples, inform the doctor or laboratory staff.

Do not share medicines prescribed for you with any other person. Always take BIOTECH CIPROFLOXACIN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide on the duration of treatment. Your doctor will explain to you exactly how much BIOTECH CIPROFLOXACIN you will have to take as well as how often and for how long. This will depend on the type and severity of infection you have. The usual treatment period is 5 to 10 days. For severe and complicated infections more prolonged therapy may be required. The dose range is 250 – 750 mg twice daily. The tablet must be swallowed whole with plenty of liquid and may be taken with or without meals.

• Severe and/or complicated infections of the lower respiratory tract: 750 mg twice daily
• Severe and/or complicated infectious diarrhoea: 500 mg twice daily
• Severe and/or complicated infection of the urinary tract: 500 mg twice daily
• Severe and/or complicated infections of the skin and bone infections: 750 mg twice daily
• For the prophylaxis of invasive infections of Neisseria meningitides, take one single dose of 500 mg.

Elderly: Elderly patients should receive a dose as low as possible depending on the severity of their illness and how well their kidneys are working.

If you take more BIOTECH CIPROFLOXACIN than you should: In the event of overdosage, consult your doctor of pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take BIOTECH CIPROFLOXACIN: Do not take a double dose to make up to the forgotten individual doses. Continue to take the next tablet at the usual time. If you have trouble remembering when to use your medicine, ask your pharmacist for some hints.

BIOTECH CIPROFLOXACIN can have side effects. Not all side effects reported for BIOTECH CIPROFLOXACIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking BIOTECH CIPROFLOXACIN, please consult your healthcare provider for advice.

If any of the following happens, stop taking BIOTECH CIPROFLOXACIN and tell your doctor immediately or go to the casualty department of your nearest hospital:

• seizures (fits)
• allergic reactions with symptoms such as swelling of the face, lips, tongue, throat and airways (breathing tubes), difficult breathing, blueness of the skin, low blood pressure, heart failure and can result in death
• muscle weakness, pain, swelling or inflammation of the tendons (ligaments), or if you have difficulty walking, as it may be a sign of rupture of a tendon, particularly affecting the Achilles tendon (the large tendon at the back of the ankle)
• if you develop a serious skin rash in the form of blistering and peeling of the skin, if you develop blisters or ulcers in the mouth, throat, nose, eyes and other mucous membranes or sensitivity to sunlight
• flu-like symptoms, followed by a painful red or purplish rash that spreads, blisters on your skin, mouth, nose or genitals, or red, painful, watery eyes, signs of the potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis
• unusual feelings of pain, burning, tingling, numbness and general muscle weakness (neuropathy), especially in your arms or legs
• sudden severe pain in your chest, abdomen (tummy) or back
• the development of severe and persistent diarrhoea can be related to inflammation of the bowel (colitis) linked to antibiotic use
• yellowing of the skin and eyes, also called jaundice (cholestatic icterus)
• high or low blood sugar, especially in diabetic patients
• if you have any suicidal thoughts or thoughts about self-harm
• a drug reaction that causes rash, fever, inflammation of internal organs, haematologic abnormalities (including increased white blood cells (eosinophilia) and liver enzymes) and systemic illness (DRESS Drug Reaction with Eosinophilia and Systemic Symptoms, AGEP Acute Generalised Exanthematous Pustulosis)
• kidney failure, blood or crystals in the urine.

These are all very serious side effects. If you have them, you may have had a serious reaction to BIOTECH CIPROFLOXACIN. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• nausea, diarrhoea

Less frequent side effects:

• fungal superinfections, antibiotic-associated colitis is an inflammation of the large intestine
• a high concentration of eosinophils, a type of white blood cell
• changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), increased or decreased amounts of a blood clotting factor (thrombocytes)
• reduction in red blood cells due to extensive destruction of these cells (haemolytic anaemia), a dangerous drop in a type of white blood cells (agranulocytosis), a drop in the number of red and white blood cells and platelets (pancytopenia), which may be fatal; and bone marrow depression, which may also be fatal
• allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes (angio-oedema)
• decreased appetite
• headache, dizziness, sleep disorders
• pins and needles, unusual sensitivity to stimuli of the senses, decreased skin sensitivity, tremors
• migraine, disturbed coordination, unsteady walk (gait disturbance), disorder of sense of smell (olfactory disorders), pressure on the brain (intracranial pressure and pseudotumor cerebri), vertigo
• psychiatric problems such as a sense that things are not there (hallucinations), restlessness, tiredness, feel anxious or nervous, confusion, depression, trouble sleeping, abnormal dreams
• double vision, colour disturbances
• ringing sound in the ears, loss of hearing, impaired hearing
• increased heart rate (tachycardia)
• widening of blood vessel (vasodilation), low blood pressure, inflammation of the wall of the blood vessels (vasculitis), fainting, flushing of the skin
• shortness of breath (dyspnoea) including asthmatic symptoms
• pancreatitis (swelling and inflammation of the pancreas) causing severe upper abdominal burning pain that spreads to your back, nausea and vomiting
• vomiting, bloating, indigestion, abdominal pain, flatulence
• increased number of certain substances in the blood (transaminase and/or bilirubin)
• liver impairment
• death of liver cells (liver necrosis) very rarely leading to life-threatening liver failure
• hives, sensitivity to light, small pin-point bleeding under the skin (petechiae); various skin eruptions or rashes
• tender red nodules or lumps that are usually seen on both shins
• general feeling of weakness and myalgia (muscle pain in back, chest, body), muscle cramps, inflammation of the tendons
• worsening of the symptoms of myasthenia gravis
• urinary tract inflammation, kidney failure
• feeling unwell (asthenia), or fever
• sweating (hyperhidrosis)
• increased levels of the enzyme amylase, blood alkaline phosphatase

Frequency unknown side effects:

• difficulty sleeping, fluid retention or excessive sweating relating to a condition called Syndrome of inappropriate secretion of antidiuretic hormone (SIADH)
• mood state characterised by persistent disinhibition and elevation (euphoria) and overactivity
• damage to the nerves located outside of the brain and spinal cord (peripheral nerves), often causes weakness, numbness and pain, usually in the hands and feet (peripheral neuropathy and polyneuropathy)
• heart rhythm abnormalities, irregular heartbeat, alteration of the heart rhythm (called ‘prolongation of QT interval’, seen on ECG, electrical activity of the heart)
• influence on blood clotting (in patients treated with Vitamin K antagonists)

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of BIOTECH CIPROFLOXACIN.

Store all medicines out of reach of children. Store in a cool dry place at or below 25 ºC. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains and sewerage systems (e.g., toilets).