Ciprobay 500 mg

CIPROBAY is an antibiotic belonging to the fluoroquinolone family. The active substance is ciprofloxacin. Ciprofloxacin works by killing bacteria that cause infections. It only works with specific strains of bacteria.

CIPROBAY is used in adults to treat a severe and/or complicated bacterial infections 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 CIPROBAY

• if you are hypersensitive (allergic) to ciprofloxacin or any of the other ingredients of CIPROBAY (listed in section 6).
• 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 are pregnant or breastfeeding your baby.
• if you are taking medicines which contain tizanidine to treat spasticity (tight or rigid muscles) because this may cause side effects such as low blood pressure and sleepiness.
• 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 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 have other risk factors or existing predisposing conditions.
• If you have a damaged mitral and/or aortic heart valve which cannot close properly.
• If you have myasthenia gravis (abnormal muscle fatigue leading to weakness and, in serious cases, paralysis).
• if you or your child are younger than 18 years.
• If you are on treatment for high blood pressure with medicines called ACE inhibitors/angiotensin-receptor blockers. Ask your doctor if you are unsure.

Warnings and precautions

Talk to your doctor before taking CIPROBAY for the first time if you:

• have ever had kidney problems as your doctor may need to adjust the dose.
• suffer from epilepsy or other neurological conditions, such as fits.
• have a history of tendon problems during previous treatment with antibiotics such as CIPROBAY (see Do not take CIPROBAY).
• have myasthenia gravis (a type of muscle weakness) (see Do not take CIPROBAY) because taking CIPROBAY may worsen the symptoms of your disease.
• have heart problems. Caution should be taken when using CIPROBAY, if you are 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 rate (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 Do not take CIPROBAY and Other medicines and CIPROBAY).
• suffer from depression or other mental health problems.
• have diabetes. Fluoroquinolone antibiotics, including CIPROBAY may cause disturbances in your blood sugar level, especially if you are elderly and treated with oral medicines or insulin to lower your blood sugar. Your doctor may wish to monitor your blood sugar during treatment with CIPROBAY.
• have a damaged mitral and/or aortic heart valve which cannot close properly.
• are currently taking other medicines that can reduce your blood potassium levels.
• have a family history of aortic aneurysm or aortic dissection or other risk factors or 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 CIPROBAY).

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

• Severe, sudden allergic reaction (an anaphylactic reaction/shock, angioedema). Even with the first dose, there is a risk that you may experience a severe allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, sick or faint, or experiencing dizziness when standing up. If this happens, stop taking CIPROBAY and contact your doctor immediately.
• Inflammation and tearing of tendons may occur even within the first 48 hours of treatment or up to several months after stopping CIPROBAY therapy. The risk of inflammation and tearing of tendons may be increased if you are elderly, during strenuous physical activity, if you are currently being treated with corticosteroids, if you have impaired kidney function or have received solid organ transplants.
• At the first sign of any pain or inflammation stop taking CIPROBAY, rest the painful area and consult your doctor immediately. Avoid any unnecessary exercise, as this might increase the risk of your tendon tearing. The recovery process for your tendons, muscles and joints may take weeks or months and full recovery to what it was before treatment with CIPROBAY may not occur (see Do not take CIPROBAY).
• If you suffer from epilepsy or other neurological conditions such as cerebral ischaemia or stroke, you may experience side effects associated with the central nervous system. If this happens, stop taking CIPROBAY and contact your doctor immediately (see Do not take CIPROBAY).
• You may experience mental health problems (psychiatric reactions) the first time you take CIPROBAY. If you suffer from depression or psychosis, your symptoms may become worse under treatment with CIPROBAY. In rare cases, depression or psychosis can progress to thoughts of suicide, suicide attempts, or completed suicide. If this happens, stop taking CIPROBAY and contact your doctor immediately.
• You may experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness in your limbs. If this happens, stop taking CIPROBAY and contact your doctor immediately. The recovery process for your nerve condition may take weeks or months and full recovery to what it was before your treatment with CIPROBAY may not occur (see Do not take CIPROBAY).
• CIPROBAY 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 CIPROBAY and contact your doctor immediately.
• If you suffer from diarrhoea while taking CIPROBAY, stop taking CIPROBAY and contact your doctor immediately as this may become life-threatening.
• Your skin may become more sensitive to sunlight or ultraviolet (UV) light when taking CIPROBAY. Avoid exposure to strong sunlight, or artificial UV light such as sunbeds. Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP) have been reported in association with CIPROBAY treatment. Stop using CIPROBAY and seek medical attention immediately if you notice the first signs of rash (see Possible side effects).
• Tell the doctor or laboratory staff that you are taking CIPROBAY if you have to provide a blood or urine sample. CIPROBAY may interfere with the interpretation of diagnostic culture tests for tuberculosis.

Children and adolescents

Do not give CIPROBAY to children and adolescents younger than 18 years due to the increased risk of damage to the cartilage of weight bearing joints.

Other medicines and CIPROBAY

Always tell your healthcare professional if you are taking any other medicine. This includes complementary or traditional medicines. If you are on treatment with ACE inhibitors/angiotensin-receptor blockers used to control your blood pressure. Ask your doctor if are not sure.

If you are taking any of the following medicines, please consult your healthcare professional:

• medicines that can affect your heart rhythm: medicines that belong to the group of Class IA and III anti-dysrhythmics, tricyclic antidepressants, some antibiotics (that belong to the group of macrolides), some antipsychotics (used for schizophrenia)
• a class of anti-coagulants (to prevent blood clots) which inhibits Vitamin K (e.g. warfarin)

Do not share medicines prescribed for you with any other person. Always take CIPROBAY exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Your doctor will explain to you exactly how much CIPROBAY you will be given as well as how often and for how long. This will depend on the type and severity of infection you have. The dosage range is 250 - 750 mg twice daily. The usual duration of treatment is less than 10 days. For severe and complicated infections more prolonged therapy may be required. For the prophylaxis of invasive infections of Neisseria meningitides, take one single dose of 500 mg. Do not change the dose prescribed by your doctor. Tell your doctor if you suffer from kidney problems because your dose may need to be adjusted.

CIPROBAY film-coated tablets

CIPROBAY film-coated tablets should be swallowed whole with plenty of liquid. Do not chew the tablets because they do not taste nice.

CIPROBAY oral suspension

Always use the graduated measuring spoon to obtain the exact dose: ½ measuring spoonful (approx. 2,5 mL) contains approx. 125 mg ciprofloxacin. 1 measuring spoonful (approx. 5,0 mL) contains approx. 250 mg ciprofloxacin. Swallow the prescribed amount of suspension as quickly as possible. Do not chew the microcapsules present in the suspension, simply swallow them. A drink of water may be taken afterwards. Replace the cap on the bottle after use. It may be stored at room temperature up to 25 °C. Do not store in the refrigerator. The ready-to-use suspension is stable for 14 days. After treatment has been completed, the container should not be re-used. Shake well each time before use for approx. 15 seconds. The graduated measuring spoon with the markings 1/2 is equivalent to 2,6 mL and contains 2,5 mL of final mixed suspension and 1/1 is equivalent to 5,2 mL and contains 5,0 mL of final mixed suspension. The graduated measuring spoon must be used for measuring the required prescribed amount of CIPROBAY suspension. CIPROBAY film-coated tablets and oral suspension can be taken independent of mealtimes. If CIPROBAY is taken on an empty stomach, the active substance is absorbed more rapidly. Do not take CIPROBAY with dairy products such as milk, yoghurt or mineral fortified drinks. Drink lots of water and avoid urine alkalinisers.

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 CIPROBAY than you should

If you take more than the prescribed dose of CIPROBAY, get medical help immediately as this can cause kidney damage. If possible, take your tablets or the box with you to show the doctor. In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.

If you forget to take CIPROBAY

If you forget to take CIPROBAY and it is:

• 6 hours or more until your next scheduled dose, take your missed dose right away. Then take the next dose at your regular time.
• less than 6 hours until your next scheduled dose, do not take the missed dose. Take the next dose at your regular time. Do not take a double dose to make up for a forgotten dose. Be sure to complete your course of treatment.

If you stop taking CIPROBAY

It is important that you finish the course of treatment even if you feel better before that. If you stop taking CIPROBAY too soon, your infection may not be completely cured, and the symptoms of the infection may return or get worse or the bacteria may become resistant to the medicine. You should always consult your doctor before deciding to interrupt the course of treatment or stop taking CIPROBAY altogether.

CIPROBAY can have side effects. Not all side effects reported for CIPROBAY are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking CIPROBAY, please consult your doctor, pharmacist or other health care professional for advice. If any of these side effects continue, are severe or bother you, tell your doctor or pharmacist. Stop using CIPROBAY and call your doctor at once if you have a serious side effect such as:

• angioedema (rapid swelling of the skin and mucous membranes of the face, lips, tongue, or throat with difficulty to breathe)
• anaphylactic reaction/shock which is a severe sudden allergic reaction and is rapid in onset. Symptoms of anaphylactic reaction include dizziness (feeling dizzy, sick or faint or experiencing dizziness when standing up), tightness in the chest, loss of consciousness, difficulty in breathing, swelling of the face, lips, tongue, throat and airways (breathing tubes), blueness of the skin, low blood pressure, heart failure, and can result in death.
• sudden severe pain in your chest, abdomen (tummy), or back;
• severe dizziness, fainting, fast or pounding heartbeats;
• sudden pain, snapping or popping sound, bruising, swelling, tenderness, stiffness, or loss of movement in any of your muscles, ligaments, tendons, or joints;
• diarrhoea that is watery or bloody;
• confusion, hallucinations, depression, unusual thoughts or behaviour;
• seizure (convulsions);
• pale or yellowed skin, dark coloured urine, fever, weakness;
• urinating less than usual or not at all;
• easy bruising or bleeding;
• numbness, tingling, burning sensation, weakness or unusual pain anywhere in your body;
• the first sign of any skin rash, no matter how mild; or
• severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Frequent side effects include:

• Nausea, diarrhoea, vomiting, stomach and abdominal pains, indigestion/heartburn, flatulence (gas)
• Yeast/mould (mycotic) superinfections
• High concentration of eosinophils (type of white blood cells)
• Loss of appetite (anorexia)
• Hyperactivity/agitation
• Headache, dizziness, sleep problems (insomnia or nightmares), taste disorders
• Increase in transaminases or increased bilirubin (increased amounts of certain substances in the blood)
• Rash, itching (pruritus), or hives (urticaria)
• Joint pain
• Poor kidney function
• Unspecific pain, feeling unwell, or fever
• Increase in blood alkaline phosphatase (a certain substance in the blood)

Less frequent side effects include:

• Antibiotic-related colitis (inflammation of the bowel linked to antibiotic use)
• Leukopenia, anaemia, neutropenia, leucocytosis (changes in blood count), thrombocytopenia or thrombocytaemia (increased or decreased amounts of blood platelets), haemolytic anaemia (a special type of anaemia due to red blood cell destruction), agranulocytosis (a drop in a type of white blood cells), or pancytopenia (a dangerous drop in the number of red and white blood cells and platelets) which may be life-threatening; or bone marrow depression, which may also be life-threatening
• Allergic reaction, allergic oedema (Swelling) or angioedema (rapid swelling of the skin and mucous membranes), anaphylactic reaction (allergic reaction), anaphylactic shock (severe allergic reaction which may be life-threatening); serum sickness-like reaction (an allergic reaction)
• Blood glucose disorders, low blood glucose (hypoglycaemia), high blood glucose (hyperglycaemia) or other changes in blood glucose
• Confusion and disorientation, anxiety reactions, abnormal (strange) dreams, depression which may lead to self-harm, such as thoughts of suicide and attempted or completed suicide, or hallucinations, psychotic reactions (mental disturbances) that may lead to self-harm such as suicidal ideations/thoughts and attempted or completed suicide
• Paraesthesia (‘pins and needles’), dysesthesia (disturbed sensation) or hypoesthesia (reduced sensation), tremors, seizures including status epilepticus (prolonged or repeated fits or seizures without any recovery between attacks), vertigo, migraine, disturbed coordination, smell disorders, hyperesthesia (increased sensitivity to stimuli), or intracranial hypertension including pseudotumour cerebri (pressure on the brain)
• Visual disturbances (eyesight problems), visual colour distortions
• Tinnitus (ringing in the ears), loss of hearing, impaired hearing
• Tachycardia (rapid heartbeat)
• Vasodilatation (expansion of blood vessels), hypotension (low blood pressure), or syncope (fainting), inflammation of the walls of the blood vessels (vasculitis)
• Dyspnoea (shortness of breath) including asthmatic condition
• Pancreatitis (inflammation of the pancreas)
• Hepatic impairment (liver disorders), jaundice, or non-infective hepatitis, liver necrosis very rarely progressing to life-threatening hepatic failure
• Photosensitivity reactions (sensitivity to light), or blistering (blistering of the skin), petechiae (small, pin-point bleeding under the skin), erythema multiforme, erythema nodosum (various skin eruptions, blisters, peeling or rashes); Stevens-Johnson syndrome or toxic epidermal necrolysis which may be life-threatening (severe allergic skin reactions)
• Myalgia (muscle pain), arthritis (inflammation of the joints), or increased muscle tone and cramping, muscular weakness, tendinitis, tendon rupture predominantly Achilles tendon (especially of the large tendon at the back of the ankle), or exacerbation of symptoms of myasthenia gravis (worsening of the symptoms of myasthenia gravis, a muscle weakness)
• Renal failure (kidney failure), haematuria (blood in the urine), crystalluria (crystals in the urine) or tubulointerstitial nephritis (a type of urinary tract inflammation)
• Sweating (hyperhidrosis) (excessive sweating), gait disturbance (unsteady walk)
• Abnormal prothrombin (a clotting factor) level or increased amylase (increased levels of the enzyme amylase)

In isolated instances, some serious adverse drug reactions may be long-lasting (> 30 days) and disabling; such as tendinitis, tendon rupture, musculoskeletal disorders, and other reactions affecting the nervous system including psychiatric disorders and disturbance of senses. The following side effects were reported with other medicines in the fluoroquinolone family: pseudotumour cerebri (pressure on the brain); High levels of sodium (hypernatremia) and calcium (hypercalcaemia) in the blood; haemolytic anaemia (a special type of anaemia due to red blood cell destruction). This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. 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 or pharmacist. You can also report side effects to SAHPRA via Med Safety APP (Medsafety X SAHPRA) and platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of CIPROBAY.

Keep out of reach and sight of children. Do not use after the expiry date stated on the label. Return unused or expired medicines to your pharmacist for safe disposal.

CIPROBAY film-coated tablets

Store the medication at or below 25 °C. Do not refrigerate or freeze. Store all medicines out of the reach of children. Do not store in bathrooms. Do not remove from the original packaging until administered.

CIPROBAY oral suspension Granules

Do not store above 25 °C.

Solvent

Do not store above 25 °C. Protect from freezing. Store the suspension in an upright position. When reconstituted as directed utilizing the individual components, the final mixed ready-to-use suspension is stable at room temperature (up to 25 °C) for 14 days. After this time the final mixed suspension should not be taken.