Ciprobay IV 100 mg/200 mg/400 mg Solution

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.

CIPROBAY should not be administered to you:

• 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.

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself CIPROBAY. It will be given by a healthcare professional who is qualified to do so.

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. Tell your doctor if you suffer from kidney problems because your dose may need to be adjusted.

Your doctor or nurse will give you each dose of the solution for infusion through a needle, into a vein and then into your bloodstream. The infusion duration is 60 minutes.

Your skin may show a reaction at the site where the needle is inserted. This will usually clear up once the infusion is finished.

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 received more CIPROBAY than you should, in the event of overdosage your doctor will take the necessary corrective action.

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 receiving 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. CIPROBAY should be stopped and your doctor be informed 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 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;
• 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.

Store all medicines out of the reach and sight of children. Do not store in bathrooms. Do not store above 30 °C. Protect from light, avoid excessive heat. Do not refrigerate or freeze. At cool storage temperatures precipitation may occur, which will re-dissolve at room temperature. Do not remove from the original packaging until administered. Do not use after the expiry date stated on the label. Return unused or expired medicines to your pharmacist for safe disposal.