Dynafloc

DYNAFLOC 500 belongs to a group of antibiotics called fluoroquinolones. DYNAFLOC 500 works by killing bacteria that cause infections. It only works with specific strains of bacteria. DYNAFLOC 500 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 DYNAFLOC 500:

• if you are hypersensitive (allergic) to ciprofloxacin and other quinolones, or any of the other ingredients of DYNAFLOC 500 (see section 6)
• if you are on treatment for high blood pressure with medicines called ACE inhibitors/angiotensin receptor blockers. Ask your doctor if you are unsure
• if you also use medicine containing fluoroquinolones and have moderate to severe kidney impairment
• 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 or your child are younger than 18 years
• if you are pregnant or breastfeeding your baby (see Pregnancy and breastfeeding)
• if you have myasthenia gravis (abnormal muscle fatigue leading to weakness and, in serious cases, paralysis)
• 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 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 are also taking a muscle relaxing medicine called tizanidine.

Warnings and precautions

Take special care with DYNAFLOC 500:

• Tell your doctor:
• if have ever had kidney problems as your doctor may need to adjust the dose
• if you have heart problems. Caution should be taken when using DYNAFLOC 500, 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 DYNAFLOC 500 and Other medicines and DYNAFLOC 500)

Do not share medicines prescribed for you with any other person. Always take DYNAFLOC 500 exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will decide on your dose and adjust your dose where necessary, depending on your condition and whether you are an elderly patient. This will depend on the type and severity of infection you have. Adults: DYNAFOC 500 should be swallowed whole with plenty of liquid.

The dosage range is 250 - 750 mg twice daily. The treatment usually lasts from 5 - 21 days but may take longer for severe infections. For the treatment of invasive infections of Neisseria meningitides (a Gram-negative bacterium that can cause meningitis and other forms of meningococcal disease such as meningococcemia, a life-threatening sepsis), 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. Elderly patients should receive a dose as low as possible depending on the severity of their illness and how well their kidneys are working. You can take the tablets at meal times or between meals. Any calcium you take as part of a meal will not seriously affect uptake. However, do not take DYNAFLOC 500 with dairy products such as milk or yoghurt or with fortified fruit juices (e.g. calcium fortified orange juice). Remember to drink plenty of fluids while you are taking this medicine. Your doctor will tell you how long your treatment with DYNAFLOC 500 will last. Do not stop treatment early because your infection may not be cleared.

DYNAFLOC 500 can have side effects. Not all side effects reported for DYNAFLOC 500 are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using DYNAFLOC 500, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop using DYNAFLOC 500 and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to DYNAFLOC 500. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• sudden severe pain in your chest, abdomen (tummy) or back, fast or pounding heartbeats (QT prolongation), chest pain
• 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 the mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms (very rare side effects, potentially life-threatening)
• sudden pain, snapping or popping sound, bruising, swelling, tenderness, stiffness, or loss of movement in any of your muscles, ligaments, tendons, or joints
• worsening of myasthenia gravis (abnormal muscle weakness)
• increase in liver enzymes and jaundice (characterised by yellowing of skin and eyes), inflammation of the liver, and very seldom, liver failure

Store all medicines out of the reach of children. Store at or below 25 ºC, in a cool, dry place. Protect from light. Keep the blisters in the carton until required for use. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).