Ciprofloxacin Fresenius 2 mg Solution

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

CIPROFLOXACIN FRESENIUS is used in adults to treat severe and/or complicated bacterial infections of the lower respiratory tract (lungs), urinary tract (kidneys or bladder), skin and soft tissue, gastro-intestinal tract (stomach or intestines), or bone.

You should not be given CIPROFLOXACIN FRESENIUS:

• If you are hypersensitive (allergic) to ciprofloxacin, any other quinolones, or any of the inactive ingredients (listed in section 6),
• If you are taking other medicines that result in abnormal heart rate and/or rhythm tracing (ECG) e.g. QT time prolongation.
• If you have or you are born with any condition with abnormal heart rhythm whether related to QT time prolongation or not (seen on electrical recording of the heart (ECG).
• If you are pregnant or breastfeeding your baby.
• If you have a muscle disorder called myasthenia gravis. (abnormal muscle fatigue, muscle weakness leading to paralysis in severe cases.
• If you also take tizanidine (a medicine used to relax the muscles).
• 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 disorders).
• If you have an enlargement of “bulge” of a large blood vessel (aortic aneurysm) or a previous episode of a tear in the aortic wall (aortic dissection) or a family history of aortic aneurysm/ dissection or other risk factors or predisposing conditions.
• If you have confirmed mitral valve/aortic heart valve which cannot close properly (leakage of blood backward through the valve) unless no safer appropriate antibiotic is available, has failed or is not well tolerated.
• If you take high blood pressure medicines of the angiotensin-converting enzyme (ACE) inhibitors /angiotensin receptor blockers type. If you are unsure ask your doctor.
• If you are younger than 18 years of age.

Warnings and precautions

Tell your doctor or healthcare provider before being given CIPROFLOXACIN FRESENIUS 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 (see “ You should not be given CIPROFLOXACIN FRESENIUS”)
• have a history of tendon problems during previous treatment with antibiotics such as CIPROFLOXACIN FRESENIUS (see “ You should not be given CIPROFLOXACIN FRESENIUS”).
• have a muscle disorder called myasthenia gravis (see “ You should not be given CIPROFLOXACIN FRESENIUS”).

You will not be expected to give yourself CIPROFLOXACIN FRESENIUS. It will be given to you by a person who is qualified to do so.

CIPROFLOXACIN FRESENIUS will be administered to you as an infusion through a needle into a vein. The infusion duration is 60 minutes.

Your doctor will decide on the suitable dose and duration of the treatment based on the type and severity of the infection that you have. Tell your doctor if you suffer from kidney problems as your dose may need to be adjusted.

You may show a skin reaction at the injection site. This will clear up once the infusion is completed.

Elderly: The 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 receive more CIPROFLOXACIN FRESENIUS than you should: Since your healthcare provider will administer this medicine, he/she will control the dosage. However, in the event of overdosage, your doctor will treat the side effects symptomatically.

CIPROFLOXACIN FRESENIUS can have side effects. Not all side effects reported for CIPROFLOXACIN FRESENIUS are included in this leaflet.

Should your general health worsen or if you experience any untoward effects while receiving CIPROFLOXACIN FRESENIUS, please consult your doctor, pharmacist or healthcare provider for advice.

If any of the following happens, stop receiving CIPROFLOXACIN FRESENIUS and tell your doctor immediately:

• allergic reactions which may include swelling of the skin and mucous membranes of the face, lips tongue and throat, which may cause difficulty in breathing (angio- oedema);
• 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, intense and persistent abdominal or back pain;
• 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;
• watery diarrhoea which may have blood in it;
• confusion, hallucinations, depression, unusual thoughts or behaviour;
• seizures/convulsions;
• pale or yellowed skin, dark coloured urine, fever, weakness; urinating less than usual or not at all;
• easy bruising or bleeding;
• burning, tingling, pain or numbness weakness or unusual pain in your body;

These are very serious side effects. If you have them, you may have a serious allergic reaction to CIPROFLOXACIN FRESENIUS. You may need medical attention.

The following frequent side effects include:

• nausea, diarrhoea,
• injection site reaction

The following side effects may occur less frequently:

• yeast/mould superinfections, inflammation of the bowel linked to antibiotic use (antibiotic-related colitis)
• high concentration of type of white blood cells (eosinophils), changes in blood count (leukopenia, anaemia, neutropenia, leucocytosis, increased or decreased amounts of blood platelets (thrombocytopenia or thrombocytaemia),
• a special type of anaemia due to red blood destruction (haemolytic anaemia),
• a drop in a type of white blood cells (agranulocytosis) or a dangerous drop in the number of red and white blood cells and platelets (pancytopenia) which may be life-threatening,
• bone marrow depression, which may also be life-threatening,
• allergic reaction, swelling (oedema) or rapid swelling of the skin and mucous membranes (angioedema), severe allergic reaction which may be life-threatening (anaphylactic shock); an allergic reaction (serum sickness-like reaction),
• loss of appetite (anorexia), blood glucose disorders: low blood sugar levels (hypoglycaemia), high blood sugar levels (hyperglycaemia),
• hyperactivity/agitation, confusion and disorientation, anxiety reactions, abnormal (strange) dreams, depression or hallucinations, mental disturbances (psychotic reactions) which may lead to self-harm, such as thoughts of suicide and attempted or completed suicide,
• headache, dizziness, sleep problems (insomnia or nightmares), taste disorders, pins and needles (paraesthesia), disturbed sensation (dysesthesia) or reduced sensation (hypoesthesia), 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 pseudo tumour 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), inflammation of the blood vessels (phlebitis or thrombophlebitis),
• dyspnoea (shortness of breath) including asthmatic condition,
• vomiting, stomach and abdominal pain, indigestion/heartburn, flatulence (gas), pancreatitis (inflammation of the pancreas),
• increase in transaminases or increased bilirubin (substances in blood), hepatic impairment (liver disorders), jaundice, or non-infective hepatitis, liver necrosis very rarely progressing to life-threatening hepatic failure,
• skin rashes (itching or hives), 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),
• joint pain, muscle pain (myalgia), 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), worsening of the symptoms of myasthenia gravis, a muscle weakness,
• poor kidney function, kidney failure, blood in the urine (haematuria), crystals in the urine (crystalluria) or a type of urinary tract inflammation (tubule-interstitial nephritis),
• unspecific pain, fever or feeling unwell, unsteady walk (gait disturbance), excessive sweating,
• increase in blood alkaline phosphatase, abnormal clotting (prothrombin) factor level or increased levels of the enzyme amylase (increased amylase).

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 CIPROFLOXACIN FRESENIUS.

• Store all medicines out of reach of children

• Store at or below 25 °C.

• Protect from light.

• Store the infusion bag/bottle pack in the outer container until ready to use.

• Do not refrigerate or freeze.

• Do not use after the expiry date printed on the label or carton.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).