Levofloxacin 5 mg/100 ml Solution

LEVOFLOXACIN FRESENIUS is an antibiotic which is used to treat various bacterial infections in adults such as sinus and lung infections, urinary tract infections and skin infections, when the oral route is not suitable.

LEVOFLOXACIN FRESENIUS should not be given to you:

• if you had a previous allergic reaction to levofloxacin or to other similar medicines called quinolones, or to any of the ingredients of LEVOFLOXACIN FRESENIUS (listed in section 6)
• if you have epilepsy or a history of seizures
• if you have a history of tendon disorders associated with previous fluoroquinolone antibiotic use
• if you are a child or growing adolescent under the age of 18 years
• if you are pregnant or breastfeeding
• if you have problems with your heart valves, unless no safer alternate antibiotic is available, has failed or is not well tolerated.

Warnings and precautions

Tell your doctor or healthcare provider before being given the injection: Take special care with LEVOFLOXACIN FRESENIUS:

• if you are prone to seizures e.g. if you have a central nervous system disorder
• if you are taking any of the medicines mentioned under “ Other medicines and LEVOFLOXACIN FRESENIUS ”
• if you experienced serious side effects in the past when using medicines called quinolones or fluoroquinolones
• if you experience serious allergic (hypersensitivity) reactions – see “ If any of the following happens, stop receiving LEVOFLOXACIN FRESENIUS and tell your doctor immediately ”
• if you develop severe, persistent and/or bloody loose stools during or after treatment with LEVOFLOXACIN FRESENIUS, including several weeks after treatment
• if you experience symptoms of tendinitis, e.g. painful swelling and inflammation especially of the Achilles tendon which is the connective tissue that connects the calf muscle to the heel.

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

You will receive LEVOFLOXACIN FRESENIUS through a needle placed into a vein. Your doctor will decide on the appropriate dose of LEVOFLOXACIN FRESENIUS depending on the type of infection you have and if you have any other medical conditions.

If you receive more LEVOFLOXACIN FRESENIUS than you should Since a healthcare provider will administer LEVOFLOXACIN FRESENIUS, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to receive LEVOFLOXACIN FRESENIUS Since a healthcare provider will administer LEVOFLOXACIN FRESENIUS, it is unlikely that the dose will be missed.

LEVOFLOXACIN FRESENIUS may have side effects. Not all side effects reported for LEVOFLOXACIN FRESENIUS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving LEVOFLOXACIN FRESENIUS, please consult your healthcare provider for advice.

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

• Allergic (hypersensitivity) reactions including itching, skin rash, hives, angioedema (swelling of the face, lips, tongue or throat), fever, low blood pressure (dizziness), cough or other lung symptoms, difficulty breathing, shock (cold, clammy skin, irregular breathing, weakness, anxiety).
• Restlessness, nervousness, trembling or shaking, anxiety, changes in mood, self-endangering behaviour including suicidal thoughts or suicide attempt, hallucinations, paranoia, seizures or fits, brain disease, confusion, coma.
• Fainting.
• Severe, persistent and/or bloody loose stools.
• Liver problems such as loss of appetite, jaundice (yellowing of the skin and the whites of the eyes), dark urine, itchy skin, tender abdomen, severe liver injury, sudden liver failure, hepatitis.
• Dangerously low blood sugar levels, coma.
• Heart problems including sudden stomach, chest or back pain, difficulty breathing, irregular, fast or pounding heartbeat, swelling of the stomach, legs or feet, heart attack.
• Nausea, feeling generally unwell, discomfort or pain in the stomach area or vomiting. These could be signs of an inflamed pancreas (acute pancreatitis). See section 2.

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

Tell your doctor if you notice any of the following:

Frequent side effects:

• Sleep disturbances including trouble sleeping.
• Headache.
• Dizziness.
• A feeling of movement or spinning (vertigo).
• Inflammation of a vein.
• Nausea, vomiting, diarrhoea and stomach or abdominal cramps.
• Increases in liver enzymes.
• Pain or reddening of the skin where the injection is given.

Less frequent side effects:

• Tendon problems, e.g. painful swelling and inflammation especially of the Achilles tendon which is the connective tissue that connects the calf muscle to the heel.
• Fungal or other infections including vaginal thrush.
• Abnormal reduction in the number of red blood cells, white blood cells, and blood platelets in the blood.
• Increase in blood bilirubin, a substance produced by your liver.
• A condition where your body makes too much of the hormone called antidiuretic hormone.
• Low blood sugar levels.
• Low blood pressure (dizziness) or a sudden drop in blood pressure while receiving LEVOFLOXACIN FRESENIUS.
• Depression.
• Abnormal dreams, nightmares.
• Drowsiness.
• Abnormal lack of energy, tiredness.
• Difficulty walking.
• Loss of appetite.
• Taste disturbances.
• Visual disturbances including blurred vision.
• Ringing in the ears.
• A feeling of pins and needles usually in the arms and legs, including pain, burning, tingling, numbness or weakness.
• Swelling.
• Hot flushes.
• Excessive sweating.
• Fever.
• Shortness of breath.
• Stomach pain, indigestion, gas, constipation.
• Pain in your joints (arthralgia).
• Muscle pain and weakness.
• Kidney problems including kidney stones, sudden kidney failure.
• Enlargement of one or both breasts in men because of a hormonal imbalance.

Frequency unknown:

• A torn tendon, e.g. of the Achilles tendon which is the connective tissue that connects the calf muscle to the heel.
• Weakness, numbness and pain usually in the hands and feet.
• Involuntary, erratic, writhing movements of the face, arms, legs or trunk.
• Muscle injury or torn muscles.
• Torn ligaments.
• Pain and inflammation in your joints (arthritis).
• Pain, including pain in back, chest, arms and legs.
• High blood sugar levels.
• Increased pressure inside the skull.
• Problems with memory, i.e. problems remembering things.
• Loss of taste.
• Smell disturbances including loss of smell.
• Temporary vision loss.
• Hearing problems, hearing loss.
• Tight chest.
• Inflammation of the pancreas which causes severe pain in the abdomen and back.
• Sensitivity to light, skin reactions when exposed to sunlight or sun beds.
• Inflamed or sore mouth.
• Attacks of porphyria in patients with porphyria.
• Bleeding problems.
• Bone marrow stops producing new blood cells, this may cause tiredness, lower ability to fight infection and uncontrolled bleeding (bone marrow failure).
• Feeling very excited, elated, agitated or enthusiastic (mania).
• Darker areas of skin (hyperpigmentation).
• Sudden involuntary jerks, twitches of the muscles or muscle contractions (myoclonus).

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 Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who- umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of LEVOFLOXACIN FRESENIUS.

Patients are asked to report any suspected adverse drug reactions to their healthcare provider or Holder of the Certificate of Registration at the following email address: [email protected] and to the relevant medicine’s regulatory authority in the country where the product is marketed.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from light. Keep in outer container until required for use. Do not refrigerate or freeze. Use within 3 hours after perforation of the rubber stopper. For single use. Discard unused portion.

Please return expired medicine to your pharmacist for safe disposal.