Cloxacillin Fresenius 250 mg Solution

CLOXACILLIN FRESENIUS belongs to the antibiotic group of medicines known as the penicillins.

CLOXACILLIN FRESENIUS is used to treat bacterial infections of the skin, bone, blood, heart valve, heart’s inner lining and lungs.

CLOXACILLIN FRESENIUS should not be administered to you:

• If you are hypersensitive (allergic) to cloxacillin, penicillins or any other ingredients of CLOXACILLIN FRESENIUS (see WHAT CLOXACILLIN FRESENIUS CONTAINS).
• If you are hypersensitive (allergic) to cephalosporin antibiotics, such as cephalexin and cefuroxime, you may also be allergic to penicillin antibiotics.
• CLOXACILLIN FRESENIUS should not be used as an eye drop.
• CLOXACILLIN FRESENIUS should not be injected into the eye or spine.

Warnings and precautions

Tell your doctor or healthcare provider before being given the injection:

• if you have kidney problems.
• if you have syphilis.

Your doctor may need to monitor your kidney function and blood during treatment with CLOXACILLIN FRESENIUS.

Take special care with CLOXACILLIN FRESENIUS:

• In newborn babies with jaundice (yellow colouration of the skin and eye).
• If you are breastfeeding. CLOXACILLIN FRESENIUS is excreted in breast milk and may affect your baby.
• If you have a condition called porphyria. CLOXACILLIN FRESENIUS may cause porphyria attack.

CLOXACILLIN FRESENIUS cannot be used together with the following antibiotics due to incompatibility: aminoglycosides, tetracyclines, erythromycin and polymyxin B.

Your doctor may need to monitor your kidney function and blood during treatment with CLOXACILLIN FRESENIUS.

Sensitivity reactions may include skin rashes, difficulty in breathing, swelling under the skin and itchy skin.

Your doctor may decide to perform a skin test for allergy, to determine if you are likely to develop an allergic reaction to penicillins.

Children and adolescents

Take special care with CLOXACILLIN FRESENIUS in newborn babies with jaundice (yellow colouration of the skin and eye).

Other medicines and CLOXACILLIN FRESENIUS

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines).

The use of CLOXACILLIN FRESENIUS with other medicines you are taking on a regular basis, including complementary medicines (such as vitamin supplements) or traditional medicines, may cause undesirable interactions.

• Aminoglycoside antibiotics interact with CLOXACILLIN FRESENIUS causing both antibiotics to become inactive. Never use these antibiotics together.
• CLOXACILLIN FRESENIUS may also interact with other antibacterial medicines such as chloramphenicol and tetracyclines.
• Blood thinning medication e.g. warfarin.
• Methotrexate – an immune suppressant medicine.

Oral contraceptives – CLOXACILLIN FRESENIUS may decrease the effectiveness of birth control pills. Use a second method of birth control while taking CLOXACILLIN FRESENIUS to protect against pregnancy.

Probenecid- medicine use for gout.

Not all the medicines that may interact with CLOXACILLIN FRESENIUS are listed above.

Do not share medicines prescribed for you with any other person.

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

CLOXACILLIN FRESENIUS is given as an injection into a vein (intravenous), into a muscle (intramuscularly), into the heart (intrapleural) or into the joint (intra-articular). Your doctor will determine the correct dose of CLOXACILLIN FRESENIUS depending on your condition. To clear up your infection completely, CLOXACILLIN FRESENIUS will be administered for the full course of treatment, even if you feel better in a few days. Your doctor will tell you how long your treatment with CLOXACILLIN FRESENIUS will last.

If you have the impression that the effect of CLOXACILLIN FRESENIUS is too strong or too weak, tell your doctor or pharmacist.

If you receive more CLOXACILLIN FRESENIUS than you should:

Since a healthcare provider will administer CLOXACILLIN FRESENIUS to you, he/she will control the dosage. However, in the event of overdosage, your doctor will manage the overdosage.

If you missed a dose of CLOXACILLIN FRESENIUS:

Since a healthcare provider will administer CLOXACILLIN FRESENIUS, it is unlikely that the dose will be missed.

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

If any of the following happens, stop taking / using CLOXACILLIN FRESENIUS and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Skin: Itching, flushing, hives or swelling
• Eyes: Itching, tearing, redness or swelling of the skin around the eyes
• Nose and mouth: Sneezing, nasal congestion, swelling of the tongue
• Lungs and throat: Difficulty getting air in or out, chest tightness, throat swelling or itching
• Fits
• Unusual bleeding or bruising
• Decreased amount of urine
• Swelling of your face or lips
• Any signs of recurrent infections such as fever or sore throat

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

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

• Sore mouth and tongue
• Diarrhoea, nausea, vomiting
• Pain and swelling where CLOXACILLIN FRESENIUS was injected into your body
• Headaches
• Fever
• Unusual tiredness
• Joint pains
• Black hairy tongue
• Heartburn
• Flatulence

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 CLOXACILLIN 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 at or below 25 °C. Solutions for injection should preferably be freshly prepared but will retain their antibacterial potency for 24 hours at room temperature or for 4 days at 4 °C. Store all medicines out of reach of children. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).