Ampicillin 250 mg Solution

The active substance is ampicillin sodium. Ampicillin is a penicillin type of antibiotic. Ampicillin can kill certain bacteria which cause infections. AMPICILLIN FRESENIUS is used for the treatment of certain infections caused by sensitive organisms.

AMPICILLIN FRESENIUS should not be administered to you:

• if you are hypersensitive (allergic) to ampicillin, other penicillins or any other antibiotics, such as cephalosporins otherwise also known as beta-lactam antibiotics.
• in new-born babies whose mothers are allergic to penicillin.
• in the eye.

Warnings and precautions

Tell your doctor or health care provider before being given the injection/infusion:

• If you have a history of other allergies;
• Tell your doctor if you are allergic to penicillins, cephalosporins, any other medications, or have a history of allergy. Serious and sometimes fatal allergic reactions are more likely to occur in patients with a history of penicillin allergy or other allergies.
• Your healthcare professional should observe you for at least one hour after you have been administered AMPICILLIN FRESENIUS.
• AMPICILLIN FRESNIUS should be stopped and emergency help given if you have any of these signs of a severe allergic reaction: difficulty breathing; swelling of your face, lips, tongue or throat.
• if you have infectious mononucleosis (also known as mono, an infection most commonly caused by the Epstein–Barr virus) - see Possible side effects;
• if you have HIV infection;
• if you have lymphatic leukaemia (a type of cancer of the blood and bone marrow) or neutropenia (a low number of certain white blood cells);
• if you are treated for syphilis – see the Jarisch-Herxheimer adverse reaction under Possible side effects;
• if you have persistent diarrhoea - see Possible side effects;
• if you have kidney problems;
• if you have heart problems;
• if you have liver problems such as hepatitis or jaundice;
• if you are on a low sodium (salt) diet;
• if you have a bleeding or blood clotting disorder;
• if a skin rash occurs, AMPICILLIN FRESENIUS injection should be stopped;
• A serious form of diarrhoea (pseudomembranous colitis) may develop if you use AMPICILLIN FRESENIUS for a long period of time. Contact your doctor right away if stomach pain or cramps, severe diarrhoea, or bloody stools occur;
• During long-term treatment, your doctor may want to take routine blood tests to monitor your kidney function, liver function and levels of blood cells;
• Following long-term treatment, numbness, tingling, pins and needles have rarely been reported;
• AMPICILLIN FRESENIUS may interfere with certain urine glucose tests. Penicillins which are excreted in urine can cause a false-positive result. Your doctor will request a test which is not affected by penicillins;
• AMPICILLIN FRESENIUS may interfere with certain laboratory tests. Be sure your doctor and laboratory personnel know you are using AMPICILLIN FRESENIUS;
• If you are receiving high doses, make sure that you take enough fluids;
• Lignocaine (lidocaine)–and benzyl alcohol should only be used together with AMPICILLIN FRESENIUS when AMPICILLIN FRESENIUS is injected into a muscle, and must not be given into a vein.

Other medicines and AMPICILLIN FRESENIUS

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

Tell your doctor if you are taking any of the following medicines:

• Allopurinol (a medicine used for gout)-There is an increased possibility of skin rashes occurring in patients taking AMPICILLIN INJECTION together with allopurinol;
• Antibiotics (aminoglycosides such as gentamycin)-There is an increased possibility of substantial inactivation of the aminoglycoside in patients receiving AMPICILLIN INJECTION together with the aminoglycoside;
• Antibiotics (beta-lactams such as cephalosporins)-There is an increased possibility of substantial mutual inactivation of both the aminoglycoside and AMPICILLIN FRESENIUS when administered concurrently in the same syringe;
• Oral contraceptives containing oestrogens; AMPICILLIN FRESENIUS may decrease the effectiveness of birth control pills. Use an alternative or additional method of birth control while taking AMPICILLIN FRESENIUS to protect against pregnancy;
• Methotrexate for the treatment of certain cancers. AMPICILLIN FRESENIUS may decrease the removal of methotrexate from the body, increasing the risk of its side effects. Your doctor may want to monitor the amount of methotrexate in your blood if you are receiving methotrexate treatment in combination with AMPICILLIN FRESENIUS. Leucovorin doses may need to be increased and administered for longer periods of time;
• NSAIDs (non-steroidal anti-inflammatory drugs) or salicylates (e.g. aspirin) – The risk of bleeding is increased when these medicines are used together with AMPICILLIN FRESENIUS;
• ACE inhibitors, potassium-sparing diuretics, potassium containing medicines or potassium supplements- Use of these medicines together with AMPICILLIN FRESENIUS may cause too much potassium in the blood, especially in patients with kidney problems;
• Anticoagulant treatment used to prevent blood clots (warfarin), when used in combination with AMPICILLIN FRESENIUS may increase the risk of haemorrhage. If your blood is drawn for laboratory tests, inform the healthcare provider that you have received AMPICILLIN FRESENIUS, as it may affect the outcome of some tests, such as the antiglobulin (Coombs’) test and some urinary sugar tests.

Do not share medicines prescribed for you with any other person. Your doctor will tell you how long your treatment with AMPICILLIN FRESENIUS will last. You will receive AMPICILLIN FRESENIUS by injection into a muscle (intramuscularly) or into a vein (intravenously). If you have the impression that the effect of AMPICILLIN FRESENIUS is too strong or too weak, tell your doctor or pharmacist. You will not be expected to give yourself AMPICILLIN FRESENIUS. It will be given to you by a person who is qualified to do so.

If you receive more AMPICILLIN FRESENIUS than you should Since a healthcare provider will administer AMPICILLIN FRESENIUS, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. Overdose symptoms are usually asymptomatic but may include increased gastrointestinal side effects such as nausea, vomiting and diarrhoea.

If you have not received a dose of AMPICILLIN FRESENIUS Since a health care provider will administer AMPICILLIN FRESENIUS, it is unlikely that the dose will be missed.

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

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

• swelling of the tongue, lips or throat, difficulty breathing or tightness of the chest;
• skin rash, red skin with fever and aching joints, peeling of skin, hives or itchy skin;
• fever, chills, headaches, reactions at the site of the lesion, problems with vision (known as the Jarisch-Herxheimer reaction) that may occur if you are treated with medicines for syphilis;
• severe and persistent watery diarrhoea with cramps and fever;
• yellowing of the skin and eyes (jaundice);
• Urinating less than usual or not at all.

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

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

• pain on the kidney with difficult urination and blood in the urine (interstitial nephritis);
• thrush or infections with other germs (you may feel feverish and tired);
• fits (convulsions);
• if you notice after an injury or a nose bleed that your blood does not clot as quickly as before;
• pain or bruising at the injection site, muscle and joint pain;
• crystals in the urine.

Laboratory tests can reveal: A positive Coomb’s test (antiglobulin test), increased liver enzyme values, changes in sodium and potassium levels. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent side effects:
• nausea (feeling sick)
• vomiting
• diarrhoea
• Less frequent side effects:
• anaemia (tiredness, being short of breath and looking pale);
• skin rash, red skin with fever and aching joints, peeling of skin, hives or itchy skin;
• Too few white blood cells (sore throat and fever);
• numbness, tingling, pins and needles;
• thrush (white patches inside your mouth or throat, vaginal itching or discharge);
• increased muscular activity;
• dizziness; nausea (queasiness, feeling that one is about to vomit);
• inflammation of the mouth; inflammation of the tongue; black hairy tongue;
• heartburn;
• inflammation of the blood vessels.

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 AMPICILLIN 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 30 °C in a dry place. Return all unused medicine to your pharmacist. Do not freeze. Protect from light. Do not dispose of unused medicine in the drains or sewerage systems (e.g. toilets).