The active substance is Amoxicillin Trihydrate. This medicine belongs to the Penicillin group.
It is an antibiotic used to treat infections of the respiratory organs, gastro-intestinal organs and other infections caused by organisms that are susceptible to Amoxicillin.
1. What AMOXYCILLIN AUSTELL is and what it is used for
2. What you need to know before you take AMOXYCILLIN AUSTELL
Do not take AMOXYCILLIN AUSTELL:
• if you are hypersensitive (allergic) to amoxicillin or penicillins or cephalosporins or to any of the other ingredients.
• if you have ever had an allergic reaction to any antibiotic. This can include a skin rash or swelling of the face or throat.
• if you have been diagnosed with or are suspected of having infectious mononucleosis
Warnings and precautions
• if you have glandular fever (fever, sore throat, swollen glands and extreme tiredness)
• if you have kidney problems
• if you are not urinating regularly.
If you are having:
• Urine tests (glucose) or blood tests for liver function
• Oestriol tests (used during pregnancy to check the baby is developing normally)
Tell your doctor or pharmacist that you are taking AMOXYCILLIN AUSTELL. This is because AMOXYCILLIN AUSTELL can affect the results of these tests.
Other medicines and AMOXYCILLIN AUSTELL
Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.) AMOXYCILLIN AUSTELL may reduce the effectiveness of the oral contraceptive pill, and you should therefore take extra precautions e.g. use a condom during your treatment.
AMOXYCILLIN AUSTELL with food, drink and alcohol
You may take this medicine with or without food.
Pregnancy, breastfeeding and fertility
AMOXYCILLIN AUSTELL is distributed into breast milk. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking AMOXYCILLIN AUSTELL.
Driving and using machines
It is not always possible to predict to what extent AMOXYCILLIN AUSTELL may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which AMOXYCILLIN AUSTELL affects them.
3. How to take AMOXYCILLIN AUSTELL
Always take AMOXYCILLIN AUSTELL exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The capsules are usually taken every eight hours. Swallow the capsules whole with a little water. Do not chew. AMOXYCILLIN AUSTELL capsules are prescribed as a course of treatment and must be taken regularly over a number of days until all the capsules have been completed. If you have the impression that the effect of AMOXYCILLIN AUSTELL is too strong or too weak, talk to your doctor or pharmacist.
Duration of administration
Your doctor will tell you how long your treatment with AMOXYCILLIN AUSTELL will last. Do not stop treatment early because, if you have the impression that the effect of AMOXYCILLIN AUSTELL is too strong or too weak, tell your doctor or pharmacist.
Method of administration
AMOXYCILLIN AUSTELL is for oral administration.
If you take more AMOXYCILLIN AUSTELL than you should:
In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control center.
If you forget to take AMOXYCILLIN AUSTELL
Do not take a double dose to make up for forgotten individual doses. Take the next dose when it is time.
If you stop taking AMOXYCILLIN AUSTELL
Do not stop taking your medicine even if you feel better. The course of treatment prescribed for you should be completed to avoid the risk of a relapse.
4. Possible side effects
AMOXYCILLIN AUSTELL can have side effects. Not all side effects reported for AMOXYCILLIN AUSTELL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking AMOXYCILLIN AUSTELL, please consult your health care provider for advice. If any of the following happens, stop taking AMOXYCILLIN AUSTELL and tell your doctor immediately or go to the casualty department at your nearest hospital:
• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting. These are very serious side effects. If you have them, you may have had a serious reaction to AMOXYCILLIN AUSTELL. You may need urgent medical attention or hospitalisation.
Tell your doctor if you notice any of the following:
Frequent side effects:
• diarrhoea
• nausea (feeling sick)
• skin rash
• upset stomach
• stomach pain
Less frequent side effects:
• mucocutaneous candidiasis
• reversible leucopenia (including severe neutropenia or agranulocytosis)
• reversible thrombocytopenia and haemolytic anaemia.
• prolongation of bleeding time and prothrombin time
• severe allergic reactions, including angioneurotic oedema, anaphylaxis, serum sickness and hypersensitivity vasculitis
• hyperkinesia
• dizziness
• convulsions
• vomiting
• antibiotic associated colitis (including pseudomembraneous colitis and haemorrhagic colitis
• black hairy tongue
• hepatitis and cholestatic jaundice. A moderate rise in AST and/or ALT
• urticaria and pruritus
• skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis, acute generalised exanthematous pustulosis (AGEP) and medicine reaction with eosinophilia and systemic symptoms (DRESS).
• interstitial nephritis
• headache
Side effects with frequency unknown:
• Jarisch-Herxheimer reaction
• aseptic meningitis
• hypersensitivity reaction that affects your arteries that pump blood away from your heart, this may cause a heart attack or other heart problems.
• medicine-induced enterocolitis syndrome
• hypersensitivity reaction that causes blisters in the skin (in the mouth, genitals or eyes).
• crystalluria (including acute renal injury)
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 AMOXYCILLIN AUSTELL. Suspected side effects can also be reported directly to the Holder of the Certificate of Registration via [email protected]
5. How to store AMOXYCILLIN AUSTELL
Keep all medicines out of the reach and sight of children. Do not store above 25 C. Keep the blister pack in the carton until required for use to protect from light. Keep the container well closed.
Do not use after the expiry date stated on the label. Return any unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems.