Austcelen 250 mg/500 mg Capsules

AUSTCELEN is an antibiotic. The active ingredient is amoxicillin. This belongs to a group of medicines called ‘penicillins’. AUSTCELEN are used to treat infection caused bacteria in different parts of the body.

Do not take AUSTCELEN

• if you are hypersensitive (allergic) to amoxicillin, penicillin, cephalosporin, or any of the other ingredients of AUSTCELEN (listed in section 6).
• if you have ever had an allergic reaction to any antibiotics. This can include a skin rash or swelling of the face or throat.

Do not take AUSTCELEN if any of the above apply. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking AUSTCELEN if you:

• previously had allergic reactions to antibiotics like penicillins, cephalosporins or other beta-lactam medicines. If you experience allergic reactions like skin rash or swelling of the face or throat, your health care provider may want to discontinue AUSTCELEN therapy and prescribe alternative therapy.
• have kidney problems, are receiving high dose or have a history of seizures or are on treatment for epilepsy as you may experience convulsions. If this happens your health care provider may want to discontinue AUSTCELEN therapy and prescribe alternative therapy.
• have kidney problems, as your health care provider may want to decrease your dose according to the degree of your kidney impairment.
• ever had or suddenly develop a fever with a severe outbreak of small blisters anywhere on the body with redness and swelling of the skin, especially at the beginning of treatment, as your health care provider will discontinue your treatment. You should not take antibiotics containing penicillin, like AUSTCELEN in future as the same allergic reaction can occur again.
• have Lyme’s disease (a disease caused by infected ticks with symptoms such as fever, headache, fatigue and a characteristic skin rash with a circular red area that sometimes clears in the middle, forming a bull's-eye pattern), as the use of AUSTCELEN may cause within 24 hours of treatment, symptoms like fever, chills, a sudden feeling of cold with shivering accompanied by a rise in temperature, often with sweating; nausea, vomiting, headache, fast heartbeat, low blood pressure, hyperventilation, redness and heat of your skin, muscle pains and worsening of skin wounds (called Jarisch-Herxheimer reaction (JHR))
• develop watery diarrhoea, abdominal cramps or pains, fever, nausea or observe pus or mucus in your stool, as you may have developed a serious and possibly life-threatening condition called antibiotic-associated colitis and will require urgent medical treatment. It is important that you do not use any medicine to stop the diarrhoea as this can make your condition worse.
• are on AUSTCELEN for a long time, as your health care provider may want to check your kidney, liver and blood functions.
• are not urinating regularly and are receiving high doses of AUSTCELEN, as you may develop crystals in your urine which may be seen as cloudy urine, or difficulty or discomfort in passing urine. You should maintain adequate fluid intake to reduce the possibility of these crystals from forming.
• are planning to have some tests, like blood sugar (glucose) or oestrogen (in pregnant woman) tests, as AUSTCELEN can affect these tests and give inaccurate results.

Other medicines and AUSTCELEN

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) AUSTCELEN may have effects on other medicine AUSTCELEN may weaken the effect of the following medicines

• oral contraceptives. AUSTCELEN may reduce the effectiveness of the oral contraceptives. You should use a reliable barrier method of contraception such as condoms while taking AUSTCELEN.
• or acenocoumarol (used to thin the blood and prevent blood clots) – this may lead to excessive bleeding. Your doctor may need to take regular blood tests to check how well your blood can clot and may need to adjust your dose of blood thinner.
• methotrexate (used to treat certain types of cancer or to control severe psoriasis or rheumatoid arthritis). AUSTCELEN may cause an increase in side effects of methotrexate, your doctor may temporarily stop your AUSTCELEN treatment.

Other medicines may interact with AUSTCELEN. The following medicines may increase the blood levels of amoxicillin and strengthen the effect of AUSTCELEN or lead to more unwanted side effects

• probenecid (used to treat chronic gout and gouty arthritis)
• allopurinol (used for gout), it may be more likely that you will experience an allergic skin reaction.

The following medicines may weaken the effect of AUSTCELEN

• antibiotics called tetracyclines (used to treat infections caused by bacteria).

Do not share medicines prescribed for you with any other person. Always take AUSTCELEN exactly as your doctor or pharmacist has instructed you. Check with your doctor or pharmacist if you are not sure.

The usual dose is:

• Adults and children over 12 years 250 mg of amoxycillin three times a day; 500 mg of amoxycillin may be required in some severe infections. In gonorrhoea the usual dose is the equivalent of 3 g given as a single dose, usually combined with 1 g probenecid.

Method of administration

• To be taken by mouth
• Swallow with enough water without opening capsule.

Duration of administration

Your doctor will tell you how long your treatment with AUSTCELEN will last. If you have the impression that the effect of AUSTCELEN is too strong or too weak, tell your doctor or pharmacist. Keep taking AUSTCELEN for as long as your doctor has told you to, even if you feel better. You need every dose to help fight the infection. If some bacteria survive, they can cause the infection to come back. Once you finish treatment, if you still feel unwell you should go back to see the doctor.

If you take more AUSTCELEN than you should

If you have taken too much AUSTCELEN, signs might be an upset stomach (feeling sick, being sick or diarrhoea) or crystals in the urine, which may be seen as cloudy urine, or problem urinating. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Take the medicine to show the doctor.

If you forget to take AUSTCELEN

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for forgotten individual doses.

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

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

• severe allergic reaction called anaphylaxis which can be fatal and causes sudden wheezing, swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing or fainting
• an allergic reaction called angiooedema which can be fatal with a rapid swelling of the area beneath the skin which tends to affect the face, throat, limbs and genitals
• severe potentially life-threatening skin rash, reddening of the skin with blisters or peeling, itching, or hives (elevated patches of red or pale skin that often itch) with flushing or ulcers and bleeding in the lips, eyes, mouth, nose and genitals. This may be associated with a high fever and joint pains (these are signs and symptoms of a very serious condition called Stevens-Johnson syndrome) or a severe rash with reddening and swelling that may lead to blistering and peeling of the skin and resembles burns (toxic epidermal necrolysis)
• experience a serious allergic syndrome called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) which can take 3 weeks up to 3 months to appear after you’ve taken AUSTCELEN. The symptoms of DRESS include a severe rash and a potentially life-threatening swelling of most of the body's skin surface followed by redness and peeling of the skin, facial swelling, enlargement of one or more lymph nodes, the bean-shaped glands found in the neck, armpits, chest, groin, and abdomen and high fever. In blood tests there can be an increase in red blood cells (eosinophils), high counts of atypical white blood cells (lymphocytes – blood cells which are activated to respond to infections) and abnormal results in liver function tests. This adverse drug reaction can also cause damage to other organs in your body like your lungs, pancreas, kidneys, brain and many others and can be life-threatening. If you experience any of these symptoms, you must discontinue AUSTCELEN immediately and see a doctor
• symptoms such as severe (bloody or repeated watery) diarrhoea, with or without fever, abdominal pain or tenderness (you may have bowel inflammation caused by a bacterial infection)
• liver inflammation (hepatitis), which may include jaundice which can cause yellowing of your skin or the whites of the eyes (jaundice), dark urine or paler stools and tiredness. These are very serious side effects. If you have them, you may have had a serious reaction to AUSTCELEN. You may need urgent medical attention or hospitalisation.

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

• inflammation and damage to blood vessels mainly in the skin, causing a skin rash (called hypersensitivity vasculitis), usually with tender purple or brownish-red spots over large areas of the skin (mostly on the legs, buttocks or trunk)
• swelling with a red coloured rash beneath the surface of the skin which may occur in a localised area on or near the feet, hands, eyes, or lips. In more severe cases, the swelling can spread to other parts of the body (angioedema)
• decrease in urine volumes or if you suspect that there is blood in your urine or if you are experiencing weakness, nausea and loss of appetite as this may be due to severe kidney problems (acute interstitial nephritis). This can lead to chronic renal failure if it is not diagnosed quickly. Your doctor will likely discontinue your treatment with AUSTCELEN
• skin reactions involving redness and peeling of the skin over large areas of the body (exfoliative dermatitis), or sudden fever with the rapid appearance of areas of red skin studded with pinhead-sized sterile blisters which usually starts on the face or in the armpits and groin and then becomes more widespread over a large area of red and swollen body surface (called acute generalised exanthematous pustulosis (AGEP))
• a reaction called Jarisch-Herxheimer reaction which occurs within 24 hours during treatment of Lyme’s disease with AUSTCELEN and causes symptoms like fever, chills, nausea, vomiting, headache, fast heartbeat, rash, redness and heat of your skin, muscle pains and worsening of skin wounds
• fever, chills, a sore throat or other signs of an infection, these may be signs of a reduction in the number of white cells in the blood (leukopenia)
• if you bruise easily, experience bleeding gums, slow blood clotting after injury, blood in stool (black, tarry-looking) or urine (haematuria) or vomit, if you have heavy menstrual periods, tiny red or purple dots on the lower legs that resemble a rash (petechiae) you may have low platelets in your blood (thrombocytopaenia)
• if you experience abnormal paleness or lack of colour in your skin, fever, weakness, headaches, dizziness, confusion, shortness of breath, increased heart rate, yellowing of the skin and the whites of the eyes or dark-coloured urine you may have a disorder in which red blood cells are destroyed faster than they can be made (haemolytic anaemia)
• fits (convulsions), seen in patients on high doses, with kidney problems or patients who have a history of seizures or are on treatment for epilepsy
• hearing or seeing things that are not there (hallucinations).

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:

• feeling sick (nausea)
• diarrhoea.
• skin rash.

Less frequent side effects:

• thrush (a yeast infection of the vagina, mouth or skin folds), you can get treatment for thrush from your doctor or pharmacist
• the blood may take longer to clot than it normally would. You may notice this if you have a nosebleed or cut yourself
• dizziness
• excessive and uncontrolled physical movement of the arms, legs, face, and other body parts (hyperkinesia)
• being sick (vomiting)
• the tongue may change to yellow, brown or black and it may have a hairy appearance
• hives which are itchy, raised, red dots or welts that appear on the skin which turns white when pressed (urticaria)
• itching
• crystals in urine, which may be seen as cloudy urine, or difficulty or discomfort in passing urine. Make sure you drink plenty of fluids to reduce the chance of these symptoms.

Side effects with frequency unknown:

sensitivity to ultraviolet (UV) rays from the sun and other light sources (photosensitivity) causing rashes, fever, fatigue, joint pain, and other symptoms. 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 or pharmacist. 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 AUSTCELEN.

• Store all medicines out of reach of children
• Store tightly closed in a dry place at or below 30 °C and protect from light.
• Do not use after the expiry date stated on the PRP pouch/label/bottle
• Do not use AUSTCELEN if there are visible signs of deterioration
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).