Betamox ® Capsules

BETAMOX ® (amoxycillin) belongs to a group of antibiotic medicines called penicillins. BETAMOX ® works by interfering with the growth of the bacteria that causes the infection. BETAMOX ® is used to treat various infections caused by bacteria in different parts of the body.

Do not take/give BETAMOX ®

• if you are allergic to penicillin (e.g. amoxycillin), or any other antibiotic or any of the other ingredients of BETAMOX ® (listed in section 6).
• if have glandular fever (symptoms include fever, sore throat, swollen glands and extreme tiredness), as you will have an increased chance of getting a rash.
• if you have lymphatic leukaemia, a type of cancer of the blood and bone marrow.
• if you have high levels of uric acid in the blood and are taking allopurinol (a medicine used to treat gout), as you will have an increased chance of getting a rash.

Warnings and precautions

Special care should be taken with BETAMOX ®:

• if you develop a rash, treatment with BETAMOX ® may need to be stopped.
• if you suffer from seizures.
• if you have kidney problems (dosage adjustment is required).
• if you develop a secondary infection, tell your doctor.
• if you are using BETAMOX ® for a prolonged period of time, your doctor may conduct kidney or liver function tests, or blood tests.
• if you are not urinating regularly.
• if you are having urine (glucose) tests or oestriol tests (used during pregnancy) as the results of these tests may be inaccurate.
• if you have a serious allergic reaction that could lead to heart problems.

Do not share medicines prescribed for you with any other person. Always take/give BETAMOX ® exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The average adult dose for BETAMOX ® is 750 mg to 1,5 g per day.

General dosages

• Adults: 250 mg (1 X 250 mg capsule or 5 ml of 250 mg/5 ml suspension) three times a day.
• Children 2 to 10 years: 125 mg (5 ml of 125 mg/5 ml suspension) three times a day.
• Children 6 months to 2 years: 125 mg (5 ml of 125 mg/5 ml suspension) three times a day.
• Infants 0 to 6 months: 62,5 mg (2,5 ml of 125 mg/5 ml suspension) three times a day.

To reconstitute 75 ml suspension, add 44 ml of water, invert the bottle and shake well until all the powder is dispersed. To reconstitute 100 ml suspension, add 57 ml of water, invert the bottle and shake well until all the powder is dispersed.

Your doctor will advise you on how much BETAMOX ® to take/give depending on the severity and type of infection. Your doctor will tell you how long your treatment with BETAMOX ® will last. If you have the impression that the effect of BETAMOX ® is too strong or too weak, tell your doctor or pharmacist.

If you take/give more BETAMOX ® than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take/give BETAMOX ®

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

If you stop taking/giving BETAMOX ®

Do not stop taking BETAMOX ® without the advice of your doctor even if you feel better.

BETAMOX ® can have side effects. Not all side effects reported for BETAMOX ® are included in this leaflet. Should your/your child’s general health worsen or if you/your child experience any untoward effects while taking BETAMOX ®, please consult your healthcare provider for advice.

If any of the following happens, stop taking/giving BETAMOX ® 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,
• fever, joint pain, swollen lymph nodes,
• blistering of the skin, peeling of the skin,
• fluid filled bumps under the skin,
• fainting.

These are all very serious side effects. If you/your child has them, you/your child may have had a serious reaction to BETAMOX ®. You/your child 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:

• low number of white blood cells (leucopenia). Signs include: fever, chills, sore throat,
• low number of cells involved with blood clotting (thrombocytopenia). Signs include: more or worse bruises than normal, small purple or red dots under your skin, nosebleeds or bleeding gums, black or bloody-looking bowel movements, red or pink urine,
• an excessive breakdown of red blood cells causing a type of anaemia (haemolytic anaemia). Signs include: tiredness, headaches, shortness of breath, dizziness, looking pale and yellowing of the skin and the whites of the eyes,
• the blood may take longer to clot than it normally would. You may notice this if you have a nosebleed or cut yourself,
• seizures,
• inflammation of the large bowel (colon) with diarrhoea (sometimes containing blood), pain and fever,
• liver problems. Signs include: severe diarrhoea and bleeding, darker urine or paler stools, yellowing of the skin or whites if the eyes (jaundice),
• kidney problems. Signs include: blood in the urine, fever, increased or decreased urine output, crystals in the urine which may be seen as cloudy urine, or difficulty or discomfort in passing urine.

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:

• diarrhoea,
• nausea.

Less frequent side effects:

• thrush (a yeast infection of the vagina, mouth or skin folds),
• muscle spasm, hyperactivity and inability to concentrate,
• dizziness,
• vomiting,
• the tongue may change to yellow, brown or black and it may have a hairy appearance,
• discolouration of teeth.

Frequency unknown side effects:

• chest pain in the context of allergic reactions, which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome).
• Rash with blisters arranged in a circle with central crusting or like a string of pearls (linear IgA disease)

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 BETAMOX ®.

• Store all medicines out of reach of children.
• Store at or below 25 °C, in a dry place.
• The reconstituted suspension must be used within 14 days if stored in a refrigerator or within 7 days if stored below 25 °C.
• Do not store in a bathroom.
• Do not use after the expiry date stated on the label or bottle.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).