Macropen Capsules

What MACROPEN is

MACROPEN belongs to a group of antibiotics called penicillins. These antibiotics work by killing the bacteria that are causing your infection.

What it is used for

MACROPEN is used to treat infections caused by bacteria in different parts of the body.

Do not take MACROPEN

• If you or your child are hypersensitive (allergic) to amoxicillin, flucloxacillin, any other penicillins or any of the other ingredients of MACROPEN (listed in section 6).
• If you or your child have had a serious allergic reaction to any antibiotics. Some of the symptoms of an allergic reaction may include asthma, wheezing, shortness of breath, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, skin rash, itching or hives.
• If you or your child previously had jaundice (a medical condition with yellowing of the skin or whites of the eyes).
• Do not give MACROPEN to neonates (see section 3 How to take MACROPEN).

Warnings and precautions

Take special care with MACROPEN:

• If you or your child have a known allergy to penicillins as this could lead to an allergic reaction with collapse and sometimes death.
• If you or your child have kidney problems.
• If you or your child have glandular fever (fever, sore throat, swollen glands and extreme tiredness).
• If you or your child are not urinating regularly.
• If you are breastfeeding or intend to breastfeed. MACROPEN passes into breast milk and can be used only with caution during breastfeeding. However, breastfeeding must be stopped if gastrointestinal disorders (diarrhoea, candidiasis or skin rash) occur in the newborn.
• If you or your child are taking paracetamol (a medicine for pain and fever). Metabolic acidosis (when the body produces too much acid, or when the kidneys are not removing enough acid from the body) can happen if you take paracetamol and MACROPEN at the same time (see section Other medicines and MACROPEN).
• If you or your child experience extreme tiredness, rapid heartbeat, muscle weakness and spasms, as these are signs of hypokalaemia.

If you or your child have or have had any medical conditions, including:

• Asthma (a condition in which a person's airways become inflamed, narrow and swell and produce extra mucus, which makes it difficult to breathe).
• Kidney problems.
• Liver problems (see section Do not take MACROPEN).
• Lymphatic leukaemia (a type of cancer of the blood and bone marrow).
• Glandular fever which can cause symptoms such as fatigue, swollen glands, a sore throat.
• Diabetes.
• A history of seizures.
• Stomach or bowel problems.
• A history of allergic problems, including hay fever.

Having urine or blood tests

If you are having:

• Urine tests (glucose) or blood tests for liver function.
• Oestriol tests (used during pregnancy to check that the baby is developing normally). This is because MACROPEN can affect the results of these tests.

Children

Your child may start to vomit uncontrollably 1 to 4 hours after taking/receiving MACROPEN. Stomach pain, a running stomach and feeling lightheaded may also be experienced.

Other medicines and MACROPEN

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines). Tell your doctor if you are taking any of the following medicines:

• Medicines used to treat gout (e.g. probenecid or allopurinol); it may be more likely that you will have an allergic skin reaction.
• Antibiotics such as piperacillin and tetracyclines.
• Digoxin, a medicine used to treat heart failure.
• Medicines used to prevent blood clots from the coumarin class (e.g. warfarin) as you may need extra blood tests.
• Methotrexate, a medicine used to treat arthritis and some types of cancers. MACROPEN may cause an increase in side effects.
• Sugammadex, which is used in surgery.
• Oral contraceptives (birth control pills). You are advised to take supplementary non-hormonal contraceptive measures e.g. condoms (see Other medicines and MACROPEN).
• Other antibiotics (e.g. tetracycline); MACROPEN may be less effective.
• Paracetamol (a medicine for pain and fever).
• Voriconazole, a medicine used to treat serious fungal or yeast infections.
• The oral typhoid vaccine is inactivated by MACROPEN.

MACROPEN with food, drink and alcohol

MACROPEN should be given on an empty stomach, approximately 1 hour before a meal.

Pregnancy, breastfeeding and fertility

The safety of MACROPEN during pregnancy has not been established. If you are pregnant or breastfeeding your baby, 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 MACROPEN. MACROPEN is excreted in breast milk and should be used with caution when taken by breastfeeding women. MACROPEN may reduce the effectiveness of some birth control pills and patients should use an additional method of contraception e.g. condoms (see section Other medicines and MACROPEN).

Driving and using machines

It is not always possible to predict to what extent MACROPEN may interfere with the daily activities of a patient. MACROPEN may cause allergic reactions, dizziness or convulsions. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which MACROPEN affects them (see section 4 Possible side effects).

Do not share medicines prescribed for you with any other person. Always take MACROPEN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is:

Adults:

• One 500 mg capsule three times a day.

Children 2 – 12:

• 5 mL of suspension (containing 250 mg MACROPEN S) three times a day.

Children under 2:

• 2,5 mL of suspension (containing 125 mg MACROPEN S) three times a day.

Neonates:

• No formulation is available at present.

Your doctor will tell you how long your treatment with MACROPEN will last. If you have the impression that the effect of MACROPEN is too strong or too weak, tell your doctor or pharmacist.

If you take more MACROPEN 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 a dose of MACROPEN

Do not take a double dose to make up for forgotten individual doses.

If you stop taking MACROPEN

Do not stop treatment early because the infection can come back. Take MACROPEN until the treatment is finished, even if you feel better.

MACROPEN can have side effects. Not all side effects reported for MACROPEN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MACROPEN, please consult your health care provider for advice. If any of the following happens, stop taking MACROPEN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.
• Inflammation of the protective membrane surrounding the brain (aseptic meningitis).

These are all very serious side effects. If you have them, you may have had a serious reaction to MACROPEN. 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:

• A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form, causing extensive peeling of the skin (more than 30 % of the body surface – toxic epidermal necrolysis).
• Widespread red skin rash with small pus-containing blisters (bullous exfoliative dermatitis).
• A red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis).
• Flu-like symptoms with a rash, fever, swollen glands and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).
• Skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge – erythema multiforme).
• Chest pain which can be a sign of a potentially serious allergic reaction called Kounis syndrome.
• Rash with blisters arranged in a circle with central crusting or like a string of pearls (linear IgA disease).

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

The following side effects have been reported frequently:

• Headache.
• Nausea (feeling sick).
• Vomiting (being sick).
• Diarrhoea.

The following side effects have been reported less frequently:

• Inflammation of blood vessels (vasculitis) which may be visible as red or purple raised spots on the skin, but can affect other parts of the body.
• Fever, joint pain, swollen glands in the neck, armpit or groin.
• Inflammation of the large intestine, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever.
• Jaundice, caused by increases in the blood of bilirubin (a substance produced in the liver) which may make your skin and whites of the eyes appear yellow.
• Inflammation of the liver (hepatitis).
• Convulsions (in people taking high doses of MACROPEN or who have kidney problems).
• Black tongue which looks hairy.
• Thrush ( Candida – a yeast infection of the vagina, mouth or skin folds).
• Indigestion.
• Dizziness.
• Excessive involuntary movements (hyperkinesia).
• Stomach pain.
• A state of excessive restlessness.
• Tooth discolouration.
• Crystals in urine.
• Inflammation of tubes in the kidney.
• Painful joints and muscles or fever that may develop 48 hours after the start of treatment.
• Metabolic acidosis (when the body produces too much acid, or when the kidneys are not removing enough acid from the body) can happen if you take paracetamol and MACROPEN at the same time (see section Other medicines and MACROPEN).

The following side effects have been reported but the frequency is unknown:

• Increase in some substances (enzymes) produced by the liver.
• Severe reduction in the number of white blood cells.
• Low number of red blood cells (haemolytic anaemia).
• Low number of cells involved in blood clotting.
• Low potassium.

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 MACROPEN.

• MACROPEN 500: Store at or below 25 °C. Do not refrigerate/freeze.
• MACROPEN S: Dry powder MACROPEN S must be stored at or below 25 °C. Once reconstituted, MACROPEN S must be used within 7 days kept at 25 °C, or used within 14 days and kept in a refrigerator at 5 °C. Do not freeze.
• Store in the original package/container.
• Keep the container tightly closed.
• Protect from moisture.
• Do not store in a bathroom.
• Do not use after the expiry date stated on the label/carton/bottle.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).
• Keep out of reach of children.