Purmycin – 125 mg Suspension

PURMYCIN SUSPENSION contains the active substance erythromycin as erythromycin estolate. PURMYCIN SUSPENSION belongs to a group of medicines called antibiotics and is used for the treatment of bacterial infections including:

• Respiratory tract infections (lung, nose, throat and ears infections);
• urinary tract infections (bladder, kidneys, ureters, and urethra infections);
• gastrointestinal infections (stomach flu causing nausea and vomiting);
• skin and soft tissue infections (bacterial skin infections of the upper dermal layer or folds of the skin, acne, painful skin lesions with pus);
• other infections (scarlet fever, tetanus, syphilis (in patients who are allergic to penicillin), joint infection, meningitis, bloodstream infection);
• preventative treatment of inflammatory diseases that can involve the heart, joints, skin, and brain.

Do not take or give PURMYCIN SUSPENSION:

• If you or your child are hypersensitive (allergic) to erythromycin, or to any of the other ingredients of PURMYCIN SUSPENSION (listed in section 6).
• If you or your child have liver function problems.
• If you or your child have developed jaundice (yellowing of the skin and eyes) during previous treatment with erythromycin.
• If you or your child are taking the following medicines:
• simvastatin (used to lower cholesterol and triglycerides (types of fat) in the blood),
• tolterodine (used for treating overactive bladder with symptoms of urinary frequency, urgency, and leakage),
• mizolastine, astemizole, terfenadine (used for hayfever and allergies),
• amisulpride, pimozide (used for psychiatric conditions),
• domperidone (used for nausea and vomiting),
• cisapride (used for stomach disorders).
• If you or your child have a history of heart rhythm disorder (ventricular cardiac arrhythmia or torsades de pointes) called “long QT syndrome”.
• If you or your child have abnormally low levels of potassium or magnesium in your blood (hypomagnesaemia or hypokalaemia).
• If you or your child are taking medicines called ergotamine and dihydroergotamine (used to treat migraines).

Warnings and precautions

Take special care with PURMYCIN SUSPENSION:

• if you are pregnant or breastfeeding your baby (see Pregnancy and breastfeeding).
• if you have heart problems.
• if you are taking other medicines which are known to cause serious disturbances in heart rhythm.
• if you have previously experienced diarrhoea following the use of antibiotics.
• rare serious allergic reactions, including acute generalised exanthematous pustulosis (AGEP) have been reported. If an allergic reaction occurs, stop using PURMYCIN SUSPENSION and tell your healthcare provider (see section 4 POSSIBLE SIDE EFFECTS).
• If you are pregnant and have been told that you have a sexually transmitted disease called syphilis. In this case erythromycin, as contained in PURMYCIN SUSPENSION, may not be effective for preventing the transfer of this infection to your baby. Consult your doctor before receiving PURMYCIN SUSPENSION.
• If you have a condition called myasthenia gravis (a condition causing abnormal weakness of the muscles).
• if you or your child go for any medical or urine tests, tell your doctor that you are taking PURMYCIN SUSPENSION, as this may interfere with some test results.
• if a high dose of PURMYCIN SUSPENSION is prescribed, reversible deafness may occur.
• A condition called rhabdomyolysis (a breakdown of muscle tissue that releases a damaging protein into the blood) has been reported in seriously ill patients receiving erythromycin as contained in PURMYCIN SUSPENSION together with statins (e.g. simvastatin).
• If your young child treated with PURMYCIN SUSPENSION becomes irritable or vomit when fed, you should contact your healthcare provider immediately.

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

The usual dose of PURMYCIN SUSPENSION is:

Adults:

The usual dose is one (1) to two (2) medicine measures (5 ml to 10 ml) of PURMYCIN - 250 SUSPENSION every 6 hours before meals.

Children:

The usual dose is 30 mg/kg to 50 mg/kg body mass of PURMYCIN - 125 SUSPENSION daily in divided doses before meals. In severe infections your doctor may double these doses.

Your doctor will tell you how long your treatment with PURMYCIN SUSPENSION will last. Do not stop treatment early. Complete the prescribed course unless otherwise directed.

If you have the impression that the effect of PURMYCIN SUSPENSION is too strong or too weak, tell your doctor or pharmacist.

If you take or give more PURMYCIN SUSPENSION than you should

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

If you forget to take or give PURMYCIN SUSPENSION

Do not take or give a double dose to make up for forgotten individual doses. If you have missed a dose of PURMYCIN SUSPENSION, take or give the dose that you have missed as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. If you have forgotten to take or give several doses, contact your doctor without delay.

If you stop taking PURMYCIN SUSPENSION

Continue to take or give PURMYCIN SUSPENSION until the course is completed or until your doctor tells you to stop. You should not stop taking PURMYCIN SUSPENSION without talking to your healthcare provider first even if you feel better.

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

If any of the following happens, stop taking or giving PURMYCIN SUSPENSION 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,
• blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens-Johnson Syndrome (SJS),
• a life-threatening skin disorder characterized by a blistering and peeling of the skin known as Toxic epidermal necrolysis (TEN),
• a skin reaction known as Erythema multiforme,
• a severe skin reaction known as Acute generalised exanthematous pustulosis (AGEP).

These are all very serious side effects. If you have them, you may have had a serious reaction to PURMYCIN SUSPENSION. 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 of the liver (hepatitis),
• yellowing of the skin and eyes (jaundice),
• liver failure (hepatic failure),
• inflammation of the organ lying behind the lower part of the stomach (pancreas) (pancreatitis),
• swelling of the large intestine caused by a bacteria (pseudomembranous colitis),
• a sudden, uncontrolled electrical disturbance in the brain (seizure),
• damage on the optic nerve in the eye (optic neuropathy),
• a type of abnormal fast heart rhythm (torsade de pointes /ventricular tachydysrhythmias),
• a sudden, unexpected loss of heart function, breathing and consciousness (cardiac arrest),
• a life-threatening heart rhythm that results in a fast, inadequate heartbeat (ventricular fibrillation),
• an extended interval between the heart contracting and relaxing (electrocardiogram QT prolonged),
• inflammation of the tubules of the kidneys and the surrounding tissue (tubulointerstitial nephritis).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Less frequent side effects:
• fever, reinfection or a second infection with a bacteria, fungus or virus (super infection),
• skin eruptions
• Frequency unknown side effects:
• a higher than normal level if disease fighting white blood cells (eosinophilia),
• reversible deafness,
• seeing or hearing things that are not real (hallucinations),
• confusion, a feeling of spinning even when you’re not moving (vertigo),
• low blood pressure (hypotension),
• nausea, vomiting, diarrhoea, upper abdominal discomfort, an eating disorder (anorexia),
• a condition in which the opening between the stomach and small intestine thickens (infantile hypertrophic pyloric stenosis),
• enlarged liver (hepatomegaly),
• chest pain, a general sense of being unwell (malaise),
• increase in liver enzymes.

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 “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088. By reporting side effects, you can help provide more information on the safety of PURMYCIN SUSPENSION.

Store all medicines out of reach of children. Store at or below 25 ºC. Keep container tightly closed. Protect from light.

• Shake the bottle before use.
• Keep in original packaging until required for use.
• Do not store in a bathroom.
• Do not use after the expiry date stated on the label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).