RONEM

Read all of this leaflet carefully before you are given RONEM

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, nurse or other health care provider.
  • RONEM has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.

SCHEDULING STATUS:

S4

RONEM 1 G POWDER FOR INJECTION (meropenem)

Each vial of RONEM 1 g contains approximately 90 mg of sodium, equivalent to 4.5 % of the WHO

recommended maximum daily intake of 2 g sodium for an adult

RONEM 500 MG POWDER FOR INJECTION (meropenem)

Each vial of RONEM 500 mg contains approximately 45.1 mg of sodium, equivalent to 2.255 % of the

WHO recommended maximum daily intake of 2 g sodium for an adult.

1. WHAT RONEM IS AND WHAT IT IS USED FOR:

RONEM is an anti-bacterial that belongs to the carbapenem group of antibiotics and can be used for the treatment of the following infections:

  • Pneumonia
  • Chest infections involving the upper airways (e.g. bronchitis)
  • Urinary tract
  • Stomach and intestines
  • Skin and soft tissue
  • Infection and inflammation of the brain lining (meningitis).

2. WHAT YOU NEED TO KNOW BEFORE YOU USE RONEM

Do not use RONEM if:

Warnings and Precautions:

  • If you have a kidney disease or any other condition that affects your kidneys or liver, your doctor may need to adjust the dose required to treat you
  • If you suffer from epilepsy or any other condition that requires you to take medication to treat fits and seizures. RONEM can affect the medication used (such as valproate) and the dose of this medicine will need to be adjusted or additional medication given while you are being treated with RONEM. Convulsions may be precipitated.
  • If you have severe or bloody diarrhea after taking RONEM.
  • RONEM should not be given to infants under the age of 3 months.

Other medicines and RONEM:

Always tell your healthcare professional if you are taking any other medicine (this includes complementary or traditional medicines.

When you are taking RONEM, it is especially important to tell your doctor or healthcare professional if you are taking any of the following medicines:

  • Valproic Acid (used to treat epilepsy)
  • Probenecid (used to treat gout)
  • Blood thinners e.g. warfarin

Pregnancy & Breastfeeding:

If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking this medicine. The use of RONEM in pregnancy has not been established.

Driving & using machinery:

RONEM has no or negligible influence on the ability to drive and use machines. However, it should be taken into consideration that fits may occur.

3. HOW TO USE RONEM:

RONEM will be administered to you by a doctor in a hospital or clinic environment only. You will not be expected to give yourself RONEM. It will be given to you by a person qualified to do so.
RONEM will be given as an injection.

Adults:

500 mg to 1g every 8 hours.

Children:

Weighing 50 kg or more: Same as per adult dose.

Weighing less than 50 kg: 10 to 40 mg/kg every 8 hours.

The doctor will prescribe different doses for different patients depending on the type and severity of the infections.

THIS MEDICATION IS NOT TO BE ADMINISTERED BY ANYONE OTHER THAN A DOCTOR OR AUTHORISED HEALTHCARE PROFESSIONAL

If you are administered more RONEM than indicated:

Too much RONEM can cause side effects to occur. Since a healthcare professional will administer RONEM, he / she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

4. POSSIBLE SIDE EFFECTS

RONEM can have side effects.

RONEM can have side effects.

Not all side effects reported for RONEM are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice

Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty swallowing or breathing.

  • Severe peeling / detachment of the skin
  • Rash or itching
  • Fits or convulsions
  • Blood disorders

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

RONEM and may need urgent medical attention.

Tell the doctor or nurse immediately if you notice any of the following:

  • Bloody vomiting
  • Black bloody stools
  • Thrush in the mouth or around the vagina
  • Pins and needles sensation

These are serious side effects and you may need urgent medical attention.

Tell your doctor if you notice any of the following:

  • Headache
  • Nausea
  • Vomiting
  • Diarrhoea
  • Pain and inflammation at site of injection

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 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. By reporting side effects, you can help provide more information on the safety of RONEM.

5. HOW TO STORE RONEM

Store this medicine away from light at or below 30 C.

Do not refrigerate or freeze RONEM Powder for Injection.

The reconstituted solution should be stored at 2 – 8 C and must be used within 24 hours.

Any expired or outdated medicines and unused medicines can be returned to your nearest pharmacy. Store all medicines out of reach and sight of children.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What RONEM contains:

RONEM 1 G:

Each 20 ml vial contains:

Meropenem 1000 mg as the active substance.

The other ingredients are anhydrous sodium carbonate.

RONEM 500 mg:

Each 10 ml vial contains:

Meropenem 500 mg as the active substance.

The other ingredients are anhydrous sodium carbonate

What RONEM looks like and contents of the pack:

RONEM 500 mg is packed as a white to yellow powder for injection in a 10 ml clear glass vial closed with a 20 mm grey butyl rubber stopper and aluminium collar covered with a light pink flip-off cap

RONEM 1000 mg is packed as a white to yellow powder for injection in a 20 ml clear glass vial closed with a 20 mm grey butyl rubber stopper and aluminium collar covered with a purple flip-off cap.

HOLDER OF CERTIFICATE OF REGISTRATION:

Epiglo Pharmaceuticals (Pty) Ltd
Allandale Building First Floor
23 Magwa Crescent
Waterfall City
Gauteng
1685

THIS LEAFLET WAS LAST REVISED IN:

02/03/2021

REGISTRATION NUMBER:

RONEM 1 G – 47/20.1.1/0811

RONEM 500 MG – 47/20.1.1/0812

 

ACCESS TO THE CORRESPONDING PROFESSIONAL INFORMATION:

This may be found in the carton of the medication or otherwise please ask your doctor, pharmacist or other health care professional.