Adco Meropenem 500 mg Solution

ADCO MEROPENEM is used for the treatment, in adults and children, of the following infections caused by single or multiple bacteria sensitive to meropenem and as therapy prior to the identification of the causative organism.

• Intra - abdominal infections
• Meningitis
• Respiratory tract infections (including cystic fibrosis patients)
• Septicaemia
• Skin infections
• Urinary tract infections

ADCO MEROPENEM should not be administered to you:

• If you are hypersensitive (allergic) to meropenem, or any of the other ingredients of ADCO MEROPENEM (listed in section 6)
• If you are hypersensitive (allergic) to any antibiotics related to meropenem

Therefore, you should tell your doctor if you have ever had any unusual or allergic reaction to carbepenems, penicillins, or other beta-lactam antibiotics. Hypersensitivity (allergic) reactions have been reported with ADCO MEROPENEM. Also tell your healthcare professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Warnings and precautions:

Tell your doctor or health care provider before being given the injection:

• If you are suffering from kidney or liver problems.
• If you have previously had severe diarrhoea after taking other antibiotics.
• If you have any disorders like epilepsy (seizures).
• If you have a condition which requires you to monitor your sodium intake, please inform your doctor or nurse.

Children:

Efficacy and tolerability in infants under 3 months old have not been established, therefore ADCO MEROPENEM is not recommended for use below this age.

Other medicines and ADCO MEROPENEM

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Certain medicines should not be used together. In these cases, your doctor may want to change the dose, or other precautions may be necessary. It is important that your healthcare professional knows if you are taking any other medications. Tell your healthcare professional if you are taking any of the following:

• If you are already taking Probenecid (used to treat gout) because meropenem and probenecid are contraindicated.
• Oral anti-coagulant medicines (used to treat or prevent blood clots).
• If you are taking valproates (used to treat epilepsy).

You will not be expected to give yourself ADCO MEROPENEM. It will be given to you by a person who is qualified to do so, by intravenous injection or infusion. The dose will be decided by your doctor depending on the severity of your condition.

If you receive more ADCO MEROPENEM than you should: Since a healthcare professional will administer ADCO MEROPENEM he/she will control the dosage. However, in the event of an overdosage, your doctor will manage the overdosage.

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

If you experience any of the following side effects, consult with your doctor or healthcare professional immediately:

• Swelling of the face, lips, tongue and other parts of the body
• Shortness of breath and/or difficulty breathing
• Severe headaches and fits
• Chest pain in the context of allergic reactions, which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome).

These are all very serious side effects. If you have them, you may have had a serious reaction to ADCO MEROPENEM. You may need urgent medical attention or hospitalisation.

The following side effects occur frequently:

• anaemia (deficiency of red blood cells)
• gastrointestinal disturbances
• pain.

The following side effects occur less frequently:

• sepsis (presence of pus-forming bacteria or their toxins in the blood or tissues)
• thrombophlebitis (conjunction with the formation of a blood clot in the vein)
• bleeding events
• haemoperitoneum (presence of blood in the peritoneal cavity)
• hypoglycaemia (abnormally low blood sugar)
• pruritus (an intense itching sensation)
• skin discolouration
• skin ulceration.

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

• thrombocytopenia (abnormally small number of platelets in the blood)
• headache
• diarrhoea (frequent and watery bowel movements) moderate or severe
• vomiting
• nausea
• rash
• pain
• itching skin, rash
• inflammation of the skin
• increased blood alkaline phosphate
• hives
• a condition called Stevens Johnson syndrome or toxic epidermal necrolysis
• phlebitis (inflammation of a vein (usually in the legs))
• infection
• hyperbilirubinaemia (high amounts of bile pigment (bilirubin) in the blood)
• blood creatinine and urea levels increased
• thrombophlebitis (conjunction with the formation of a blood clot).

Tell your doctor if you notice any of the following:

• feeling weak, trembling and headache (feeling hungry)
• redness, swelling and pain at the site of injection
• severe, bloody, black or watery stools and/or diarrhoea
• constipation, abdominal or stomach cramps and pain
• nausea and vomiting and/or black vomit
• severe skin rash and itching
• nose bleeds
• red or brown urine
• increase in blood platelets (shown by blood tests)

The following side effects frequency cannot be determined:

• eosinophilia (increase in number of eosinophils - type of white blood cells)
• seizures.

The following side effects occur less frequently:

• lymphopenia (an abnormally small number of lymphocytes in the circulating blood)
• neutropenia (decrease is primarily in number of neutrophils)
• oral fungal infection
• paraesthesia (abnormal skin sensations).

Consult with your doctor or healthcare professional, should you experience any side effects even if they are not listed above.

Reporting of side effects: If you get side effects, talk to your doctor. You 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 ADCO MEROPENEM.

Store all medicines out of reach of children. ADCO MEROPENEM powder vials should be stored in a cool dry place at or below 25 °C. Do not use ADCO MEROPENEM if you noticed any discolouration.