Recarbrio 500 mg/500 mg/250 mg powder for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Recarbrio is and what it is used for
2. What you need to know before you are given Recarbrio
3. How you are given Recarbrio
4. Possible side effects
5. How to store Recarbrio
6. Contents of the pack and other information

• you are allergic to imipenem, cilastatin, relebactam or any of the other ingredients of this medicine (listed in section 6)
• you are allergic to carbapenem antibiotics
• you ever had a severe allergic reaction to penicillin antibiotics or cephalosporin antibiotics

You should not be given Recarbrio if any of the above apply to you. If you are not sure, talk to your doctor or nurse before being given Recarbrio.

Talk to your doctor or nurse before being given Recarbrio if:

• you are allergic to any medicines - especially antibiotics
• you have ever had convulsions (seizures or fits)
• you have ever had confusion or muscle twitches with a medicine
• you are taking a medicine containing valproic acid
• you have had diarrhoea while taking antibiotics in the past
• you have kidney problems – your doctor may lower your dose

Tell your doctor right away if you have an allergic reaction, convulsions (seizures or fits), diarrhoea, or develop kidney problems while receiving Recarbrio (see section 3).

Do not give this medicine to children with kidney problems who weigh less than 30 kg, children who weigh less than 2 kg, or preterm infants (less than 37 weeks post-menstrual age). This is because it is not known if the medicine is safe to use in these patients.

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.

Tell your doctor about all the medicines you take, especially if you take:

• medicines that contain ganciclovir, used for treating some viral infections
• medicines that contain valproic acid or divalproex sodium, usually used for treating epilepsy, bipolar disorder, or migraine
• medicines to control blood clotting, such as warfarin

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine.

Recarbrio may make you feel dizzy, shaky, or cause convulsions or seizures. This may affect your ability to drive or use machines.

This medicine contains approximately 37.5 mg of sodium (main component of cooking/ table salt) in each vial. This is equivalent to about 2 % of the adult recommended maximum amount of sodium you should take daily, and needs to be taken into account if you are on a low-salt diet.

Recarbrio will be given to you by a doctor or a nurse, so it is unlikely you will be given the wrong dose. If you think you have been given too much Recarbrio, tell your doctor or nurse right away.

Tell your doctor or nurse right away if you think you were not given your dose of Recarbrio.

Tell your doctor right away if you notice any of the following serious side effects - the medicine must be stopped:

• allergic reactions – the signs may include hives, swelling of the face, lips, tongue or throat, difficulty in breathing or swallowing
• severe skin reactions (e.g., severe rash, skin peeling or blistering)

Common: (may affect up to 1 in 10 people)

• nausea, being sick (vomiting), diarrhoea
• blood test results that may show changes in the liver
• blood test results that may show an increase in the number of some types of blood cells called ‘eosinophils’
• blood test results that may show an increase in some white blood cells
• rash
• inflammation and pain caused by a blood clot in the vein

Uncommon: (may affect up to 1 in 100 people)

• hives
• skin itchiness
• convulsions (fits) and nervous system problems like tremor
• confusion
• seeing, hearing or feeling something that is not there (hallucinations)
• dizziness, sleepiness
• low blood pressure
• blood test results that may show changes in the kidney
• blood test results that may show a decrease in the number of red blood cells, white blood cells, and blood cells called platelets
• blood test results that may show an increase in the number of some blood cells called platelets
• abnormal kidney, liver, and blood function detected by blood tests
• pain or redness or formation of a lump where the medicine was injected
• fever
• blood test (called a Coombs test) results showing antibodies that can cause anaemia by destroying red blood cells

Rare: (may affect up to 1 in 1 000 people)

• fungal infection (candidiasis)
• changes in taste
• disease of the brain, tingling sensation (pins and needles), localised tremor
• hearing loss
• staining of the teeth and/or tongue
• inflammation of the colon with severe diarrhoea (colitis)
• low number of white blood cells which may make it difficult for your body to fight infections
• inflammation of the liver
• liver failure
• inability of the kidney to perform normal function
• changes in the amount of urine, changes in urine colour
• swelling of the skin
• painful rash with flu-like symptoms
• redness and scaling of the skin

Very rare: (may affect up to 1 in 10 000 people)

• inflammation of stomach or intestine (gastro-enteritis)
• anaemia due to destruction of red blood cells, leading to symptoms like tiredness, pale skin
• headache
• worsening of a rare disease associated with muscle weakness (aggravation of myasthenia gravis)
• a spinning sensation (vertigo)
• ringing in the ears (tinnitus)
• irregular heartbeat, the heart beating forcefully or rapidly
• chest discomfort, difficulty breathing, abnormally fast and superficial breathing, pain in the upper spine
• pain in the throat
• flushing, bluish discolouration of the face and lips, changes in skin texture, excessive sweating
• increase in the production of saliva
• inflammation of intestine with bloody diarrhoea (haemorrhagic colitis)
• stomach pain
• heartburn
• red swollen tongue, overgrowth of the normal projections on the tongue giving it a hairy appearance
• severe loss of liver function due to inflammation (fulminant hepatitis)
• pain in several joints
• itching of the vulva in women
• weakness, lack of energy

Not known: (frequency cannot be estimated from the available data)

• agitation
• abnormal movements
• jaundice (yellowing of your skin and eyes)
• blood tests showing an increase in a substance called lactic dehydrogenase (LDH) which may be a sign of tissue damage

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substances are imipenem, cilastatin, and relebactam. Each vial contains 500 mg imipenem, 500 mg cilastatin, and 250 mg relebactam.
• The other ingredient is sodium hydrogen carbonate.

Recarbrio is a white to light yellow powder supplied for solution for infusion in glass vials. Pack size is 25 vials.

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