Meropenem 1 g powder for solution for injection or infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• 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 Meropenem is and what it is used for
2. What you need to know before you use Meropenem
3. How to use Meropenem
4. Possible side effects
5. How to store Meropenem
6. Contents of the pack and other information

• If you are allergic (hypersensitive) to meropenem or any of the other ingredients of this medicine (listed in Section 6).
• If you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins or carbapenems as you may also be allergic to meropenem.

Talk to your doctor, pharmacist or nurse before using Meropenem.

• If you have health problems, such as liver or kidney problems.
• If you have had severe diarrhoea after taking other antibiotics.

You may develop a positive test (Coombs test) which indicates the presence of antibodies that may destroy red blood cells. Your doctor will discuss this with you.

You may develop signs and symptoms of severe skin reactions (see section 4). If this happens talk to your doctor or nurse immediately so that they can treat the symptoms.

Liver problems

If you notice yellowing of the skin and eyes, itchy skin, dark-coloured urine or light-coloured stool tell your doctor. This may be a sign of liver problems which your doctor needs to check.

If you are not sure if any of the above applies to you, talk to your doctor or nurse before using Meropenem.

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

This is because Meropenem can affect the way some medicines work and some medicines can have an effect on Meropenem.

In particular, tell your doctor or nurse if you are taking any of the following medicines:

• Probenecid (used to treat gout).
• Valproic acid/sodium valproate/valpromide (used to treat epilepsy). Meropenem should not be used because it may decrease the effect of sodium valproate.
• Oral anti-coagulant agent (used to treat or prevent blood clots).

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. It is preferable to avoid the use of meropenem during pregnancy. Your doctor will decide whether you should use meropenem.

It is important that you tell your doctor if you are breast-feeding or if you intend to breast-feed before receiving meropenem. Small amounts of this medicine may pass into the breast milk. Therefore, your doctor will decide whether you should use meropenem while breast-feeding.

No studies on the effect on the ability to drive and use machines have been performed. Meropenem has been associated with headache; tingling or pricking skin (paraesthesia). Any of these side effects could affect your ability to drive or operate machines.

Meropenem may cause and involuntary muscle movements, leading the person's body to shake rapidly and uncontrollably (convulsions). This is usually accompanied with a loss of consciousness. Do not drive or use machines if you experience this side effect.

The maximum recommended daily dose of this medicinal product contains 540 mg sodium (found in table salt). This is equivalent to 27% of the adult recommended maximum daily dietary intake for sodium.

Meropenem 500 mg

Talk to your doctor if you need 9 or more vials daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.

Meropenem 1 g

Talk to your doctor if you need 5 or more vials daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.

• The dose depends on the type of infection that you have, where the infection is in the body and how serious the infection is. Your doctor will decide on the dose that you need.
• The dose for adults is usually between 500 mg (milligrams) and 2 g (gram). You will usually receive a dose every 8 hours. However you may receive a dose less often if your kidneys do not work very well.

• The dose for children over 3 months old and up to 12 years of age is decided using the age and weight of the child. The usual dose is between 10 mg and 40 mg of Meropenem for each kilogram (kg) that the child weighs. A dose is usually given every 8 hours.
  Children who weigh over 50 kg will be given an adult dose.

• Meropenem will be given to you as an injection or infusion into a large vein.
• Your doctor or nurse will normally give Meropenem to you.
• However, some patients, parents and carers are trained to give Meropenem at home. Instructions for doing this are provided in this leaflet (in the section called ‘Instructions for giving Meropenem to yourself or someone else at home’). Always use Meropenem exactly as your doctor has told you. You should check with your doctor if you are not sure.
• Your injection should not be mixed with or added to solutions that contain other medicines.
• The injection may take about 5 minutes or between 15 and 30 minutes. Your doctor will tell you how to give Meropenem.
• You should normally have your injections at the same times each day.

If you accidentally use more than your prescribed dose, contact your doctor or nearest hospital straight away.

If you miss an injection, you should have it as soon as possible. However, if it is almost time for your next injection, skip the missed injection. Do not take a double dose (two injections at the same time) to make up for a forgotten dose.

Do not stop having Meropenem until your doctor tells you to.

If you have any of these signs and symptoms, tell your doctor or nurse straight away. You may need urgent medical treatment. The signs and symptoms may include a sudden onset of:

• Severe rash, itching or hives on the skin.
• Swelling of the face, lips, tongue or other parts of the body.
• Shortness of breath, wheezing or trouble breathing.
• Serious skin reactions which include
  • Serious hypersensitivity reactions involving fever, skin rash, and changes in the blood tests that check how the liver is working (increased levels of liver enzymes) and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes. These may be signs of a multi-organ sensitivity disorder known as DRESS syndrome.
  • Severe red scaly rash, skin bumps that contain pus, blisters or peeling of skin, which may be associated with a high fever and joint pain.
  • Severe skin rashes that can appear as reddish circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or a more severe form (toxic epidermal necrolysis).

Damage to red blood cells (not known)

The signs include:

• Being breathless when you do not expect it.
• Red or brown urine.

If you notice any of the above, see a doctor straight away.

Common (may affect up to 1 in 10 people)

• Abdominal (stomach) pain.
• Feeling sick (nausea).
• Being sick (vomiting).
• Diarrhoea.
• Headache.
• Skin rash, itchy skin.
• Pain and inflammation.
• Increased numbers of platelets in your blood (shown in a blood test).
• Changes in blood tests, including tests that show how well your liver is working.

Uncommon (may affect up to 1 in 100 people)

• Changes in your blood. These include reduced numbers of platelets (which may make you bruise more easily), increased numbers of some white blood cells, decreased numbers of other white cells and increased amounts of a substance called ‘bilirubin’. Your doctor may do blood tests from time to time.
• Changes in blood tests, including tests that show how well your kidneys are working.
• A tingling feeling (pins and needles).
• Infections of the mouth or the vagina that are caused by a fungus (thrush).
• Inflammation of the bowel with diarrhoea.
• Sore veins where Meropenem is injected.
• Other changes in your blood. The symptoms include frequent infections, high temperature and sore throat. Your doctor may do blood tests from time to time.
• Reduced levels of potassium in your blood (which can cause weakness, muscle cramps, tingling and heart rhythm disturbances).
• Liver problems. Yellowing of the skin and eyes, itchy skin, dark-coloured urine or light-coloured stool. If you notice these signs or symptoms, see a doctor straight away.

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

• Fits (convulsions).
• Acute disorientation and confusion (delirium).

Sudden chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome has been noted with other medicines of the same type. If this happens talk to a doctor or nurse immediately.

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 Yellow Card Scheme. Website: 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.

After reconstitution: The reconstituted solutions for intravenous injection should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous injection should not exceed:

• 3 hours when stored at controlled room temperature (15-25°C);
• 8 hours when stored under refrigerated conditions (2-8°C);

Do not freeze the reconstituted solution.

After reconstitution: The reconstituted solutions for intravenous infusion should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous infusion should not exceed:

• 6 hours when stored at controlled room temperature (15-25°C) when meropenem is dissolved in sodium chloride;
• 12 hours when stored at 2-8°C when meropenem is dissolved in sodium chloride. In this case, the prepared solution if stored under refrigeration (i.e. 2-8°C) should be used within 1 hour after it has left the refrigerator.
• 30 minutes when meropenem is dissolved in glucose (dextrose).

From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbiological contamination, the product should be used immediately.

If not used immediately in-use storage times and conditions are the responsibility of the user.

Do not freeze the reconstituted solution.

Do not throw away any medicines via waste water or house hold waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

• The active ingredient is meropenem.
  Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem.
  Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem.
• The other ingredient is sodium carbonate, anhydrous.

Meropenem is a white to pale yellow crystalline powder for solution for injection or infusion in vial.

Product after reconstitution is clear colourless to yellow solution.

Meropenem 500 mg:

674.78 mg powder in a 30ml Type-I, tubular, clear glass vial with stopper (bromobutyl rubber with aluminum seals having taxim blue colour polypropylene discs).

Meropenem 1 g:

1349.56 mg powder in a 40ml Type-I, tubular, clear glass vial with stopper (bromobutyl rubber with aluminum seals having white colour polypropylene discs).

The medicinal product is supplied in pack sizes of 1 or 10 vials.

Not all pack sizes may be marketed.

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