MEROPENEM ACCORDPHARMA 1 g POWDER FOR INJECTION AND INFUSION SOLUTION

2. What you need to know before you use Meropenem Accordpharma

Do not use Meropenem Accordpharma:

• if you are allergic to meropenem or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”).
• If you are allergic to other antibiotics such as penicillins, cephalosporins, or carbapenems, as you may also be allergic to meropenem.

Warnings and precautions

Talk to your doctor or nurse before starting Meropenem Accordpharma if:

• You have health problems, such as liver or kidney problems.
• You have had severe diarrhea after taking other antibiotics.

You may develop a positive response to a test (Coombs test) that indicates the presence of antibodies that can 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, inform your doctor or nurse immediately so that they can treat the symptoms.

Liver problems

Tell your doctor if you notice yellowing of the skin and eyes, itching of the skin, dark-colored urine, or light-colored stools. This may be a sign of liver problems that your doctor should check.

If you are in any of these situations, or if you have doubts, consult your doctor, pharmacist, or nurse before using Meropenem Accordpharma.

Using Meropenem Accordpharma with other medicines

Tell your doctor or nurse if you are using, have recently used, or might use any other medicines.

This is because Meropenem Accordpharma may affect the way some medicines work, and some of these may have an effect on Meropenem Accordpharma.

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 Accordpharma should not be used, as it may decrease the effect of sodium valproate.
• Oral anticoagulant agent (used to treat or prevent blood clots).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. It is preferable to avoid the use of meropenem during pregnancy. Your doctor will decide if you should use meropenem.

It is very important that you inform your doctor if you are breastfeeding or plan to breastfeed before receiving treatment with meropenem. A small amount of this medicine may pass into breast milk. Therefore, your doctor will decide if you should use meropenem during breastfeeding.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines.

Meropenem has been associated with headache and tingling or numbness in the skin (paresthesia). Either of these side effects could affect your ability to drive or use machines. Meropenem may cause involuntary muscle movements, which can cause the person's body to shake rapidly and uncontrollably. This is usually accompanied by a loss of consciousness. Do not drive or use machines if you experience this side effect.

Meropenem Accordpharma contains sodium.

This medicine contains 45.1 mg of sodium (main component of table/cooking salt) in each 500 mg dose. This is equivalent to 2.25% of the maximum daily sodium intake recommended for an adult.

If you have a condition that requires you to control your sodium intake, inform your doctor, pharmacist, or nurse.

3. How to use Meropenem Accordpharma

Follow exactly the administration instructions of this medicine as indicated by your doctor or nurse. If in doubt, consult your doctor or nurse again.

Use in adults

• The dose depends on the type of infection you have, the area of the body where it is located, and its severity. Your doctor will decide what dose you need.
• The normal dose in adults is between 500 mg (milligrams) and 2 g (grams). You will usually be given a dose every 8 hours. However, if your kidneys do not work well, you may receive the dose less frequently.

Use in children and adolescents

• The dose for children over 3 months and up to 12 years is decided using the child's age and weight. The normal dose is between 10 mg and 40 mg of Meropenem Accordpharma per kilogram (kg) of the child's weight. You will usually be given a dose every 8 hours. Children who weigh over 50 kg will be given an adult dose.

How to use Meropenem Accordpharma

Meropenem Accordpharma will be administered to you as an injection or infusion into a large vein.

• Meropenem Accordpharma will usually be administered by your doctor or nurse.
• However, some patients, parents, or caregivers are trained to administer Meropenem Accordpharma at home. The instructions for this are found in this leaflet (in the section called “Instructions for administering Meropenem Accordpharma to yourself or another person at home”). Follow exactly the administration instructions of Meropenem Accordpharma as indicated by your doctor. Consult your doctor or pharmacist if you have doubts.
• Your injection should not be mixed with other injections or added to other solutions that contain other medicines.
• The injection may last approximately 5 minutes or between 15 and 30 minutes. Your doctor will tell you how Meropenem Accordpharma is administered.
• Injections should usually be administered at the same time every day.

If you use more Meropenem Accordpharma than you should

If you accidentally use more than the prescribed dose, contact your doctor or go to the nearest hospital immediately. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Meropenem Accordpharma

If you forget an injection, you should receive it as soon as possible. However, if it is almost time for your next injection, do not receive the missed one.

Do not use a double dose (two injections at the same time) to make up for missed doses.

If you stop using Meropenem Accordpharma

Do not stop using Meropenem Accordpharma until your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe allergic reactions

If you experience any of these signs and symptoms, tell your doctor or nurse immediately.You may need urgent medical treatment. The signs and symptoms can 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 difficulty breathing.
• Severe skin reactions that include:
• Severe hypersensitivity reactions with fever, skin rash, and changes in blood test results that check liver function (increased liver enzyme levels), increased eosinophils, and swollen lymph nodes. These can be signs of a multi-organ sensitivity disorder known as DRESS syndrome.
• Severe scaly red rash, bumps on the skin that contain pus, blisters, or peeling of the skin, which can be associated with high fever and joint pain.
• Severe skin reactions that can appear as circular red patches often with central blisters on the trunk, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes, and which 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 (unknown)

The symptoms include:

• Shortness of breath when you do not expect it.
• Red or brown urine.

If you notice any of the above, go to a doctor immediately.

Other possible side effects:

Common (may affect up to 1 in 10 people)

• Abdominal pain (stomach pain).
• Nausea.
• Vomiting.
• Diarrhea.
• Headache.
• Skin rash, itching.
• Pain and inflammation.
• Increased platelet count in the blood (checked in a blood test).
• Changes in blood tests, including tests that show how your liver is working.

Uncommon (may affect up to 1 in 100 people)

• Changes in your blood. These include a decrease in platelet count (which can make you bruise more easily), increased white blood cells, decreased white blood cells, and increased bilirubin. Your doctor may perform periodic blood tests.
• Changes in blood tests, including tests that show how your kidneys are working.
• Tingling sensation (numbness).
• Mouth or vaginal infections caused by a fungus (thrush).
• Inflammation of the intestine with diarrhea.
• Pain in the veins where Meropenem is injected.
• Other changes in your blood. The symptoms include frequent infections, fever, and sore throat. Your doctor may perform periodic blood tests.
• Decreased potassium levels in the blood (which can cause weakness, muscle cramps, numbness, and heart rhythm disturbances).
• Liver problems. Yellowing of the skin and eyes, itching of the skin, dark-colored urine, or light-colored stools. If you notice these signs or symptoms, consult a doctor immediately

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

• Seizures (convulsions).

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Meropenem Accordpharma

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date that appears on the packaging after EXP. The expiry date is the last day of the month indicated.

Injection

After reconstitution: The reconstituted solutions for intravenous injection should be used immediately. The time interval between the start of reconstitution and the end of intravenous injection should not exceed 1 hour when stored at controlled room temperature (15-25°C).

Infusion

After reconstitution: The reconstituted solutions for intravenous infusion should be used immediately. The time interval between the start of reconstitution and the end of intravenous infusion should not exceed 1 hour.

Do not freeze the reconstituted solution.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Meropenem Accordpharma

Each vial contains meropenem trihydrate equivalent to 500 mg of anhydrous meropenem.

The other component is anhydrous sodium carbonate.

Appearance of the Product and Container Contents

Meropenem Accordpharma is a white to light yellow powder, for solution for injection and infusion in a vial.

Meropenem Accordpharma is available in packs of 1 or 10 vials. Not all pack sizes may be marketed.

Marketing Authorization Holder:

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6ª planta

08039 Barcelona

Manufacturer:

Accord Healthcare Polska Sp. z o.o.

ul. Lutomierska 50,

Pabianice

95-200

Poland

Date of Last Revision of this Leaflet: July 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

Health Advice/Education

Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused by viruses.

Sometimes a bacterial infection does not respond to treatment with an antibiotic. One of the most common reasons for this to happen is that the bacteria causing the infection are resistant to the antibiotic being taken. This means they can survive and even multiply, despite the antibiotic.

Bacteria can become resistant to antibiotics for many reasons. Using antibiotics with caution can help reduce the opportunity for bacteria to become resistant to them.

When your doctor prescribes you antibiotic treatment, it is to treat only your current illness. Paying attention to the following advice will help prevent the emergence of resistant bacteria that could stop the antibiotic from working.

1. You should not use an antibiotic unless it has been specifically prescribed for you, and you should only use it to treat the infection for which it was prescribed.
2. You should not use antibiotics that have been prescribed for other people, even if they have had a similar infection to yours.
3. You should not give antibiotics that were prescribed for you to other people.
4. If you have any antibiotic left over after completing the treatment as indicated by your doctor, you should take it to the pharmacy for proper disposal.

This information is intended only for healthcare professionals:

Instructions for Administering Meropenem Accordpharma to Yourself or Another Person at Home

Some patients, parents, and caregivers may be trained to administer Meropenem Accordpharma at home.

Warning – You should only administer this medicine to yourself or another person at home after a doctor or nurse has trained you.

• The medicine must be mixed with another liquid (the diluent). Your doctor will tell you what amount of diluent to use.
• Use the medicine immediately after preparation. Do not freeze it.

How to Prepare this Medicine

1. Wash your hands and dry them thoroughly. Prepare a clean work area.

1. Remove the Meropenem Accordpharma vial from the packaging. Check the vial and the expiration date. Check that the vial is intact and has not been damaged.

1. Remove the colored cap and clean the rubber stopper with a cotton swab impregnated with alcohol. Let the rubber stopper dry.

1. Insert a new sterile needle into a new sterile syringe, without touching the ends.

1. Draw up the recommended amount of sterile "Water for Injection" with the syringe. The amount of liquid you need is shown in the table below:

Note that:If the amount of Meropenem Accordpharma prescribed for you is more than 1 g, you will need to use more than one Meropenem Accordpharma vial. You can then draw up the liquid from the vials into a syringe.

1. Pierce the center of the rubber stopper with the syringe needle and inject the recommended amount of "Water for Injection" into the Meropenem Accordpharma vial(s).

1. Remove the needle from the vial and shake it well for about 5 seconds, or until all the powder has dissolved. Clean the gray rubber stopper again with a new cotton swab impregnated with alcohol and let it dry.

1. With the syringe plunger fully pushed into the syringe, pierce the rubber stopper again with the needle. You should then hold the syringe and the vial and turn the vial upside down.

1. Keeping the needle tip in the liquid, pull the plunger and draw all the liquid from the vial into the syringe.

1. Remove the needle and syringe from the vial and discard the empty vial in an appropriate container.

1. Hold the syringe vertically, with the needle facing upwards. Gently tap the syringe to make any air bubbles in the liquid rise to the top of the syringe.

1. Remove the air from the syringe by gently pushing the plunger until the air has been expelled.

1. If you are using Meropenem Accordpharma at home, dispose of the needles and infusion lines you have used properly. If your doctor decides to interrupt your treatment, dispose of any unused Meropenem Accordpharma properly.

Administration of the Injection

You can administer this medicine through a peripheral intravenous catheter, or through a central port or line.

Administration of Meropenem Accordpharma through a Peripheral Intravenous Catheter

1. Remove the needle from the syringe and discard it carefully in authorized containers for sharp objects.

1. Clean the end of the peripheral intravenous catheter with a cotton swab impregnated with alcohol and let it dry. Open the cannula cap and connect the syringe.

1. Slowly press the syringe plunger to administer the antibiotic constantly over about 5 minutes.

1. Once you have finished administering the antibiotic and the syringe is empty, remove it and flush the line as recommended by your doctor or nurse.

1. Close the cannula cap and discard the syringe carefully in authorized containers for sharp objects.

Administration of Meropenem Accordpharma through a Central Port or Line

1. Remove the cap from the port or line, clean the end of the line with a cotton swab impregnated with alcohol, and let it dry.

1. Connect the syringe and slowly press the plunger to administer the antibiotic constantly over about 5 minutes.

1. Once you have finished administering the antibiotic, remove the syringe and flush the line as recommended by your doctor or nurse.

1. Place a new clean cap on the central line and discard the syringe carefully in authorized containers for sharp objects.