MEROPENEM ACCORDPHARMA 500 mg POWDER FOR SOLUTION FOR INJECTION AND FOR INFUSION

Introduction

Package Leaflet: Information for the User

Meropenem Accordpharma 500 mg Powder for Solution for Injection and Infusion EFG

Meropenem

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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.

Contents of the pack

1. What is Meropenem Accordpharma and what is it used for
2. What you need to know before you use Meropenem Accordpharma
3. How to use Meropenem Accordpharma
4. Possible side effects
5. Storage of Meropenem Accordpharma
6. Contents of the pack and other information

1. What is Meropenem Accordpharma and what is it used for

Meropenem Accordpharma belongs to a group of medicines called carbapenem antibiotics. It works by killing bacteria that can cause serious infections.

Antibiotics are used to treat bacterial infections and will not work for infections caused by viruses, such as the common cold or flu.

It is important that you follow the instructions regarding dose, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

Meropenem is used to treat the following infections in adults and children from 3 months of age:

• Infection affecting the lungs (pneumonia).
• Bronchial and lung infections in patients with cystic fibrosis.
• Complicated urinary tract infections.
• Complicated infections in the abdomen.
• Infections that you can acquire during and after childbirth.
• Complicated skin and soft tissue infections.
• Bacterial infection of the brain (meningitis).

Meropenem Accordpharma may be used to treat patients with neutropenia who have fever that is suspected to be due to a bacterial infection.

Meropenem Accordpharma can be used to treat bacterial infection of the blood that may be associated with one of the aforementioned infections.

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 reaction 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 (used to treat or prevent blood clots).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 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 whether you should use meropenem during breastfeeding.

Driving and using machines

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

Meropenem has been associated with headache and tingling or numbness of 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 cooking/table salt) per 500 mg dose. This is equivalent to 2.25% of the maximum daily intake of sodium 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 affected, 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 take 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 miss 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 product, 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 get 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 (increase in liver enzyme levels), increase in a type of white blood cell (eosinophilia), and enlargement of 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).

Damaged red blood cells (frequency not known)

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.
• Rash, itching of the skin.
• 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 the number of platelets (which can make you bruise more easily), an increase in some white blood cells, a decrease in other white blood cells, and an increase in the amount of a substance called “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.
• Decrease in potassium levels in the blood (which can cause weakness, muscle cramps, numbness, and changes in heart rhythm).
• 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 which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

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. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE point. 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 a treatment with an antibiotic, it is to treat only your current illness. Paying attention to the following advice will help prevent the appearance of resistant bacteria that could stop the activity of the antibiotic.

This information is intended only for doctors or 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.

How to Prepare this Medicine

Note that:If the amount of Meropenem Accordpharma prescribed for you is greater than 1 g, you will need to use more than one Meropenem Accordpharma vial. You can then withdraw 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 must 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 withdraw 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. Remove the air from the syringe by gently pushing the plunger until the air has come out.

Administration of the Injection

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

Administration of Meropenem Accordpharma through a Peripheral Intravenous Catheter

1. Remove the needle from the syringe and carefully discard it 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.

Administration of Meropenem Accordpharma through a Port or Central 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.

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