MEROPENEM SUN 500 mg POWDER FOR INJECTION AND INFUSION SOLUTION

Introduction

Package Leaflet: Information for the Patient

MEROPENEM SUN 500 mg POWDER FOR SOLUTION FOR INJECTION AND INFUSION EFG

(meropenem trihydrate)

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, pharmacist, 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Meropenem and what is it used for
2. What you need to know before you use Meropenem
3. How to use Meropenem
4. Possible side effects

5 Conservation of Meropenem

1. Contents of the pack and further information

1. What is Meropenem and what is it used for

Meropenem belongs to a group of medicines called carbapenem antibiotics.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as flu or the common cold.

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 finishing the treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

It works by killing bacteria that can cause serious infections.

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

??Acute bacterial infection of the brain (meningitis)

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

Meropenem 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

Do not use Meropenem if

?? you are allergic (hypersensitive) to meropenem or any of the other ingredients of this medicine (listed in section 6).

?? you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or carbapenems, as you may also be allergic to meropenem.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Meropenem 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.

If you notice muscle pain, sensitivity, or unexplained weakness, and/or dark urine, inform your doctor immediately. This could be a sign of muscle deterioration (rhabdomyolysis), which can cause kidney problems.

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 or nurse before using Meropenem.

Other medicines and MeropenemTell your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicines, including those obtained without a prescription and herbal medicines.

This is because Meropenem can affect how some medicines work, and some of these may have an effect on Meropenem.

In particular, tell your doctor, pharmacist, 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, 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 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 if you should use meropenem.

It is important that you inform your doctor if you are breastfeeding or plan to breastfeed before receiving meropenem. Small amounts of this medicine pass into breast milk. Therefore, your doctor will decide if 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.

However, Meropenem has been associated with headache, tingling, or numbness of the skin (paresthesia). Any of these side effects may affect your ability to drive or use machines.

Meropenem may cause involuntary muscle movements, leading to rapid and uncontrolled body agitation (convulsions), which is usually accompanied by loss of consciousness. Do not drive or use machines if you experience this side effect.

Meropenem contains sodium.

Meropenem 500 mg: This medicine contains 45 mg of sodium (main component of table/cooking salt) per 500 mg. This is equivalent to 2.25% of the maximum recommended daily sodium intake 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

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist 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 11 years is decided using the child's age and weight. The normal dose is between 10 mg and 40 mg of Meropenem 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

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

??Meropenem will usually be administered by your doctor or nurse.

??However, some patients, parents, or caregivers are trained to administer meropenem at home. The instructions for this are found in this leaflet (in the section called "Instructions for administering meropenem to yourself or another person at home"). Follow the instructions for administration of Meropenem exactly as indicated by your doctor. Consult your doctor if you have doubts.

??Your injection must not be mixed with or added to solutions that contain other medicines.

??The injection can last approximately 5 minutes or between 15 and 30 minutes. Your doctor will tell you how Meropenem is administered.

??The injections should usually be administered at the same time every day.

If you use more Meropenem 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, accidental ingestion, or if you accidentally use more than the prescribed dose, 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

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 the missed dose.

If you stop using Meropenem

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

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

4. Possible side effects

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

Severe allergic reactions

If you have a severe allergic reaction, stop using Meropenem and see a doctor immediately. You may need urgent medical treatment. The 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, skin bumps 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 frequency)

The symptoms include:

??Shortness of breath when you do not expect it.

??Red or brown urine.

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

Muscle damage

Muscle pain, sensitivity, or unexplained weakness, and/or dark urine. If you notice these signs or symptoms, consult 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 of the skin.

??Pain and inflammation.

??Increase in the number of platelets 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 blood tests periodically.

??Changes in blood tests, including tests that show how your kidneys are working.

??Tingling sensation (numbness).

??Infections of the mouth or vagina 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 blood tests periodically.

• 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 1000 people)

??Seizures (convulsions).

? Sudden confusion and disorientation (delirium).

Sudden chest pain has been observed, which can be a sign of a potentially severe allergic reaction called Kounis syndrome, with other medicines of the same type. If this happens to you, consult a doctor or nurse immediately.

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. Conservation of Meropenem

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 label and carton after EXP. The expiry date is the last day of the month shown.

Do not store above 25°C.

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

Do not freeze the reconstituted solution.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Meropenem

The active ingredient is meropenem trihydrate.

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 is a white to light yellow powder, for solution for injection or infusion in a vial. Container sizes of 1 or 10 vials.

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, Netherlands

Manufacturer

TERAPIA S.A.

124 Fabricii Street

400 632 Cluj Napoca

Romania

Or

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Austria

Or

Basics GmbH

Hemmelrather Weg 201

D-51377 Leverkusen

Germany

Local Representative

Sun Pharma Laboratorios S.L.

Rambla de Catalunya, 53-55

08007 Barcelona.

Spain

Tel.:+34 93 342 78 90

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Meropenem SUN 500 mg powder for solution for injection or infusion EFG.

Northern Ireland: Meropenem 500 mg powder for solution for injection or infusion

Date of the last revision of this leaflet: July 2025.

Detailed and updated information on this medicinal product 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 tips will help prevent the emergence of resistant bacteria that could stop the activity of the antibiotic.

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 receiving treatment as directed 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 to Yourself or Another Person at Home

Some patients, parents, and caregivers are trained to administer Meropenem at home.

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

How to Prepare this Medication

The medication must be mixed with another liquid (the diluent). Your doctor will tell you what amount of diluent to use.

Use the medication immediately after preparation. Do not freeze it.

1. Wash your hands and dry them very well. Prepare a clean work area.
2. Remove the Meropenem vial from the container. Check the vial and the expiration date. Check that the vial is intact and has not been damaged.
3. Remove the colored cap and clean the gray rubber stopper with a cotton swab soaked in alcohol. Let the rubber stopper dry.
4. Insert a new sterile needle into a new sterile syringe, without touching the ends.
5. 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 prescribed for you is greater than 1 g, you will need to use more than one Meropenem vial. You can then draw up the liquid from the vials into a syringe.

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

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 soaked in alcohol and let it dry.

1. With the syringe plunger fully pushed into the syringe, pierce the gray rubber stopper again with the needle. You should then hold the syringe and the vial and turn the vial upside down.
2. Keeping the needle tip in the liquid, pull the plunger and draw up all the liquid from the vial into the syringe.
3. Remove the needle and syringe from the vial and discard the empty vial in an appropriate container.
4. Hold the syringe vertically, with the needle facing up. Gently tap the syringe to make any bubbles in the liquid rise to the top of the syringe.
5. Remove the air from the syringe by gently pushing the plunger until the air has come out.
6. If you are using Meropenem 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 properly.

Administration of the Injection

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

Administration of Meropenem through a Peripheral Intravenous Catheter

1. Remove the needle from the syringe and discard it carefully in authorized containers for sharp objects.
2. Clean the end of the peripheral intravenous catheter with a cotton swab soaked in alcohol and let it dry. Open the cannula cap and connect the syringe.
3. Slowly press the syringe plunger to administer the antibiotic constantly

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

Administration of Meropenem 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 soaked in

alcohol and let it dry.

1. Connect the syringe and slowly press the plunger to administer the antibiotic constantly

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

Administration of Meropenem through Intravenous Infusion

Meropenem can be administered by intravenous infusion over approximately 15 to 30 minutes. The vials for intravenous infusion of meropenem can be reconstituted directly with 9 mg/ml (0.9%) sodium chloride infusion solutions or 50 mg/ml (5%) glucose infusion solutions, up to a final concentration of 1 to 20 mg/ml.