MEROPENEM HIKMA 2 g POWDER FOR SOLUTION FOR INJECTION AND INFUSION

Introduction

Package Leaflet: Information for the User

Meropenem Hikma 2 g Powder for Solution for Injection and Infusion

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 Package Leaflet

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

1. Contents of the pack and further information

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

Meropenem Hikma contains the active substance meropenem, which 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 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 indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after finishing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

Meropenem is used to treat the following 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 low levels of white blood cells (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 Hikma

Do not useMeropenem Hikma:

• if you are allergic to meropenem or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and further 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

Consult your doctor or nurse before starting to use Meropenem Hikma:

• if you have health problems, such as liver or kidney problems.
• if 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.

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.

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

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

Other medicines and Meropenem Hikma

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

Meropenem may affect the way some medicines work, and some of these may 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 Hikma 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 Hikma during breastfeeding.

Driving and using machines

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

However, meropenem has been associated with headache and tingling or numbness in the skin (paresthesia); and involuntary muscle movements, which can cause the body to shake rapidly and uncontrollably (convulsions), usually accompanied by loss of consciousness, and this may affect your ability to drive or use machines.

Do not drive or use machines if you experience this side effect.

Meropenem Hikma contains sodium

This medicine contains 180 mg of sodium (main component of table/cooking salt) per 2 g dose. This is equivalent to 9% 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 or nurse.

3. How to use Meropenem Hikma

Follow exactly the administration instructions of this medicine 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 Hikma 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 Hikma

• Meropenem Hikma will be administered to you as an injection or infusion into a large vein.
• Meropenem Hikma will usually be administered by your doctor or nurse.

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

• Your injection should not be mixed 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 Hikma is administered.
• The injections should usually be administered at the same time every day.

If you use more Meropenem Hikma than you should

If you accidentally use more than the prescribed dose, contact your doctor, go to the nearest hospital immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount received.

If you forget to use Meropenem Hikma

If you forget an injection, you should receive it as soon as possible. However, if it is almost time to administer the next injection, do not receive the forgotten one.

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

If you stop treatment with Meropenem Hikma

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

If you have any other questions about 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 a severe allergic reaction , stop taking Meropenem Hikma and go to the doctor immediately.You may need urgent medical treatment. The signs and symptoms can include a sudden onset of:

• Severe hives, itching, and blisters 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 that include fever, rash, and changes in blood tests that check liver function (elevated liver enzymes) and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes. These can be signs of a multi-organ sensitivity disorder known as DRESS syndrome.
• Severe red scaly 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 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 (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 the doctor immediately.

Other possible side effects:

Frequent (may affect up to 1 in 10 people)

• Abdominal pain (stomach pain).
• Nausea.
• Vomiting.
• Diarrhea.
• Headache.
• 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 Hikma 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, tingling, 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).
• Sudden confusion and disorientation (delirium).

Reporting of side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Meropenem Hikma

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.

Do not store above 30°C.

Injection

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

• 3 hours when stored up to 25°C;
• 12 hours when stored under refrigeration conditions (2-8°C).

There are limited safety data available to support the administration of a 2 g dose in adults as an intravenous bolus injection.

After reconstitution, the solution should be colorless to pale yellow.

Infusion

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

• 3 hours when stored up to 25°C, when meropenem is dissolved in sodium chloride;
• 24 hours when stored under refrigeration conditions (2-8°C), when meropenem is dissolved in sodium chloride;
• when meropenem is dissolved in dextrose, the solution should be used immediately.

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

If not used immediately, the storage times and conditions are the responsibility of the user.

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 ofMeropenem Hikma

Each vial contains meropenem trihydrate equivalent to 2 g of anhydrous meropenem.

The other component is anhydrous sodium carbonate.

Appearance of the Product and Container Contents

Meropenem Hikma is a white to light yellow powder, for solution for injection or infusion in a glass vial with a rubber stopper and an aluminum flip-off cap.

Container sizes of 1, 6, or 10 vials.

Not all container sizes may be marketed.

Marketing Authorization Holder

Hikma Farmacêutica (Portugal) S.A.

Estrada do Rio da Mó, nº8, 8A e 8B, Fervença

2705-906 Terrugem SNT

Portugal

Manufacturer

ACS Dobfar S.p.A Nucleo Industriale S. Atto

• Nicolò a Tordino

64100 TERAMO

Italy

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

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

Austria: Meropenem Hikma 2g Pulver zur Herstellung einer Injektions-/Infusionslösung

Ireland: Meropenem 2g Powder for solution for injection/infusion

Italy: Meropenem Hikma 2g Polvere per soluzione iniettabile o infusione

Germany: Meropenem Hikma 2g Pulver zur Herstellung einer Injektions-/Infusionslösung

Portugal: Meropenem Hikma 2g Pó para solução injetável ou para perfusão

Netherlands: Meropenem Hikma 2g Poeder voor oplossing injectie voor infusie

Spain: Meropenem Hikma 2 g polvo para solución inyectable y para perfusión

United Kingdom: Meropenem 2g Powder for solution for injection/infusion

France: Meropenem Hikma 2g Poudre pour solution injectable/pour perfusion

Date of the last revision of thisleaflet: August 2025.

Other sources of information:

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

This information is intended only for healthcare professionals:

The following sections contain practical information about the preparation and administration of the product. When the prescriber assesses the suitability for use in a particular patient, they should be familiar with the medication's technical data sheet. See also section 3 "How to use Meropenem" in this leaflet.

Instructions for administering Meropenem Hikma to yourself or another person at home

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

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

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

How to prepare this medication

1. Wash your hands and dry them thoroughly. Prepare a clean work area.
2. Remove the Meropenem Hikma 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 color cap and clean the gray rubber stopper with an alcohol-soaked cotton swab. 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 injections" with the syringe. The amount of liquid you need is shown in the table below:

Note that:If the amount of Meropenem Hikma prescribed for you is more than 1 g, you will need to use more than one Meropenem Hikma 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 injections into the Meropenem Hikma vial(s).
2. 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 alcohol-soaked cotton swab and let it dry.
3. 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 vial and turn the vial upside down.
4. Keeping the needle tip in the liquid, pull the plunger and draw up all the liquid from the vial into the syringe.
5. Remove the needle and syringe from the vial and discard the empty vial in an appropriate container.
6. 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.
7. Remove the air from the syringe by gently pushing the plunger until the air has been expelled.
8. If you are using Meropenem Hikma 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 Hikma properly.

Administration of the injectable

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

Administration ofMeropenem Hikmathrough 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 an alcohol-soaked cotton swab and let it dry. Open the cap of the cannula and connect the syringe.
3. Slowly press the syringe plunger to administer the antibiotic constantly over about 5 minutes.
4. 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.
5. Close the cap of the cannula and discard the syringe carefully in authorized containers for sharp objects.

Administration ofMeropenem Hikmathrough a port or central line

1. Remove the cap from the port or line, clean the end of the line with an alcohol-soaked cotton swab, and let it dry.
2. Connect the syringe and slowly press the plunger to administer the antibiotic constantly over about 5 minutes.
3. Once you have finished administering the antibiotic, remove the syringe and flush the line as recommended by your doctor or nurse.
4. Place a new clean cap on the central line and discard the syringe carefully in authorized containers for sharp objects.

Administration of Meropenem Hikma through intravenous infusion

Meropenem can be administered by intravenous infusion over approximately 15-30 minutes. For intravenous infusion, the Meropenem Hikma vials can be reconstituted directly to a final concentration of 1 to 20 mg/ml with 0.9% sodium chloride or 5% glucose solution for infusion.

The solution should be shaken before use

The vials are for single use.