Label: information for the user

Meropenem Qilu 1 g powder for injectable solution and for infusion EFG

Read this label carefully before starting to use this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
  If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

1. What isMeropenem Qiluand for what it is used

2. What you need to know before starting to useMeropenem Qilu

3. How to useMeropenem Qilu

4. Possible adverse effects

5. Storage ofMeropenem Qilu

6. Contents of the package and additional information

Meropenem Qilu contains the active ingredient meropenem and belongs to a group of medicines called carbapenem antibiotics. It works by destroying bacteria that can cause serious infections.

Meropenem Qilu is used to treat the following infections in adults and children aged 3 months or older:

• Lung infection (pneumonia)
• Respiratory and lung infections in patients with cystic fibrosis (a hereditary condition in which the lungs and digestive system can become blocked by thick and sticky secretions)
• Complicated urinary tract infections
• Complicated abdominal infections
• Infections you can get during and after childbirth
• Complicated skin and soft tissue infections
• Acute bacterial infection of the brain (meningitis)

This medicine may be used to treat neutropenic patients (with a weakened immune system) who have a fever suspected to be due to a bacterial infection.

Meropenem Qilu can be used to treat bacterial blood infection that may be associated with one of the infections mentioned above.

Do not use Meropenem Qilu

• if you are allergic to meropenem or any of the other components of this medication (listed in section 6).
• 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 pharmacist before starting to use Meropenem Qilu

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

Blood tests

You may develop a positive result on a test (Coombs test) indicating the presence of antibodies that can destroy red blood cells.

Your doctor will discuss this with you.

Skin reactions

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

If you are in any of these situations, or if you have doubts, consult your doctor before using this medication.

Other medications and Meropenem Qilu

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is because Meropenem Qilu may affect the way some medications work, and some of these may have an effect on Meropenem Qilu.

Particularly, inform your doctor or nurse if you are taking any of the following medications:

• Probenecid (used to treat gout).
• Valproic acid/sodium valproate/valpromide (used to treat epilepsy). Meropenem Qilu 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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

It is preferable to avoid using meropenem during pregnancy.

Your doctor will decide if you should use Meropenem Qilu.

It is essential to inform your doctor if you are breastfeeding or intend to breastfeed before receiving Meropenem Qilu. Small amounts of this medication pass into breast milk. Therefore, your doctor will decide if you should use meropenem during breastfeeding.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and operate machinery.

However, meropenem has been associated with headaches and tingling or prickling sensations in the skin (paresthesia). Either of these effects could affect your ability to drive or operate machinery.

This medication 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 operate machinery if you experience this side effect.

Meropenem Qilu contains sodium

This medication contains 90mg of sodium (main component of table salt/for cooking) in each 1 g dose. This is equivalent to 4.5% of the recommended daily maximum sodium intake for an adult.

If you have a situation that requires controlling your sodium intake, inform your doctor, pharmacist, or nurse.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist or nurse.

Use in adults

• The dose depends on the type of infection you present, 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 and 2 g. You will normally be given a dose every 8 hours. However, if your kidneys do not function 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 per kilogram (kg) of the child's weight. You will normally be given a dose every 8 hours. Children weighing over 50 kg will be given an adult dose.

How to use Meropenem Qilu

• Meropenem Qilu will be administered to you as an injection or infusion in a large-caliber vein.
• Normally, Meropenem Qilu will be administered by your doctor or nurse.
• However, some patients, parents, or caregivers are trained to administer Meropenem Qilu at home. The instructions for this are found in this leaflet (in the section called "Instructions for administering Meropenem Qilu to yourself or another person at home"). Follow exactly the administration instructions of Meropenem Qilu indicated by your doctor. Consult your doctor if you have doubts.
• Your injection should not be mixed with or added to solutions that contain other medications.
• The injection may take approximately 5 minutes or between 15 and 30 minutes. Your doctor will tell you how Meropenem Qilu is administered.
• Injections should normally be administered at the same time every day.

If you use more Meropenem Qilu than you should

If you accidentally use more doses than prescribed, 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Meropenem Qilu

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 missed one. Do not use a double dose (two injections at once) to compensate for a missed dose.

If you interrupt the treatment with Meropenem Qilu

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

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe allergic reactions

If you experience any of the following symptoms, inform your doctor or nurse immediately. You may need urgent medical treatment. The symptoms may include a sudden onset of:

• Severe skin rash, itching, or hives.
• Swelling of the face, lips, tongue, or other parts of the body.
• Lack of air, wheezing, or difficulty breathing.
• Severe skin reactions that include:

• Severe hypersensitivity reactions with fever, skin rashes, and changes in blood test results that control liver function (elevated liver enzyme levels), increased levels of 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 containing pus, blisters, or skin peeling, which may be associated with high fever and joint pain.
• Severe skin reactions that may appear as circular red patches often with central blisters on the trunk, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers, and may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or a more severe form (toxic epidermal necrolysis).

Blood cell damage

The symptoms include:

• Lack of air when not expected
• Red or brown urine

If you notice any of the above, seek medical attention immediately.

Possible side effects

Frequent (may affect up to 1 in 10 people)

• Abdominal pain (stomach pain).
• Unpleasant feeling (nausea).
• Vomiting.
• Diarrhea.
• Headache.
• Skin rash, itching skin.
• Pain and inflammation (swelling at the injection site).
• Increased platelet count in the blood (checked in a blood test).
• Changes in blood test results, including tests that show how the liver functions.

Rare (may affect up to 1 in 100 people)

• Changes in the blood. These include a decrease in platelet count (which may make you bruise more easily), increased levels of some white blood cells, decreased levels of other white blood cells, and increased levels of a substance called «bilirubin». Your doctor may perform blood tests periodically.
• Changes in blood test results, including tests that show how the kidneys function.
• Itchy sensation (tingling).
• Fungal infections of the mouth (aphtha) or vagina.
• Intestinal inflammation with diarrhea.
• Pain in the veins where Meropenem Qilu is injected.
• Other changes in your blood. The symptoms include frequent infections, fever, and sore throat. Your doctor may perform blood tests periodically. Your doctor may perform blood tests periodically.

Rare (may affect up to 1 in 1000 people)

• Seizures.
• Acute disorientation and confusion (delirium).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and the vial label after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

After reconstitution/dilution:

Intravenous injection administration

A bolus injection solution is prepared by dissolving the medication in injection water, to a final concentration of 50mg/ml.

The reconstituted product solution in injection water must be used immediately.

Intravenous infusion administration

A perfusion solution is prepared by dissolving the medication in a 9mg/ml sodium chloride (0.9%) solution, or in a 50mg/ml dextrose (5%) solution, to a final concentration of 1 to 20mg/ml.

The reconstituted medication solution in 9mg/ml sodium chloride (0.9%) solution must be used immediately. The maximum time that should elapse between the start of reconstitution and the end of infusion should not exceed one hour.

The reconstituted medication solution in 50mg/ml dextrose (5%) solution must be used immediately.

Do not freeze the reconstituted solution.

Medicines should not be disposed of through drains or trash.Ask your pharmacist how to dispose of the containers and medications that you no longer need.This will help protect the environment.

Composition of Meropenem Qilu

The active ingredient is meropenem.

Each vial contains 1 g of meropenem (in the form of meropenem trihydrate).

The other component is sodium carbonate.

Appearance of Meropenem Qilu and packaging contents

Meropenem Qilu is presented in vials containing a white or slightly yellowish powder for injectable or infusion solution.

Packaging sizes of 1 or 10 vials (clinical pack).

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

QILU PHARMA SPAIN S.L.

Paseo de la Castellana 40, 8th floor,

28046 Madrid,

Spain

Manufacturing

KYMOS, S.L.

Ronda de Can Fatjó,

7B (Parque Tecnológico del Vallès),

Cerdanyola del Vallès,

08290 Barcelona,

Spain

Eurofins Analytical Services Hungary Kft.

Anonymus utca 6, Budapest

H-1045,

Hungary

LLC “UNIFARMA”

Vangazu street 23,

Riga, LV-1024,

Latvia

Local representative:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 – Barcelona

Spain

Phone: +34 93 342 7890

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: 12/2023

Other sources of information:

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