Label: Information for the Patient

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

(meropenem trihydrate)

1. What Meropenem is and for what it is used

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

3. How to use Meropenem

4. Possible adverse effects

5. Storage of Meropenem

6. Contents of the package and additional information

Meropenem belongs to a group of medications called carbapenem antibiotics.

It works by destroying bacteria that can cause severe infections.

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

??Lung infection (pneumonia)

??Respiratory and lung infections in patients with cystic fibrosis

??Complicated urinary tract infections

??Complicated abdominal infections

??Infections you may acquire during and after childbirth

??Complicated skin and soft tissue infections

??Acute bacterial meningitis

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

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

No use Meropenem if

??he is allergic (hypersensitive) to meropenem or any of the other components of this medication (listed in section 6).

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

Warnings and precautions

Consult a doctor, pharmacist, or nurse before starting to use Meropenem if:

??he has health problems, such as liver or kidney problems.

??he has had severe diarrhea after taking other antibiotics.

He may develop a positive response to a test (Coombs test) indicating the presence of antibodies that can destroy red blood cells. His doctor will discuss this with him.

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

If he is in any of these situations, or has doubts, consult with his doctor or nurse before using Meropenem.

Other medications and MeropenemInform his doctor, pharmacist, or nurse if he is using, has used, or may need to use any other medication, including those purchased without a prescription and herbal remedies.

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

In particular, inform his doctor, pharmacist, or nurse if he is taking any of the following medications:

??Probenecid (used to treat gout).

??Valproic acid / sodium valproate / valpromide (used to treat epilepsy). Meropenem should not be used, as it may reduce the effect of sodium valproate.

??Oral anticoagulant (used to treat or prevent blood clots).

Pregnancy and breastfeeding

If he is pregnant or breastfeeding, or thinks he may be pregnant, consult his doctor or pharmacist before using this medication.

It is preferable to avoid using meropenem during pregnancy. His doctor will decide if he should use meropenem.

It is essential to inform his doctor if he is breastfeeding or intends to breastfeed before receiving meropenem. Small amounts of this medication pass into breast milk. Therefore, his doctor will decide if he 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 headache, tingling or pins and needles in the skin (paresthesia); and involuntary muscle movements, leading to rapid and uncontrolled body agitation (convulsions), which is usually accompanied by loss of consciousness. Any of these effects could affect his ability to drive or operate machinery.

Meropenem contains sodium.

Meropenem 500 mg: This medication contains 45 mg of sodium (main component of table salt/for cooking) in each 500 mg. This is equivalent to 2.25% of the maximum daily sodium intake recommended for an adult.

If he has a situation that requires controlling his sodium intake, inform his doctor, pharmacist, or nurse.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Use in adults

??The dose depends on the type of infection you present, the area of the body in which 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 normally be administered 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 administered a dose every 8 hours. Children weighing over50 kgwill be administered an adult dose.

How to use Meropenem

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

??Meropenem will normally 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 exactly the administration instructions for Meropenem as indicated by your doctor. Consult your doctor if you have any 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 to administer Meropenem.

??Injections should normally be administered at the same time every day.

If you use more Meropenem 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, accidental ingestion, or if you accidentally use more doses than prescribed, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone91 562 04 20indicating the medication and the amount ingested.

If you forget to use Meropenem

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

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

If you interrupt treatment with Meropenem

Do not stop Meropenem until your doctor tells you to.

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

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

Severe allergic reactions

If you experience a severe allergic reaction,stop taking Meropenem and seek medical attention immediately. You may need urgent medical treatment. 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.

??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 control liver function (elevated liver enzymes), increased levels of a type of white blood cell (eosinophilia), and enlargement of 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 (unknown)

Symptoms include:

??Shortness of breath when not expected.

??Red or brown urine.

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

Other possible side effects:

Frequent (may affect up to 1 in 10 people)

??Abdominal pain (stomach pain).

??Nausea.

??Vomiting.

??Diarrhea.

??Headache.

??Skin rash, itching skin.

??Pain and inflammation.

??Increased platelet count in the blood (checked in a blood test).

??Changes in blood test results, including tests that show how well the liver is functioning.

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 possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://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 label and on the box after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above25ºC.

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

Do not freeze the reconstituted solution.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

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 contents of the package

Meropenem is a white to light yellow powder, for injection or infusion solution in a vial. Vial sizes are 1 or 10.

Only some vial sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, Netherlands

Responsible for manufacturing

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

Phone: +34 93 342 78 90

This medicine is authorized in the Member States of the European Economic Area with the following names:

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

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

Last review date of this leaflet: March 2021.

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

This information is intended only for healthcare professionals:

Instructions for administering Meropenem yourself or to another person at home

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

Attention – You should only administer this medicine to yourself or to 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 just after preparing it. Do not freeze it.

How to prepare this medicine

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

2.Remove the vial (vial) of Meropenem from the package. Check the vial and expiration date. Check that the vial is intact and not damaged.

3.Remove the colored cap and clean the rubber stopper with an alcohol-soaked cotton swab. Let the stopper dry.

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

5.Extract the recommended amount of "Intravenous Water" sterile with the syringe. The amount of liquid needed is shown in the table below:

Take note that: if the amount of Meropenem prescribed to you is greater than1 g, you will need to use more than one vial of Meropenem. You can then extract the liquid from the

viales in a syringe.

6.Pass the center of the rubber stopper with the needle of the syringe and inject the recommended amount of "Intravenous Water" into the/ Meropenem vial.

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

8.With the plunger of the syringe pushed all the way in, pass the needle through the rubber stopper again. You should then hold the syringe and vial and turn the vial upside down.

9.Keeping the end of the needle in the liquid, pull the plunger and extract all the liquid from the vial into the syringe.

10.Remove the needle and syringe from the vial and dispose of the empty vial in an appropriate container.

11.Hold the syringe vertically, with the needle pointing up. Give the syringe gentle taps to remove any bubbles that may be in the liquid.

12.Remove the air from the syringe by gently pushing the plunger until the air has come out.

13.If you are using Meropenem at home, dispose of the needles and infusion sets you have used properly. If your doctor decides to stop your treatment, dispose of the Meropenem you have not used 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 through a peripheral intravenous catheter

1. Remove the needle from the syringe and dispose of it properly in your authorized sharp objects containers.

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 push the plunger of the syringe to administer the antibiotic at a constant rate

for about 5 minutes.

4. Once you have finished administering the antibiotic and the syringe is empty, remove it and clean the site as recommended by your doctor or nurse.

5. Close the cap of the cannula and dispose of the syringe properly in your authorized sharp objects containers.

Administration of Meropenem through a central port or line

1. Remove the cap from the central 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 push the plunger to administer the antibiotic at a constant rate

for about 5 minutes.

3. Once you have finished administering the antibiotic, remove the syringe and clean the site as recommended by your doctor or nurse.

4. Place a new clean cap on the central line and dispose of the syringe properly in your authorized sharp objects containers.

Administration of Meropenem through intravenous infusion

Meropenem can be administered through intravenous infusion for about15 to30 minutes.Meropenem vials for intravenous infusion can be reconstituted directly with sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solutions, up to a final concentration of1 to20 mg/ml.