Package Insert: Information for the User

Meropenem Hikma 500 mg Powder for Injection and Infusion EFG

Read this package insert carefully before starting to use this medication, as it contains important information for you.

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

6. Contents of the pack and additional informationadditional information

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

• Pneumonia, an infection affecting the lungs

• Respiratory and pulmonary infections in patients with cystic fibrosis
• Complicated urinary tract infections
• Complicated abdominal infections
• Infections you may acquire during and after delivery
• Complicated skin and soft tissue infections
• Acute bacterial meningitis, a bacterial infection of the brain

Meropenem may be used to treat neutropenic patients who present with fever suspected to be due to a bacterial infection.Meropenem can be used to treat bacterial blood infections that may be associated with one of the aforementioned infections.

No useMeropenem Hikma:

• If you are allergic to meropenem or any of the other ingredients in this medicine (listed in the section 6 “Contents of the pack and special precautions for use”).
• 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 any health problems, such as liver or kidney problems.
• If you have had severe diarrhea after taking other antibiotics.

You may develop a positive test (Coombs test) indicating the presence of antibodies that can destroy red blood cells. Your doctor will discuss this with you.

If you are in any of these situations, or if you are unsure, consult your doctor ornurse before using Meropenem Hikma.

Use of Meropenem Hikmawith other medicines

Inform your doctor or nurse if you are taking, have recently taken or may need to take any other medicine.

Meropenem may affect the way some medicines work, and some of these may affect meropenem.

In particular, inform 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). Do not useMeropenem Hikma, as it may reduce 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 medicine.

It is best to avoid using meropenem during pregnancy.

It is very important to 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 to use Meropenem Hikma during breastfeeding.

Driving and operating machines

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

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

Meropenem Hikma contains sodium

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

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

Follow exactly the administration instructions for this medication 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 usual dose in adults is between 500 mg (milligrams) and 2 g (grams). 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 determined using the child's age and weight. The usual dose is between 10 mg and 40 mg of Meropenem Hikma 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 Hikma

• Meropenem Hikma will be administered to you as an injection or infusion into a large vein.
• Meropenem Hikma will normally 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 for Meropenem Hikma 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 Hikma.
• The injections should normally be administered at the same time each day.

If you use more Meropenem Hikma than you should

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

If you forget to use Meropenem Hikma

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 missed one.

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

If you interrupt the treatment with Meropenem Hikma

Do not stop Meropenem Hikma 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 a severe allergic reaction, stop taking Meropenem Hikma and seek medical attention immediately.You may need urgent medical treatment. The signs and symptoms may include a sudden onset of:

• Severe urticaria, 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.

Bleeding in red blood cells (unknown)

The 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 on 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 works.

Occasional (may affect up to 1 in 100 people)

• Changes in your blood. These include a decrease in the number of platelets (which may 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 work.
• Tickling sensation (tingling).
• Fungal infections of the mouth or vagina (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.
• Sudden appearance of severe rash, blisters, or skin peeling. They may be associated with high fever and joint pain.

Rare (may affect up to 1 in 1,000 people)

• Seizures.

Unknown (cannot be estimated from available data)

• Severe hypersensitivity reactions with fever, skin rash, and changes in blood test results that control liver function (increased levels of liver enzymes), increased eosinophils, and enlarged lymph nodes. These may be signs of a multi-organ sensitivity disorder known as DRESS syndrome.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 the Pharmacovigilance of Medicines for Human Use: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 packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Injectable

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

- 3 hours when storedup to 25°C;

- 12 hours when stored under refrigeration conditions (2-8°C).

Infusion

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

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

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

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

Do not freeze the reconstituted solution.

Medicines should not be thrown away through drains or in the trash. Dispose of the packaging and medicines that you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

Composition ofMeropenem Hikma

Each vial contains meropenem trihydrate equivalent to 1 g of meropenem anhydrous.

The other component is anhydrous sodium carbonate.

Appearance of the product and contents of the container

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

Container sizes of 1 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

Responsible for manufacturing

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

S. Nicolò a Tordino

64100 TERAMO

Italy

You can request more information about this medicine 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 medicine is authorized in the Member States of the European Economic Area with the following names:

Austria:Meropenem Hikma 1g Powder for the preparation of an injection/infusion solution

Irlanda:Meropenem 1g Powder for solution for injection/infusion

Italia:Meropenem Hikma 1g Powder for injectable solution or infusion

Alemania:Meropenem Hikma 1g Powder for the preparation of an injection/infusion solution

Portugal:Meropenem Hikma 1g Powder for injectable solution or for perfusion

Países Bajos:Meropenem Hikma 1g Powder for injection solution for infusion

Reino Unido:Meropenem 1g Powder for solution for injection/infusion

Francia: Meropenem Hikma 1mg Powder for injectable solution/pour perfusion

Last review date of thisleaflet:December 2020.

Other sources of information:

The detailed information about 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 solely for healthcare professionals:

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

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

Some patients, parents, and caregivers are trained to administer Meropenem Hikma 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 thoroughly. Prepare a clean work area.
2. Remove the vial (vial) of Meropenem Hikma from the packaging. Check the vial and the expiration date. Check that the vial is intact and not damaged.
3. Remove the colored cap and clean the gray rubber stopper with an alcohol-soaked cotton ball. 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 “Sterile Water for Injection” with the syringe. The amount of liquid needed is shown in the table below:

Important note:If the amount of Meropenem Hikma prescribed to you is greater than 1g, you will need to use more than one vial of Meropenem Hikma. You can then extract the liquid from the vials into a syringe.

1. Pierce the center of the gray rubber stopper with the needle of the syringe and inject the recommended amount of Sterile Water for Injection into the/each vial of Meropenem Hikma.
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 ball and let it dry.
3. With the plunger of the syringe pushed all the way in, pierce the gray rubber stopper again with the needle. You should then hold the syringe and the vial and turn the vial upside down.
4. Hold the end of the needle in the liquid and pull the plunger to extract all the liquid from the vial into the syringe.
5. Remove the needle and syringe from the vial and dispose of the empty vial in an appropriate container.
6. Hold the syringe vertically, with the needle pointing upwards. Gently tap the syringe to remove any bubbles that may be in the liquid.
7. Remove the air from the syringe by gently pushing the plunger until the air has come out.
8. If you are using Meropenem Hikma at home, dispose of the needles and infusion sets used properly. If your doctor decides to stop your treatment, dispose of the unused Meropenem Hikma properly.

Administration of the injectable

You can administer this medicine 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 dispose of it properly in your authorized sharp objects container.
2. Clean the end of the peripheral intravenous catheter with an alcohol-soaked cotton ball 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 continuously 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 container.

Administration ofMeropenem Hikmathrough a port or central line

1. Remove the cap from the port or central line, clean the end of the line with an alcohol-soaked cotton ball and let it dry.
2. Connect the syringe and slowly push the plunger to administer the antibiotic continuously 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 container.

Administration of Meropenem Hikma through intravenous infusion

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

The solution should be shaken before use

The vials are for single use.