Leaflet: information for the user

Ertapenem Hikma1 g powder for concentrate for solution for infusion EFG

Read this leaflet carefully before you start using this medicine, because

it contains important information for you.

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor, pharmacist or nurse.

- If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start using Ertapenem Hikma

3. How to use Ertapenem Hikma

4. Possible side effects

5. Storage of Ertapenem Hikma

6. Contents of the pack and additional information

Ertapenem Hikma contains ertapenem, which is an antibiotic belonging to the beta-lactam group. It has the ability to destroy a wide variety of bacteria (microorganisms) that cause infections in different parts of the body.

Ertapenem Hikma can be administered to individuals aged 3 months and above.

Treatment:

Your doctor has prescribed ertapenem because you or your child suffer from one (or more) of the following types of infections:

?Abdominal infection

?Lung infection (pneumonia)

?Gynecological infections

?Skin infections of the foot in diabetic patients

Prevention:

?Prevention of surgical wound infections in adults after colon or rectal surgery.

No use Ertapenem Hikma:

- if you are allergic to the active ingredient (ertapenem) or any of the other components of this

medication (listed in section 6).

- if you are allergic to antibiotics such as penicillins, cephalosporins, or carbapenems (used to treat various infections).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to useertapenem.

If during treatment you experience an allergic reaction (such as swelling of the face, tongue, or throat, difficulty breathing or swallowing, skin rash), inform your doctor immediately as you may need urgent medical treatment.

Although antibiotics, includingertapenemdestroy certain bacteria, other bacteria and fungi may continue to grow more than usual. This is known as bacterial overgrowth. Your doctor will monitor bacterial overgrowth and treat you if necessary.

It is essential to inform your doctor if you have diarrhea before, during, or after your treatment withertapenem. This is because you may develop a condition known as colitis (inflammation of the intestine). Do not take any medication to treat diarrhea without consulting your doctor first.

Inform your doctor if you are using medications called valproic acid or sodium valproate (see belowOther medications and Ertapenem Hikma).

Inform your doctor of any other medical condition you have or have had, including:

• Kidney disease. It is especially important for your doctor to know if you have kidney disease and if you are receiving dialysis treatment
• Allergies to any medication, including antibiotics
• Central nervous system disorders, such as localized tremors or seizures.

Children and adolescents (3 months to 17 years of age)

The experience withertapenemin children under two years is limited. For this age group, your doctor will decide on the possible benefit of its use. There is no experience in children under 3 months of age.

Other medications and Ertapenem Hikma

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

Inform your doctor, pharmacist, or nurse if you are using medications called valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraines, or schizophrenia). This is becauseertapenemmay affect how other medications work. Your doctor will decide if you should useertapenemin combination with these medications.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Ertapenemhas not been studied in pregnant women.Ertapenemshould not be used during pregnancy unless your doctor decides that the potential benefit justifies the potential risk to the fetus.

Women receivingertapenemshould not breastfeed because it has been found in breast milk and may affect the infant.

Driving and operating machinery

Do not drive or use any tools or machines until you know how you react to the medication.

Certain adverse effects, such as dizziness and somnolence, associated withertapenemmay affect patients' ability to drive or operate machinery.

Ertapenem Hikma contains sodium

This medication contains approximately 137 mg of sodium (main component of table salt/for cooking) in each 1.0 g dose. This is equivalent to 6.85% of the maximum daily sodium intake recommended for an adult.

Ertapenem will always be prepared and administered by a healthcare professional via intravenous (IV) injection into a vein.

The recommended dose of ertapenem for adults and adolescents 13 years of age and older is 1 gram (g) administered once a day. The recommended dose for children 3 months to 12 years of age is 15 mg/kg, administered twice a day (not exceeding 1 g/day). Your doctor will decide how many days of treatment you need.

To prevent surgical wound infections after colon or rectal surgery, the recommended dose of ertapenem is 1 g administered as a single IV dose 1 hour before surgery.

It is very important that you continue receiving ertapenem for the entire time your doctor has prescribed.

If you use moreErtapenem Hikmathan you should

If you are concerned that you may have been given too much ertapenem, consult your doctor or another healthcare professional immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to useErtapenem Hikma

If you are concerned that you may have forgotten a dose, consult your doctor or another healthcare professional immediately.

immediately.

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

Adults 18 years of age and older:

Since the drug was marketed, severe allergic reactions (anaphylaxis) and hypersensitivity syndromes (allergic reactions such as: skin rash, fever, abnormal blood tests) have been reported. The first signs of a severe allergic reaction may include swelling of the face and/or throat. If these symptoms appear, inform your doctor immediately, as you may need urgent medical treatment.

Frequent side effects (can affect up to 1 in 10 people) are:

• Headache
• Diarrhea, nausea, vomiting
• Skin rash, itching
• Problems with the vein in which the medicine is administered (including inflammation,
• Formation of a lump, swelling at the injection site, or leakage of liquid into the tissue and skin surrounding the injection site)
• Increased platelet count
• Changes in liver function tests

Less frequent side effects (can affect up to 1 in 100 people) are:

• Dizziness, drowsiness, insomnia, confusion, convulsions
• Low blood pressure, slow heart rate
• Difficulty breathing, throat pain
• Constipation, oral thrush infection, antibiotic-associated diarrhea, acid reflux, dry mouth, indigestion, loss of appetite
• Redness of the skin
• Vaginal discharge and irritation
• Abdominal pain, fatigue, fungal infection, fever, edema/swelling, chest pain, altered taste.
• Alterations in some urine and blood tests

Rare side effects (can affect up to 1in 1,000people) are:

• Decreased white blood cell count, decreased platelet count in the blood
• Low blood sugar
• Irritability, anxiety, depression, tremors
• Irregular heart rate, high blood pressure, bleeding, rapid heart rate
• Congestion, cough, nasal bleeding, pneumonia, unusual breathing sounds and beeps
• Bile duct inflammation, difficulty swallowing, fecal incontinence, yellowing of the skin (jaundice), liver disorder
• Skin inflammation, fungal skin infection, skin peeling, wound infection after surgery
• Muscle cramps, shoulder pain
• Urinary tract infection, kidney insufficiency
• Abortion, genital bleeding
• Allergy, discomfort, pelvic peritonitis, changes in the white part of the eye, fainting
• The skin may harden at the injection site
• Swelling of blood vessels in the skin

Side effects reported with unknown frequency (cannot be estimated from available data) are:

• Hallucinations
• Decreased level of consciousness
• Altered mental state (including aggression, delirium, disorientation, changes in mental state)

Also, changes in some parameters measured in blood tests have been reported.

If you experience blisters filled with fluid or raised on a large area of your body, inform your doctor or nurse immediately.

Children and adolescents (3 months to 17 years of age):

Frequent side effects (can affect up to 1 in 10 people) are:

• Diarrhea
• Diaper rash
• Pain at the perfusion site
• Changes in white blood cell count
• Changes in liver function tests

Less frequent side effects (can affect up to 1in 100people) are:

• Headache
• Fevers, high blood pressure, small, smooth, red or purple spots under the skin
• Colored stools, black stools like tar
• Redness of the skin, skin rash
• Itching, prickling, redness, and warmth at the perfusion site, redness at the injection site
• Increased platelet count
• Changes in some blood tests

Side effects reported with unknown frequency (cannot be estimated from available data)are:

• Hallucinations
• Altered mental state (including aggression)

Reporting 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, website:www.notificaram.es.

By reporting side effects, you can contribute to providing more information about 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.

The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C. Store in the original packaging.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ertapenem Hikma

The active ingredient of Ertapenem Hikma is ertapenem

- Each vial contains 1 g of ertapenem (as ertapenem sodium).

- The other components are: sodium hydrogen carbonate and sodium hydroxide.

Appearance of the product and contents of the container

Ertapenem Hikma is a lyophilized powder for concentrate for solution for infusion, white to yellowish in color.

The solutions of Ertapenem Hikma vary from colorless to pale yellow. Variations in color within this range do not affect efficacy.

Ertapenem Hikma is presented in vials of 1 vial or 10 vials.

Only some sizes of containers may be commercially available.

For further information about this medicinal product, please contact 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

France:Ertapenem Hikma 1 g, poudre pour solution à diluer pour perfusion

Italy:Ertapenem Hikma 1 g Polvere per concentrato per soluzione per infusione

Portugal:Ertapenem Hikma 1 g

Spain:Ertapenem Hikma 1 g Polvo para concentrado para solución para perfusión EFG

United Kingdom:Ertapenem 1 g Powder for concentrate for solution for infusion

Last update of the summary of product characteristics:February 2023

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

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This information is intended solely for healthcare professionals:

Instructions for reconstituting and diluting Ertapenem Hikma:

For single use.

Preparation for intravenous administration:

Ertapenem Hikma must be reconstituted and then diluted before administration.

Adults and adolescents (13 to 17 years of age)

Reconstitution:

Reconstitute the contents of the 1 g vial of Ertapenem Hikma with 10 ml of water for injection or 9 mg/ml (0.9 %) sodium chloride solution to obtain a reconstituted solution of approximately 100 mg/ml. Shake well to dissolve.

Dilution

For a 50 ml diluent bag:For a dose of 1 g, transfer the contents of the reconstituted vial immediately to a 50 ml bag of 9 mg/ml (0.9 %) sodium chloride solution;

For a 50 ml diluent vial:For a dose of 1 g, remove 10 ml from a 50 ml vial of 9 mg/ml (0.9 %) sodium chloride solution and discard. Transfer the contents of the 1 g vial of Ertapenem Hikma reconstituted to the 50 ml vial of 9 mg/ml (0.9 %) sodium chloride solution.

Infusion

Infuse over a period of 30 minutes.

Children (3 months to 12 years of age)

Reconstitution

Reconstitute the contents of the 1 g vial of Ertapenem Hikma with 10 ml of water for injection or 9 mg/ml (0.9 %) sodium chloride solution to obtain a reconstituted solution of approximately 100 mg/ml. Shake well to dissolve.

Dilution

For a diluent bag: transfer a volume equivalent to 15 mg/kg of body weight (not exceeding 1 g/day) to a bag of 9 mg/ml (0.9 %) sodium chloride solution, for a final concentration of 20 mg/ml or less; or For a diluent vial: transfer a volume equivalent to 15 mg/kg of body weight (not exceeding 1 g/day) to a vial of 9 mg/ml (0.9 %) sodium chloride solution, for a final concentration of 20 mg/ml or less.

Infusion

Infuse over a period of 30 minutes.

The reconstituted solution must be diluted in 9 mg/ml (0.9 %) sodium chloride solution immediately after preparation. The solutions are physically and chemically stable for 6 hours at room temperature (25 °C) or for 24 hours between 2 and 8 °C (in the refrigerator). From a microbiological point of view, the diluted solutions must be used immediately. If not used immediately, the storage times in use are the responsibility of the user and should not normally exceed 24 hours between 2 and 8 °C, unless the reconstitution was performed in controlled and validated aseptic conditions.

Once removed from the refrigerator, the solutions must be used within 4 hours. Do not freeze the reconstituted solutions.

Whenever the container permits, the reconstituted solutions must be visually inspected before administration for the presence of particles or discoloration. The solutions of Ertapenem Hikma vary from colorless to pale yellow. A variation in color within this range does not affect efficacy.

The disposal of unused medicinal product and all materials that have been in contact with it, will be carried out in accordance with local regulations.