ERTAPENEM CIPLA 1 g POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

2. What you need to know before you use Ertapenem Cipla

Do not use Ertapenem Cipla:

• if you are allergic to 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 use Ertapenem Cipla.

During treatment, if 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.

It is essential that you inform your doctor if you have diarrhea before, during, or after treatment with Ertapenem Cipla. The reason is that you may suffer from a disorder known as colitis (intestinal inflammation). Do not take any medication to treat diarrhea without consulting your doctor first.

Inform your doctor if you are taking medications called valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraines, or schizophrenia). This is because Ertapenem Cipla may affect how other medications work. Your doctor will decide if you should use Ertapenem Cipla in combination with these medications.

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

• Kidney disease. It is particularly important that your doctor knows if you have kidney disease and if you are undergoing dialysis to treat it.
• Allergies to any medication, including antibiotics
• Central nervous system disorders, such as localized tremors or convulsive seizures (seizures)

While antibiotics, including ertapenem, destroy certain bacteria, other bacteria and fungi may continue to grow more than usual. This is known as overgrowth. Your doctor will monitor you for possible overgrowth and treat it if necessary.

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

Experience with ertapenem is limited in children under two years of age. In this age group, your doctor will decide on the potential benefit of its use. There is no experience with the use of this medication in children under 3 months of age.

Using Ertapenem Cipla with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication, including those obtained without a prescription.

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

Pregnancy and breastfeeding

It is essential that you inform your doctor if you are pregnant or plan to become pregnant before receiving Ertapenem Cipla.

Ertapenem Cipla has not been studied in pregnant women. Ertapenem Cipla should not be used during pregnancy unless your doctor decides that the potential benefit justifies the potential risk to the fetus.

It is essential that you inform your doctor if you are breastfeeding or plan to breastfeed before receiving Ertapenem Cipla.

Women who are receiving Ertapenem Cipla should not breastfeed, as ertapenem is excreted in breast milk and may affect the infant.

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.

Driving and using machines

Do not drive or use any tools or machines until you know how this medication affects you.

Certain side effects, such as dizziness or drowsiness, that have been reported with Ertapenem Cipla may affect some patients' ability to drive or use machines.

Ertapenem Cipla contains sodium

This medication contains 137 mg of sodium (the main component of table salt/cooking salt) per 1 g of ertapenem injectable. This is equivalent to 6.85% of the maximum recommended daily sodium intake for an adult.

3. How to use Ertapenem Cipla

Ertapenem Cipla is always prepared and administered to you by a doctor or other healthcare professional via intravenous route (in a vein).

The recommended dose of Ertapenem Cipla is:

• In adults and adolescents over 13 years: 1 gram (g) administered once a day.
• In children from 3 months to 12 years of age: 15 mg/kg administered twice a day (not exceeding 1 g/day).
• In the prevention of surgical wound infections after colon or rectal surgery: 1 g administered as a single intravenous dose 1 hour before surgery.

Your doctor will decide on the duration of treatment.

It is very important that you continue to receive Ertapenem Cipla for the entire time your doctor prescribes it.

If you use more Ertapenem Cipla than you should

If you are concerned that you may have been given too much Ertapenem Cipla, 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 915 620 420, indicating the medication and the amount ingested.

If you miss a dose of Ertapenem Cipla

If you think you may have missed a dose, talk to your doctor or another healthcare professional immediately.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Adults 18 years of age and older:

Since the marketing of ertapenem, serious allergic reactions (anaphylaxis) and hypersensitivity syndromes (allergic reactions that include rash, fever, and abnormal blood test results) have been reported. The first signs of a severe allergic reaction may be swelling of the face or throat. If these symptoms occur, inform your doctor immediately as you may need urgent medical treatment.

Other side effects:

Common: may affect up to 1 in 10 people

• Headache
• Diarrhea, nausea, vomiting
• Rash, itching
• Problems with the vein where the medication is administered (including inflammation, lump formation, swelling at the injection site, or fluid leakage to the surrounding tissue and skin)
• Increased platelet count
• Changes in liver function test results

Uncommon: may affect up to 1 in 100 people

• Dizziness, drowsiness, insomnia, confusion, seizures
• Low blood pressure, slow pulse
• Shortness of breath, throat pain
• Constipation, oral candidiasis, 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, abnormal taste
• Changes in some blood and urine test results

Rare: may affect up to 1 in 1,000 people

• Decreased white blood cell count, decreased platelet count
• Low blood sugar
• Agitation, anxiety, depression, tremors
• Irregular heartbeat, increased blood pressure, bleeding, rapid pulse
• Nasal congestion, cough, nosebleeds, pneumonia, abnormal breathing sounds, wheezing
• Gallbladder inflammation, difficulty swallowing, fecal incontinence, jaundice, liver disorder
• Skin inflammation, skin fungal infection, skin peeling, surgical wound infection
• Muscle cramps, shoulder pain
• Urinary tract infection, kidney failure
• Spontaneous abortion, genital bleeding
• Allergy, general malaise, pelvic peritonitis, changes in the white part of the eye, fainting

Frequency not known: cannot be estimated from available data (reported since the marketing of the medication)

• Hallucinations
• Decreased consciousness
• Altered mental state (including aggression, delirium, disorientation, changes in mental state)
• Abnormal movements
• Muscle weakness
• Unsteady gait
• Discolored teeth

Changes in some blood test results have also been reported.

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

Common: may affect up to 1 in 10 people

• Diarrhea
• Diaper rash
• Pain at the infusion site
• Changes in white blood cell count
• Changes in liver function test results

Uncommon: may affect up to 1 in 100 people

• Headache
• Flushing, high blood pressure, small flat red or purple spots under the skin
• Change in stool color, black tarry stools
• Redness of the skin, skin rash
• Burning, itching, redness, and warmth at the infusion site, redness at the injection site
• Increased platelet count
• Changes in some blood test results

Frequency not known: cannot be estimated from available data (reported since the marketing of the medication)

• Hallucinations
• Altered mental state (including aggression)

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use www.notificaRAM.es.

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

5. Storage of Ertapenem Cipla

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the carton after EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medications should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy or any other medication waste collection system. If in doubt, ask your pharmacist how to dispose of the packaging and medication you no longer need. This will help protect the environment.

6. Container contents and additional information

Composition of Ertapenem Cipla

• The active ingredient is ertapenem 1 g.
• The other components are: sodium bicarbonate (E500) and sodium hydroxide (E524).

Appearance of the product and container contents

Ertapenem Cipla is a white to light yellow lyophilized powder for concentrate for solution for infusion.

The solutions of ertapenem can range from colorless to pale yellow. Color variations within this range do not affect the potency of the medication.

Ertapenem Cipla is presented in a container that contains 10 vials.

Marketing authorization holder and manufacturer

Marketing authorization holder

Cipla Europe NV

De Keyserlei 58-60,

Box 19, 2018 Antwerp, Belgium

Manufacturer

Wave Pharma Limited

Ground Floor Cavendish House, 369 Burnt Oak Broadway, Edgware,

HA8 5AW

United Kingdom

KYMOS, S.L.

Ronda de Can Fatjó,

7B (Parque Tecnológico del Vallès),

Cerdanyola del Vallès, 08290,

Barcelona, Spain

Cipla Europe NV

De Keyserlei 58-60,

Box 19, 2018 Antwerp, Belgium

Local representative

Cipla Europe NV branch in Spain,

C/ Guzmán el Bueno, 133 Edif Britannia-28003- Madrid, Spain

This medication is authorized in the member states of the European Economic Area under the following names:

Date of the last revision of this prospectus: December 2022

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

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This information is intended solely for healthcare professionals:

Instructions for the reconstitution and dilution of Ertapenem:

For single use only.

Preparation for intravenous administration:

Ertapenem must be reconstituted and then diluted before administration.

Adults and adolescents (13 to 17 years of age)

Reconstitution

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

Dilution

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

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

Infusion

Infuse over a period of 30 minutes.

Children (3 months to 12 years of age)

Reconstitution

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

Dilution

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

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

Infusion

Infuse over a period of 30 minutes.

The reconstituted solution must be diluted in 0.9% sodium chloride solution (9 mg/ml) immediately after preparation. The diluted solutions must be used immediately. If not used immediately, the storage times are the responsibility of the user. The diluted solutions (approximately 20 mg/ml of ertapenem) remain physically and chemically stable for 6 hours at room temperature (25 °C) or for 24 hours between 2 and 8 °C (in the refrigerator). The solutions must be used within 4 hours of removal from the refrigerator. Do not freeze the reconstituted solutions.

The reconstituted solutions must be visually inspected for possible particles and color changes before administration, whenever the container allows it. The solutions of Ertapenem can range from colorless to pale yellow. Color variations within this range do not affect the potency.

The disposal of any residual antibiotic solution and all materials used for its administration will be carried out in accordance with local regulations.