Ertapenem Cipla 1 g powder for concentrate for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ertapenem Cipla 1g powder for concentrate for solution for infusion EFG

Read all of 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Ertapenem Cipla is and what it is used for
2. What you need to know before using Ertapenem Cipla
3. How to use Ertapenem Cipla
4. Possible side effects
5. How to store Ertapenem Cipla
6. Contents of the pack and other information

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

Ertapenem Cipla contains ertapenem, an antibiotic belonging to the beta-lactam group. It is capable of destroying a wide range of bacteria (germs) that cause infections in various parts of the body.

Ertapenem can be administered to adults and children from 3 months of age.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not keep or reuse this medicine. If you have leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

This medicine is used for:

• Treatment:

Your doctor has prescribed Ertapenem Cipla because you or your child have one (or more) of the following types of infection:

• Abdominal infection (in the stomach area)

• Infection affecting the lungs (pneumonia)

• Gynecological infections

• Skin infections in the feet of diabetic patients

• Prevention:

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

2. What you need to know before using Ertapenem Cipla

Do not use Ertapenem Cipla

• if you are allergic to ertapenem or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to antibiotics such as penicillins, cephalosporins, or carbapenems (used to treat various infections).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting treatment with ertapenem.

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 require urgent medical treatment.

It is important that you inform your doctor if you develop diarrhoea before, during, or after treatment with Ertapenem Cipla. This is because you may have a condition known as colitis (inflammation of the intestine). Do not take any medicine for diarrhoea without first consulting your doctor.

Inform your doctor if you are taking medicines called valproic acid or sodium valproate (see "Use of Ertapenem Cipla with other medicines" below).

Inform your doctor of any medical conditions you currently have or have had in the past, including the following:

• Kidney disease. It is particularly important that your doctor knows if you have kidney disease and if you are undergoing dialysis for its treatment.
• Allergies to any medicines, including antibiotics.
• Disorders of the central nervous system, such as localized tremors or seizures (convulsions).

While antibiotics, including ertapenem, destroy certain bacteria, other bacteria and fungi may overgrow abnormally. This is known as overgrowth. Your doctor will monitor you for possible overgrowth and treat it if necessary.

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

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

Use of Ertapenem Cipla with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

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

Pregnancy and breastfeeding

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

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.

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

Driving and using machines

Do not drive or operate any tools or machinery until you know how this medicine affects you.

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

Ertapenem Cipla contains sodium

This medicine contains 137 mg of sodium (a key component of table/cooking salt) per 1 g dose. This is equivalent to 6.85% of the maximum daily recommended sodium intake for an adult.

3. How to use Ertapenem Cipla

Ertapenem Cipla is always prepared and administered to you intravenously (into a vein) by a doctor or other healthcare professional.

The recommended dose of Ertapenem Cipla is:

• In adults and adolescents over 13 years of age: 1 gram (g) given once daily.
• In children from 3 months to 12 years of age: 15 mg/kg given twice daily (without exceeding 1 g/day).
• For prevention of surgical site infections after colon or rectal surgery: 1 g given as a single intravenous dose 1 hour before surgery.

Your doctor will decide the duration of treatment.

It is very important that you continue receiving Ertapenem Cipla for the entire duration prescribed by your doctor.

If you use more Ertapenem Cipla than you should

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

In case of overdose or accidental ingestion, immediately contact your doctor or pharmacist or call the Toxicology Information Service at telephone number 915 620 420, indicating the medication and the amount ingested.

If you forget to use Ertapenem Cipla

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

4. Possible adverse effects

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

Adults aged 18 years and older:

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

Frequent adverse effects (may affect up to 1 in 10 people) are:

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

Uncommon adverse effects (may affect up to 1 in 100 people) are:

• Dizziness, drowsiness, insomnia, confusion, seizures
• Low blood pressure, slow pulse
• Shortness of breath, sore throat
• Constipation, oral candidiasis, antibiotic-associated diarrhea, acid regurgitation, dry mouth, indigestion, loss of appetite
• Skin redness
• Vaginal discharge and irritation
• Abdominal pain, fatigue, fungal infection, fever, edema/swelling, chest pain, abnormal sense of taste
• Changes in certain blood and urine test results

Rare adverse effects (may affect up to 1 in 1,000 people) are:

• Decreased number of white blood cells, decreased platelet count
• Low blood sugar levels
• Agitation, anxiety, depression, tremors
• Irregular pulse, increased blood pressure, bleeding, rapid pulse
• Nasal congestion, cough, nosebleeds, pneumonia, abnormal breathing sounds, wheezing
• Inflammation of the gallbladder, difficulty swallowing, fecal incontinence, jaundice, liver disorder
• Skin inflammation, fungal skin infection, skin peeling, surgical wound infection
• Muscle cramps, shoulder pain
• Urinary tract infection, kidney failure
• Spontaneous abortion, genital bleeding
• Allergic reaction, general malaise, 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

Adverse effects 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 status)
• Abnormal movements
• Muscle weakness
• Unsteady gait
• Stained teeth

Changes in certain blood test results have also been reported.

If you develop fluid-filled or raised skin lesions over a large area of your body, inform your doctor or nurse immediately.

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

Frequent adverse effects (may affect up to 1 in 10 people) are:

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

Uncommon adverse effects (may affect up to 1 in 100 people) are:

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

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

• Hallucinations
• Altered mental state (including aggression)

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

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

5. Storage of Ertapenem Cipla

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

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25 °C.

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy or any other medicine waste collection system. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ertapenem Cipla

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

Appearance of the product and contents of the pack

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

Solutions of ertapenem may range from colourless to pale yellow. Variations in colour within this range do not affect the potency of the medicine.

Ertapenem Cipla is supplied in packs containing 1 or 10 vials.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Cipla Europe NV
De Keyserlei 60C, Bus-1301,
2018 Antwerp, Belgium

Manufacturer

KYMOS, S.L.
Ronda de Can Fatjó,
7B (Parc Tecnològic del Vallès),
Cerdanyola del Vallès, 08290,
Barcelona, Spain

Cipla Europe NV
De Keyserlei 60C, Bus-1301,
2018 Antwerp, Belgium

Local representative

Cipla Europe NV, Spanish branch,
C/ Guzmán el Bueno, 133, Edif. Britannia, 28003 Madrid, Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

ES Ertapenem Cipla 1 g powder for concentrate for solution for infusion EFG

Date of the most recent revision of this leaflet: October 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Instructions for reconstitution and dilution of Ertapenem:

For single use only.

Preparation for intravenous administration:

Ertapenem must be reconstituted and then diluted prior to administration.

Adults and adolescents (13 to 17 years of age)

Reconstitution

Reconstitute the contents of one 1 g vial of Ertapenem with 10 ml of water for injections 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 infusion bag: for a 1 g dose, immediately transfer the entire contents of the reconstituted vial into a 50 ml bag of 0.9% sodium chloride solution (9 mg/ml); or

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

Infusion

Infuse over a period of 30 minutes.

Children (from 3 months to 12 years of age)

Reconstitution

Reconstitute the contents of one 1 g vial of Ertapenem with 10 ml of water for injections 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 an infusion bag: transfer a volume equivalent to 15 mg/kg body weight (not exceeding 1 g/day) to an infusion bag containing 0.9% sodium chloride solution (9 mg/ml) to achieve a final concentration of 20 mg/ml or less; or

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

Infusion

Infuse over a period of 30 minutes.

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

The reconstituted solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever possible. Ertapenem solutions may range from colourless to pale yellow. Colour variations within this range do not affect potency.

Any residual antibiotic solution and all materials used during administration must be disposed of in accordance with local regulations.