Label: information for the patient

Ertapenem Cipla 11 g powder for concentrate for solution for infusion EFG

Ertapenem

Read this label carefully before starting to use this medication, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section4.

Ertapenem Cipla contains ertapenem, which is 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 may be administered to adults and children aged 3 months or older.

This medication is used for:

• Treatment:

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

• Abdominal infection (stomach)
• Pulmonary infection (pneumonia)
• Gynecological infections
• Skin infections on the feet in diabetic patients

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

Do not use Ertapenem Cipla:

• if you are allergic to ertapenem or any of the other ingredients of this medicine (listed in section6).
• 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.

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 to inform your doctor if you have diarrhea before, during, or after treatment with Ertapenem Cipla. This is because you may suffer from 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 taking medications called valproic acid or sodium valproate (see "Use of Ertapenem Cipla with other medicines" below).

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

• Renal disease. It is particularly important for your doctor to know if you have renal 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 (convulsions)

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

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

The 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 of using this medicine in children under 3months of age.

Use of Ertapenem Cipla with other medicines

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

Inform your doctor, nurse, or pharmacist if you are taking medications calledvalproic 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 if you should use Ertapenem Cipla in combination with these medicines.

Pregnancy and breastfeeding

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

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

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

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

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

Driving and operating machinery

Do not drive or use any tools or machines until you know how you react to this medicine.

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

Ertapenem Cipla contains sodium

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

Ertapenem Cipla is always prepared and administered to you by a doctor or other healthcare professional through an intravenous (IV) route (into a vein).

The recommended dose of Ertapenem Cipla is:

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

Your doctor will decide 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 other healthcare professional immediately.

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

If you forgot to use Ertapenem Cipla

If you fear that you may have missed a dose, speak immediately with your doctor or other healthcare professional.

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

Adults aged 18 years and older:

Since the marketing of ertapenem, severe 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:

Frequent: may affect up to 1 in 10 people

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

Poorly frequent: may affect up to 1 in 100 people

• Dizziness, drowsiness, insomnia, confusion, convulsions
• Low blood pressure, slow pulse
• Shortness of breath, sore throat
• Constipation, oral thrush, antibiotic-associated diarrhea, regurgitation, 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
• Restlessness, anxiety, depression, tremors
• Irregular pulse, high blood pressure, bleeding, rapid pulse
• Congestion, cough, nosebleed, pneumonia, abnormal breathing sounds, wheezing
• Bile duct inflammation, 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 insufficiency
• Spontaneous abortion, genital bleeding
• Allergy, general malaise, pelvic peritonitis, changes in the white part of the eye, fainting

Frequency unknown: cannot be estimated from the available data (reported since the marketing of the medicine)

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

Changes in some blood test results have also been reported.

Children and adolescents (3 months to 17 years old):

Frequent: 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

Poorly frequent: may affect up to 1 in 100 people

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

Frequency unknown: cannot be estimated from the available data (reported since the marketing of the medicine)

• Hallucinations
• Altered mental state (including aggression)

Reporting of 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 leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Usewww.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 box after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE point of the pharmacyor in any other medication waste collection system. If in doubt, please ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Ertapenem Cipla

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

Appearance of the product and contents of the container

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

The ertapenem solutions may be colorless to pale yellow. Variations in color within that range do not affect the potency of the medication.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cipla Europe NV

De Keyserlei 58-60,

Box 19, 2018Amberes, Belgium

Responsible for manufacturing

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, 2018Amberes, Belgium

Local representative

Cipla Europe NV subsidiary 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 with the following names:

Last review date of this leaflet: December 2022

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

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This information is intended solely for healthcare professionals:

Instructions for 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 17years of age)

Reconstitution

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

Dilution

For a 50ml diluent bag:

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

For a 50ml diluent vial:

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

Infusion

Infuse over a period of 30minutes.

Children (3months to 12years of age)

Reconstitution

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

Dilution

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

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

Infusion

Infuse over a period of 30minutes.

The reconstituted solution must be diluted in sodium chloride 0.9% (9mg/ml) solution 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 20mg/ml of ertapenem) are physically and chemically stable for 6hours at room temperature (25°C) or for 24hours at 2 to 8°C (in the refrigerator). The solutions must be used within 4hours 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. The Ertapenem solutions may be colorless to pale yellow. Variations in color within that 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.