Prospecto: Information for the User

Imipenem/Cilastatina Aurovitas 500 mg/500 mgpowder for solution for infusion EFG

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

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

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

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

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

1.What is Imipenem/Cilastatina Aurovitas and how it is used

2.What you need to know before starting to use Imipenem/Cilastatina Aurovitas

3.How to use Imipenem/Cilastatina Aurovitas

4.Possible adverse effects

5.Storage of Imipenem/Cilastatina Aurovitas

6.Contents of the package and additional information

Imipenem/cilastatina belongs to a group of medications called carbapenem antibiotics. It eliminates a wide variety of bacteria (germs) that cause infections in different parts of the body in adults and children one year of age or older.

Treatment

Your doctor has prescribedimipenem/cilastatinabecause you have one (or more) of the following types of infections:

-Complicated abdominal infections

-Pulmonary infections (pneumonia)

-Infections that can be acquired during or after childbirth

-Complicated urinary tract infections

-Complicated skin and soft tissue infections

Imipenem/cilastatinamay be used in the treatment of patients with low white blood cell counts, fever, and suspected bacterial infection.

Imipenem/cilastatinamay be used to treat bacterial sepsis, which may be associated with one of the aforementioned infections.

No use Imipenem/Cilastatina Aurovitas

-If you are allergic to imipenem, cilastatina or any of the other components of this medication (listed in section 6).

-If you are allergic to other antibiotics such as penicillins, cephalosporins or carbapenems.

Warnings and Precautions

Inform your doctor about any problem you have or have had, such as:

-Allergies to any medication including antibiotics (life-threatening allergic reactions require immediate medical treatment)

-Colitis or any other gastrointestinal disease

-Any central nervous system disorder, such as localized tremors or epileptic seizures

-Problems with the liver, kidneys or urine

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.

Inform your doctor if you are taking valproic acid or sodium valproate (seeUse of Imipenem/Cilastatina Aurovitas with other medicationsbelow).

Children

Administration ofimipenem/cilastatinais not recommended in children under one year of age or children with kidney problems.

Use of Imipenem/Cilastatina Aurovitas with other medications

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

Inform your doctor if you are taking ganciclovir, used to treat some viral infections.

Also inform your doctor if you are taking valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraines or schizophrenia) or any anticoagulant medication such as warfarin.

Your doctor will decide if you should useimipenem/cilastatinain combination with these medications.

Pregnancy, breastfeeding and fertility

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

Imipenem/cilastatinahas not been studied in pregnant women. Imipenem/cilastatinashould not be used during pregnancy unless your doctor decides that the potential benefits outweigh the potential risks to the fetus.

Small amounts of this medication may pass into breast milk and may affect the baby. Your doctor will decide if you should useimipenem/cilastatinaduring breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

There are some side effects associated with this product (such as seeing, hearing or feeling something that is not there, dizziness, drowsiness and sensation of objects spinning) that may affect some patients' ability to drive or operate machinery (see section 4).

Imipenem/Cilastatina Aurovitas contains sodium

Patients on low-sodium diets should note that this medication contains 37.6 mg (1.6 mmol) of sodium per dose.

Imipenem/cilastatina will be prepared and administered by a doctor or other healthcare professional. Your doctor will decide how much imipenem/cilastatina you need.

Use in adults and adolescents

The usual dose of imipenem/cilastatina for adults and adolescents is 500 mg/500 mg every 6 hours or 1,000 mg/1,000 mg every 6 or 8 hours. If you have kidney problems, your doctor may reduce your dose.

Use in children

The usual dose in children one year of age or older is 15/15 mg/kg/dose every 6 hours. Imipenem/cilastatina is not recommended for children under one year of age and for children with kidney problems.

Administration form

Imipenem/cilastatina is administered intravenously (into a vein) over 20-30 minutes for a dose of ≤500 mg/500 mg or 40-60 minutes for a dose of >500 mg/500 mg.

If you use more Imipenem/Cilastatina Aurovitas than you should

The symptoms of overdose may include seizures, confusion, tremors, nausea, vomiting, low blood pressure, and slow heart rate. If you are concerned that you may have received too much imipenem/cilastatina, contact your doctor or other healthcare professional immediately.

If you forgot to use Imipenem/Cilastatina Aurovitas

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

Do not take a double dose to make up for missed doses.

If you interrupt treatment with Imipenem/Cilastatina Aurovitas

Do not stop using imipenem/cilastatina until your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

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

-Nausea, vomiting, diarrhea. Nausea and vomiting appear to occur more frequently in patients with a low white blood cell count

-Swelling and redness along a vein, extremely sensitive to touch

-Rash on the skin

-Liver function alterations detected by blood tests

-Increased number of certain white blood cells

Occasional (may affect up to 1 in 100 people):

-Localized skin redness

-Localized pain and formation of a firm lump at the injection site

-Itching on the skin

-Urticaria

-Fever

-Blood disorders affecting cells and usually detected by blood tests (symptoms may be fatigue, pale skin, and prolonged bleeding after injuries)

-Liver, kidney, and blood function alterations detected by blood tests

-Tremors and uncontrolled muscle contractions

-Seizures

-Psychological alterations (such as mood changes and mental faculties deterioration)

-Seeing, hearing, or feeling something that is not there (hallucinations)

-Confusion

-Dizziness, drowsiness

-Low blood pressure (hypotension)

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

-Allergic reactions such as skin rash, facial swelling, lip, tongue, and/or throat swelling (with difficulty breathing or swallowing) and/or low blood pressure (hypotension).If these side effects occur while receiving or after receiving imipenem/cilastatin, discontinue the medication administration and immediately contact your doctor.

-Peeling of the skin (toxic epidermal necrolysis)

-Intense skin reactions (Stevens-Johnson syndrome and erythema multiforme)

-Intense skin rash, with skin and hair loss (exfoliative dermatitis)

-Fungal infection (candidiasis)

-Teeth and/or tongue discoloration

-Intense colon inflammation with severe diarrhea

-Taste alterations

-Liver unable to perform its normal function

-Liver inflammation

-Kidney unable to perform its normal function

-Changes in urine quantity, changes in urine color

-Brain disease, sensation of pins and needles, localized tremor

-Loss of hearing (hearing loss)

Very rare (may affect up to 1 in 10,000 people):

-Severe liver dysfunction due to inflammation (fulminant hepatitis)

-Gastroenteritis (inflammation of the stomach or intestine)

-Intestinal inflammation with diarrhea with blood (hemorrhagic colitis)

-Redness and swelling of the tongue, excessive growth of normal tongue projections, giving a hairy appearance, stomach burning, sore throat, increased saliva production

-Stomach pain

-Sensation of objects spinning (vertigo), headache

-Ringling in the ears (tinnitus)

-Pain in multiple joints, weakness

-Irregular heartbeat, heart beats strongly or rapidly

-Chest discomfort, difficulty breathing, abnormal breathing rate and depth, pain in the upper back

-Face redness (flushing), blue discoloration of the face and lips, skin texture changes, excessive sweating

-Vulvar itching in women

-Changes in blood cell counts

-Worsening of a rare disease associated with muscle weakness (increased severity of myasthenia gravis)

Frequency unknown (cannot be estimated from available data):

-Abnormal movements

-Agitation

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 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 carton and vials after “CAD”. The expiration date is the last day of the month indicated.

Imipenem/Cilastatina Aurovitas dry vials: do not require special storage conditions.

After reconstitution:

Diluted solutions must be used immediately. The time interval between the start of reconstitution and the completion of intravenous infusion should not exceed two hours.

Do not freeze the reconstituted solution.

Medicines should not be disposed of through drains or trash. If in doubt, ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Imipenem/Cilastatina Aurovitas

-The active ingredients are imipenem (in the form of monohydrate) and cilastatina (in the form of sodium salt).

Cada vial of Imipenem/Cilastatina Aurovitas 500 mg/500 mg powder for solution for infusion contains 500 mg of imipenem (in the form of 530 mg of imipenem monohydrate)and 500 mg of cilastatina (in the form of 530 mg of sodium cilastatina salt).

-The other component is sodium hydrogenocarbonate.

Aspect of the product and content of the package

Imipenem/Cilastatina 500 mg is presented in type III glass vials, colourless, of 20 ml capacity, closed with a 20 mm diameter bromobutyl rubber stopper and a flip-off cap.

Package sizes:

1 x vial of 500 mg

10 x vial of 500 mg

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Responsible for manufacturing

ACS Dobfar S.p.A.

Nucleo Industriale S.Atto, S. Nicolò a Tordino

64100 Teramo

Italy

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Date of the last review of this leaflet: January 2018

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/).

This information is intended solely for healthcare professionals:

Each vial is for single use only.

Preparation of the intravenous solution

The following table is provided to facilitate the reconstitution of Imipenem/CilastatinaAurovitasfor intravenous infusion.

Reconstitution of Imipenem/CilastatinaAurovitas500 mg:

The contents of the vials must be dissolved and transferred to an appropriate infusion solution to reach a volume of 100 ml.

A procedure that is suggested is to add approximately 10 ml of the infusion solution (see “Compatibility and stability”) to the vial. Shake well and transfer the resulting suspension to the infusion solution flask.

WARNING: THE SUSPENSION IS NOT FOR DIRECT INFUSION.

Repeat with 10 ml additional infusion solution to ensure the complete transfer of the vial contents to the infusion solution flask. Dilute to 100.0 with the same infusion solution. The resulting mixture must be shaken until a transparent solution is obtained.

The concentration of the reconstituted solution, following the procedure described above, is approximately 5 mg/ml for both imipenem and cilastatina.

The reconstituted solution must be visually inspected for particles and/or colour change before administration. Once reconstituted, the imipenem/cilastatina solution varies from colourless to yellow. The colour variation in this range does not affect the potency of the product.

Compatibility and stability

The reconstituted solutions must be used immediately. The time interval between the start of reconstitution and the end of intravenous infusion must not exceed two hours.

Imipenem/CilastatinaAurovitascan be reconstituted in sterile water for injection or in aninfusion solutionof sodium chloride9?mg/ml(0.9%).

Do not freeze the reconstituted solution.

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.