Label: information for the patient

Imipenem/Cilastatina Hikma 500mg/500mg powder for solution for infusion EFG

Imipenem/cilastatina

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

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribedonlyto you, and you should not give it to other people even iftheyhave the same symptomsas you,as it may harm them
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this label. See section4.

Imipenem/Cilastatina Hikmabelongs 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 prescribed Imipenem/cilastatina Hikma because you have one (or more) of the following types of infections:

• Complicated abdominal infections.
• Pulmonary infections (pneumonia).
• Infections that can be contracted during or after delivery.
• Complicated urinary tract infections.
• Complicated skin and soft tissue infections.

Imipenem/cilastatina Hikma may be used to treat patients with low white blood cell counts, fever, and suspected bacterial infection.

Imipenem/cilastatina Hikma may be used to treat bacterial blood infections, which may be associated with one of the aforementioned infections.

Do not use Imipenem/cilastatina Hikma

• if you are allergic (hypersensitive) to imipenem, cilastatina or to any of the other components of this medication (listed in section6).
• if you are allergic to other antibiotics such as penicillins, cephalosporins or carbapenems.

Warnings and precautions

Inform your doctor or pharmacist before starting to use imipenem/cilastatina about any disease you suffer from or have suffered from, including:

• allergies to any medication including antibiotics(unexpected allergic reactions that put your life at risk require immediate medical treatment).
• colitis or any other gastrointestinal disease.
• kidney problems or urinary problems, including reduced kidney function (imipenem/cilastatina Hikma plasma levels increase in patients with renal insufficiency. Central nervous system adverse reactions may occur if the dose is not adjusted to kidney function).
• any central nervous system disorder,such as localized tremors or seizures (attacks)
• liver problems.

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.

Children

Imipenem/cilastatina Hikma is not recommended for children under one year of age or for children with kidney problems.

Other medications and Imipenem/cilastatina Hikma

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, which is used to treat some viral infections.

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 can use Imipenem/cilastatina Hikma with these medications.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, it is essential to consult your doctor before using this medication. Imipenem/cilastatina Hikma has not been studied in pregnant women. Imipenem/cilastatina Hikma 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 plan to breastfeed before you are administered imipenem/cilastatina. This medication may pass into breast milk in small amounts and could affect the baby. Your doctor will decide if you should use imipenem/cilastatina during breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

There are several adverse effects associated with this medication (such as seeing, hearing or perceiving things that do not exist, dizziness, drowsiness and sensation of objects spinning) that may affect some patients' ability to drive or operate machinery (see section4).

Imipenem/cilastatina Hikma contains sodium.

This medication contains 37.5 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 1.88% of the maximum daily sodium intake recommended for an adult.

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

Use in Adults and Adolescents

The recommended dose of Imipenem/Cilastatina Hikma for adults and adolescents is 500 mg/500 mg every 6 hours or 1000 mg/1000 mg every 6 or 8 hours. If you have any kidney problems, your doctor may reduce the dose.

Use in Children

The usual dose in children one year of age and older is 15/15 mg/kg/dose or 25/25 mg/kg/dose every 6 hours. Imipenem/Cilastatina Hikma is not recommended for children under one year of age and children with kidney problems.

Administration Form

Imipenem/Cilastatina Hikma is administered intravenously (into a vein) for 20-30 minutes for a dose ≤ 500 mg/500 mg or for 40-60 minutes for a dose > 500 mg/500 mg. If you feel nauseous, the infusion rate may be reduced.

If You Take More Imipenem/Cilastatina Hikma 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 taken too much imipenem/cilastatina, contact your doctor or other healthcare professional immediately.

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

If You Forget to Use Imipenem/Cilastatina Hikma

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

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.

• The following side effects occur rarely, however if they occur while receiving or after receiving Imipenem/cilastatina Hikma, the administration of the medicine should be interrupted and the patient should contact their doctor immediately. 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)
• Peeling of the skin (toxic epidermal necrolysis)

• Severe skin alterations (Stevens-Johnson syndrome and erythema multiforme)
• Severe skin rash, with skin and hair loss (exfoliative dermatitis)

Other possible side effects:

Frequent (can affect up to 1 in 10 people)

• Increased number of some white blood cells
• Swelling and redness along a vein, extremely sensitive to touch
• Skin rash
• Liver function alteration detected by blood tests
• Nausea, vomiting, diarrhea. Nausea and vomiting appear to occur more frequently in patients with low white blood cell counts

Rare (can affect up to 1 in 100 people)

• Redness of the skin in the local area
• Localized pain and formation of a firm lump at the injection site
• Itching of the skin
• Urticaria
• Fever
• Blood disorders that affect cells and are normally 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 (attacks)
• Psychological alterations (such as mood changes and mental faculties deterioration)
• To see, hear, or feel things that do not exist (hallucinations)
• Confusion
• Dizziness, somnolence
• Low blood pressure (hypotension)

Rare (can affect up to 1 in 1,000 people)

• Fungal infection (candidiasis)

• Coloration of the teeth and/or tongue
• Colitis with intense diarrhea
• Alteration of the sense of taste
• Liver inability to perform its normal activity
• Liver inflammation
• Kidney inability to perform its normal activity
• Changes in urine volume, changes in urine color
• Brain disease, sensation of prickling (pins and needles), localized tremor
• Loss of hearing (hearing loss)

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

• Severe liver function loss due to inflammation (fulminant hepatitis)
• Gastroenteritis
• Colitis with bloody diarrhea
• Swelling and redness of the tongue, excessive growth of normal tongue projections, giving it a hairy appearance, stomach burning, throat pain, increased saliva production

• Abdominal pain
• Sensation of spinning objects (vertigo), headache
• Tinnitus in the ears (tinnitus)
• Pain in multiple joints, weakness
• Irregular heartbeat, strong or rapid heartbeats
• 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
• Itching of the vulva in women
• Changes in blood cell counts
• Worsening of a rare disease associated with muscle weakness (increase in the severity of myasthenia gravis)

Unknown frequency (cannot be estimated from available data)

• Abnormal movements
• Restlessness

Reporting of 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 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 packaging and vials after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Store the vials in the original packaging.

After reconstitution:

The 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 in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Imipenem/Cilastatina Hikma

• The active ingredients are imipenem and cilastatina. Each vial of Imipenem/Cilastatina Hikma 500mg/500mg contains 530 mg of imipenem monohydrate, equivalent to 500mg of imipenem and 530 mg of cilastatina sodium, equivalent to 500mg of cilastatina.

• The other components are: 20 mg of sodium bicarbonate.

Appearance of the product and contents of the package

Imipenem/Cilastatina Hikma is a white to off-white or pale yellow powder for solution for infusion, contained in a transparent glass vial of 20 ml, type III with a bromobutyl closure of 20 mm in diameter.

Package size:

Box of 1 vial (20 ml).

Box of 10 vials (20 ml)

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Hikma Farmacêutica (Portugal) S.A.

Estrada do Rio da Mó, nº8, 8A e 8B, Fervença

2705-906 Terrugem SNT

Portugal

Tel.: 351-21-960 84 10 / Fax: 351-21-961 51 02

E-mail: [email protected]

Responsible manufacturer

ACS Dobfar S.p.A

Nucleo Industriale S. Atto

S. Nicolò a Tordino

64100 TERAMO

Italy

You can request more information about this medication by contacting 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 medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: January 2020

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

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This information is intended solely for healthcare professionals:

Each vial is intended for single use.

Reconstitution

The contents of each vial should be transferred to an appropriate infusion solution to a volume of 100ml (see the sectionsIncompatibilitiesandAfter reconstitution): sodium chloride 0.9%. In exceptional circumstances where sodium chloride 0.9%. cannot be used for medical reasons, a solution of glucose 5%. can be used instead. A procedure that is suggested is to add approximately 10ml of the appropriate infusion solution to the vial. Shake well and transfer the resulting mixture to the infusion solution container.

WARNING: THE MIXTURE IS NOT FOR DIRECT INFUSION.

Repeat with 10ml more of the infusion solution to ensure the complete transfer of the vial contents to the infusion solution. The resulting mixture should be shaken until it becomes transparent.

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

The variation in color, from colorless to yellow, does not affect the product's ability.

Compatibilities and stability

According to proper clinical and pharmaceutical practices,Imipenem/Cilastatinashould be administered as a freshly prepared solution with the following diluent: Sodium chloride 0.9%.

Incompatibilities

This medicationis chemically incompatible with lactate and should not be reconstituted in diluents containing lactate. However, it can be administered through an IV system that will infuse the lactate solution.

This medication should not be mixed with other medications, except those listed in theReconstitutionsection.

After reconstitution

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

The elimination of unused medication and all materials that have come into contact with it should be carried out in accordance with local regulations.