IMIPENEM/CILASTATIN HIKMA 500 mg/500 mg POWDER FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

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

Imipenem/cilastatina

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Imipenem/Cilastatina Hikma and what is it used for
2. What you need to know before you use Imipenem/Cilastatina Hikma
3. How to use Imipenem/Cilastatina Hikma
4. Possible side effects
5. Storage of Imipenem/Cilastatina Hikma
6. Contents of the pack and other information

1. What is Imipenem/Cilastatina Hikma and what is it used for

Imipenem/Cilastatina Hikma belongs to a group of medicines called carbapenem antibiotics. It eliminates a wide variety of bacteria (germs) that cause infections in different parts of the body in adults and children over 1 year of age.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as flu or common cold.

It is important that you follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after finishing the treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

Treatment

Your doctor has prescribed Imipenem/cilastatina Hikma because you have one (or more) of the following types of infections:

• Complicated infections in the abdomen.
• Infection affecting the lungs (pneumonia).
• Infections that can be contracted during or after childbirth.
• Complicated urinary tract infections.
• Complicated skin and soft tissue infections.

Imipenem/cilastatina Hikma can be used to treat patients with low white blood cell counts, who have fever and are suspected to have a bacterial infection.

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

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

Do not use Imipenem/cilastatina Hikma

• if you are allergic (hypersensitive) to imipenem, cilastatina, or any of the other components of this medicine (listed in section 6).
• if you are allergic to other antibiotics such as penicillins, cephalosporins, or carbapenems.

Warnings and precautions

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

• allergies to any medicine, including antibiotics (unexpected allergic reactions that can be life-threatening require immediate medical treatment).
• colitis or any other gastrointestinal disease.
• kidney or urine problems, including reduced kidney function (imipenem/cilastatina Hikma plasma levels increase in patients with renal insufficiency. Adverse reactions of the central nervous system may occur if the dose is not adjusted to kidney function).
• any central nervous system disorder, such as localized tremors or epileptic seizures (attacks).
• liver problems.

You may develop a positive test (Coombs test), which indicates 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 1 year of age or in children with kidney problems.

Other medicines and Imipenem/cilastatina Hikma

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor if you are taking ganciclovir, which is used to treat some viral infections.

Tell your doctor if you are taking valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraine, or schizophrenia) or any anticoagulant medicine such as warfarin.

Your doctor will decide if you can use Imipenem/cilastatina Hikma with these medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. 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 important that you tell your doctor if you are breastfeeding or planning to breastfeed before imipenem/cilastatina is administered. This medicine 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.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

There are several side effects associated with this medicine (such as seeing, hearing, or perceiving things that do not exist, dizziness, drowsiness, and sensation of spinning objects) that may affect some patients' ability to drive or use machines (see section 4).

Imipenem/cilastatina Hikma contains sodium.

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

3. How to use Imipenem/Cilastatina Hikma

Imipenem/cilastatina Hikma will be prepared and administered by a doctor or other healthcare professional. Your doctor will decide the amount of 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 kidney problems, your doctor may reduce the dose.

Use in children

The usual dose in children over 1 year of age is 15/15 or 25/25 mg/kg/dose every 6 hours. Imipenem/cilastatina Hikma is not recommended in children under 1 year of age and children with kidney problems.

Method of administration

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

If you use more Imipenem/cilastatina Hikma than you should

Symptoms of overdose may include seizures (attacks), 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.

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

If you forget to use Imipenem/cilastatina Hikma

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• The following side effects may occur rarely; however, if they occur while receiving or after receiving Imipenem/cilastatina Hikma, the administration of the medicine should be interrupted, and you should contact your doctor immediately. Allergic reactions such as skin rash, swelling of the face, lips, tongue, and/or throat (with difficulty breathing or swallowing) and/or low blood pressure (hypotension).
• Skin peeling (toxic epidermal necrolysis).

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

Other possible side effects:

Common (may 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.
• Abnormal liver function detected by blood tests.
• Nausea, vomiting, diarrhea. Nausea and vomiting seem to occur more frequently in patients with a low number of white blood cells.

Uncommon (may affect up to 1 in 100 people)

• Local skin redness.
• Pain and swelling at the injection site.
• Itching of the skin.
• Hives.
• Fever.
• Blood disorders that affect cells and are usually detected by a blood test (symptoms may be fatigue, pale skin, and prolonged bruising after injuries).
• Abnormal kidney, liver, and blood function, detected by a blood test.
• Tremors and uncontrolled muscle contractions.
• Seizures (attacks).
• Psychiatric disorders (such as mood changes and mental impairment).
• Seeing, hearing, or perceiving things that do not exist (hallucinations).
• Confusion.
• Dizziness, drowsiness.
• Low blood pressure (hypotension).

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

• Fungal infection (candidiasis).

• Discoloration of teeth and/or tongue.
• Colon inflammation with severe diarrhea.
• Abnormal taste.
• Liver failure.
• Liver inflammation.
• Kidney failure.
• Changes in urine volume, changes in urine color.
• Brain disease, tingling sensation (pins and needles), localized tremor.
• Hearing loss (hearing impairment).

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

• Severe liver failure due to inflammation (fulminant hepatitis).
• Stomach or intestine inflammation (gastroenteritis).
• Intestine inflammation with bloody diarrhea (hemorrhagic colitis).
• Tongue swelling and redness, excessive growth of normal tongue projections, giving it a hairy appearance, heartburn, sore throat, increased saliva production.

• Stomach pain.
• Sensation of spinning objects (vertigo), headache.
• Ringing in the ears (tinnitus).
• Pain in several joints, weakness.
• Irregular heartbeat, strong or rapid heartbeats.
• Chest discomfort, difficulty breathing, abnormally rapid and shallow breathing, pain in the upper back.
• Facial flushing (redness of the face), bluish discoloration of the face and lips, changes in skin texture, 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 not known (cannot be estimated from the available data)

• Abnormal movements.
• Agitation.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website www.notificaram.es.

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

5. Storage of Imipenem/Cilastatina Hikma

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

Do not use this medicine after the expiry date which is stated on the carton and vials after EXP. The expiry date is the last day of the month stated.

Do not store above 25°C.

Store the vials in the original package.

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 2 hours.

Do not freeze the reconstituted solution.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Imipenem/Cilastatin Hikma

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

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

Appearance of the Product and Container Content

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

Container Size:

Box of 1 vial (20 ml).

Box of 10 vials (20 ml)

Only some container sizes may be marketed.

Marketing Authorization Holder and 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]

Manufacturer

ACS Dobfar S.p.A

Nucleo Industriale S. Atto

• Nicolò a Tordino

64100 TERAMO

Italy

For further information about this medicinal product, please contact 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: January 2020

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

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This information is intended only for healthcare professionals:

Each vial is intended for single use.

Reconstitution

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

PRECAUTION: THE MIXTURE IS NOT FOR DIRECT INFUSION.

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

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

Color variation, from colorless to yellow, does not affect the product's ability.

Compatibilities and Stability

In accordance with correct clinical and pharmaceutical practices, Imipenem/Cilastatinshould be administered as a freshly prepared solution with the following diluent: 0.9% Sodium Chloride.

Incompatibilities

This medicinal productis chemically incompatible with lactate and should not be reconstituted in diluents containing lactate. However, it can be administered in an I.V. system through which a lactate solution is being infused.

This medicinal product should not be mixed with other medicinal products, except those used in the Reconstitutionsection.

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.

Disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.