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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

Imipenem/cilastatin

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 questions, ask your doctor or pharmacist.
• 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 adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Imipenem/Cilastatin Hikma belongs to a group of medicines called carbapenem antibiotics. It kills a wide range of bacteria (germs) that cause infections in various parts of the body in adults and children one year of age and older.

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

Treatment

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

• Complicated abdominal infections.
• Infection affecting the lungs (pneumonia).
• Infections that may occur during or after childbirth.
• Complicated urinary tract infections.
• Complicated skin and soft tissue infections.

Imipenem/Cilastatin Hikma can be used to treat patients with low white blood cell counts who have fever and in whom a bacterial infection is suspected.

Imipenem/Cilastatin Hikma can be used to treat bloodstream infections caused by bacteria, which may be associated with one of the types of infection mentioned above.

2. What you need to know before using Imipenem/Cilastatin Hikma

Do not use Imipenem/Cilastatin Hikma

• if you are allergic (hypersensitive) to imipenem, cilastatin, or any of the other ingredients 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 imipenem/cilastatin about any medical conditions you currently have or have had in the past, including:

• allergies to any medicines, including antibiotics (unexpected allergic reactions that are life-threatening require immediate medical treatment).
• colitis or any other gastrointestinal disease.
• kidney or urinary problems, including reduced kidney function (plasma levels of imipenem/cilastatin Hikma increase in patients with renal impairment. Adverse central nervous system reactions may occur if the dose is not adjusted according to kidney function).
• any disorders of the central nervous system, such as localized tremors or epileptic 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/cilastatin Hikma is not recommended for children under one year of age or in children who have kidney problems.

Other medicines and Imipenem/cilastatin Hikma

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

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

Inform 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 whether you can use Imipenem/cilastatin Hikma together with these medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, it is important that you consult your doctor before using this medicine. Imipenem/cilastatin Hikma has not been studied in pregnant women. Imipenem/cilastatin 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 inform your doctor if you are breastfeeding or intend to breastfeed before receiving imipenem/cilastatin. This medicine may pass into breast milk in small amounts and could affect the baby. Therefore, your doctor will decide whether you should use imipenem/cilastatin during breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

There are several adverse effects associated with this medicine (such as seeing, hearing, or perceiving things that are not real, dizziness, drowsiness, and sensation of spinning) that may affect the ability of some patients to drive or operate machinery (see section 4).

Imipenem/cilastatin Hikma contains sodium.

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

3. How to use Imipenem/Cilastatin Hikma

Imipenem/cilastatin Hikma will be prepared and administered by a doctor or other healthcare professional. Your doctor will decide the amount of Imipenem/cilastatin Hikma you need.

Use in adults and adolescents

The recommended dose of Imipenem/cilastatin 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 your dose.

Use in children

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

Method of administration

Imipenem/cilastatin 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 may be reduced.

If you use more Imipenem/cilastatin Hikma than you should

Symptoms of overdose may include seizures (fits), confusion, tremors, nausea, vomiting, low blood pressure, and slow heartbeat. If you are concerned that you may have received too much imipenem/cilastatin, contact your doctor or other healthcare professional immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Imipenem/cilastatin 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

• The following adverse effects occur rarely; however, if they occur while receiving or after receiving Imipenem/cilastatin Hikma, administration of the medicine must be discontinued and you must 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 disorders (Stevens-Johnson syndrome and erythema multiforme)

• Severe skin rash, with loss of skin and hair (exfoliative dermatitis)

Other possible adverse effects:

Frequent (may affect up to 1 in 10 people)

• Increase in the number of certain 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 appear to occur more frequently in patients with a low white blood cell count

Uncommon (may affect up to 1 in 100 people)

• Localized skin redness
• Localized pain and formation of a firm lump at the injection site
• Itching of the skin
• Hives (urticaria)
• Fever
• Blood disorders affecting blood cells, usually detected by blood tests (symptoms may include fatigue, paleness of the skin, and prolonged bruising after injuries)
• Changes in kidney, liver, and blood function, detected by blood tests
• Tremors and uncontrolled muscle contractions
• Seizures (fits)
• Psychiatric disturbances (such as mood changes and deterioration of mental abilities)
• Seeing, hearing, or feeling things that are not real (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

• Inflammation of the colon with severe diarrhea

• Disturbance of taste sensation

• Inability of the liver to perform its normal function

• Inflammation of the liver

• Inability of the kidneys to perform their normal function

• 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 dysfunction due to inflammation (fulminant hepatitis)

• Inflammation of the stomach or intestine (gastroenteritis)

• Inflammation of the intestine with bloody diarrhea (haemorrhagic colitis)

• Swelling and redness of the tongue, excessive growth of the normal projections on the tongue 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 fast and shallow breathing, pain in the upper spine

• Facial redness (flushing), bluish discoloration of the face and lips, changes in skin texture, excessive sweating

• Itching of the vulva in women

• Changes in the counts of blood cells

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

Frequency not known (cannot be estimated from available data)

• Abnormal movements
• Agitation

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Imipenem/Cilastatin Hikma

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

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

Do not store above 25 °C.

Keep vials in the original packaging.

After reconstitution:

Diluted solutions should be used immediately. The time interval between the start of reconstitution and the end of intravenous infusion must not exceed two 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 and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Imipenem/Cilastatin Hikma

• The active substances 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 sodium cilastatin, equivalent to 500 mg of cilastatin.

• The other component is: 20 mg of sodium bicarbonate.

Nature of the product and pack contents

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

Pack sizes:

Carton pack of 1 vial (20 ml).

Carton pack of 10 vials (20 ml).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Hikma Farmacêutica (Portugal) S.A.

Estrada do Rio da Mó, nº8, 8A and 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

Further information about this medicinal product is available from the local representative of the Marketing Authorization Holder:

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, 1st floor, office 2

28108 - Alcobendas, Madrid

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this summary: January 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/

This information is intended for healthcare professionals only:

Each vial is intended for single use only.

Reconstitution

The contents of each vial should be transferred into a suitable infusion solution to achieve a final volume of 100 ml (see sections Incompatibilities and After reconstitution): 0.9% sodium chloride. Under exceptional circumstances where 0.9% sodium chloride solution cannot be used for medical reasons, 5% glucose solution may be used instead. A suggested procedure is to add approximately 10 ml of the appropriate infusion solution to the vial. Mix well and transfer the resulting mixture to the infusion container.

PRECAUTION: THE MIXTURE IS NOT FOR DIRECT INFUSION.

Repeat with an additional 10 ml of the infusion solution to ensure complete transfer of the vial contents into the infusion solution. The resulting mixture should be mixed until clear.

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

Variation in color, from colorless to yellow, does not affect the product's efficacy.

Compatibility and stability

According to good clinical and pharmaceutical practices, Imipenem/Cilastatina should be administered as a freshly prepared solution using the following diluent: 0.9% sodium chloride.

Incompatibilities

This medicinal product is chemically incompatible with lactate and must not be reconstituted with diluents containing lactate. However, it may be administered via an intravenous system through which lactate solution is being infused.

This medicinal product must not be mixed with other medicinal products except those mentioned in the section Reconstitution.

After reconstitution

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

Disposal of unused medicinal product and of all materials that have been in contact with it must be carried out in accordance with local regulations.