Imipenem and cilastatin Aurobindo

Package leaflet: Information for the user

Imipenem and Cilastatin Aurobindo 500 mg/500 mg powder for solution for infusion

Generic medicine
Please read this leaflet carefully before 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Imipenem and Cilastatin Aurobindo is and what it is used for

Imipenem and Cilastatin Aurobindo 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 aged 1 year and older.
Treatment
Your doctor has prescribed Imipenem and Cilastatin Aurobindo because you have one (or more) of the following types
of infection:

• Complicated intra-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 and Cilastatin Aurobindo may be used to treat patients with low numbers of white blood cells in the blood, who have fever suspected to be caused by a bacterial infection.

Imipenem and Cilastatin Aurobindo may also be used to treat bacterial bloodstream infections that
could be associated with one of the above-described infections.

2. What you need to know before using Imipenem and Cilastatin Aurobindo

Do not use Imipenem and Cilastatin Aurobindo

• if you are allergic to imipenem, cilastatin, or any of the excipients of this medicine (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 medical conditions you currently have or have had in the past, including:

• allergies to any type of medicine, including antibiotics (sudden, life-threatening allergic reactions requiring immediate medical treatment);
• colitis or any other gastrointestinal disease;
• any disorders of the central nervous system such as localized tremors or seizures;
• any liver, kidney, or urinary tract problems. You may test positive in a 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 medicines called valproic acid or sodium valproate (see below
Other medicines and Imipenem and Cilastatin Aurobindo).
Children
Imipenem and Cilastatin Aurobindo is not recommended in children under 1 year of age or in children
with kidney problems.
Other medicines and Imipenem and Cilastatin Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
Inform your doctor if you are taking ganciclovir, which is used to treat certain viral infections.
Also inform your doctor if you are taking valproic acid or sodium valproate (used to treat epilepsy,
bipolar disorder, migraine, or schizophrenia) or any other blood thinner such as warfarin.
Your doctor will decide whether you should use Imipenem and Cilastatin Aurobindo in combination with these medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, if you suspect you may be pregnant or are planning a
pregnancy, consult your doctor before taking this medicine.
Imipenem and Cilastatin Aurobindo has not been studied in pregnant women. Imipenem and Cilastatin
Aurobindo should not be used during pregnancy unless your doctor decides that the potential benefits
justify the potential risks to the fetus.
Small amounts of this medicine may pass into breast milk and could affect the baby.
Therefore, your doctor will decide whether you should use Imipenem and Cilastatin Aurobindo during breast-feeding.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
There are some side effects associated with this medicine (such as seeing, hearing or sensing things that
are not there, dizziness, drowsiness, feeling of vertigo) which may interfere with driving or
operating machinery (see section 4).
Imipenem and Cilastatin Aurobindo contains sodium
For patients on a low-sodium diet, it should be noted that this medicine contains approximately 1.6 mEq (about 37.6 mg) of sodium.

3. How to use Imipenem and Cilastatin Aurobindo

Imipenem and Cilastatin Aurobindo will be prepared and administered by a doctor or other healthcare
professional. Your doctor will determine the appropriate dose of Imipenem and Cilastatin Aurobindo for you.
Use in adults and adolescents
The usual dose of Imipenem and Cilastatin Aurobindo 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 the dose.
Use in children
The usual dose for children aged 1 year and older is 15/15 or 25/25 mg/kg every 6 hours. Imipenem and Cilastatin Aurobindo is not recommended for children under 1 year of age or for children with kidney problems.
Method of administration
Imipenem and Cilastatin Aurobindo is administered intravenously (into a vein) over 20–30 minutes when given at a dose less than or equal to 500 mg/500 mg, or over 40–60 minutes when given at a dose greater than 500 mg/500 mg.
If you are given more Imipenem and Cilastatin Aurobindo than you should have
Symptoms of overdose may include seizures, confusion, tremors, nausea, vomiting, low blood pressure, and slow heart rate. If you think you have been given too much Imipenem and Cilastatin Aurobindo, contact your doctor or another healthcare professional immediately.
If you miss a dose of Imipenem and Cilastatin Aurobindo
If you think a dose has been missed, contact your doctor or another healthcare professional immediately.
Do not take a double dose to make up for a forgotten dose.
If you stop treatment with Imipenem and Cilastatin Aurobindo
Do not stop treatment with Imipenem and Cilastatin Aurobindo unless instructed to do so by your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Common (may affect up to 1 in 10 people)

• Nausea, vomiting, diarrhoea. Nausea and vomiting appear to occur more frequently in patients with a low white blood cell count.
• Swelling and redness along the vein, which is extremely painful to touch.
• Skin rash.
• Changes in liver function detected by blood tests.
• Increase in certain types of white blood cells in the blood.

Uncommon (may affect up to 1 in 100 people)

• Localised skin redness.
• Local pain and formation of a hard lump at the injection site.
• Itching of the skin.
• Hives (urticaria).
• Fever.
• Blood disorders affecting the cellular components of blood, usually detected by blood tests (symptoms may include fatigue, pale skin, and persistent bruising after injuries).
• Changes in kidney, liver, and blood function detected by blood tests.
• Tremors and uncontrolled muscle spasms.
• Seizures.
• Psychiatric disturbances (such as mood changes and impaired judgment).
• Seeing, hearing, or sensing things that are not there (hallucinations).
• Confusion.
• Dizziness, drowsiness.
• Low blood pressure.

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

• Allergic reactions including skin rash, swelling of the face, lips, tongue and/or throat (with difficulty breathing or swallowing), and/or low blood pressure. If these side effects

occur during or after treatment with Imipenem and Cilastatin
Aurobindo, administration of the medicine must be stopped and the doctor must be
contacted immediately.

• Skin peeling (toxic epidermal necrolysis).
• Severe skin reactions (Stevens-Johnson syndrome and erythema multiforme).
• Severe skin rash with loss of skin and hair (exfoliative dermatitis).
• Fungal infection (candidiasis).
• Discoloration of teeth and/or tongue.
• Inflammation of the colon with severe diarrhoea.
• Taste disturbances.
• Inability of the liver to perform its normal function.
• Inflammation of the liver.
• Inability of the kidney to perform its normal function.
• Changes in urine volume, changes in urine colour.
• Brain disease, tingling sensation, localized tremor.
• Hearing loss.

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

• Severe loss of liver function due to inflammation (fulminant hepatitis).
• Inflammation of the stomach or intestine (gastroenteritis).
• Inflammation of the intestine with bloody diarrhoea (haemorrhagic colitis).
• Red and swollen tongue, excessive growth of the normal projections on the tongue giving it a "hairy" appearance, heartburn, sore throat, increased salivation.
• Stomach pain.
• A sensation of spinning (vertigo), headache.
• Ringing in the ears (tinnitus).
• Pain in multiple joints, weakness.
• Irregular heartbeat, strong or rapid heartbeat.
• Chest pain, difficulty breathing, abnormally rapid and shallow breathing, pain in the upper part of the spine.
• Redness, bluish discoloration of the face and lips, skin tissue changes, excessive sweating.
• Vulval itching in women.
• Changes in the number of red blood cells.
• Worsening of a rare disease associated with muscle weakness (worsening of myasthenia gravis).

Not known (frequency cannot be estimated from the available data)

• Abnormal movements.
• Restlessness.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website [insert address]. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Imipenem and Cilastatin Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the vial (after the word EXP.). The expiry date refers to the last day of the month.
The vials of Imipenem and Cilastatin Aurobindo in dry form do not require any special storage conditions.
After reconstitution:
Diluted solutions must 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.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Imipenem and Cilastatin Aurobindo contains

• The active substances are imipenem (as monohydrate) and cilastatin (as sodium salt). Each vial of Imipenem and Cilastatin Aurobindo 500 mg/500 mg powder for solution for infusion contains 500 mg of imipenem (equivalent to 530 mg of imipenem monohydrate) and 500 mg of cilastatin (equivalent to 530 mg of cilastatin sodium salt).
• The other component is sodium bicarbonate.

Description of the appearance of Imipenem and Cilastatin Aurobindo and the contents of the pack
The 500 mg imipenem/cilastatin dosage is available in colorless glass vials of type III with a capacity of 20 ml, closed with 20 mm diameter bromobutyl rubber stoppers and flip-off caps.
Packs:
1 vial of 500 mg
10 vials of 500 mg
Not all pack sizes may be marketed.

Marketing Authorization Holder
Eugia Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront,
Floriana FRN 1914, Malta

Responsible manufacturer for batch release
ACS Dobfar S.p.A. - S. Nicolò a Tordino - S. Atto Industrial Area – 64100 Teramo

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy Imipenem and Cilastatin Aurobindo
Portugal Imipenem + Cilastatin Aurovitas
Spain Imipenem/Cilastatin Aurovitas 500 mg/500 mg powder for solution for infusion EFG

The following information is intended exclusively for physicians or healthcare professionals:
Each vial is for single use only.

Preparation of the intravenous solution
The following table is provided to assist in the reconstitution of Imipenem and Cilastatin Aurobindo for intravenous infusion.

Reconstitution of Imipenem and Cilastatin Aurobindo 500 mg:
The contents of the vials must be dissolved and transferred into an appropriate infusion solution to obtain a final volume of 100 ml.
A recommended procedure is to add approximately 10 ml of the appropriate infusion solution (see "Compatibility and stability") into the vial. Mix well and transfer the resulting suspension to the infusion container.
WARNING: THE SUSPENSION MUST NOT BE USED DIRECTLY FOR INFUSION.
Repeat with another 10 ml of infusion solution to ensure complete transfer of the vial contents into the infusion container. Dilute to 100.0 ml with the same infusion solution. Mix thoroughly until a clear solution is obtained.
The concentration of the reconstituted solution prepared according to the above procedures is approximately 5 mg/ml for both imipenem and cilastatin.
Before administration, the reconstituted solution must be inspected visually for particulate matter and discoloration. After reconstitution, Imipenem and Cilastatin Aurobindo ranges from colourless to yellow. Colour variations within this range do not affect the potency of the product.
Compatibility and stability
The reconstituted solution must be used immediately. The time interval between the start of reconstitution and the end of intravenous infusion must not exceed two hours.
Imipenem and Cilastatin Aurobindo can be reconstituted with water for injections or sodium chloride 9 mg/ml (0.9%) infusion solution.
Do not freeze the reconstituted solution.
Any unused medicinal product or waste material must be disposed of in accordance with local regulations.