Document: leaflet MAH GENERIC_PL 39655-0018 change

• leaflet MAH GENERIC_PL 08828-0190
• leaflet MAH GENERIC_PL 39655-0018
• leaflet MAH GENERIC_PL 41697-0003

---

Package leaflet: Information for the user

Imipenem/Cilastatin 500 mg/500 mg, powder for solution for infusion

Imipenem/Cilastatin

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

-    Keep this leaflet. You may need to read it again.

-    If you have further questions, ask your doctor, pharmacist or nurse.

-    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, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse. See section 4.

What is in this leaflet

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

2.    What you need to know before you are given Imipenem/Cilastatin

3.    How to administer Imipenem/Cilastatin

4.    Possible side effects

5.    How to store Imipenem/Cilastatin

6.    Contents of the pack and other information

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

Imipenem/Cilastatin 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 above.

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

•    Complicated infections in the abdomen

•    Infection affecting the lungs (pneumonia)

•    Infections that you can catch during or after the delivery

•    Complicated urinary tract infections

•    Complicated skin and soft tissue infections

Imipenem/Cilastatin may be used in the management of patients with low white blood cell counts, who have fever that is suspected to be due to a bacterial infection. This product may be used to treat bacterial infection of the blood which might be associated with a type of infection mentioned above.

2. What you need to know before you are given Imipenem/Cilastatin Do not use Imipenem/Cilastatin:

-    if you are allergic 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

Talk to your doctor, pharmacist or nurse before you are given Imipenem/Cilastatin, especially about any medical condition you have or have had including:

-    allergies to any medicines including antibiotics (sudden life-threatening allergic reactions require immediate medical treatment)

-    colitis or any other gastrointestinal disease

-    kidney or urinary problems, including reduced kidney function (Imipenem/Cilastatin blood levels increase in patients with reduced kidney function. Central nervous system adverse reactions may occur if the dose is not adjusted to the kidney function)

-    any central nervous system disorders such as localized tremors or epileptic seizures (fits)

-    liver.

You may develop a positive test (Coombs test) which indicates the presence of antibodies that may destroy red blood cells. Your doctor will discuss this with you.

Tell your doctor if you are taking medicines called valproic acid or sodium valproate (see Other medicines and Imipenem/Cilastatin below).

Children and adolescents

Imipenem/Cilastatin is not recommended in children less than 1 year of age or children with kidney problems.

Other medicines and Imipenem/Cilastatin

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.

-valproic acid or sodium valproate, which are used to treat epilepsy, bipolar disorder, migraine, or schizophrenia

-    any blood thinners such as warfarin.

Your doctor will decide whether you should use Imipenem/Cilastatin in combination with these medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine. Imipenem/Cilastatin has not been studied in pregnant women.

Imipenem/Cilastatin should not be used during pregnancy unless your doctor decides the potential benefit justifies the potential risk to the foetus.

Small amounts of this medicine may pass into breast milk and it may affect the baby. Therefore, your doctor will decide whether you should use Imipenem/Cilastatin while breast-feeding.

Driving and using machines

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

Imipenem/Cilastatin contains sodium

This medicinal product contains 1.6 mmol (or 37.6 mg) of sodium per 500 mg dose. To be taken into consideration by patients on a controlled sodium diet.

3. How to administer Imipenem/Cilastatin

Imipenem/Cilastatin will be prepared and given to you by a doctor or another health care professional. Your doctor will decide how much Imipenem/Cilastatin you need.

Adults

The usual dose of Imipenem/Cilastatin for adults 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 or weigh less than 70 kg, your doctor may lower your dose.

Children and adolescents

The usual dose for children 1 year of age or older is 15/15 or 25/25 mg/kg/dose every 6 hours.

For adolescents, it is 500 mg/500 mg every 6 hours or 1,000 mg/1,000 mg every 6 or 8 hours. Imipenem/Cilastatin is not recommended in children under 1 year of age and children with kidney problems.

Method of administration

Imipenem/Cilastatin is given 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 are given more Imipenem/Cilastatin than you should

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 been given too much Imipenem/Cilastatin, contact your doctor or another healthcare professional immediately.

If you forget to use Imipenem/Cilastatin

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

Do not take a double dose to make up for a forgotten dose.

If you stop using Imipenem/Cilastatin

Do not stop using Imipenem/Cilastatin until your doctor tells you to.

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

4. Possible side effects

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

The following side-effects occur rarely, however if they do occur, while receiving or after receiving Imipenem/Cilastatin, the medicine must be stopped and your doctor contacted immediately:

•    Allergic reactions including rash, swelling of the face, lips, tongue, and/or throat (with difficulty in breathing or swallowing), and/or low blood pressure

•    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)

Other possible side effects:

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

•    Nausea, vomiting, diarrhoea. Nausea and vomiting appear to occur more frequently in patients with low number of white blood cells

•    Swelling and redness along a vein which is extremely tender when touched (thrombophlebitis)

•    Rash

•    Abnormal liver function detected by blood tests

•    Increase in some white blood cells

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

•    Local skin redness

•    Local pain and formation of a firm lump at the injection site

•    Skin itchiness

•    Hives

•    Fever

•    Blood disorders affecting the cell components of the blood and usually detected by blood tests (symptoms may be tiredness, paleness of skin, and prolonged bruising after injury)

•    Abnormal kidney, liver and blood function detected by blood tests

•    Tremors and uncontrolled twitching of muscles

•    Seizures (fits)

•    Psychic disturbances (such as mood swings and impaired judgment)

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

•    Confusion

•    Dizziness, sleepiness

•    Low blood pressure

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

•    Fungal infection (candidiasis)

•    Staining of the teeth and/or tongue

•    Inflammation of the colon with severe diarrhoea

•    Disturbances in taste

•    Inability of the liver to perform normal function

•    Inflammation of the liver

•    Inability of the kidney to perform normal function

•    Changes in the amount of urine, changes in urine colour

•    Disease of the brain, tingling sensation (pins and needles), localised 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 stomach or intestine (gastro-enteritis)

•    Inflammation of intestine with bloody diarrhoea (haemorrhagic colitis)

•    Red swollen tongue (glossitis), overgrowth of the normal projections on the tongue giving it a hairy appearance, heartburn, sore throat, increase in the production of saliva

•    Stomach pain

•    A spinning sensation (vertigo), headache

•    Ringing in the ears (tinnitus)

•    Pain in several joints, weakness

•    Irregular heartbeat, the heart beating forcefully or rapidly

•    Chest discomfort, difficulty breathing, abnormally fast and superficial breathing, pain in the upper spine

•    Flushing, bluish discoloration of the face and lips, skin texture changes, excessive sweating

•    Itching of the vulva in women

•    Changes in the amounts of blood cells

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

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

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

5.    How to store Imipenem/Cilastatin

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 vial. The expiry date refers to the last day of that month.

This product requires no special storage conditions.

After reconstitution: Diluted solutions should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous infusion should not exceed 2hours.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6.    Contents of the pack and other information What Imipenem/Cilastatin contains

-    The active substances are imipenem and cilastatin. Each vial contains imipenem monohydrate equivalent to 500 mg imipenem and cilastatin sodium equivalent to 500 mg cilastatin.

-    The other ingredient is sodium hydrogen carbonate.

What Imipenem/Cilastatin looks like and contents of the pack

Imipenem/Cilastatin is a white to light yellow sterile powder for solution for infusion in a glass vial. Pack sizes of 1, 10 or 25 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder STRAVENCON Ltd

Landmark house, 17 Hanover Square, Mayfair London, W1S 1HU United Kingdom

Manufacturer

IPG PHARMA LIMITED

Atrium Court, The Ring, Bracknell, Berkshire, RG12 1BW United Kingdom

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last revised in <{16/12/2014}>.

MA number - PL 39655/0018

The following information is intended for medical or healthcare professionals only:

Each vial is for single use only.

Reconstitution

Contents of each vial must be transferred to 100 ml of an appropriate infusion solution (see Incompatibility and After reconstitution): 0.9% sodium chloride. In exceptional circumstances where 0.9% sodium chloride cannot be used for clinical reasons, 5% glucose may be used instead.

A suggested procedure is to add approximately 10 ml of the appropriate infusion solution to the vial. Shake well and transfer the resulting mixture to the infusion solution container. The solution should only be used if it is clear and free from particles.

CAUTION: THE MIXTURE IS NOT FOR DIRECT INFUSION.

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

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

Incompatibility

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

This medicinal product must not be mixed with other medicinal products except those mentioned under Reconstitution.

After reconstitution

Diluted solutions should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous infusion should not exceed 2hours.

Any unused product or waste material should be disposed of in accordance with local requirements.