Document: leaflet MAH GENERIC_PL 30306-0112 change

• leaflet MAH GENERIC_PL 04515-0237
• leaflet MAH GENERIC_PL 15413-0021
• leaflet MAH GENERIC_PL 30306-0112

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Imipenem/Cilastatin 500mg/500mg Powder for Solution for Infusion

Read all of this leaflet carefully before you start

taking 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

•    The full name of this product is Imipenem/Cilastatin 500mg/500mg Powder for Solution for Infusion but within the leaflet it will be referred to as Imipenem/ Cilastatin powder.

What is in this leaflet:

T| What Imipenem/Cilastatin powder is and what it is used for

2| What you need to know before you use How to use

BIT Possible side effects How to store

^1 Contents of the pack and other information

j What Imipenem/Cilastatin powder is and what it is used for

Imipenem/Cilastatin powder 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.

Treatment

Your doctor has prescribed Imipenem/Cilastatin powder 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 powder 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.

Imipenem/Cilastatin powder may be used to treat bacterial infection of the blood which might be associated with a type of infection mentioned above.

^ What you need to know before you use

Do not use Imipenem/Cilastatin powder if you

•    are allergic to imipenem, cilastatin or any of the other ingredients of this medicine (listed in section 6).

•    are allergic to other antibiotics such as penicillins, cephalosporins or carbapenems

Warnings and precautions

Tell your doctor 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

•    any central nervous system disorders such as localized tremors or epileptic seizures

•    liver, kidney or urinary problems

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 Imipenen/Cilastatin below).

Children

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

Using other medicines

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.

Also, tell your doctor if you are taking valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraine, or schizophrenia) or any blood thinners such as warfarin.

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

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Imipenem/Cilastatin powder has not been studied in pregnant women. Imipenem/Cilastatin powder 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 powder while breast-feeding.

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

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 powder contains sodium

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

The following information is intended for healthcare professionals only:

Each vial is for single use only.

Preparation of intravenous solution

The following table is provided for convenience in reconstituting Imipenem/Cilastatin powder for intravenous infusion.

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3| How to use

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

Adults and adolescents

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

Children

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

Method of administration

Imipenem/Cilastatin powder is given intravenously (into a vein) over 20-30 minutes for a dose of <500 mg/500 mg or 40-60 minutes for a does of >500 mg/500 mg.

If you use more Imipenem/Cilastatin powder 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 powder, contact your doctor or another healthcare professional immediately.

If you forget to use Imipenem/Cilastatin powder

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 powder

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

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

^ Possible side effects

Like all medicines, Imipenem/Cilastatin powder 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 low number of white blood cells

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

•    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

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Jr'ST_______________

CAUTION: THE SUSPENSION IS NOT FOR DIRECT INFUSION.

Repeat with an additional 10ml of infusion solution to ensure complete transfer of vial contents to the infusion solution container. Take to 100.0 with the same infusion solution. The resulting mixture should be agitated until a clear solution is obtained.

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

continued on top of next column AAAI4227

•    Tremors and uncontrolled twitching of muscles

•    Seizures

•    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):

•    Allergic reactions including rash, swelling of the face, lips, tongue and/or throat (with difficulty in breathing or swallowing), and/or low blood pressure. If these side-effects occur while receiving or after receiving Imipenem/Cilastatin powder, the medicine must be stopped and your doctor 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)

•    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, 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)

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.

How to store

Keep this medicine out of the sight and reach of children. Do not use the powder for solution for infusion after the expiry date stated on the carton and on the vials (EXP). The expiry date refers to the last day of that month.

Vials of dry Imipenem/Cilastatin powder do not require any special storage conditions.

continued on top of next column

The reconstituted solution should be expected visually for particulate matter and discoloration prior to administration. When reconstituted, Imipenem/Cilastatin powder ranges from colourless to yellow. Variation of colour within this range does not affect the potency of product.

Compatibility and stability

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

continued on top of next column

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 two hours. Do not freeze the reconstituted solution.

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 protect the environment.

Contents of the pack and other information

What Imipenem/Cilastatin powder contains

•    The active substances are imipenem (as the monohydrate) and cilastatin (as the sodium salt).

Each vial of Imipenem/Cilastatin 500mg/500mg Powder for Solution for Infusion contains 500mg imipenem (as 530mg imipenem monohydrate) and 500mg cilastatin (as 530mg cilastin sodium salt).

•    The other ingredient is sodium hydrogen carbonate.

What Imipenem/Cilastatin powder looks like and contents of the pack

Imipenem/cilastatin 500mg strength is available in uncoloured glass vials type III having a capacity of 20ml stoppered with bromobutyl rubber stoppers having a diameter of 20mm and with flip-off cap.

Pack size: 1 x 500mg vial

Marketing Authorisation Holder

Actavis Group PTC ehf, Reykjavikurvegur 76-78 IS-220 Hafnarfjordur, Iceland

Manufacturer

Facta Farmaceutici, Nucleo Industriale S. Atto,

S. Nicolo a Tordino, 64100 Teramo, Italy

This leaflet was last revised in November 2015

If you would like a leaflet with larger ^% text, please contact 01271 311257.

^actavis

Actavis, Barnstaple, EX32 8NS, UK

Imipenem/Cilastatin powder can be reconstituted in WFI or Sodium chloride 9mg/ml (0.9%) solution for infusion. Do not freeze the reconstituted solution.

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

actavis

Actavis, Barnstaple, EX32 8NS, UK