Document: leaflet MAH GENERIC_PL 24598-0039 change

• leaflet CREO PHARMA_PL 41697-0001
• leaflet MAH GENERIC_PL 08828-0224
• leaflet MAH GENERIC_PL 16363-0443
• leaflet MAH GENERIC_PL 18179-0014
• leaflet MAH GENERIC_PL 24598-0039
• leaflet MAH GENERIC_PL 34985-0003
• leaflet MAH GENERIC_PL 39655-0013
• leaflet MAH GENERIC_PL 41697-0001

---

PACKAGE LEAFLET: INFORMATION FOR THE

USER

Meropenem 500mg Powder for Solution for Injection or

Infusion

Meropenem 1g Powder for Solution for Injection or Infusion

Meropenem

Read all of this leaflet carefully before you start taking this medicine.

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

•    If you have any further questions, ask your doctor or nurse.

•    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 you notice any side effects not listed in this leaflet please tell your doctor or nurse.

The name of your medicine is one of the following:

-    Meropenem 500mg Powder for Solution for Injection or Infusion

-    Meropenem 1g Powder for Solution for Injection or Infusion

In the rest of this leaflet your medicine is called Meropenem.

In this leaflet:

1.    What Meropenem is and what it is used for

2.    Before you are given Meropenem

3.    How Meropenem is given

4.    Possible side effects

5.    How to store Meropenem

6.    Further Information

1. WHAT MEROPENEM IS AND WHAT IT IS USED FOR

Meropenem belongs to a group of medicines called carbapenem antibiotics. It works by killing bacteria, which can cause serious infections.

•    Infection affecting the lungs (pneumonia)

•    Lung and bronchial infections in patients suffering from cystic fibrosis

•    Complicated urinary tract infections

•    Complicated infections in the abdomen

•    Infections that you can catch during or after the delivery

•    Complicated skin and soft tissues infections

•    Acute bacterial infection of the brain (meningitis) Meropenem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE MEROPENEM

Do not use Meropenem

If you are allergic (hypersensitive) to meropenem or any of the other ingredients of Meropenem (listed in Section 6 Contents of the Pack and Other Information).

• If you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or carbapenems as you may also be allergic to meropenem.

Warnings and precautions

Talk to your doctor before using Meropenem if you have or have had:

•    health problems, such as liver or kidney problems.

•    severe diarrhoea after taking other antibiotics.

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.

If you are not sure if any of the above applies to you, talk to your doctor or nurse before using Meropenem.

Other medicines and Meropenem

Tell your doctor if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription and herbal medicines.

This is because Meropenem can affect the way some medicines work and some medicines can have an effect on Meropenem. In particular, tell your doctor or nurse if you are taking any of the following medicines:

•    Probenecid (used to treat gout).

•    Sodium valproate (used to treat epilepsy). Meropenem should not be used because it may decrease the effect of sodium valproate.

Pregnancy and breast-feeding

It is important that you tell your doctor if you are pregnant or are planning to become pregnant before receiving meropenem. It is preferable to avoid the use of meropenem during pregnancy.

Your doctor will decide whether you should use Meropenem. It is important that you tell your doctor if you are breastfeeding or if you intend to breast-feed before receiving meropenem. Small amounts of this medicine may pass into the breast milk and it may affect the baby. Therefore, your doctor will decide whether you should use Meropenem while breast-feeding.

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

Driving and using machines

No studies on the effect on the ability to drive and use machines have been performed.

Important information about some of the ingredients of Meropenem

Meropenem contains sodium.

Meropenem 500 mg: This medicinal product contains approximately 2.0 mEq (45 mg) of sodium per 500 mg dose which should be taken into consideration by patients on a controlled sodium diet.

Meropenem 1 g: This medicinal product contains approximately 4.0 mEq (90 mg) of sodium per 1.0g dose which should be taken into consideration by patients on a controlled sodium diet.

If you have a condition which requires you to monitor your sodium intake please inform your doctor or nurse.

3. HOW TO USE MEROPENEM

Adults

•    The dose depends on the type of infection that you have, where the infection is in the body and how serious the infection is. Your doctor will decide on the dose that you need.

•    The dose for adults is usually between 500 mg (milligrams) and 2 g (grams). You will usually receive a dose every 8 hours. However you may receive a dose less often if your kidneys do not work very well.

Children and adolescents

•    The dose for children over 3 months old and up to 12 years of age is decided using the age and weight of the child. The usual dose is between 10 mg and 40 mg of Meropenem for each kilogram (kg) that the child weighs. A dose is usually given every 8 hours. Children who weigh over 50 kg will be given an adult dose.

Method of administration

•    Meropenem will be given to you as an injection or infusion into a large vein.

•    Your doctor or nurse will normally give Meropenem to you.

•    However, some patients, parents and carers are trained to give Meropenem at home. Instructions for doing this are provided in this leaflet (in the section called ‘Instructions for giving Meropenem to yourself or someone else at home’). Always use Meropenem exactly as your doctor has told you. You should check with your doctor if you are not sure.

•    Your injection should not be mixed with or added to solutions that contain other medicines.

•    The injection may take about 5 minutes or between 15 and 30 minutes. Your doctor will tell you how to give Meropenem.

•    You should normally have your injections at the same times each day.

If you use more Meropenem than you should

If you accidentally use more than your prescribed dose, contact your doctor or nearest hospital straight away.

If you forget to use Meropenem If you miss an injection, you should have it as soon as possible. However, if it is almost time for your next injection, skip the missed injection. Do not take a double dose (two injections at the same time) to make up for a forgotten dose.

If you stop using Meropenem

Do not stop having Meropenem until your doctor tells you to. If you have any further questions on the use of this product, ask your doctor or nurse.

4. POSSIBLE SIDE EFFECTS

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

The frequency of possible side effects listed below is defined

using the following convention:

very common (affects more than 1 user in 10)

common (affects 1 to 10 users in 100)

uncommon (affects 1 to 10 users in 1,000)

rare (affects 1 to 10 users in 10,000)

very rare (affects less than 1 user in 10,000)

not known (frequency cannot be estimated from the available

data but this is rare or very rare)

Severe allergic reactions

If you have a severe allergic reaction, stop having Meropenem and see a doctor straight away. You may need urgent medical treatment. The signs may include a sudden onset of:

•    Severe rash, itching or hives on the skin.

•    Swelling of the face, lips, tongue or other parts of the body.

•    Shortness of breath, wheezing or trouble breathing.

Damage to red blood cells (not known)

The signs include:

•    Being breathless when you do not expect it.

•    Red or brown urine.

If you notice any of the above, see a doctor straight away. Other possible side effects:

Common

•    Abdominal (stomach) pain

•    Feeling sick (nausea)

•    Being sick (vomiting)

•    Diarrhoea

•    Headache

•    Skin rash, itchy skin

•    Pain and inflammation

•    Increased numbers of platelets in your blood (shown in a blood test)

•    Changes in blood tests, including tests that show how well your liver is working

Uncommon

•    Changes in your blood. These include reduced numbers of platelets (which may make you bruise more easily), increased numbers of some white blood cells, decreased numbers of other white cells and increased amounts of a substance called ‘bilirubin’. Your doctor may do blood tests from time to time.

•    Changes in blood tests, including tests that show how well your kidney is working.

•    A tingling feeling (pins and needles).

•    Infections of the mouth or the vagina that are caused by a fungus (thrush).

Rare

•    Fits (convulsions).

Other possible side effects of unknown frequency

•    Inflammation of the bowel with diarrhoea.

•    Sore veins where Meropenem is injected.

•    Other changes in your blood. The symptoms include frequent infections, high temperature and sore throat. Your doctor may do blood tests from time to time.

•    Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains.

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 For UK: Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.

For IE: HPRA Pharmacovigilance, Earlsfort Terrace, IRL -Dublin 2, Tel: +353 1 6764971; Fax: +353 1 6762517, Website: www. hpra.ie; E-mail: medsafety@hpra.ie.

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

5. HOW TO STORE MEROPENEM

Keep out of the reach and sight of children.

Do not use Meropenem after the expiry date which is stated on the outer carton and the vials after abbreviation (EXP). The expiry date refers to the last day of that month.

After reconstitution: The reconstituted solutions for intravenous injection or infusion should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous injection or infusion should not exceed one hour.

Do not refrigerate or 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. These measures will help to protect the environment.

The solution should only be used if it is clear, colourless to pale yellow and free from particles.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Meropenem contains:

Meropenem 500 mg: Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem. Meropenem 1 g: Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem.

The other ingredient is anhydrous sodium carbonate.

What Meropenem looks like and contents of the pack:

Meropenem is a white to light yellow crystalline powder for solution for injection or infusion in glass vial sealed with a rubber stopper and aluminium flip-off cap. Pack sizes of 1 or 10 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

The marketing authorisation holder is:

Noridem Enterprises Ltd, Evagorou and Makariou Mitsi Building 3, Suit.115, 1065 Nicosia, Cyprus.

The manufacturer is:

DEMO S.A., 21^st km National Road Athens-Lamia, 14568 Krioneri, Athens, Greece.

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

UK: Meropenem 500mg and 1g Powder for Solution for Injection or Infusion IE:    Meropenem 500mg and 1g Powder for

Solution for Injection or Infusion AT: Meropenem Noridem 500 mg und 1g Pulver zur Herstellung einer Injektions-oder Infusionslosung

DE: Meropenem Noridem 500 mg und 1g Pulver zur Herstellung einer Injektions-oder Infusionslosung

EL: Meropenem Noridem 500mg Kai 1g Kovig yia evsoipo Sia^npa ES:    Meropenem KERN PHARMA 500 mg

y 1000 mg polvo para solution inyectable y para perfusion EFG PL: Meropenem Noridem 500mg i 1g proszek do sporz^dzania roztworu do wstrzykiwan lub wlewow

This leaflet was last revised in 03/2016.

resistant to the antibiotic that is being taken. This means that they can survive and even multiply despite the antibiotic. Bacteria can become resistant to antibiotics for many reasons. Using antibiotics carefully can help to reduce the chance of bacteria becoming resistant to them.

When your doctor prescribes a course of an antibiotic it is intended to treat only your current illness. Paying attention to the following advice will help prevent the emergence of resistant bacteria that could stop the antibiotic working.

1.    It is very important that you take the antibiotic at the right dose, at the right times and for the right number of days. Read the instructions on the label and if you do not understand anything ask your doctor or pharmacist to explain.

2.    You should not take an antibiotic unless it has been prescribed specifically for you and you should use it only to treat the infection for which it was prescribed.

3.    You should not take antibiotics that have been prescribed for other people even if they had an infection that was similar to yours.

4.    You should not give antibiotics that were prescribed for you to other people.

5.    If you have any antibiotic left over when you have taken the course as directed by your doctor you should take the remainder to a pharmacy for appropriate disposal.

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

Instructions for giving Meropenem to yourself or someone else at home.

Some patients, parents and carers are trained to give Meropenem at home.

Warning - You should only give this medicine to yourself or someone else at home after a doctor or nurse has trained you.

•    The medicine must be mixed with another liquid (the diluent). Your doctor will tell you how much of the diluent to use.

•    Use the medicine straight after preparing it. Do not freeze it. How to prepare this medicine

1.    Wash your hands and dry them very well. Prepare a clean working area.

2.    Remove the Meropenem vial from the packaging. Check the vial and the expiry date. Check that the vial is intact and has not been damaged.

3.    Remove the coloured cap (red for the vials of 1g and blue for the vials of 500mg) and clean the grey rubber stopper with an alcohol wipe. Allow the rubber stopper to dry.

4.    Connect a new sterile needle to a new sterile syringe, without touching the ends.

5.    Draw up the recommended amount of sterile ‘Water for Injections’ into the syringe. The amount of liquid that you

6.    Put the needle of the syringe through the centre of the grey rubber stopper and inject the recommended amount of Water for Injections into the vial or vials of Meropenem.

7.    Remove the needle from the vial and shake the vial well for about 5 seconds, or until all the powder has dissolved. Clean the grey rubber stopper once more with a new alcohol wipe and allow the rubber stopper to dry.

8.    With the plunger of the syringe pushed fully into the syringe, put the needle back through the grey rubber stopper. You must then hold both the syringe and the vial and turn the vial upside down.

9.    Keeping the end of the needle in the liquid, pull back the plunger and draw all the liquid in the vial into the syringe.

10.    Remove the needle and syringe from the vial and throw the empty vial away in a safe place.

11.    Hold the syringe upright, with the needle pointing upwards. Tap the syringe so that any bubbles in the liquid rise to the top of the syringe.

12.    Remove any air in the syringe by gently pushing the plunger until all the air has gone.

13.    If you are using Meropenem at home, dispose of any needles and infusion lines that you have used in an appropriate way. If your doctor decides to stop your treatment, dispose of any unused Meropenem in an appropriate way.

Giving the injection

You can either give this medicine through a tube (short cannula or venflon), or through a port or central line.

Giving Meropenem through a tube (short cannula or venflon)

1.    Remove the needle from the syringe and throw the needle away carefully in your sharps bin.

2.    Wipe the end of the tube with an alcohol wipe and allow it to dry. Open the cap on your tube and connect the syringe.

3.    Slowly push the plunger of the syringe to give the antibiotic steadily over about 5 minutes.

4.    Once you have finished giving the antibiotic and the syringe is empty, remove the syringe and use a flush as recommended by your doctor or nurse.

5.    Close the cap of your tube and carefully throw the syringe away in your sharps bin.

Giving Meropenem through a port or central line

1.    Remove the cap on the port or line, clean the end of the line with an alcohol wipe and allow it to dry.

2.    Connect the syringe and slowly push the plunger on the syringe to give the antibiotic steadily over about 5 minutes.

3.    Once you have finished giving the antibiotic, remove the syringe and use a flush as recommended by your doctor or nurse.

4.    Place a new clean cap on your central line and carefully throw the syringe away in your sharps bin.

If this leaflet is difficult to see or read please contact the following address for help:

Athlone Laboratories, Ballymurray, Co. Roscommon, Ireland.

Tel +353-9066-61109

Email medical@athlone-laboratories.com.