MEROPENEM VENUS PHARMA 1000 mg POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

Introduction

Package Leaflet: Information for the User

Meropenem Venus Pharma 1,000 mg powder for solution for injection and infusion EFG

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 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, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Meropenem Venus Pharma and what is it used for
2. What you need to know before you use Meropenem Venus Pharma
3. How to use Meropenem Venus Pharma
4. Possible side effects
5. Storage of Meropenem Venus Pharma
6. Contents of the pack and other information

1. What is Meropenem Venus Pharma and what is it used for

Meropenem contains the active substance meropenem and belongs to a group of medicines called carbapenem antibiotics. It works by killing bacteria that can cause serious infections.

Meropenem is used to treat the following infections in adults and children from 3 months of age:

• Infection affecting the lungs (pneumonia)
• Lung and bronchial infections in patients with cystic fibrosis
• Complicated urinary tract infections
• Complicated infections in the abdomen
• Infections that can be acquired during or after childbirth
• Complicated skin and soft tissue infections
• Acute bacterial infection of the brain (meningitis)

Meropenem may be used to treat patients with neutropenia and fever who are suspected of having a bacterial infection.

Meropenem may be used to treat bacterial infection of the blood that may be associated with one of the aforementioned infections.

2. What you need to know before you use Meropenem Venus Pharma

Do not use Meropenem Venus Pharma if:

• You are allergic (hypersensitive) to meropenem or any of the other ingredients of this medicine (listed in section 6).
• 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, pharmacist, or nurse before using meropenem if:

• You have health problems, such as liver or kidney problems.
• You have had severe diarrhea after taking other antibiotics.

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

You may develop signs and symptoms of severe skin reactions (see section 4). If this happens, talk to your doctor or nurse immediately so that they can treat the symptoms.

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 Venus Pharma

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because meropenem may affect how some medicines work and some medicines may have an effect on meropenem.

In particular, tell your doctor, pharmacist, or nurse if you are taking any of the following medicines:

• Probenecid (used to treat gout).
• Valproic acid/sodium valproate/valpromide (used to treat epilepsy). Meropenem should not be used because it can decrease the effect of valproate.
• Oral anticoagulant agent (used to treat or prevent blood clots).

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 using this medicine. 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 inform your doctor if you are breast-feeding or intend to breast-feed before receiving meropenem. Small amounts of this medicine may pass into breast milk. Therefore, your doctor will decide whether you should use meropenem during breast-feeding.

Driving and using machines

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

Meropenem has been associated with headache and tingling or numbness in the skin (paresthesia). Either of these side effects could affect your ability to drive or use machines.

Meropenem may cause involuntary muscle movements that can make your body shake rapidly and uncontrollably (convulsions). This is usually accompanied by a loss of consciousness. Do not drive or use machines if you experience this side effect.

Meropenem Venus Pharma contains sodium

This medicine contains 90.2 mg of sodium (main component of cooking/table salt) per 1,000 mg dose. This is equivalent to 4.5% of the maximum recommended daily intake of sodium for an adult.

If you have a condition that requires you to control your sodium intake, inform your doctor, pharmacist, or nurse.

3. How to use Meropenem Venus Pharma

Follow exactly the instructions for administration of this medicine given by your doctor, pharmacist, or nurse. If you are unsure, consult your doctor, pharmacist, or nurse.

Use in adults

• The dose depends on the type of infection you have, the area of the body where it is located, and the severity of the infection. Your doctor will decide the dose you need.
• The dose for adults usually ranges from 500 mg (milligrams) to 2 g (grams). You will usually receive a dose every 8 hours. However, you may receive a dose less frequently if your kidneys do not work very well.

Use in children and adolescents

• The dose for children over 3 months and up to 12 years is decided based on the child's age and weight. The usual dose is between 10 mg and 40 mg of meropenem per kilogram (kg) of the child's weight. A dose is usually given every 8 hours. Children who weigh more than 50 kg will receive an adult dose.

How to use Meropenem Venus Pharma

• Meropenem will be given to you as an injection or infusion into a large vein.
• Normally, your doctor or nurse will give you meropenem.
• However, some patients, parents, and caregivers are trained to administer meropenem at home. This leaflet (in the section "Instructions for administering Meropenem to yourself or another person at home") provides instructions for doing so. Follow exactly the instructions for administration of meropenem given by your doctor. Consult your doctor if you have doubts.
• Your injection should not be mixed or added to solutions that contain other medicines.
• The injection may take approximately 5 minutes or between 15 and 30 minutes. Your doctor will tell you how to administer meropenem.
• Normally, injections should be given at the same time every day.

If you use more Meropenem Venus Pharma than you should

If you accidentally use a higher dose than prescribed, contact your doctor or go to the nearest hospital immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Meropenem Venus Pharma

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

If you stop using Meropenem Venus Pharma

Do not stop meropenem until your doctor tells you to.

If you have any other questions about 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.

Severe allergic reactions

If you get any of these signs and symptoms, tell your doctor or nurse immediately. You may need urgent medical treatment. The signs and symptoms can include:

• 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 problems breathing.
• Severe skin reactions that include
  • Severe hypersensitivity reactions with fever, skin rash, and changes in blood test results that check liver function (increased liver enzyme levels), increased levels of a type of white blood cell (eosinophilia), and enlargement of the lymph nodes. These can be signs of a multi-organ sensitivity disorder known as DRESS syndrome.
  • Severe red and scaly rash, skin bumps that contain pus, blisters, or peeling of the skin, which can be associated with high fever and joint pain.
  • Severe skin reactions that can appear as circular red patches, often with central blisters, on the trunk, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes, and can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or a more severe form (toxic epidermal necrolysis).

Damaged red blood cells (frequency not known)

The symptoms include:

• Shortness of breath when you do not expect it.
• Red or brown urine.

If you notice any of the above, go to your doctor immediately.

Other possible side effects:

Common (may affect up to 1 in 10 people)

• Abdominal pain (stomach).
• Feeling sick (nausea).
• Being sick (vomiting).
• Diarrhea.
• Headache.
• Skin rash, itching.
• Pain and inflammation.
• Increased number of platelets in the blood (checked in a blood test).
• Changes in blood tests, including those that show liver function.

Uncommon (may affect up to 1 in 100 people)

• Changes in the blood. These include a decrease in the number of platelets (which can make you bruise more easily), an increase in the number of some white blood cells, a decrease in the number of other white blood cells, and an increase in the amount of a substance called "bilirubin". Your doctor may perform regular blood tests.
• Changes in blood tests, including those that show kidney function.
• Tingling sensation (numbness).
• Mouth or vaginal infections caused by a fungus (thrush).
• Inflammation of the intestine with diarrhea.
• Pain in the veins where meropenem is injected.
• Other changes in the blood. The symptoms include frequent infections, fever, and sore throat. Your doctor may perform regular blood tests.

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

• Seizures (fits).
• Sudden confusion and disorientation (delirium).

Reporting of side effects

If you experience 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 through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Meropenem Venus Pharma

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 carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Injection

After reconstitution: The reconstituted solutions for intravenous injection should be used immediately. The time between the start of reconstitution and the end of intravenous injection should not exceed:

• 3 hours when stored up to 25°C;
• 12 hours if stored in a refrigerator (2-8°C).

Infusion

After reconstitution: The reconstituted solutions for intravenous infusion should be used immediately. The time between the start of reconstitution and the end of intravenous infusion should not exceed:

• 3 hours when stored up to 25°C when meropenem is dissolved in sodium chloride;
• 24 hours when stored in a refrigerator (2-8°C) if meropenem is dissolved in sodium chloride;
• If meropenem is dissolved in dextrose, the solution should be used immediately.

From a microbiological point of view, unless the method of opening/reconstitution/dilution excludes the risk of microbiological contamination, the product should be used immediately.

If not used immediately, the storage times and conditions are the responsibility of the user.

Do not freeze the reconstituted solution.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to a pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Meropenem Venus Pharma

The active substance is meropenem trihydrate equivalent to 1,000 mg of anhydrous meropenem.

The other ingredient is anhydrous sodium carbonate {E 500 (I)}.

Appearance of the product and pack contents

Meropenem is a white to slightly yellow crystalline powder for solution for injection and infusion, in a vial.

Pack sizes of 1 vial or 10 vials (Clinical Pack).

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Venus Pharma GmbH,

Am-Bahnhof 1-3,

59368, Werne,

Germany

European Pharma Hub Kft.

Gorcsev Ivan Utca 5, Gyal, 2360,

Hungary

This medicine is authorized in the EEA Member States with the following names:

Netherlands: Meropenem Venus Pharma

Germany: Meropenem Venus Pharma

Italy: Meropenem Venus

United Kingdom: Meropenem

Spain: Meropenem Venus Pharma 1,000 mg powder for solution for injection and infusion EFG

France: Meropenem Venus Pharma

Belgium: Meropenem Venus Pharma

Croatia: Meropenem Ligula Pharma

Romania: Meropenem Antibiotice

Date of last revision of the leaflet: 10/2021

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