MEROPENEM VENUS PHARMA 2000 mg POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

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

Consult 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 test positive (Coombs test) for 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 occurs, talk to your doctor or nurse immediately so that they can treat the symptoms.

If you are unsure whether 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 sodium valproate.
• Oral anticoagulant agent (used to treat or prevent blood clots).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 breastfeeding or plan to breastfeed before receiving meropenem. Small amounts of this medicine may pass into breast milk. Therefore, your doctor will decide whether you should use meropenem during breastfeeding.

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 of 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 cause the body to 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 180.4 mg of sodium (main component of cooking/table salt) per 2,000 mg dose. This is equivalent to 9.0% of the maximum recommended daily sodium intake 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 the instructions for administration of this medicine exactly as indicated 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 affected, 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 administered to you as an injection or infusion into a large vein.
• Normally, your doctor or nurse will administer meropenem to you.
• 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 the instructions for administration of meropenem exactly as indicated by your doctor. Consult your doctor if you have any doubts.
• Your injection must not be mixed or added to solutions that contain other medicines.
• The injection can take approximately 5 minutes or between 15 and 30 minutes. Your doctor will indicate how to administer meropenem.
• Normally, injections should be administered 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 missed dose. 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 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.

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:

• Sudden 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 difficulty 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 eosinophils, and swollen lymph nodes. These can be signs of a multi-organ sensitivity disorder known as DRESS syndrome.
  • Severe red and scaly rash, skin bumps containing pus, blisters, or skin peeling, which can be associated with high fever and joint pain.
  • Severe skin reactions that can appear as circular reddish patches often with central blisters on the trunk, skin peeling, 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).

Damage to red blood cells (frequency not known)

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 pain).
• Feeling sick (nausea).
• Being sick (vomiting).
• Diarrhea.
• Headache.
• Skin rash, itching.
• Pain and inflammation.
• Increased platelet count in the blood (checked in a blood test).
• Changes in blood tests, including those that show how your liver is working.

Uncommon (may affect up to 1 in 100 people)

• Changes in the blood. These include reduced platelet count (which can make you bruise more easily), increased count of some white blood cells, decreased count of other white blood cells, and increased amount of a substance called "bilirubin". Your doctor may perform periodic blood tests.
• Changes in blood tests, including those that show how your kidneys are working.
• Tingling sensation (paresthesia).
• 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. Symptoms include frequent infections, fever, and sore throat. Your doctor may perform periodic blood tests.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: 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 interval between the start of reconstitution and the end of intravenous injection must 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 interval between the start of reconstitution and the end of intravenous infusion must 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 precludes the risk of microbiological contamination, the product should be used immediately.

If not used immediately, the in-use 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. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition of Meropenem Venus Pharma

The active ingredient is meropenem trihydrate equivalent to 2000 mg of anhydrous meropenem.

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

Appearance of the Product and Container Content

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

Container sizes are 1 vial or 10 vials (Clinical Packaging).

Only some container 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 Medication is Authorized in EEE Member States with the Following Names:

Netherlands:Meropenem Venus Pharma

Germany:Meropenem Venus Pharma

Italy: Meropenem Venus

United Kingdom: Meropenem

Spain: Meropenem Venus Pharma 2000 mg powder for injectable and infusion solution

France: Meropenem Venus Pharma

Belgium: Meropenem Venus Pharma

Croatia:Meropenem Ligula Pharma

Romania:Meropenem Antibiotice

Date of the Last Revision of the Leaflet: 10/2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/