Tarsime

Package Leaflet: Information for the Patient

TARSIME, 750 mg, powder for solution for injection or infusion

TARSIME, 1500 mg, powder for solution for injection and infusion

Cefuroxime

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

• 1. What is Tarsime and what is it used for
• 2. Important information before taking Tarsime
• 3. How to take Tarsime
• 4. Possible side effects
• 5. How to store Tarsime
• 6. Contents of the pack and other information

1. What is Tarsime and what is it used for

Tarsime is an antibiotic used in adults and children. The medicine works by killing bacteria sensitive to cefuroxime that cause infections. It belongs to a group of medicines called cephalosporins.

Tarsime is used to treat infections of:

• the lungs or chest,
• the urinary system,
• the skin and soft tissues,
• the abdomen.

Tarsime is also used:

• to prevent infections during surgery.

2. Important information before taking Tarsime

When not to take Tarsime:

• if you are allergic (hypersensitive) to cefuroxime or any other cephalosporin antibiotic or any of the other ingredients of Tarsime;
• if you have ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotic (penicillins, monobactams or carbapenems);
• if you have ever had a severe skin rash or blistering of the skin, or peeling and (or) mouth sores after taking cefuroxime or other cephalosporin antibiotics.
• If you think any of these apply to you, tell your doctor before taking Tarsime. You should not take Tarsime.

before starting treatment with Tarsime. You must not take Tarsime.

Warnings and precautions

During treatment with Tarsime, pay attention to whether you experience any symptoms such as allergic reactions and stomach and gut disturbances (e.g. diarrhea). This will reduce the risk of complications (see "Symptoms to watch for" in section 4). If you have had allergic reactions to other antibiotics, such as penicillin, you may also be allergic to Tarsime. Severe, potentially life-threatening skin reactions have been reported with cefuroxime, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). If you notice any of the symptoms associated with severe skin reactions described in section 4, seek medical advice immediately.

Blood and urine tests

Tarsime may affect the results of tests for sugar in the urine or blood, and a blood test called the Coombs test. If you are going to have these tests, you should:

• tell the person taking the samplethat you are taking Tarsime.

Tarsime and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, and about any medicines you plan to take. This includes medicines that you can buy without a prescription. Some medicines may affect the action of Tarsime or increase the risk of side effects. These include:

• aminoglycoside antibiotics
• diuretics (water tablets), e.g. furosemide
• probenecid
• oral anticoagulants (blood thinners). If this applies to you, tell your doctor. You may need to have extra checks on your kidney function while taking Tarsime.

Oral contraceptives

Tarsime may reduce the effectiveness of oral contraceptives. If you are taking oral contraceptives while taking Tarsime, you should also use mechanical methods of contraception(e.g. condoms). Ask your doctor for advice.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine. Your doctor will assess whether the benefits of taking Tarsime during pregnancy and breastfeeding outweigh the risks to the baby.

Driving and using machines

You should not drive or operate machinery if you do not feel well.

Tarsime, 750 mg contains 38.6 mg of sodium (the main component of common salt) per vial.

This corresponds to 1.93% of the maximum recommended daily intake of sodium in the diet for adults. This should be taken into account in patients with reduced kidney function and in patients on a controlled sodium diet. Considering the dosing schedule presented in section 3, the maximum amount of sodium that can be administered to a patient in the maximum daily dose is 308.8 mg, which corresponds to 15.44% of the WHO-recommended maximum daily intake of 2 g of sodium for adults.

Tarsime, 1500 mg contains 77.3 mg of sodium (the main component of common salt) per vial.

This corresponds to 3.86% of the maximum recommended daily intake of sodium in the diet for adults. This should be taken into account in patients with reduced kidney function and in patients on a controlled sodium diet. Considering the dosing schedule presented in section 3, the maximum amount of sodium that can be administered to a patient in the maximum daily dose is 309.2 mg, which corresponds to 15.46% of the WHO-recommended maximum daily intake of 2 g of sodium for adults.

3. How to take Tarsime

Tarsime is usually given by a doctor or nurse.It can be given as an infusion (intravenous infusion)or as an injectiondirectly into a vein or muscle. The recommended dose will be decided by your doctor, taking into account the severity and type of infection, any other antibiotics you are taking, your body weight, age, and kidney function.

Newborns and infants (0-3 weeks old)

The dose is 30-100 mg of Tarsime per kilogram of body weight per day, divided into two or three doses.

Infants (over 3 weeks old) and children weighing less than 40 kg

The dose is 30-100 mg of Tarsime per kilogram of body weight per day, divided into three or four doses.

Adults and children weighing over 40 kg

750 mg to 1.5 g of Tarsime per day, divided into two, three, or four doses. Not more than 6 g per day.

Patients with kidney problems

If you have kidney problems, your doctor may change the dose of Tarsime.

• If this applies to you, tell your doctor.

4. Possible side effects

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

Symptoms to watch for

A small number of people taking Tarsime have reported an allergic reaction or potentially serious skin reaction. The symptoms may be:

• allergic reaction with rash, itching, low blood pressure, swelling of the upper airways, sometimes of the face or mouth, which can make breathing difficult, including anaphylaxis, anaphylactic shock - rapidly progressing, life-threatening reactionswith dizziness, disorientation, and fainting due to insufficient blood flow to the organs;
• angioedema (Quincke's edema)characterized by localized swelling of the skin and mucous membranes, which can be life-threatening if it occurs in the throat or larynx;
• widespread skin changes (pink spots on the skin of the limbs and inside the mouth)with blisters and peeling skin;may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis - Lyell's syndrome;
• widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or hypersensitivity syndrome);

bacterial or fungal infection;

• severe hemolysis (breakdown of red blood cells),
• thrombocytopenia (low platelet count),
• high fever, vasculitis (inflammation of blood vessels),
• interstitial nephritis (kidney inflammation), with fever, dull pain in the kidney area, and changes in laboratory tests: increased levels of urea and creatinine in the blood, decreased creatinine clearance.

If you experience any of these symptoms, contact your doctor or nurse immediately.

Other side effects that may occur during treatment

Frequent side effects (in 1 to 10 per 100 patients):

• pain, swelling, and redness at the injection site
• increased activity of liver enzymes
• changes in white blood cell count (neutropenia or eosinophilia)
• decreased hemoglobin levels in red blood cells.

Uncommon side effects (in 1 to 10 per 1,000 patients):

• skin rash, urticaria, and itching
• leukopenia (low white blood cell count)
• gastrointestinal disorders
• increased bilirubin levels (a substance produced by the liver)
• positive Coombs test result.

Side effects with unknown frequency:

• fungal or bacterial infection (Clostridioides difficile),
• hemolytic anemia (rapid breakdown of red blood cells),
• thrombocytopenia (low platelet count),
• high fever, vasculitis (inflammation of blood vessels),
• interstitial nephritis (kidney inflammation), with fever, dull pain in the kidney area, and changes in laboratory tests: increased levels of urea and creatinine in the blood, decreased creatinine clearance.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301; fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tarsime

Keep the medicine out of the sight and reach of children. Store in a temperature below 25°C. Store in the original packaging to protect from light. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tarsime contains

The active substance is cefuroxime (as cefuroxime sodium). Tarsime, 750 mg- one vial contains 750 mg of cefuroxime. Tarsime, 1500 mg- one vial contains 1500 mg of cefuroxime. Tarsime contains sodium (see section 2).

What Tarsime looks like and contents of the pack

White or almost white powder. Packaging: one vial in a cardboard box.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A., ul. A. Fleminga 2, 03-176 Warsaw, Phone: 22 811-18-14. For more detailed information on this medicine, please contact the marketing authorization holder.

Date of last revision of the package leaflet:

Information intended for healthcare professionals only

• Preparation of solutions

Intramuscular injections

Add 4 mL of water for injections to the vial containing 750 mg of cefuroxime. Shake gently to obtain a uniform suspension.

Intravenous injections

Add approximately 9 mL or 15 mL of water for injections to the vial containing 750 mg or 1500 mg of cefuroxime, respectively. This gives a solution with a concentration of 83.3 mg/mL or 100 mg/mL, respectively. Shake gently to obtain a clear solution. Inject slowly over 3 to 5 minutes.

Intravenous infusions

Cefuroxime solutions prepared as for intravenous injections should be diluted to a volume of 50 to 100 mL with water for injections, 5% glucose solution, or 0.9% sodium chloride solution. Shake gently to obtain a clear solution. Administer through a large vein. The infusion should last 30 to 60 minutes. In accordance with good practice, solutions should be administered immediately after preparation. If the solution is not used immediately after preparation, the user is responsible for the storage time and conditions. The solution or suspension retains its stability at a temperature of 2°C to 8°C (in a refrigerator) for 24 hours, provided that the preparation of the solution is carried out under controlled aseptic conditions. A change in the color of the solutions to yellow or amber does not affect the activity or properties of the product.

• Incompatibilities

Cefuroxime should not be mixed in a syringe with aminoglycoside antibiotics. Cefuroxime mixed with sodium bicarbonate solutions changes the color of the solution significantly, so it is not recommended to use it to dilute cefuroxime solutions. If necessary, a cefuroxime solution in water for injections can be introduced into the infusion line of a patient receiving a sodium bicarbonate infusion.

For further information, please refer to the Summary of Product Characteristics.

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