Tarsime

Leaflet accompanying the packaging: patient information

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

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

Cefuroxime

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Tarsime and what is it used for
• 2. Important information before using Tarsime
• 3. How to use 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 using Tarsime

When not to use Tarsime:

• if the patient has been diagnosed with an allergy(hypersensitivity) to cefuroxime or another cephalosporin antibioticor any of the other ingredients of Tarsime;
• if the patient has ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotic (penicillins, monobactams or carbapenems);
• if the patient has ever had a severe skin rash or peeling of the skin, blisters, and (or) ulcers in the mouth after treatment with cefuroxime or other cephalosporin antibiotics.
• If the patient thinks they are affected by the above circumstances, they should tell their doctor before

starting to use Tarsime. The patient must not take Tarsime.

Warnings and precautions

During treatment with Tarsime, attention should be paid to whether the following complaints occur, such as allergic reactions and stomach and intestinal disorders (e.g., diarrhea). This will reduce the risk of complications (see "Symptoms to watch out for" in section 4). If the patient has had any allergic reactions to other antibiotics, such as penicillin, they may also be allergic to Tarsime.

Severe, unwanted skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have occurred with cefuroxime treatment. If any of the symptoms associated with severe skin reactions described in section 4 are noticed, medical advice should be sought immediately.

Blood and urine tests

Tarsime may affect the results of tests that detect sugar in urine or blood and a blood test called the Coombs test. If the patient is to have such tests, they should:

• tell the person taking the test samplesthat they are taking Tarsime.

Tarsime and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines that are available without a prescription.

Some medicines may affect the action of Tarsime or increase the risk of side effects. These include:

• antibiotics from the aminoglycoside group
• diuretic tablets(e.g., furosemide)
• probenecid
• oral anticoagulant medicines(anticoagulants). If this applies to the patient, they should tell their doctor. During Tarsime treatment, it may be necessary to perform additional kidney function tests on the patient.

Oral contraceptives

Tarsime may reduce the effectiveness of oral contraceptives. If the patient is taking oral contraceptives during Tarsime treatment, they should also use mechanicalmethods of preventing pregnancy(e.g., condoms). The patient should consult their doctor for advice.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.

The doctor will assess whether the benefits of using Tarsime during pregnancy and breastfeeding outweigh the risks to the child.

Driving and using machines

The patient should not drive or operate machinery if they 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 sodium intake in the diet for adults.

This should be taken into account in patients with reduced kidney function and in patients controlling their sodium intake.

Considering the dosing schedule presented in section 3, the maximum amount of sodium that can be administered to the patient in the maximum daily dose is 308.8 mg, which corresponds to 15.44% of the WHO-recommended maximum daily sodium intake of 2 g 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 sodium intake in the diet for adults.

This should be taken into account in patients with reduced kidney function and in patients controlling their sodium intake.

Considering the dosing schedule presented in section 3, the maximum amount of sodium that can be administered to the patient in the maximum daily dose is 309.2 mg, which corresponds to 15.46% of the WHO-recommended maximum daily sodium intake of 2 g for adults.

3. How to use Tarsime

Tarsime is usually administered by a doctor or nurse.It can be administered as an infusion(intravenous infusion) or as an injectiongiven directly into a vein or muscle.

The recommended dose

The doctor will decide on the appropriate dose of Tarsime for the patient, taking into account the severity and type of infection, the patient's use of any other antibiotics, their body weight, age, and kidney function.

Newborns and infants (0-3 weeks old)

A dose of 30 to 100 mg of Tarsime per kilogram of body weight is administered over 24 hours, divided into two or three doses.

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

A dose of 30 to 100 mg of Tarsime per kilogram of body weight is administered over 24 hours, divided into three or four doses.

Adults and children weighing more than 40 kg

750 mg to 1.5 g of Tarsime per day, administered in two, three, or four divided doses. No more than 6 g per day.

Patients with kidney disease

If the patient has kidney disease, the doctor may change the dosing of Tarsime.

• If this applies to the patient, they should tell their doctor.

4. Possible side effects

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

Symptoms to watch out for

In a small number of people taking Tarsime, an allergic reaction or potentially severe skin reaction has been reported. Their symptoms may be:

• allergic reaction with hives, itching rash, 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 reactions that can be life-threatening, with dizziness, disorientation, and fainting due to insufficient blood flow to the organs;
• angioedema(Quincke's edema) characterized by localized skin and mucous membrane swelling, 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;this may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis - a disease called Lyell's syndrome;
• widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or hypersensitivity syndrome);

bacterial or fungal infection (Clostridioides difficile);

• chest pain associated with an allergic reaction, which can be a sign of a heart attack caused by an allergy (Kounis syndrome).

➢ Profuse and watery diarrhealasting for a longer period, accompanied by fever and abdominal pain; may be a sign of colitis (pseudomembranous colitis).

If the patient experiences any of these symptoms, they should contact their doctor or nurse immediately.

Other side effects that may occur during treatment

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

• pain at the injection site, swelling, and redness along the vein
• increased activity of substances (enzymes) produced in the liver
• change in white blood cell count (neutropenia or eosinophilia)
• decrease in hemoglobin levels in red blood cells.

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

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

Side effects whose frequency cannot be determined from available data:

• fungal or bacterial infection (Clostridioides difficile)
• rapid breakdown of red blood cells (hemolytic anemia)
• decrease in platelet count (thrombocytopenia)
• high fever, vasculitis
• interstitial nephritis (fever, dull pain in the lumbar region), in test results: increased levels of urea and creatinine in blood serum, decreased creatinine clearance.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C, 02-222 Warsaw

Phone: +48 22 49 21 301; fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Tarsime

The medicine should be stored out of 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 given month.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Tarsime contains

The active substance of the medicine is cefuroxime (in the form of 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" Spółka Akcyjna

ul. A. Fleminga 2

03-176 Warsaw

Phone number: 22 811-18-14

To obtain more detailed information about this medicine, the patient should contact the marketing authorization holder.

Date of last revision of the 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. Gently shake until a uniform suspension is obtained.

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 results in a solution with a concentration of 83.3 mg/mL or 100 mg/mL, respectively. Gently shake 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. Gently shake to obtain a clear solution. Infuse into large veins. The infusion should last 30 to 60 minutes.

In accordance with good handling practices, 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.

• Pharmaceutical incompatibilities

Cefuroxime should not be mixed in a syringe with aminoglycoside antibiotics.

Cefuroxime mixed with sodium bicarbonate solutions significantly changes the color of the solution, 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.

To obtain additional information, refer to the Summary of Product Characteristics.

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