Tarcefandol

Package Leaflet: Information for the Patient

TARCEFANDOL, 1 g, powder for solution for injection

Cefamandol

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

• 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 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 those not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Tarcefandol and what is it used for

Tarcefandol contains the active substance cefamandol. Cefamandol is an antibiotic belonging to the group of cephalosporins, similar to penicillins.
Tarcefandol is used to treat the following infections caused by bacteria susceptible to this medicine:

• lower respiratory tract infections;
• urinary tract infections;
• peritonitis;
• septicaemia;
• skin and soft tissue infections;
• bone and joint infections;
• prevention of postoperative infections.

2. Important information before using Tarcefandol

When not to use Tarcefandol

If you are allergic (hypersensitive) to cefamandol or other cephalosporin antibiotics.

Warnings and precautions

Before starting treatment with Tarcefandol, tell your doctor if you have ever had an allergic reaction to any antibiotic, or if you have had any other allergic reaction or asthma.

• if you have ever had kidney problems;
• if you have ever had colitis (inflammation of the colon) or any other serious gastrointestinal disease;
• if you have a vitamin K deficiency (mainly in elderly or weakened patients).

Tell your doctor if you experience any of the following during treatment:

• sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching (symptoms of an allergic reaction);
• severe and persistent diarrhoea;
• a new infection (e.g. thrush).

Tarcefandol and other medicines Tell your doctor or nurse about all medicines you are taking, have recently taken, or might take.

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

• probenecid (used to treat gout);
• aminoglycoside antibiotics, such as amikacin, streptomycin, or neomycin.

Effect on laboratory tests
Tarcefandol may affect the results of urine tests for sugar, performed using a non-enzymatic method. If you have diabetes and regularly perform urine tests, you should inform your doctor. During treatment with Tarcefandol, it may be necessary to use other tests to monitor your diabetes.

Tarcefandol and alcohol

Do not drink alcohol while taking Tarcefandol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Tarcefandol should only be used in pregnant women if the doctor considers it essential.
If you are taking Tarcefandol and breastfeeding, be cautious.

Driving and using machines

There is no information on the negative effect of Tarcefandol on the ability to drive or use machines.

3. How to use Tarcefandol

Use Tarcefandol exactly as your doctor has told you.
If you are not sure, ask your doctor.
Tarcefandol is administered by a doctor or nurse.

Route and method of administration

Tarcefandol, powder for solution for injection, after reconstitution as described at the end of the leaflet, in the section "Information intended for healthcare professionals only", can be administered:

• by intravenous injection, administered over approximately 3 to 5 minutes,
• by intravenous infusion,
• by intramuscular injection.

The dose recommended by your doctor depends on the type and severity of the infection, as well as your body weight and kidney function. Your doctor will provide further explanations.

Usual doses Adults

Usually administered intravenously or intramuscularly 500 mg to 1 g every 4 to 8 hours.
In severe infections, 2 g can be administered every 4 hours (up to a maximum of 12 g per day).
Infants and children
Usually administered 50 to 100 mg/kg body weight per day in divided doses every 4 to 8 hours;Prophylaxis of postoperative infections
Adults – 1 g to 2 g intravenously or intramuscularly 30 minutes to 1 hour before surgery, and then 1 g to 2 g every 6 hours for 24 to 48 hours.
Children – 50 to 100 mg/kg body weight per day in divided doses every 4 to 8 hours.
Dosing in patients with impaired renal function
Your doctor will adjust the dose according to your kidney function, as described at the end of the leaflet, in the section "Information intended for healthcare professionals only"

Duration of treatment

The duration of treatment is decided by your doctor.

Using more Tarcefandol than prescribed

Since the medicine is administered by a doctor or nurse, it is unlikely that you will be given too much. However, if you think you have been given too much, contact your doctor or nurse immediately or go to the nearest hospital emergency department. Take the medicine package with you so that the staff can check what medicine has been used.

Missing a dose of Tarcefandol

Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Tarcefandol

It is important to use the medicine according to the recommended treatment cycle. Do not stop treatment because you feel better. If the treatment cycle is stopped too early, the infection may return.
If you feel worse during treatment or do not feel well after completing the recommended treatment cycle, contact your doctor.

• If you have any further questions about using this medicine, ask your doctor.

4. Possible side effects

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

Severe side effects

Occurring very rarely(less than 1 in 10,000 patients)

• allergic reactions: fever, sudden shortness of breath and chest tightness, swelling of the eyelids, face or lips, loss of consciousness (fainting).

Occurring rarely(between 1 in 10,000 and 1 in 1,000 patients)

• severe and persistent diarrhoea, which may be bloody, accompanied by abdominal pain or fever. This may be a sign of a serious condition called pseudomembranous colitis, which can occur after taking antibiotics.

Occurring with unknown frequency(frequency cannot be estimated from available data)

• severe skin rashes, which may be accompanied by blistering of the eyes, mouth, throat, and genitals.
• If you experience any of the above severe side effects, stop using the medicine and immediatelyinform your doctor or go to the nearest hospital emergency department.

Other side effects that may occur when using Tarcefandol

Occurring not very commonly(between 1 in 1,000 and 1 in 100 patients)

• pain at the injection site after intramuscular injection.

Occurring rarely(between 1 in 10,000 and 1 in 1,000 patients)

• skin and mucous membrane fungal infections;
• decreased platelet count, decreased white blood cell count;
• nausea, vomiting;
• transient hepatitis, jaundice;
• thrombophlebitis and pain at the injection site after intravenous injection.

Occurring with unknown frequency(frequency cannot be estimated from available data)

• genital and anal itching;
• mild, transient changes in blood test results used to monitor liver function;
• false-positive results of direct Coombs tests.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, e-mail: [email protected]. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tarcefandol

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Protect from light.
Do not use the 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 Tarcefandol contains

The active substance is cefamandol in the form of a nafate.
One vial contains 1 g of cefamandol.
The medicine does not contain any other ingredients.

What Tarcefandol looks like and contents of the pack

White to light cream-coloured powder.

Packaging

1 vial in a cardboard box.

Marketing authorisation 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, please contact the marketing authorisation holder's representative.

Date of last revision of the leaflet:

Information intended for healthcare professionals only

Dosing in patients with impaired renal function

Instructions for preparing the solution for injection Intramuscular injection

Dissolve the contents of the 1 g vial in approximately 3 ml of water for injection or 0.9% sodium chloride solution.
Administer the prepared solution deep into a large muscle.
Intravenous injection
Dissolve the contents of the 1 g vial in 10 ml of water for injection, 0.9% sodium chloride solution, or 5% glucose solution.
Administer slowly - 3 to 5 minutes - into a large peripheral vein.
Intravenous infusion
Dissolve the contents of the 1 g vial in 10 ml of water for injection, and then add an appropriate amount of infusion fluid (e.g. 0.9% sodium chloride solution, 5% glucose solution).
The choice of infusion fluid and its volume depends on the principles of fluid and electrolyte management.
Cefamandol solutions should be administered immediately after preparation.

Incompatibilities

Cefamandol should not be mixed in the same syringe with other medicines.