Tarsime

Package leaflet: information for the patient

Tarsime, 125 mg, film-coated tablets
Tarsime, 250 mg, film-coated tablets
Tarsime, 500 mg, film-coated tablets
Cefuroximum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Tarsime is and what it is 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 Tarsime is and what it is used for

Tarsime is an antibiotic used in adults and children aged 3 months and older. It works
by destroying bacteria sensitive to cefuroxime that cause infections. It belongs to a group
of medicines called cephalosporins.
Tarsime is used to treat infections of:

• throat
• sinuses
• middle ear
• lungs or chest
• urinary tract
• skin and soft tissues.

Tarsime may also be used:

• in the treatment of early-stage Lyme disease (Lyme borreliosis – an infection transmitted by ticks).

2. Important information before using Tarsime

When not to use Tarsime

• if the patient is allergic (hypersensitive) to cephalosporin antibiotics or to any of the other ingredients of Tarsime (listed in section 6);
• if the patient has ever experienced a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotics (penicillins, monobactams or carbapenems);
• if the patient has ever developed severe skin rash, skin peeling, blisters and (or) mouth ulcers after treatment with cefuroxime or other cephalosporin antibiotics.

➢ If any of the above situations apply, the patient should not take Tarsime
without consulting a doctor.
Warnings and precautions
Tarsime is not recommended for use in children under 3 months of age, as the safety and efficacy of the medicine in this age group have not been established.
During treatment with Tarsime, be alert for symptoms such as allergic reactions, fungal infections (e.g. candidiasis) and severe diarrhoea (pseudomembranous colitis). This will help reduce the risk of complications. See “Symptoms to be aware of” in section 4.
Serious severe skin reactions have been reported during treatment with cefuroxime, such as:
Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). If any of the symptoms associated with severe skin reactions described in section 4 occur, seek immediate medical advice.
Blood tests
Tarsime may affect the results of blood sugar tests and the blood test known as the Coombs test. If the patient is to undergo blood tests, they should:
➢ inform the person collecting the sample that they are taking Tarsime.
Tarsime and other medicines
Tell your doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. This includes medicines available without a prescription.

• Medicines that reduce stomach acid (e.g. antacids used to treat heartburn) may affect the action of Tarsime.
• Probenecid (a medicine used for gout and other conditions).
• Oral anticoagulants (medicines that reduce blood clotting).
  ➢ If the patient is taking any of the above (or similar) medicines, they should inform their doctor.

Oral contraceptives
Tarsime may reduce the effectiveness of oral contraceptives. If a patient is taking oral contraceptives while using Tarsime, additional mechanical methods of contraception (e.g. condoms) should be used. If in doubt, consult a doctor.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
The doctor will assess whether the benefits to the patient from using Tarsime during pregnancy and breastfeeding outweigh the risks to the child.
Driving and operating machinery
Tarsime may cause dizziness and other adverse effects that may impair the patient's alertness.
➢ The patient should not drive or operate machinery if they do not feel well.
Tarsime contains sodium
Tarsime contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free."

3. How to use Tarsime

This medicine should always be used according to the instructions given by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
Recommended dose
Adults
The usual dose of Tarsime is 250 mg to 500 mg twice daily,
depending on the severity and type of infection.
Children
The usual dose of Tarsime is 10 mg/kg body weight (not exceeding 125 mg) to
15 mg/kg body weight (not exceeding 250 mg) twice daily, depending on:

• the severity and type of infection,
• the child's body weight and age, not exceeding 500 mg per day.

Tarsime is not recommended for use in children under 3 months of age, as the safety and efficacy of the medicine in this age group have not been established.
Depending on the disease and how the patient responds to treatment, the doctor may adjust the initial dose or recommend more than one treatment cycle.
Patients with kidney problems
If the patient has impaired kidney function, the doctor may adjust the dosage of the medicine.
➢ If this applies to the patient, they should inform their doctor.
Method of administration
Tarsime should be taken after a meal. This will help increase the effectiveness of treatment.
Tarsime tablets should be swallowed whole with water. The tablets must not be chewed, crushed, or divided – doing so may reduce the effectiveness of treatment.
For children who cannot swallow tablets, an oral suspension formulation of the product may be used.
Duration of treatment
The duration of treatment will be determined by the doctor depending on the severity and type of infection. You must follow the doctor's instructions.
Taking more Tarsime than recommended
If the patient takes more Tarsime than recommended, neurological disturbances may occur, in particular an increased risk of seizures (epileptic fits).
➢ Seek immediate medical advice or call emergency services. If possible, show the medicine packaging to the healthcare provider.
Missed dose of Tarsime
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Stopping Tarsime treatment
It is important not to shorten the prescribed duration of Tarsime treatment. Do not stop treatment without consulting your doctor, even if the patient feels better. Shortening the recommended treatment period may lead to recurrence of the disease.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Symptoms to be aware of
A small number of people taking Tarsime have experienced an allergic reaction or potentially severe
skin reaction. Symptoms may include:

• Severe allergic reaction. Symptoms include raised, itchy rash, swelling, sometimes of the face or lips, which may make breathing difficult.
• Skin rash that may develop into blisters and look like small rings (a dark spot in the middle surrounded by a lighter ring with a dark edge).
• Widespread skin lesions with blisters and peeling skin. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis - Lyell's disease).
• Fungal infections. Medicines such as Tarsime may cause an overgrowth of yeast (Candida) in the body, which may lead to fungal infection (e.g. candidiasis). The risk of this adverse reaction is higher if Tarsime is used for a prolonged period.
• Severe diarrhoea (pseudomembranous colitis). Medicines such as Tarsime may cause inflammation of the colon (large intestine), resulting in severe diarrhoea, usually with blood, mucus, abdominal pain and fever.
• Jarisch-Herxheimer reaction. When Tarsime is used to treat Lyme disease, some patients may experience high temperature (fever), chills, muscle and joint pain, and skin rash. This is known as a Jarisch-Herxheimer reaction. These symptoms usually last from several hours to one day.
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Chest pain associated with an allergic reaction, which may be a sign of allergy-induced heart attack (Kounis syndrome).

➢ If any of these symptoms occur in a patient, contact a doctor or nurse immediately.
Common adverse reactions (occurring in 1 to 10 out of 100 patients)

• fungal infections (e.g. candidiasis)
• headache
• dizziness
• diarrhoea
• nausea
• stomach pain

Common adverse reactions that may be revealed in blood tests:

• increased white blood cell count (eosinophilia)
• increased liver enzyme activity

Uncommon adverse reactions (occurring in 1 to 10 out of 1,000 patients)

• vomiting
• skin rashes

Uncommon adverse reactions that may be revealed in blood tests:

• decreased platelet count (cells involved in blood clotting)
• decreased white blood cell count (leukopenia)
• positive Coombs test

Other adverse reactions
Other adverse reactions occur in a very small number of patients, but the exact frequency is unknown:

• severe diarrhoea (pseudomembranous colitis)
• allergic reactions
• skin reactions (including severe)
• high temperature (fever)
• yellowing of the whites of the eyes or skin
• hepatitis

Other adverse reactions that may be revealed in blood tests:

• excessive breakdown of red blood cells (haemolytic anaemia).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Tarsime

Keep this medicine out of sight and reach of children.
Store in the original packaging to protect from light.
Store below 30ºC.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must 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 package and other information

What Tarsime contains
The active substance is: cefuroxime (as cefuroxime axetil).
Tarsime, 125 mg – one tablet contains 125 mg of cefuroxime as cefuroxime axetil.
Tarsime, 250 mg – one tablet contains 250 mg of cefuroxime as cefuroxime axetil.
Tarsime, 500 mg – one tablet contains 500 mg of cefuroxime as cefuroxime axetil.

The other ingredients are: sodium croscarmellose, anhydrous colloidal silica, microcrystalline cellulose type 101, microcrystalline cellulose type 102, sodium lauryl sulfate, calcium carbonate, sodium stearyl fumarate, hypromellose, propylene glycol, titanium dioxide (E 171), talc.
Tarsime contains sodium (see section 2).

What Tarsime looks like and contents of the pack
Film-coated tablets, round, white to cream in colour.

Packaging:
Tarsime, 125 mg, film-coated tablets
10 film-coated tablets in a cardboard box.
Tarsime, 250 mg, film-coated tablets
10 or 14 film-coated tablets in a cardboard box.
Tarsime, 500 mg, film-coated tablets
10 or 14 film-coated tablets in a cardboard box.

Marketing Authorisation Holder
Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warszawa
Telephone number: 22 811-18-14

Manufacturer (film-coated tablets 125 mg, 250 mg and 500 mg)
Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warszawa
Poland

Manufacturer (film-coated tablets 250 mg and 500 mg)
PenCef Pharma GmbH
Hildebrandstr. 12
37081 Göttingen
Germany

For more detailed information on this medicinal product, please contact the marketing authorisation holder.