Tarsime

Leaflet accompanying the packaging: patient information

Tarsime, 125 mg, coated tablets

Tarsime, 250 mg, coated tablets

Tarsime, 500 mg, coated tablets

Cefuroxime

Read the leaflet carefully before taking 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 taking Tarsime
• 3. How to take Tarsime
• 4. Possible side effects
• 5. How to store Tarsime
• 6. Package contents and other information

1. What is Tarsime and what is it used for

Tarsime is an antibiotic used in adults and children from 3 months of age. 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:

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

Tarsime may also be used:

• to treat early stages of Lyme disease (borreliosis - an infection transmitted by ticks).

2. Important information before taking Tarsime

When not to take Tarsime

• if the patient is allergic (hypersensitive) to cephalosporin antibiotics or any of the other ingredients of Tarsime (listed in section 6);
• 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 skin peeling, blisters, and (or) mouth ulcers after treatment with cefuroxime or other cephalosporin antibiotics.

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If the above circumstances apply to the patient, they 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 are not known.
During treatment with Tarsime, attention should be paid to whether the following complaints occur, such as allergic reactions, fungal infections (e.g. with Candida) and severe diarrhea (pseudomembranous colitis). This will reduce the risk of complications. See “Complaints to watch out for”in section 4.
Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported 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 tests
Tarsime may affect the results of blood sugar tests and the Coombs test. If the patient is to have blood tests, they should:
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tell the person taking the blood sample that 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.

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

Oral contraceptives
Tarsime may reduce the effectiveness of oral contraceptives. If the patient is taking oral contraceptives while taking Tarsime, they should also use mechanical methods of preventing pregnancy (e.g. condoms). In case of doubts, they should contact their doctor.

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 taking this medicine.
The doctor will assess whether the benefits to the patient of taking Tarsime during pregnancy and breastfeeding outweigh the risks to the child.

Driving and using machines

Tarsime may cause dizziness and other side effects that may impair the patient's alertness.
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The patient should not drive or operate machineryif they do not feel well.

Tarsime contains sodium

Tarsime contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered “sodium-free”

3. How to take Tarsime

This medicine should always be taken exactly as advised by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

Recommended dose

Adults

The usual dose of Tarsime is 250 mg to 500 mg twice a day, depending on the severity and type of infection.

Children

The usual dose of Tarsime is 10 mg/kg body weight (not more than 125 mg) to 15 mg/kg body weight (not more than 250 mg) twice a day, depending on:

• the severity and type of infection,
• the child's body weight and age, not more than 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 are not known.
Depending on the disease and the patient's response to treatment, the doctor may change the initial dose or recommend more than one treatment cycle.

Patients with kidney problems

If the patient has kidney problems, the doctor may change the dosage of Tarsime.
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If this applies to the patient, they should tell their doctor.

Method of administration

Tarsime should be taken after a meal. This will help increase the effectiveness of the treatment.
Tarsime tablets should be swallowed whole with water. The tablets should not be chewed, crushed, or divided - this may reduce the effectiveness of the treatment.
In children who cannot swallow tablets, an oral suspension may be used.

Duration of treatment

The duration of treatment will be determined by the doctor, depending on the severity and type of infection. The patient should follow the doctor's instructions.

Taking more Tarsime than prescribed

If the patient takes more Tarsime than prescribed, they may experience neurological disorders, in particular, the risk of seizures (epileptic fits) increases.
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The patient should contact their doctor or call emergency services immediately. If possible, they should show the packaging of Tarsime.

Missing a dose of Tarsime

The patient should not take a double dose to make up for a missed dose. They should take the next dose at the usual time.

Stopping Tarsime treatment

It is important not to shorten the prescribed treatment period with Tarsime. The patient should not stop treatment without their doctor's advice, even if they feel better. Shortening the recommended treatment period may lead to a recurrence of the disease.

4. Possible side effects

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

Complaints to watch out for

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

• Severe allergic reaction. Symptoms include: a raised, itchy rash, swelling, sometimes of the face or lips, which may make breathing difficult.
• Skin rash, which may develop into blisters and look like small rings (a dark spot in the center surrounded by a lighter border with a dark ring around the edge).
• Widespread skin changes with blisters and peeling skin. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis - Lyell's disease).
• Fungal infections. Medicines like Tarsime can cause an overgrowth of Candida in the body, leading to a fungal infection (e.g. thrush). The risk of this side effect is higher if Tarsime is taken for a long time.
• Severe diarrhea(pseudomembranous colitis). Medicines like Tarsime can cause inflammation of the colon (large intestine), leading to severe diarrhea, usually with blood, mucus, abdominal pain, and fever.
• Jarisch-Herxheimer reaction. When taking Tarsime to treat Lyme disease (borreliosis), some patients may experience a high temperature (fever), chills, muscle and headache, and skin rash. This is known as a Jarisch-Herxheimer reaction. These symptoms usually last from a few hours to a day.
• Widespread rash, high body temperature, and swollen lymph nodes(DRESS syndrome or drug hypersensitivity syndrome).
• Chest painassociated with an allergic reaction, which may be a sign of an allergic myocardial infarction (Kounis syndrome).

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

Common side effects (occurring in 1 to 10 in 100 patients)

• fungal infections (e.g. with Candida)
• headache
• dizziness
• diarrhea
• nausea
• stomach pain

Common side effects that may be revealed by blood tests:

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

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

• vomiting
• skin rashes

Uncommon side effects that may be revealed by blood tests:

• decreased platelet count (thrombocytopenia)
• decreased white blood cell count (leukopenia)
• positive Coombs test result

Other side effects

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

• severe diarrhea (pseudomembranous colitis)
• allergic reactions
• skin reactions (including severe ones)
• high temperature (fever)
• yellowing of the whites of the eyes or skin
• liver inflammation

Other side effects that may be revealed by blood tests:

• rapid breakdown of red blood cells (hemolytic anemia).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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 the original packaging to protect from light.
Store at a temperature below 30°C.
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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Tarsime contains

The active substance of Tarsime is: cefuroxime (in the form of cefuroxime axetil).
Tarsime, 125 mg- one tablet contains 125 mg of cefuroxime in the form of cefuroxime axetil.
Tarsime, 250 mg- one tablet contains 250 mg of cefuroxime in the form of cefuroxime axetil.
Tarsime, 500 mg- one tablet contains 500 mg of cefuroxime in the form of cefuroxime axetil.
The other excipients are: sodium croscarmellose, colloidal silica anhydrous, 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

Coated tablets, round, white to cream-colored.
Packaging:
Tarsime, 125 mg, coated tablets
10 coated tablets, in a cardboard box.
Tarsime, 250 mg, coated tablets
10 or 14 coated tablets, in a cardboard box.
Tarsime, 500 mg, coated tablets
10 or 14 coated tablets, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder
Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14
Manufacturer (coated tablets of 125 mg, 250 mg, and 500 mg)
Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Poland
Manufacturer (coated tablets of 250 mg and 500 mg)
PenCef Pharma GmbH
Hildebrandstr. 12
37081 Göttingen
Germany
To obtain more detailed information about this medicine, the patient should contact the marketing authorization holder.
Date of last revision of the leaflet: