Package leaflet: Information for the patient

Cefuroxime Genoptim, 250 mg, film-coated tablets
Cefuroxime Genoptim, 500 mg, film-coated tablets
Cefuroximum
Please read the entire leaflet carefully before use, as it contains important information for the patient.
Keep this leaflet for future reference.
For any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms appear identical.
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

What is Cefuroxime Genoptim and what is it used for
Important information before taking Cefuroxime Genoptim
How to take Cefuroxime Genoptim
Possible side effects
How to store Cefuroxime Genoptim
Contents of the pack and other information

1. What is Cefuroxime Genoptim and what is it used for

Cefuroxime Genoptim contains cefuroxime, an antibiotic used in adults and children.
The medicine works by killing the bacteria causing infection. It belongs to a group of medicines called cephalosporins.
Cefuroxime Genoptim is used to treat infections of:
throat,
sinuses,
middle ear,
lungs or chest,
urinary tract,
skin and soft tissues.
Cefuroxime Genoptim may also be used:
in the treatment of early-stage Lyme disease (borreliosis – an infection transmitted by ticks).
Your doctor may test which type of bacteria caused the infection and may check during treatment whether the bacteria are sensitive to Cefuroxime Genoptim.

2. Information before using Cefuroxime Genoptim

When not to use Cefuroxime Genoptim:
if the patient is allergic to any of the cephalosporin antibiotics or to any of the
other components of Cefuroxime Genoptim (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
oral ulcers after treatment with cefuroxime or other antibiotics from the cephalosporin group.
If any of the above circumstances apply to the patient, the patient should not take Cefuroxime
Genoptim without consulting a doctor.

Warnings and precautions
Cefuroxime Genoptim is not recommended for use in children under 3 months of age,
as the safety and efficacy of the drug have not been established in this age group.
During treatment with Cefuroxime Genoptim, attention should be paid to possible adverse effects such as allergic reactions, fungal infections (e.g. candidiasis) and severe diarrhoea (pseudomembranous colitis). This may reduce the risk of complications. See "Side effects which need attention" in section 4.
Severe skin adverse reactions have been reported during treatment with cefuroxime, including:
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, medical advice should be sought immediately.

Blood tests
Cefuroxime Genoptim may affect the results of blood glucose tests and the blood test known as the Coombs test. If the patient is due to have blood tests, he or she should:
➢ inform the person taking the sample that he or she is taking Cefuroxime Genoptim.

Cefuroxime Genoptim and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has 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 Cefuroxime Genoptim.
Probenecid
Oral anticoagulants
➢ If the patient is taking any of the above (or similar) medicines, he or she should inform the doctor or pharmacist.

Oral contraceptives
Cefuroxime Genoptim may reduce the effectiveness of oral contraceptives. If the patient is taking oral contraceptives during treatment with Cefuroxime Genoptim, additional mechanical methods of contraception (e.g. condoms) should be used. In case of 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 a doctor or pharmacist before using this medicine. The doctor will assess the benefit of using cefuroxime against the potential risk to the foetus or infant.

Driving and operating machinery
Cefuroxime Genoptim may cause dizziness and other adverse effects which may impair the patient's alertness.
➢ The patient should not drive or operate machinery if he or she does not feel well.

3. How to use Cefuroxime Genoptim

This medicine should always be used as directed by a doctor or pharmacist. If in
doubt, contact your doctor or pharmacist again.
Cefuroxime Genoptim should be taken after food. This will help increase the effectiveness of treatment.
Cefuroxime Genoptim tablets should be swallowed whole with water.
Do not chew, crush or split the tablets – this may reduce the effectiveness of treatment.

Recommended dose
Adults
The usual dose of Cefuroxime Genoptim is 250 mg to 500 mg twice daily, depending on the severity and type of infection.

Children
The usual dose of Cefuroxime Genoptim is 10 mg/kg body weight (not more than 125 mg) to 15 mg/kg body weight (not more than 250 mg) twice daily, depending on the severity and type of infection.
Cefuroxime Genoptim is not recommended for use in children under 3 months of age,
as the safety and efficacy of the medicine have not been established in this age group.

Depending on the disease and the patient's response to treatment, the initial dose may be adjusted or more than one treatment course may be required.

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, he or she should inform the doctor.

Taking more than the recommended dose of Cefuroxime Genoptim
If the patient has taken more than the recommended dose of Cefuroxime Genoptim, neurological disturbances may occur, particularly an increased risk of seizures (epileptic fits).
➢ Seek immediate medical advice or call emergency services. If possible, show the packaging of Cefuroxime Genoptim.

Missing a dose of Cefuroxime Genoptim
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

Stopping Cefuroxime Genoptim
Do not stop taking Cefuroxime Genoptim unless instructed by a doctor.
It is important not to shorten the prescribed duration of treatment with Cefuroxime Genoptim. Do not stop treatment without medical advice, even if the patient feels better. Shortening the recommended treatment period may lead to recurrence of the illness.

Cefuroxime Genoptim contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Symptoms to be aware of
In a small number of people taking Cefuroxime Genoptim, an allergic reaction or potentially severe skin reaction has been reported. Symptoms may include:
Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or mouth, which may make breathing difficult.
Skin rash, which may develop into blisters and appear as target-like lesions (a dark spot in the centre surrounded by a paler ring and a dark rim around the edge).
Widespread skin lesions with blisters and peeling of the outer layer of skin (this may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis).
Fungal infections. Medicines such as Cefuroxime Genoptim may cause overgrowth of yeast ( Candida ) in the body, leading to fungal infection (e.g. thrush). The risk of this side effect is higher if Cefuroxime Genoptim is used for a prolonged period.
Severe diarrhoea (pseudomembranous colitis). Medicines such as Cefuroxime Genoptim may cause inflammation of the colon (large intestine), resulting in severe diarrhoea, usually with blood and mucus, abdominal pain and fever.
Jarisch-Herxheimer reaction. During treatment with Cefuroxime Genoptim for Lyme disease, some patients may experience high temperature (fever), chills, muscle and headache, and skin rash. This is known as 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 symptom of an allergic heart attack (Kounis syndrome).
➢ If any of these symptoms occur in a patient, contact a doctor or nurse immediately.
Common side effects (may occur in up to 1 in 10 patients):
fungal infections (e.g. candidiasis),
headache,
dizziness,
diarrhoea,
nausea,
stomach pain.
Common side effects that may be revealed in blood tests:
increased number of white blood cells (eosinophilia),
increased liver enzyme activity.
Uncommon side effects (may occur in up to 1 in 100 patients):
vomiting,
skin rashes.
Uncommon side effects that may be revealed in blood tests:
decreased number of platelets (cells involved in blood clotting),
decreased number of white blood cells (leukopenia),
positive Coombs test.
Other side effects
Other side effects occur in a very small number of patients, but the exact frequency is unknown:
severe diarrhoea (pseudomembranous colitis),
allergic reactions,
skin reactions (including severe ones),
high temperature (fever),
yellowing of the whites of the eyes or skin,
liver inflammation.
Side effects that may be revealed in blood tests:
excessive breakdown of red blood cells (haemolytic anaemia).
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Cefuroxime Genoptim

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the specified month.
Store below 25 °C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Cefuroxime Genoptim contains
The active substance is cefuroxime (in the form of cefuroxime axetil). Each coated tablet contains either 250 mg or 500 mg of cefuroxime.
The other ingredients are: microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, colloidal anhydrous silica, calcium stearate, calcium carbonate, crospovidone type A, hypromellose 6 cP, titanium dioxide (E 171), propylene glycol, brilliant blue FCF (E 133), lake no. 1 (11%-13%), brilliant blue FCF (E 133), lake no. 1 (28%-31%).

What Cefuroxime Genoptim looks like and contents of the pack
Cefuroxime Genoptim, 250 mg
Blue, capsule-shaped, film-coated tablets, biconvex, with "204" embossed on one side and smooth on the other.
Aluminium/Aluminium foil blisters containing 2, 6, 10, 12, 14, 15, 20, 24 or 50 tablets, packed in a cardboard box.

Cefuroxime Genoptim, 500 mg
Blue, capsule-shaped, film-coated tablets, biconvex, with "203" embossed on one side and smooth on the other.
Aluminium/Aluminium foil blisters containing 2, 6, 10, 12, 14, 15, 20, 24 or 50 tablets, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Poland

Importer:
Tecnimede - Sociedade Técnico-Medicinal S.A.
Quinta da Cerca, Caixaria
2565-187 Dois Portos
Portugal

Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
Poland

Interpharma Services Ltd.
43A Cherni Vrach Blvd
1407 Sofia
Bulgaria

Ascend GmbH
Sebastian-Kneipp-Straße 41
60439 Frankfurt am Main
Germany