Package leaflet: Information for the patient

Cefuroxime Genoptim, 500 mg, film-coated tablets
Cefuroximum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
Keep this leaflet, so that you can read it again if necessary.
If you have any further questions, please consult your doctor, pharmacist, or
nurse.
This medicine has been prescribed for a specific individual. 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 adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

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

2. Important 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, peeling of the skin, blisters and
(or) mouth ulcers after treatment with cefuroxime or other antibiotics from the
cephalosporin group.
If any of the above conditions 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 medicine in this age group have not been established.
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 will help reduce the risk of complications. See
"Side effects that require attention" in section 4.
Serious skin adverse reactions, including 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 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, they should:
➢ Inform the person taking the sample for testing that they are 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, including medicines obtained without a prescription.
Medicines that reduce stomach acid (e.g. antacids used to treat heartburn) may affect the action of Cefuroxime Genoptim.
Probenecid
Oral anticoagulant medicines
➢ If the patient is taking any of the above (or similar) medicines, they should inform their
doctor or pharmacist.

Oral contraceptives
Cefuroxime Genoptim may reduce the effectiveness of oral contraceptives. If the patient is taking oral contraceptives while using Cefuroxime Genoptim, 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 or pharmacist before using this medicine. The doctor will assess the benefit of using cefuroxime versus the potential risk to the unborn or nursing child.

Driving and operating machinery
Cefuroxime Genoptim 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.

3. How to use Cefuroxime Genoptim

This medicine should always be used exactly as directed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist again.
Cefuroxime Genoptim should be taken after a meal. This will help increase the effectiveness of treatment.
Cefuroxime Genoptim tablets should be swallowed whole with water.
Do not chew, crush, or divide 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 exceeding 125 mg) to 15 mg/kg body weight (not exceeding 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, the patient should inform the doctor.

Taking more than the recommended dose of Cefuroxime Genoptim
If a patient takes 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 treatment
Do not stop taking Cefuroxime Genoptim unless advised by your doctor.
It is important not to shorten the prescribed duration of treatment with Cefuroxime Genoptim. Do not discontinue 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 it is considered "sodium-free".

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Symptoms to be aware of
A small number of people taking Cefuroxime Genoptim 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, which may develop into blisters and look like small targets (a dark spot in the centre surrounded by a paler ring with a dark rim around the edge).
Widespread skin lesions with blisters and peeling 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 yeasts (Candida) in the body, which may lead to fungal infection (e.g. thrush). The risk of this side effect is higher if Cefuroxime Genoptim is used for a long time.
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. When Cefuroxime Genoptim is used to treat 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Chest pain associated with an allergic reaction, which may be a symptom of an allergy-induced heart attack (Kounis syndrome).
➢ If any of these symptoms occur in the patient, contact a doctor or nurse immediately.
Common side effects (may occur in up to 1 in 10 patients):
fungal infections (e.g. by yeasts),
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, tell 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 authorization 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 the 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 stated 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. These measures will 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 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, 500 mg
Blue, capsule-shaped, film-coated tablets, biconvex, with "203" embossed on one side of the tablet and smooth on the other side.
Aluminium/Aluminium foil blisters containing 2, 6, 10, 12, 14, 15, 20, 24 and 50 tablets, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Alliance Pharma Sp. z o.o.
Żeromskiego 3/1
01-887 Warsaw
Poland

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