Cefuroxime Genoptim

Package Leaflet: Information for the Patient

Cefuroxime Genoptim, 250 mg, Film-Coated Tablets

Cefuroxime Genoptim, 500 mg, Film-Coated Tablets

Cefuroxime

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

Keep this package leaflet, you may need to read it again.
In case of any doubts, consult a doctor or pharmacist, or
nurse.
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 those not listed in this package leaflet, they should inform their doctor or pharmacist,
or nurse. See section 4.

Package Leaflet Contents

• 1. What is Cefuroxime Genoptim and what is it used for
• 2. Important information before taking Cefuroxime Genoptim
• 3. How to take Cefuroxime Genoptim
• 4. Possible side effects
• 5. How to store Cefuroxime Genoptim
• 6. Package contents 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 bacteria that cause infections. It belongs to a group of medicines called
cephalosporins.

Cefuroxime Genoptim is used to treat infections of:

the throat,
sinuses,
middle ear,
lungs or chest,
urinary tract,
skin and soft tissues.
Cefuroxime Genoptim may also be used:
to treat early stages of Lyme disease (borreliosis – an infection transmitted by ticks).
The doctor may examine what type of bacteria caused the patient's infection and check if the bacteria are sensitive to Cefuroxime Genoptim during treatment.

2. Important information before taking Cefuroxime Genoptim

When not to take Cefuroxime Genoptim:

If the patient is allergicto any of the cephalosporin antibioticsor any of the
other ingredients of Cefuroxime Genoptim (listed in section 6),
if the patient has ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotics (penicillins, monobactams or carbapenems),
if the patient has ever had a severe skin rash or skin peeling and blistering and (or) mouth sores after taking cefuroxime or other cephalosporin antibiotics.
If any of these conditions apply to the patient, they should not take Cefuroxime Genoptimwithout consulting a doctor.

Warnings and precautions

Cefuroxime Genoptim is not recommended for use in children under 3 months,
as the safety and efficacy of the medicine in this age group are not known.
During treatment with Cefuroxime Genoptim, attention should be paid to whether the following complaints occur: allergic reactions, fungal infections (e.g. thrush) 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 observed, medical advice should be sought immediately.

Blood tests

Cefuroxime Genoptim may affect the results of blood tests for sugar and the Coombs test. If the patient is to have blood tests, they should:
➢ tell the person taking the blood samplethat they are taking Cefuroxime Genoptim.

Cefuroxime Genoptim and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan 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 (blood thinners)
➢ If the patient is taking any of the above (or similar) medicines, they should tell their doctor or pharmacist.

Oral contraceptives

Cefuroxime Genoptim may reduce the effectiveness of oral contraceptives. If the patient is taking oral contraceptives while taking Cefuroxime Genoptim, they should also use mechanical methods of contraception(e.g. condoms). In case of doubts, they should consult a 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 or pharmacist before taking this medicine. The doctor will assess the benefit of using cefuroxime compared to the risk to the child.

Driving and using machines

Cefuroxime Genoptim may cause dizzinessand other side effects that may impair the patient's alertness.
➢ The patient should not drive or operate machineryif they do not feel well.

3. How to take Cefuroxime Genoptim

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist again.
Cefuroxime Genoptim should be taken after a meal.This will help increase the effectiveness of the treatment.
Cefuroxime Genoptim tablets should be swallowed whole with water.
The tablets should not be chewed, crushed, or divided– this may reduce the effectiveness of the treatment.

Recommended dose

Adults

The usual dose of Cefuroxime Genoptim is 250 mg to 500 mg twice a day, 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 a day, depending on the severity and type of infection.
Cefuroxime Genoptim is not recommended for use in children under 3 months,
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 initial dose may be changed or more than one treatment cycle may be necessary.

Patients with kidney problems

If the patient has kidney problems, the doctor may change the dose of the medicine.
➢ If this applies to the patient, they should tell their doctor.

Taking more than the recommended dose of Cefuroxime Genoptim

If the patient has taken more than the recommended dose of Cefuroxime Genoptim, they may experience neurological disorders, in particular, the risk of seizures (epileptic fits) increases.
➢ The patient should contact a doctor or call an emergency number immediately. If possible, they should show the packaging of Cefuroxime Genoptim.

Missing a dose of Cefuroxime Genoptim

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 treatment with Cefuroxime Genoptim

The patient should not stop taking Cefuroxime Genoptim unless their doctor tells them to.

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

Cefuroxime Genoptim contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

4. Possible side effects

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

Complaints to watch out for

A small number of people taking Cefuroxime Genoptim have reported an allergic reaction or a potentially severe skin reaction. The symptoms may be:
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 blisteringand look like small targets(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).
fungal infections. Medicines like Cefuroxime Genoptim can cause an overgrowth of yeast ( Candida) in the body, leading to a fungal infection (e.g. thrush). The risk of this side effect is higher if Cefuroxime Genoptim is taken for a long time.
severe diarrhea (pseudomembranous colitis). Medicines like Cefuroxime Genoptim can cause inflammation of the colon (large intestine), leading to severe diarrhea, usually with blood and mucus, abdominal pain, and fever.
Jarisch-Herxheimer reaction. During treatment with Cefuroxime Genoptim for Lyme disease (borreliosis), some patients may experience a high temperature (fever), chills, muscle and headache, and a 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).
➢ If the patient experiences any of these symptoms, they should contact their doctor or nurse immediately.
Common side effects(may affect up to 1 in 10 people):
fungal infections (e.g. thrush),
headache,
dizziness,
diarrhea,
nausea,
stomach pain.
Common side effects that may be seen in blood tests:
increased white blood cell count (eosinophilia),
increased liver enzyme activity.
Uncommon side effects(may affect up to 1 in 100 people):
vomiting,
skin rashes.
Uncommon side effects that may be seen in 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),
high temperature (fever),
yellowing of the whites of the eyes or skin,
inflammation of the liver.
Side effects that may be seen in blood tests:
rapid breakdown of red blood cells (hemolytic anemia).

Reporting side effects

If the patient experiences any side effects, including those not listed in the package leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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 will help to gather more information on the safety of the medicine.

5. How to store Cefuroxime Genoptim

The medicine should be stored 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 month.
Store in a temperature below 25 °C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Cefuroxime Genoptim contains

The active substance of the medicine is cefuroxime (in the form of cefuroxime axetil). Each film-coated tablet contains 250 mg or 500 mg of cefuroxime.
The other ingredients of the medicine 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), lacquer no. 1 (11%-13%), brilliant blue FCF (E 133), lacquer no. 1 (28%-31%).

What Cefuroxime Genoptim looks like and contents of the pack

Cefuroxime Genoptim, 250 mg

Blue film-coated tablets, capsule-shaped, biconvex, with "204" embossed on one side and smooth on the other.
Aluminum/Aluminum foil blisters containing 2, 6, 10, 12, 14, 15, 20, 24, and 50 tablets, in a cardboard box.

Cefuroxime Genoptim, 500 mg

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

Marketing Authorization Holder:

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw

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
Interpharma Services Ltd.
43A Cherni Vrach Blvd
1407 Sofia
Bulgaria
Ascend GmbH
Sebastian-Kneipp-Straße 41
60439 Frankfurt am Main
Germany

Date of last revision of the package leaflet: June 2023