CEFUROXIME TECNIGEN 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Cefuroxime TecniGen 500 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet.You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only.Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse.This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Cefuroxime TecniGen tablets are and what they are used for
2. What you need to know before you take Cefuroxime TecniGen tablets
3. How to take Cefuroxime TecniGen tablets
4. Possible side effects
5. Storage of Cefuroxime TecniGen tablets
6. Contents of the pack and other information

1. What Cefuroxime TecniGen tablets are and what they are used for

Cefuroxime TecniGen tablets contain cefuroxime, an antibiotic used in adults and children. It works against the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Antibiotics are used to treat bacterial infections and will not work for viral infections such as the common cold or flu.

It is essential that you follow the dosage, administration, and treatment duration instructions indicated by your doctor.

Do not store or reuse this medicine.If you have any leftover antibiotic after completing your treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or into the trash.

Cefuroxime TecniGen tablets are used to treat infections of:

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

Cefuroxime can also be used to:

• Treat Lyme disease (an infection transmitted by parasites called ticks)

Your doctor may analyze the type of bacteria causing the infection and monitor whether the bacteria are sensitive to cefuroxime tablets during treatment.

2. What you need to know before you take Cefuroxime TecniGen tablets

Do not take Cefuroxime TecniGen tablets:

• If you are allergic(hypersensitive) to cephalosporinsor to any of the other ingredients of this medicine (listed in section 6);
• If you have ever had a severe allergic reaction(hypersensitivity) to any other type of beta-lactam antibiotic (penicillins, monobactams, and carbapenems).
• If you have ever developed a severe skin rash, blistering, or peeling of the skinafter treatment with cefuroxime or any other cephalosporin antibiotic.

If any of these cases apply to you, do not take this medicineuntil you have consulted your doctor.

Warnings and precautions

Cefuroxime TecniGen tablets are not recommended for children under 3 months, as the safety and efficacy for this age group are unknown.

You should be aware of certain symptoms such as allergic reactions, fungal infections (like Candida), and severe diarrhea(pseudomembranous colitis) while taking Cefuroxime TecniGen tablets. This will reduce the risk of possible complications. See "Symptoms to be aware of" in section 4.

Be careful with Cefuroxime TecniGen tablets

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with cefuroxime treatment.Seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

If you need a blood test

Cefuroxime TecniGen tablets may affect the results of blood sugar levels or a blood test known as the Coombs test. If you need a blood test:

• Tell the person taking the samplethat you are taking Cefuroxime TecniGen tablets.

Taking Cefuroxime TecniGen tablets with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Medicines used to reduce stomach acidity(e.g., antacidsfor heartburn) may affect the action of Cefuroxime TecniGen tablets.

Probenecid

Oral anticoagulants

• Tell your doctor or pharmacistif you are taking any of these medicines.

Contraceptive pills

Cefuroxime TecniGen tablets may reduce the effectiveness of the contraceptive pill. If you are taking the contraceptive pill during treatment with Cefuroxime TecniGen tablets, you should also use a barrier method of contraception(such as condoms). Consult your doctor.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advicebefore taking this medicine.

Your doctor will assess the benefits of being treated with Cefuroxime TecniGen tablets against the risks for your child.

Cefuroxime TecniGen tablets contain sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

Driving and using machines

Cefuroxime TecniGen tablets may cause dizzinessand other side effects that may affect your ability to stay alert.

Do not drive or use machinesif you do not feel well.

3. How to take Cefuroxime TecniGen tablets

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist.If you are unsure, consult your doctor or pharmacist again.

Take Cefuroxime TecniGen tablets after meals.This will help make the treatment more effective.

Swallow the cefuroxime tablets whole with water.

Do not chew, crush, or divide the tablets,as this may make the treatment less effective.

Usual dose

Adults

The usual dose of Cefuroxime TecniGen tablets is 250 mg twice daily, depending on the severity and type of infection.

Children

The usual dose of Cefuroxime TecniGen tablets is 10 mg/kg (up to a maximum of 125 mg) to 15 mg/kg (up to a maximum of 250 mg) twice daily, depending on:

• the severity and type of infection

Cefuroxime TecniGen tablets are not recommended for children under 3 months, as the safety and efficacy for this age group are unknown.

Depending on the disease and how you or your child responds to treatment, the initial dose may be adjusted or it may be necessary to administer more than one treatment cycle.

Patients with kidney problems

If you have kidney problems, your doctor may change the dose.

• Consult your doctorif you are affected by this problem.

If you take more Cefuroxime TecniGen tablets than you should

If you take too much Cefuroxime TecniGen tablets, you may experience neurological disorders, particularly an increased risk of seizures (convulsions).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Cefuroxime TecniGen tablets

Do not take a double dose to make up for forgotten doses.Simply continue with the next dose as usual.

If you stop taking Cefuroxime TecniGen tablets

It is essential that you complete the full treatment with Cefuroxime.Do not stop it unless your doctor tells you to, even if you have started to feel better. If you do not complete the treatment cycle, the infection may recur.

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 TecniGen tablets have experienced a severe allergic reaction or potentially severe skin reaction. The symptoms of these reactions include:

• Severe allergic reaction.The signs include skin rash with itching, swelling, sometimes of the face or mouth, causing difficulty breathing.
• Skin rash, with possible blistering, resembling small targets(dark spot in the center surrounded by a lighter area, with a dark ring around the edge).
• Widespread skin rash with blisters and skin peeling(these can be symptoms of Stevens-Johnson syndromeor toxic epidermal necrolysis).
• Fungal infections.Medicines like Cefuroxime TecniGen tablets can cause an overgrowth of fungi (Candida) in the body, leading to fungal infections (such as thrush). This side effect is more likely to occur if you have taken Cefuroxime TecniGen tablets for an extended period.
• Severe diarrhea (pseudomembranous colitis).Medicines like Cefuroxime TecniGen tablets can cause inflammation of the colon (large intestine), resulting in diarrhea, usually accompanied by blood and mucus, stomach pain, and fever.
• Jarisch-Herxheimer reaction.Some patients may experience an increase in temperature (fever), chills, headache, muscle pain, and skin rash while taking Cefuroxime TecniGen tablets to treat Lyme disease. This is known as a Jarisch-Herxheimer reaction.The symptoms usually last from a few hours to a day.
• Generalized rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Chest pain in the context of allergic reactions, which can be a symptom of allergy-induced myocardial infarction (Kounis syndrome).

• Contact a doctor or nurse immediately if you experience any of these symptoms.

Common (may affect up to 1 in 10 people):

• fungal infections (such as Candida)
• headache
• dizziness
• diarrhea
• nausea
• stomach pain

Common side effects that may appear in blood tests:

• increase in a type of white blood cell count (eosinophilia)
• increase in liver enzyme levels

Uncommon (may affect up to 1 in 100 people):

• vomiting
• skin rashes

Uncommon side effects that may appear in blood tests:

• decrease in blood platelet count (cells that help blood clot)
• decrease in white blood cell count
• positive Coombs test

Other side effects

Other side effects have occurred in a very small number of people, but their 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
• inflammation of the liver (hepatitis)

Side effects that may appear in blood tests:

• rapid destruction of red blood cells (hemolytic anemia)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefuroxime TecniGen tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry datestated on the carton after EXP. The expiry date is the last day of the month shown.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste.Return any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cefuroxime TecniGen tablets

• The active substance is cefuroxime (present as cefuroxime axetil). Each tablet contains 500 mg of cefuroxime.
• The other ingredients are microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, anhydrous colloidal silica, calcium stearate, crospovidone type A, calcium carbonate, hypromellose E464, titanium dioxide E171, propylene glycol E1520, FD & C Blue No. 1 Brilliant Blue FCF E133.

Appearance of Cefuroxime TecniGen tablets and pack contents

Cefuroxime 500mg film-coated tablets

Film-coated tablets are blue, biconvex, capsule-shaped, and engraved with "203" on one side and blank on the other.

They are available in blister packs of paper-aluminum, packaged in a cardboard box. Each pack contains 2, 6, 10, 12, 14, 15, 20, 24, and 50 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. Bruselas, 13

28108 Alcobendas (Madrid)

Spain.

Manufacturer:

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 Swarzedz, Poland,

Interpharma Services Ltd.

43A Cherni Vrach Blvd, Sofia, 1407

Bulgaria

Ascend GmbH

Sebastian-Kneipp-Straße 41

60439 Frankfurt am Main,

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

United Kingdom: Cefuroxime 500mg film-coated tablets

Germany: Cefuroxim Alkem 500mg Filmtabletten

Spain: Cefuroxima TecniGen 500 mg comprimidos recubiertos con película EFG

Date of last revision of this leaflet:June 2023.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/