Zintax

Leaflet attached to the packaging: patient information

Zyntax, 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 the symptoms of their illness 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 Zyntax and what is it used for
• 2. Important information before taking Zyntax
• 3. How to take Zyntax
• 4. Possible side effects
• 5. How to store Zyntax
• 6. Contents of the packaging and other information

1. What is the medicine Zyntax and what is it used for

Zyntax contains the active substance cefuroxime. It is 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.

Zyntax is used to treat infections of:

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

Zyntax may also be used:

• to treat Lyme disease (a tick-borne infection called borreliosis).

The doctor may perform a test to determine the type of bacteria causing the infection and to check if the bacteria are sensitive to Zyntax during treatment.

2. Important information before taking Zyntax

When not to take Zyntax

• if the patient is allergic (hypersensitive) to cefuroxime or cephalosporin antibiotics or any of the other ingredients of this medicine (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) ulcers of the mouth after treatment with cefuroxime or other cephalosporin antibiotics.

If the above circumstances apply to the patient, they should not take Zyntax until they have consulted a doctor.

Warnings and precautions

Before starting treatment with Zyntax, the patient should discuss it with their doctor or pharmacist.

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 the patient notices any symptoms related to severe skin reactions, as described in section 4, they should seek medical advice immediately.

Children

Zyntax 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 Zyntax, the patient should be aware of the following symptoms:

allergic reactions, fungal infections (e.g., thrush), and severe diarrhea (pseudomembranous colitis). This will reduce the risk of complications. See "Symptoms to watch out for" in section 4.

If the patient is to have blood tests

Zyntax may affect the results of blood sugar tests and a blood test called the Coombs test. If the patient is to have blood tests, they should tell the person taking the blood sample that they are taking Zyntax.

Zyntax and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.

Medicines that reduce stomach acid (e.g., antacids) may affect the action of Zyntax.

• probenecid
• oral anticoagulants. If the patient is taking such medicines, they should tell their doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

This medicine should not be used during pregnancy and breastfeeding, unless the doctor has explicitly recommended it.

If the breastfed baby experiences digestive problems (diarrhea, fungal infections) or rashes, the patient should stop breastfeeding and contact their doctor immediately.

Driving and using machines

Zyntax may cause dizziness and other side effects that may impair the patient's alertness.

The patient should not drive or operate machinery if they do not feel well.

Zyntax contains sodium

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

The patient should discuss with their doctor whether Zyntax is suitable for them.

3. How to take Zyntax

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

Recommended dose

Adults

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

Children

The usual dose of Zyntax 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.

Zyntax 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 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 Zyntax.

The patient should tell their doctor if this applies to them.

Method of administration

Oral administration.

Zyntax should be taken after a meal. This will increase the effectiveness of the treatment. The tablets should be swallowed whole with water.

The tablets should not be crushed or chewed.

Taking a higher dose of Zyntax than recommended

If the patient has taken a higher dose of Zyntax than recommended, they may experience neurological disorders, in particular, an increased risk of seizures (epileptic fits).

The patient should contact their doctor or the nearest hospital immediately. If possible, they should show the packaging of Zyntax.

Missing a dose of Zyntax

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 Zyntax

The patient should not stop taking Zyntax without consulting their doctor.

It is important to complete the full treatment cycle with Zyntax. The patient should not stop treatment, unless their doctor recommends it – even if they feel better. If the patient does not complete the full treatment cycle, the infection may return.

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

Symptoms to watch out for

A small number of patients taking Zyntax have reported an allergic reaction or 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.
• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or hypersensitivity syndrome).
• Chest pain associated with an allergic reaction, which may be a sign of a heart attack caused by an allergy (Kounis syndrome).
• 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).

Other symptoms to watch out for while taking Zyntax:

• Fungal infections. Medicines like Zyntax can cause an overgrowth of fungi (Candida) in the body, leading to a fungal infection (such as thrush). The risk of this side effect is higher if Zyntax is taken for a long time.
• Severe diarrhea (pseudomembranous colitis). Medicines like Zyntax 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 Zyntax for Lyme disease (borreliosis), some patients may experience a high fever, chills, muscle and headache, and skin rash. This is called a Jarisch-Herxheimer reaction. These symptoms usually last from a few hours to a day.

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

Frequent side effects

May occur in up to 1 in 10 patients:

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

Frequent side effects that may be seen in blood tests:

• increased white blood cell count (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 seen in blood tests:

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

Other side effectsOther 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 fever
• yellowing of the whites of the eyes or skin
• liver inflammation.

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 any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181 C

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 Zyntax

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month stated.

Do not store above 25°C.

Store in the original packaging to protect from light.

Do not use Zyntax if the tablets are cracked or show other visible signs of damage.

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. Contents of the packaging and other information

What Zyntax contains

• The active substance is cefuroxime. One coated tablet contains 500 mg of cefuroxime (as cefuroxime axetil).
• The other ingredients are: Tablet core: microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate

Coating: hypromellose, titanium dioxide (E 171), hydroxypropylcellulose, microcrystalline cellulose, stearic acid

What Zyntax looks like and contents of the pack

White to almost white, oval, biconvex, film-coated tablets, 9 mm x 18.5 mm in size. The tablets are packaged in PVC/PVDC/Aluminum blisters.

Package sizes: 10, 12, 14, 16, 20, and 24 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma Sp. z o.o.

ul. Baletowa 30

02-867 Warsaw

tel: +48 22 855 40 93

Manufacturer

Aristo Pharma GmbH

Wallenroder Strasse 8-10

13435 Berlin

Germany

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

Germany

Cefurax

Austria

Cefuroxim Aristo

Spain

Cefuroxima Aristo

Poland

Zyntax

Portugal

Cefuroxima Aristo

Date of last revision of the leaflet: