Zyntax

Package leaflet: Information for the patient

Zyntax, 500 mg, film-coated tablets
Cefuroximum
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Zyntax is and what it is 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 pack and other information

1. What Zyntax is and what it is used for
Zyntax contains the active substance cefuroximum. It is 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.
Zyntax 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.

Zyntax may also be used:

• in the treatment of Lyme disease (a tick-borne infection known as Lyme borreliosis).

Your doctor may perform tests to identify the type of bacteria causing the infection and to monitor whether the bacteria are sensitive to Zyntax during treatment.

2. Important information before taking Zyntax

When not to take Zyntax

• if you are allergic (hypersensitive) to cefuroximum or to other cephalosporin antibiotics, or to any of the other ingredients of this medicine (listed in section 6);
• if you have ever experienced a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotics (penicillins, monobactams or carbapenems);
• if you have ever developed severe skin rash, skin peeling, blisters and/or oral ulcers after treatment with cefuroximum or other cephalosporin antibiotics.

If any of the above apply to you, do not take Zyntax until you have consulted your doctor.
Warnings and precautions
Before starting Zyntax, discuss this with your doctor or pharmacist.
Severe skin reactions have occurred during treatment with cefuroximum, such as:
Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). If you notice any of the symptoms related to severe skin reactions described in section 4, seek immediate medical advice.
Children
Zyntax 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.
During treatment with Zyntax, be alert for symptoms such as:
allergic reactions, fungal infections (e.g. candidiasis), and severe diarrhoea (pseudomembranous colitis). This will help reduce the risk of complications. See “Symptoms to watch for” in section 4.
If you are due to have blood tests
Zyntax may affect the results of blood sugar tests and of a blood test called the Coombs test. If you are due to have blood tests,
you should inform the person taking the sample that you are taking Zyntax.
Zyntax with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Medicines that reduce stomach acid (e.g. antacids used to treat heartburn) may affect the action of Zyntax.

• probenecid
• oral anticoagulants (blood thinners). If you are taking such medicines, inform your doctor or pharmacist.

Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, think you may be pregnant or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy or breastfeeding unless clearly advised by your doctor.
If a breastfed infant develops gastrointestinal problems (diarrhoea, fungal infections) or skin rashes, breastfeeding should be stopped and you should contact your doctor immediately.
Driving and operating machinery
Zyntax may cause dizziness and other side effects that may impair your alertness.
You should not drive or operate machinery if you do not feel well.
Zyntax contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".
You should consult your doctor to confirm whether Zyntax is suitable for you.
3. How to take Zyntax
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Recommended dose
Adults
The usual dose of Zyntax is 250 mg to 500 mg twice daily, depending on the severity and type of infection.
Children
The usual dose of Zyntax 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.

Zyntax 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 illness and your response to treatment, the initial dose may be adjusted or more than one treatment course may be required.
Patients with kidney problems
If you have kidney problems, your doctor may adjust the dosage.
Inform your doctor if this applies to you.
Method of administration
Oral use.
Zyntax should be taken after food. This helps to increase the effectiveness of treatment. Zyntax tablets should be swallowed whole with water.
Do not crush or chew the tablets.
Taking more Zyntax than recommended
If you take more Zyntax than recommended, neurological disturbances may occur, particularly an increased risk of seizures (epileptic fits).
Contact your doctor or nearest hospital department immediately. If possible, show the medicine packaging.
Missing a dose of Zyntax
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Stopping Zyntax
Do not stop taking Zyntax without consulting your doctor.
It is important to complete the full course of treatment with Zyntax. Do not stop treatment unless your doctor tells you to – even if you feel better. If you do not complete the full course, the infection may return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Symptoms that require attention

In a small number of patients taking Zyntax, an allergic reaction or potentially severe skin reaction has been reported. Symptoms may include:

• Severe allergic reaction. Symptoms include raised, itchy rash (urticaria), swelling, sometimes of the face or lips, which may cause difficulty breathing.
• 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 allergy-induced heart attack (Kounis syndrome).
• Skin rash that may develop into blisters and appear as small rings (a dark spot in the center surrounded by a lighter ring and a dark 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).

Other symptoms to watch for during treatment with Zyntax:

• Fungal infections. Medicines such as Zyntax may cause overgrowth of yeast ( Candida ) in the body, which may lead to fungal infection (such as thrush). The risk of this adverse reaction is higher if Zyntax is used for a prolonged period.
• Severe diarrhoea (pseudomembranous colitis). Medicines such as Zyntax 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 Zyntax for Lyme disease (borreliosis), some patients may experience high temperature (fever), chills, muscle and headache, and skin rash. This is known as the Jarisch-Herxheimer reaction. These symptoms usually last from several hours to one day.

If any of these symptoms occur in a patient, contact a doctor or nurse immediately.

Common adverse reactions

May occur in up to 1 in 10 patients:

• fungal infections (e.g. candidiasis)
• headache
• dizziness
• diarrhoea
• nausea
• stomach pain

Common adverse reactions that may be detected in blood tests:

• increased number of white blood cells (eosinophilia)
• increased activity of liver enzymes

Uncommon adverse reactions

May occur in up to 1 in 100 patients:

• vomiting
• skin rashes

Uncommon adverse reactions that may be detected in blood tests:

• decreased number of platelets (cells involved in blood clotting)
• decreased number of white blood cells (leukopenia)
• positive Coombs test

Other adverse reactions Other adverse reactions occur in a very small number of patients, but the exact frequency is unknown:

• severe diarrhoea (pseudomembranous colitis)
• allergic reactions
• skin reactions (including severe)
• high temperature (fever)
• yellowing of the whites of the eyes or skin
• hepatitis

Adverse reactions that may be detected in blood tests:

• excessive breakdown of red blood cells (hemolytic anaemia)

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 181 C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Zyntax

Keep out of the sight and reach of children.

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

Do not store above 25°C.

Store in the original packaging to protect from light.

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

Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack 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, sodium croscarmellose, 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 coated tablets with dimensions of 9 mm x 18.5 mm. The tablets are packed in PVC/PVDC/Aluminium blisters.
Pack sizes: 10, 12, 14, 16, 20 and 24 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa 30 Street
02-867 Warsaw
Phone: +48 22 855 40 93

Manufacturer
Aristo Pharma GmbH
Wallenroder Strasse 8-10
13435 Berlin
Germany

This medicinal product is authorised in the European Economic Area member states under the following names:
Germany Cefurax
Austria Cefuroxim Aristo
Spain Cefuroxima Aristo
Poland Zyntax
Portugal Cefuroxima Aristo