Cetix

Package leaflet: Information for the patient

Cetix, 400 mg, film-coated tablets
Cefiximum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Cetix is and what it is used for
2. Important information before taking Cetix
3. How to take Cetix
4. Possible side effects
5. How to store Cetix
6. Contents of the pack and other information

1. What Cetix is and what it is used for

Cetix contains a medicine called cefixime. It belongs to a group of antibiotics known as cephalosporins, which are used to treat bacterial infections.
Cetix is used to treat:

• middle ear infections;
• sinus infections;
• throat infections;
• infections causing exacerbation of chronic bronchitis;
• severe community-acquired pneumonia;
• urinary tract infections.

2. Important information before taking Cetix

When not to take Cetix:

• if the patient is allergic to cefixime or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to other antibiotics in the cephalosporin group;
• if the patient has ever had a severe allergic reaction to antibiotics in the penicillin group or other beta-lactam antibiotics.

This medicine should not be taken if any of the above conditions apply.
Before starting to take Cetix, consult a doctor or pharmacist.
Warnings and precautions
Before starting to take Cetix, discuss with a doctor or pharmacist if:

• the patient has ever had inflammation of the large intestine (colitis);
• the patient has kidney problems;
• the person taking this medicine is under 12 years of age.

If in doubt whether any of the above apply to the patient, consult a doctor or pharmacist before starting to take this medicine.
Cetix is not suitable for every patient.
Before starting to take Cetix, inform the doctor if:

• the patient is allergic to antibiotics in the penicillin group or other beta-lactam antibiotics. Allergic reactions may include rash, itching, difficulty swallowing or breathing, swelling of the face, lips, throat or tongue. Not all individuals allergic to penicillins are also allergic to cephalosporins. However, particular caution is required if the patient has ever had an allergic reaction to penicillins, as there may also be an allergy to this medicine. In patients who develop a severe allergic reaction or anaphylaxis (a serious allergic reaction causing difficulty breathing or dizziness) after taking Cetix, the drug must be discontinued and appropriate treatment initiated;
• if the patient is taking other medicines known to have harmful effects on the kidneys. The doctor should also be informed if the patient has any kidney disease. The doctor may decide to perform regular tests to monitor kidney function during treatment;
• if the patient develops severe or persistent diarrhoea, which may be accompanied by stomach pain or cramps – these symptoms may occur during treatment with Cetix or shortly after its completion – the medicine should be discontinued and medical advice sought immediately. Do not take medicines that slow down or stop intestinal motility.

If, during treatment with Cetix, the patient experiences symptoms known as drug hypersensitivity syndrome (DRESS), Stevens-Johnson syndrome, or a skin reaction called toxic epidermal necrolysis (see section 4. Possible side effects), the medicine must be discontinued and medical help sought immediately.
Prolonged use of Cetix may temporarily increase the risk of infections caused by other types of bacteria not affected by Cetix. For example, candidiasis (a fungal infection caused by Candida species) may occur.
Cetix and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform the doctor or pharmacist if the patient is taking:

• medicines known to have harmful effects on the kidneys:
• antibiotics, including aminoglycoside antibiotics, colistin, polymyxin, and viomycin;
• medicines that increase urine volume (diuretics), such as ethacrynic acid or furosemide;
• nifedipine, a medicine used to treat high blood pressure or heart conditions;
• anticoagulant medicines (blood thinners), such as warfarin in some patients. Cefixime may cause disturbances in blood clotting and may prolong clotting time.

Effect on laboratory test results
If the patient is undergoing blood or urine tests, inform the doctor that the patient is taking Cetix, as cefixime may alter the results of certain tests.
Cetix may affect the results of certain urine sugar tests (e.g. Benedict's or Fehling's test). If the patient has diabetes and frequently undergoes urine testing, they should inform the doctor, as alternative tests may be required to monitor blood sugar levels during treatment with this medicine.
Cetix may affect the results of urine tests for ketones. Inform the doctor if the patient is taking Cetix, as alternative tests may be necessary.
Cetix may affect blood tests detecting antibodies (the so-called direct Coombs test).
Cetix with food and drink
Cetix may be taken during or independently of meals. Swallow the tablet with a glass of water.
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 a doctor or pharmacist before using this medicine. Consult a doctor or pharmacist before using any medicine.
Driving and operating machinery
Cetix usually does not affect the ability to drive or operate machinery.

3. How to take Cetix

This medicine should always be taken as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The prescribed dose depends on the type and severity of the infection. It also depends on the patient's kidney function. Detailed information on this can be obtained from your doctor or pharmacist.

Recommended dose:
Adults
The usual dose for adults is 400 mg (1 tablet) once daily, or divided into two doses of 200 mg (half a tablet) every 12 hours. The tablet may be divided into equal doses. The medicine should always be taken at the same time each day.

Patients with kidney disease
In patients with kidney disease, a dose reduction of Cetix may be necessary. Your doctor will recommend the appropriate dose based on blood or urine test results assessing kidney function.
There is insufficient data on the use of Cetix in children and adolescents with kidney disease. Therefore, the use of Cetix is not recommended in these patients.

Elderly patients
Doses in elderly patients do not require adjustment if kidney function is normal.

Adolescents aged 12 years and older
Adolescents aged 12 years and older should receive the same dose as adults.

Children under 12 years of age
The tablet form of this medicine is not intended for use in children under 12 years of age.

Taking more Cetix than recommended
If a patient or child accidentally takes more than the recommended dose, contact a doctor immediately or go to the nearest emergency department.

Missed dose of Cetix
If you forget to take a tablet, take it as soon as you remember. However, if the next dose is due within less than 6 hours, skip the missed dose and return to your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping treatment with Cetix
It is important to continue taking this medicine for the full prescribed duration of treatment. Do not stop taking Cetix just because you feel better. Stopping treatment too early may lead to recurrence of infection. Consult your doctor if you still feel unwell after completing the prescribed course of treatment, or if you feel worse during treatment.

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 everybody will experience them.
The following adverse reactions are important and require immediate action. You should stop taking Cetix and seek immediate medical advice if any of the symptoms listed below occur.
Very rare (may affect up to 1 in 10,000 people):

• watery, severe diarrhoea, which may be bloody;
• sudden severe allergic reactions (anaphylactic shock), such as skin rash or hives, itching, swelling of the face, lips, tongue or other parts of the body, tightness in the chest, wheezing or collapse;
• severe skin disease with blistering of the skin, mouth, eyes and genital organs (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2. Important information before taking Cetix – Warnings and precautions).

Unknown frequency (cannot be estimated from available data):

• severe skin rashes, fever, swollen lymph nodes, increased number of white blood cells called eosinophils (drug hypersensitivity syndrome - DRESS) (see section 2. Important information before taking Cetix – Warnings and precautions).

The following adverse reactions have also been reported:
Common (may affect up to 1 in 10 people):

• diarrhoea.

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

• headache;
• nausea;
• vomiting;
• abdominal pain;
• changes in blood test results used to assess liver function;
• skin rash.

Rare (may affect up to 1 in 1,000 people):

• increased risk of infection caused by microorganisms not susceptible to cefixime, e.g. candidiasis;
• increased number of white blood cells called eosinophils;
• allergic reaction;
• loss of appetite;
• dizziness;
• bloating (gas);
• skin itching;
• inflammation of the mucous membranes of the mouth and/or other internal surfaces;
• fever;
• changes in blood test results used to assess kidney function.

Very rare (may affect up to 1 in 10,000 people):

• decreased number of various blood cells (symptoms may include fatigue, new infections, increased tendency to bruising or bleeding);
• allergic reaction characterised by skin rashes, fever, joint pain and organ enlargement;
• restlessness and increased activity;
• liver disorders, including jaundice (yellowing of the skin or whites of the eyes);
• kidney inflammation.

Unknown (frequency cannot be estimated from available data):

• increased number of platelets (thrombocytosis);
• decreased number of a certain type of white blood cells (neutropenia);
• indigestion;
• skin rash or skin lesions with red/pink rings and a pale center, which may cause itching, peeling, or may be fluid-filled. The rash may appear especially on the palms and soles. These may be symptoms of a serious drug allergy, known as "erythema multiforme".

Reporting of adverse reactions
If you experience any adverse reactions, 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, 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Cetix

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Cetix contains

• The active substance is cefixime. Each film-coated tablet contains 400 mg of cefixime (as cefixime trihydrate).
• Other ingredients are: Tablet core: microcrystalline cellulose (type 101 and type 102); calcium hydrogen phosphate dihydrate; pregelatinized starch; magnesium stearate. Tablet coating: Opadry White Y-1-7000: hypromellose 5 cP; polyethylene glycol 400; titanium dioxide (E171).

What Cetix looks like and contents of the pack
Cetix film-coated tablets are white or slightly cream-colored, elongated, biconvex film-coated tablets with a division line on one side. The tablet can be divided into equal doses.
The film-coated tablets are packed in blisters made of transparent PVC/PVDC/Aluminum foil. Each blister contains 5 tablets or 7 tablets. The printed cardboard box contains 1 blister with 5 tablets (5 tablets) or 1 blister with 7 tablets (7 tablets) or 2 blisters with 5 tablets (10 tablets) and the package leaflet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. (42) 22-53-100

Importer
Alkaloid-INT d.o.o., Šlandrova ulica 4, 1231 Ljubljana – Črnuče, Slovenia
Tel.: +386 1 300 42 90
Fax: +386 1 300 42 91
email: [email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Cefixim InnFarm 400 mg Filmtabletten
Spain XIFIA 400 mg comprimidos recubiertos con película EFG
Poland Cetix
Portugal Cefixima InnFarm
Czech Republic Cefixime InnFarm 400 mg, potahované tablety
Slovakia Cefixime InnFarm 400 mg
Romania XIFIA 400 mg comprimate filmate
Hungary Sufixin Forte 400 mg filmtabletta

Medical advice/education
Antibiotics are used to treat bacterial infections. They are ineffective against viral infections.
If your doctor has prescribed an antibiotic, it is necessary specifically for treating your current illness.
Despite antibiotic use, some bacteria may survive or continue to grow. This phenomenon is known as resistance: certain antibiotics become ineffective.
Improper use of antibiotics increases resistance. You may even help bacteria develop resistance, thereby delaying treatment or reducing the antibiotic's effectiveness if you do not properly follow:
 dosage instructions
 treatment schedule
 duration of treatment.

Therefore, to maintain the effectiveness of this medicine:
1 - Use antibiotics only when prescribed by a doctor.
2 - Strictly follow all instructions.
3 - Do not reuse antibiotics without a doctor's prescription, even if the condition being treated appears similar.
4 - Never give your antibiotics to another person; they may not be suitable for their condition.
5 - After completing treatment, return any unused medicine to the pharmacy for proper disposal.