Cetix

Package leaflet: Information for the patient

Cetix, 100 mg/5 ml, granules for oral suspension
Cefiximum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else 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.

Leaflet contents

1. What Cetix is and what it is used for
2. What you need to know 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 an active substance called cefixime. It belongs to a group of antibiotics known as cephalosporins, which are used to treat bacterial infections.
Cetix is used in children over 6 months of age, adolescents and adults to treat:

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

2. 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 (hypersensitive) to other antibiotics belonging to the cephalosporin group,
• if the patient has ever experienced a severe allergic reaction to penicillin antibiotics or other beta-lactam antibiotics.

Cetix must not be administered to premature infants or newborns born at term.
Do not take this medicine if any of the above conditions apply to the patient.
Before starting treatment with Cetix oral suspension, consult a doctor or pharmacist.

Warnings and precautions
Before starting treatment with 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 patient is a child under 6 months of age.

If in doubt whether any of the above warnings apply to the patient, consult a doctor or pharmacist before starting treatment with this medicine.
Cetix is not suitable for every patient.
If any of the situations described below apply to the patient, inform the doctor before starting treatment with Cetix.

• The patient is allergic to penicillin antibiotics 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, special caution is required if the patient has ever experienced an allergic reaction to penicillins, as they may also be allergic to Cetix.
• In patients who develop a severe allergic reaction or anaphylaxis (a serious allergic reaction causing difficulty breathing or dizziness) after taking Cetix, the medicine must be discontinued and appropriate treatment initiated.
• The patient is taking other medicines known to have harmful effects on the kidneys. If the patient has any kidney disease, this should also be reported to the doctor. The doctor may recommend regular specific tests to monitor kidney function during treatment.
• The patient develops severe or persistent diarrhoea, possibly accompanied by stomach pain or cramps – these symptoms may occur during treatment with Cetix or shortly after its discontinuation. In such cases, stop taking the medicine immediately and consult a doctor without delay. Do not take medicines that slow down or stop intestinal motility.

If, during treatment with Cetix, the patient experiences symptoms known as DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms) or Stevens–Johnson syndrome, or toxic epidermal necrolysis (see section 4. Possible adverse effects), treatment with this medicine must be stopped immediately and medical advice sought without delay.
During treatment with Cetix, there may be an increased temporary risk of infections caused by other types of bacteria not affected by Cetix. For example, candidiasis (an infection caused by the yeast Candida) may occur.
This medicine may cause vomiting and diarrhoea (see section 4. Possible adverse effects). This may reduce the effectiveness of Cetix and/or other medicinal products taken orally (e.g. oral contraceptives).

Cetix and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently taken, or planned for use.
In particular, inform the doctor or pharmacist if the patient is taking:

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

Effect on laboratory test results
If the patient is to undergo 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 tests for glucose (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 glucose levels during treatment with this medicine.
• Cetix may affect the results of certain urine tests for ketones. Inform the doctor that the patient is taking Cetix, as alternative tests may be necessary.
• Cetix may affect blood tests detecting antibodies (so-called direct Coombs test).

Cetix with food and drink
Cetix may be taken during meals or independently of meals.

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 before using this medicine.

Driving and using machines
Cetix generally does not affect the ability to drive or operate machinery.

Cetix contains sucrose
This medicine contains 2.52 g of sucrose in 5 ml of reconstituted oral suspension.
This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

Cetix contains sodium benzoate (E211)
This medicine contains 2.5 mg of sodium benzoate (E211) in 5 ml of reconstituted oral suspension. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).
The medicine contains less than 1 mmol (23 mg) of sodium per 5 ml of reconstituted oral suspension, meaning the medicine is considered "sodium-free".

3. How to take Cetix

This medicine should always be taken according to the instructions given by your doctor or pharmacist.
If in doubt, 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. Further information on this subject can be obtained from your doctor or pharmacist.
The ready-to-use suspension should be administered undiluted, before or during a meal.
Typical dosage
Adults
400 mg (= 20 ml of ready-to-use suspension) once daily, as a single dose, or 200 mg (= 10 ml) twice
daily every 12 hours.
Elderly patients
In elderly patients, dose adjustment is not necessary 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
8 mg of cefixime per kg body weight per day, as a single dose or divided into two doses given every 12 hours.
Dosing recommendations are presented in the table below:

In adolescents and adult patients without swallowing difficulties, cefixime should be used in the form of tablets.
Renal function disorders
Cefixime may be administered to patients with impaired renal function. In patients with creatinine clearance of 20 ml/min or higher, the standard dose and dosing regimen may be used.
In patients with creatinine clearance below 20 ml/min/1.73 m², the dose should not exceed 200 mg once daily.
In children under 12 years of age with creatinine clearance below 20 ml/min/1.73 m², the dose of 4 mg of cefixime/kg body weight should be administered only once daily.
Preparation of the oral suspension
60 ml oral suspension: to prepare the suspension, use the measuring cup provided in the cardboard box. Add 40 ml of water in two portions, shaking after each addition.
100 ml oral suspension: to prepare the suspension, use the measuring cup provided in the cardboard box. Add 66 ml of water in two portions, shaking after each addition.
The ready-to-use suspension is a viscous liquid ranging in color from almost white to pale yellow.
Shake the bottle well before each use.
An oral plastic syringe with a graduated scale is provided for measuring the prescribed dose of the suspension.
The oral plastic syringe is included in the package.
Instructions for using the oral syringe

1. Shake the bottle well before use, then remove the cap.
2. Remove the syringe cap and insert the syringe into the bottle.
3. Pull back the plunger until the edge of the plunger aligns with the mark on the plunger indicating the prescribed dose.

4. Remove the syringe from the bottle.
5. Place the tip of the syringe into the mouth of the patient sitting upright, directing it towards the inner cheek.
6. Slowly press the plunger to administer the medication to avoid choking. DO NOT administer the medication as a forceful stream.
7. Repeat steps 2–6 in the same manner until the total prescribed dose has been administered.
8. After administration, replace the cap on the bottle. Disassemble the syringe and wash thoroughly under running water. Allow the plunger and cylinder to air dry.

Duration of treatment
Treatment usually lasts 7 days. It may be extended up to 14 days depending on the severity of the infection.
Treatment of acute uncomplicated cystitis in women lasts from 1 to 3 days.
Accidental overdose of Cetix
If the patient accidentally takes more than the recommended dose of the medicinal product, contact a doctor immediately or go to the nearest emergency department.
Missed dose of Cetix
If the patient forgets to take a dose, they should take it as soon as they remember. However, if less than 6 hours remain before the next scheduled dose, the missed dose should be omitted and the patient should return to the regular dosing schedule. Do not take a double dose to make up for a missed dose.
Interrupting treatment with Cetix
It is important to continue taking this medicinal product for the entire prescribed duration of treatment. Do not discontinue treatment with Cetix just because the patient feels better. Stopping treatment too early may lead to recurrence of infection. Consult a doctor if the patient still feels unwell at the end of the prescribed treatment course or if symptoms worsen during treatment.
If there are any further doubts regarding the use of this medicinal product, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions are important, and if they occur, immediate action must be taken.
If any of the symptoms listed below occur, stop taking Cetix and seek medical advice immediately.

Very rare (may occur in not more than 1 in 10,000 patients):

• Watery, severe diarrhoea, which may also 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 (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome)) (see section 2. Important information before taking Cetix – Warnings and precautions).

Frequency not known (cannot be estimated from available data):

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

The following adverse reactions have also been reported:

Common (may occur in not more than 1 in 10 patients):

• Diarrhoea.

Uncommon (may occur in not more than 1 in 100 patients):

• Headache;
• Nausea;
• Vomiting;
• Abdominal pain;
• Changes in blood test results used to assess liver function;
• Skin rash.

Rare (may occur in not more than 1 in 1,000 patients):

• Increased risk of infection caused by microorganisms not affected by cefixime, e.g. candidiasis;
• Increased number of white blood cells called eosinophils;
• Allergic reaction;
• Loss of appetite;
• Dizziness;
• Flatulence (gas);
• Itching of the skin;
• 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 occur in not more than 1 in 10,000 patients):

• Decrease in the number of various blood cells (symptoms may include fatigue, new infections, increased tendency to bruise or bleed);
• 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.

Frequency not known (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 changes with a red or pink ring and a pale centre, which may itch, peel or contain fluid. The rash may appear especially on the palms and soles. These may be symptoms of a serious drug allergy called "erythema multiforme".

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 181C, PL-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 to provide more information on the safety of the medicine.

5. How to store Cetix

Keep this medicine out of sight and reach of children.
Store the granulate below 25°C.
Reconstituted suspension: the prepared suspension may be stored for 14 days below 25°C or in the refrigerator.
Do not use this medicine after the expiry date stated on the cardboard box after "Expiry date". 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 package and other information

What Cetix contains

• The active substance is cefixime. Each 5 ml of reconstituted oral suspension contains 100 mg of cefixime in the form of trihydrate cefixime (111.9 mg).
• The other ingredients are: sucrose, xanthan gum, sodium benzoate (E211), orange flavour (Flavour durarome orange) [flavouring substances, maltodextrin, sucrose, soy lecithin (E322), silicon dioxide (E551)].

What Cetix looks like and contents of the pack
Cetix, granules for the preparation of oral suspension, is white to pale yellow in colour.
The granules for oral suspension are packed directly in 150 ml amber glass bottles (type III) with an aluminium cap and polyethylene seal.
The cardboard package contains one (1) bottle, one plastic (polypropylene) measuring cup intended exclusively for preparing the suspension, marked with a volume of 40 ml or 66 ml, one 5 ml plastic oral dosing syringe with graduations from 0.5 ml to 5 ml and increments of 0.25 ml printed on the plunger, and the package leaflet. Each bottle contains 32 g of granules (1.2 g cefixime) for the preparation of 60 ml oral suspension or 53 g of granules (2 g cefixime) for the preparation of 100 ml oral suspension.

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
e-mail: [email protected]

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria: Sorcelif 100 mg/5 ml Granulat zur Herstellung einer Suspension zum Einnehmen
Poland: CETIX
Portugal: Cefixima InnFarm
Czech Republic: Cefixime InnFarm 100 mg/5 ml granule pro perorální suspenzi
Slovakia: Cefixime InnFarm 100 mg/5 ml, granulát na perorálnu suspenziu
Romania: XIFIA 100 mg/5 ml granule pentru suspensie orală
Hungary: XIFIA 100 mg/5 ml granulátum belsőleges szuszpenzióhoz

Advice and medical education
Antibiotics are used to treat bacterial infections. They are ineffective in treating viral infections.
The antibiotic prescribed by a doctor is necessary only for treating the patient's current illness.
Some bacteria may survive or continue to multiply despite antibiotic treatment. This phenomenon is known as resistance: treatment with certain antibiotics becomes 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, please follow the recommendations below.

1. Use antibiotics only when prescribed by a doctor.
2. Strictly follow the instructions provided.
3. Do not reuse an antibiotic without a doctor's prescription, even if the treatment is for a similar condition.
4. Never give your antibiotic to others; it may not be suitable for treating their illness.
5. After completing treatment, return any unused medicine to the pharmacy for proper disposal.