Cetix

Package Leaflet: Information for the Patient

Cetix, 400 mg, Film-Coated Tablets

Cefixime

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Cetix and what is it 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 is Cetix and what is it used for

Cetix contains the active substance cefixime. It belongs to a group of antibiotics called cephalosporins, which are used to treat bacterial infections.
Cetix is used to treat:

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

2. Important information before taking Cetix

When not to take Cetix:

Do not take this medicine if you have any of the above conditions.
Before taking Cetix, consult your doctor or pharmacist.

Warnings and precautions

Before taking Cetix, discuss with your doctor or pharmacist if:

• you have ever had colitis (inflammation of the colon),
• you have kidney problems,
• the person taking this medicine is under 12 years of age.

If in doubt whether any of the above applies to you, consult your doctor or pharmacist before taking this medicine.
Cetix is not suitable for everyone.
Before taking Cetix, tell your doctor if:

• you are allergic to penicillin or other beta-lactam antibiotics. An allergic reaction may include rash, itching, difficulty swallowing or breathing, swelling of the face, lips, throat or tongue. Not everyone who is allergic to penicillin is also allergic to cephalosporins. However, if you have ever had an allergic reaction to penicillin, you should be careful when taking this medicine, as you may also be allergic to it. If a severe allergic reaction or anaphylaxis (a severe allergic reaction that causes difficulty breathing or dizziness) occurs after taking Cetix, stop taking the medicine and seek medical attention;
• you are taking other medicines that are known to be harmful to the kidneys. You should also tell your doctor if you have any kidney disease. Your doctor may decide to perform regular tests to check your kidney function during treatment;
• you have severe or persistent diarrhea, which may be accompanied by stomach pain or cramps - these symptoms may occur during or shortly after treatment with Cetix - stop taking the medicine and consult your doctor immediately. Do not take medicines that slow down or stop bowel movements.

If you experience symptoms known as drug hypersensitivity syndrome (DRESS) or Stevens-Johnson syndrome or a skin reaction called toxic epidermal necrolysis (see section 4. Possible side effects), stop taking the medicine and seek medical attention immediately.
Prolonged use of Cetix may temporarily increase the risk of infections caused by other types of bacteria that Cetix does not affect. For example, thrush (a yeast infection) may occur.

Cetix with food and drink

Cetix can be taken with or without food. Swallow the tablet with a glass of water.

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 or pharmacist for advice before taking this medicine. Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Cetix usually does not affect the ability to drive or use machines.

3. How to take Cetix

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The dose prescribed by your doctor depends on the type and severity of the infection. It also depends on your kidney function. For more information, ask your doctor or pharmacist.
Recommended dose:

Adults

The usual dose for adults is 400 mg (1 tablet) once daily or 200 mg (half a tablet) twice daily, every 12 hours. The tablet can be divided into equal doses. Take the medicine at the same time every day.

Patients with kidney disease

In patients with kidney disease, the dose of Cetix may need to be reduced. Your doctor will recommend the appropriate dose based on the results of blood or urine tests that assess kidney function.
There is not enough data on the use of Cetix in children and adolescents with kidney disease. Therefore, Cetix is not recommended for these patients.

Elderly patients

No dose adjustment is necessary in elderly patients with normal kidney function.

Adolescents over 12 years of age

Adolescents over 12 years of age are given the same dose as adults.

Children under 12 years of age

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

Accidental overdose of Cetix

If you or your child accidentally take more than the recommended dose of Cetix, contact your doctor or go to the nearest emergency department immediately.

Missing a dose of Cetix

If you miss a dose, take it as soon as you remember. However, if it is less than 6 hours before the next dose is due, skip the missed dose and continue with 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 until the end of the prescribed treatment period. Do not stop taking Cetix just because you feel better. Stopping treatment too early may lead to a recurrence of the infection. If you still feel unwell or feel worse during treatment, consult your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cetix can cause side effects, although not everybody gets them.
The following side effects are important and may require immediate action. Stop taking Cetix and see a doctor immediately if you experience any of the following symptoms.
Very rare (may affect up to 1 in 10,000 people):

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

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

• severe skin rash, fever, swollen lymph nodes, and increased levels of a type of white blood cell called eosinophils (drug hypersensitivity syndrome, DRESS) (see section 2. Important information before taking Cetix - Warnings and precautions).

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

• diarrhea.

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

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

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

• increased risk of infection caused by microorganisms that cefixime does not affect, such as thrush;
• increased levels of a type of white blood cell called eosinophils;
• allergic reaction;
• loss of appetite;
• dizziness;
• bloating (gas);
• itching;
• inflammation of the mucous membrane of the mouth and (or) other surfaces inside the body;
• fever;
• changes in blood test results that assess kidney function.

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

• decrease in the number of various blood cells (symptoms may include fatigue, new infections, increased tendency to bruise or bleed);
• allergic reaction characterized by skin rash, fever, joint pain, and swollen lymph nodes;
• nervousness and increased activity;
• liver disorders, including jaundice (yellowing of the skin or the whites of the eyes);
• kidney inflammation.

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

• increased platelet count (thrombocytosis);
• decreased neutrophil count (neutropenia);
• indigestion;
• skin rash or skin changes with a pink/red ring and a white center, which may cause itching, peeling, or be filled with fluid. The rash may appear especially on the palms and soles. These may be symptoms of a serious allergic reaction to the medicine, called "erythema multiforme".

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Pharmacovigilance, 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.
By reporting side effects, you can help 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 which is stated on the packaging after EXP.
The expiry date refers to the last day of that month.
Medicines should 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).
• The other ingredients are: Tablet core: microcrystalline cellulose (type 101 and type 102); calcium hydrogen phosphate dihydrate; sodium starch glycolate; magnesium stearate. Tablet coating: Opadry White Y-1-7000: hypromellose 5 cP; macrogol 400; titanium dioxide (E171).

What Cetix looks like and contents of the pack

Cetix film-coated tablets are white or slightly cream-colored, oblong, biconvex, film-coated tablets with a dividing line on one side of the tablet. The tablet can be divided into equal doses.
The tablets are packaged in PVC/PVDC/Aluminum blisters. Each blister contains 5 tablets or 7 tablets. The cardboard box contains 1 blister of 5 tablets (5 tablets) or 1 blister of 7 tablets (7 tablets) or 2 blisters of 5 tablets (10 tablets) and a leaflet.
Not all pack sizes may be marketed.

Marketing authorization 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 authorized in the Member States of the European Economic Area 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
Date of last revision of the leaflet:11.2023

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 needed to treat your current illness.
Despite the use of antibiotics, some bacteria may survive or continue to grow. This phenomenon is called resistance: some antibiotics become ineffective.
Incorrect use of antibiotics increases resistance. You can even help bacteria develop resistance and, in this way, delay treatment or reduce the effectiveness of the antibiotic if you do not follow:
 dosing
 treatment schedule
 treatment duration.

As a result, to maintain the effectiveness of this medicine:

• 1 - Only use antibiotics when prescribed by a doctor.
• 2 - Always follow the instructions.
• 3 - Never reuse an antibiotic without a doctor's prescription, even if the treatment is for a similar illness.
• 4 - Never give your antibiotic to another person; it may not be suitable for their illness.
• 5 - After completing treatment, return any unused medicine to the pharmacy for proper disposal.