Xifia

Package leaflet: Information for the user

Xifia, 400 mg, film-coated tablets
Cefixime
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Xifia is and what it is used for

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

• middle ear infection
• sinus infection
• throat infection
• infection causing acute exacerbation of chronic bronchitis
• severe lung infection (pneumonia), acquired outside hospital
• uncomplicated urinary tract infections, including certain types of kidney infection (pyelonephritis).

Xifia 400 mg film-coated tablets are used in adults and adolescents aged ≥ 12 years.

2. Important information before taking Xifia

When not to take Xifia

• 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 of the cephalosporin group.
• if the patient has ever had a severe allergic reaction to penicillin antibiotics or other beta-lactam antibiotics.

Do not take this medicine if any of the above conditions apply to the patient. Before starting
treatment with Xifia, consult a doctor or pharmacist.
Warnings and precautions
Before starting treatment with Xifia, discuss with a doctor or pharmacist if:

• the patient has ever had inflammation of the large intestine (colitis)
• the patient has impaired kidney function
• the patient has ever developed haemolytic anaemia (low number of red blood cells, which may cause paleness, weakness or breathlessness) after taking a cephalosporin antibiotic.

If in doubt whether any of the above situations apply to the patient, speak with a doctor or pharmacist before starting
treatment with this medicine.
Xifia is not suitable for every patient.
Before starting treatment with Xifia, inform the doctor:

• If the patient is allergic to penicillin antibiotics 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 all individuals allergic to penicillins are also allergic to cephalosporins. However, special caution is required if the patient has ever had an allergic reaction to penicillins, as they may also be allergic to this medicine. In patients who experience a severe allergic reaction or anaphylaxis (a serious allergic reaction causing difficulty breathing or dizziness) after administration of Xifia, treatment must be discontinued immediately and appropriate therapy initiated.
• If the patient is taking other medicines known to have harmful effects on the kidneys. Also inform the doctor 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 Xifia or shortly after stopping it. In such cases, stop taking this medicine and contact a doctor immediately. Do not take medicines that slow down or stop intestinal motility.

If, during treatment with Xifia, the patient develops a syndrome known as drug hypersensitivity syndrome (DRESS), Stevens-Johnson syndrome, or a skin reaction called toxic epidermal necrolysis (see section 4. "Possible side effects"), treatment must be stopped immediately and medical advice sought without delay.
Treatment with Xifia may temporarily increase the risk of infections caused by other types of bacteria not affected by this medicine. For example, candidiasis (an infection caused by fungi of the genus Candida) may occur.
As with all antibiotics belonging to this class (beta-lactam antibiotics), use of this medicine may be associated with a risk of encephalopathy, which may manifest as seizures (epileptic fits), disorientation, disturbances of consciousness or abnormal movements, particularly in cases of overdose or impaired kidney function.
If such symptoms occur, contact a doctor or pharmacist immediately (see sections 3 and 4).
Xifia and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned to be used by the patient.
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 production (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 blood clotting time.

Effect on laboratory test results
If the patient is to undergo blood or urine tests, inform the doctor about taking Xifia, as cefixime may alter the results of certain tests.
Xifia may affect the results of certain urine tests for sugar (e.g. Benedict's or Fehling's test). If the patient has diabetes and frequently undergoes urine testing, this should be reported to the doctor, as alternative tests may be required during treatment with this medicine.
Xifia may affect the results of urine tests for ketone bodies. Inform the doctor about taking this medicine, as alternative tests may be necessary.
Xifia may affect blood tests detecting antibodies, known as the direct Coombs test.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
If treatment is necessary during pregnancy or breastfeeding, the doctor will assess and discuss with the patient the benefits and risks associated with treatment.
If, during breastfeeding, the patient's child develops gastrointestinal disturbances (diarrhoea, fungal infection) or a rash, medical advice should be sought, as these adverse effects require monitoring.
Driving and using machines
As with all antibiotics belonging to this class (beta-lactam antibiotics), use of this medicine may be associated with a risk of encephalopathy, which may cause seizures (epileptic fits), disorientation, disturbances of consciousness or abnormal movements, particularly in cases of overdose or impaired kidney function.
If such symptoms occur, contact a doctor or pharmacist immediately (see sections 3 and 4).

3. How to take Xifia

This medicine should always be taken as prescribed by the doctor. 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 can be obtained from your doctor or
pharmacist.
Recommended dose:
Adults and adolescents aged ≥ 12 years
The recommended dose of Xifia is 400 mg (1 tablet) once daily or divided into two equal
doses of 200 mg (½ tablet) every 12 hours. The medicine should always be taken at the same
time each day.
The usual duration of treatment is 7 days. If necessary, this period may be extended up to 14 days.
In cases of acute otitis media and acute bacterial pharyngitis, the duration of treatment is 7–10 days.
In cases of acute uncomplicated cystitis in women, the duration of treatment is 1–3 days.
Special patient groups
Elderly patients
No dose adjustment is necessary in elderly patients, provided kidney function is normal.
Children under 12 years of age
Xifia should not be used in children under 12 years of age. Check whether other pharmaceutical
forms of the medicine are available.
Patients with kidney disease
In patients with kidney disease, a reduced dose of Xifia may be required. 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 Xifia in adolescents with kidney disease.
Therefore, the use of Xifia is not recommended in these patients.
Method of administration
Xifia is intended for oral use only. Xifia may be taken with or without food. The tablet should be
swallowed with a glass of water.
The tablet may be divided into equal doses.
Overdose of Xifia
If a patient or their child has taken more than the recommended dose of this medicine, contact
a doctor immediately or go to the nearest hospital emergency department.
As with all antibiotics belonging to this class (beta-lactam antibiotics), use of this medicine may be
associated with the risk of encephalopathy, which may cause seizures, disorientation, disturbances
of consciousness, or abnormal movements, particularly in cases of overdose. If such symptoms
occur, contact a doctor or pharmacist immediately (see sections 2 and 4).
Missed dose of Xifia
If a dose is missed, take it as soon as you remember. However, if less than 6 hours remain before
the next scheduled dose, skip the missed dose and return to the regular dosing schedule. Do not
take a double dose to make up for a missed dose.
Stopping Xifia
It is important to continue taking this medicine until the end of the prescribed treatment course. Do not
stop taking Xifia just because you feel better. Stopping treatment too early may lead to recurrence
of the infection. Inform your doctor if you still feel unwell at the end of the prescribed treatment course
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 side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The following side effects are important, and if they occur, immediate action must be taken.
You should stop taking Xifia and seek medical help immediately if any of the following symptoms occur:

• Watery, severe diarrhoea, which may also contain blood.
• 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 and collapse.
• Severe skin illness with blistering of the skin, mouth, eyes and genital organs (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2. Warnings and precautions).
• Severe skin rashes, fever, swollen lymph nodes, increased number of white blood cells called eosinophils (DRESS syndrome) (see section 2. "Warnings and precautions").

The following side effects 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
• Seizures (fits).

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

• Increased risk of infection caused by microorganisms not affected by cefixime, e.g. candidiasis (thrush)
• Increased number of white blood cells called eosinophils
• Allergic reaction
• Loss of appetite
• Dizziness
• Bloating (gas)
• Itchy 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
• Dyspepsia (indigestion).

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 characterized by skin rashes, fever, joint pain and organ enlargement
• Restlessness and increased activity
• Urticaria (hives)
• Liver function disorders, including jaundice (yellowing of the skin or whites of the eyes)
• Kidney disease (kidney failure)
• Encephalopathy (which may cause seizures, disorientation, disturbances of consciousness or abnormal movements).

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

• Increased number of platelets (thrombocytosis)
• Decreased number of a certain type of white blood cells (neutropenia)
• Skin rash or skin lesions with a pink/red ring and pale center, which may cause itching, peeling, or may be filled with fluid. The rash may appear particularly on the palms and soles. These may be symptoms of a serious drug allergy called "erythema multiforme".

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +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 helps provide more information on the safety of this medicine.

5. How to store the medicine Xifia

Store below 25°C.
Keep the medicine in a place invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the cardboard box and blister: Expiry (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. Such measures will help protect the environment.

6. Contents of the package and other information

What Xifia contains

• The active substance is cefixime. Each 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; pregelatinized starch (corn); magnesium stearate. Tablet coating: hypromellose type 2910 (5 mPa.s); macrogol 400; titanium dioxide (E171).

What Xifia looks like and contents of the pack
Xifia is a white to slightly cream-coloured, elongated, biconvex coated tablet with a breakline on one side.
The coated tablets are packed in blisters made of transparent PVC/PVDC/Aluminium foil. Each blister contains 5 or 7 tablets. The cardboard carton contains 1 blister with 5 tablets (5 tablets) or 1 blister with 7 tablets (7 tablets), or 2 blisters with 5 tablets each (10 tablets), and a leaflet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
INN-FARM d.o.o.
Maleševa ulica 14
1000 Ljubljana
Slovenia
Tel.: +386 70 390 711
Fax: +386 5191 116
e-mail: [email protected]

Manufacturer
Alkaloid-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana-Črnuče
Slovenia

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Sorcelif
Poland: Xifia

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 only for treating your current illness.
Despite using antibiotics, some bacteria may survive or continue to multiply.
This phenomenon is called resistance: certain antibiotics become ineffective.
Improper use of antibiotics increases resistance. You may contribute to bacteria becoming resistant, and thus delay recovery or reduce the antibiotic's effectiveness if you do not follow correctly:

• dosage
• treatment regimen
• duration of treatment.

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