Cefixime Doc Generici

Package leaflet: Information for the user

CEFIXIMA DOC Generici 400 mg film-coated tablets

Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if
their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in
this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet

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

1. What CEFIXIMA DOC Generici is and what it is used for

CEFIXIMA DOC Generici belongs to a group of medicines called cephalosporins, which
are antibiotics used to treat bacterial infections.
CEFIXIMA DOC Generici can be used to treat:
middle ear infections
sinus infections
throat infections
infections causing sudden worsening of pre-existing bronchitis
severe lung infections (pneumonia) acquired outside the hospital
urinary tract infections
genital infections.
If you need further information about your condition, please consult your doctor.

2. What you need to know before taking CEFIXIMA DOC Generici

Do not take CEFIXIMA DOC Generici

• if you are allergic to cefixime, soy, or any of the other ingredients of this medicine (listed in section 6)
• if you have previously experienced an immediate or severe allergic reaction to treatment with penicillins or other beta-lactam antibiotics.

Warnings and precautions
Talk to your doctor or pharmacist before taking CEFIXIMA DOC Generici.
Consult your doctor if:

• you have ever had an allergic reaction to penicillins or other medicines
• you have severe kidney problems
• you develop severe, bloody, or prolonged diarrhea during or after treatment with this medicine. If this occurs, contact your doctor as soon as possible. Do not take any medicine to stop diarrhea before consulting your doctor.

Starting a course of treatment with CEFIXIMA DOC Generici may temporarily
increase the likelihood that you develop an infection caused by other types of
microorganisms against which cefixime is not effective. For example, candidiasis
(an infection caused by a yeast called Candida) may occur.
Effects on laboratory tests
If you are due to have a blood or urine test, inform your doctor that you are taking
CEFIXIMA DOC Generici, as cefixime may alter the results of certain tests.
CEFIXIMA DOC Generici may alter the results of certain urine sugar tests
(such as Benedict's or Fehling's test). If you have diabetes and routinely perform urine tests,
inform your doctor. This is because different tests may be needed to monitor
your diabetes while you are taking this medicine.
CEFIXIMA DOC Generici may affect the results of a blood test for antibodies known as the Coombs test.
Other medicines and CEFIXIMA DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might
take any other medicines.
In particular, inform your doctor if you are taking:

• anticoagulants (such as warfarin or heparin)
• aminoglycoside antibiotics such as gentamicin or other antibiotics called polymyxin B, colistin, or viomycin, or certain potent diuretics such as furosemide, because your doctor may need to check how well your kidneys are functioning, especially if you have previously had kidney problems
• nifedipine (a medicine used to treat heart conditions such as arrhythmias and high blood pressure). If nifedipine is taken with CEFIXIMA DOC Generici, blood levels of cefixime may increase.

CEFIXIMA DOC Generici with food and drink
CEFIXIMA DOC Generici can be taken with water, before, during, or after a meal.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this
medicine.
If you are pregnant, think you might be pregnant, or are trying to become pregnant, you must not take
CEFIXIMA DOC Generici unless your doctor has specifically instructed you to do so.
If you are breastfeeding, your doctor will decide whether you should stop taking CEFIXIMA DOC
Generici in order to continue breastfeeding.
Driving and using machines
CEFIXIMA DOC Generici has no effect on your ability to drive or operate
machinery. If you are concerned about this or would like further information, consult your doctor.
CEFIXIMA DOC Generici contains soy lecithin
This medicine contains soy lecithin. If you are allergic to peanuts or soy, do not use
this medicine.

3. How to take CEFIXIMA DOC Generici

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
These tablets must be taken orally. Try to take them at approximately the same time each day.
The tablet may be divided into equal doses.

Adults and adolescents over 12 years:
400 mg daily as a single dose or
200 mg twice daily.

Children under 12 years:
CEFIXIMA DOC Generici tablets are not suitable for treating children. Please consult your doctor for further information.

Renal problems:
If you have severe kidney problems or are undergoing dialysis, your doctor will reduce your dose.

Duration of treatment:
The duration of treatment varies depending on the type and severity of the infection. The usual duration of treatment is 7 days. If recommended by your doctor, the treatment may be extended up to 14 days.

If you take more CEFIXIMA DOC Generici than you should
If you have accidentally taken too many tablets or if a child has swallowed any tablets, contact the nearest emergency department or inform your doctor immediately. Bring the tablets with you, even if none remain in the pack, so that the doctor knows exactly what has been taken.

If you forget to take CEFIXIMA DOC Generici
If you forget to take a dose of this medicine, take it as soon as you remember. Do not take a double dose to make up for the missed dose.

If you stop taking CEFIXIMA DOC Generici
Do not stop taking the tablets without informing your doctor, even if you feel better. It is important to complete the full course of treatment prescribed by your doctor.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately or go to the nearest emergency room if you experience any of
the following serious side effects – you may require urgent treatment:

• You have an allergic reaction. Signs may include: skin redness, difficulty swallowing or breathing, palpitations, feeling faint, swelling of the lips, face, throat or tongue. This is rare.
• Severe rash with blisters, in which layers of skin may peel off, leaving large areas of damaged skin exposed on the body. Also general feeling of illness, fever, chills, and muscle pain.
• Inflammation of the skin and soft tissues.
• Skin rash or skin lesions consisting of a pink/red ring with a pale center, which may be itchy, scaly, or filled with fluid. The rash appears especially on the palms of the hands or soles of the feet.
• You develop bruises or bleed more easily than usual, or show signs of infection such as severe sore throat or fever.
• Severe diarrhoea, with blood or prolonged diarrhoea accompanied by weakness and fever, while taking or after stopping this medicine.

Other side effects
If any side effect worries you, consult your doctor. If any of the following side effects worsen or if you notice any side effects not listed in this leaflet, consult your doctor or pharmacist.
Common side effects (occur in less than 1 in 10 people):

• Diarrhoea or loose stools.

Uncommon side effects (occur in less than 1 in 100 people):

• Feeling unwell (nausea) or sickness (vomiting)
• Stomach ache, indigestion
• Headache
• Skin rashes
• Temporary abnormalities in liver function tests.

Rare side effects (occur in less than 1 in 1,000 people):

• Dizziness or fever
• New infections caused by resistant bacteria or fungi (such as candidiasis, causing itching in the genital or vaginal area) after prolonged use
• Loss of appetite, flatulence
• Inflammation of the inside of the mouth and/or other internal surfaces
• Temporary increase in blood urea levels.

Very rare side effects (occur in less than 1 in 10,000 people):

• Decrease in the number of various blood cells (symptoms may include fatigue, new infections, and increased tendency to bruise or bleed)
• Inflammation of the liver (hepatitis), yellowing of the skin and whites of the eyes (jaundice)
• Impaired kidney function
• Feeling hyperactive.

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• Vaginal infection (vaginitis), genital itching
• Decrease in certain blood cells (neutropenia, granulocytopenia)
• Increase in platelet count (thrombocytosis)
• Fever caused by the medicine, joint pain (arthralgia)
• Difficulty in digestion (dyspepsia)
• Skin reactions (DRESS, erythema multiforme, urticaria)
• Severe kidney problems (acute kidney failure, including tubulointerstitial nephritis)
• Difficulty breathing (dyspnoea)
• Facial swelling (facial oedema)
• Increased blood bilirubin levels.

Other antibiotics of this type (cephalosporins) may increase the risk of seizures.
This cannot be ruled out while taking CEFIXIMA DOC Generici.
Blood tests
Your doctor may ask you to have some blood tests, as cefixime can rarely cause changes in the number of red blood cells, white blood cells, or platelets (the cells that help blood to clot). These changes usually return to normal after stopping treatment.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CEFIXIME DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Store below 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CEFIXIMA DOC Generici contains

• The active substance is cefixime in the form of cefixime trihydrate.
• The other components are anhydrous calcium hydrogen phosphate, pregelatinized starch, hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate. Tablet coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum.

Description of the appearance of CEFIXIMA DOC Generici and pack contents
Film-coated tablet.
Film-coated tablet, white to off-white, capsule-shaped, with bevelled edges,
marked with "E" and a breakline on one side, and a breakline between "8" and "7".
CEFIXIMA DOC Generici is available in PVC-PA-Alu-PVC/Alu blisters, in packs of 5
film-coated tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano – Italy.
Manufacturer

• APL Swift Services (Malta) Limited - HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia BBG 3000 - Malta.
• Facta Farmaceutici S.p.A. - V. Laurentina Km 24,730 - 00040 Pomezia (Rome) - Italy.

This medicinal product is authorized in the European Economic Area (EEA) Member States
under the following names:
Italy: CEFIXIMA DOC Generici 400 mg film-coated tablets