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Treść ulotki
CEFIXIMA DOC Generici 400 mg film-coated tablets
Generic medicine
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 that cause a sudden worsening of pre-existing bronchitis
severe lung infections (pneumonia) acquired outside the hospital
urinary tract infections
genital infections.
If you need more information about your condition, ask 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 other ingredient of this medicine (listed in section 6)
- if you have previously suffered an immediate or severe allergic reaction caused by 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 suffer from severe diarrhoea, with blood or prolonged during or after treatment with this medicine. If this happens, you should contact your doctor as soon as possible. Do not take any medicine to stop the diarrhoea 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 on which cefixime is not active. For example, candidiasis may occur
(an infection produced by a yeast called Candida).
Effects on laboratory tests
If you are going to have a blood or urine test, tell your doctor that you are taking
CEFIXIMA DOC Generici because cefixime can alter the results of some tests.
CEFIXIMA DOC Generici can alter the results of some urine tests for sugars
(such as the Benedict or Fehling test). If you have diabetes and routinely have urine tests,
tell your doctor. This is because different tests may be needed to monitor
your diabetes while you are taking this medicine.
CEFIXIMA DOC Generici can alter the results of a blood test for the detection of
antibodies called the Coombs test.
Other medicines and CEFIXIMA DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
In particular, tell 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 want to check how your kidneys are working, especially if you have already had kidney problems
- nifedipine (a medicine used to treat heart problems such as arrhythmias and high blood pressure). If nifedipine is taken with CEFIXIMA DOC Generici, the levels of cefixime in the blood may increase.
CEFIXIMA DOC Genericiwith food and drink
CEFIXIMA DOC Generici can be taken with water before, during or after a meal.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are
breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
If you are pregnant, think you may be pregnant or are trying to become pregnant, you should not take
CEFIXIMA DOC Generici unless your doctor has told 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 vehicles or operate
machinery. If this worries you or you want more information, ask 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 following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
These tablets must be taken by mouth. You should try to take them at about the same
time each day.
The tablet can be divided into equal doses.
Adults and adolescents over 12 years:
400 mg per day in a single dose or
200 mg twice a day.
Children under 12 years:
CEFIXIMA DOC Generici tablets are not suitable for the treatment of children. Ask your doctor
for further information.
Kidney problems:
If you have severe kidney problems or are on dialysis, your doctor will reduce the 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 your doctor recommends it, the duration of treatment
may be extended up to 14 days.
If you take more CEFIXIMA DOC Genericithan you should
If you accidentally took too many tablets or if a child swallowed some
tablets, contact the nearest emergency room or inform your doctor immediately. Bring
with you the tablets, even if there are none left in the package, so that the doctor
knows exactly what you have taken.
If you forget to take CEFIXIMA DOC Generici
If you forget to take a dose of this medicine, take it as soon as possible. Do not
take a double dose to make up for a 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 entire course of therapy that your doctor has prescribed.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediately inform your doctor or go to the nearest emergency room if you notice any of the following serious side effects – you may need urgent medical treatment:
- you have an allergic reaction. Signs may include: redness of the skin, difficulty swallowing or breathing, palpitations, feeling faint, swelling of lips, face, throat or tongue. This is rare.
- severe rash with blisters, where layers of skin may peel off leaving large areas of torn skin on the body. Also feeling generally unwell, fever, chills and muscle pain.
- inflammation of skin and soft tissues.
- skin rash or skin lesions consisting of a pink/red ring and a pale centre, which may be itchy, scaly or fill with fluid. The rash appears especially on the palms of the hands or the soles of the feet.
- you bruise or bleed more easily than usual or have signs of an infection such as a severe sore throat or fever.
- severe diarrhoea, with blood or prolonged accompanied by a feeling of weakness and fever, while taking or after taking this medicine.
Other side effects
If any side effect bothers you, speak to your doctor. If any of the following side effects gets worse or if you notice any side effects not
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 sick (vomiting)
- stomach pain, indigestion
- headache
- skin rashes
- temporary changes in liver function tests.
Rare side effects(occur in less than 1 in 1,000 people):
- feeling dizzy or feverish
- after prolonged use, new infections from bacteria resistant or fungi, such as candidiasis (causes itching in the genital or vaginal area)
- loss of appetite, flatulence
- inflammation of the inside of the mouth and/or other internal surfaces
- temporary increase in the level of urea in the blood.
Very rare side effects(occur in less than 1 in 10,000 people):
- reduction in the number of different blood cells (symptoms may include fatigue, new infections and a tendency to bruise and bleed)
- inflammation of the liver (hepatitis), yellowing of the skin and whites of the eyes (jaundice)
- alteration of kidney function
- feeling of hyperactivity.
Side effects with unknown frequency(frequency cannot be estimated on the basis of
available data)
- vaginal infection (vaginitis), itching of the genitals
- reduction in the number of some blood cells (neutropenia, granulocytopenia)
- increase in the number of platelets (thrombocytosis)
- fever caused by taking the medicine, joint pain (arthralgia)
- difficulty digesting (dyspepsia)
- skin reactions (DRESS, erythema multiforme, urticaria)
- serious kidney problems (acute renal failure, including tubulointerstitial nephritis)
- difficulty breathing (dyspnoea)
- swelling of the face (facial oedema)
- increase in the level of bilirubin in the blood.
Other antibiotics of this type (cephalosporins) may increase the risk of seizures.
It cannot be excluded that this happens while taking CEFIXIMA DOC Generici.
Blood tests
Your doctor may ask you to have some blood tests because cefixime can rarely
cause changes in the number of red blood cells or 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 get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through 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 CEFIXIMA DOC Generici
Keep this 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.
Store at a temperature below 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What CEFIXIMA DOC Generici contains
- The active ingredient is cefixime in the form of cefixime trihydrate.
- The other ingredients 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 contents of the pack
Film-coated tablet.
Film-coated tablet from white to off-white, capsule-shaped, with rounded edges,
with "E" and a fracture line on one side, and a fracture line between "8" and "7".
CEFIXIMA DOC Generici is available in PVC-PA-Alu-PVC/Alu blisters, in packs of 5
film-coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 (Roma) - Italy.
This medicinal product is authorised in the Member States of the European Economic Area
under the following denominations:
Italy: CEFIXIMA DOC Generici 400 mg film-coated tablets
- Kraj rejestracji
- Postać farmaceutycznaFilm-coated tablet, 400 MG
- Kod ATCJ01DD08
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki KEFIXIMA DOK JENERIKIPostać farmaceutyczna: Film-coated tablet, 400 MGSubstancja czynna: cefiximeProducent: AUROBINDO PHARMA (ITALIA) S.R.L.Wymaga receptyPostać farmaceutyczna: Film-coated tablet, 400 MGSubstancja czynna: cefiximeProducent: MYLAN S.P.A.Wymaga receptyPostać farmaceutyczna: Film-coated tablet, 400 MGSubstancja czynna: cefiximeProducent: SANDOZ S.P.A.Wymaga recepty
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KEFIXIMA DOK JENERIKI wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w KEFIXIMA DOK JENERIKI jest cefixime. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
KEFIXIMA DOK JENERIKI jest produkowany przez DOC GENERICI SRL. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie KEFIXIMA DOK JENERIKI jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
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Możesz kupić KEFIXIMA DOK JENERIKI w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (cefixime) to m.in. KEFIXIMA AUROBINDO, KEFIXIMA MYLAN, KEFIXIMA SANDOTS. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
















