CEFIXIMA 400 mg Film-Coated Tablets

Зміст інструкції

1. Cefixima Aurobindo 400 mg film-coated tablets
   1. What is Cefixima Aurobindo and what is it used for
   2. What you need to know before taking Cefixima Aurobindo
   3. How to take Cefixima Aurobindo
   4. Possible side effects
   5. How to store Cefixima Aurobindo
   6. Package contents and other information

Cefixima Aurobindo 400 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start 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 their symptoms are the same as yours, as it could 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 Aurobindo is and what it is used for
• 2. What you need to know before you take Cefixima Aurobindo
• 3. How to take Cefixima Aurobindo
• 4. Possible side effects
• 5. How to store Cefixima Aurobindo
• 6. Contents of the pack and other information

1. What is Cefixima Aurobindo and what is it used for

Cefixima Aurobindo contains a substance called cefixime, which belongs to a group of
medicines called cephalosporins, which are used to treat bacterial infections.
Cefixima Aurobindo is used to treat:

• middle ear infections,
• infections that cause a sudden worsening of chronic bronchitis,
• acute uncomplicated bladder infections
• uncomplicated kidney infections

Consult your doctor if you would like more information about your condition.

2. What you need to know before taking Cefixima Aurobindo

Do not take Cefixima Aurobindo

• if you are allergic to cefixime, soy or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to any other type of cephalosporin.
• If you have ever had a severe allergic reaction caused by penicillins or any other beta-lactam antibiotics. Do not use this medicine if this applies to you. Consult your doctor or pharmacist before taking Cefixima Aurobindo film-coated tablets.

Warnings and precautions
Consult your doctor or pharmacist before taking Cefixima Aurobindo:

• if you have ever had colitis;
• if you have kidney problems;
• if the person taking this medicine is a child under 12 years of age. If you are not sure if this applies to you, consult your doctor or pharmacist before taking Cefixima Aurobindo.

Cefixima is not suitable for everyone.

Before taking Cefixima Aurobindo you must inform your doctor:

• if you are allergic to penicillins or any other beta-lactam antibiotic. An allergic reaction may include skin rashes, itching, difficulty swallowing or breathing, or swelling of the face, lips, throat or tongue. Not all people who are allergic to penicillins are also allergic to cephalosporins. However, you should not take this medicine if you have had a severe allergic reaction to a penicillin, because you may also be allergic to this medicine. In patients who develop a severe allergic reaction or anaphylaxis (a severe allergic reaction that causes difficulty breathing and dizziness) after the administration of cefixime, this medicine must be stopped and appropriate medical treatment must be administered.
• if you are taking other medicines that are known to be dangerous for your kidneys. Tell your doctor if you have kidney problems. Your doctor may prescribe you regular tests to measure how well your kidneys are working during treatment.
• if you suffer from severe or persistent diarrhea, with stomach pain or cramps during or immediately after treatment with cefixime, stop taking this medicine and contact your doctor immediately. Medicines that can slow down or block bowel movements should not be taken.

If you develop a syndrome known as DRESS syndrome or Stevens-Johnson syndrome or a skin reaction known as toxic epidermal necrolysis (see section 4 Possible side effects) while taking Cefixima Aurobindo, stop taking this medicine and contact your doctor immediately.
Taking a course of Cefixima Aurobindo may temporarily increase the possibility that you develop infections caused by other pathogens on which cefixime does not act. For example, thrush (infection caused by a fungus called Candida) may appear.

Other medicines and Cefixima Aurobindo
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:

• Medicines that are known to be harmful to the kidneys, such as:
• antibiotics, including aminoglycoside antibiotics, polymyxin B, colistin or viomycin,
• medicines that increase the amount of urine produced by the body (diuretics) such as ethacrinic acid and furosemide
• nifedipine (a drug used to treat heart problems such as arrhythmia and high blood pressure).
• anticoagulants (medicines that thin the blood) such as warfarin. In some patients, cefixime causes problems with blood clotting and may increase the time it takes for blood to clot.
• Oral contraceptives (birth control pills).

Effects on laboratory tests
If you are going to have blood or urine tests, tell your doctor that you are taking Cefixima Aurobindo, as Cefixima Aurobindo may alter the results of these tests.
Cefixima Aurobindo can alter the results of some urine tests for sugars (such as Benedict or Fehling tests). If you have diabetes and undergo regular urine tests, tell your doctor. In fact, other tests may be used to monitor diabetes while you take this medicine.
Cefixima Aurobindo can alter the results of some urine tests for ketones. Tell your doctor that you are taking Cefixima Aurobindo, as other tests may be needed.
Cefixima Aurobindo can alter the results of a blood test for antibodies called the direct Coombs test.

Cefixima Aurobindo with food, drinks and alcohol
Cefixima Aurobindo can be taken with or without food. The tablets should be swallowed with a glass of water.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Ask your doctor or pharmacist before taking any medicine.

Driving and operating machinery
Cefixima Aurobindo should not affect your ability to drive and operate machinery.

Cefixima Aurobindo contains
Cefixima Aurobindo contains soy lecithin. If you are allergic to peanuts or soy, do not use this medicine.

3. How to take Cefixima Aurobindo

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
These tablets must be taken by mouth. You should try to take this medicine every day at about the same
time.
The recommended dose is:
Adults and adolescents over 12 years of age:
1 X 400 mg per day as a single dose
2 X 200 mg in daily dose.

Patients with kidney problems:
If you have severe kidney problems or are undergoing dialysis, your doctor will reduce your dose. The doctor
will calculate the right dose for you according to the results of blood or urine tests that measure your
kidney function. There is not enough information about the use of cefixime in children and
adolescents with kidney problems. Therefore, the use of Cefixima is not recommended in these patients.

Elderly people
No dose changes are necessary in elderly patients, if kidney function is normal.

Adolescents aged 12 years and over:
Adolescents aged 12 years and over can take the same dosage as adults.

Children under 12 years of age:
The tablet pharmaceutical form is not suitable for the treatment of children. Ask your doctor for more
information.

If you take more Cefixima Aurobindo than you should
If you have accidentally taken too many tablets or if a child has ingested any tablets, contact
the emergency room of the nearest hospital or inform your doctor immediately. Bring the
tablets with you even if there are no more left in the box so that the doctor knows exactly
what you have taken.

If you forget to take Cefixima Aurobindo
If you have missed a dose of this medicine, take it as soon as you remember. However, if less than
6 hours remain until the next dose, skip the missed dose and return to your usual schedule.
Do not take a double dose to make up for the missed dose.

If you stop taking Cefixima Aurobindo
Do not stop taking the tablets without your doctor's advice, even if you feel better. It is
important that you take the medicine until the end of the cycle prescribed by your doctor. If you stop too
early, the infection may start again. If the patient undergoing treatment continues to feel unwell at the end
of the prescribed cycle, or if they get worse during treatment, inform the doctor.
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.
manifest.

The following side effects are important and require immediate action if you
experience them. You must stop taking cefixima and see your doctor immediately
if you develop the following symptoms:
Very rare (may affect up to 1 in 10,000 people)

• severe watery 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 leading to a feeling of tightness in the chest, wheezing and collapse;
• severe skin disease with blistering on the skin, in the mouth, eyes and genitals (Stevens Johnson Syndrome, toxic epidermal necrolysis) (see section 2 What you need to know before taking Cefixima Aurobindo - Warnings and precautions).

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

• severe skin rash, fever, swollen lymph nodes, increased number of white blood cells called eosinophils (DRESS syndrome) (see section 2 What you need to know before taking Cefixima Aurobindo - 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 (stomach ache), indigestion
• abnormalities in blood tests checking liver function
• skin rash

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

• increased possibility of developing infections caused by germs on which cefixima does not act, such as, for example, “thrush”
• increased number of white blood cells called eosinophils
• allergic reaction
• loss of appetite
• dizziness
• flatulence (gas in the intestines)
• skin itching
• inflammation of mucous membranes (moist) such as those of the mouth and/or other internal surfaces
• fever
• changes in blood tests checking kidney function

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

• decrease in the number of different blood cells (symptoms may include fatigue, new infections, bruising or bleeding)
• allergic reaction characterized by skin rash, fever, joint pain and enlargement of organs
• restlessness and hyperactivity
• liver problems including jaundice (yellowing of the skin and whites of the eyes)
• kidney inflammation

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

• increased number of platelets in the blood (thrombocytosis)
• reduction in the number of a type of white blood cells (neutropenia)
• dyspepsia
• skin rash or skin lesions with a pink/red ring and a clear central part that may be itchy, scaly or filled with fluid. The rash may appear especially on the palms of the hands or soles of the feet. These may be signs of a serious allergic reaction to the medicine called “erythema multiforme”.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. 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 Aurobindo

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 pack 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 waste water 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 Aurobindo contains

• The active ingredient is cefixime. Each film-coated tablet contains 400 mg of cefixime (equivalent to 447.68 mg of cefixime in trihydrate form)
• The other ingredients are: Tablet core:Dibasic calcium phosphate anhydrous, pre-gelatinized starch (corn starch), hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate. Coating:Partially hydrolyzed polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, Xanthan gum

Description of the appearance of Cefixima Aurobindo and contents of the pack
Film-coated tablet.

Cefixima Aurobindo 400 mg film-coated tablets:
Tablets from white to almost white, film-coated, capsule-shaped, with beveled edges and
imprinted “E” and an incision line on one side and “8” and “7” separated by an incision line on the
other side. The tablet can be divided into two equal doses. The size of the tablet is 19.1 mm x
8.6 mm.
Cefixima Aurobindo is available in blister packs and in HDPE bottle packs.
Blister packs:
400 mg: 5, 6, 7, 8, 12 and 30 film-coated tablets
HDPE bottle packs: 20 and 500 film-coated tablets
Not all pack sizes may be marketed.

Marketing authorisation holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road, Ruislip
HA4 6QD
United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Bulgaria: Цефиксим Ауробиндо 400 mg филмирани таблетки
Hungary: Cefixim Aurovitas 200 mg filmtabletta
Italy: Cefixima Aurobindo
Portugal: Cefixima Aurovitas
Romania: Cefixima Aurobindo 200 mg/ 400 mg comprimate filmate

Medical advice/information
Antibiotics are used to treat bacterial infections. They are ineffective against viral infections.
If your doctor has prescribed antibiotics, you need them to properly treat your illness.
Despite antibiotics, some bacteria can survive or grow. This phenomenon is
called resistance: some antibiotic treatments become ineffective.
The misuse of antibiotics increases resistance. It can even help bacteria become resistant

• adequate dosage
• appropriate dosages
• duration of treatment.

Therefore, in order to preserve the effectiveness of this medicine:

• 1 - Use antibiotics only when they are prescribed to you.
• 2 - Follow the prescription strictly.
• 3 - Do not reuse the antibiotic without a prescription, even if you want to treat a similar condition.
• 4 - Never give an antibiotic to another person; it may not be suitable for their illness.
• 5 – After completing the treatment, return the unused medicine to your pharmacy, to be sure to dispose of it correctly.