Cefixime Aurobindo

Patient Information Leaflet

Cefixima Aurobindo 400 mg film-coated tablets

Generic medicine
Please read all of 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 give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to 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 taking 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 Cefixima Aurobindo is and what it is used for

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

• middle ear infections,
• infections causing acute exacerbation of chronic bronchitis,
• acute uncomplicated bladder infections,
• uncomplicated kidney infections.

Talk to 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-type 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
Talk to 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 unsure whether 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-type antibiotics. 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 penicillin, as you may also be allergic to this medicine. In patients who develop a severe allergic reaction or anaphylaxis (a serious allergic reaction causing difficulty breathing and dizziness) after administration of cefixime, this medicine must be discontinued and appropriate medical treatment must be administered.
• if you are taking other medicines known to be harmful to your kidneys. Inform your doctor if you have kidney problems. Your doctor may prescribe regular tests to monitor kidney function during treatment.
• if you experience severe or persistent diarrhoea, stomach pain, or cramps during or shortly after treatment with cefixime, stop taking this medicine and contact your doctor immediately. Medicines that slow down or stop intestinal movements must not be taken.

If you develop a condition 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 likelihood of developing infections caused by other pathogens not affected by cefixime. For example, oral thrush (a fungal infection caused by Candida) may occur.
Other medicines and Cefixima Aurobindo
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:

• Medicines 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 ethacrynic acid and furosemide,
• nifedipine (a medicine used to treat heart conditions such as arrhythmia and high blood pressure).
• anticoagulants (medicines that thin the blood) such as warfarin. In some patients, cefixime may cause problems with blood clotting and may increase the time required for blood to clot.
• oral contraceptives (birth control pills).

Effects on laboratory tests
If you need to undergo blood or urine tests, inform your doctor that you are taking Cefixima Aurobindo, as Cefixima Aurobindo may alter the results of these tests.
Cefixima Aurobindo may alter the results of certain urine sugar tests (such as Benedict's or Fehling's tests). If you have diabetes and undergo regular urine testing, inform your doctor. Alternative tests may be used to monitor diabetes while you are taking this medicine.
Cefixima Aurobindo may alter the results of certain urine ketone tests. Inform your doctor that you are taking Cefixima Aurobindo, as alternative tests may be required.
Cefixima Aurobindo may 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, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
Cefixima Aurobindo should not affect your ability to drive or operate machinery.
Cefixima Aurobindo contains
Cefixima Aurobindo contains soya lecithin. If you are allergic to peanuts or soya, do not use this medicine.

3. How to take Cefixima Aurobindo

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
These tablets are to be taken by mouth. Try to take this medicine at about the same time each day.
The recommended dose is:
Adults and adolescents over 12 years of age:
1 x 400 mg once daily as a single dose
or
2 x 200 mg as the total daily dose.

Patients with kidney problems:
If you have severe kidney problems or are undergoing dialysis, your doctor will reduce your dose. Your doctor will calculate the appropriate dose based on blood or urine test results assessing kidney function. There is insufficient information on the use of cefixime in children and adolescents with kidney problems. Therefore, the use of Cefixima is not recommended in these patients.

Elderly patients:
Dose adjustments are not necessary in elderly patients if kidney function is normal.

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

Children under 12 years of age:
The tablet form is not suitable for treating children. Please consult your doctor for further information.

If you take more Cefixima Aurobindo than you should
If you accidentally take too many tablets or if a child swallows any tablets, contact the nearest hospital emergency department or inform your doctor immediately. Take the tablets with you, even if none are left in the pack, so that the doctor knows exactly what has been taken.

If you forget to take Cefixima Aurobindo
If you miss a dose of this medicine, 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 your regular dosing schedule. Do not take a double dose to make up for the forgotten dose.

If you stop taking Cefixima Aurobindo
Do not stop taking the tablets without consulting your doctor, even if you feel better. It is important to continue taking the medicine for the full duration prescribed by your doctor. Stopping treatment too early may cause the infection to return. If the patient being treated still does not feel well at the end of the prescribed course, or if symptoms worsen during treatment, inform 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 will get them.
The following side effects are important and require immediate action if you experience them. You must stop taking cefixime and seek immediate medical attention if you develop any of 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 chest tightness, wheezing and collapse;
• severe skin disease with blistering of the skin, 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, increase in white blood cells called eosinophils (DRESS syndrome) (see section 2 What you need to know before taking Cefixima Aurobindo – Warnings and precautions).

The following adverse reactions 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 assessing liver function
• skin rash

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

• increased risk of developing infections caused by microorganisms not affected by cefixime, such as "thrush"
• increase in white blood cells called eosinophils
• allergic reaction
• loss of appetite
• dizziness
• flatulence (intestinal gas)
• inflammation of moist mucous membranes such as those of the mouth and/or other internal surfaces
• fever
• changes in blood tests assessing 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, bruising or bleeding)
• allergic reaction characterised by skin rash, fever, joint pain and organ enlargement
• 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 lesions with a pink/red ring and a pale central area which may be itchy, scaly or filled with fluid. The rash may appear particularly on the palms of the hands or soles of the feet. These could be signs of a serious allergic reaction to the medicine called "erythema multiforme".

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. 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 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 carton after EXP. The expiry
date refers to the last day of that month.
Store below 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Cefixima Aurobindo contains

• The active substance is cefixime. Each film-coated tablet contains 400 mg of cefixime (equivalent to 447.68 mg of cefixime trihydrate)
• The other components are: Tablet core: Dibasic anhydrous calcium phosphate, pregelatinized starch (corn starch), hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate. Coating: Partially hydrolyzed polyvinyl alcohol, titanium dioxide, talc, soya 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:
White to almost white, film-coated, capsule-shaped tablets with bevelled edges, marked with “E” and a breakline on one side, and “8” and “7” separated by a breakline on the other side. The tablet can be divided into two equal doses. The tablet size is 19.1 mm x 8.6 mm.
Cefixima Aurobindo is available in blister packs and in HDPE bottles.
Blister packs:
400 mg: 5, 6, 7, 8, 12 and 30 film-coated tablets
HDPE bottles: 20 and 500 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization 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 authorized in the European Economic Area Member States under the following names:
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 antibiotic treatment, some bacteria may survive or grow. This phenomenon is called resistance: certain antibiotic treatments become ineffective.
Improper use of antibiotics increases resistance. It may even help bacteria become resistant, delaying treatment or reducing the effectiveness of the antibiotic if the following are not respected:

• Adequate dosage
• Appropriate dosing regimen
• Duration of treatment

Therefore, to preserve the effectiveness of this medicine:
1 – Use antibiotics only when prescribed by a doctor.
2 – Follow the prescription exactly.
3 – Do not reuse antibiotics without a medical prescription, even if you wish to treat a similar condition.
4 – Never give antibiotics to another person; they may not be suitable for their illness.
5 – After completing treatment, return any unused medicine to your pharmacy for proper disposal.