CEFIXIMA 400 mg Film-Coated Tablets

Зміст інструкції

1. Cefixima Sandoz 400 mg film-coated tablets
   1. What is Cefixima Sandoz and what is it used for
   2. What you need to know before taking Cefixima Sandoz
2. Cefixima Sandoz (reduction of red blood cells which may cause paleness, weakness or shortness of breath)
   1. How to take Cefixima Sandoz
   2. Possible side effects
   3. How to store Cefixima Sandoz
   4. Package contents and other information

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

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

Cefixima Sandoz contains the active ingredient cefixime. This medicine belongs to a group of
antibiotics called "cephalosporins", for the treatment of bacterial infections in adults and
adolescents aged 12 years and over, such as:

• Acute ear infection
• Acute infection of nasal cavities and paranasal sinuses
• Acute exacerbation of chronic bronchitis
• Community-acquired pneumonia
• Uncomplicated urinary tract infections
• Uncomplicated acute gonorrhea

You should see a doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Cefixima Sandoz

Do not take Cefixima Sandoz if:

• you are allergic to cefixime or to any of the other ingredients of this medicine (listed in section 6).
• you are allergic to any other cephalosporin antibiotic.

Warnings and precautions
Talk to your doctor or pharmacist before taking Cefixima Sandoz:

• if you have ever had an allergic reaction due to an antibiotic treatment. You may also be allergic to this treatment.
• if you suffer from kidney disease. Your doctor will need to adjust the daily dose.
• if you have ever had hemolytic anemia after taking a cephalosporin antibiotic, including

Cefixima Sandoz (reduction of red blood cells which may cause paleness, weakness or shortness of breath)

During or after treatment, you must immediately inform your doctor:

• if you have diarrhoea. Do not take any treatment for diarrhoea without your doctor's advice.
• if you have pimples or itching.
• as with all drugs of this class of antibiotics (beta-lactam antibiotics), the administration of this medicine may involve a risk of encephalopathy, which can lead to convulsions, confusion, altered consciousness or abnormal movements, particularly in case of overdose or impaired renal function. If such symptoms occur, consult your doctor or pharmacist immediately (see paragraphs 3 and 4).
• if you have severe skin reactions such as toxic epidermal necrolysis (TEN, also known as Lyell's syndrome), Stevens-Johnson syndrome (SJS), drug hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) which have been reported with Cefixima Sandoz (see paragraph 4).

The doctor may decide to stop treatment with this medicine and/or prescribe an
appropriate treatment (see paragraph 4: "Possible side effects").
If you develop severe skin reactions or any of the reactions listed in paragraph 4, stop
treatment immediately and contact your doctor or healthcare professional.

Children
Cefixima Sandoz should not be used in children under 12 years of age.

Other medicines and Cefixima Sandoz
Tell your doctor if you are taking, have recently taken or might take any other
medicines. Tell your doctor if you are taking the following medicines, as they may interact with
Cefixima Sandoz:

• anticoagulant therapy (blood thinner)
• caution should be exercised when taking a calcium antagonist.

Effect on laboratory tests
If you are to undergo blood or urine tests, tell your doctor that you are taking Cefixima
Sandoz, as cefixima may alter the results of some of these tests.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Other substances of the group of medicines to which cefixima belongs are well tolerated during
pregnancy. The doctor will assess whether the benefits of therapy outweigh the possible risks to the newborn.
Breastfeeding
Since cefixima is excreted in small amounts in breast milk, you should ask your doctor if you can
take this medicine while breastfeeding. The doctor will decide whether to stop
breastfeeding or stop/abstain from therapy with Cefixima Sandoz, taking into account the
benefit of breastfeeding for the child and the benefit of therapy for you.

Driving and using machines
Cefixima may cause dizziness. If so, you should not drive vehicles or use
machinery.

Cefixima Sandoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially
‘sodium-free’.

3. How to take Cefixima Sandoz

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.

Dosage
The doctor will establish the correct dose of Cefixima Sandoz and will tell you for how long to take the
medicine. The number of Cefixima Sandoz tablets you will need to take will depend on your
condition. Follow the doctor's instructions scrupulously and never change the dose
autonomously. Ask your doctor or pharmacist if you have any doubts about the quantity or timing
of taking it.
Adults and adolescents (≥ 12 years)
The recommended dose is 400 mg of Cefixima Sandoz orally
1 tablet of 400 mg per day, as a single dose within 24 hours.
This medicine should always be taken at the same time each day.
Duration of treatment
Most infections can be treated in 7 days of therapy. However, in severe cases,
Cefixima Sandoz can also be used for 14 days.
Children under 12 years of age
Please note that Cefixima Sandoz tablets are not suitable for children; alternatively, it is
possible to use the oral suspension or consult your doctor for further information.
Elderly
For the elderly, the doses are the same as for adults, provided that renal function is normal.
Kidney problems
If you have severe kidney problems or are undergoing dialysis, your doctor will reduce the dose.
There is insufficient data on the use of Cefixima Sandoz in children with kidney problems. Therefore,
the use of Cefixima Sandoz is not recommended in these patients.
In case of creatinine clearance values < 20 ml/min, ambulatory peritoneal dialysis or
hemodialysis, the recommended dosage is 200 mg once a day.
Impaired liver function
No dosage adjustment is necessary for patients with impaired liver function.
Route of administration
For oral use.
The tablet should be taken with a sufficient amount of water and the tablets should be
swallowed whole. The fracture line is only to help you break the tablet if you have difficulty
swallowing it whole. The two halves should be taken immediately one after the other.
Cefixima Sandoz can be taken with or without food.

If you take more Cefixima Sandoz than you should
If you accidentally take too many tablets or if a child ingests any of the tablets
of Cefixima Sandoz, contact the emergency room of the nearest hospital or your
doctor immediately.

If you forget to take Cefixima Sandoz
If you forget to take a tablet, take it as soon as you remember. However, if the next dose
is due within less than 6 hours, skip the missed dose and resume your normal schedule of
taking it. Do not take a double dose to make up for the forgotten tablet.

If you stop taking Cefixima Sandoz
Do not interrupt the treatment prematurely, because it is important to complete the ENTIRE cycle of
this medicine to reduce the risk of infection recurrence.
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.
You should contact your doctor immediately if you experience any of the following
serious side effects:

Allergic reactions
All medicines can cause allergic reactions, although severe allergic reactions are rare
(may affect up to 1 in 1,000 people), very rare (may affect up to 1 in

• 10,000) or whose frequency is not known (the frequency cannot be estimated on the basis of the available data). These may include the following allergic reactions whose frequency is not known:
• Serum sickness-like reaction (an allergic reaction that can include symptoms such as rash, joint pain, muscle pain, fever)
• sudden wheezing and tightness in the chest
• swelling of the eyelids, face or lips

Diarrhoea (may affect up to 1 in 10 people):

• If you have diarrhoea during or after taking this medicine, you should not try to treat it yourself. You should contact your doctor immediately. The doctor may decide to stop treatment and prescribe appropriate treatment.
• There is a frequent risk of diarrhoea. There may be blood in the diarrhoea. In very rare cases, this may be a serious form of colitis (pseudomembranous colitis or enterocolitis), which requires stopping treatment.

Serious skin reactions

• Flu-like symptoms with rash, fever, swollen glands and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)). (frequency not known)
• Blisters or bleeding of the skin around the lips, eyes, mouth, nose and genitals. There are also flu-like symptoms and fever (Stevens-Johnson syndrome) (may affect up to 1 in 10,000).
• Severe rash with blisters, where layers of skin may peel off, leaving large areas of skin alive and exposed all over the body. There is also a feeling of general malaise, fever, chills and muscle pain (toxic epidermal necrolysis) (may affect up to 1 in 10,000).
• AGEP symptoms may include a red, scaly, widespread rash with bumps under the skin (including skin folds, chest, abdomen (including stomach), back and arms) and blisters accompanied by fever (may affect up to 1 in 10,000).

All these allergic reactions require urgent medical attention. If you think you have one of these types
of reaction, stop taking this medicine and contact your doctor or the nearest hospital emergency
room.
The following other side effects have been reported:

Not common (may affect up to 1 in 100):

• headache
• nausea
• vomiting
• stomach pain
• rash
• changes in blood tests that check liver function

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

• severe allergic reaction that causes swelling of the face or throat (angioedema)
• hypersensitivity reactions (these are skin rashes that are less severe allergic reactions than those mentioned above, nodular rash [urticaria], itching)
• dizziness/vertigo
• loss of appetite (anorexia)
• flatulence (wind)
• indigestion
• itching
• fever
• abnormally increased number of cells (eosinophils) in the blood, characteristic of allergic states
• increased urea in the blood (an indicator of kidney function)
• inflammation of the mucous membranes
• recurrent infections caused by bacteria
• recurrent infections caused by fungi

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

• severe allergic reaction that causes difficulty breathing or shock (anaphylactic shock)
• intestinal inflammation that sometimes occurs following antibiotic treatment (antibiotic-associated colitis)
• severe reduction in the number of white blood cells that increases the likelihood of infections (agranulocytosis)
• severe reduction in blood cells that can cause weakness, bruising or increase the likelihood of infections (pancytopenia)
• decrease in the number of small cells needed for blood clotting, which increases the risk of bleeding or bruising (thrombocytopenia) (if you are having a blood test for any reason, tell the person taking your blood sample that you are taking this medicine, as it may affect the result)
• reduction in red blood cells that can make the skin pale yellow and cause weakness or shortness of breath (hemolytic anemia)
• low white blood cell count (leukopenia)
• feeling of restlessness associated with increased activity (psychomotor hyperactivity)
• reversible inflammation of the kidney that impairs its structure and function
• inflammation of the liver (hepatitis)
• bile disorder (cholestatic jaundice)
• changes in specific blood tests showing kidney function (increased creatinine in the blood)

Not known (frequency cannot be estimated on the basis of the available data):

• acute kidney failure, including inflammation of the kidney that impairs its structure and function (acute renal failure, including tubulo-interstitial nephritis)
• a brain condition with symptoms including seizures, confusion, feeling less attentive or aware than usual, unusual muscle movements or stiffness.

This may be a condition called encephalopathy. This side effect is
more likely if you have taken too many tablets or already have kidney problems

• feeling of itching in the genital or vaginal area
• thrombocytosis
• decreased number of neutrophils in the blood (neutropenia)

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Cefixima Sandoz

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 blister and the outer packaging after
“Exp.”. The expiry date refers to the last day of that month.
Store at a temperature below 30 °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. Package contents and other information

What Cefixima Sandoz contains
The active ingredient is cefixime.
Each film-coated tablet contains 400 mg of cefixime (as cefixime trihydrate).
The other ingredients are:

• tablet core: dibasic calcium phosphate, microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate.
• tablet coating: macrogol copolymer grafted with poly(vinyl alcohol), talc, mono/diglycerides, titanium dioxide (E171), poly(vinyl alcohol)

Description of Cefixima Sandoz and package contents
Film-coated tablet.
Color from white to pale white, oblong, biconvex, with a breaking line on both sides and with
dimensions of approximately 8.4 x 19.8 mm.
This medicine is available in Alu/Alu blisters.
Packs: 5, 7, 10 and 14 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
Sandoz GmbH
Biochemiestraße 10,
6250 Kundl
Austria

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
BulgariaЦифемекс 400 mg филмирани таблеткиs

GermanyCefixim HEXAL 400 mg Filmtabletten

ItalyCefixima Sandoz

RomaniaAxtrifia 400 mg, film-coated tablets

SloveniaCefixim Sandoz 400 mg

SpainCefixima Sandoz 400 mg film-coated tablets EFG

Medical advice/education
Antibiotics are used to treat infections caused by bacteria. They are ineffective against
infections caused by viruses.
Sometimes an infection caused by bacteria does not respond to a course of antibiotic treatment. One
of the most common reasons is that the bacteria causing the infection are resistant to the antibiotic taken. This
means that they can survive and even multiply despite the antibiotic.
Bacteria can become resistant to antibiotics for several reasons. Using antibiotics with
caution can help reduce the risk that bacteria become resistant.
When your doctor prescribes a course of antibiotic treatment, they do so only to cure the
current illness. Paying attention to the following advice will help prevent the emergence of resistant bacteria that
could compromise the effectiveness of the antibiotic.

• 1. It is very important to take the antibiotic at the correct dosage, at the right times and for

If you have any doubts, ask your doctor or pharmacist for clarification.

• 2. You should not take an antibiotic unless it has been specifically prescribed for you and you should only use it to treat the infection for which it was prescribed.
• 3. You should not take antibiotics prescribed for other people, even if they have had an infection similar to yours.
• 4. You should not give your prescribed antibiotics to other people.
• 5. If you have any antibiotic left over after completing the treatment course as directed by your doctor, you should take it to the pharmacy for appropriate disposal.