CEFUROXIME MYLAN

Package leaflet: Information for the patient

Cefpodoxima Mylan 100 mg film-coated tablets, 200 mg film-coated tablets

cefpodoxime (as proxetil)
Generic medicine
Please read all of this leaflet carefully before you take 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 side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Cefpodoxima Mylan is and what it is used for

Cefpodoxima tablets contain cefpodoxime, which is an antibiotic. It belongs to a group of
antibiotics called cephalosporins. These types of antibiotics are similar to penicillins.
Cefpodoxime kills bacteria and can be used against various types of infections.
Like all antibiotics, cefpodoxime is effective only against certain types of bacteria. Therefore, it
is suitable for treating only certain types of infections.
Cefpodoxime may be used to treat:

• Acute bacterial sinus infections
• Throat infections
• Chest infections, such as bronchitis and certain types of pneumonia

2. What you need to know before taking Cefpodoxima Mylan

Do not take Cefpodoxima Mylan if:

• you are allergic to cefpodoxime or to any of the other ingredients of this medicine (listed in section 6);
• you are allergic to any other type of cephalosporin;
• you have ever had a severe allergic reaction to any antibiotic belonging to the penicillin class.

Not all patients who are allergic to penicillins are also allergic to cephalosporins.
However, you must not take this medicine if you have had a severe allergic reaction to
penicillin. This is because you may also be allergic to this medicine.
If you are unsure, ask your doctor or pharmacist.
Warnings and precautions
Severe skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal
necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and generalized
acute exanthematous pustulosis (GEP), associated with cefpodoxime therapy. Discontinue the use of cefpodoxime and seek immediate medical advice if
you develop any of the symptoms related to these severe skin reactions described in
section 4.
Talk to your doctor or pharmacist before taking Cefpodoxima Mylan if:

• you have ever had an allergic reaction to any antibiotic.
• you suffer from other allergies, for example hay fever or asthma.
• you have been told that your kidneys do not function properly or you are undergoing any type of treatment for kidney failure (such as dialysis). In such cases you may take cefpodoxime, but you may need a lower dose.
• you have ever had an intestinal inflammation called colitis or any other serious intestinal disease.
• you currently have, or have recently had, severe diarrhoea and sickness (vomiting).
• you have diabetes and regularly test your urine, as this medicine may alter the results of urine sugar tests (such as Benedict's or Fehling's tests). Other tests may be needed to monitor your diabetes while taking this medicine.
• you experience skin or mucous membrane disorders.

During treatment

• This medicine may alter the results of certain blood tests (such as blood grouping tests and Coombs test). It is important to inform your doctor that you are taking this medicine if you are due to undergo any of these tests.
• Your doctor may need to monitor your liver enzyme levels in the blood, as this medicine may increase these values.
• Speak with your doctor or pharmacist if you develop severe diarrhoea or feel unwell, especially if you are also taking other medicines, including oral contraceptives, as you may need to use alternative contraceptive methods.
• If you develop other infections such as thrush, consult your doctor or pharmacist.

Other medicines and Cefpodoxima Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
This medicine may be affected by other medicines that are eliminated via the
kidneys; particularly if these other medicines also affect kidney function. There
are many medicines that can do this, so you must check with your doctor or
pharmacist before taking this medicine.
In particular, inform your doctor or pharmacist if you are taking:

• antibiotics known as aminoglycosides (such as gentamicin) or other antibiotics such as chloramphenicol, erythromycin, tetracycline or sulphonamides (e.g. co-trimoxazole).
• diuretics, oral or injectable, such as furosemide, used to increase urine flow. Kidney function may need to be monitored frequently during treatment. This can be done through blood and urine tests.
• Antacids (used to treat indigestion) and medicines used to treat ulcers (such as ranitidine and cimetidine): take antacids and ulcer medicines 2-3 hours after taking this medicine, since they may reduce the effect of cefpodoxime if taken at the same time.
• Probenecid may reduce the kidney's ability to eliminate cefpodoxime.
• Coumarin anticoagulants such as warfarin (used to thin the blood), as their effect may be increased by cefpodoxime.
• Oral contraceptives, as this type of medicine may reduce their contraceptive effectiveness.

Cefpodoxima Mylan with food
Take Cefpodoxima Mylan with meals. This helps the absorption of the
medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Are you pregnant, think you might be, or are planning to have a baby? Although it is not known that
this medicine harms the unborn child, it should be used in pregnant women only if clearly necessary.
Breastfeeding
This medicine should not be given to women who are breastfeeding, as small amounts
may pass into breast milk. This could cause an allergic reaction or other adverse effects
in the breastfed infant.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
When taking this medicine, you may experience dizziness or a feeling of light-headedness, or in more severe cases, seizures, confusion, altered consciousness, and movement disorders. This may affect your ability to drive or operate machinery. If this occurs, you must not drive or operate machinery.
Cefpodoxima Mylan contains lactose monohydrate.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking
this medicine.
Cefpodoxima Mylan contains less than 1 mmol (23 mg) of sodium per tablet, i.e.
essentially “sodium-free”.

3. How to take Cefpodoxima Mylan

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your prescription will tell you how much of this medicine to take and how often: please read it carefully. The dose prescribed by your doctor depends on the type and severity of the infection, as well as on how well your kidneys are functioning. Your doctor will explain this to you.
The information regarding how many tablets to take and when to take them will be clearly indicated on the prescription; it is recommended that you read it carefully.
The tablets should be taken with meals, as this improves the absorption of cefpodoxime into the body. Swallow the tablets whole with a glass of water.

The recommended doses are listed below. However, your doctor may prescribe a different dose: if this applies to you, discuss it with your doctor if you have not already done so.
The dose prescribed for you depends on the type and severity of the infection.

Recommended dose:
Adults and elderly patients without kidney problems:

• Acute bacterial sinus infections: 200 mg twice daily
• Throat infections: 100 mg twice daily
• Chest infections and pneumonia: 200 mg twice daily

Use in children and adolescents:
For the treatment of infants over four weeks of age and children, Cefpodoxima Mylan oral suspension powder may be available.

Adults with kidney problems:
Depending on the severity of kidney impairment, the usual dose of cefpodoxime for the type of infection may need to be administered once daily instead of twice daily, or may be taken once every two days. Your doctor will decide which dose is appropriate for you.
If you are undergoing haemodialysis, you will usually be given a dose after each dialysis session. Your doctor will tell you the exact dose to take each time.

If you take more Cefpodoxima Mylan than you should
If you have taken more of this medicine than you were supposed to, contact your doctor immediately or go to the nearest hospital emergency department. You may experience lack of concentration, reduced energy, and decreased level of consciousness. These effects are more likely if you have kidney problems. Take the medicine with you in its original packaging so that doctors can clearly see what you have taken.

If you forget to take Cefpodoxima Mylan
If you forget to take a dose of this medicine at your usual time, take it as soon as you remember.
Do not take a double dose to make up for the missed dose.

If you stop taking Cefpodoxima Mylan
It is important that you continue taking this medicine for the full duration of the prescribed treatment. Do not stop taking the medicine just because you feel better. If you stop too early, the infection may return. If the patient being treated does not feel better by the end of the prescribed treatment course, or feels worse during treatment, consult the doctor.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Stop using cefpodoxime and contact your doctor immediately if you notice any of the following symptoms:

• Widespread skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome);
• A widespread, red, scaly rash with formation of subcutaneous pustules and blisters accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalised exanthematous pustulosis).

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking the medicine and contact your doctor or go to the nearest hospital emergency department:

• A reduction in the number of white blood cells, which may increase the risk of infections such as sore throat or mouth ulcers, or damage to red blood cells, which may cause fatigue or shortness of breath with possible yellowing of the skin.
• Severe allergic reactions which may cause sudden wheezing and tightness in the chest, swelling of the eyelids, face or lips, or loss of consciousness (fainting).
• Severe skin rash which may include skin peeling (toxic epidermal necrolysis) or formation of blisters (bullous dermatitis), possibly affecting eyes, mouth, throat and genitals (Stevens-Johnson syndrome).
• A course of cefpodoxime may increase the likelihood of developing an infection. For example, oral thrush (white patches on the tongue) or severe diarrhoea, which may be bloody and associated with stomach pain, may occur.
• Liver damage causing jaundice (this appears as yellowing of the skin and whites of the eyes).
• Sudden, severe, dull pain in the upper abdomen spreading to the back, feeling unwell, which may be signs of inflammation of the pancreas.
• A condition affecting the structure and/or function of the brain (encephalopathy). Symptoms may include, among others, memory disturbances, difficulty concentrating, and personality changes.

Other possible side effects
Very common (may affect more than 1 in 10 people):

• Headache.
• Stomach pain.
• Diarrhoea. If you have severe diarrhoea or notice blood in your stool, you must stop taking this medicine and speak to your doctor immediately.

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

• Dizziness
• Swelling, feeling or state of discomfort (nausea, vomiting), flatulence (gas)
• Loss of appetite
• Changes in certain blood test values assessing liver function
• Skin rash, hives, itching
• Ringing in the ears

Uncommon (may affect up to 1 in 100 people):

• Allergic reactions of the skin and mucous membranes
• Tingling sensations
• Weakness, fatigue, and general feeling of malaise

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

• Increase in certain types of white blood cells, reduction in the number of small cells needed for blood clotting, which may lead to easy bruising or bleeding
• Increase in the number of small cells needed for blood clotting, which may be detected in blood tests
• Changes in blood tests used to monitor kidney function

Very rare (may affect less than 1 in 1,000 people):

• Reduction in red blood cells (haemolytic anaemia)

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

• Presence of bright red blood in stools (haematochezia)
• Reddish-purple spots
• Kidney problems

During treatment
If you need to have a blood test for any reason, tell the person taking the sample that you are taking this medicine, as it may affect the test results.
Reporting of side effects
If you get any side effects, 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
https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cefpodoxima Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the term “Exp.”. The expiry date refers to the last day of the month.
Aluminum-PVC/PE/PVDC blisters: Do not store above 25°C. Keep in the original packaging.
Aluminum-aluminum blisters: Keep in the original packaging.
Do not dispose of any medicine 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 Cefpodoxima Mylan contains

• The active substance is cefpodoxime proxetil, equivalent to 100 mg or 200 mg of cefpodoxime.
• The excipients are: calcium carboxymethylcellulose, monohydrate lactose (see section “Cefpodoxima Mylan contains monohydrate lactose”), crospovidone, hydroxypropylcellulose, magnesium stearate, sodium lauryl sulfate, hypromellose, talc, titanium dioxide (E171).

Description of the appearance of Cefpodoxima Mylan and contents of the pack
Cefpodoxima Mylan 100 mg film-coated tablets are round, white to yellowish tablets, approximately 9 mm in diameter.
Cefpodoxima Mylan 100 mg film-coated tablets are available in blister packs containing 10, 12, 20 or 30 tablets.
Cefpodoxima Mylan 200 mg film-coated tablets are oblong, white to yellowish tablets, with a breakline on both sides, approximately 6.5 x 16 mm in size.
The tablets can be divided into two equal parts.
Cefpodoxima Mylan 200 mg film-coated tablets are available in blister packs containing: 6, 10, 14 or 15 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano, Italy

Manufacturer responsible for batch release:
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria
Mc Dermott Laboratories Ltd t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland
Mylan Hungary Kft
H-2900 Komárom
Mylan utca 1
Hungary

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Italy: Cefpodoxima Mylan