CEFPODOXIME PROXETIL 100 MG FILM-COATED TABLETS - Patient leaflet, side effects, dosage

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet:

• 1. What Cefpodoxime is and what it is used for

• 2. What you need to know before you take Cefpodoxime

• 3. How to take Cefpodoxime

• 4. Possible side effects

• 5. How to store Cefpodoxime

• 6. Contents of the pack and other information

1. what cefpodoxime is and what it is used for

Cefpodoxime tablets contain cefpodoxime, which is an antibiotic. It belongs to a group of antibiotics that are called cephalosporins. These types of antibiotics are similar to penicillin.

Cefpodoxime kills bacteria and it can be used against various sorts of infections.

Like all antibiotics, cefpodoxime is only effective against some types of bacteria. So, it is only suitable for treating some types of infection.

Cefpodoxime can be used to treat:

• acute bacterial sinus infections
• throat infections
• chest infections such as bronchitis and some types of pneumonia

2. what you need to know before you take cefpodoxime if you are allergic to cefpodoxime or to any of the other ingredients of this medicine (listed in section 6).

• if you are allergic to any other cephalosporin type of antibiotic.
• if you have ever had a severe allergic reaction to any sort of penicillin antibiotic.

Not all people who are allergic to penicillins are also allergic to cephalosporins. However, you should not take this medicine if you have ever had a severe allergic reaction to any penicillin. This is because you might also be allergic to this medicine.

If you are not sure about anything, ask your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before taking Cefpodoxime:

• If you have ever had an allergic reaction to any antibiotic.
• If you have any other allergies, e.g. hayfever, asthma.
• If you have ever been told that your kidneys do not work very well. Also, if you are having

any sort of treatment (like dialysis) for kidney failure. You may take cefpodoxime but you may need a lower dose.

• If you have ever had inflammation of your bowel, called colitis or any other severe disease affecting your gut.
• If you have, or have recently had, severe diarrhoea and sickness (vomiting).
• If you have diabetes and routinely test your urine, this medicine can alter the results of urine

tests for sugar (such as Benedict's or Fehling's tests). Other tests may have to be used to monitor your diabetes while you are taking this medicine.

• has signs of diseases of the skin or mucous.

During treatment

• This medicine can alter the results of some blood tests (such as cross-matching blood and the Coombs' test). It is important to tell the doctor that you are taking this medicine if you have to have any of these tests.
• Your doctor might have to monitor your blood liver enzymes levels as this medicine may increase their values.
• Talk to your doctor or pharmacist if you suffer from severe diarrhoea or being sick especially if you are also taking other medicines, including oral contraceptives, as you may need to use another form of contraception.
• If you get other infections such as thrush, talk to your doctor or pharmacist.

Other medicines and Cefpodoxime

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This medicine can be affected by other medicines that are removed by the kidneys. This is especially if these other medicines also affect how well kidneys work. There are many medicines that can do this, so you should check with your doctor or pharmacist before taking this medicine.

In particular, tell your doctor or pharmacist if you are taking:

• Antibiotics called aminoglycosides (such as gentamicin) or other antibiotics such as chloramphenicol, erythromycin, tetracycline or sulfonamides (e.g. co-trimoxazole).
• Water tablets or injections (diuretics) such as furosemide used to increase the flow of your water (urine). It might be necessary to check your kidneys often during treatment. This can be done with blood and urine tests.
• Antacids (used to treat indigestion) and medicines for treating ulcers (such as ranitidine or cimetidine): Take antacids and medicines for ulcers 2–3 hours after this medicine as they may reduce the effect of cefpodoxime when taken at the same time.
• Probenecid as it may slow down the kidneys’ ability to get rid of cefpodoxime.
• Coumarin anti-coagulants such as warfarin (used to thin the blood) as their effect may be increased by cefpodoxime.
• Contraceptive pills as this type of medicines can reduce their contraceptive effect.

Cefpodoxime with food

Take this medicine with meals. This is because it helps this medicine to be absorbed into the body.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Are you pregnant, think you might be pregnant or planning to have a baby? Although this medicine is not known to harm the unborn child, it will only be given to a pregnant woman if it is really necessary.

Breast-feeding

This medicine should not be given to women who are breast-feeding. This is because small amounts of it enter the milk. This could cause an allergic reaction or other side effects in the breast-fed baby.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You may get dizzy, light headed or in more extreme cases experience convulsions, confusion, change of consciousness and movement disorders when taking this medicine. This may affect your ability to drive or operate machinery. If this happens, do not drive or use machines.

Cefpodoxime contains lactose monohydrate.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Cefpodoxime contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. how to take cefpodoxime

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. //

The dispensing label will tell you how much of this medicine you should take and how often you should take it. Please read it carefully. The dose your doctor prescribes depends on the type of infection and how bad the infection is. It also depends on how well the kidneys are working. Your doctor will explain this to you.

Information on how many tablets and how often they should be taken will exactly be written on the dispensing label. Please read it carefully.

The tablets should be taken with meals because this improves the absorption of cefpodoxime into the body. The tablets should be swallowed whole with a glass of water.

The recommended doses are given below. However, your doctor may prescribe a different dose to those below: if this applies to you, discuss it with your doctor if you have not already done so.

The dose you are prescribed will depend on the type and severity of the infection.

The recommended dose is:

Adults and Elderly with no kidney problems:

Acute bacterial sinus infections: 200mg twice a day.

Throat infections: 100mg twice a day.

Chest infections and pneumonia: 200mg twice a day.

Use in children and adolescents

Cefpodoxime Powder for Oral Suspension may be available to treat infants over the age of four weeks and children.

Adults with kidney problems:

Depending on how serious the kidney problems are, the usual dose of cefpodoxime for the type of infection you have may need to be given only once a day instead of twice a day or even once every two days. Your doctor will decide how much you need to take.

If you are on haemodialysis you will usually be given a dose after each dialysis session. Your doctor will tell you how much to take each time.

If you take more Cefpodoxime than you should

If you have taken more of this medicine than you should, talk to your doctor straight away or go to the nearest hospital accident and emergency department. You may feel unable to concentrate, lack energy and experience a decrease in consciousness. These effects are more likely to occur if you have kidney problems. Take the medicine with you in the carton, so that staff will know exactly what has been taken.

If you forget to take Cefpodoxime

If you forget to take a dose of this medicine at the right time, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.

If you stop taking Cefpodoxime

It is important that you take this medicine until you finish the prescribed course. You should not stop the medicine just because you feel better. If you stop too soon, the infection may start up again. If the person being treated still feels unwell at the end of the prescribed course of treatment, or feels worse during treatment, tell your doctor.

If you have any further questions on 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.

If you notice any of the following side effects, stop taking this medicine and contact your doctor or go to the nearest hospital casualty department straight away:

• A reduction of white blood cells, that may cause an increase in the number of new infections that you get, such as sore throat or mouth ulcers, or damage to red blood cells, that may cause you to feel tired and breathless with possible yellowing of the skin.
• Severe allergic reactions which may cause sudden wheeziness and tightness of chest, swelling of eyelids, face or lips, loss of consciousness (fainting).
• Severe skin rashes which may include peeling of the skin (Toxic epidermal necrolysis) or that can blister (bullous dermatitis) and may involve the eyes, mouth and throat and genitals (Stevens-Johnson syndrome).
• A course of cefpodoxime can increase the chance that you get other types of infection. For example, thrush may occur (white patches on the tongue or a creamy white discharge from the penis or vagina) or severe diarrhoea which may be bloody with stomach pain.
• Liver damage causing jaundice (this may show as a yellowing of the skin or whites of the eyes).
• Sudden severe dull pain around the top of the stomach which radiates to the back, feeling and being sick, which may be due to inflammation of the pancreas.
• A disease that affects the function or structure of your brain (encephalopathy). The symptoms might include among others difficulty with memory or focusing and changes in personality.

Other possible side effects

• Stomach pain.
• Diarrhoea. If you have severe diarrhoea or if you see blood in your diarrhoea you should stop taking this medicine and talk to your doctor immediately.

Common (may affect up to 1 in 10 people

• Dizziness.
• Bloating, feeling or being sick (nausea, vomiting), , flatulence (wind).
• Loss of appetite.
• Changes in blood tests that check how your liver is working.
• Skin rash, hives, itching
• Ringing in the ears

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

• Skin and mucosa skin allergic reactions.
• Pins and needles.
• Weakness, tiredness and a feeling of generally being unwell.

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

• Increases in some types of white blood cells, reduced number of small cells that are needed for clotting of the blood, which may cause easy bruising or bleeding.
• Increases in the numbers of small cells that are needed for clotting of the blood, which may show up in blood tests.
• Changes in the way that the kidney is working, which may show up in blood tests.

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

• Reduction of red blood cells (haemolytic anaemia)

Not Known (frequency cannot be estimated from the available data)

• Fresh, red blood in your stools (haematochezia).
• Purplish-red patches
• Kidney problems.

During treatment

If you are having a blood test for any reason, tell the person who is taking your blood sample that you are taking this medicine as it may affect your result.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via [to be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store cefpodoxime

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 label and carton after EXP. The expiry date refers to the last day of that month.

Aluminium/PVC/PVDC blisters: Do not store above 25°C. Store in the original package.

Aluminium blisters : Store in the original package.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information- the active substance is cefpodoxime proxetil, equivalent to 100mg or 200mg cefpodoxime.

• – The other ingredients are carboxymethyl cellulose calcium, lactose monohydrate (see section 2,

What Cefpodoxime looks like and contents of the pack

Cefpodoxime proxetil 100 mg Film-coated tablets are round, white to yellowish tablets with a diameter of approx. 9 mm.

Cefpodoxime proxetil 100 mg Film-coated tablets are available in blister packs of 10, 12, 20 or 30 tablets

Cefpodoxime proxetil 200 mg Film-coated tablets are Oblong, white to yellowish tablets, scored on both sides, size approx. 6.5 × 16 mm. The tablet can be divided into equal halves.

Cefpodoxime proxetil 200 mg Film-coated tablets are available in blister packs of 6, 10, 14 or 15 tablets

Marketing Authorisation Holder

[To be completed nationally]

Manufacturer

Sandoz GmbH, Biochemiestrasse 10, 6250Kundl, Austria

Mylan dura GmbH, WittichstraBe 6, D-64295 Darmstadt, Germany

Generics [UK] Ltd

Station Close, Potters Bar,

Hertfordshire, EN6 1TL, United Kingdom

Mc Dermott Laboratories Ltd t/a Gerard Laboratories

35/36, Baldoyle Industrial Estate,

Grange Road, Dublin 13, Ireland

Mylan Hungary Kft

H-2900 Komarom

Mylan utca 1

Hungary

This medicinal product is authorised in the Member States of the EEA under the following names:

UK: Cefpodoxime proxetil 100 mg film-coated tablets

Italy: Cefpodoxima Mylan

This leaflet was last revised in June 2019