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CEFPODOXIME PROXETIL 200 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

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Patient leaflet - CEFPODOXIME PROXETIL 200 MG FILM-COATED TABLETS

In this leaflet

  • 1. What Cefpodoxime proxetil Film-coated tablets is and what it is used for

  • 2. Before you take Cefpodoxime proxetil Film-coated tablets

  • 3. How to take Cefpodoxime proxetil Film-coated tablets

  • 4. Possible side effects

  • 5. How to store Cefpodoxime proxetil Film-coated tablets

  • 6. Further information

1. what cefpodoxim proxetil film-coated tablets is and what it is used for

Cefpodoxime 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:

  • sinus infections
  • throat infections
  • chest infections such as bronchitis and some types of pneumonia
  • 2. Before you take Cefpodoxim proxetil film-coated tablets

Do not take Cefpodoxim proxetil film-coated tablets if:

  • – You are allergic (hypersensitive) to cefpodoxime proxetil or to any of the other ingredients of Cefpodoxim proxetil film-coated tablets (See Further Information in Section 6).

  • – You are allergic (hypersensitive) to any other cephalosporin type of antibiotic

  • – 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:

Take special care with Cefpodoxim proxetil film-coated tablets if:

  • – You have ever had an allergic reaction to any antibiotic, tell your doctor or pharmacist before you take this medicine.

  • – 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.

  • – 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.

  • – This medicine can also alter the results of urine tests for sugar (such as Benedict's or Fehling's tests). If you have diabetes and routinely test your urine, tell your doctor. This is because other tests may have to be used to monitor your diabetes while you are having this medicine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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 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)

  • ■ Water tablets or injections (diuretics) such as furosemide. It might be necessary to check your kidneys often during treatment. This can be done with blood and urine tests.

Do not take cefpodoxime at the same time as medicines which act against stomach acid. These include:

  • ■ Antacids

  • ■ Medicines like ranitidine, famotidine or cimetidine (called H2-receptor antagonists). Leave two or three hours after taking this medicine before taking any of these other medicines.

Taking Cefpodoxime Proxetil Film-coated tablets with food and drink

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

Pregnancy and breast-feeding

  • Are you pregnant, or do you think you might be pregnant? 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.
  • Are you breast-feeding? This medicine should not be given to women who are breastfeeding. This is because small amounts of it enter the milk.

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

Driving and using machines

You may get dizzy when taking this medicine. This may affect your ability to drive or operate machinery. If this happens, do not drive or use machines.

Important information about some of the ingredients of Cefpodoxim proxetil film-coated tablets

Cefpodoxime proxetil Film-coated tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to take cefpodoxime proxetil film-coated tablets

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The dispensing label will tell you much of this medicine you should take and how often you should take. 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 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 usual dose is:

Adults and Elderly with no kidney problems:

Sinus infections: 200mg twice a day.

Throat infections: 100mg twice a day.

Chest infections: 200mg twice a day.

Children:

Cefpodoxime proxetil Powder for Oral Suspension is available to treat infants over the age of two 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.

Taking more of Cefpodoxim proxetil film-coated tablets 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. Take the medicine with you in the carton, so that staff will know exactly what has been taken.

If you forget to take Cefpodoxim proxetil film-coated tablets

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 forgotten doses.

If you stop taking Cefpodoxim proxetil film-coated tablets

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 product, ask your doctor or pharmacist.

Film-Coated Tablets

4. possible side effects

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

Severe allergic reactions to this medicine are very rare (affects less than 1 in 10 000 people). These can include:

  • – Sudden wheeziness and tightness of chest

  • – Swelling of eyelids, face or lips

  • – Severe skin rashes that can blister and may involve the eyes, mouth and throat and genitals.

  • – Loss of consciousness (fainting).

All of these allergic reactions need urgent medical attention. If you think you are having any of these types of reaction, stop taking this medicine and contact your doctor or your nearest hospital accident and emergency department.

Common side effects (affect less than 1 in 10 people) include:

Stomach problems: bloating, nausea, vomiting, stomach pain, flatulence (wind) and 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.

Eating problems: loss of appetite.

Uncommon side effects (affect less than 1 in 100 people) include:

Immune system problems: hypersensitivity reactions (These are skin rashes that are less severe allergic reactions than mentioned above, lumpy rash (hives), itching) Nervous system disorders: headaches, pins and needles, dizziness Ear problems: ringing in the ears

General problems: feeling or being sick, weakness and a feeling of generally being unwell.

Rare side effects (affect less than 1 in 1000 people) include:

Liver and bile problems: changes in blood tests that check how your liver is working; Blood problems: anaemia, drops in the numbers of different cells in the blood (symptoms can include tiredness, new infections and easy bruising or bleeding), increases in some types of white blood cells, increases in the numbers of small cells that are needed for clotting of the blood.

Very rare side effects (affect less than 1 in 10 000 people) include:

Immune system problems: anaphylactic reactions(e.g. bronchospasms, purpura and edema of the face and extremities);

Kidney problems: changes in kidney function;

Liver and bile problems: liver damage causing jaundice (this may show as a yellowing of the skin or whites of the eyes);

Infections: Having a course of cefpodoxime can temporarily increase the chance that you can get infections caused by other sorts of germs. For example, thrush may occur.

Blood and the lymphatic system problems: a type of anaemia that can be severe and is caused by red blood cells breaking up. 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 Yellow Card Scheme (). By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store cefpodoxim proxetil film-coated tablets

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month. Do not use the medicine after the expiry date.

Do not store above 25°C. Store in the original package.

You should not throw away any medicine through wastewater or household waste. Ask your pharmacist how to dispose of medicines that you know longer need. This will help to protect the environment.

  • 6. Further Information

What Cefpodoxime Proxetil Film-coated tablets contains

  • – The active substance is: cefpodoxime. One film-coated tablet contains 100 or 200 mg cefpodoxime (as cefpodoxime proxetil).

  • – The other ingredients are: tablet core: carboxymethyl­cellulose calcium, lactose monohydrate, crospovidone, hydroxypropyl­cellulose, magnesium stearate, sodium lauryl sulphate; coating: hypromellose, talc and titanium dioxide (E171).

contents of the pack

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

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

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

Film-Coated Tablets

Cefpodoxime Proxetil 200 mg Film-coated Tablets is available in blister packs of 6, 10, 14 or 15 film-coated tablets.

Not all pack sixes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sandoz Ltd,

Frimley Business Park,

Frimley, Camberley,

Surrey,

GU16 7SR,

UK

Leaflet was last approved in 08/201 9

PIL.1586–1587.006.0d Change of ownership

MSB