Cefixime

Cefixime

    Cefixim belongs to a group of medicines called Cephalosporins, which are used for treating mild to moderate infection caused by susceptible organisms.   Ce. Meer info

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Bijsluiter(s)

1. What Cefixim is and what it is used for

 

 

Cefixim belongs to a group of medicines called Cephalosporins, which are used for treating mild to moderate infection caused by susceptible organisms.

 

Cefixim can be used to treat:

  • Acute infection of the middle ear
  • Acute throat infection caused by bacteria
  • Uncomplicated acute infections in the urinary tract (Uncomplicated acute cystitis)
  • Uncomplicated acute gonorrhoea

 

 

2. What you need to know before you take Cefixim

 

DO NOT take Cefixim

  • if you are allergic to cefixime or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
  • if you are allergic to any other cephalosporin type of antibiotic
  • if you have ever had a severe allergic reaction to penicillin antibiotic or to any other betalactam type of antibiotic

 

Warnings and precautions

Talk to your doctor of pharmacist before taking Cefixim.

Tell your doctor if you:

  • Are allergic to penicillin antibiotics or to any other beta-lactam type of antibiotics. Not all people who are allergic to penicillins are also allergic to cephalosporins. However, you take special care if you ever had an allergic reaction to any penicillin. This is because you might also be allergic to this medicine.

 

In patients who develop severe allergic reaction or anaphylaxis (serous allergic reaction which causes difficulty in breathing or dizziness) after administration of Cefixim, the medicine should be discontinued and appropriate treatment should be given.

 

  • Have ever been told that your kidneys do not work very well. Also if you are taking any sort of treatment (like dialysis) for kidney failure. You may take Cefixim but you may need a lower dose. (Children with kidney problems should not get Cefixim)
  • Have severe or persistent diarrhoea that may be bloody and that may be associated with stomach pain or cramps: these symptoms may occur during or shortly after treatment and signal are rare, but potentially life threatening adverse reaction. Stop taking Cefixim and contact your doctor immediately. Medicines which may slow or stop bowel movements must not be taken.

 

Having a course of Cefixim can temporarily increase the chance that you can get infections caused by other sort of germs on which Cefixim does not act. For example, thrush (infection caused by a yeast germ called Candida) may occur.

 

Other medicines and Cefixim

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 medicine as it may interact with your Cefixim:

  • anticoagulant (blood thinning) therapy

 

Effect on laboratory tests

If you are to undertake any blood or urine tests, inform your doctor that you are taking Cefixim, as cefixime can alter the results of some of these tests.

Cefixim can alter the results of some urine tests for sugar of the types called as Benedict’s, Fehling’s or with copper sulphate test. As with other cephalosporins, Cefixim can alter the results of a blood test for antibodies called direct Coomb´s test.

 

Cefixim with food and drink

Cefixim may be taken with or without food. You should swallow the tablets whole with a glass of water.

 

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

Other substances from the group of medicines, to which cefixime belongs, are well tolerated during pregnancy.

Your doctor will decide whether the benefit of the therapy outweighs the possible risk for your infant.

 

Breast-feeding

As cefixime is excreted in small amounts in breast-milk, you should ask your doctor whether you can take Cefixim in breast-feeding.

 

Driving and using machines

Cefixime can cause dizziness. If affected, you should not drive or operate machinery.

 

3. How to take Cefixim

 

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

 

Dosage

Your doctor will decide the right dose of Cefixim and will tell you how long to take your medicine. The number of Cefixim tablets you need to take will depend on your condition. Follow your doctor's instructions exactly and never change the dose yourself. Ask your doctor or pharmacist if you are unsure about how much medicine to take or when to take it.

 

Usual dose for adults and adolescents (12 years and older)

The recommended adult dosage is two Cefixim tablets daily, either as a single dose or in two divided doses:

The recommended adult dosage is one Cefixim tablets daily, either as a single dose or in two divided doses (the tablet can be divided into equal doses):

 

1 X 400 mg daily as a single dose or 2 X 200 mg daily at intervals of 12 hours

 

If your doctor has prescribed one dose a day, it should be taken every 24 hours. If your doctor has prescribed two doses a day, each dose should be taken every 12 hours. The medicine should always be taken at the same time each day.

 

Children below 12 years

Please note that Cefixim tablets are not suitable for children. You should ask your doctor for more information.

 

Older people

For older people, the doses are the same as adults provided the kidney function are normal.

 

Kidney Problems

If you have severe kidney problems or are undergoing dialysis, your doctor will reduce your dose.

There are insufficient data regarding the use of Cefixim in children with kidney problems. Cefixim is therefore not recommended for use in these patients.

 

If you take more Cefixim than you should

If you accidentally take too many tablets or a child swallows any Cefixim tablets, contact your nearest hospital casualty department or your doctor immediately.

 

If you forget to take Cefixim

If you forget to take a tablet, take one as soon as you remember. However, if the next dose is due in less than 6 hours, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten tablet.

 

If you stop taking Cefixim

Do not stop treatment early because it is important that you complete the FULL course of this medicine in order to reduce the chance of the infection returning.

 

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.

 

Allergic reactions

All medicines can cause allergic reactions, although severe allergic reactions are rare (may affect up to 1 in 1,000 people). These can include:

 

  • sudden wheeziness and tightness of chest
  • swelling of the eyelids, face or lips
  • severe skin rashes that can blister and may involve the eyes, mouth and throat and genitals

 

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.

 

The following other side-effects have been reported:

 

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

  • diarrhoea (if you have severe diarrhoea or if you see blood in your stools, you should stop taking this medicine and talk to your doctor immediately because you may have a very rare infection of the large bowel that needs special treatment)

 

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

  • headache
  • nausea
  • vomiting
  • stomach pain
  • rash
  • changes in blood tests that check how your liver is working

 

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

  • serious allergic reaction which causes swelling of the face or throat (angioneurotic oedema)
  • hypersensitivity reactions (these are skin rashes that are less severe allergic reactions than mentioned above, lumpy rash [hives], itching)
  • dizziness/vertigo
  • loss of appetite (anorexia)
  • flatulence (wind)
  • itching
  • fever
  • abnormal increase in the number of cells (eosinophils) in the blood characteristic of allergic states
  • inflammation of mucous membranes
  • repeated infections caused by bacteria
  • repeated infections caused by fungi

 

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

  • Blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Also flu-like symptoms and fever (Stevens-Johnson syndrome)
  • Severe blistering rash where layers of the skin may peel off to leave large areas of raw, exposed skin over the body. Also a feeling of being generally unwell, fever, chills and aching muscles (Toxic epidermal necrolysis)
  • Serious allergic reaction which causes difficulty in breathing or shock (anaphylactic shock)
  • Inflammation of the intestines that sometimes occurs following antibiotic treatment (antibiotic associated colitis)
  • Severe reduction in number of white blood cells which makes infections more likely (agranulocytosis)
  • Severe reduction in blood cells which can cause weakness, bruising or make infections more likely (pancytopenia)
  • decreases in the numbers of small cells that are needed for clotting of the blood, which increases the risk of bleeding or bruising (thrombocytopenia) (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)
  • Reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness (haemolytic anaemia)
  • Low counts of white blood cells (leucopenia)
  • Hypersensitivity reaction causing symptoms like rash, joint pain, fever and shock (serum sickness)
  • A feeling of restlessness associated with increased activity (psychomotor hyperactivity)
  • Reversible inflammation of the kidney affecting its structure and function
  • Inflammation of the liver (hepatitis)
  • Bile disorder (cholestatic jaundice)
  • Changes in special blood tests that show how your kidney is working (blood creatinine increased)

 

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 the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

 

5. How to store Cefixim

 

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 product packaging. The expiry date refers to the last day of that month.

  • Do not store above 25 °C.
  • If your doctor tells you to stop your treatment, return any leftover Cefixim to your pharmacist for safe destruction.

 

 

6. Contents of the pack and other information

What Cefixim contains

 

Cefixim 200 mg film-coated tablets:

The active substance is cefixime. Each film coated tablet contains 200 mg cefixime equivalent to 223.81 mg cefixime trihydrate.

 

Cefixim 400 mg film-coated tablets:

The active substance is cefixime. Each film coated tablet contains 400 mg cefixime equivalent to 447.63 mg cefixime trihydrate.