ZEFACET 400 mg. 5 tablets
ZEFACET belongs to a group of drugs called cephalosporins, which are used to treat mild to moderate infections caused by susceptible organisms.
ZEFACET can be used for treatment of:
Acute infection of the middle ear;
Acute infection of the throat caused by bacteria;
Uncomplicated acute urinary tract infections (acute uncomplicated cystitis);
Uncomplicated acute gonorrhea.
2. Before you take ZEFACET
Do not take ZEFACET
if you are allergic (hypersensitive) to cefixime or any of the other ingredients of this medicine (listed in section 6. Further information). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue;
if you are allergic (hypersensitive) to another type of cephalosporin antibiotic;
if you have experienced a severe allergic reaction to penicillin antibiotics or other beta-lactam antibiotic.
Take special care with ZEFACET
Before you take ZEFACET, you should talk with your doctor:
if you are allergic to penicillin antibiotics or other beta-lactam antibiotics. Not all people who are allergic to penicillin are also allergic to cephalosporins. However, you should pay special attention if you have ever had an allergic reaction to the antibiotic penicillin, as you may be allergic to this medicine. Patients who develop severe allergic reaction or anaphylaxis (serious allergic reaction which causes difficulty in breathing or dizziness) after taking ZEFACET should stop taking the drug and switch to another appropriate treatment;
If you ever been told that your kidneys do not function very well, also if you are receiving other treatments (eg dialysis) in renal failure. In this case, you can take ZEFACET, but at a lower dose. Children with kidney problems should not take Zefatset;
If you have severe and persistent diarrhea which may be bloody and may be associated with abdominal pain or cramping, these symptoms may occur during or shortly after completion of treatment and generally are rare, but potentially life threatening side effects . Stop taking Zefatset and contact your doctor immediately. Should not be taking medications that can slow or stop intestinal peristalsis.
Spent course of treatment with Zefatset may increase the risk of developing microbes against which he has no activity. Such infections such as thrush (caused by the genus Candida).
Taking other medicines
Tell your doctor or pharmacist if you are taking, have recently taken any other medicines as they may interact with ZEFACET
Anticoagulation (blood thinning).
Always tell your doctor what medications you are taking, including those obtained without a prescription.
Effects on laboratory tests
If you are going to undergo a blood and urine, tell your doctor that you are taking ZEFACET as cefixime can affect the results of these studies. ZEFACET can change the results of some urine tests, such as tests for sugar, made with several types of test: Benedict's reagent, Fehling reagent or copper sulphate test.
Like other cephalosporins, Zefatset can affect the results of a blood test for antibodies called direct Coombs test.
Taking ZEFACET with food and drink
ZEFACET can be taken with or without food. You should swallow the tablets whole with a glass of water.
Pregnancy and lactation
Other drugs in the group to which it belongs cefixime well tolerated during pregnancy.
Your doctor will decide if the benefits of treatment outweigh the possible risks to your baby.
As cefixime a small extent is excreted in breast milk, you should ask your doctor whether taking Zefatset during lactation.
Driving and using machines
ZEFACET can cause dizziness. If you are affected, you should not drive or operate machinery.
3. How to take ZEFACET
Your doctor will decide the correct dose ZEFACET and will tell you how long to take your medicine. The number of tablets ZEFACET that should take depends on your condition. Follow the instructions of your doctor and never alone does not change the dose. If you are not sure how or when taking this medicine, ask your doctor or pharmacist.
Usual dose for adults and adolescents (over 12 years)
The usual dose is one tablet Zefatset daily taken as a single daily oral dose or divided into two equal oral adopt:
1 x 400 mg daily as a single dose or
2 x 200 mg daily at intervals of 12 hours.
If your doctor prescribe a single dose, it must be taken every 24 hours. If your doctor prescribe two doses a day, they must be taken every 12 hours. This medication should be taken at the same time each day.
Children under 12 years
Note that ZEFACET tablets are not suitable for children. You should ask your doctor for more information.
In elderly patients with normal renal function, doses are the same as in adults described above.
Patients with kidney problems
If you have severe kidney problems or are undergoing dialysis, your doctor will lower your dose.
There are no adequate data on the use of ZEFACET in children with kidney problems. Therefore ZEFACET not recommended for use in these patients.
If you take more than the amount ZEFACET
If by chance you take more than the required amount tablets or child has taken tablets ZEFACET, immediately contact your doctor or nearest hospital.
If you forget to take ZEFACET
If you forget to take a tablet, the next dose should be taken as soon as you remember. If it is time for your next dose is less than six hours, the missed dose should be skipped and to continue treatment in the prescribed schedule. Do not take a double dose.
If you stop taking ZEFACET
Do not stop treatment early because it is important to complete the full course of treatment to reduce the risk of recurrence of infection.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
All medicines may cause allergic reactions, although serious allergic reactions are rare (affects 1 to 10 users in 10,000).
They may include:
Sudden onset of wheezing during breathing and tightness in the chest;
Swelling of the eyelids, face or lips;
Severe skin rashes that can pass into blisters and affect the eyes, mouth, throat and genitals.
All these allergic reactions require emergency medical intervention. If you think it appears any of these effects, stop taking the drug and contact your doctor or to the emergency room of the nearest hospital.
Reported the following side effects:
Common side effects (affects 1 to 10 users in 100) include:
Diarrhea (if you have severe diarrhea or if you notice blood in your stool, you should stop taking this medication and tell your doctor immediately because it can have a very rare infection of the colon that needs special treatment).
Uncommon side effects (affects 1 to 10 users in 1000) include:
Changes in blood indicators of liver function.
Rare side effects (affects 1 to 10 users in 1000) include:
Serious allergic reaction which causes swelling of the face or throat (angioneurotic edema);
Hypersensitivity reaction (these are skin rashes that occur more easily compared with those listed in the beginning, hives, itching);
Dizziness / vertigo;
Loss of appetite (anorexia);
Pathological increase in cell number (eosinophilia) in the blood status of allergic conditions;
Inflammation of the mucous membranes;
Recurrent infections caused by bacteria;
Repeated infections caused by fungi.
Very rare side effects (affects less than 1 in 10,000 users) include:
Blistering or bleeding in the skin around the lips, eyes, mouth, nose and genitals. Also, flu-like symptoms may occur and fever (Stevens-Johnson);
Severe blistering rash, wherein the peeling can be layers of skin and remain open wounds on the skin of the whole body. Also feeling of poor physical condition, fever, stiffness and muscle pain (toxic epidermal necrolysis);
Severe reduction in the number of blood cells, which can cause weakness, bruising or incidence of infections (pancytopenia);
Reduction in the number of blood platelets needed for blood clotting, increasing the risk of bleeding or bruising (thrombocytopenia). If for some reason you are having blood tests, tell the person who takes your blood that you are taking this medicine as it may affect the results);
Fewer red blood cells in the skin can look pale and cause weakness or shortness of breath (hemolytic anemia);
Low white blood cells (leukopenia);
Hypersensitivity reaction, causing symptoms such as rash, joint pain, fever and shock (serum sickness);
Feelings of restlessness associated with increased activity (psychomotor hyperactivity);
Reversible inflammation of the kidneys, affecting their structure and function;
Inflammation of the liver (hepatitis);
Damage to bile (cholestatic jaundice);
Changes in blood tests that show how your kidneys work (elevated creatinine in the blood).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please ask your doctor or pharmacist.
5. How to store ZEFACET
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Do not store above 25 ° C.
If your doctor tells you to stop treatment, return left Zefatset to your pharmacist for safe disposal.
6. Further information
The active substance is cefixime. Each tablet contains 400 mg of cefixime, equivalent to 447.63 cefixime trihydrate.
Other ingredients are: calcium hydrogen phosphate, pregelatinized starch, microcrystalline cellulose, silica, colloidal anhydrous, magnesium stearate and Opadry White (Y-1-7000) and purified water.
The tablets are coated with HPMC 2910 / Hypromellose Wed 5 (E464), titanium dioxide (E171) and macrogol / PEG 400 (E1520).
ZEFACET looks like and contents of the pack
White, off-white with a modified rectangular tablets scored on both sides. The tablet can be divided into two equal halves.
The product is available in packs of:
Aluminium / PVC / PVDC blisters and Aklar PVC / aluminum blister packs with 5, 7, 10 tablets.
Not all pack sizes may be marketed.