SEDAX suspension 36 mg. / 1 ml. 30 ml.

WHAT SEDAX powder for oral suspension AND WHAT IT IS USED?

Sedax is a semisynthetic antibiotic belonging to the cephalosporin. Sedax be used to treat infections of the upper and lower respiratory tract, ear, urinary tract infections, caused by susceptible microorganisms to ceftibuten. Sedax powder for oral suspension can be used in children over 6 months of age, as advised by your doctor.

2. BEFORE YOU TAKE SEDAX powder for oral suspension

Do not take SEDAX
- If you are allergic (hypersensitive) to ceftibuten or any of the other ingredients of Sedaks.
- If you are allergic (hypersensitive) to any other antibiotic penicillin or cephalosporins.
- Before taking Sedaks consult your doctor if you are pregnant or breast-feeding.


Take special care with Sedax
- If you develop an allergic reaction (eg. Sneezing, wheezing or hives), seek immediate medical attention.
- If your kidney function is impaired, your doctor may prescribe a lower dose Sedaks and during your treatment to monitor your kidney function. - If you suffer from disorders of the gastrointestinal tract and, in particular, chronic colitis, or a severe diarrhea or vomiting, report it immediately
- If your doctor has told you that you or the child you are caring for has an intolerance to some sugars, contact your doctor before you start taking Sedaks powder for oral suspension.

Taking other medicines
There were no reports of significant interactions with other drugs Sedaks. There have been studies on the interaction of Sedax with each of the following products: aluminum-magnesium hydroxide, ranitidine and single intravenous dose theophylline.
There were no significant drug interactions. There is no known impact of Sedax on plasma levels and pharmacokinetics of orally administered theophylline.
Cephalosporins can lower prothrombin activity and prolong prothrombin time in patients treated with oral anticoagulants, who achieved stabilization of coagulation parameters. At-risk patients should be monitored prothrombin time or INR, if necessary to apply vitamin K.


Taking Sedax with food and drink
Co-administration with food may delay or weaken the absorption of Sedaks suspension. The drug should be administered 1-2 hours before or after a meal.


Pregnancy and lactation
Pregnancy: Due to lack of clinical experience with ceftibuten during pregnancy, the drug should be administered only if necessary, under direct medical supervision.
Breast-feeding has been shown ceftibuten passes in small amounts in breast milk. Breastfeeding should be evaluated potential risk.


Use in infants
The safety and efficacy of Sedax in infants under 6 months of age have not been established.


For all patients
In patients with severe renal insufficiency or hemodialysis patients may need a dose adjustment. Patients who do dialysis 2-3 times a week should be closely monitored and recommended intake to 400 mg Sedaks immediately after each dialysis.
In patients with creatinine clearance 30-49ml / min, the daily dose should be reduced by half. At even lower creatinine clearance is needed additional dose adjustment.
Prolonged treatment with broad-spectrum antibiotics such as ceftibuten can cause disorder of the intestinal flora and the occurrence of severe diarrhea, dehydration and / or pseudomembranous colitis. If you develop diarrhea, check with your doctor. Mild pseudomembranous colitis usually be managed in stopping the antibiotic treatment, but may need additional medical intervention.


Driving and using machines
Sedax not affect your ability to drive and use machines.


Important information about some of the ingredients of Sedax
This drug contains sucrose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product.

3. HOW TO TAKE SEDAX

Always Sedax just as you have been told your doctor. If you're not sure, ask your doctor or pharmacist. The usual dose is;


Children older than 6 months:
Infections of the lower respiratory tract without complications
9,0 mg / kg once daily
Infections of the upper respiratory tract (eg. Otitis media)
9,0 mg / kg once daily
Urinary tract infections
9,0 mg / kg once daily


The maximum daily dose in children should not exceed 400 mg.


If you take more than the amount Sedax
Tell your doctor about it. Usually the accidental greater dose were observed toxicity. Overdose may perform gastric lavage. There is no specific antidote.


If you forget to take SEDAX
If you miss a dose Sedax, take it as soon as you remember it, and then continue with your regular dosing schedule. Do not take a double dose to make up the missed dose.


4. POSSIBLE SIDE EFFECTS


Like all medicines, Sedax can cause side effects, although not everybody gets them. Clinical trials reported the following adverse reactions:


Common side effects (at least 1 in every 100 patients but less than 1 in every 10 patients):
nausea, diarrhea, headache.


Uncommon side effects (at least 1 in every 1000 patients but less than 1 in every 100 patients):
indigestion (dyspepsia), gastritis, vomiting, abdominal pain.


Rare reports of side effects (at least 1 in every 10,000 patients, but less than 1 in 1000 patients):
diarrhea due to overgrowth of the bacterium Clostridium difficile; decreased levels of hemoglobin in the blood, decreased number of white blood cells (leukopenia), eosinophilia, thrombocytosis, transient increases in some liver function tests (ALT, AST and LDH).


Very rare side effects (in less than 1 in 10,000 patients): convulsions.


Besides the above adverse reactions in patients treated with Sedax, adverse effects known to be associated with the intake of drugs from the group of cephalosporins:
- Infections and infestations: development of additional second infection in the presence of such unresolved (superinfection).
- Immune system disorders: allergic reactions, including anaphylactic (severe allergic reaction which causes difficulty in breathing or dizziness), bronchospasm, difficulty breathing (dyspnea), urticaria, increased light sensitivity (photosensitivity), itching, severe, life-threatening conditions such as angioneurotic edema (allergic reaction which causes swelling of the face or throat), Stevens-Johnson, erythema multiforme, toxic epidermal necrolysis.
- Gastrointestinal disorders: severe diarrhea, inflammation of the colon that cause abdominal pain and diarrhea / constipation - antibiotic colitis, including pseudomembranous colitis.
- Blood and lymphatic system: changes in the values of certain laboratory tests of bleeding and clotting - prolonged prothrombin time / increase INR.


Administration of cephalosporins have been reports of aplastic anemia - greatly reducing the number of blood cells, causing weakness, bruising or increased likelihood of infection; hemolytic anemia - reducing the number of red blood cells which can lead to a pallor or yellowing of the skin, weakness, or shortness of breath; bleeding, renal failure, increased bile pigment bilirubin, and positive direct test of Coombs, radiation of glucose and acetone in urine (glycosuria and ketonuria), suppressing the growth of blood cells in the bone marrow (pancytopenia, neutropenia and agranulocytosis).


If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor.


5. HOW TO STORE SEDAX

Storage at temperatures below 25 ° C.
Storage after reconstitution of the suspension: 14 days in a refrigerator (2 ° C - 8 ° C).
Do not use Sedaks after the expiry date stated on the label and carton. The expiry date refers to the last day of that month.
Keep out of reach of children!


Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.


6. FURTHER INFORMATION

What Sedax

- The active substance is ceftibuten.
- The other ingredients are: polysorbate 80, simethicone, xanthan gum, silicon dioxide, titanium dioxide, sodium benzoate (E211), cherry flavor (natural and artificial), sucrose.


When opening the vial can feel the smell of sulfur, which does not mean that product quality is poor. After reconstitution smell of sulfur disappears.


Sedax looks like and contents of the pack
Sedax 36 mg / ml powder for oral suspension is supplied in an amber glass bottle 30 ml or 60 ml, with a child resistant screw cap. Bottle with an information leaflet about the user is in a cardboard box.
The package further comprises: a measuring cup with a partition 25 ml (for the container of 30 ml) or 50 ml (for the package of 60 ml) and a dosing syringe.
Not all pack sizes may be marketed.


Instructions for reconstitution
Prepared according to the manufacturer's instructions Sedaks suspension contains 36 mg / ml ceftibuten (180 mg / 5 ml).


Shake the bottle well before adding water to facilitate dissolution of dust.
Fill the enclosed measuring cup with water to the marked line. Add half the water in the bottle, close it, turn it upside down and shake nice.
Then add in the bottle and the rest of the water and shake vigorously again. After reconstitution, the oral suspension is stored for up to 14 days in a refrigerator (2 ° C to 8 ° C).
Before taking any suspension should be well shaken.


After preparing the suspension:
1. Remove the red protective cap on the syringe.
2. Place the dosing syringe into the bottle.
3. Withdraw the suspension by pulling only calibrated plunger until it reaches the line corresponding to the weight of the child.