CEC FORTE suspension 250 mg. / 5 ml. 100 ml.

What is the active ingredient?
 
63 g of granules for the preparation of an oral suspension containing: 5,244 g cefaclor monohydrate, corresponding to 2,5 g cefaclor
5 ml (1 scoop) of reconstituted oral suspension contains: 262,24 mg cefaclor monohydrate, equivalent to 250 mg cefaclor
 
What else contain CEC forte granules for oral suspension?
himeteloza, sodium lauryl sulfate, sodium starch glkzholat (type A), sucrose, silicone emulsion, xanthan gum, flavors (strawberry, raspberry)
 
Tip for diabetics
5 mf (1 scoop) of reconstituted oral suspension contains 2,86 g sucrose, corresponding to 0.24 carbohydrate units.
 
Formulation and packaging:
Original packs containing 1 vial with 63 g granules for the preparation of 100 ml oral suspension
 
 
What is CECe forte granules for oral suspension?
CEC is an antibiotic belonging to the group of cephalosporins, which are used to treat bacterial infections.
 
 
What is it used CEC forte granules for oral suspension?
It is used to treat acute and chronic infections exacerbated with varying degrees of severity, which are caused by a cefaclor-sensitive bacteria and disease are suitable for oral therapy.
For treating these infections are shown:
- The upper and lower respiratory tract
- Ear, Nose and Throat - as otitis media (otitis media), sinusitis, tonsillitis (tonsillitis) and pharyngitis (sore throat)
- Kidney and the lower urinary tract
- Skin and soft tissue
- gonorrhea
 
 
When you must not take CEC forte granules for oral suspension?
You should not take CEC forte, if you are allergic to cefaclor, other antibiotics of this group (cephalosporins) or any of the ingredients.
Tell your doctor if you have had hypersensitivity reactions to penicillin antibiotics as possible be allergic to cephalosporins (cross-allergy).
If you are informed that you have an intolerance to some sugars, contact your doctor before starting treatment with this product.
 
In which case, you can use CEC forte granules for oral suspension only after consulting a doctor?
In certain diseases or conditions CEC forte can be used only after consulting your doctor.
Tell your doctor if you suffer from asthma or allergy manifested as you are under increased risk of allergic reactions to the product.
 
 
What precautions should be taken when taking CEC forte granules for oral suspension?
Tell your doctor if you suffer from severe gastrointestinal disorders accompanied by vomiting and diarrhea, as in these cases it is not providing adequate absorption and efficacy CEC forte.
CEC forte could affect the efficacy of certain products that inhibit blood coagulation (coumarin-type anticoagulants). In these patients should be monitored carefully Coagulation. If necessary, your doctor will reduce the dose of CEC forte.
If you need to examine your urine and / or blood, please tell your doctor that you are taking CEC forte, because certain tests can give inaccurate results (eg. Non-enzymatic methods for the determination of glucose and protein in urine, Coombs test ).
This medicinal product contains sucrose 2,86 g / 5 ml. When taken according to the dosage recommendations each dose provide up to 2,86 g sucrose.
The product is not suitable for people with hereditary fructose intolerance, glucose / galactose malabsorption or sucrase / isomaltase deficiency.
 
 
Other products that interfere with the effect of CEC forte granules for oral suspension, or may be influenced by the product?
Tell your doctor if you are taking or have recently received any medicines, even those not prescribed.
antibiotics
 
CEC forte should not be combined - where possible - with drugs that inhibit the growth of bacteria (e.g.. Chloramphenicol, erythromycin, sulfonamides, or tetracyclins), since the effect of CEC forte can be reduced.
Probenecid (a product for the treatment of gout)
The additional use of probenecid leads to suppressing the secretion of cefaclor by the kidneys, resulting in yielding higher concentrations of cefaclor and prolonged presence in the blood.
anticoagulants
In patients receiving concomitant CEC forte and medicines that suppress blood coagulation (coumarin-type anticoagulants) observed some patients with prolonged prothrombin time with or without bleeding.
Please note that these figures apply to the recently approved drugs.
 
What foods and spices you should avoid?
No evidence of foods and spices should be avoided.
 
What should I take into account children and elderly patients on CEC forte granules for oral suspension?
CEC forte should not be given to premature infants because there is not enough clinical data.
 
What special precautions should be taken during pregnancy and lactation?
Observations in pregnant women have not shown evidence of harm to the fetus. Studies in animals have found embryo / fetotoxic effects.
However, in pregnancy, particularly during the first three months CEC forte should be taken only if the doctor considers it necessary, the treatment and after careful consideration of the benefit / risk ratio.
During lactation CEC forte should be taken only in very urgent need of treatment because the active ingredient may pass into breast milk. Breastfed infant may develop hypersensitivity to the active ingredient and to experience diarrhea or colonization of the intestinal mucosa with fungi (e.g.. Blastomitseti).
 
What to be aware when driving or operating machinery?
So far it is not known CEC forte affecting concentration and reaction speed, but side effects such as low blood pressure or vertigo may increase the risk of a breach of those activities.
 
Dosage, method and duration of administration
It is recommended that the following dosage unless your doctor has prescribed CEC forte another dosing regimen. Please follow these instructions for use. Otherwise CEC forte will not work correctly.
 
How much and how often you can take CEC forte granules for oral suspension?
Children under 6 years should take 30 mg cefaclor / kg bw / day in three divided doses.
In the case of severe infections, otitis media, or infections caused by less sensitive pathogens, recommended 40 to 50 mg of cefaclor / kg body weight / day for a maximum of 1 g of cefaclor per day. In the case of otitis media, the total daily dose can be administered in two divided doses every 12 hours.
In mild infections such as uncomplicated infections of the lower urinary tract is sufficient dosage of 20 mg of cefaclor / kg body weight / day, divided into 2-3 single doses every 8 or 12 hours.
Children 6 to 10 years should receive 1 scoop 3 times daily (corresponding to 250 mg of cefaclor three times daily).
In severe infections, inflammation of the middle ear (otitis media) or infections caused by less sensitive bacteria need a dose of 1 scoop 4 times per day (corresponding to 250 mg of cefaclor 4 times daily).
Otitis may be treated with the same 2 scoops 2 times per day (corresponding to 500 mg of cefaclor 2 times a day). In mild infections such as uncomplicated infections of the lower urinary tract is sufficient dosage of 1 scoop in the morning and evening (corresponding to 250 mg of cefaclor 2 times a day).
Adults, adolescents and children over 10 years should receive a standard dose of 2 scoops three times daily (500 mg cefaclor three times daily):. The dose may be doubled for severe infections (like pneumonia) and infections caused by less sensitive bacteria. In some cases, adults have received doses up to 4 g daily cefaclor her they were well tolerated. This dose should be nadvishavanal.
In mild infections such as infections of the lower urinary tract, uncomplicated, it is recommended that a dosage of 1 scoop 3 times per day (corresponding to 250 mg of cefaclor 3 times daily).
In the treatment of acute gonorrhea urethritis in men and women appointed 3 g cefaclor, possibly combined with 1 g of probenecid.
Dosage in patients with impaired renal function
CEC forte can be applied even in patients with renal impairment without dose adjustment.
Haemodialysis decreases serum half-life by 25-30%.
In patients on regular hemodialysis before dialysis should be administered a starting dose of 250 mg to 1 g. Maintenance dosage adopted between dialysis treatments is the same as in patients without dialysis.
 
 
When and how you can take CEC forte granules for oral suspension?
Preparation of Oral Suspension
- Mix the pellets by shaking
- Protected against open child resistant closure by pushing down while turning left
- Fill the bottle with cold water to about ½ cm above the mark (ring on the lens)
- Close the vial and shake vigorously until dissolved granules at the bottom of the vial
- Fill again with water to the mark (ring on the lens) and shake. This procedure must be repeated until the oral suspension reaches the level of the mark (ring on the lens).
Shake the bottle vigorously at each intake.
  Please use added to the pack scoop (with a readability of 1,25 ml, 2,5 ml and 5 ml) to measure the prescribed amount.
You can take CEC forte during the meal, which does not violate absorption.
 
How long can you take CEC forte granules for oral suspension?
Generally CEC forte should be taken from 7 to 10 days, or at least 2-3 days after disappearance of the symptoms of the disease.
In the treatment of infection with beta-hemolytic streptococci recommended treatment duration of at least 10 days in order to prevent late complications (e. Rheumatic fever, and glomerulonephritis). The duration of application are determined by your doctor.
What should I do if CEC forte granules for oral suspension has been adopted in very large quantities (intentional or unintentional overdose)?
So far there are no reported cases of intoxication cefaclor; If 'accepted large quantities of product, you should consult a doctor. Please keep the pack to be able to identify the accepted amount of the active ingredient.
 
 
What should you do if you take more than the prescribed dose CEC forte granules for oral suspension or you missed taking the drug?
If you forgot accepted, please take your dose as soon as possible. If you forget to take your medicine several times, you should consult your doctor to monitor the progress of the disease and promptly take necessary treatment.
 
 
What you should know if you are discontinued or have it terminated prematurely?
If you discontinued prematurely, the risk of relapse.
 
What side effects can cause the application of CEC forte granules for oral suspension?
 
Like all medicines, administration of CEC forte can cause side effects.

Blood and blood cells
Very rarely were no changes in the number of blood cells (eosinophilia, leukopenia, lymphocytosis, thrombocytopenia, -neutropeniya uncommon, and in some cases, aplastic and haemolytic anemia). These side effects are normalized spontaneously after treatment. Infrequently observed a significant reduction in the number of white blood cells (agranulocytosis).

Liver and bile ducts


Uncommon may occur reversibly increase of liver enzymes in the serum (transaminases, alkaline phosphatase).
Have been reported instances of transient liver cell damage (hepatitis) and disorder swelling of bile (jaundice).
 
digestive system
Uncommonly, a lack of appetite, abdominal pain, diarrhea, vomiting, heaviness in the stomach, nausea or loose stools. These events are mild and usually disappear during or after therapy interruption and. As with other broad-spectrum antibiotics may occur bowel inflammation (colitis), including psevdomemranozen colitis.
Kidney and urinary tract
Infrequently may cause acute inflammation of the kidney (acute interstitial nephritis), but it disappears after completion of therapy. It was also observed a slight increase in blood urea and / or creatinine.
 
nervous system
Reported were infrequent cases of temporary hallucinations, hyperactivity, nervousness, insomnia or drowsiness, dizziness or embarrassed behavior. As with other drugs of this class (cephalosporin antibiotics) can not be excluded increased tendency to convulsions.
 
Hypersensitivity reactions
Often possible allergic skin reactions (eg. Reddening skin burning sensation (rash), itching, hives, swelling and blistering (urticarial exanthema), rash similar to measles (maculopapular, morbilliform exanthema).
Other symptoms of hypersensitivity reactions may be increasing the number of eosinophilic cells (eosinophilia), a positive test Coomb (detecting certain types of antibodies in the blood) (angioneurotic) edema, drug fever, and inflammation of the vagina.
Reported cases were uncommon, serum sickness-like -multiformena erythema (redness different manifestations of the skin) or the aforementioned skin reactions accompanied by joint symptoms and fever. In these cases, in contrast to serum sickness, lymphadenopathy and proteinuria have been observed only rarely. There are no circulating antibodies.
In general, these allergic reactions occur during or after repeated treatment with cefaclor (more common in children than in adults) and disappear a few days after discontinuation of treatment.
Severe hypersensitivity reactions can be expressed by a fall in blood pressure to life-threatening shock, swelling of the face (facial edema), increased heart rate, swelling of the larynx with the tightening of the airways, difficulty breathing, swelling of the tongue. In individual patients, these reactions occurred after the first administration of the drug. In appearance they need immediate medical attention.
Uncommon cases of severe skin manifestations of life-threatening systemic reactions (Syndrome Stevens-Johnson, exfoliative dermatitis syndrome, Lyell) have been reported in association with administration of CEC.
 
 
Other side effects
After taking CEC occasionally been reported transient increases in blood pressure.
Prolonged or repeated administration of CEC forte can lead to secondary infections (superinfection) and colonization by resistant bacteria cefaclor or the development of a fungal infection (blastomitseti).
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
 
 
What measures should be taken in relation to the side effects?
If during or after treatment with the product observed severe or persistent diarrhea, please consult your doctor as this may be a manifestation of a serious intestinal disease (pseudomembranous colitis) which should be treated immediately. Please do not take self with drugs that inhibit gastrointestinal motility.
If you experience sudden severe hypersensitivity reactions, please consult your doctor as you may need immediate treatment.
Storage Instructions:
The ready-to-use suspension has a shelf life of 14 days when stored in a refrigerator (below 8 ° C). Unused after this period amount should be discarded.
The shelf life of the drug printed on the packaging.
Do not use after the expiry date stated on the packaging.
How should I store CEC forte granules for oral suspension?
The product should be stored at temperatures below 25 ° C.
The reconstituted suspension should be stored in a refrigerator (at temperatures no higher than 8 ° C).
Keep out of reach of children!