TSEFZIL suspensions. 250 mg. / 5 ml. 60 ml

TSEFZIL WHAT IS AND WHAT IT IS USED

Tsefzil 250 mg / 5 ml powder for oral suspension contains as active ingredient 250 mg monohydrate tsefprozil as tsefprozil 5 mL of reconstituted suspension.

Tsefzil is a semisynthetic, broad-spectrum cephalosporin antibiotic.

Tsefzil is used to treat patients with the following infections caused by susceptible bacteria tsefprozil:

 Infections of the upper respiratory tract, including pharyngitis, tonsillitis and sinusitis.

 Acute otitis media in children.

 Infections of the lower respiratory tract, including bronchitis and pneumonia.

 Uncomplicated skin and soft tissues.

NOTE: Abscesses usually require surgical drainage.

 Uncomplicated urinary tract infections, including acute cystitis.

 BEFORE YOU TAKE TSEFZIL

Do not take Tsefzil

 if you are allergic (hypersensitive) to tsefprozil or any of the other ingredients of Tsefzil.

 if you are allergic (hypersensitive) to the class of antibiotics cephalosporins.

Take special care with Tsefzil

 if you are allergic to Tsefzil, cephalosporins, penicillins, or other drugs, tell your doctor.

 if you have or have had kidney or liver disease, colitis or stomach problems, tell your doctor.

 if you are pregnant or planning to become pregnant, or are breast-feeding, tell your doctor

 if you have surgery, including dental, tell your doctor that you are taking tsefprozil.

 If you are having laboratory tests as Tsefzil can lead to a change in the results of some tests.

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.

If you are taking other medications (prescription or non-prescription), and especially other antibiotics, anticoagulants, vitamins, tell your doctor.

Cephalosporins, including Tsefzil should be used with caution in patients receiving concomitant diuretics and aminoglycoside antibiotics as they further affect renal function.

Taking Tsefzil with food and drink

Tsefzil can be taken with or without food. Food does not affect the extent of absorption.

Pregnancy and lactation

Tsefzil should be used during pregnancy only if the doctor considers it absolutely necessary. Caution should be exercised when Tsefzil be used during lactation. Ask your doctor or pharmacist before taking any medicine.

Driving and operating machinery

No studies on the effects of Tsefzil on ability to drive and use machines.

Important information about some of the ingredients of Tsefzil

Fenilketonuritsi: Tsefzil powder for oral suspension contains phenylalanine 28 mg per 5 ml (1 tsp) suspension thus should not be taken by people with fenilketouriya.

 HOW TO TAKE TSEFZIL

Always Tsefzil exactly as your doctor tells you. If you're not sure, ask your doctor or pharmacist.

If your doctor advises otherwise, comply with the following dosage and method of administration:

Adults and children over 12 years - is appropriate to use Tsefzil tablets.

Children

Tsefzil oral suspension is used in children aged between 6 months and 12 years.

It is administered orally for the treatment of infections caused by susceptible bacteria tsefprozil in the following doses:

Otitis

15 mg / kg per 12 hours

Pharyngitis and tonsillitis

20 mg / kg every 24 hours or 15 mg / kg per 24 hours, divided into two equal doses

Sinusitis

7.5 to 15 mg / kg per 12 hours

Infections of skin and soft tissue

20 mg / kg per 24 hours

Instructions for Preparation of Oral Suspension:

Reconstitution of the powder for oral suspension in the bottle should be as follows:

 Add water to the level indicated on the bottle.

 Shake well to dissolve the powder.

 Wait a few minutes and, if necessary, add water to the level indicated on the bottle.

Thus prepared suspension is ready for use. It should be stored in a refrigerator and used within 14 days.

To use the dosing syringe, withdraw the required amount from the vial of reconstituted solution, according to doctor's instructions.

The maximum daily infant dose should not exceed the recommended adult dose.

Safety and effectiveness in children under 6 months has not been established.

The duration of treatment is determined by the doctor and is usually 7 to 10 days.

If you take more than the dose Tsefzil

If you take more than the dose Tsefzil, seek medical attention.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you missed taking Tsefzil

Usual dose as soon as possible and then continue as usual. Do not take a double dose to make up for a missed dose.

If you stop taking Tsefzil

It is important to complete the full course of treatment even if you already feel better. If treatment is stopped too soon, as infection is not completely cured and symptoms to reappear.

 POSSIBLE SIDE EFFECTS

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

Common (between 1 and 10 in every 100 patients) - sensitive to infection with microorganisms, yeast infection of the vagina increase of eosinophilic cells in the blood: dizziness, abdominal pain, diarrhea, nausea, vomiting, increased liver function tests.

Uncommon (between 1 and 10 in every 1000 patients) - reduced number of white blood cells, confusion, insomnia, somnolence, nervousness, headache, rash, urticaria (hives).

Rare side effects (between 1 and 10 in every 10,000 patients) - reduced number of platelets, blood clotting difficulty, angioedema (swelling of the face, eyelids, tongue, throat), colitis (including pseudomembranous), yellowing of the skin and eclairs; severe skin reactions with blistering of the skin and mucous membranes, genital itching, fever.

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

 HOW TO STORE TSEFZIL

Keep out of reach of children.

Reconstituted suspension Tsefzil is stable 14 days when stored in a refrigerator at 2-8 ° C. Any unused solution should be discarded after 14 days.

Tsefzil Do not use after the expiry date stated on the carton. The expiry date refers to the last day of that month.

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

 ADDITIONAL INFORMATION

What Tsefzil

 The active substance is tsefprozil.

 The other ingredients are sodium benzoate, polysorbate 80, microcrystalline cellulose, 50 aspartame, sucrose, flavor (natural and artificial), vanilla extract, colloidal silica, glycine, croscarmellose sodium, sodium chloride, DS antifoam (1%) of sucrose, yellow dye FD & C № 6 1%, anhydrous citric acid, guarana flavoring and sweetener.