WILPRAFEN suspension

Ingredients:
10 ml suspension (1 scoop) contains: 320.4 mg of josamycin propionate, equivalent to 300 mg of josamycin.

Excipients:
Hydroxypropyl methylcellulose: 0.1 g / 100 ml;
Sorbitan trioleate (Arlatsel 85): 0.05 g / 100 ml;
Microcrystalline cellulose: 1.55 g / 100 ml;
Sodium carboxymethyl cellulose (Tselugen F7A): 0.1 g / 100 ml;
Sodium citrate: 0.624 g / 100 ml
Cetylpyridinium chloride: 0.01 g / 100 ml;
Silicone S184: 0.005 g / 100 ml;
G 2099 strawberry flavor: 0.06 g / 100 ml;
101 Milk flavor: 0.018 g / 100 ml;
Sucrose: 65.0 g / 100 ml;
Distilled water: 55.279 g / 100 ml.

Properties and action:
Wilprafen is a macrolide antibiotic used to treat bacterial infections.

Indications:
Wilprafen be used in the treatment of acute and chronic acute infections caused by pathogenic strains that are sensitive to Josamycin.

Infections of the nasopharynx:
pharyngitis and tonsillitis caused by streptococcal strains, infections of the middle ear, sinusitis, laryngitis, diphtheria (in addition to treatment with diphtheria antitoxin) and scarlet fever in the case of allergy or intolerance to penicillin.

Respiratory infections:
whooping cough, bronchitis, pneumonia, pneumonia, atypical pneumonia and psittacosis.

Dental infections:
gingivitis, tooth abscess.

Infections of skin and soft tissue infections and genitourinary tract:
Pyoderma; furuncle, anthrax, erysipelas in case of intolerance or allergy to penicillin, acne, limfangit, lymphadenitis, inguinal limfogranuloma, inflammation of the prostate, as well as gonorrhea and syphilis in case of intolerance or allergy to penicillin.

Contraindications
Medicinal product is contraindicated in:
hypersensitivity to erythromycin and other macrolide antibiotics;
hypersensitivity to any of the excipients;
severe hepatic impairment;
concomitant administration of antihistamines and Wilprafen containing terfenadine or astemizole should be avoided as the excretion of terfenadine or astemizole respectively may be extended, leading to life-threatening cardiac arrhythmias;
premature babies, because there is not enough experience.
Special warnings and precautions
To achieve optimal serum concentrations of individual administrations to apply between meals.
Shake before use.
According to WHO recommendations duration of the treatment of streptococcal infections is at least 10 days.
In the treatment of patients with renal failure is necessary to use appropriate laboratory tests as additional information necessary for the therapy.
In newborns it is necessary to monitor renal function.
Should expect cross-resistance between macrolide antibiotics.

Important for diabetics:
10 ml Wilprafen suspension contains 6.5 g sucrose, 0.54 equivalent diabetic agents.

Interactions with other drugs
Wilprafen / Other antibiotics
Since the bacteriostatic antibiotics may result in bactericidal activity of other antibiotics such as penicillins or cephalosporins, it is preferably co-administration can be avoided. Because of possible mutual reduction of efficiency, josamycin should not be administered concomitantly with the antibiotic lincomycin.

Wilprafen / Theophylline
Certain representatives of the group of macrolide antibiotics affect the excretion of Theophylline, which can lead to intoxication. Although Wilprafen is a macrolide antibiotic, experimental and clinical studies have shown that the josamycin affected to a lesser extent, the excretion of Theophylline compared with other macrolides.

Wilprafen / antihistamine
After concomitant administration of antihistamines and Wilprafen containing terfenadine or astemizole, excretion of terfenadine or astemizole respectively can be extended, leading to life-threatening cardiac arrhythmias.

Wilpafen / Ergot alkaloids
Reported instances of increased vasoconstriction following co-administration of ergot alkaloids and macrolide antibiotics. Reported a single case of intolerance to ergotamine in a female patient treated with josamycin. Since the mechanism of this interaction is not yet known, it is not known whether there is a causal link between josamycin and ergot intolerance as ischemia occurs also when taking only ergotamine. Nevertheless, the simultaneous application of ergot alkaloids and josamycin need to be accompanied by appropriate monitoring of patients.

Wilprafen / Cyclosporin
Coadministration of Cyclosporin josamycin and can lead to increased plasma levels of Cyclosporin and lead to nephrotoxic concentrations in serum. It should regularly monitor the plasma concentration of Cyclosporin.

Wilprafen / Digoxin
In patients receiving concomitant digoxin josamycin and should be expected to increase plasma levels of digoxin.

Wilprafen / Hormonal contraceptive drugs
In rare cases of hormonal contraceptive contraceptive drugs may not be effective in the treatment of josamycin. It is therefore recommended the additional use of other, non-hormonal contraceptive drugs.

Wilprafen / Triazolam
It is Josamycin potentiate the action of triazolam and lead to drowsiness. It recommended the suspension of the medicinal product in the event of an overdose triazolam.

Josamycin / Bromocriptin mesilate
Josamycin can potentiate the effect of bromocriptine mesilate and lead to drowsiness, dizziness, ataxia and others. In cases of intoxication bromocriptine mesilate recommended suspension of medicinal products.

Pregnancy and lactation
Although not embryotoxic effects Wilprafen be administered to pregnant and lactating women only after careful risk / benefit ratio.

Effects on ability to drive and use machines
No effects on ability to drive and use machines.

Route of administration and dosage
1 scoop (10 ml) Wilprafen suspension equivalent to 300 mg of josamycin.
Unless otherwise prescribed, the recommended daily dose for newborns, infants and children up to 14 years is 30 to 50 mg josamycin / kg body weight, divided into 3 doses.
In newborns and children up to 3 years dosing must be exactly adapted to their individual body weight.
The daily dose for adults and adolescents over 14 years is 1 to 2 g josamycin, divided into 3 doses.
Age Body weight (kg) Daily dose spoonfuls suspension
Babies (more than 3 months to 1 year) over the 5.5 to 3 x 10 ml of 2.5 to 3 x 5 ml
Small children (1 to 6 years) over 10 to 21 3 x 5 ml and 3 x 10 ml
Children (6 to 14 years old) over 21 3 x 10 ml to 3 x 15 ml
Overdose
So far there are no known cases and signs of poisoning medicinal product. In case of overdose can occur symptoms described in section "Adverse reactions", especially gastrointestinal disorders. Have been reported dose-related hearing impairment, which later disappear.
In case of intake of very high doses of medicinal product and emergent side effects, tell your doctor.
If you forgot a dose, immediately take appropriate dose. If it is time for the next dose intake - skip the forgotten and carry on as usual. Do not take double doses!
Interruption or premature discontinuation might make it questionable therapy.
Before interruption or premature discontinuation of treatment, consult your doctor.

Adverse reactions
Gastrointestinal tract
Rarely violations by the gastrointestinal tract, such as loss of appetite, nausea, heartburn, diarrhea. In case of severe, persistent diarrhea should be given to the possibility of developing pa life-threatening pseudomembranous colitis. In this case Wilprafen therapy should be discontinued immediately and appropriate therapy instituted (eg. Oral vancomycin 4x20 mg daily). Contraindicated drugs that inhibit peristalsis.

Hypersensitivity Reactions
In extremely rare cases may experience allergic skin reactions (eg. Urticaria) caused by josamycin.

Liver and bile
In individual cases have been observed transient changes in liver enzyme levels, sometimes accompanied by retention of bile and jaundice.

Sense organs
In separate reports of transient dose-related hearing impairment.

General symptoms
Sometimes, as a result of the adoption of antibiotics may develop micro-organisms sensitive to antibiotics. In this case, treatment with the antibiotic should be discontinued and appropriate therapy instituted.

Storage instructions
Wilprafen suspension can be stored at room temperature, both before and after opening.

Expiry date
3 years.
Recommended Wilprafen suspension be used until four weeks after opening.

Packing
Packs of 100 ml suspension.