WILPRAFEN 10 tablets

Astellas
WILPRAFEN 10 tablets
€ 59.00
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1 film-coated tablet contains: 500 mg of josamycin.

Excipients:
Methylcellulose: 0.12825 mg / tb;
Microcrystalline cellulose: 101 mg / tb;
Colloidal anhydrous silica: 14 mg / tb;
Polysorbate 80: 5 mg / tb;
Sodium carboxymethylcellulose, 5 mg / tb;
Talc: 2.0513 mg / tb;
Magnesium stearate: 5 mg / tb;
Macrogol 6000: 0.3846 mg / tb;
Titanium dioxide E171: 0.641 mg / tb;
Aluminum hydroxide: 0.641 mg / tb;
Poly- (etilakrilatmetilmetakrilat) dispersion - 30%: 1.15385 mg / tb.

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 infection caused by pathogenic strains that are sensitive to Josamycin.

Infections of the pharynx:
pharyngitis and tonsillitis caused by streptococcal strains, middle ear infections, sinusitis, laryngitis, diphtheria (in addition to treatment with diphtheria antitoxin) and scarlet fever in cases 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, lymphadenopathy, inguinal limfogranuloma, inflammation of the prostate, as well as gonorrhea and syphilis in the case of allergy or intolerance 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 and astemizole respectively may be extended, leading to life-threatening cardiac arrhythmias;
premature babies, because there is not enough experience.
Special warnings and precautions
Until now not known.

Interactions with other drugs
Wilprafen / Other antibiotics
Since the bacteriostatic antibiotics may result in bactericidal activity of other antibiotics such as penicillins or cephalosporins, 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, which may lead to life-threatening cardiac arrhythmias.

Wilpafen / Ergot alkaloids
Reported instances of increased vasoconstriction after 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, co-administration of ergot alkaloids and josamycin need to be accompanied by proper monitoring of patients.

Wilprafen / Cyclosporin
Coadministration of josamycin and Cyclosporin can lead to increased plasma levels of Cyclosporin and lead to nephrotoxic concentrations in serum. You 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, contraceptive hormonal 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 possible Josamycin potentiate the action of triazolam and lead to drowsiness. Recommended the suspension of the medicinal product in the event of an overdose of triazolam.

Josamycin / Bromocriptin mesilate
Josamycin can potentiate the effect of bromocriptine mesilate and cause drowsiness, dizziness, ataxia, etc. In case of intoxication with 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.

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

Route of administration and dosage
Unless otherwise prescribed, the recommended dose for adults and adolescents over '14 is 1-2 d josamycin (2 to 4 film-coated tablets) daily, divided into 2 to 3 doses. As an initial dose is recommended 1 g josamycin (2 film-coated tablets).

Special dosages:
for acne vulgaris u acne conglobala:
Josamycin 500 mg - twice daily (one film-coated tablet in the morning and one in the evening) as initial therapy (2 to 4 weeks), then - 500 mg josamycin (1 film-coated tablet) as maintenance therapy for 8 weeks. To achieve optimal serum concentrations of individual doses to be administered between meals.
Wilprafen film-coated tablets should be swallowed whole with some liquid.
According to WHO recommendations duration of the treatment of streptococcal infections is at least 10 days.
When treating patients with renal failure is necessary to use appropriate laboratory tests as an additional information required for therapy.
In newborns it is necessary to monitor renal function. Should be expected to cross-resistance between macrolide antibiotics.

Overdose
So far there are no known cases and signs of poisoning with the 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 medicine and emergent side effects, tell your doctor.
If you forget a dose, immediately take appropriate dose. If it is time for the next dose intake - skip the missed and carry on as usual. Do not take double doses!
Interruption or premature discontinuation of treatment could make the outcome of the therapy questionable.
Before interruption or premature discontinuation of treatment, consult your doctor.

Undesirable effects
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 life-threatening pseudomembranous colitis. In this case, treatment with Wilprafen should be discontinued immediately and appoint appropriate therapy (eg. Oral vancomycin 4x20 mg daily). Are contraindicated drugs that inhibit peristalsis.

Hypersensitivity reactions
In extremely rare cases may be 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 microorganisms insensitive to antibiotics. In this case, treatment with the antibiotic should be discontinued and appropriate therapy appoint.

Storage instructions
Wilprafen film-coated tablets can be stored at temperatures below 25 ° C and protected from light.

Expiry date
Four years.
Do not use after the expiry date stated on the packaging.

Packing
1 blister x 10 film-coated tablets.
€ 59.00
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