Medicinal Products


Generic drug of Zithromax Monodose
Therapeutic class: Infectiology - Parasitology
active ingredients: Azithromycin
laboratory: Tradiphar

Coated tablet
Box of 4
All forms


They arise from the antibacterial activity and pharmacokinetic characteristics of azithromycin. They take into account both the clinical studies that gave rise to this drug and its place in the range of antibacterial products currently available.

They are limited to infections due to germs defined as sensitive:

· Non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis .

The ability of azithromycin treatment to eradicate an undiagnosed treponematosis has not been evaluated.

Official recommendations concerning the appropriate use of antibacterials should be taken into account.

Dosage AZITHROMYCIN MONODOSE SANDOZ 250 mg Film-coated tablet Box of 4



1 g, or 4 tablets, in a single dose.

· No dosage modification in the elderly.

· Same dosage in patients with moderate to moderate hepatic impairment (see Warnings and Precautions for Use section Special warnings and special precautions for use).

Administration mode

The tablets can be taken during or after meals, in a single daily dose

Against indications

This medicine MUST NEVER BE USED in case of:

· A history of allergic reaction to azithromycin, erythromycin, any other macrolide or any of the excipients,

· Combination with alkaloids of ergot: dihydroergotamine, ergotamine (see sections Warnings and precautions for use and Interactions with other medicinal products and other forms of interaction ),

· Combination with cisapride (see section Interactions with other medicinal products and other forms of interaction ),

· Combination with colchicine (see section Interactions with other medicinal products and other forms of interaction ),

· Severe hepatic impairment (see Warnings and Precautions section ).

Due to the presence of soy lecithin, this medicine is contraindicated in cases of peanut or soy allergy.

Adverse effects Azithromycin Monodose Sandoz

· Cutaneous-mucous and allergic: rash, photosensitivity, arthralgia, urticaria, pruritus, rarely angioedema, anaphylactic reactions. Rare cases of severe skin reactions have been reported.

· Gastrointestinal: nausea, vomiting, dyspepsia, diarrhea (rarely severe), abdominal pain, pancreatitis. Rare cases of pseudomembranous colitis have been reported.

· Hepatic: increased liver enzymes reversible upon discontinuation of treatment. Rare cases of hepatic necrosis and hepatic insufficiency have rarely been life-threatening. However, no causal link could be established. Isolated cases of cholestatic hepatitis have been reported.

· Neurological: dizziness; rare cases of seizures have been reported.

· Hematologic: isolated cases of thrombocytopenia have been reported.

· Psychiatric: rare cases of aggressive behavior, nervousness, agitation and anxiety have been reported.

· Genitals: vaginitis.

· Hearing aids: rare cases of hearing problems with tinnitus or deafness have been reported.

· General: candidiasis.

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