Medicinal Products

AMOXICILLIN CRISTERS 250 mg / 5 ml

Clamoxyl Generic Drug
Therapeutic class: Infectiology - Parasitology
active ingredients: Amoxicillin
laboratory: Cristers

Powder for oral suspension
bottle of reconstituted suspension (+ c.mesure) of 60 ml
All forms

Indication

AMOXICILLINE CRISTERS is indicated for the treatment of the following infections in adults and children (see sections 4.2 and 5.2). Dosage and Administration, Warnings and Precautions and Pharmacodynamic Properties :

 · Acute bacterial sinusitis.

 · Acute otitis media.

 · Angina / pharyngitis documented at streptococcus.

 · Acute exacerbations of chronic bronchitis.

· Community pneumonia.

 · Acute cystitis.

 · Bacteriuria asymptomatic pregnancy.

 · Acute pyelonphritis.

 · Typhoid and paratyphoid fever.

· Abcès dental with cellulite.

 · Joint infections on prostheses.

· Elimination of Helicobacter pylori.

 · Lyme disease.

AMOXICILLINE CRISTERS is also indicated for the prophylaxis of endocarditis.

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

Dosage AMOXICILLINE CRISTERS 250 mg / 5 ml powder for oral suspension vial of reconstituted suspension (+ c.mesure) of 60 ml

AMOXICILLINE CRISTERS is indicated for the treatment of the following infections in adults and children (see sections 4.2 and 5.2). Dosage and Administration, Warnings and Precautions and Pharmacodynamic Properties :

 · Acute bacterial sinusitis.

 · Acute otitis media.

 · Angina / pharyngitis documented at streptococcus.

 · Acute exacerbations of chronic bronchitis.

· Community pneumonia.

 · Acute cystitis.

 · Bacteriuria asymptomatic pregnancy.

 · Acute pyelonphritis.

 · Typhoid and paratyphoid fever.

· Abcès dental with cellulite.

 · Joint infections on prostheses.

· Elimination of Helicobacter pylori.

 · Lyme disease.

AMOXICILLINE CRISTERS is also indicated for the prophylaxis of endocarditis.

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

Against indications

· Hypersensitivity to the active substance, penicillins or any of the excipients listed under Composition .

 · Previous serious hypersensitivity reaction (eg, anaphylaxis) to another beta-lactam (eg cephalosporin, carbapenome or monobactam) ).

Adverse effects Amoxicilline Cristers

The most common untoward effects are diarrhea, nausea and skin rash.

The adverse effects identified in the clinical studies and since the marketing of amoxicillin are mentioned below according to the MedDRA system-organ classification.

The following terminology is used to classify the undesirable effects according to their frequency:

· Very common (³ 1/10)

· Frequent (³ 1/100 to <1/10)

· Not very common (³ 1/1000 to <1/100)

· Rare (³ 1/10000 to <1/1000)

· Very rare (<1/10 000)

· Uncertain frequency (can not be estimated based on available data)

Infections and infestations

Very rare

Skin and mucous membrane candidiasis

Hematologic and lymphatic system disorders

Very rare

Reversible leukopenia (including agranulocytosis or severe neutropenia), reversible hemolytic anemia and thrombocytopenia.

Prolongation of bleeding time and Quick time (see Warnings and Precautions section ).

Immune system disorders

Very rare

Severe allergic reactions, including angioedema, anaphylaxis, serous sickness and hypersensitivity vasculitis (see Warnings and Precautions section ).

Unconditional frequency

Jarisch-Herxheimer reaction (see Warnings and Precautions section )

Nervous system disorders

Very rare

Hyperkinesia, vertigo and seizures (see Warnings and Precautions section ).

Gastrointestinal disorders

Clinical studies data

* Frà © Quent

Diarrhea and nausea

* Not very frequent

vomiting

Post-market data

Very rare

Antibiotic-associated colitis (including pseudo-membranous colitis and hemorrhagic colitis, see Warnings and Precautions section ).

Hairy black tongue

Superficial dental coloring #

Hereditary conditions

Very rare

Hepatitis and cholestatic jaundice. Moderate increase in ASAT and / or ALAT.

Skin and subcutaneous tissue disorders

Clinical studies data

* Frà © Quent

Skin rash

* Not very frequent

Urticaria and pruritus

Post-market data

Very rare

Skin reactions such as polymorphic rheumatism, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis, and acute generalized exanthematous pustulosis (PEAG) ) (see section Warnings and Precautions ).

Renal and urinary disorders

Very rare

Interstitial nephritis

Crystalline (see sections Warnings and Precautions and Overdose Overdose)

* The frequency of these AEs was determined based on data from clinical studies involving a total of approximately 6, 000 adult and pediatric patients on amoxicillin.

# Superficial tooth staining has been reported in children. Good oral hygiene can help prevent tooth discoloration, which is usually reversible after brushing teeth.

Declaration of suspected untoward effects

The declaration of suspected adverse effects after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals disclose any suspected adverse effects via the national reporting system: National Agency for Drug and Health Product Safety (ANSM) and network Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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