Medicinal Products

AMOXICILLIN CRISTERS 500 mg

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

capsule
box of 12
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 / documented pharyngitis with streptococcus

· Acute exacerbations of chronic bronchitis

· Community pneumonia

· Acute cystitis

· Bacteruria asymptomatic gravidarum

· Acute pyelonephritis

· Typhoid and paratyphoid fever

· Dental abscess with cellulite

· Joint infections on prostheses

· Eradication of Helicobacter pylori

· Lyme disease

AMOXICILLINE CRISTERS is also indicated for the prophylaxis of endocarditis.

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

Dosage AMOXICILLINE CRISTERS 500 mg Capsule box of 12

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 / documented pharyngitis with streptococcus

· Acute exacerbations of chronic bronchitis

· Community pneumonia

· Acute cystitis

· Bacteruria asymptomatic gravidarum

· Acute pyelonephritis

· Typhoid and paratyphoid fever

· Dental abscess with cellulite

· Joint infections on prostheses

· Eradication of Helicobacter pylori

· Lyme disease

AMOXICILLINE CRISTERS is also indicated for the prophylaxis of endocarditis.

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

Against indications

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

History of severe immediate hypersensitivity reaction (eg, anaphylaxis) to another beta-lactam (eg cephalosporin, carbapenem or monobactam).

Adverse effects Amoxicilline Cristers

The most common side effects are diarrhea, nausea and rash.

Adverse reactions identified in clinical studies and since the marketing of amoxicillin are listed below according to the MedDRA system organ classification.

The following terminology is used to classify adverse reactions according to their frequency:

· Very common (≥ 1/10)

· Common (≥ 1/100 to <1/10)

· Uncommon (≥ 1/1000 to <1/100)

· Rare (≥ 1/10 000 to <1/1000)

· Very rare (<1 / 10, 000)

· Frequency not known (can not be estimated from available data)

Infections and infestations

Very rare

Cutaneous and mucosal candidiasis

Blood 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 section Warnings and precautions for use ).

Immune system disorders

Very rare

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

Not known frequency

Jarisch-Herxheimer reaction (see section Warnings and precautions for use )

Nervous system disorders

Very rare

Hyperkinesis, vertigo and convulsions (see Warnings and Precautions ).

Gastrointestinal disorders

Clinical study data

*Frequent

Diarrhea and nausea

*Rare

vomiting

Post-marketing data

Very rare

Antibiotic-associated colitis (including pseudo-membranous colitis and haemorrhagic colitis, see Warnings and precautions for use ).

Hairy black tongue

Hepatobiliary disorders

Very rare

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

Skin and subcutaneous tissue disorders

Clinical study data

*Frequent

Skin rash

*Rare

Urticaria and pruritus

Post-marketing data

Very rare

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

Renal and urinary disorders

Very rare

Interstitial nephritis

Crystalline (see sections Warnings and precautions for use and Overdose Overdose)

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

Reporting of suspected adverse reactions

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

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