Medicinal Products

AMOXICILLIN / CLAVULANIC ACID TEVA 1 g / 125 mg ADULTS

Generic drug of Adult Augmentin
Therapeutic class: Infectiology - Parasitology
active ingredients: Amoxicillin + clavulanic acid
laboratory: Teva Sante

Powder for oral suspension
in sachet-dose (ratio amoxicillin / clavulanic acid: 8/1) sachets-dose box of 12
All forms

Indication

AMOXICILLIN / CLAVULANIC ACID TEVA is indicated for the treatment of the following infections in adults and children (see section 4.2 Posology and method of administration, Warnings and precautions for use, and Pharmacodynamic properties ). :

· Acute bacterial sinusitis (diagnosed appropriately),

· Acute otitis media,

· Exacerbation of chronic bronchitis (diagnosed appropriately),

· Acute community pneumonia,

· Cystitis,

· Pyelonphritis,

· Infections of the skin and soft tissues, especially cellulitis, animal bites, severe dental abscesses with spread of cellulite,

· Infections of bones and joints, especially osteomyelitis.

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

Dosage AMOXICILLIN / CLAVULANIC ACID TEVA 1 g / 125 mg ADULTS powder for oral suspension in sachet-dose (amoxicillin / clavulanic acid ratio: 8/1) sachets-dose box of 12

AMOXICILLIN / CLAVULANIC ACID TEVA is indicated for the treatment of the following infections in adults and children (see section 4.2 Posology and method of administration, Warnings and precautions for use, and Pharmacodynamic properties ). :

· Acute bacterial sinusitis (diagnosed appropriately),

· Acute otitis media,

· Exacerbation of chronic bronchitis (diagnosed appropriately),

· Acute community pneumonia,

· Cystitis,

· Pyelonphritis,

· Infections of the skin and soft tissues, especially cellulitis, animal bites, severe dental abscesses with spread of cellulite,

· Infections of bones and joints, especially osteomyelitis.

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

Against indications

· Hypersensitivity to the active substances, penicillins or any of the excipients.

 · Previous serious hypersensitivity reaction (eg, anaphylaxis) to another beta-lactam (eg, cephalosporin, carbamphenol) Or a monobactam).

 · History of jaundice / hepatitis related to amoxicillin / clavulanic acid (see section Unnecessary effects ).

Adverse effects Amoxicil / ac Clav Teva Ad

The most common untoward effects are diarrhea, nausea and vomiting.

The adverse effects identified in the clinical studies and post-marketing of AMOXICILLIN / CLAVULANIC ACID are listed below according to the MedDRA system-organ classification.

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

Very frequent (³ 1/10)

Frequent (³ 1/100 to <1/10)

Not very frequent (³ 1/1 000 to <1/100)

Rare (³ 1/10 000 to <1/1000)

Very rare (<1 / 10, 000)

Unlimited frequency (can not be estimated based on available data)

Infections and infestations

Skin and mucous membrane candidiasis

Frà © Quent

Excessive development of non-susceptible organisms

Unconditional frequency

Hematologic and lymphatic system disorders

Reversible leukopenia (including neutropenia)

Rare

Thrombocytopà © nie

Rare

Reversible agranulocytosis

Unconditional frequency

Hemolytic anemia

Unconditional frequency

Prolongation of bleeding time and Quick 1 time

Unconditional frequency

Immune system disorders 10

Angels of Quincke

Unconditional frequency

anaphylaxis

Unconditional frequency

Serial sickness

Unconditional frequency

Hypersensitivity vasculitis

Unconditional frequency

Nervous system disorders

à ‰ dizziness

Not very frequent

CÃ © Phala © es

Not very frequent

Reversible hyperactivity

Unconditional frequency

Convulsions 2

Unconditional frequency

Aseptic meningitis

Unconditional frequency

Gastrointestinal disorders

Diarrhea

Very frequent

Nausea 3

Frà © Quent

vomiting

Frà © Quent

Indigestion

Not very frequent

Colitis associated with antibiotics 4

Unconditional frequency

Glossophytie

Unconditional frequency

Hereditary conditions

ASAT and / or ALAT 5 elevations

Not very frequent

Hepatitis 6

Unconditional frequency

Cholestatic Icarus 6

Unconditional frequency

Skin and subcutaneous tissue disorders 7

Skin rash

Not very frequent

itching

Not very frequent

Urticaria

Not very frequent

Polymorphic rhythm

Rare

Stevens-Johnson Syndrome

Unconditional frequency

Epidermolysis necrotizing hyperacute

Unconditional frequency

Bullous dermatitis or exfoliator

Unconditional frequency

Acute Generalized Exanthematous Pustulosis (PEAG) 9

Unconditional frequency

Renal and urinary disorders

Interstitial nephritis

Unconditional frequency

Crystalline 8

Unconditional frequency

1 See Warnings and Precautions section

2 See Warnings and Precautions section

3 Nausea is more often associated with higher oral doses. Gastrointestinal manifestations may be alleviated by taking AMOXICILLIN / CLAVULANIC ACID TEVA at the beginning of a meal.

4 Including pseudomembranous colitis and hemorrhagic colitis (see Warnings and Precautions )

5 A moderate increase in ASAT and / or ALT levels has been noted in patients treated with antibiotics in the beta-lactam family, but significance of these increases is unknown.

6 These effects have been observed with other penicillins and cephalosporins (see Warnings and Precautions ).

7 In the event of hypersensitivity dermatitis, treatment should be discontinued (see Warnings and Precautions ).

8 See Overdose section

9 See Warnings and Precautions section

10 See sections Contraindications and Warnings and Precautions

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 should report any suspected adverse effects via the national reporting system: National Agency for Drug and Health Product Safety (Ansm) and Ree Bucket of the Regional Centers for Pharmacovigilance - Website: // www.ansm.sante.fr.

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