Medicinal Products

PARIET 20 mg

Generic drug of the therapeutic class: Gastro-Entero-Hepatology
active ingredients: Rabeprazole
laboratory: Janssen Cilag

Gastroresistant tablet
Box of 14
All forms

Indication

PARIET, is indicated in the treatment:

· Progressive duodenal ulcer,

· Benign evolutionary gastric ulcer,

· Erosive or ulcerative esophagitis symptomatic by gastroesophageal reflux,

· Maintenance of oesophagitis by gastroesophageal reflux,

· Symptomatic moderate to very severe gastro-oesophageal reflux,

· The eradication of Helicobacter pylori in peptic ulcer disease, in combination with appropriate antibiotic therapy,

· Zollinger Ellison syndrome

Dosage PARIET 20 mg Gastroresistant tablet Box of 14

Adult - Elderly:

Evolutionary duodenal ulcer, benign evolutionary gastric ulcer:

The recommended daily dose for the treatment of active duodenal ulcer or benign progressive gastric ulcer is 20 mg once daily in the morning.

Scarring is achieved in most patients with progressive duodenal ulcer within 4 weeks of treatment. However, in a small number of patients it may be necessary to continue treatment for an additional 4 weeks for complete healing. Scarring is achieved in most patients with benign progressive gastric ulcer within 6 weeks of treatment. However, in a small number of patients, it may be necessary to continue treatment for an additional 6 weeks for complete healing.

Erosive or ulcerative esophagitis by gastroesophageal reflux:

The recommended daily dose for treatment of gastroesophageal reflux esophagitis is 20 mg once daily in the morning for 4 to 8 weeks.

Maintenance treatment of gastroesophageal reflux esophagitis:

During long-term treatment, the maintenance dose is 20 or 10 mg once a day, in the morning, depending on the patient's response.

Symptomatic treatment of moderate to very severe gastro-oesophageal reflux:

10 mg once daily, in patients without esophagitis. If symptoms persist after 4 weeks, additional tests should be performed.

After resolution of symptoms, symptomatic recurrence can be controlled by taking PARIET 10 mg once daily as needed.

Eradication of Helicobacter pylori :

A combination medication is recommended for 7 days according to the following dosing schedule.

20 mg PARIET 2 times daily with clarithromycin 500 mg twice daily and amoxicillin 1 g twice daily.

Treatment of Zollinger-Ellison syndrome:

The recommended starting dose is 60 mg rabeprazole once daily. This can be increased to 120 mg per day depending on the needs of the patient.

Single daily doses of 100 mg rabeprazole can be administered. Daily doses of 120 mg can be divided into 2 doses of 60 mg. Treatment should be continued as long as clinically necessary.

In the indications where PARIET is administered once a day, PARIET should be taken in the morning before breakfast. Although neither time of intake nor diet influences rabeprazole sodium activity, this regimen facilitates adherence.

Patients should be warned that PARIET tablets should not be chewed or chewed but should be swallowed whole.

Renal and hepatic insufficiency:

Dosage adjustment is not required in patients with renal or hepatic impairment.

See Special warnings and precautions for use of PARIET in patients with severe hepatic impairment.

Child:

The use of PARIET is not recommended in children because of the lack of study in these patients.

Against indications

PARIET is contraindicated in patients with known hypersensitivity to rabeprazole sodium or to any of the components of this drug. PARIET is contraindicated during pregnancy and lactation.

Pariet side effects

The most commonly reported adverse events in clinical trials with rabeprazole were headache, diarrhea, abdominal pain, asthenia, flatulence, rash and dry mouth.

The majority of adverse events experienced in clinical trials were of mild or moderate intensity and transient type.

The following adverse events have been reported during clinical studies and during post-marketing follow-up.

Frequencies are defined as follows: Frequent (> 1/100, 1 / 1, 000, 1 / 10, 000, <1 / 1, 000), very rare (<1 / 10, 000).

Classes of organ system

frequent

Uncommon

few

Very rare

unknown

Infections and infestations

infections

Blood and lymphatic system disorders

neutropenia

leukopenia

thrombocytopenia

leukocytosis

Immune system disorders

Hypersensitivity 1, 2

Metabolism and nutrition disorders

Anorexia

hyponatremia

Hypomagnesemia 4

Psychiatric disorders

Insomnia

Nervousness

Depression

Confusion

Nervous system disorders

headaches

Dizziness

Drowsiness

Eye disorders

Vision disorders

Vascular disorders

Peripheral edema

Respiratory, thoracic and mediastinal disorders

Cough

Pharyngitis

rhinitis

Bronchitis

Sinusitis

Gastrointestinal disorders

Diarrhea

vomiting

nausea

Abdominal pain

Constipation

meteorism

Dyspepsia

Dryness of the mouth

Eructation

gastritis

stomatitis

dysgeusia

Hepatobiliary disorders

Hepatitis

icterus

Hepatic encephalopathy 3

Skin and subcutaneous tissue disorders

rash

Erythema 2

itching

Sweat

Bullous reactions 2

Erythema multiforme

Stevens Johnson Syndrome

Lyell Syndrome

Musculoskeletal and systemic disorders

Non-specific pains /

Back pain

myalgia

Cramps of the lower limbs

arthralgia

Fracture of the hip, wrist or vertebrae 4

Renal and urinary disorders

Urinary infection

Interstitial nephritis

Disorders of reproductive organs and breast

gynecomastia

General disorders and administration site conditions

Asthenia

Flu-like syndrome

Chest pain

Chills

pyrexia

investigations

Increased liver enzymes 3

Weight gain

1 including edema of the face, hypotension and dyspnea

2 Erythema, bullous reactions and hypersensitivity reactions have usually resolved after discontinuation of treatment

3 There have been rare reports of hepatic encephalopathy in patients with cirrhosis. In patients with severe hepatic dysfunction, prescribers are advised to exercise increased surveillance when initiating therapy with PARIET (see Warnings and Precautions ).

4 See Special warnings and precautions for use ( Warnings and precautions for use ).

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