Medicinal Products

PANTOZOL CONTROL 20 mg

Generic drug of the therapeutic class: Gastro-Entero-Hepatology
active ingredients: Pantoprazole
laboratory: Nycomed Gmbh

Enteric coated tablet
Box of 7
All forms

Indication

PANTOPRAZOL Control is indicated for the short-term treatment of symptoms of gastroesophageal reflux (eg, heartburn, acid regurgitation) in adults.

Dosage PANTOZOL CONTROL 20 mg Enteric coated tablet Box of 7

Dosage

The recommended dose is 20 mg pantoprazole (one tablet) daily.

Taking tablets for 2 or 3 consecutive days may be necessary for symptom improvement. Once the symptoms are gone, treatment should be stopped. The duration of treatment should not exceed 4 weeks without medical advice.

If symptoms persist after 2 weeks of continuous treatment, the patient should consult a doctor.

Special populations

No adjustment of the dose is necessary in the elderly or the hepatic or renal insufficiency.

Pediatric population
PANTOZOL Control is not recommended for use in children and adolescents under 18 years of age due to insufficient data on efficacy and safety.

Administration mode

PANTOZOL Control 20 mg gastro-resistant tablet should not be crushed or crushed. It must be swallowed whole with a little water before a meal.

Against indications

Hypersensitivity to the active substance or to any of the excipients (see section Composition ).

Should not be administered with atazanavir (see section 4.5. Interactions with other medicinal products and other forms of interaction ).

Pantozol Control side effects

About 5% of patients are likely to have side effects. The most commonly reported adverse events are diarrhea and headache in approximately 1% of patients. The following side effects have been reported with pantoprazole.

The adverse reactions listed in the table below are classified according to the order of frequency defined by the MedDRA classification:

Very common (≥ 1/10), common (≥1 / 100, <1/10), infrequent (≥ 1/1000, <1/100), rare (≥ 1/10 000, <1 / 1, 000), very rare (<1 / 10, 000), not known (can not be estimated based on available data).

Within each frequency group, adverse effects are presented in descending order of severity.

Table 1. Adverse effects of pantoprazole reported in post-marketing clinical trials

Frequency

organ system

Uncommon

few

Very rare

Not known frequency

Blood and lymphatic system disorders

agranulocytosis

Thrombocytopenia Leukopenia
pancytopenia

Nervous system disorders

Headache Dizziness

Taste disorder

Eye disorders

Visual disorders / blurred vision

Gastrointestinal disorders

Diarrhea; nausea / vomiting; abdominal distension and meteorism; constipation; dry mouth; abdominal pain and discomfort

Renal and urinary disorders

Interstitial nephritis

Skin and subcutaneous tissue disorders

Skin rash / rash / eruption; pruritus

Hives; Quincke's edema

Stevens-Johnson Syndrome; Lyell syndrome; erythema multiforme; photosensitivity

Musculoskeletal and systemic disorders

Arthralgia; myalgia

Metabolism and nutrition disorders

Hyperlipidemia and lipid increase

(triglycerides, cholesterol); change in weight

hyponatremia
hypomagnesemia

General disorders and administration site conditions

Asthenia, fatigue and discomfort

Increase in body temperature; peripheral edema

Affections of

system

immune

Hypersensitivity (including anaphylactic reaction and anaphylactic shock)

Hepatobiliary disorders

Increased liver enzymes (transaminases, γ-GT)

Increased bilirubinemia

Lesion

hepatocellular; jaundice; hepatocellular insufficiency

Psychiatric disorders

Sleeping troubles

Depression (and other aggravations)

Disorientation (and other aggravations)

Hallucinations; confusion (especially in predisposed patients); aggravation of these disorders in case of pre-existence

Reproductive organs and breast disease

gynecomastia

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