Dosanloc 20 mg Pantoprazolo Reflusso 14 Compresse

Pantoprazole-based tablets.

Therapeutic indications

Dosanloc is used for the short-term treatment of reflux symptoms (eg heartburn, acid regurgitation) in adults.

Dosage and Posology

The drug should be taken according to the following doses and methods: the recommended dose is 20 mg of pantoprazole (one tablet) per day. It may be necessary to take the tablets for 2-3 consecutive days to achieve an improvement in symptoms. Once complete healing of symptoms is achieved, treatment should be stopped. Treatment should not exceed 4 weeks without consulting a doctor. If no improvement in symptoms is noted within 2 weeks of continuous treatment, the patient should seek medical attention.

No dose adjustment is necessary in elderly patients or in patients with renal or hepatic impairment. Dosanloc Control is not recommended for use in children and adolescents below 18 years due to insufficient data on safety and efficacy.

Dosanloc Control 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal.

Overdose

Doses up to 240 mg administered intravenously over 2 minutes were well tolerated. Since pantoprazole is extensively protein bound, it is not readily dialyzable. In the event of an overdose with clinical signs of intoxication, other than symptomatic and supportive treatment, no specific therapeutic recommendations can be made.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients
• Simultaneous administration with atazanavir

Side effects

Approximately 5% of patients can be expected to experience adverse reactions. The most commonly reported adverse reactions are diarrhea and headache, both occurring in approximately 1% of patients. The following adverse reactions have been observed with pantoprazole. Within the table below, adverse reactions are ranked under MedDRA frequency classification: Very common (≥1 / 10); common (≥1 / 100 to <1/10); uncommon (≥1 / 1,000 to <1/100); rare (≥1 / 10,000, <1 / 1,000); very rare (<1 / 10,000), not known (cannot be estimated from the available data). Within each frequency class, adverse reactions are reported in order of decreasing severity.

- Disorders of the blood and lymphatic system

• Rare: Agranulocytosis
• Very rare: Thrombocytopenia; Leukopenia; Pancytopenia

- Disorders of the immune system

• Rare: Hypersensitivity (including anaphylactic reactions and anaphylactic shock)

- Metabolism and nutrition disorders

• Rare: Hyperlipidemias and increased lipids (triglycerides, cholesterol); Weight changes
• Not known: Hyponatremia; Hypomagnesemia

- Psychiatric disorders

• Uncommon: Sleep disturbances
• Rare: Depression (and all aggravations of this symptom)
• Very rare: Disorientation (and all aggravations of this symptom)
• Not known: Hallucinations; Confusion (especially in predisposed patients, as well as aggravation of these symptoms in case of pre-existence)

- Nervous system disorders

• Uncommon: Headache; Dizziness
• Rare: Changes in taste

- Eye disorders

• Rare: Disturbance in vision / blurred vision

- Gastrointestinal disorders

• Uncommon: Diarrhea; Nausea / vomiting; Abdominal distension and bloating; Constipation; Dry mouth Abdominal pain and discomfort

- Hepatobiliary disorders

• Uncommon: Increased levels of liver enzymes (transaminases, -GT)
• Rare: Increased bilirubin
• Not known: Hepatocellular injury; Jaundice Hepatocellular insufficiency

- Skin and subcutaneous tissue disorders

• Uncommon: Rash / rash / eruption; Itching
• Rare: Hives; Angioedema
• Not known: Steven-Johnson syndrome; Lyell's syndrome; Erythema multiforme; Photosensitivity

- Musculoskeletal and connective tissue disorders

• Uncommon: Arthralgia; Myalgia

- Renal and urinary disorders

• Not known: Interstitial nephritis

Reproductive system and breast disorders

• Rare: Gynecomastia

- General disorders and administration site conditions

• Uncommon: Asthenia, fatigue and malaise
• Rare: Increased body temperature; Peripheral edema

Pregnancy and breastfeeding

There are no adequate data from the use of pantoprazole in pregnant women. Studies in animals have shown reproductive toxicity. Preclinical studies revealed no signs of impaired fertility or teratogenic effects. The potential risk for humans is unknown. Pantoprazole should not be used in pregnancy.

It is unknown whether pantoprazole is excreted in human milk. Animal studies have shown the excretion of pantoprazole in breast milk. Pantoprazole should not be used during breastfeeding

Special warnings

Patients should be instructed to contact their physician if: - They have unintentional weight loss, anemia, gastrointestinal bleeding, dysphagia, persistent vomiting or bloody vomiting, as the medicine may relieve symptoms and delay the diagnosis of a serious condition . In these cases, a malignant form must be excluded. - Have had previous stomach ulcers or gastrointestinal surgery. - I have been on continuous symptomatic treatment for indigestion or heartburn for 4 weeks or more. - Have jaundice, liver impairment, or liver disease. - Have any other serious pathology that impairs general well-being. - Are over 55 with new or recently changed symptoms.

Patients with chronic recurring symptoms of indigestion or heartburn should see their doctor at regular intervals. Especially, patients over 55 who take any non-prescription medicine for indigestion or heartburn on a daily basis should inform their pharmacist or doctor. Patients should not take any other proton pump inhibitors or H2 antagonists at the same time. Patients undergoing endoscopy or breath testing (UBT) should consult their doctor before taking this medicine. Patients should be advised that the tablets are not intended to provide immediate relief. Patients may begin to experience improvement in symptoms after approximately one day of treatment with pantoprazole, but it may be necessary to take it for 7 days to achieve complete control of heartburn. Patients should not take pantoprazole as a preventative drug.

Decreased gastric acidity for any reason - including proton pump inhibitors - increases the gastric counts of bacteria normally found in the gastrointestinal tract. Treatment with acid-reducing medicinal products leads to a slightly increased risk of gastrointestinal infections such as Salmonella, Campylobacter, or Clostridium difficile.

This medicinal product contains the coloring agent Ponceau 4R aluminum lake (E 124), which may cause allergic reactions.

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. This medicinal product does not require any special storage precautions.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

Each Dosanloc tablet contains:

Active principle

Pantoprazole 20 mg (as sodium sesquihydrate)

Excipients

Core: Calcium stearate, Microcrystalline cellulose, Crospovidone (type A), Hydroxypropylcellulose (type EXF), Sodium carbonate anhydrous, Silica, colloidal anhydrous. Coating: Hypromellose, Yellow iron oxide (E 172), Macrogol400, Methacrylic acid-ethylacrylate copolymer (1: 1), Polysorbate80, Ponceau4R, aluminum lake (E 124, Yellow alu-quinoline lake (E 104), Sodiolauryl sulfate, Titanium dioxide ( E 171), Triethyl citrate