Pantecta Control

Posology The recommended dose is 20 mg pantoprazole (one tablet) per day. It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms. Once complete relief of symptoms has occurred, treatment should be discontinued.

The treatment should not exceed 4 weeks without consulting a doctor. If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor. Special populations No dose adjustment is necessary in elderly patients or in those with impaired renal or liver function.

Paediatric population PANTECTA Control is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy. Method of administration PANTECTA Control 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal.

Summary of the safety profile Approximately 5% of patients can be expected to experience adverse reactions . The most commonly reported adverse reactions are diarrhoea and headache, both occuring in approximately 1% of patients. Tabulated list of adverse reactions The following adverse reactions have been reported with pantoprazole.

Within the following table, adverse reactions are ranked under the MedDRA frequency classification: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

Medicinal product no longer authorised 5 Table 1. Adverse reactions with pantoprazole in clinical trials and post-marketing experience Frequency System Organ Class Uncommon Rare Very rare Not known Blood and lymphatic system disorders Agranulocytosis Thrombocytopenia; Leukopenia, Pancytopenia Immune system disorders Hypersensitivity (incl.

anaphylactic reactions and anaphylactic shock) Metabolism and nutrition disorders Hyperlipidaemias and lipid increases (triglycerides, cholesterol); Weight changes Hyponatraemia, Hypomagnesae- mia Psychiatric disorders Sleep disorders Depression (and all aggravations) Disorientation (and all aggravations) Hallucination; Confusion (especially in pre-disposed patients, as well as the aggravation of these symptoms in case of pre-existence) Nervous system disorders Headache; Dizziness Taste disorders Eye disorders Disturbances in vision / blurred vision Gastrointestinal disorders Diarrhoea; Nausea / vomiting; Abdominal distension and bloating; Constipation; Dry mouth; Abdominal pain and discomfort Hepatobiliary disorders Liver enzymes increased (transaminases, γ-GT) Bilirubin increased Hepatocellular injury; Jaundice; Hepatocellular failure Skin and subcutaneous tissue disorders Rash / exanthema / eruption; Pruritus Urticaria; Angioedema Stevens-Johnson syndrome; Lyell syndrome; Erythema multiforme; PhotosensitivityMedicinal product no longer authorised 6 Musculoskeletal and connective tissue disorders Arthralgia; Myalgia Renal and urinary disorders Interstitial nephritis Reproductive system and breast disorders Gynaecomastia General disorders and administration site conditions Asthenia, fatigue and malaise Body temperature increased; Oedema peripheral Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Medicinal product no longer authorised 3 Patients should be instructed to consult a doctor if:  They have unintentional weight loss, anaemia, gastrointestinal bleeding, dysphagia, persistent vomiting or vomiting with blood, since it may alleviate symptoms and delay diagnosis of a severe condition.

In these cases, malignancy should be excluded.  They have had previous gastric ulcer or gastrointestinal surgery.  They are on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks.  They have jaundice, hepatic impairment, or liver disease.

 They have any other serious disease affecting general well-being.  They are aged over 55 years with new or recently changed symptoms. Patients with long-term recurrent symptoms of indigestion or heartburn should see their doctor at regular intervals.

Especially, patients over 55 years taking any non-prescription indigestion or heartburn remedy on a daily basis should inform their pharmacist or doctor. Patients should not take another proton pump inhibitor or H2 antagonist concomitantly.

Patients should consult their doctor before taking this medicinal product if they are due to have an endoscopy or urea breath test. Patients should be advised that the tablets are not intended to provide immediate relief. Patients may start to experience symptomatic relief after approximately one day of treatment with pantoprazole, but it might be necessary to take it for 7 days to achieve complete heartburn control.

Patients should not take pantoprazole as a preventive medicinal product. Gastrointestinal infections caused by bacteria Decreased gastric acidity, due to any means - including proton pump inhibitors - increases gastric counts of bacteria normally present 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.

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