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Somac Control is a brand name for Pantoprazole. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SOMAC Control is indicated for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Verbatim from this product's EMA label. Tap a section to expand.
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 SOMAC 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 SOMAC Control 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal.
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Summary of the safety profile Approximately 5% of patients can be expected to experience adverse reactions. 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).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 1. Adverse reactions with pantoprazole in clinical trials and post-marketing experience Frequency System organ class Common Uncommon Rare Very rare Not known Blood and lymphatic system disorders Agranulocytosis Thrombocytopenia; Leukopenia; Pancytopenia Immune system disorders Hypersensitivity (incl.
4). Musculoskeletal and connective tissue disorders Fracture of wrist, hip and spine. 4) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 8
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 pantoprazole 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. 8). Patients should be advised of the signs and symptoms and monitored closely for skin reactions.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Pantoprazole in European Union.
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If signs and symptoms suggestive of these reactions appear, pantoprazole should be withdrawn immediately and an alternative treatment considered. Subacute cutaneous lupus erythematosus (SCLE) Proton pump inhibitors are associated with very infrequent cases of SCLE.
If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping SOMAC Control. SCLE after 4 previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Interference with laboratory tests Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. 1). If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.
2). Patients should be warned about additional risks with long-term use of the medicinal products and the need for prescription and regular surveillance should be emphasised. Influence on vitamin B12 absorption Pantoprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria.
This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed. Bone fracture Proton pump inhibitors, especially if used in high doses and over long durations (> 1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in the presence of other recognised risk factors.
Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10–40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.
Hypomagnesaemia Severe hypomagnesaemia has been rarely reported in patients treated with proton pump inhibitors (PPIs) like pantoprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness, and ventricular arrhythmia can occur, but they may begin insidiously and be overlooked.
8). In most affected patients, hypomagnesaemia (and hypomagnesaemia associated hypocalcaemia and/or hypokalaemia) improved after magnesium replacement and discontinuation of the PPI. , diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.
SOMAC Control contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. 5