Descrizione Clinica
XOOLAM REFLUS 20 MG COMPRESENT
active ingredients
Each gastrorous tablet contains 20 mg of pantoprazole (such as sodium sesquidrate 22,55 mg). For the full list of excipients see paragraph 6.1.Excellent
Nucleus: Sodium carbonate, Mannitolo (E421), Crospovidone, Mais pregelatinizzato, Calcium stearate. Intermediate coating: Ipromellose, Triacetin, Titanium Dioxide (E171). Gastro-resistant coating: Methacrylic-ethylacrylate copolymer 1:1, Sodium lauril sulphate, Polysorbate 80, Triethylcytrate, Talco, Titanium dioxide (E171), Yellow Iron oxide (E172), Red Iron oxide (E172).Therapeutic indications
Short-term treatment of reflux symptoms (e.g. pyrosis, acid regurgitation).Contraindications
Hypersensitivity to the active ingredient, benzimidazolics, substitutes or any other excipient listed in the paragraph 6.1.Population
Population. The recommended dose for oral administration is an Xoolam reflux 20 mg per day. You may need to take tablets for 2-3 consecutive days to obtain an improvement of symptoms. Once the complete healing of symptoms is achieved, the treatment must be suspended. Treatment should not exceed 4 weeks. If no symptoms are improved within 2 weeks of continuous treatment, medical consultation is required. Once you get the relief of symptoms, you can check the recurrence of symptoms using, when necessary, a need treatment with 20 mg once a day. In cases where a satisfactory control of the symptoms cannot be maintained with the administration of the need, it should be assessed the passage to a continuous therapy. Special popularity. Pediatric population: The use of Xoolam reflux is not recommended in children due to limited data on safety and effectiveness in this age group. Patients with liver impairment: In patients with severely compromised liver function, a daily dose of 20 mg of pantoprazole should not be exceeded (see paragraph 4.4). Patients with kidney damage: Dose adjustment is not required in patients with compromised kidney function (see paragraph 5.2). Seniors: Dose adjustment is not necessary in elderly patients (see paragraph 5.2). Method of administration: Oral use. Tablets should not be chewed or crushed, and should be swallowed whole with a little water 1 hour before a meal.Conservation
No special precaution for conservation.Warnings
Epathetic Comprogation. In patients with severe liver impairment, hepatic enzymes must be checked regularly during pantoprazole therapy, especially in long-term use. In case of increased liver enzymes, treatment must be stopped (see paragraph 4.2). Co-administration with FANS. The use of Xoolam reflux 20 mg in the prevention of gastroduodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAID) should be limited to patients requiring continuous treatment with NSAIDs and presenting an increased risk of gastrointestinal complications. The assessment of the increased risk must be carried out according to the presence of individual risk factors, e.g. high age (>65 years), positive anamnesi for gastric or duodenal ulcer or for the bleeding of the upper gastrointestinal tract. Gastric neoplasia. In the presence of any alarming symptoms (e.g. significant non-intentional weight loss, recurring vomiting, dysphagia, hematemesis, anemia or melena) and when suspected or confirmed the presence of gastric ulcer, malignant nature must be excluded, as treatment with pantoprazole can relieve symptoms and delay diagnosis. If symptoms persist despite proper treatment, further investigation must be considered. Co-administration with HIV protease inhibitors. Co-administration of pantoprazole with HIV protease inhibitors whose absorption depends on intragastric acid pH as atazanavir, due to significant reduction in their bioavailability (see paragraph 4.5). 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. Long-term treatment. In long-term treatment, especially when over a 1 year treatment period, patients must be kept under regular surveillance. Gastrointestinal infections caused by bacteria. Treatment with Xoolam reflux can lead to a slight increase in the risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter or C. difficult. . Hypomaginemia. Severe hypomagnesiaemia was reported in patients treated with PPI as pantoprazolefor at least three months, and in many cases for a year. Severe symptoms of hypomagnesia such as fatigue, tetania, delirium, convulsions, dizziness and ventricular arrhythmia may initially manifest insidious and may be neglected. In most patients, hypomagnesiaemia improves after magnesium intake and PPI suspension. For patients in therapy for a prolonged period or taking PPIs with digoxin or medicines that may cause hypomagnesiemia (e.g. diuretics), health professionals should consider the possible measurement of magnesium levels before starting treatment with PPI and periodically during treatment in patients. Bone fractures. Protonic pump inhibitors, especially when used for high doses and prolonged periods (> 1 year), may cause a slight increase in risk of hip fractures, pulse and spine fractures, especially in elderly patients or in the presence of other known risk factors. Observation studies suggest that protonic pump inhibitors could increase the overall risk of fracture from 10% to 40%. This increase may be partly due to other risk factors. Patients at risk of osteoporosis should receive treatment according to current clinical practice guidelines and should take appropriate amounts of vitamin D and calcium. Subacute cutaneous erythematose lupus (LECS). Protonic pump inhibitors are associated with extremely infrequent cases of LECS. In the presence of injuries, especially on the skin parts exposed to the sun rays, and if accompanied by artralgia, the patient must immediately address to the doctor and the healthcare provider must assess the opportunity to stop treatment with Xoolam reflux. The appearance of LECS following a treatment with a protonic pump inhibitor can increase the risk of LECS onset with other protonic pump inhibitors. Interference with laboratory tests. An increased level of Chromogranin A (CgA) can interfere with diagnostic tests for neuroendocrine tumors. To avoid this interference, Xoolam reflux treatment must be suspended for at least 5 days before CgA measurements (see paragraph 5.1). If the levels of CgA and gastrin are not returned within the reference range after initial measurement, it is necessary to repeat the measurements 14 days after the interruption of treatment with protonic pump inhibitor.Interactions
Effect of pantoprazole on the absorption of other medicines . Due to the marked and long-term inhibition of gastric acid secretion, pantoprazole may interfere with the absorption of other drugs where gastric pH is an important factor in oral availability, e.g. some azolic antifungals such as ketoconazole, itraconazole, poseconazole and other medicines such as herlotinib. HIV protease inhibitors . Co-administration of pantoprazole is not recommended with HIV protease inhibitors whose absorption depends on intragastric acid pH such as atazanavir, due to significant reduction in their bioavailability (see paragraph 4.4). If the combination of HIV protease inhibitors with a protonic pump inhibitor is considered inevitable, strict clinical monitoring (e.g. viral charge) is recommended. A dose of 20 mg of pantoprazole per day should not be exceeded. It is necessary to adjust the dosage of HIV protease inhibitors Cucumin antiagulants (fenprocumone or warfarin). Concurrent administration of pantoprazole with warfarin or fenprocumone did not affect the pharmacokinetics of warfarin, fenprocumone or the INR. However, there have been reports of increased protrombine and INR time in patients in treatment with PPI and warfarin or fenprocumone in conjunction. Increasing INR and protrombine time can lead to abnormal bleeding, and even death. Patients treated with pantoprazole and warfarin or fenprocumone may need to be monitored for increase of INR and protrombine time. Metotress. It has been reported that the concomitant use of high-dose metotressate (e.g. 300 mg) and protonic pump inhibitors increases meto-tressed levels in some patients. Therefore, where high doses of methorate are administered, e.g. for cancer and psoriasis, it should be considered a temporary suspension of pantoprazole. Other interaction studies. Pantoprazol is widely metabolized in the liver by the enzyme system of the P450 cytochrome. The main method of metabolization is demethylation by CYP2C19 and other metabolic pathways include oxidation by CYP3A4. Studies of interaction with drugs also metabolized through these enzymatic systems, such as carbamazepine, diazepam, glibenclamide, nifedipine, and an oral contraceptive containing levonorgestrel and etinilestradiol have not revealed clinically significant interactions. An interaction of pantoprazole with other products or medicinal compounds, which are metabolized through the same enzymatic system cannot be excluded. The results of a series of interaction studies show that pantoprazole does not affect the metabolism of metabolized active substances from CYP1A2 (such as caffeine, theophylline), CYP2C9 (such as piroxicam, diclofenac, naproxins), CYP2D6 (such as metoprolol), CYP2E1 (such as ethanol) or mediatein absorption. There were no evidence of interactions with antacids administered at the same time. Interaction studies were also conducted by administering pantoprazole in conjunction with their respective antibiotics (clarithromycin, metronidazole, amoxicillin). No clinically significant interactions have been highlighted. Medicines that inhibit or induce CYP2C19: CYP2C19 inhibitors as fluvoxamine can increase systemic exposure of pantoprazole. A dose reduction can be considered for long-term treated patients with high doses of pantoprazole, or those with liver failure. Enzymatic inductors influencing CYP2C19 and CYP3A4 as a rifamp and St. John's grass (Hypericum perforatum) can reduce the plasma concentrations of PPIs that are metabolized through such enzymatic systems.Effects
One can expect that about 5% of patients manifest adverse reactions to the drug (ADRs). The most commonly reported ADRs are diarrhea and headaches, both found in about 1% of patients. The following table lists the adverse reactions reported with pantoprazole, arranged according to the following frequency classification: very common (≥1/10); common (≥1/100,Overdosing
No known symptoms of overdose in man. Systemic exposure up to 240 mg was well tolerated intravenously in 2 minutes. Since pantoprazol is widely linked to proteins, it is not readily dialysis. In case of overdose with clinical signs of intoxication, specific therapeutic recommendations cannot be made, except for symptomatic treatment and support. Pregnancy
: A moderate number of data in pregnant women (between 300 and 1000 exposed pregnancy) indicates that Xoolam reflux does not cause malformation or fetal/neonatal toxicity. Animal studies showed reproductive toxicity (see paragraph 5.3). For precautionary purposes, it is preferable to avoid the use of Xoolam reflux during pregnancy. Food
: Animal studies have shown the excretion of pantoprazole in breast milk. There is insufficient information on the excretion of pantoprazole in human breast milk, but excretion in human breast milk has been reported. Therefore a decision whether to continue/suspend breastfeeding or continue/suspend therapy with Xoolam reflux should be taken taking into account the benefit of breastfeeding for the newborn and the benefit of therapy with Xoolam reflux for mothers. Fertility
: There was no evidence of altered fertility following the administration of pantoprazole in animal studies (see paragraph 5.3).
Source: Farmadati
