MAALOX REFLUX * 14CPR 20MG

  • Opella Healthcare Italy S.r.l
  • 041056021

Maalox Reflusso is a drug based on the active ingredient pantoprazole sodium salt sesquihydrate - belonging to the category of Antacids and specifically Acid pump inhibitors. Maalox Reflux can be prescribed with OTC Recipe - self-medication. Short-term treatment of reflux symptoms (e.g. heartburn - acid regurgitation) in adults.

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MAALOX REFLUX * 14CPR 20MG

Therapeutic indications

Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.

Dosage and method of use

DosageThe 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 improve symptoms. Once complete healing of symptoms is achieved, treatment should be discontinued. 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. Special populations No dose adjustment is necessary in elderly patients or in patients with renal or hepatic impairment. Pediatric population The use ofMAALOX REFLUXit is not recommended in children and adolescents below 18 years due to insufficient data on safety and efficacy.Method of administrationThe gastro-resistant tablets ofMAALOX REFLUX20 mg should not be chewed or crushed, and should be swallowed whole with liquid before a meal.

Contraindications

Hypersensitivity to the active substance, substituted benzimidazoles, to peanuts, to soy or to any of the other excipients listed in section 6.1. The simultaneous administration ofMAALOX REFLUXwith HIV protease inhibitors whose absorption depends on the acidity of the intragastric pH, such as atazanavir and nelfinavir, is contraindicated due to the significant reduction in their bioavailability (see section 4.5). (see section 4.5).

Side effects

Summary of the safety profileApproximately 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. Tabulated list of adverse reactions The following adverse reactions have been observed with pantoprazole. Within the table below, adverse reactions are ranked under the MedRA frequency classification: very common (≥1 / 10); common (≥1 / 100, Table 1. Adverse reactions with pantoprazole in clinical studies and post-marketing experience

Frequency System organ class Common Uncommon Rare Very rare Not known
Disorders of the blood and lymphatic system     Agranulocytosis Thrombocytopenia; Leukopenia, Pancytopenia  
Disorders of the immune system     Hypersensitivity (including anaphylactic reactions and anaphylactic shock)    
Metabolism and nutrition disorders     Hyperlipidemias and increased lipids (triglycerides, cholesterol); weight changes   Hyponatremia, Hypomagnesaemia Hypocalcemia in association with hypomagnesaemia
Psychiatric disorders   Sleep disorders Depression (and all aggravated forms) Disorientation (and all aggravated forms) Hallucinations; Confusion (especially in predisposed patients, as well as the aggravation of these events in case of pre-existence)
Nervous system disorders   Headache; dizziness Taste disturbances   Paresthesia
Eye disorders     Disturbed vision / blurred vision    
Gastrointestinal disorders Fundic gland polyps (benign) Diarrhea; Nausea / vomiting; Abdominal distension and bloating; Constipation; Dry mouth Abdominal pain and discomfort     Microscopic colitis
Hepatobiliary disorders   Increased levels of liver enzymes (transaminases, γ-GT) Increased bilirubin   Hepatocellular injury; Jaundice Hepatocellular insufficiency
Skin and subcutaneous tissue disorders   Skin rash / exanthema / rash; Itching Urticaria; Angioedema   Steven-Johnson Syndrome; Lyell's syndrome; Erythema multiforme; Photosensitivity subacute cutaneous lupus erythematosus (see section 4.4)
Musculoskeletal and connective tissue disorders   Fractures of the wrist, hip and spine Arthralgia; Myalgia    
Renal and urinary disorders         Interstitial nephritis
Reproductive system and breast disorders     Gynecomastia    
General disorders and administration site conditions   Asthenia, fatigue and malaise Increased body temperature; Peripheral edema    

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili. http://www.aifa.gov.it/content/segnalazioni-reazioni- avverse

Special warnings

Patients should be instructed to contact their physician if: • they have unintended weight loss, anemia, gastrointestinal bleeding, dysphagia, recurrent vomiting or blood vomiting, as treatment with pantoprazole can relieve symptoms and delay the diagnosis of a serious illness. In these cases a malignant pathology must be excluded. • have previously had gastric ulcer or gastrointestinal surgery. • have been on continuous symptomatic treatment for indigestion or heartburn for 4 weeks or more. • have jaundice, hepatic impairment, or liver disease • have any other serious illness that affects general well-being. • are over 55 with new or recently changed symptoms. Patients with recurrent symptoms of indigestion or heartburn should see their doctor at regular intervals. In particular, 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 another proton pump inhibitor or H antagonist at the same time2. Patients who need to undergo endoscopy or breath tests 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.Gastrointestinal infections caused by bacteriaDecreased 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 drugs causes a slightly increased risk of gastrointestinal infections such asSalmonella,CampylobacterorClostridium difficile. Subacute cutaneous lupus erythematosus (SCLE) Proton pump inhibitors are associated with very infrequent cases of SCLE. In case of lesions, especially in areas of the skin exposed to the sun, and if accompanied by arthralgia, the patient should seek medical attention promptly and the physician should consider discontinuing MAALOX REFLUSSO. Subacute cutaneous lupus erythematosus (SCLE) after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.Soy lecithinThis medicine contains lecithin derived from soybean oil. If the patient is allergic to peanuts or soy, they should not use this medicine.MaltitolThis medicine contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.SodiumThis medicinal product contains less than 1 mmol sodium (23 mg) per tablet, ie essentially 'sodium-free'.Interference with laboratory testsAn increased level of Chromogranin A (CgA) can interfere with diagnostic tests for neuroendocrine tumors. To avoid this interference, MAALOX REFLUX treatment should be stopped for at least 5 days before CgA measurements (see section 5.1). If the CgA and gastrin levels have not returned to the reference range after the initial measurement, measurements should be repeated 14 days after discontinuation of the proton pump inhibitor treatment. This medicinal product is intended for short-term use only (up to 4 weeks) (refer to section 4.2). Patients should be warned of the additional risks with long-term use of the medicinal product and the need for prescribing and periodic monitoring should be emphasized. The following additional risks are considered relevant in long-term treatment: Influence on the absorption of vitamin B12 Pantoprazole, like all acid-blocking medicinal products, can 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 in long-term therapy or if related symptoms are observed. Bone fractures Proton pump inhibitors, especially when used in high doses and for prolonged periods (> 1 year), may slightly increase the risk of hip, wrist and spine fractures, especially in the elderly population or in the presence of other recognized risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fractures by 10-40%. This increase may be partly due to other risk factors. Patients at risk of osteoporosis should receive treatment based on current clinical guidelines and should take adequate amounts of vitamin D and calcium.Hypomagnesaemia In patients treated with PPI such as pantoprazole for at least 3 months and in many cases for patients treated for one year, severe hypomagnesaemia was reported. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness, and ventricular arrhythmia can occur, which may be subtly onset and underestimated. In most patients, hypomagnesaemia improves after replenishment of magnesium stores and discontinuation of the PPI. For patients anticipated on prolonged PPI treatment or in combination with digoxin or medicinal products that can cause hypomagnesaemia (e.g. diuretics), healthcare professionals should consider measuring magnesium levels prior to initiating PPI treatment and periodically during treatment.

Pregnancy and breastfeeding

PregnancyThere are no adequate data from the use of pantoprazole in pregnant women. Animal studies have shown reproductive toxicity. Preclinical studies did not reveal impaired fertility or teratogenic effects (see section 5.3). The potential risk for humans is unknown.MAALOX REFLUXit should not be used during pregnancy.Feeding timeThe presence of pantoprazole / metabolites has been detected in breast milk. The effect of pantoprazole on newborns / infants is unknown.MAALOX REFLUXit should not be used during breastfeeding.FertilityThere was no evidence of impaired fertility following administration of pantoprazole in animal studies (see section 5.3).

Expiry and retention

This medicinal product does not require any special storage conditions.

Interactions with other drugs

Effect of pantoprazole on the absorption of other medicinal products MAALOX REFLUXit can reduce the absorption of active ingredients whose bioavailability depends on the gastric pH (eg ketoconazole).HIV protease inhibitorsCo-administration of pantoprazole with HIV protease inhibitors, such as atazanavir and nelfinavir whose absorption depends on the acidity of the intragastric pH, is contraindicated due to the significant reduction in their bioavailability (see section 4.3).Coumarin anticoagulants (phenprocoumon or warfarin)Although no interactions were observed during concomitant treatment with phenprocoumon or warfarin in clinical pharmacokinetic studies, some isolated cases of variation in International Normalized Ratio (INR) have been reported during concomitant treatment in the post-marketing period. Therefore, in patients treated with coumarin anticoagulants (e.g. phenprocoumon or warfarin), it is recommended to monitor the prothrombin time / INR when pantoprazole treatment is initiated, when it is discontinued or when administered intermittently.MethotrexateIn some patients, concomitant use of high dose methotrexate (e.g. 300 mg) and proton pump inhibitors has been reported to increase methotrexate levels. Therefore, in cases where methotrexate is used in high doses, for example in the treatment of cancer and psoriasis, a temporary suspension of pantoprazole therapy should be considered.Other interaction studiesPantoprazole is metabolised in the liver by the cytochrome P450 enzyme system. Interaction studies with carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline and an oral contraceptive containing levonorgestrel and ethinyl estradiol did not show clinically significant interactions. In any case, an interaction of pantoprazole with other substances which are metabolised by the same enzyme system cannot be excluded. There were no interactions with concomitantly administered antacids.

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.

Active principles

Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate). Excipients with known effects: 38.425 mg of maltitol and 0.345 mg of soy lecithin (derived from soybean oil) and a maximum of 1.84 mg of sodium. For the full list of excipients, see section 6.1.

Excipients

Nucleus: maltitol (E965), crospovidone type B, sodium carmellose, anhydrous sodium carbonate, calcium stearate.Coating: Poly (vinyl alcohol), talc, titanium dioxide (E 171), macrogol 3350, soy lecithin, yellow iron oxide (E 172), anhydrous sodium carbonate, ethyl acrylate methacrylic acid copolymer (1: 1) (dispersion containing polysorbate 80 and sodium lauryl sulfate), triethyl citrate.

041056021

Data sheet

Packaging
20 mg 14 gastro-resistant tablets
Product Type
HUMAN DRUG
ATC code
A02BC02
ATC description
Pantoprazole
Therapeutic Group
Antacids
Active principle
pantoprazole sodium salt sesquihydrate
Class
C.
Pharmaceutical form
gastro-resistant tablet
Type of Administration
oral
Container
blister
Quantity
14 gastro-resistant tablet
Capacity
20 milligrams
Quantity of the Active Ingredient
20MG
Recipe required
OTC - self-medication medicine
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