MAALOX 14CPR 20MG

MAALOX REFLUS 20 MG COMPRESENT

active ingredients

Each gastrorous tablet contains 20 mg of pantoprazole (such as sodium sesquidrate). Excipients with known effects: 38,425 mg of maltitol and 0.345 mg soy lecithin (derived by soy oil) and a maximum of 1,84 mg sodium. For the full list of excipients, see paragraph 6.1.

Excellent

Nucleus: maltitol (E965), crospovidone type B, sodium carmellosa, sodium carbonate anidro, calcium stearate. Coating: Poly(vinyl alcohol), talc, titanium dioxide (E 171), macrogol 3350 soybean lecithin, iron yellow oxide (E 172), sodium carbonate anidro copolimer metacrilic acid etil acrilate (1:1) (dispersion containing polysorbate 80 and laurilsulphate sodium), triethylcytrate.

Therapeutic indications

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

Contraindications

Hypersensitivity to the active ingredient, substituted benzimidazoles, peanuts, soybeans or any other excipient listed in the paragraph 6.1. The contemporary administration of MAALOX REFLUS with HIV protease inhibitors whose absorption is dependent on intragastric pH acidity, such as atazanavir and nelfinavir, is contraindicated due to significant reduction in their bioavailability (see section 4.5).(see section 4.5).

Population

Population The recommended dose is 20 mg pantoprazole (one tablet) per day.It may be necessary to take the tablets for 2-3 consecutive days to obtain an improvement in symptoms.Once complete relief of symptoms has been 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 contact a doctor.Special populations No dose adjustment is necessary in elderly patients or in patients with renal or hepatic impairment. Paediatric population The use of MAALOX REFLUS it is not recommended for use in children and adolescents under 18 years of age due to insufficient data on safety and efficacy. Method of administration Gastro-resistant tablets of MAALOX REFLUS 20 mg should not be chewed or crushed, and should be swallowed whole with liquid before a meal.

Conservation

Do not store above 25°C.

Warnings

Patients should be instructed to contact their doctor if: • they have unintentional weight loss, anaemia, gastrointestinal bleeding, dysphagia, recurrent vomiting or bloody vomiting, as treatment with pantoprazole may alleviate symptoms and delay diagnosis of serious disease.Malignancy should be excluded in these cases.• they have previously had gastric ulcer or gastrointestinal surgery.• they are on continuous symptomatic treatment for indigestion or heartburn for 4 weeks or more.• they have jaundice, hepatic impairment, or liver disease. • they have any other serious disease affecting general well-being.• they are over 55 years of age with new or recently changed symptoms.Patients with recurrent symptoms of indigestion or heartburn should consult their doctor at regular intervals.In particular, patients over 55 years of age who are taking 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 concomitantly₂. Patients who are 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 feel an improvement in their symptoms after about one day of treatment with pantoprazole, but may need to take it for 7 days to achieve complete control of heartburn.Patients should not take pantoprazole as a preventative medicine. Gastrointestinal infections caused by bacteria Reduction of gastric acidity, due to any cause, including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract.Treatment with acid-reducing drugs causes a slightly increased risk of gastrointestinal infections such as Salmonella, , Campylobacter or Clostridium difficile. 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 attention promptly and the physician should consider discontinuing MAALOX REFLUX.Subacute cutaneous lupus erythematosus (SCLE) after prior treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors. Soy lecithin This medicine contains lecithin derived from soya oil.If the patient is allergic to peanuts or soya, this medicine should not be used. Maltitol This medicinal product contains maltitol.Patients with rare hereditary problems of fructose intolerance should not take this medicine. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. Interference with laboratory tests An increased level of Chromogranin A (CgA) may interfere with diagnostic tests for neuroendocrine tumors.To avoid this interference, treatment with MAALOX REFLUX should be stopped for at least 5 days before CgA measurements (see section 5.1).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.This medicinal product is intended for short-term use (up to 4 weeks) only (see section 4.2).Patients should be warned of the additional risks with long-term use and the necessity of a prescription and periodic monitoring should be emphasised.The following additional risks are considered relevant in long-term treatment: 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 symptoms are observed.Bone fractures 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 older people 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 based on current clinical guidelines and should have an adequate intake of vitamin D and calcio.Ipomagnesemia Severe hypomagnesaemia has been reported in patients treated with PPIs such as pantoprazole for at least 3 months, and in many cases for a year.Serious manifestations of hypomagnesaemia, such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia, may occur, but may be insidious in onset and under-recognized.In most patients, hypomagnesaemia improves after magnesium replacement and discontinuation of the PPI.For patients expected to be treated with PPIs for a long time or in combination with digoxin or medicinal products that may cause hypomagnesaemia (e.g. diuretics), healthcare professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

Interactions

Effect of pantoprazole on the absorption of other medicinal products MAALOX REFLUS may reduce the absorption of active substances whose bioavailability depends on gastric pH (e.g. ketoconazole). HIV protease inhibitors Co-administration of pantoprazole with HIV protease inhibitors, such as atazanavir and nelfinavir whose absorption is dependent on the acidity of the intragastric pH, is contraindicated due to significant reduction in their bioavailability (see section 4.3). Cucumin antiagulants (fenprocumone or warfarin) Although no interactions during concomitant treatment with phenprocoumon or warfarin have been observed in clinical pharmacokinetic studies, a few isolated cases of changes in International Normalised 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), monitoring of prothrombin time/INR is recommended after initiation, discontinuation or discontinuation of pantoprazole. Methotrexate Concomitant use of high-dose methotrexate (e.g. 300 mg) and proton pump inhibitors has been reported to increase methotrexate levels in some patients.Therefore, in cases where high-dose methotrexate is used, for example in the treatment of cancer and psoriasis, a temporary withdrawal of pantoprazole therapy should be considered. Other interaction studies Pantoprazole is metabolised in the liver via 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 ethinylestradiol have not revealed any clinically significant interactions.However, an interaction of pantoprazole with other substances metabolised by the same enzyme system cannot be excluded.There were no interactions with concomitantly administered antacids.

Effects

Summary of safety profile Approximately 5% of patients can be expected to experience adverse reactions.The most commonly reported adverse reactions are diarrhoea 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 classified according to the MedRA frequency classification: very common (≥1/10);common (≥1/100, Table 1. Adverse reactions with pantoprazole in clinical trials and post-marketing experience

Frequency Classification by systems and organs	Town	Uncommon	Rare	Very rare	Notable
Emolinfopoietic system pathologies			Agranulocytosis	Thrombocytopenia;Leukopenia, Pancytopenia
Immune system disorders			Hypersensitivity (including anaphylactic reactions and anaphylactic shock)
Metabolism and nutrition disorders			Hyperlipidemia and increased lipids (triglycerides, cholesterol);weight changes		Hyponatremia, Hypomagnesemia Hypocalcemia in association with hypomagnesemia
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)
Diseases of the nervous system		Headache;dizziness	Taste disorders		Paresthesia
Eye pathologies			Vision disturbances / blurred vision
Gastrointestinal disorders	Fundic gland polyps (benign)	Diarrhea; Nausea / vomiting; Abdominal distension and swelling; Stitching; Dry mouth; Pain and abdominal disorders			Microscopic colitis
Hepatobiliary pathologies		Increased levels of liver enzymes (transaminases, γ-GT)	Increased bilirubin		Hepatocellular injury;Jaundice;Hepatocellular failure
Pathologies of skin and subcutaneous tissue		Skin rash / exanthema / eruption;Itching	Urticaria;Angioedema		Steven-Johnson syndrome; Lyell syndrome; Multiform erythema; Photosensitivity lupus erythematose subacute skin (see paragraph 4.4)
Musculoskeletal and connective tissue disorders		Wrist, hip and spine fractures	Artralgia; Mialgia
Kidney and urinary pathologies					Interstitial nephritis
Pathologies of the reproductive apparatus and of the breast			Gynecomastia
Systemic pathologies and conditions for administration		Astenia, fatigue and malaise	Increased body temperature; Peripheral edema

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

Overdosing

Doses up to 240 mg administered intravenously in 2 minutes were well tolerated. Since pantoprazole is widely linked to proteins, it is not readily dialysis. In case of overdose with clinical signs of intoxication, other than symptomatic and support treatment, specific therapeutic recommendations cannot be made.

Pregnancy

There is no adequate data regarding the use of pantoprazole in pregnant women. Animal studies have shown reproductive toxicity. Preclinical studies have not shown any impairment of fertility or teratogenic effects (see paragraph 5.3). The potential risk for human beings is not known. MAALOX REFLUS should not be used during pregnancy.

Food

The presence of pantoprazole/metabolites has been identified in breast milk. The effect of pantoprazole on infants/ infants is not known. MAALOX REFLUS should not be used during breastfeeding.

Fertility

There was no evidence of reduced fertility following the administration of pantoprazole in animal studies (see paragraph 5.3).

Source: Farmadati