Pentoz Otc 20mg delayed release FC tablet

PENTOZ OTC is used for the short term temporary relief of heartburn and hyperacidity.

Posology
PENTOZ OTC is indicated for short term relief of heartburn and hyperacidity. The maximum dose is 20 mg per day and the treatment is for a maximum period of 14 days. If no symptom relief is obtained within 2 weeks of continuous treatment, the patient must be advised to consult a doctor.

Elderly patients
No dosage adjustment is necessary in the elderly.

Impaired renal and liver function
No dosage adjustment is required in the presence of impaired renal function (mild to moderate). A daily dose of one PENTOZ OTC tablet should not be exceeded in patients with mild to moderately severe liver impairment (See Sections 4.4 and 5.2).

Method of administration
PENTOZ OTC should be swallowed whole with a little water either before or during breakfast.

Hypersensitivity to pantoprazole or any of the ingredients of PENTOZ OTC. Safety in pregnancy and lactation (see Section 4.6). Safety and efficacy in children have not been established. Severely impaired liver function (See Section 4.4). Co-administration with atazanavir and nelfinavir and other HIV medicines with pH dependent absorption (See Section 4.5).

Patients should be advised to consult a medical practitioner if:

• They have unintentional weight loss, anaemia, gastrointestinal bleeding, dysphagia, persistent vomiting with blood, previously had gastric ulcer or gastrointestinal surgery. In these cases, malignancy must be excluded as treatment with PENTOZ OTC may alleviate symptoms and delay diagnosis.
• They have been taking an indigestion or heartburn remedy continuously for 4 or more weeks in order to control their symptoms.
• They have jaundice or hepatic impairment.

Clostridium difficile associated diarrhoea (CDAD)
Treatment with proton pump inhibitors (PPIs), such as PENTOZ OTC, have been associated with an increased risk of CDAD, especially in hospitalised patients. If a patient develops persistent diarrhoea, this diagnosis should be excluded. Patients should use the lowest dose and shortest duration of PENTOZ OTC treatment appropriate to the condition being treated.

Treatment with PENTOZ OTC may lead to slightly increased risk of gastrointestinal infections caused by bacteria (Salmonella and Campylobacter).

Bone fractures
PENTOZ OTC, 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 presence of other recognised risk factors. PENTOZ OTC 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.

Liver impairment
In patients with severe liver impairment the liver enzymes should be monitored regularly during treatment with PENTOZ OTC, particularly during long-term use. In the case of a rise in liver enzymes, PENTOZ OTC should be discontinued.

Mild gastrointestinal complaints
PENTOZ OTC is not indicated for mild gastrointestinal complaints such as nervous dyspepsia.

Presence of alarm symptoms e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena). Prior to treatment, the possibility of malignancy of gastric ulcer or a malignant disease of the oesophagus should be excluded, as the treatment with PENTOZ OTC may alleviate the symptoms of malignant ulcers and can thus delay diagnosis.

Proton pump inhibitors, such as PENTOZ OTC, especially if used in high doses and over long periods of time (> 1 year), may increase the risk of hip, wrist and spine fracture by 10 to 40 %, mainly in the elderly or in presence of other recognised risk factors.

Effect on cyanocobalamin (vitamin B12) absorption
Daily treatment with any acid-blocking medicines such as PENTOZ OTC, over a long period of time (e.g. longer than 3 years) may lead to malabsorption of cyanocobalamin due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption or if deficiency symptoms are observed.

Gastrointestinal infections caused by bacteria
PENTOZ OTC, as a proton pump inhibitor (PPI), might be expected to increase the counts of bacteria normally present in the upper gastrointestinal tract and may therefore lead to an increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter.

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 PENTOZ OTC. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

Interference of laboratory tests for neuro endocrine tumours
Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, treatment with PENTOZ OTC should be stopped for at least 5 days before CgA measurements. 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.

Acute Tubulointerstitial Nephritis
Acute Tubulointerstitial Nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. TIN is characterised by an inflammatory reaction within the tubulointerstitial space of the kidney. Acute interstitial inflammatory reactions are associated with damage to the tubulointerstitium, leading to acute kidney injury. TIN may be drug-related, infectious, systemic, autoimmune, genetic, and idiopathic with the most common cause being related to a medication or drug exposure. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decrease renal function (e.g., malaise, nausea, anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extrarenal manifestations (e.g., fever rash or arthralgia). Discontinue PENTOZ OTC and evaluate patients with suspected acute TIN.

Concomitant intake of food has no influence on bioavailability. PENTOZ OTC may increase the availability of digoxin if administered for prolonged periods.

Decreased absorption of medicines that are gastric pH dependent
The bioavailability of the following medicines may be reduced when co-administered with PENTOZ OTC, thereby impacting on their efficacy e.g. - some azole antifungals such as ketoconazole, itraconazole and posaconazole; - other medicines such as erlotinib, atazanavir, nelfinavir and other HIV medicines with pH- dependent absorption (See u201cCONTRAINDICATIONSu201d Section 4.3).

Coumarin anticoagulants (e.g. warfarin)
There have been reports of increased PT (Prothrombin Time)/INR (International Normalised Ratio) in patients receiving proton pump inhibitors, including PENTOZ OTC. Therefore, patients must be advised that additional PT/INR determinations may be required when taking PENTOZ OTC.

Other interactions studies
Pantoprazole, as in PENTOZ OTC, is extensively metabolised in the liver via the cytochrome P450 enzyme system (by CYP2C19 and other metabolic pathways including oxidation by CYP3A4) and may affect or be affected by other medicines metabolised by the same enzymes.

Voriconazole
Voriconazole inhibits the metabolism of proton-pump inhibitors: The exposure of both medicines is increased when PENTOZ OTC is co-administered with voriconazole.

Methotrexate
Concomitant use of high doses of methotrexate (e.g. 300 mg daily) and PENTOZ OTC is not recommended as proton-pump inhibitors have been reported to increase methotrexate levels in some patients. There were no interactions with concomitantly administered antacids, and with antibiotics (clarithromycin, metronidazole, amoxicillin). The elimination of diazepam and phenytoin may be prolonged.

Safety in pregnancy and during lactation has not been established (see Section 4.3).

PENTOZ OTC can cause dizziness and blurred vision. Patients should be cautioned about operating hazardous machinery, including motor vehicles, while taking PENTOZ OTC.

Infections and Infestations
Frequency not known: Clostridium difficile associated diarrhoea and increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter.

Blood and lymphatic system disorders
Less frequent: Agranulocytosis, leukopenia, thrombocytopenia, pancytopenia.

Immune system disorders
Less frequent: Hypersensitivity including anaphylactic reactions and anaphylactic shock, allergic reactions such as pruritus, skin rash, urticaria and angioedema.

Metabolism and nutrition disorders
Less frequent: Hyperlipidaemias and lipid increases (triglycerides, cholesterol); weight changes. Frequency unknown: Hypomagnesaemia, hyponatraemia, hypocalcaemia.

Nervous System disorders
Frequent: Headache. Less frequent: Dizziness, taste disorders.

Eye disorders
Less frequent: Vision disturbances (blurred vision).

Psychiatric disorders
Less frequent: Mental depression, sleep disorders, disorientation/confusion. Frequency unknown: Hallucinations.

Vascular disorders
Less frequent: Peripheral oedema.

Gastrointestinal disorders
Frequent: Gastrointestinal complaints such as upper abdominal pain and discomfort, diarrhoea, constipation, abdominal distention and bloating. Less frequent: Nausea, vomiting, dry mouth.

Hepato-biliary disorders
Frequency unknown: Severe hepatocellular damage leading to jaundice with or without hepatic failure, increased bilirubin.

Skin and subcutaneous tissue disorders
Less frequent: Severe skin reactions such as Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis (TEN) (Lyell syndrome) and photosensitivity, subacute cutaneous lupus erythematosus.

Musculoskeletal, connective tissue and bone disorders
Less frequent: Arthralgia, myalgia, increased risk of hip, wrist and spine fractures, muscle spasm.

Renal and urinary system disorders
Less frequent: Interstitial nephritis.

Reproductive system and breast disorders
Frequency unknown: Gynaecomastia.

General disorders and administration site conditions
Less frequent: Asthenia, fatigue, malaise, increased body temperature.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.

See Section 4.8. Treatment is symptomatic and supportive.