Panflux Otc 20 mg Gastro-resistant tablets

PANFLUX OTC is indicated for the short-term temporary relief of heartburn and hyperacidity.

Posology
PANFLUX 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 PANFLUX 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
PANFLUX OTC should be swallowed whole with a little water either before or during breakfast.

Hypersensitivity to pantoprazole or to any of the excipients of PANFLUX OTC listed in section 6.1. 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).

Clostridium difficile associated diarrhoea (CDAD)
Treatment with proton pump inhibitors (PPIs), such as PANFLUX 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 PANFLUX OTC treatment appropriate to the condition being treated.
Treatment with PANFLUX OTC may lead to slightly increased risk of gastrointestinal infections caused by bacteria ( Salmonella and Campylobacter ).
Bone fractures
PANFLUX 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 the presence of other recognised risk factors. PANFLUX OTC may increase the overall risk of fracture by 10 to 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.
Patients should be advised to consult a medical practitioner if:
u2022 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 PANFLUX OTC may alleviate symptoms and delay diagnosis.
u2022 They have been taking an indigestion or heartburn remedy continuously for 4 or more weeks in order to control their symptoms.
u2022 They have jaundice or hepatic impairment.
Liver impairment
In patients with severe liver impairment the liver enzymes should be monitored regularly during treatment with PANFLUX OTC, particularly during long-term use. In the case of a rise in liver enzymes, PANFLUX OTC should be discontinued.
Mild gastrointestinal complaints
PANFLUX 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 PANFLUX OTC may alleviate the symptoms of malignant ulcers and can thus delay diagnosis.
Effect on cyanocobalamin (vitamin B12) absorption
Daily treatment with any acid-blocking medicines such as PANFLUX 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
PANFLUX 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.

Concomitant intake of food has no influence on bioavailability. PANFLUX 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 PANFLUX OTC, thereby impacting on their efficacy e.g.
u2022 some azole antifungals such as ketoconazole, itraconazole and posaconazole;
u2022 other medicines such as erlotinib, atazanavir, nelfinavir and other HIV medicines with pH-dependent absorption (see 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 PANFLUX OTC. Therefore, patients must be advised that additional PT / INR determinations may be required when taking PANFLUX OTC.
Other interactions studies
Pantoprazole, as in PANFLUX 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 PANFLUX OTC is co-administered with voriconazole.
Methotrexate
Concomitant use of high doses of methotrexate (e.g. 300 mg daily) and PANFLUX OTC is not recommended as proton-pump inhibitors have been reported to increase methotrexate levels in some patients.

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

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

Adverse reactions
Adverse reactions and their frequencies are reported in Table 1 by system organ class and by frequency.
Table 1: Tabulated summary of adverse reactions
The following undesirable effects have been reported.
System Organ Class PANFLUX OTC Side Effects
Infections and infestations Frequency unknown: 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 (1), hypokalaemia (1).
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.
(1) Hypocalcaemia and/or hypokalaemia may be related to the occurrence of hypomagnesaemia (see section 4.4)
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions after authorisation of PANFLUX OTC is important. It allows continued monitoring of the benefit/risk balance of PANFLUX OTC. Health care providers are requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website or to Cipla Medpro (Pty) Ltd. by email: [email protected] or telephone: 080 222 6662 (toll free).

See section 4.8. Treatment is symptomatic and supportive.