Pantocid Otc 20mg Gastro-resistant tablets

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

Posology
PANTOCID 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 medical practitioner.
Special Populations
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 PANTOCID 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
PANTOCID OTC should be swallowed whole with a little water either before or during breakfast.

• Hypersensitivity to pantoprazole or to any of the excipients (see section 6.1).
• 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 human immunodeficiency virus (HIV) medicines with pH dependent absorption (see section 4.5).

Hepatic Impairment
In patients with severe liver impairment the liver enzymes should be monitored regularly during treatment with PANTOCID OTC, particularly on long-term use. In the case of a rise of the liver enzymes, the treatment with PANTOCID OTC should be discontinued.
Mild gastrointestinal complaints
PANTOCID OTC is not indicated for mild gastrointestinal complaints, such as nervous dyspepsia.
Gastric malignancy
Symptomatic response to PANTOCID OTC may mask the symptoms of gastric malignancy and may delay diagnosis. In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena) and when gastric ulcer is suspected or present, malignancy of gastric ulcer or of the oesophagus should be excluded. Further investigation is to be considered if symptoms persist despite adequate treatment.
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 PANTOCID 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.

Medicines with pH-dependent absorption pharmacokinetics
Because of profound and long-lasting inhibition of gastric acid secretion, PANTOCID OTC may interfere with the absorption of other medicines where gastric is an important determinant of oral availability, e.g. ketoconazole, itraconazole, posaconazole and other medicine, such as erlotinib.
HIV protease inhibitors
Co-administration of pantoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH, such as atazanavir and nelfinavir, due to significant reduction in their bioavailability (see sections 4.3 and 4.4).
Coumarin anticoagulants (e.g. warfarin)
Co-administration of PANTOCID OTC with warfarin did not affect the pharmacokinetics of warfarin or international normalised ratio (INR). However, there have been reports of increased INR and prothrombin time in patients receiving PPIs, including PANTOCID OTC, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding, and even death. Patients treated with PANTOCID OTC and warfarin may need to be monitored for increase in INR and prothrombin time.
Methotrexate
Concomitant use of high dose methotrexate (e.g. 300 mg) and proton-pump inhibitors, such as PANTOCID OTC, have been reported to increase methotrexate levels in some patients. Therefore, in settings where high-dose methotrexate is used, for example cancer and psoriasis, a temporary withdrawal of PANTOCID OTC may need to be considered.
Voriconazole
Voriconazole inhibits the metabolism of proton-pump inhibitors. The exposure of both medicines is increased when PANTOCID OTC is co-administered with voriconazole.
Other interactions studies
Pantoprazole is extensively metabolised in the liver via the cytochrome (CYP) P450 enzyme system. The main metabolic pathway is demethylation by CYP2C19 and other metabolic pathways include oxidation by CYP3A4. Interaction studies with medicines also metabolised with these pathways, such as carbamazepine, glibenclamide, nifedipine, and an oral contraceptive containing levonorgestrel and ethinyl estradiol did not reveal clinically significant interactions. The elimination of diazepam and phenytoin may be prolonged. An interaction of pantoprazole with other medicines or compounds, which are metabolised using the same enzyme system, cannot be excluded. Results from a range of interaction studies demonstrate that pantoprazole, as in PANTOCID OTC, does not affect the metabolism of active substances metabolised by CYP1A2 (such as caffeine, theophylline), CYP2C9 (such as piroxicam, diclofenac, naproxen), CYP2D6 (such as metoprolol), CYP2E1 (such as ethanol). There were no interactions with concomitantly administered antacids and no clinically relevant interactions with antibiotics (clarithromycin, metronidazole, amoxicillin).
Medicines that inhibit or induce CYP2C19
Inhibitors of CYP2C19, such as fluvoxamine, could increase the systemic exposure of pantoprazole, as in PANTOCID OTC. Enzyme inducers affecting CYP2C19 and CYP3A4 such as rifampicin and St Johnu00b4s wort (Hypericum perforatum) may reduce the plasma concentrations of PPIs that are metabolised through these enzyme systems.

Pregnancy
Safety in pregnancy and during lactation has not been established (see section 4.3).
Breastfeeding
Animal studies have shown excretion of pantoprazole in breast milk. There is insufficient information on the excretion of pantoprazole in human milk but excretion into human milk has been reported. A risk to the newborns/infants cannot be excluded. PANTOCID OTC should be avoided during breastfeeding (see section 4.3)
Fertility
There was no evidence of impaired fertility following the administration of pantoprazole in animal studies.

PANTOCID OTC causes side effects, such as dizziness and visual disturbances (see section 4.8). Caution is advised before driving a vehicle or operating machinery until the effects of PANTOCID OTC are known.

Summary of the safety profile
The most frequently reported side effects are diarrhoea and headache.
Table 1. Adverse reactions in clinical trials and post-marketing experience
System organ class
Frequent
Less Frequent
Frequency unknown
Infections and infestations
Clostridium difficile associated diarrhoea and increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter
Blood and lymphatic system disorders
agranulocytosis, thrombocytopenia, leukopenia, pancytopenia
Immune system disorders
hypersensitivity (including anaphylactic reactions and anaphylactic shock)
Metabolism and nutrition disorders
hyperlipidaemias and lipid increases (triglycerides, hyponatraemia hypomagne-saemia, hypocalcaemia 1 , hypokalaemia cholesterol), weight changes
Psychiatric disorders
sleep disorders, depression (and all aggravations), disorientation, confusion (especially in predisposed patients, as well as the aggravation of these symptoms in case of pre-existence) hallucination
Nervous system disorders
headache dizziness, taste disorders paraesthesia
Eye disorders
visual disturbances (blurred vision)
Gastrointestinal disorders
fundic gland polyps (benign), upper abdominal pain and discomfort, diarrhoea, constipation, abdominal distention and bloating nausea / vomiting, dry mouth, microscopic colitis
Hepatobiliary disorders
liver enzymes increased (transaminases, u03b3 - GT), bilirubin increased hepatocellular injury, jaundice, hepatocellular failure
Skin and subcutaneous tissue disorders
rash / exanthema / eruption, pruritus, urticaria, angioedema, Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme, photosensitivity, subacute cutaneous lupus erythematosus (see section 4.4)
Musculoskeletal and connective tissue disorders
fracture of the hip, wrist or spine (see section 4.4), arthralgia, myalgia, muscle spasm 2
Renal and urinary disorders
interstitial nephritis
Reproductive system and breast disorders
gynaecomastia
General disorders and administration site conditions
asthenia, fatigue and malaise, body temperature increased, oedema peripheral
1 Hypocalcaemia in association with hypomagnesemia
2 Muscle spasm as a consequence of electrolyte disturbance.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. 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.

Treatment is symptomatic and supportive.