Peploc Otc 20 mg Tablets

PEPLOC OTC is indicated for the temporary short-term relief of heartburn and hyperacidity for a maximum daily dose of 20 mg and a maximum treatment period of 14 days.

Posology
PEPLOC OTC should be taken in the morning. The recommended oral dose is 20 mg of PEPLOC OTC per day.
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. A daily dose of 20 mg PEPLOC OTC should not be exceeded in patients with mild to moderately severe liver impairment (see sections 4.4 and 5.2).
Paediatric population
Safety and efficacy in children have not been established (see section 4.3).
Method of administration
PEPLOC OTC should be swallowed whole with a little water either before or during breakfast.

• hypersensitivity to pantoprazole or to any of the ingredients of PEPLOC OTC (see section 6.1)
• Safety and efficacy in children have not been established.
• severely impaired liver function (see section 4.4)
• co-administration with atazanavir (see section 4.5).

Co-administration with anticoagulants
The response to anticoagulants such as warfarin may be affected by any concomitant medication. It is therefore good practice to monitor the patient with additional PT (prothrombin time)/INR (international normalised ratio) determinations when PEPLOC OTC is initiated, discontinued or taken irregularly. Changes in absorption should be observed when medicines whose absorption is pH-dependent, e.g. ketoconazole, are taken concomitantly.
Gastric malignancy
Prior to treatment, or in the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena) the possibility of malignancy of a gastric ulcer or a malignant disease of the oesophagus should be excluded, as the treatment with PEPLOC OTC may alleviate the symptoms of malignant ulcers and can thus delay diagnosis.
Diagnosis of reflux oesophagitis
Diagnosis of reflux oesophagitis should be confirmed by endoscopy.
Clostridium difficile associated diarrhoea (CDAD)
PEPLOC OTC may be associated with an increased risk of Clostridium difficile associated diarrhoea (CDAD). A diagnosis of CDAD should be considered for patients taking PEPLOC OTC who develop diarrhoea that does not improve. Patients should use the lowest dose and shortest duration of PEPLOC OTC therapy appropriate to the condition being treated.
Gastrointestinal infections caused by bacteria
Treatment with Pantoprazole may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter or C. difficile especially in hospitalised patients. Pantoprazole, like all proton pump inhibitors (PPIs), might be expected to increase the counts of bacteria normally present in the upper gastrointestinal tract. This diagnosis should be considered for diarrhoea that does not improve (see section 4.8).
Hypomagnesaemia
Severe hypomagnesaemia has been rarely reported in patients treated with proton pump inhibitors (PPIs) like PEPLOC OTC for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. Hypomagnesaemia may lead to hypocalcaemia and/or hypokalaemia (see section 4.8). In most affected patients, hypomagnesaemia (and hypomagnesaemia associated hypocalcaemia and/or hypokalaemia) improved after magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs with digoxin or medicines that may cause hypomagnesaemia (e.g. diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.
Bone fractures
The use of PEPLOC OTC may be associated with an increased risk of bone fractures in the hip, wrist or spine. This effect has been reported mostly in people taking high doses, on long-term treatment, and in those who were 50 years and older or in 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 according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.
Hepatic impairment
In patients with severe liver impairment the liver enzymes should be monitored regularly during treatment with PEPLOC OTC. In the case of a rise of the liver enzymes, PEPLOC OTC should be discontinued.
Mild gastro-intestinal complaints
PEPLOC OTC should not be used for mild gastrointestinal complaints such as nervous dyspepsia.
Vitamin B12 absorption
PEPLOC OTC, over a long period of time (e.g. longer than 3 years), may lead to malabsorption of vitamin B12 caused by 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 clinical symptoms are observed.
Co-administration with NSAIDs
The use of PEPLOC OTC as a preventive of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) should be restricted to patients who require continued NSAID treatment and have an increased risk to develop gastrointestinal complications. The increased risk should be assessed according to individual risk factors, e.g. high age (>65 years), history of gastric or duodenal ulcer or upper gastrointestinal bleeding.
Combination therapy
In the case of combination therapy, the summaries of product characteristics of the respective medicines should be observed.
Co-administration with HIV protease inhibitors
Co-administration of PEPLOC OTC is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, due to significant reduction in their bioavailability (see section 4.5).
Long-term treatment
In long-term treatment, especially when exceeding a treatment period of 1 year, patients should be kept under regular surveillance.
Subacute cutaneous lupus erythematosus (SCLE)
Proton pump inhibitors are associated with very infrequent cases of Subacute cutaneous lupus erythematosus (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 healthcare provider should consider stopping PEPLOC OTC. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Interference with laboratory tests
Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, PEPLOC OTC treatment 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 Interstitial Nephritis:
Acute interstitial nephritis has been observed in patients taking proton pump inhibitors (PPIs) including PEPLOC OTC. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction and is associated with damage to the tubulointerstitium, leading to acute kidney injury. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia). Interstitial nephritis may lead to renal failure. Discontinue PEPLOC OTC if acute interstitial nephritis develops (see section 4.8).
Sodium: PEPLOC OTC contains sodium. To be taken into consideration in patients on a sodium-controlled diet.

Concomitant intake of food has no influence on the bioavailability.
Coumarin anticoagulants (phenprocoumon or warfarin)
The response to anticoagulants such as warfarin, phenprocoumon and acenocoumarol may be affected by any concomitant medicine. There have been reports of increased INR and prothrombin time in patients receiving PPIs and warfarin or phenprocoumon concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding, and even death. It is therefore good practice to monitor the patient with additional PT (prothrombin time) /INR (international normalised ratio) determinations when PEPLOC OTC is initiated, discontinued or taken irregularly.
Medicines with pH-dependent absorption pharmacokinetics
PEPLOC OTC may reduce or increase the absorption of medicines whose bioavailability is pH-dependent, e.g. ketoconazole, itraconazole, posaconazole and other medicines like erlotinib.
HIV protease inhibitors
It has been shown that co-administration of atazanivir 300 mg/ritonavir 100 mg with proton pump inhibitors (PPIs) such as PEPLOC OTC resulted in a substantial reduction in the bioavailability of atazanivir. The absorption of atazanavir is pH-dependent. Therefore, PPIs, including PEPLOC OTC, should not be co-administered with atazanavir (see section 4.3). If the combination of HIV protease inhibitors with a proton pump inhibitor is judged unavoidable, close clinical monitoring (e.g. virus load) is recommended. A PEPLOC OTC dose of 20 mg per day should not be exceeded. Dosage of the HIV protease inhibitor may need to be adjusted.
Methotrexate
Concomitant use of PPIs, including PEPLOC OTC, with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. Therefore in settings where high-dose methotrexate is used, for example cancer and psoriasis, a temporary withdrawal of PEPLOC OTC may need to be considered.
Inhibitors of CYP2C19
Inhibitors of CYP2C19, such as fluvoxamine, could increase the systemic exposure of pantoprazole. A dose reduction may be considered for patients treated long-term with high doses of PEPLOC OTC, or those with hepatic impairment.
Enzyme inducers affecting CYP2C19 and CYP3A4
Enzyme inducers affecting CYP2C19 and CYP3A4, such as rifampicin and St Johnu00b4s wort (Hypericum perforatum), may reduce the plasma concentrations of PPIs that are metabolized through these enzyme systems.
Other interactions studies:
The active ingredient of PEPLOC OTC is metabolised in the liver via the cytochrome P450 enzyme system. An interaction of PEPLOC OTC with other medicines or compounds which are metabolised using the same enzyme system cannot be excluded. However no clinically significant interactions were observed when used concomitantly with caffeine, carbamazepine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline, warfarin and oral contraceptives. There were no interactions with concomitantly administered antacids. Interaction studies have also been performed by concomitantly administering pantoprazole with the respective antibiotics (clarithromycin, metronidazole, amoxicillin) No clinically relevant interactions were found.

Pregnancy
Animal studies have shown reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of PEPLOC OTC during pregnancy.
Breastfeeding
There is insufficient information on the excretion of pantoprazole in human milk but excretion into human milk has been reported. A risk to the new-borns/infants cannot be excluded. Therefore, breastfeeding while on PEPLOC OTC is not recommended.
Fertility
There was no evidence of impaired fertility following the administration of pantoprazole in animal studies. There is no data on fertility in humans with PEPLOC OTC.

PEPLOC OTC has no or negligible influence on the ability to drive and use machines. PEPLOC OTC may affect the ability to drive in that adverse effects, such as dizziness and visual disturbances may occur (see section 4.8). If affected, patients should not drive or operate machines.

a. Summary of the safety profile
The most commonly reported side effects are diarrhoea and headache. Approximately 5 % of patients can be expected to experience adverse drug reactions (ADRs).
b. Tabulated list of adverse effects

*Post-marketing reports. **Hypocalcaemia in association with hypomagnesaemia.

Signs and symptoms:
The described side effects may be exacerbated. There are no known symptoms of overdose in man. Systemic exposure with up to 240 mg administered intravenously over 2 minutes was well tolerated.
Management of overdose:
As pantoprazole is extensively protein bound, it is not readily dialysable. No specific therapeutic recommendation can be made in cases of overdosage with clinical signs of intoxication. Treatment is symptomatic and supportive.