Prazoloc Otc 20 mg Enteric coated tablets

PRAZOLOC OTC is indicated when intended for the temporary short-term relief of heartburn and hyperacidity for a maximum of 14 days.

Posology
PRAZOLOC OTC should be taken preferably in the morning. PRAZOLOC OTC may be taken with food or on an empty stomach. PRAZOLOC OTC should be swallowed whole with a little water either before or during breakfast. Do not crush, break, or chew the tablet. The maximum daily dose is 20 mg per day and the treatment is for a maximum period of 14 days.

Special populations
Elderly patients
No dosage adjustment is necessary in the elderly.
Impaired renal function
No dosage adjustment is required in the presence of impaired renal function.
Impaired liver function
A daily dose of PRAZOLOC OTC should not be exceeded in patients with mild to moderate liver impairment (see section 4.4 and 5.2).
Method of administration
For oral use only.

PRAZOLOC OTC is contraindicated in the following:
u2022 Hypersensitivity to pantoprazole or to any of the other ingredients of PRAZOLOC OTC (see section 6.1).
u2022 Severe impairment of liver function.
u2022 Safety and efficacy in children have not been established.
u2022 Co-administration with atazanavir and nelfinavir (see section 4.5).

PRAZOLOC OTC is not indicated for mild gastro-intestinal complaints such as nervous dyspepsia. Prior to treatment the possibility of malignancy of gastric ulcer or a malignant disease of the oesophagus should be excluded, as the treatment with PRAZOLOC OTC may alleviate the symptoms of malignant ulcers and can thus delay diagnosis. Daily treatment with any acid-blocking medicines over a long period of time (e.g. longer than 3 years) may lead to malabsorption of cyanocobalamin caused by hypo- or achlorhydria. Rare cases of cyanocobalamin deficiency under acid-blocking therapy have been reported in the literature. This should be considered when respective clinical symptoms are observed. In the case of a rise of the liver enzymes, PRAZOLOC OTC should be discontinued. Diagnosis of reflux oesophagitis should be confirmed by endoscopy. The risk of tubulointerstitial nephritis leading to chronic renal inflammation and reduced renal function is associated with the use of PPIu2019s. Tubulointerstitial nephritis may progress to renal failure as is it not necessarily reversed when treatment is discontinued. Use of PRAZOLOC OTC as preventative 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 gastro-intestinal complications.

Pantoprazole decreases the concentrations of atazanavir and nelfinavir. Co-administration of PRAZOLOC OTC and atazanavir or nelfinavir is contraindicated (see section 4.3). PRAZOLOC OTC is metabolised by the cytochrome P450 system, primarily by isoenzyme CYP2C19, and may alter the metabolism of some medicines metabolised by these enzymes. No clinically significant interactions were, however, observed in specific tests with a number of such medicines or compounds, namely antipyrine, caffeine, carbamazepine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline, warfarin and oral contraceptives. However, the response to anticoagulants such as warfarin, may be affected by PRAZOLOC OTC. It is therefore good practice to monitor the patient with additional PT (prothrombin time) / INR (international normalised ratio) determinations when PRAZOLOC 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. There are no interactions with concomitantly administered antacids. Concomitant intake of food has no influence on the bioavailability of PRAZOLOC OTC.

The use of PRAZOLOC OTC in pregnancy and lactation is not recommended as safety and efficacy have not been established.

PRAZOLOC OTC may cause dizziness, disturbances in vision, somnolence or vertigo. Patients should be advised to refrain from operating machinery or driving, until they know how PRAZOLOC OTC affects them.

The following side effects may occur:
Infections and infestations:
Frequent: Gastrointestinal infection.
Blood and lymphatic system disorders:
Less frequent: Thrombocytopenia, leukopenia, agranulocytosis.
Immune system disorders:
Less frequent: Anaphylactic reactions including anaphylactic shock, allergic reactions such as skin rash, pruritus, and angioedema.
Metabolism and nutrition disorders:
Less frequent: Elevated triglycerides and increased body temperature.
Psychiatric disorders:
Frequent: Insomnia.
Less frequent: Depression subsiding after termination of therapy, reversible confusional state, agitation, hallucinations, somnolence.
Nervous system disorders:
Frequent: Headache.
Less frequent: Dizziness or disturbances in vision (blurred vision), paraesthesia.
Eye disorders:
Less frequent: Disturbances in vision (blurred vision), anterior ischaemic optic neuropathy.
Ear and labyrinth disorders:
Less frequent: Vertigo, tinnitus.
Vascular disorders:
Less frequent: Peripheral oedema.
Respiratory, thoracic and mediastinal disorders:
Less frequent: Dyspnoea, bronchospasm.
Gastrointestinal disorders:
Frequent: Gastro-intestinal complaints such as upper abdominal pain, diarrhoea, nausea, constipation, or flatulence, vomiting and dry mouth have been reported.
Less frequent: Stomatitis, taste disturbances.
Hepatobiliary disorders:
Less frequent: Severe hepatocellular damage leading to jaundice with or without hepatic failure, increased liver enzymes (transaminases, u03b3-GT), hepatitis, hepatic encephalopathy.
Skin and subcutaneous tissue disorders:
Less frequent: Allergic reactions such as pruritus, and skin rash, urticaria, severe skin reactions, such as Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis (Lyell-syndrome) and photosensitivity.
Musculoskeletal, connective tissue and bone disorders:
Less frequent: Arthralgia, myalgia subsiding after termination of therapy.
Renal and urinary system disorders:
Less frequent: Difficulty in urinating, increased frequency and volume of urination, painful urination, and interstitial nephritis (with possible progression to renal failure as it is not necessarily reversed when treatment is discontinued).
Reproductive system and breast disorders:
Less frequent: Impotence, gynaecomastia.
General disorders and administrative site conditions:
Frequent: Fatigue.
Less frequent: Increased sweating, malaise, Increased body temperature and peripheral oedema, both subsiding after termination of treatment.
Post-marketing exposure:
Frequency unknown: Interstitial nephritis with possible progression to renal failure as it is not necessarily reversed when treatment is discontinued.

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 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 and to Cipla Medpro (Pty) Ltd at [email protected] or telephone 080 222 6662 (toll free).

No specific therapeutic recommendation can be made in cases of overdosage. There are no known symptoms of overdosage.