Truloc Otc 20 mg Gastro-resistant FC tablet

Short-term treatment of reflux symptoms such as heartburn and regurgitation in adults.

Posology
The recommended dose is 20 mg esomeprazole, one tablet per day. It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms. The duration of treatment is up to 2 weeks. Once complete relief of symptoms has occurred, treatment should be discontinued. If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should consult a medical practitioner.

Special populations
Impaired renal function
Dose adjustment is not required in patients with impaired renal function. Due to limited experience in patients with severe renal insufficiency, such patients should be treated with caution (see section 5.2).

Impaired hepatic function
Dose adjustment is not required in patients with mild to moderate liver impairment. However, patients with severe liver impairment should be advised by a doctor before taking TRULOC OTC (see sections 4.4 and 5.2).

Elderly
Dose adjustment is not required in the elderly.

Paediatric population
There is no relevant use of TRULOC OTC in paediatric population below 18 years of age for the indication of u201cshort-term treatment of reflux symptoms (e.g., heartburn and acid regurgitation)u201d.

Method of administration
For oral use. The tablets should be swallowed whole with liquid and should not be chewed or crushed.

TRULOC OTC is contraindicated in:

• known hypersensitivity to esomeprazole, substituted benzimidazoles or any other constituents of TRULOC OTC
• concomitant administration of TRULOC OTC with atazanavir or nelfinavir (see section 4.5).

General
Patients should be instructed to consult a medical practitioner if:

• they have significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena and when gastric ulcer is suspected or present, malignancy should be excluded as treatment with esomeprazole may alleviate symptoms and delay diagnosis
• they have had previous gastric ulcer or gastrointestinal surgery
• they have been on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks
• they have jaundice or severe liver disease
• they are aged over 55 years with new or recently changed symptoms.

Patients with long-term recurrent symptoms of indigestion or heartburn should see their medical practitioner at regular intervals. Patients over 55 years taking any non-prescription indigestion or heartburn remedy daily should inform their pharmacist or doctor. Patients should not take TRULOC OTC as a long-term preventative medicinal product.

Decreased gastric acidity due to any means, including proton pump inhibitors such as TRULOC OTC tablets, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors (PPIs) may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and in hospitalized patients, also possibly Clostridium difficile (see section 5.1). Clostridium difficile is a bacterium that can cause severe debilitating diarrhoea that does not improve. Symptoms may include watery stools, abdominal pain, fever, and patients may develop more serious intestinal conditions.

Patients should consult their medical practitioners before taking this medicinal product if they are due to have an endoscopy or urea breath test.

There is an increased risk of subclinical Acute Interstitial Nephritis (AIN), associated with Proton pump inhibitors (PPIs), such as TRULOC OTC, which may progress to acute kidney injury and/or chronic renal failure. Symptoms of interstitial nephritis may persist, even when treatment with the PPI is terminated.

Effects of TRULOC OTC on the pharmacokinetics of other medicines: The gastric acid suppression during treatment with TRULOC OTC, might decrease or increase the absorption of medicines with a gastric pH dependent absorption. The absorption of medicines such as ketoconazole, itraconazole and erlotinib can decrease while the absorption of medicines such as digoxin can increase during treatment with TRULOC OTC.

Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy subjects increased the bioavailability of digoxin by 10 % (up to 30 % in 2 out of 10 subjects). Digoxin toxicity has been reported. Caution should be exercised when TRULOC OTC is given at high doses in elderly patients. Therapeutic monitoring of digoxin levels should be done.

TRULOC OTC inhibits CYP2C19, the major TRULOC OTC metabolising enzyme. Concomitant administration of 30 mg esomeprazole resulted in a 45 % decrease in clearance of the CYP2C19 substrate diazepam. This interaction is unlikely to be of clinical relevance. Concomitant administration of 40 mg esomeprazole resulted in a 13 % increase in trough plasma levels of phenytoin in epileptic patients. Concomitant administration of 40 mg esomeprazole to warfarin-treated patients showed that, despite elevation in the trough plasma concentration of the less potent R-isomer of warfarin, the coagulation times were within the accepted range. From post marketed use, cases of elevated INR of clinical significance have been reported during concomitant treatment with warfarin. Close monitoring is recommended when warfarin is co-administered with TRULOC OTC at initiation of treatment, during the treatment and at ending treatment.

Results from studies in healthy subjects have shown a pharmacokinetic/pharmacodynamic interaction between clopidogrel (300 mg loading dose/75 mg daily maintenance dose) and esomeprazole (40 mg p.o. daily) resulting in decreased exposure to the active metabolite of clopidogrel by an average of 40 % and resulting in decreased maximum inhibition of (ADP induced) platelet aggregation by an average of 14 %. Based on these data, concomitant use of TRULOC OTC and clopidogrel should be avoided.

Pregnancy
Safety during pregnancy has not been established.

Breastfeeding
Safety during lactation has not been established.

Fertility
Animal studies with the racemic mixture omeprazole, given by oral administration do not indicate effects with respect to fertility.

TRULOC OTC may cause dizziness and blurred vision, thereby affecting the ability to drive or use machinery.

a) Summary of the safety profile
Headache, abdominal pain, diarrhoea and nausea are among those adverse reactions that have been most commonly reported in clinical trials (and also from post-marketing use). In addition, the safety profile is similar for different formulations, treatment indications, age groups and patient populations.

b) Tabulated summary of adverse reactions

Blood and lymphatic system disorders
Less frequent: Leukopenia, thrombocytopenia
Frequency unknown: Agranulocytosis, pancytopenia

Immune system disorders
Less frequent: Hypersensitivity reactions e.g. angioedema and anaphylactic reaction/shock

Metabolism and nutrition disorders
Less frequent: Peripheral oedema, hyponatraemia, hypomagnesaemia, vit B12 malabsorption
Frequency unknown: Severe hypomagnesaemia can correlate with hypocalcaemia. Hypomagnesaemia may also be associated with hypokalaemia

Psychiatric disorders
Less frequent: Insomnia, agitation, confusion, depression, aggression, hallucination

Nervous system disorders
Frequent: Headache
Less frequent: Dizziness, paraesthesia, somnolence, taste disturbance

Eye disorders
Less frequent: Blurred vision

Ear and labyrinth disorders
Less frequent: Vertigo

Respiratory, thoracic and mediastinal disorders
Less frequent: Bronchospasm

Gastrointestinal disorders
Frequent: Abdominal pain, diarrhoea, flatulence, nausea/vomiting, constipation, fundic gland polyps (benign)
Less frequent: Dry mouth, stomatitis, gastrointestinal candidiasis, gastrointestinal infections, microscopic colitis

Hepatobiliary disorders
Less frequent: Increased liver enzymes, hepatitis with or without jaundice, hepatic encephalopathy

Skin and subcutaneous tissue disorders
Less frequent: Dermatitis, pruritus, urticaria, rash, alopecia, photosensitivity
Frequency unknown: Subacute cutaneous lupus erythematosus

Musculoskeletal and connective tissue disorders
Less frequent: Arthralgia, myalgia, muscular weakness, fracture of the hips, wrists or spine

Renal and urinary disorders
Less frequent: Interstitial nephritis which may progress to acute kidney injury and/or chronic renal failure, in some patients renal failure has been reported concomitantly

Reproductive system and breast disorders
Less frequent: Gynaecomastia

General disorders and administration site conditions
Less frequent: Malaise, hyperhidrosis

No specific antidote is known. TRULOC OTC is extensively plasma protein bound and is therefore not readily dialysable. In any case of overdose, treatment should be symptomatic and general supportive measures should be utilised.