Truloc 20 mg Film-Coated Tablets

TRULOC is indicated for the following (see sections 4.4 and 5.1):

• Gastro - oesophageal Reflux Disease (GORD):
• treatment of erosive reflux oesophagitis
• long-term management of patients with healed oesophagitis to prevent relapse
• symptomatic treatment of Gastro-oesophageal Reflux Disease (GORD).
• Patients requiring continued nonsteroidal anti - inflammatory drug (medicine) (NSAID) therapy:
• prevention of gastric and duodenal ulcers associated with nonsteroidal anti-inflammatory drug (medicine) (NSAID) therapy in patients at risk.
• In combination with appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori:
• healing of Helicobacter pylori associated duodenal ulcer, and
• prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcer disease.
• TRULOC has been used in pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion.

4.3 Contraindications

• hypersensitivity to esomeprazole, substituted benzimidazoles or to any of the ingredients of TRULOC
• concomitant administration of TRULOC with atazanavir or nelfinavir (see section 4.5).

4.4 Special warnings and precautions for use

TRULOC is not indicated for mild gastrointestinal complaints such as nervous dyspepsia. Prior to treatment or in the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present, the possibility of malignancy of gastric ulcer or a malignant disease of the oesophagus should be excluded, as the treatment with TRULOC may alleviate the symptoms of malignant ulcers and can thus delay diagnosis.

Acute Interstitial Nephritis

There is an increased risk of subclinical Acute Interstitial Nephritis (AIN), associated with Proton pump inhibitors (PPIs), such as TRULOC, 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.

Hypomagnesaemia

Severe hypomagnesaemia has been reported in patients treated with proton pump inhibitors (PPIs) like TRULOC 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 dysrhythmia can occur, but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs, including TRULOC, with digoxin or medicine that may cause hypomagnesaemia (e.g. diuretics), healthcare professionals should consider measuring magnesium levels before starting TRULOC treatment and periodically during treatment.

Concomitant use with other medicines

Concomitant administration with TRULOC and medicines such as atazanavir and nelfinavir is not recommended (see sections 4.3 and 4.5). Therapeutic medicine monitoring is recommended during concomitant treatment with warfarin (see section 4.5).

4.2 Posology and method of administration

Adults: Gastro - oesophageal Reflux Disease (GORD):

• treatment of erosive reflux oesophagitis: 40 mg once daily for 4 weeks. An additional 4-week treatment is recommended for patients in whom oesophagitis has not healed or who have persistent symptoms. If Gastro-oesophageal Reflux Disease (GORD) symptom control has not been achieved after four weeks of treatment with the prescribed daily dose, especially where differentiation of diagnosis of GORD with angina and congestive heart failure is present, further investigation is recommended.
• long-term management of patients with healed oesophagitis to prevent relapse: 20 mg once daily
• symptomatic treatment of Gastro-oesophageal Reflux Disease (GORD): 20 mg once daily in patients without oesophagitis. If symptom control has not been achieved after 4 weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen, taking 20 mg once daily, when needed.
• Patients requiring continued NSAID therapy: prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk: 20 mg or 40 mg once daily.

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

4.8 Undesirable effects

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.

The following adverse reactions have been identified or suspected in the clinical trials programme for omeprazole, as in TRULOC.

* Post marketing experience: The indicated (*) adverse events have also been reported during the post marketing use of TRULOC. Because these are spontaneous reports from a population of uncertain size, it is not possible to reliably estimate their frequency.

6.4 Special precautions for storage

Store at or below 25 °C. Store in the original package in order to protect from light and moisture.