Nexium Sachet & Tablet

NEXIAM 20 and 40 mg tablets and NEXIAM 10 mg Sachets are indicated for:

• 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 NSAID therapy:
• prevention of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drug (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.
• NEXIAM has been used in pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion.

NEXIAM 20 and 40 mg tablets:

The tablets should be swallowed whole with liquid. The tablets should not be chewed or crushed. The tablets can also be dispersed in half a glass of non-carbonated water. No other liquids should be used. Stir until the tablets disintegrate and drink the liquid with the pellets immediately or within 30 minutes. Rinse the glass with half a glass of water and drink. The pellets must not be chewed or crushed. For patients who cannot swallow, the tablets can be dispersed in non-carbonated water and administered through a gastric tube.

NEXIAM 10 mg Sachets:

The contents of a 10 mg sachet should be emptied into a container containing a tablespoon (15 ml) of water. Stir the contents and leave for a few minutes to thicken. Stir again and drink within 30 minutes. If any material remains after drinking, add more water, stir, and drink immediately. For patients who have a nasogastric or gastric tube in place, the contents of the sachet can be added to a syringe containing 15 ml of water. Immediately shake the syringe and leave for a few minutes to thicken. Shake the syringe and inject through the nasogastric or gastric tube within 30 minutes. Refill the syringe with an equal amount of water and shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.

Gastro-oesophageal Reflux Disease (GORD):

• treatment of erosive reflux oesophagitis 40 mg once daily for 4 weeks. An additional 4 weeks treatment is recommended for patients in whom oesophagitis has not healed or who have persistent symptoms.
• 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.

In combination with appropriate antibacterial therapeutic regimens 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 20 mg NEXIAM with 1 g amoxicillin and 500 mg clarithromycin, all twice daily for 7 days.

Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion:

The recommended initial dosage is NEXIAM 40 mg twice daily. The dosage should then be individually adjusted and treatment continued as long as clinically indicated. Doses up to 120 mg twice daily have been administered.

Adolescents 12-18 years:

• Gastro-oesophageal Reflux Disease (GORD):
• treatment of erosive reflux oesophagitis 40 mg once daily for 4 weeks. An additional 4 weeks treatment is recommended for patients in whom oesophagitis has not healed or who have persistent symptoms.
• 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 20 mg once daily under medical supervision.

Children 1-11 years:

• Gastro-oesophageal Reflux Disease (GORD):
• treatment of erosive reflux oesophagitis Weight < 20 kg: 10 mg once daily for 8 weeks.
• Weight u2265 20 kg: 10 mg or 20 mg once daily for 8 weeks.
• symptomatic treatment of Gastro-oesophageal Reflux Disease (GORD) 10 mg once daily for up to 8 weeks.
• long-term management of patients with healed oesophagitis to prevent relapse 10 mg once daily. Doses over 1 mg/kg/day have not been studied.

Children:

NEXIAM should not be used in children younger than 1 year since no data is available.

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.

Impaired hepatic function:

Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, a maximum daily dose of 20 mg NEXIAM should be used.

Elderly:

Dose adjustment is not required in the elderly.

Known hypersensitivity to NEXIAM, substituted benzimidazoles or any other constituents of the formulation. Concomitant administration of NEXIAM with atazanavir or nelfinavir (see u201cINTERACTIONSu201d).

NEXIAM 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 NEXIAM may alleviate the symptoms of malignant ulcers and can thus delay diagnosis.

Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance. Concomitant administration of clopidogrel and esomeprazole resulted in decreased exposure to the active metabolite of clopidogrel by an average of 40 %. The maximum inhibition of (ADP induced) platelet aggregation decreased by an average of 14 %. Based on these data, concomitant use of NEXIAM and clopidogrel should be avoided. During treatment with antisecretory medicines, serum gastrin increases in response to the decreased acid secretion. Also chromogranin A (CgA) increase due to decreased gastric acidity. The increased CgA level may interfere with investigations for neuroendocrine tumours. To avoid this interference, the esomeprazole treatment should be temporarily stopped 5 days before CgA measurements. Decreased gastric acidity increases gastric contents counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to increased risk of gastrointestinal infections such as Salmonella and Campylobacter and, in hospitalised patients, possibly also Clostridium difficile. 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.

Special Precautions: Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance.

Decreased gastric acidity due to any means including proton pump inhibitors such as NEXIAM tablets, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with NEXIAM may lead to increased risk of gastrointestinal infections such as Salmonella and Campylobacter and also Clostridium difficile in hospitalised patients. NEXIAM contains sucrose and is not suitable for patients with glucose-galactose malabsorption syndrome, fructose intolerance, or sucrose isomaltase deficiency.

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

The following definitions of frequency are used: Common: u2265 1/100 Uncommon: u2265 1/1 000 and < 1/100 Rare: u2265 1/10 000 and < 1/1 000 Very rare: < 1/10 000

Clinical trials: The following adverse reactions have been identified or suspected in the clinical trials programme for NEXIAM. None, however, were found to be dose-related.

Blood and lymphatic system disorders:

• Rare: Leukopenia, thrombocytopenia

Immune system disorders:

• Rare: Hypersensitivity reactions e.g. angioedema and anaphylactic reaction/shock

Metabolism and nutrition disorders:

• Uncommon: Peripheral oedema
• Rare: Hyponatraemia
• Very rare: Hypomagnesaemia

Psychiatric disorders:

• Uncommon: Insomnia
• Rare: Agitation, confusion, depression
• Very rare: Aggression, hallucination

Nervous system disorders:

• Common: Headache
• Uncommon: Dizziness, paraesthesia, somnolence
• Rare: Taste disturbance

Eye disorders:

• Rare: Blurred vision

Ear and labyrinth disorders:

• Uncommon: Vertigo

Respiratory, thoracic and mediastinal disorders:

• Rare: Bronchospasm

Gastrointestinal disorders:

• Common: Abdominal pain, diarrhoea, flatulence, nausea/vomiting, constipation
• Uncommon: Dry mouth
• Rare: Stomatitis, gastrointestinal candidiasis, gastrointestinal infections
• Very rare: Microscopic colitis

Hepatobiliary disorders:

• Uncommon: Increased liver enzymes
• Rare: Hepatitis with or without jaundice
• Very rare: Hepatic encephalopathy

Skin and subcutaneous tissue disorders:

• Uncommon: Dermatitis, pruritus, urticaria, rash
• Rare: Alopecia, photosensitivity

Musculoskeletal, connective tissue and bone disorders:

• Rare: Arthralgia, myalgia

Reproductive system and breast disorders:

• Very rare: Gynaecomastia

General disorders and administration site conditions:

• Rare: Malaise, hyperhidrosis

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

Blood and lymphatic system disorders:

• Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia

Immune system disorders:

• Hypersensitivity reactions e.g. angioedema and anaphylactic reaction/shock

Metabolism and nutrition disorders:

• Peripheral oedema, hyponatraemia

Psychiatric disorders:

• Insomnia, agitation, confusion, depression, aggression, hallucination

Nervous system disorders:

• Headache, dizziness, paraesthesia, somnolence, taste disturbance

Eye disorders:

• Blurred vision

Ear and labyrinth disorders:

• Vertigo

Respiratory, thoracic and mediastinal disorders:

• Bronchospasm

Gastrointestinal disorders:

• Abdominal pain, diarrhoea, flatulence, nausea/vomiting, constipation, dry mouth, stomatitis, gastrointestinal candidiasis

Hepatobiliary disorders:

• Increased liver enzymes, hepatitis with or without jaundice, hepatic encephalopathy, hepatic failure

Skin and subcutaneous tissue disorders:

• Dermatitis, pruritus, urticaria, rash, alopecia, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN)

Musculoskeletal, connective tissue and bone disorders:

• Arthralgia, myalgia, muscular weakness

Renal and urinary disorders:

• Interstitial nephritis

Reproductive system and breast disorders:

• Gynaecomastia

General disorders and administration site conditions:

• Malaise, hyperhidrosis

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