VENTRA Gastro-resistant capsule, hard Ref.[49656] Active ingredients: Esomeprazole

The capsules should be swallowed whole with liquid. The capsules should not be chewed or crushed.

For patients who have difficulty in swallowing, the capsules can be opened and their content dispersed in half a glass of non-carbonated water. No other liquids should be used as the enteric coating may be dissolved. Stir and drink the liquid with the granules immediately or within 30 minutes. Rinse the glass with half a glass of water and drink. The granules must not be chewed or crushed.

For patients who cannot swallow, the content of the capsules can be dispersed in non-carbonated water and administered through a gastric tube. It is important that the appropriateness of the selected syringe and tube is carefully tested. For preparation and administration instructions see section 6.6.

Adults and adolescents from the age of 12 years

Gastroesophageal Reflux Disease (GERD)

• treatment of erosive reflux esophagitis

40 mg once daily for 4 weeks.

An additional 4 weeks treatment is recommended for patients in whom esophagitis has not healed or who have persistent symptoms.

• long-term management of patients with healed esophagitis to prevent relapse 20 mg once daily.
• symptomatic treatment of gastroesophageal reflux disease (GERD)

20 mg once daily in patients without esophagitis. 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. In adults, an on demand regimen taking 20 mg once daily, when needed, can be used. In NSAID treated patients at risk of developing gastric and duodenal ulcers, subsequent symptom control using an on demand regimen is not recommended.

Adults

In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and

• healing of Helicobacter pylori associated duodenal ulcer and
• prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers.

20 mg Ventra with 1 g amoxicillin and 500 mg clarithromycin, all twice daily for 7 days.

Patients requiring continued NSAID therapy

Healing of gastric ulcers associated with NSAID therapy: The usual dose is 20 mg once daily. The treatment duration is 4-8 weeks.

Prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk: 20 mg once daily.

Prolonged treatment after i.v. induced prevention of rebleeding of peptic ulcers.

40 mg once daily for 4 weeks after i.v. induced prevention of rebleeding of peptic ulcers.

Treatment of Zollinger Ellison Syndrome

The recommended initial dosage is Ventra 40 mg twice daily. The dosage should then be individually adjusted and treatment continued as long as clinically indicated. Based on the clinical data available, the majority of patients can be controlled on doses between 80 to 160 mg esomeprazole daily. With doses above 80 mg daily, the dose should be divided and given twice daily.

Adolescents from the age of 12 years

Treatment of duodenal ulcer caused by Helicobacter pylori

When selecting appropriate combination therapy, consideration should be given to official national, regional and local guidance regarding bacterial resistance, duration of treatment (most commonly 7 days but sometimes up to 14 days), and appropriate use of antibacterial agents. The treatment should be supervised by a specialist.

The posology recommendation is:

Children below the age of 12 years

Ventra should not be used in children younger than 12 years 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. (See Section 5.2).

Impaired hepatic function

Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, a maximum dose of 20 mg Ventra should not be exceeded. (See section 5.2).

Elderly

Dose adjustment is not required in the elderly.

There is very limited experience to date with deliberate overdose. The symptoms described in connection with 280 mg were gastrointestinal symptoms and weakness. Single doses of 80 mg esomeprazole were uneventful. No specific antidote is known. Esomeprazole is extensively plasma protein bound and is therefore not readily dialyzable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilised.

Blisters:

2 years.

Bottles:

Before opening of the bottle: 2 years.

After opening of the bottle: 3 months.

Do not store above 25°C.

Keep the container tightly closed in order to protect from moisture (bottle). Store in the original package in order to protect from moisture (blister).

HDPE bottles containing a silica gel desiccant and closed with a child resistant white PP cap. The opening of bottle is sealed with an aluminium induction seal.

Pack sizes: 28, 30, 90 or 98 capsules.

PA-Aluminium-PVC/Aluminium foil blisters

Pack sizes: 3, 7, 14, 15, 25, 28, 30, 50, 56, 60, 90, 98, 100 or 140 capsules

Not all pack sizes may be marketed.

Administration through gastric tube

1. Add the contents of a capsule into approximately 25 ml or 50 ml of water. (For some tubes, dispersion in 50 ml water is needed to prevent the granules from clogging the tube). Stir.
2. Draw the suspension into a syringe and add approximately 5 ml of air.
3. Immediately shake the syringe for approximately 2 minutes to disperse the granules.
4. Hold the syringe with the tip up and check that the tip has not clogged.
5. Attach the syringe to the tube whilst maintaining the above position.
6. Shake the syringe and position it with the tip pointing down. Immediately inject 5-10 ml into the tube. Invert the syringe after injection and shake (the syringe must be held with the tip pointing up to avoid clogging of the tip).
7. Turn the syringe with the tip down and immediately inject another 5-10 ml into the tube. Repeat this procedure until the syringe is empty.
8. Fill the syringe with 25 ml of water and 5 ml of air and repeat step 6 if necessary to wash down any sediment left in the syringe. For some tubes, 50 ml water is needed.

Any unused product or waste material should be disposed of in accordance with local requirements.

Special precautions for disposal

No special requirements.