Nexium 10 mg sachet. 28 sachet

NAME OF THE MEDICINAL PRODUCT

Nexium 10 mg gastro-resistant granules for oral suspension, sachet

Nexium 10 mg gastro-resistant granules for oral suspension, sachet

 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet contains: 10 mg ezomeprazol (esomeprazole) as magnesium trihydrate.

List of ingredients: 6,8 mg 2,8 mg sucrose and glucose.

Esomeprazole pellets:

Glycerol monostearate 40-55

Hydroxypropyl

Hypromellose

Magnesium stearate

Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%

Polysorbate 80

Sugar spheres (sucrose and maize starch)

Talc

Triethyl citrate

Help granules:

Citric acid anhydrous (to adjust pH)

Crospovidone

Glucose

Hydroxypropyl

Yellow iron oxide (E172 colorant)

Xanthan gum

PHARMACEUTICAL FORM

Gastro-resistant granules for oral suspension, sachet.

Fine pale yellow granules. Can be seen and brown granules.

 Clinical DATA

Indications

Nexium granules for oral suspension are indicated primarily for:

Children 1 to 11 years

Gastro-oesophageal reflux disease (GERD):

 Treatment of endoscopically proven erosive reflux esophagitis;

Symptomatic treatment of gastroesophageal reflux disease (GERD).

Children over 4 years

In combination with antibiotics to treat duodenal ulcers caused by Helicobacter pylori

Nexium oral suspension may be used in patients who have difficulty swallowing dissolved gastro-resistant tablets Nexium. For readings in patients over 12 years is necessary to refer to the prescribing information in the SPC for Nexium gastro-resistant tablets.

Dosage and method of administration

Adults and children over 12 years

For dosage in patients 12 years and older is necessary to consult the Summary of Nexium gastro-resistant tablets.

Paediatric population

Children 1-11 years weighing ≥ 10 kg

Gastro-oesophageal reflux disease (GERD)

Treatment of endoscopically proven erosive reflux oesophagitis

Weight ≥ 10 kg - <20 kg: 10 mg once daily for 8 weeks.

Weight ≥ 20 kg: 10 mg or 20 mg once daily for 8 weeks.

Symptomatic treatment of gastroesophageal reflux disease (GERD)

10 mg once daily for 8 weeks.

Children over 4 years

Treatment of duodenal ulcers caused by Helicobacter pylori

When selecting appropriate combination therapy 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 the appropriate use of antibacterial agents.

Treatment should be supervised by a specialist.

Impaired renal function

There is no need for dosage adjustment in patients with impaired renal function. Due to limited experience in patients with severe renal insufficiency, such patients should be treated with caution.

Impaired liver function

No adjustment is necessary for patients with mild to moderate hepatic impairment. In patients over 12 years of age with severe hepatic impairment should not exceed a maximum dose of 20 mg Nexium. In children 1-11 years with severe hepatic impairment the maximum dose should not exceed 10 mg (see section 5.2).

Method of application

For the 10 mg dose empty the contents of the sachet 10 mg in a cup containing 15 ml of water. Dosage of 20 mg empty the contents of two sachets of 10 mg in a cup containing 30 ml of water. Do not use carbonated water. Stir the mixture until the granules dissolve and allow the solution for a few minutes to thicken. Stir again and drink within 30 minutes of preparation. The granules should not be chewed or crushed. Rinse with 15 ml of water to accept all granules.

Patients who use a nasogastric or gastric tube, see section 6.6 for instructions for preparation and administration.

For patients with a nasogastric or gastric tube:

 For a dose of 10 mg add content of 10 mg to 15 ml sachet water.

 For the 20 mg dose add the contents of two sachets of 10 mg to 30 ml of water.

Stir.

 Leave for a few minutes to thicken.

 Stir again.

 Withdraw the suspension into a syringe.

Inject through the enteral tube size 6 or larger, into the stomach within 30 minutes of reconstitution.

 Refill the syringe with 15 ml of water for 10 mg and 30 ml dose of 20 mg.

 Shake and enter the remainder of the mixture through enteral tube into the stomach.

Any unused suspension should be discarded.

Contraindications

Known hypersensitivity to esomeprazole, substituted benzimidazoles or any other constituents of the product.

Ezomeprazol should not be coadministered with nelfinavir.

Special warnings and precautions for use

With any troublesome symptoms (eg significant weight loss without patsienta is to goal is weight reduction, recurrent vomiting, dysphagia, haematemesis or melaena) and in cases with suspected or diagnosed gastric ulcer should be ruled out malignancy as treatment with Nexium may mask symptoms and delay diagnosis.

Patients on long-term treatment (particularly those receiving therapy for more than a year) should be monitored regularly. Long term treatment is indicated for adults and adolescents (12 years and older).

Patients treated with Nexium if necessary, should be advised to immediately contact their physician if their symptoms change in character. Treatment need not studied in children and is therefore not recommended in these patients.

When prescribing esomeprazole for treatment need to be given to the possibility of interactions with other pharmaceuticals, due to fluctuating plasma concentrations of esomeprazole.

This medicinal product contains sucrose and glucose. Patients with rare hereditary diseases characterized by intolerance to fructose malabsorption of glucose-galactose or sucrase-isomaltase insufficiency should not take this medicine.

Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter ..

Concomitant administration of esomeprazole with atazanavir is not recommended. If it is considered that the combination of atazanavir with a proton pump inhibitor is inevitable, careful clinical observation in combination with increasing doses of atazanavir 400 mg with ritonavir 100 mg, the dose of esomeprazole 20 mg should not be exceeded.

Results from studies in healthy volunteers showed a pharmacokinetic / pharmacodynamic interaction between clopidogrel (300 mg loading doza/75 mg daily maintenance dose) and esomeprazole (40 mg daily), which leads to reduced exposure to the active metabolite of clopidogrel on average 40% and reducing the maximum inhibition (ADP-induced) platelet aggregation by 14% on average. Based on these data, concomitant administration of esomeprazole and clopidogrel should be avoided.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those not prescribed by a doctor. Nexium can affect the way some other medicines work and some medicines can have an effect on the action of Nexium.

In particular, tell your doctor or pharmacist if you are taking any of these medicines:

 Atazanavir (used to treat HIV). Do not take Nexium if you are taking nelfinavir.

 Ketoconazole, itraconazole or voriconazole (used to treat fungal infections).

 Diazepam (used to treat anxiety or muscle relaxants).

 Citalopram, imipramine or clomipramine (used to treat depression).

 Phenytoin (used in epilepsy).

 Warfarin or coumarin (medicines called anticoagulants, is applied to thin the blood).

 Cisapride (used for indigestion and "acid"

 Clarithromycin (used to treat infections).

Pregnancy and lactation

Insufficient clinical data on exposure to Nexium during pregnancy. Epidemiological studies with omeprazole racemic mixture of a large number of exposures during pregnancy showed no malformative or foetotoxic effect. Animal studies with esomeprazole do not indicate direct or indirect harmful effects with respect to embryonal / fetal development. Animal studies with the racemic mixture do not indicate direct or indirect harmful effects with respect to pregnancy, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.

It is not known whether esomeprazole is excreted in human milk. No studies in lactating women. Therefore Nexium should not be used during breastfeeding.

Effects on ability to drive and use machines

No effects were observed.

 SIDE EFFECTS

The following adverse reactions have been identified or suspected in the clinical trials of esomeprazole and postmarketing use. None of them were related to dose.

General disorders and administration site conditions

Rare: Malaise, increased sweating

Respiratory, thoracic and mediastinal disorders

Rare: Bronchospasm

Blood and lymphatic system

Rare: Leukopenia, thrombocytopenia

Very Rare: Agranulocytosis, pancytopenia

Nervous System

Common: Headache

Uncommon: dizziness, paresthesia, somnolence

Rare: Disturbances of taste

Immune System

Rare: Hypersensitivity reactions eg. fever, angioedema and anaphylactic reaction / shock

Skin and subcutaneous tissue disorders

Uncommon: dermatitis, pruritus, rash, urticaria

Rare: Alopecia, photosensitivity

Very rare: Erythema multiforme syndrome, Stevens-Johnson, toxic epidermal necrolysis (TEN)

Hepatobiliary disorders

Uncommon: Increased liver enzymes

Rare: Hepatitis with or without jaundice

Very rare: Hepatic failure, encephalopathy in patients with pre-existing liver disease

Gastrointestinal Disorders

Common: Abdominal pain, constipation, diarrhea, flatulence, nausea / vomiting

Uncommon: Dry mouth

Rare: Stomatitis, gastrointestinal candidiasis

Very rare: Microscopic colitis

Metabolism and nutrition

Uncommon: Peripheral edema

Rare: Hyponatraemia

Very rare: Hypomagnesaemia

Musculo-skeletal and connective tissue disorders

Rare: Arthralgia, myalgia

Very rare: Muscle weakness

Renal and urinary disorders

Very rare: Interstitial nephritis

Psychiatric Disorders

Uncommon: Insomnia

Rare: Agitation, confusion, depression

Very rare: Aggression, hallucinations

Reproductive system and breast disorders

Very rare: Gynaecomastia

Eye Disorders

Uncommon: Blurred vision

Ear and labyrinth disorders

Uncommon: Vertigo

Overdose

Currently there is very limited experience with intentional overdose. The symptoms described in connection with 280 mg, were gastrointestinal symptoms and weakness. Single doses of 80 mg did not result in any event. There is no specific antidote. Esomeprazole is extensively bound to plasma proteins to a very high degree and therefore not readily dialyzable. As in any case of overdose, treatment should be symptomatic and general supportive measures.

Incompatibilities

Not applicabl

Special precautions for storage

There are no special storage instructions.

Nature and contents of container

Cardboard box containing 28 sachets. Sachets (containing granules): laminate of three layers: polyethylene terephthalate (PET), aluminum, low density polyethylene (LDPE), which protects the grain from moisture.