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Normon S.A. - Sapin

ANASTROZOLE NORMON
BISOPROLOL NORMON
DESLORATIDINE NORMON
ESCITALOPRAM NORMON
ESOMEPRAZOLE NORMON
ESTECINA Inj.
ESTECINA Tablets
FIXIM
GASTRIMUT
LAMOTRIGINE NORMON
LETROZOLE NORMON
LEVOFLOXACIN NORMON
LIDOCAINE 2% EPINEPHRINE NORMON
NORMOCEF
NORMOPRIL
PARACETAMOL NORMON
SIMVASTATIN NORMON
TOPAGAN

Forms and presentation
Powder for injectable solution and for infusion: Vial of 5 ml: Box of 1.

Composition
Each vial contains: Espmeprazoie sodium: 40 mg.
Excipients: disodium edetate, sodium hydroxide.

Properties
Proton pump inhibitor.

Indications
Esomeprazole Normon is used when the oral route is not possible for the short term treatment of:
• Gastro-oesophageal reflux disease (GORD) in adults, adolescents and children.
• Treatment and prevention of gastric ulcers associated with NSAIDs.
• Prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal Ulcers.

Contraindications
Hypersensitivity to esomeprazole or any of the excipients.
Hypersensitivity to other proton pump inhibitors (e.g. pantoprazole, lanzoprazole, rabeprazole, omeprazole)
Esomeprazole Normon should not be used concomitantly with nelfinavir.

Precautions
Caution is advised in patients with severe renal or hepatic insufficiency.
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, malignancy should be excluded, as treatment with Esomeprazole Normon may alleviate symptoms and delay diagnosis.
Esomeprazole Normon contains less than 1 mmol sodium (23 mg) per vial i.e. essentially "sodium-free".

Drug interactions
Caution should be exercised when Esomeprazole Normon is given with the following medicinal products: nelfinavir, atazanavir, ketoconazole, itraconazole or voriconazole, erlotinib, citalopram, imipramine or clomipramine, diazepam, phenytoin, warfarin, cilostazol, cisapride, methotrexate, rifampicin, St. John's wort (Hypericum perforatum).

Ability to drive and use machine
Esomeprazole Normon is not likely to affect the ability to drive or use machines.

Pregnancy and lactation
Pregnancy: Caution should be exercised when prescribing Esomeprazole Normon to pregnant women.
Lactation: It is not known if Esomeprazole Normon is excreted in breast milk. Therefore, Esomeprazole Normon should not be used during breast-feeding.

Side effects
Common: Headache, diarrhoea, abdominal pain, constipation, flatulence, nausea, vomiting, injection site reaction.
Uncommon: peripheral oedema, insomnia, dizziness, paraesthesia, somnolence, vertigo, blurred vision, dry mouth,  increased liver enzymes, pruritus, rash, urticaria.
Rare: leukopenia, thrombocytopenia, hyponatraemia, agitation, confusion, depression, taste disturbance, bronchospasm, stomatitis, gastrointestinal candidiasis, hepatitis with jaundice, alopecia, photosensitivity, arthralgia, myalgia, malaise, increased sweating.
Very rare: agranulocytosis, pancytopenia, aggression, hallucinations, severe hepatic failure, encephalopathy, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, muscle weakness, severe renal failure, gynaecomastia, severe hypomagnesaemia can correlate with hypocalcaemia.
Unknown frequency: microscopic colitis, hypomagnesaemia may be associated with hypokalaemia, fracture of the hip, wrist or spine.

Dosage and administration
For single use only.
Esomeprazole Normon can be given to the children and adolescents aged 1-18 years and adults, including the elderly.
Adults: The usual dose is 20 mg or 40 mg once a day.
The medicine should be given as an IV injection or infusion over 30 minutes.
The usual dose for prevention of rebleeding of gastric or duodenal ulcer is 80 mg administered as IV infusion over 30 minutes followed by a continuous infusion of 8 mg/hr given over 3 days.
In patients with severe liver impairment, the maximum dose is 20 mg a day (GORD).
In patients with severe liver impairment, a continuous infusion of 4 mg/hr given over 3 days may be sufficient.
Children aged 1-18 years:
• For children 1-11 years, the usual dose is 10 or 20 mg once a day.
• For children 12-18 years, the usual dose is 20 or 40 mg once a day.
The medicine should be given as an IV injection or infusion over 30 minutes.
Preparation of reconstituted solution: The reconstituted solution for injection is clear and colourless to very slightly yellow.
The reconstituted solution should be inspected visually for particulate matter and discoloration prior to administration. Only clear solution should be used.
Chemical and physical in-use stability has been demonstrated for 12 hrs at 30°C. From a microbiological point of view, the product should be used immediately.
Injection:
- 40 mg dose: A solution for injection (8 mg/ml) is prepared by adding 5 ml of 0.9% sodium chloride for IV use to the esomeprazole 40 mg vial.
5 ml of the reconstituted solution should be given as an IV injection over a period of at least 3 minutes.
Infusion:
- 40 mg dose: The solution for infusion is prepared by dissolving the content of one vial of esomeprazole in up to 100 ml of 0.9% sodium chloride for IV use.
- 80 mg dose: The solution for infusion is prepared by dissolving the contents of two vials of esomeprazole in up to 100 ml of 0.9% sodium chloride for IV use.

Storage conditions
Do not store above 30°C. Protect from humidity. Keep the vial in the outer carton in order to protect from light. Vials can, however, be stored exposed to normal indoor light outside the box for up to 24 hours.

Origin: Spain
Laboratories: Normon
Distributor: Droguerie Phenicia
Number Registration: 23614/2014