Adults

· In association with dual antibiotic therapy · Eradication of Helicobacter pylori in case of disease · Gastroduodenal ulcer (after evidence, endoscopic lesion and infection)
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· Evolutionary gastric or duodenal ulcer

· Esophagitis by gastroesophageal reflux.

· Zollinger-Ellison syndrome.

Children (3 to 18 years)

· Short-term treatment of gastric or duodenal ulcers

· Treatment of gastroesophageal reflux, including esophagitis, by reflux and relief of symptoms related to gastroesophageal reflux

Since the absorption is not influenced by the diet, tablets can be taken during or outside meals.
Adults and teenagers from 12 years old

Duodenal ulcer, evolutive

1 tablet of ranitidine 300 mg in the evening, for 4 weeks.
Gastric ulcer, evolutionary

1 tablet of ranitidine 300 mg in the evening, for 4 to 6 weeks.
Oesophagitis
1 tablet of ranitidine 300 mg in the evening, for 4 weeks with a possible second period of 4 weeks at the same dosage as a function of the endoscopic results. >
Adults

Eradication of Helicobacter pylori in cases of gastroduodenal ulcer disease

The following dosage regimens are recommended

300 mg ranitidine morning and evening, associated for 14 days at

· 1 g of amoxicillin morning and evening and 500 mg of clarithromycin morning and evening

· Either 500 mg of clarithromycin morning and evening associated with either 500 mg of metronidazole or tinidazole morning and evening or 1000 mg of tetracycline morning and evening
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· As an alternative to the preceding regimens, 1 g amoxicillin morning and evening and 500 mg metronidazole or tinidazole morning and evening.
This triple therapy will be followed by 300 mg ranitidine per day for 2 weeks, additional in case of duodenal ulcer, progression or 2 to 4 more weeks in case of evolutionary gastric ulcer
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Zollinger-Ellison syndrome

The recommended starting dose is 600 mg per day. The dose should be adjusted individually, if necessary up to 1200 mg / day, and continued treatment as long as necessary, clinically.
In case of renal insufficiency, reduce the dosage * according to serum creatinine according to the following
· Serum creatinine from 25 to 60 mg / l (220 to 530 μmol / l): 150 mg every 24 hours
· Serum creatinine greater than 60 mg / l (530 μmol / l): 150 mg every 48 hours or 75 mg every 24 hours.
* For reduced dosages, preferably use tablets dosed at 150 mg.

Children aged 3 to 11 and those over 30 kg

See section Properties, Pharmacokinetics Properties, Pharmacokinetics-Special Populations of Patients.

Depending on the dosage and indication applied to the treatment, the use of other 75 mg and 150 mg dosage forms may be necessary.
Treatment of acute gastric or duodenal ulcer

The oral dosage recommended for the treatment of gastric ulcer or duodenal in children is 4 mg / kg / day to 8 mg / kg / day administered in two separate doses with a maximum dose of 300 mg Per day of ranitidine for 4 weeks.

For patients with incomplete healing, 4 weeks, additional treatment is indicated, as recovery occurs, usually after 8 weeks of treatment. >
Gastroesophageal reflux disease

The oral dosage recommended for the treatment of gastroesophageal reflux in children is 5 mg / kg / day to 10 mg / kg / day administered in two separate doses with a maximum dose of 600 mg Day (maximum dosage likely to apply to children and adolescents with high and severe symptoms)

Safety and efficacy in newborns have not been established.

Pharmacotherapeutic group H 2 RECEPTOR ANTAGONIST 2.

ATC code: A02BA02.

(A: digestive system and metabolism)

Ranitidine is an antagonist of histamine H 2 receptors.

Ranitidine inhibits the secretion of gastric acid caused not only by histamine, but also by pentagastrin, insulin, caffeine or by food.

Ranitidine does not alter the production of mucus, does not affect the secretion, pancreatic and appears to have no effect on the sphincter, lower esophagus
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Antacid activity supported by the couple, effervescent "citrate / bicarbonate"

· The theoretical maximum antacid capacity for 1 300 mg tablet is 71.2 mmol H + ions

· The neutralizing power is about 95-96% of total antacid activity

· The buffer capacity is approximately 4 - 5%.

Not applicable.

· Hypersensitivity to ranitidine.

· Phenylketonuria due to the presence of aspartame

Warnings, special

The administration of antisecretory of the class of inhibitors of H 2 receptors promotes development, intragastric bacteria by decreasing acidity, gastric

An acute, intermittent case of acute porphyria has been reported with this drug. In case of doubt, this medication should not be used in people with a history of acute porphyria, intermittent.


· In the case of gastric ulcer, it is recommended to check the benignity of the lesion before treatment.

· In patients with renal insufficiency, the dose should be reduced according to the creatinine or serum creatinine clearance (see section 4.2).

· In the elderly and renal insufficiency, discontinue treatment if a confounding condition occurs.

· In case of severe hepatocellular insufficiency, especially if there is an associated renal insufficiency, it is preferable to reduce the dosage (see Dosage and Administration). Br>

Related to excipients

This medicinal product contains sodium This medicinal product contains 476 mg sodium per tablet to be taken into account in patients on a strict diet.
This medicinal product contains sorbitol and is not recommended for use in patients with fructose intolerance (rare hereditary disease)

Associations, subject to precautions for use

+, Gastrointestinal Topics, Antacids and Coal

Decreased digestive absorption of antihistamine H 2.

Take the gastrointestinal and antihistamine topical antihistamine H 2 (over 2 hours, if possible).

Associations to be taken into account

+; Atazanavir

Risk of decreased plasma concentrations of atazanavir

+; Itraconazole

Decreased absorption of antifungal azole by increased intragastric pH by the antisecretory

+; Ketoconazole

Decreased absorption of antifungal azole by increased intragastric pH by the antisecretory

+; Posaconazole

Decreased absorption of antifungal azole by increasing the pH intragastric by the antisecretory

+; Cyanocobalamin

Risk of cyanocobalamin deficiency after prolonged treatment (a few years): the reduction in gastric acidity by these drugs may decrease the digestive absorption of vitamin B12
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+; Erlotinib

Risk of decreased plasma concentrations of erlotinib.

Not applicable.

Oral doses of 6 grams per day were administered without adverse effects in Zollinger-Ellison syndrome

In case of overdose, symptomatic treatment is recommended.
Pregnancy

Studies in animals have not shown any teratogenic effect. In the absence of teratogenic effect in animals, a malformative effect in the human species is not expected. Indeed, to date, the substances responsible for malformations in the human species have been found to be teratogenic in animals in well-conducted studies of two species

Clinically, the use of ranitidine in a limited number of pregnancies has apparently shown no particular malformative or fetotoxic effects to date. However, further studies are needed to evaluate the consequences of exposure during pregnancy.
Breastfeeding

The passage of H 2 receptor antagonists into breast milk is documented with a high milk to plasma concentration ratio but the doses injected by the child remain low (about 1% of the maternal dose). , Only kinetic data are available. Tolerance in children in case of maternal treatment, a fortiori if prolonged or at high doses, is not known.


Adverse reactions are classified by frequency using the following classification

Very frequent (> 1/10), frequent (> 1/100, 1/1000, 1/10000,