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Mutual Recognition Procedure

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Mutual Recognition Procedure SUMMARY OF PRODUCT CHARACTERISTICS RANITIDINA ABC 150 mg Film-coated Tablets RANITIDINA ABC 300 mg Film-coated Tablets 1. NAME OF THE MEDICINAL PRODUCT RANITIDINA ABC 150 mg Film-coated Tablets RANITIDINA ABC 300 mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION RANITIDINA ABC 150 mg film-coated tablets One film-coated tablet contains Active ingredient: 170 mg ranitidine hydrochloride equivalent to 150 mg of ranitidine. For a full list of excipients, see section 6.1. RANITIDINE ABC 300 mg film-coated tablets One film-coated tablet contains Active ingredient: 340 mg ranitidine hydrochloride equivalent to 300 mg of ranitidine For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. 4. CLINICAL PARTICULARS 4.1 Therapeutic Indications Adults Duodenal ulcer and benign gastric ulcer, including that associated with non-steroidal anti- inflammatory agents, recurrent ulcer, post-operative ulcer, reflux oesophagitis, Zollinger- Ellison Syndrome, prophylaxis and treatment of upper gastrointestinal haemorrhages, premedication under anaesthesia, prevention and treatment of stress ulcers. Ranitidine is also indicated in conditions such as gastritis or duodenitis when associated with acid hypersecretion. Children (3 to 18 years) Short term treatment of peptic ulcer Treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux disease. 4.2. Posology and method of administration 1 Adults (including the elderly) / Adolescent (12 years and older) Usual dosage is 300 mg per day: 150 mg in the morning and 150 mg in the evening. In patients with gastric or duodenal ulcer, 300 mg may be administered as a single administration in the evening before bedtime (Ranitidina ABC 300 mg 1 tablet at bedtime). Moreover, in the following situations: patients with large ulcers and / or heavy smokers and severe peptic esophagitis, it may be useful to increase the dosage up to 600 mg per day, returning as soon as possible to the standard dosing schedule and under direct medical supervision. In the prophylaxis of severe stress ulcer bleeding, recurrent haemorrhage in patients with bleeding peptic ulcer or patients in parenteral ranitidine therapy still considered to be at risk, as soon as feeding is resumed by mouth, can be treated with Ranitidina ABC 150 mg twice a day. Duodenal ulcer, gastric ulcer, recurrent ulcer, post-operative ulcer The recommended daily dosage regimen is 300 mg. Healing usually occurs in 4 weeks. If necessary, treatment can be prolonged up to 6-8 weeks. In case of ulcers resulting from treatment with Non-steroidal Anti-inflammatory drugs (NSAID) and / or if continued treatment with such drugs is necessary, the recommended dose is 300 mg for 8 weeks. The treatment may need to be continued for up to 12 weeks. In the case of patients with large ulcers and / or heavy smokers, 300 mg twice daily may be more useful. In patients in whom, after the positive response to short-term therapies, it is desirable to maintain the effect on gastric secretion, particularly in those with a tendency to relapse of ulcerative episodes, a maintenance therapy of 150 mg can be adopted in the evening. In patients already being treated with 600 mg a day it may be helpful to start maintenance therapy with a dosage of 300 mg in the evening for a period of 8-12 weeks, continuing successively with the standard dose. Smoking is associated with a higher incidence of ulcer recurrence. Therefore, smoking patients should be advised to abandon this habit; if this does not happen, the maintenance dose of 300 mg in the evening offers additional protection compared to the standard dose of 150 mg. Maintenance therapy (150 mg and 300 mg orally in the evening) should be prescribed by the doctor and performed under his supervision. Reflux esophagitis The recommended daily dose in oesophageal reflux disease is 300 mg / day, divided into two 150 mg doses, over a period of 8 weeks. In moderate-to-severe peptic esophagitis, the dosage can be increased to 600 mg / day, divided into 2-4 administrations, up to 12 weeks, under the direct supervision of the physician, returning as soon as possible to the standard posology. In long-term treatment, for the prevention of relapse, the recommended dose is 150 mg twice a day. Zollinger-Ellison syndrome The daily dose is 450 mg (150 mg three times a day) which can be increased if necessary at 600-900 mg (Ranitidina ABC 300 mg, 2-3 tablets a day). Hemorrhages of the upper gastro-intestinal tract In the prophylaxis and treatment of haemorrhages of the upper gastro-intestinal tract the oral dose is 300 mg per day. 2 If oral therapy is not immediately possible, treatment can be started with ranitidine solution for injection and continued with oral therapy (300 mg per day for as long as necessary). Premedication under anaesthesia Those patients who run the risk of developing an acidic aspiration syndrome (Mendelson's syndrome) may be given an oral dose of 150 mg 2 hours before the induction of general anesthesia and, preferably, also a dose of 150 the previous evening. The parenteral route of administration can also be used. Stress ulcer In the prevention and treatment of stress ulcers in severe patients the recommended daily dose is 300 mg. If the patient's condition does not allow oral administration, treatment can be started with injectable ranitidine and then continued with oral therapy. Patients with renal impairment In patients with severe renal impairment (creatinine clearance less than 50 ml / min), ranitidine accumulation occurs, resulting in increased plasma concentrations. It is recommended that the daily dose in such patients is 150 mg to be taken in the evening. Children from 3 to 11 year and over 30 kg of weight See section 5.2 Pharmacokinetic properties (other special populations) Peptic ulcer acute treatment The recommended oral dose for the treatment of peptic ulcer in children is 4 mg/kg/day to 8 mg/kg/day administered as two divided doses to a maximum of 300 mg ranitidine per day for a duration of 4 weeks. For those patients with incomplete healing, another 4 weeks of therapy is indicated, as healing usually occurs after 8 weeks of treatment. Gastro-Oesophageal reflux The recommended oral dose for treatment of gastro-oesophageal reflux in children is 5 mg/kg/day to 10 mg/kg/day administered as two divided doses to a maximum of 600 mg (the maximum dose is likely to apply to heavier children or adolescents with severe symptoms). Neonates Safety and efficacy in new-born patients has not been established. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 Special warnings and precautions for use Gastric carcinoma Before to initiating ranitidine therapy in patients with gastric ulcer or in middle-aged or older patients who have recently or recently-changed dyspeptic symptoms, its possible malignancy must be excluded since treatment with ranitidine may mask the symptoms of gastric carcinoma. Renal disease 3 Ranitidine is excreted via the kidney and so plasma levels of the drug are increased in patients with severe renal impairment. The dosage should be adjusted as detailed in section 4.2 Patients with renal impairment. Rare clinical reports suggest that ranitidine may precipitate acute porphyric attacks. Ranitidine should therefore be avoided in patients with a history of acute porphyria. In patients such as the elderly, persons with chronic lung disease, diabetes or the immunocompromised, there may be an increased risk of developing community acquired pneumonia. A large epidemiological study showed an increased risk of developing community acquired pneumonia in current users of ranitidine alone H2 receptor antagonists (monotherapy with ranitidine) versus those who had stopped treatment, with an observed adjusted relative risk increase of 1.82 (95% CI 1.26-2.64). Regular supervision of patients who are taking non-steroidal anti-inflammatory drugs concomitantly with ranitidine is recommended, especially in the elderly and in those with a history of peptic ulcer. Recurrences of objective and subjective symptomatology may occur either after the suspension of drug intake, or during long-term maintenance treatment at a lower than full dose. Dosage and duration of administration should always be established by the physician, bearing in mind that the symptoms usually disappear before the ulcer has scarred. Ranitidine administration, like all H2-receptor antagonists, favours intragastric bacterial development due to decreased gastric acidity. Caution should be used in patients with hepatic impairment. 4.5 Interaction with other medicinal products and other forms of interactions Ranitidine has the potential to affect the absorption, metabolism or renal excretion of other drugs. The altered pharmacokinetics may necessitate dosage adjustment of the affected drug or discontinuation of treatment. Interactions occur by several mechanisms including: 1) Inhibition of cytochrome P450-linked mixed function oxygenase system: Ranitidine at usual therapeutic doses does not potentiate the actions of drugs which are inactivated by this enzyme system such as diazepam, lidocaine, phenytoin, propranolol and theophylline. There have been reports of altered prothrombin time with coumarin anticoagulants (e.g. warfarin). Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin time is recommended during concurrent treatment with ranitidine. 2) Competition for renal tubular secretion: Since ranitidine is partially eliminated by the cationic system, it may affect the clearance of other drugs eliminated by this route. High doses of ranitidine (e.g. such as those used in the treatment of Zollinger-Ellison syndrome) may reduce the excretion of procainamide and N- acetylprocainamide resulting in increased plasma levels of these drugs. 3) Alteration of gastric pH: The bioavailability of certain drugs may be affected. This can result in either an increase in absorption (e.g.
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