COMPOSITION:

Active substance:

Ranitidine;

1 tablet contains Ranitidine hydrochloride, which is equivalent to 150 mg of Ranitidine;

Additional ingredients:

microcrystalline cellulose, croscarmellose sodium, magnesium stearate, Opadry II 85G53691 Orange coating: polyvinyl alcohol, lecithin, polyethylene glycol, talc, titanium dioxide (E 171), Ponceau 4R (E 124), Sunset Yellow FCF (E 110), Indigo Carmine (E 132).

INDICATIONS:

– Peptic gastric and duodenal ulcers not associated with H. Pylori (in acute phase), including ulcers not related to the use of non-steroid anti-inflammatory drugs (NSAIDs);

– Functional dyspepsia;

– Chronic acute gastritis with increased acute acid-forming function;

– Gastroesophageal reflux disease (for symptoms relief) or reflux-esophagitis.

DOSAGE:

It is administered to adults and children over12 years old. It is used per orally, without chewing and with enough water, regardless of meal.

Peptic and duodenal ulcers not associated with Helicobacter pylori (in acute phase): 150 mg (1 tablet) 2 times per day or 300 mg (2 tablets) one time per day before going to bed are administered for 4 weeks. In ulcers, which are not cicatrized, the treatment is continued for the next 4 weeks.

Prophylaxis of peptic gastric and duodenal ulcers associated with the use of non-steroid anti-inflammatory drugs:

For a period of NSAIDs therapy 150 mg (1 tablet) 2 times per day are administered.

Functional dyspepsia:

150 mg (1 tablet) 2 times per day are administered for 2 – 3 weeks.

Chronic acute gastritis with high acid-forming gastric function:

150 mg (1 tablet) 2 times per day are administered for 2 – 4 weeks.

Gastroesophageal reflux disease:

For symptoms relief 150 mg (1 tablet) 2 times per day are administered for 2 weeks; if necessary, the treatment is continued.

For long-term treatment and in case of acute gastroesophageal reflux disease 150 mg (1 tablet) 2 times per day or 300 mg (2 tablets) once a day before going to bed are administered for 8 weeks; if necessary, the treatment is continued up to 12 weeks.

Patients with severe kidney insufficiency (creatinine clearance is < 50 ml/min):

daily dose of the preparation for this age group of patients is 1 tablet (150 mg).

ADVERSE REACTIONS:

Cardio-vascular system:

bradycardia, tachycardia, extrasystole, asystole, atrioventricular block, decrease of blood pressure, arrhythmia.

Blood and lymphatic system: leukopenia and thrombocytopenia (usually reversible); agranulocytosis or pancytopenia, sometimes with hypoplasia or aplasia of bone marrow, neutropenia.

Nervous system:

headache, dizziness, drowsiness, involuntary movements (reversible), agitation, fatigue.

Organ of vision:

visual impairment, blurred vision associated with accommodation impairment.

Digestive tract:

diarrhea, constipation, nausea, vomiting, abdominal pain, acute pancreatitis, anorexia, meteorism, dry mouth.

Urinary system:

acute interstitial nephritis, renal failure.

Skin and subcutaneous tissue:

skin rash, erythema multiforme, alopecia, dry skin, itch.

Musculoskeletal system and connective tissue disorders: arthralgia, myalgia.

Vascular system:

vasculitis.

Immune system:

hypersensitivity reactions (urticaria, angioedema, fever, bronchospasm, hypotension, chest pain), anaphylactic shock.

Hepatobiliary system:

transient and reversible changes of levels of individual laboratory parameters (transaminase, gamma-glutamyltransferase, alkaline phosphatase, bilirubin); hepatitis (hepatocellular, cholestatic or mixed hepatitis) with or without jaundice (usually reversible).

Reproductive system and mammary glands:

reversible impotence, decreased libido, gynecomastia and galactorrhea.

Psychics:

reversible mental disorders (hallucinations, desorientation, state of perplexity, agitation and anxiety, depression), predominantly in elderly and seriously ill patients.

Drug interactions:

Ranitidine can influence on absorption, metabolism and renal excretion of other medicines.

Ranitidine at therapeutic doses does not change the activity of cytochrome P450 enzyme system and does not potentiate the action of agents, which are metabolized by this system (diazepam, lidocaine, phenytoin, propranolol, theophylline, etc.).

Ranitidine, changing the acidity of stomach, may affect the bioavailability of some medicines. This can result in either an increase of their absorption (triazolam, midazolam, glipizide) or a decrease of their absorption (ketoconazole, atazanavir, delavirdine, gefitinib).

Antacids and sucralfate inhibit Ranitidine absorption, as a result of what the interval between intake of these medicines and ranitidine should be at least 1 – 2 hours.

Concurrent use of metoprolol may increase the concentration of metoprolol in serum.

Ranitidine in combination with coumarin anticoagulants (warfarin) may alter the prothrombin time (prothrombin time monitoring is recommended).

High doses of Ranitidine may slow down the excretion of procainamide and N-acetylprokainamid that causes an increase of their level in blood plasma.

There is no data concerning the interaction between Ranitidine and amoxicillin or metronidazole.

Pregnancy and lactation:

The preparation is contraindicated during pregnancy. If the preparation use is necessary during the treatment, then lactation should be stopped.

Children:

For children above 12 years old the preparation is used to reduce the duration of the treatment of peptic gastric and duodenal ulcers, for the treatment of gastroesophageal reflux disease, including reflux-esophagitis, and for relief of symptoms of gastroesophageal reflux disease.

PRECAUTIONS:

In case of allergy to other agents of group of histamine H2-receptors blockers allergic reaction to Ranitidine are possible, therefore, in case of hypersensitivity to other medicines of this group the preparation should be used with caution.

The preparation is used with caution in acute porphyria (including it in anamnesis), immunodeficiency.

Ranitidine is excreted via kidney; therefore, the plasma preparation level in patients with severe kidney insufficiency is increased (see dosage for those patients in “Administration and Dosage” section).

In elderly patients with liver or kidney dysfunction it is possible an impairment of consciousness (mental confusion) that requires a dose lowering.

This preparation treatment may mask the symptoms of gastric carcinoma, therefore, before the treatment it is necessary to exclude presence of malignant neoplasm in stomach.

Patients (especially elderly and with peptic and/or duodenal ulcer in anamnesis) who use Ranitidine concurrently with non-steroid anti-inflammatory drugs should be under a regular observation.

In elderly patients, patients with chronic pulmonary diseases, diabetes mellitus or those with weakened immunity an increased susceptibility to the development of outhospital pneumonia was observed. In simultaneous treatment with theophylline it is necessary to monitor plasma levels of theophylline and adjust the dose.

This preparation treatment is withdrawn gradually due to risk of development of “ricochet” syndrome in case of its abrupt withdrawal.

Overdose:

Symptoms:

enhancement of adverse reactions.

Treatment:

symptomatic and supportive therapy.

Ability to influence reaction velocity while driving or operating any other mechanisms.

During the treatment period it is necessary to avoid potentially dangerous activities that require a high concentration of attention and rate of psychomotor reactions.

CONTRAINDICATIONS:

Individual hypersensitivity to Ranitidine or other preparation’s ingredients; presence of malignant diseases of stomach; liver cirrhosis with portal systemic encephalopathy in anamnesis; pregnancy and lactation periods; children age less than 12 years old.

PHARMACOLOGICAL PROPERTIES:

Pharmacodynamics:

Ranitidine is an antagonist of H2-histamine receptors. Competitively reversibly binding to H2-histamine receptors of parietal cells of mucous coat of stomach, it inhibits basal and stimulated secretion of hydrochloric acid, and eliminates activity of pepsin, promotes pH content of stomach. It decreases the volume of gastric juice caused by baroreceptors irritation (stomach stretch), overeating, action of hormones and biogenic stimulators (gastrin, histamine, pentagastrin, caffeine). Medicine`s action after a single dose lasts 12 hours.

Pharmakokinetics:

After internal use Ranitidine is absorbed quickly. Its absorption does not depend on food intake. Plasma peak concentration is within the limits of 300 – 500 mcg/ml and is reached in 1 – 3 hours after per oral use of 150 mg of the preparation. Ranitidine bioavailability is 50%. Ranitidine concentration in plasma is proportional to the used dose. Binding to plasma proteins is 15%. It is partly metabolized in liver.

The preparation is excreted mainly via kidneys (60 – 70% of per oral dose) and 26% – with faeces. Half-life period is 2 – 3 hours. Approximately 30% of per oral dose is excreted as unchanged one.

PHARMACEUTICAL CHARACTERISTICS:

General physic-chemical properties:

orange, circular, biconvex, coated tablets;

Shelf-life:

3 years.

Storage:

Store it at the temperature not more than 25°C, in a dry, protected from light place. Keep it out of reach of children.

Package:

There are 10 tablets in a strip; there are 10 strips in a carton box.

Conditions of supply:

By prescription.