Instructions for use Ranitidine-Zdorovya forte film-coated tablets 300 mg blister No. 20
Composition
active ingredient: ranitidine;
1 tablet contains ranitidine 300 mg;
Excipients: lactose monohydrate; hypromellose; croscarmellose sodium; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; titanium dioxide (E 171); tropeolin 0.
Dosage form
Film-coated tablets.
Main physicochemical properties: film-coated tablets, yellow in color, with a specific odor. Two layers are visible on the cross section.
Pharmacotherapeutic group
Drugs for the treatment of peptic ulcer and gastroesophageal reflux disease. H2-histamine receptor antagonists. ATC code A02B A02.
Pharmacological properties
Pharmacodynamics. Ranitidine is an antiulcer agent, an antagonist of H2-histamine receptors.
The mechanism of action is due to competitive inhibition of H2-histamine receptors of the parietal cell membranes of the gastric mucosa. Reduces basal and stimulated secretion of hydrochloric acid, reducing the volume of gastric juice, which is formed due to irritation of baroreceptors (stomach distension), food load, the action of hormones and biogenic stimulants (gastrin, histamine, pentagastrin, caffeine). Ranitidine reduces the amount of hydrochloric acid in gastric juice, does not affect the concentration of gastrin in blood plasma, as well as mucus production. Ranitidine is characterized by a long-lasting effect.
Ranitidine does not affect the cytochrome P450 enzyme system of the liver.
Pharmacokinetics. After oral administration, ranitidine is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 50%. Cmax in the blood is reached after 2-3 hours and is 478 ng/ml. It is partially metabolized in the liver to N-oxide (the main metabolite, 4% of the dose), S-oxide and demethylated.
T½ (after oral administration) with normal creatinine clearance is 2-3 hours, with reduced (20-30 ml/min) - 8-9 hours. Excreted by the kidneys within 24 hours, about 30% of the orally administered dose is excreted unchanged.
Penetrates through histohematological barriers, including the placental barrier, but poorly through the blood-brain barrier. Sufficiently significant concentrations are determined in breast milk. The rate and extent of elimination depend little on the state of the liver and are mainly associated with kidney function.
Indication
Peptic ulcer of the stomach and duodenum, not associated with Helicobacter pylori (in the exacerbation phase), including ulcers associated with taking non-steroidal anti-inflammatory drugs (NSAIDs);
functional dyspepsia;
chronic gastritis with increased acid-forming function of the stomach in the acute stage;
gastroesophageal reflux disease (to relieve symptoms) or reflux esophagitis.
Contraindication
Increased individual sensitivity to ranitidine and other components of the drug; presence of malignant gastric diseases, history of liver cirrhosis with portosystemic encephalopathy, liver failure, severe renal failure (creatinine clearance < 50 ml/min).
Interaction with other medicinal products and other types of interactions
Ranitidine may affect the absorption, metabolism and renal excretion of other drugs.
Ranitidine in therapeutic doses does not change the activity of the cytochrome P450 enzyme system and does not potentiate the effect of drugs metabolized by this system (diazepam, lidocaine, phenytoin, propranolol, theophylline).
Ranitidine, by altering gastric acidity, may affect the bioavailability of some drugs. This leads to either increased absorption (triazolam, midazolam, glipizide) or decreased absorption (ketoconazole, itraconazole, atazanavir, gefitinib).
Antacids and sucralfate slow down the absorption of ranitidine, as a result of which the interval between taking these drugs and ranitidine should be at least 1-2 hours.
Concomitant use with metoprolol may lead to increased serum concentrations of metoprolol.
Ranitidine, when used simultaneously with coumarin anticoagulants (warfarin), may alter prothrombin time (monitoring of prothrombin time is recommended).
High doses of ranitidine may slow the excretion of procainamide and N-acetylprocainamide, leading to increased plasma levels.
There are no data on the interaction between ranitidine and amoxicillin or metronidazole.
Tobacco smoking reduces the effectiveness of ranitidine.
Application features
If you are allergic to other drugs in the group of histamine H2 receptor blockers, allergic reactions to ranitidine are possible, therefore, if you are hypersensitivity to other drugs in this group, the drug should be used with caution.
Use the drug with caution in acute porphyria (including a history), immunodeficiency, and phenylketonuria.
Ranitidine is excreted by the kidneys, therefore in patients with severe renal insufficiency its plasma levels are increased (see dosage for such patients in the section "Method of administration and dosage").
Treatment with the drug may mask the symptoms of gastric carcinoma, therefore, before starting treatment, the presence of malignant neoplasms in the stomach should be excluded.
Regular monitoring is necessary for patients (especially the elderly and those with a history of peptic ulcer of the stomach and/or duodenum) taking ranitidine together with NSAIDs.
Elderly patients, those with chronic lung disease, diabetes, or those with weakened immune systems have been observed to be at increased risk of developing community-acquired pneumonia.
Treatment with the drug should be discontinued gradually due to the risk of developing rebound syndrome with abrupt discontinuation.
Ranitidine should not be used in patients with liver failure.
This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Use during pregnancy or breastfeeding
The drug is contraindicated during pregnancy. If necessary, breastfeeding should be discontinued.
Ability to influence reaction speed when driving vehicles or other mechanisms
Considering that sensitive patients may experience adverse reactions (dizziness, hallucinations, accommodation disorders) when using the drug, you should refrain from driving vehicles or other mechanisms while taking the drug.
Method of administration and doses
For adults and children over 12 years of age, take orally, without chewing, with a small amount of water, regardless of meals.
Peptic ulcer of the stomach and duodenum, not associated with Helicobacter pylori (in the acute phase). Prescribe 1 tablet (300 mg) 1 time per day at night for 4 weeks. For ulcers that have not healed, continue treatment for another 4 weeks.
Peptic ulcer of the stomach and duodenum associated with NSAIDs. In the acute phase, prescribe 1 tablet (300 mg) once a day at night for 8-12 weeks.
Functional dyspepsia. Prescribe 1 tablet (300 mg) once a day for 2–3 weeks.
Chronic gastritis with increased acid-forming function of the stomach in the acute stage. Prescribe 1 tablet (300 mg) once a day for 2-4 weeks.
Gastroesophageal reflux disease. In case of exacerbation and for long-term treatment, prescribe 1 tablet (300 mg) at night for 8 weeks; if necessary, continue the course of treatment for up to 12 weeks.
Patients with severe renal impairment (creatinine clearance < 50 ml/min). This dosage form of ranitidine is contraindicated in patients in this group and they should use ranitidine in a lower dosage.
Children. The use of the drug is indicated for children aged 12 years and older to shorten the treatment period for peptic ulcer of the stomach and duodenum, for the treatment of gastroesophageal reflux disease, including reflux esophagitis, and to relieve the symptoms of gastroesophageal reflux disease.
Overdose
Possible increase in adverse reactions.
Treatment: if necessary, carry out adequate symptomatic and supportive therapy. Ranitidine can be removed from the blood serum by hemodialysis.
Side effects
From the blood system: leukopenia, reversible thrombocytopenia, agranulocytosis or pancytopenia, sometimes with bone marrow hypoplasia or aplasia, neutropenia, immune hemolytic and aplastic anemia (usually reversible).
On the part of the immune system: hypersensitivity reactions, including urticaria, angioedema, fever, anaphylactic shock, bronchospasm, erythema multiforme exudative, exfoliative dermatitis, Stevens-Johnson syndrome, Lyell's syndrome, hyperthermia.
On the part of the psyche: increased fatigue, reversible confusion, drowsiness, agitation, insomnia, emotional lability, anxiety, restlessness, depression, nervousness, hallucinations, tinnitus, irritability, disorientation, confusion. These manifestations are observed mainly in seriously ill or elderly patients.
Nervous system: headache (sometimes severe), dizziness and reversible involuntary movement disorders.
On the part of the organs of vision: blurred visual perception, accommodation disorders.
Cardiovascular system: decreased blood pressure, bradycardia, tachycardia, asystole, atrioventricular block, vasculitis, chest pain, arrhythmia, extrasystole.
On the part of the digestive tract: dry mouth, nausea, vomiting, constipation, diarrhea, abdominal pain, flatulence, acute pancreatitis, decreased appetite.
Hepatobiliary system: transient and reversible changes in liver function tests; hepatocellular, cholestatic or mixed hepatitis with or without jaundice (usually reversible).
Skin and subcutaneous tissue disorders: hyperemia, itching, skin rashes, erythema multiforme, alopecia, dry skin.
Musculoskeletal system: arthralgia, myalgia.
From the urinary system: renal dysfunction, acute interstitial nephritis, increased plasma creatinine levels.
From the reproductive system: hyperprolactinemia, galactorrhea, gynecomastia, amenorrhea, decreased potency (reversible) and/or libido.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
Tablets No. 10, No. 10×2 in blisters in a box.
Vacation category
According to the recipe.
Producer
Limited Liability Company "Pharmaceutical Company "Zdorovya".
Limited Liability Company "PHARMEX GROUP".
Location of the manufacturer and address of its place of business.
Ukraine, 61013, Kharkiv region, Kharkiv city, Shevchenko street, building 22.
(Limited Liability Company "Pharmaceutical Company "Zdorovya")
Ukraine, 08301, Kyiv region, Boryspil city, Shevchenko street, building 100.
(Pharmex Group Limited Liability Company)
