Rupafin pills 10mg №14

Indications

Symptomatic treatment in adults and adolescents over 12 years old:

- allergic rhinitis;

- urticaria.

Dosing regimen

Inside, regardless of the meal.

Have adults and children over 12 years old The recommended dose is 10 mg (1 tab.) 1 time / day.

Adverse Effects

Most often, patients receiving rupatadine reported adverse reactions to the drug, such as drowsiness, headache, and fatigue, occurring in 9.5%, 6.9%, and 3.2% of patients, respectively. In most cases, drug withdrawal was not required.

Classification of adverse reactions according to the frequency of development (number of registered cases / number of patients): very often - more than 1/10 of cases, often from 1/10 to 1/100 cases, infrequently - from 1/100 to 1/1000 cases.

Nervous system: often - drowsiness, headache, dizziness, fatigue, asthenia; infrequently - decreased concentration, irritability.

Respiratory: infrequently - nasal bleeding, dry nasal mucosa, pharyngitis, cough, dry throat, pain in the throat and larynx, rhinitis.

Gastrointestinal: often - dry mouth; infrequently - nausea, diarrhea, dyspepsia, vomiting, abdominal pain, constipation.

Metabolism and nutrition: Infrequently - increased appetite.

Dermatological: infrequently - rash.

Musculoskeletal system: infrequently - back pain, arthralgia, myalgia.

On the part of the body as a whole: infrequently - thirst, malaise, fever, weight gain.

Changes in laboratory parameters: infrequently - increase in KFK, ALT, AST, change of indicators of functional hepatic tests.

Contraindications

- renal failure;

- liver failure;

- pregnancy;

- lactation period;

- children's age up to 12 years (efficiency and safety are not established);

- rare hereditary intolerance to galactose, lactase deficiency or glucose-galactose absorption insufficiency syndrome;

- hypersensitivity to the drug.

WITH caution should be prescribed to patients with an extended QT interval, uncorrected hypokalemia, persistent proarrhythmic conditions, such as clinically significant bradycardia, acute myocardial ischemia; elderly patients (65 years and older); simultaneously with statins, simultaneously with grapefruit juice

Pregnanacy and breastfeeding

Ruphine drug^® contraindicated for use during pregnancy and lactation.

Application for violations of the liver

Contraindicated in liver failure

Application for violations of kidney function

Contraindicated in renal failure

Use in children

Contraindications: children under 12 years of age (efficacy and safety have not been established);

Use in elderly patients

WITH caution should be prescribed for elderly patients (65 years and older).

Since the results for rupatadine and for its metabolites were not clinically significant, it was concluded that the prescription of the drug in elderly patients at a dose of 10 mg did not require dose adjustment.

Special notes

Influence on ability to drive motor transport and control mechanisms

When using the drug in a dose of 10 mg, no effect on the ability to drive a car and other mechanisms was noted. At the same time, there are reports of drowsiness, noted during treatment with Rupafin. In this regard, it is recommended to exercise caution when driving a car or practicing other potentially hazardous activities that require increased concentration and psychomotor speed, until the patient's individual response to rupatadine is established.

Overdosage

The literature does not describe cases of drug overdose. In a study on the clinical safety of rupatadine well tolerated in a daily dose of 100 mg for 6 days.

Symptoms: the most common adverse reaction is drowsiness.

Treatment: in case of accidental ingestion of the drug in very high doses, it is shown to cause vomiting in a patient with the subsequent intake of Activated carbon. If this manipulation is impossible or ineffective, it is necessary to wash the stomach with isotonic sodium chloride solution.

Drug interactions

Interaction with Ketoconazole and Erythromycin

The combined use of rupatadine in a dose of 20 mg and ketoconazole or erythromycin enhances the systemic effects of rupatadine 10 times and the latter - by 2-3 times. These combinations are not accompanied by changes in the QT interval or an increase in the frequency of adverse reactions compared with the separate use of these drugs.

However, rupatadine should be used with caution in conjunction with these drugs and with other inhibitors of the CYP3A4 isoenzyme.

Interaction with grapefruit juice

The simultaneous intake of rupatadine and grapefruit juice 3.5 times enhances the overall effect of rupatadine. Do not eat grapefruit juice while taking the drug.

Interaction with ethanol

With simultaneous use with ethanol, rupatadine in a dose of 10 mg does not cause a more pronounced change in cognitive, psychomotor activity compared with ethanol alone. Rupatadin, taken in a dose of 20 mg, enhances the changes caused by the intake of ethanol.

Interaction with drugs that inhibit the central nervous system

We can not exclude the possibility of the interaction of rupatadine with other antihistamines and drugs that depress the central nervous system.

Interaction with statins

Due to the fact that some of the statins, as well as rupatadin, are metabolized by the cytochrome P450 CYP3A4 isoenzyme, it is impossible to exclude the possibility of increasing the level of CPK when they are used together.For these reasons, rupatadine should be used with caution along with statins.

Storage conditions

The drug should be stored in a dry place inaccessible to children in the original packaging at a temperature not higher than 25 ° C.