Instruction for use
The composition of the drug:
active ingredients: guaifenesin extract for Novo-Pasito complex.
1 ml solution contains: extract for Novo-Pasito complex (Hyperici herba (herb St. John's wort), Passiflorae herba (passionflower herb), Valerianae radix (Valerian root), Crataegi folium cum flore (the leaves and flowers of hawthorn), Lupuli flos (hop cones), Melissae herba (grass lemon balm), Sambusi flos (elder flowers)) 0,0775 g, guaifenesin-0.04 g;
auxiliary substances: sodium cyclamate, xanthan gum, invert sugar, saccharin sodium, sodium benzoate (E 211), ethanol 96 %, orange flavor, sodium citrate, maltodextrin, propylene glycol, purified water.
Dosage form. Solution oral.
Syrupy clear or slightly turbid liquid from red-brown to brown, with a characteristic odor and taste. Light precipitate, drop-down during storage and dissolves when shaken, does not reduce the effectiveness of the drug.
Pharmacotherapeutic group. Sleeping pills and sedatives.
ATC code N05С M 50.
Pharmacologically active components of the drug are guaifenesin and extracts from medicinal plants has mainly a sedative effect. Soothing extract is combined with a muscle relaxant action guaifenesina (relaxes smooth muscle).
Guaifenesin is rapidly absorbed from the gastrointestinal tract, metabolized in the liver by conjugation with glucuronic acid and is excreted in the form of inactive metabolites, mainly with urine. Biological half-life is approximately 1 hour.
Indications for use.
A mild form of neurasthenia, especially if it is accompanied by anxiety, fear, sadness, restlessness, irritability, diminished concentration or fatigue; a mild form of insomnia, exhaustion or neurotic disorders of memory. Supportive therapy for migraines, headaches caused by nervous tension, vascular, psychosomatic disorders, with soldier's heart fatigue, neuromuscular excitability, pain in the face, climacteric syndrome. Functional diseases of the gastrointestinal tract (dyspeptic syndrome, the syndrome of "irritable bowel"). Psychosomatic dermatoses, accompanied by itching (urticaria, atopic eczema).
Hypersensitivity to the active components or auxiliary substances of the drug, myasthenia gravis, epilepsy. Children up to age 12 years.
Appropriate security measures when using.
During the application of drugs patients, especially those with fair skin, should avoid prolonged exposure to UV radiation (sunbathing, Solarium, diathermy).
With caution use in patients with severe liver disease, intoxication by substances which inhibit the action of the Central nervous system.
The product contains of 12.19 % (V/V) ethanol, single dose (5 ml) contains 0,481 g of ethanol, which must be included in the application during pregnancy, lactation, children and risk groups (patients with liver disease, epilepsy, patients with alcoholism).
The drug is contraindicated in patients with a rare genetic disease the disadvantageous to fructose or glucose-galactose malabsorption.
Use during pregnancy or breast-feeding.
Study on reproductive functions during the application of the preparation were not carried out; the safety of the drug during pregnancy is not established. In this regard, the drug Novo-Passit to assign during pregnancy only necessary in exceptional cases. Before applying it, especially during the first trimester should be carefully evaluated for potential risk to the fetus in comparison with the expected effect of the drug.
Unknown, selects guaifenesin and the other active components of the drug in breast milk, so you should carefully weigh the potential risk effect of the drug on the child and the potential benefit to the mother.
The ability to influence the rate of reaction at management of motor transport or operating other mechanisms.
Due to the fact that Novo-Passit contains ethanol and guaifenesin, its use can lead to inhibition, which manifests itself individually in each patient. Therefore, you should refrain from potentially hazardous activities that require attention such as driving or operating other mechanisms.
The drug is used in children aged 12 years.
Method of application and doses.
Usually prescribed 5 ml (1 teaspoon) of the drug three times a day.
If necessary, the dose can be increased to 10 ml three times a day or decrease to 2.5 ml in the morning and afternoon and 5ml in the evening. The dose can be changed in accordance with the condition of the patient. The interval between doses, each individual dose should be between 4 to 6 hours. The maximum daily dose is 30 ml.
The drug can be mixed with beverages (juice, tea, etc.).
First, overdose is manifested by CNS depression, drowsiness. Later these symptoms may be accompanied by nausea, easy muscle weakness, joint pain and a feeling of heaviness in the stomach. Treatment is symptomatic and consistent with the General principles of treatment of overdose. There is no specific antidote.
Novo-Passit is well tolerated by patients. However, in a few cases were noted following adverse reactions:
Rarely: dizziness, drowsiness.
Rare: nausea, vomiting, spasms, heartburn, diarrhea or constipation.
Changes in the skin and subcutaneous tissue:
Rare: rash, pruritus.
Violations of the musculoskeletal system and connective tissue:
Rarely: easy muscle weakness.
Interaction with other medicinal products and other forms of interaction.
Guaifenesin enhances the analgesic effect of paracetamol and acelalsito acid and enhances the influence of alcohol and other substances, oppressive Central nervous system. Central nervous action of myo relaxants may increase adverse effects guaifenesin, especially muscle weakness.
The perforated St. John's wort can cause an induction of isoenzymes 3A 4 1A 2 2S and 9 of the cytochrome P-450 that can cause a decrease action of other drugs that are also taken and metaboles these isoenzymes. The specified action may also be due to the ability to induction of intestinal transport system P-glycoprotein. This interaction was first detected in healthy volunteers during simultaneous reception of indinavir and St. John's wort perforated. You can also expect that a similar interaction occurs with other inhibitors of retroviral protease (amprenavir, nelfinavir, ritonavir, saquinavir), as well as dinucleotide inhibitors of reverse transcriptase (delavirdine, efavirenz, nevirapine), which are used in the treatment of HIV-1-positive patients. While the use of antiretrovirals and St. John's wort perforated there is a decrease in their actions with the possible appearance of resistance. Therefore, St. John's wort is not used concurrently with these medications.
Significant clinical interactions with St. John's wort have also been described with concomitant use of cyclosporine, digoxin and warfarin. The interaction can lead to decreased concentrations of drugs in blood plasma and, consequently, to reduction of therapeutic action. Therefore, St. John's wort cannot be used with cyclosporine. If the patient uses cyclosporine must stop taking St. John's wort and on the basis of determining the level of cyclosporine in the blood plasma to adjust the dosage of cyclosporine.
Concomitant use of St. John's wort with digoxin or warfarin is not recommended. If necessary, the appointment of St. John's wort, then you need to monitor the level of digoxin in the blood plasma or control protram new index during treatment with warfarin, the dose should be amended accordingly. When the dose of warfarin or digoxin increases the dose of St. John's wort do not change.
The perforated St. John's wort can significantly decrease the effect of theophylline, therefore concurrent use is not recommended. In the case where there is a need to take St. John's wort, you need control of cotton the level of theophylline in blood plasma and, if necessary, to adjust the dose of theophylline without changing the dose of St. John's wort.
Simultaneous use of oral contraceptives can cause menstrual disorders, bleeding, and reduced efficacy. Therefore, the simultaneous use of St. John's wort and oral contraceptives is not recommended.
Simultaneous treatment with amitriptyline is not recommended.
Effect on laboratory test results.
Guaifenesin can cause false-positive results of diagnostic tests, which identify 5-Garachico acid (photometric method using nitrosonaphthol as a reagent) and vanilmandelic acid in the urine. With this in mind, treatment with Novo-Passit should be discontinued 48 hours before urine collection for this analysis.
The expiration date.
A solution of 100 ml in a bottle 4 years. After first opening of 28 days.
The storage conditions.
Keep at temperature not exceeding 25 °C in the original packaging and out of reach of children place. Do not freeze.
100 ml solution in bottle of dark glass with measuring cap in a box along with instructions for medical use.