Instruction for use: Grippostad® Rino

Active substance: Xylometazoline

ATX Code R01AA07 Xylometazoline

Pharmacotherapeutic group:

Decongestant agent - vasoconstrictor (alpha-agonists) [alpha-agonists]

Decongestant agent - vasoconstrictor (alpha-agonists) [decongestant]

The nosological classification (ICD-10)

H65 purulent otitis media

Inflammation of the middle ear, Allergic otitis media

J00 Acute nasopharyngitis [runny nose]

Viral rhinitis, Inflammation of the nasopharynx, Inflammatory diseases of the nose, purulent rhinitis, Nasal congestion, Nasal congestion with colds and flu, The difficulty of nasal breathing, The difficulty of nasal breathing for colds, Difficulty in nasal breathing, Difficulty in nasal breathing in colds, nasal, hypersecretion, cold, ARI with rhinitis phenomena, coryza, Acute rhinitis of various origins, Acute rhinitis with thick purulent mucous exudate, Acute nasopharyngitis, Swelling of the mucosa of the nasopharynx, Rhinitis, rhinorrhea, Infectious-inflammatory diseases of ENT organs, heavy cold, rhinopharyngitis, nasopharyngitis

J01 Acute sinusitis

Inflammation of the sinuses, Inflammatory diseases of the paranasal sinuses, Purulent inflammation of the paranasal sinuses, Infectious-inflammatory diseases of ENT organs, Infection of the sinuses, Combined sinusitis, Exacerbation of sinusitis, Acute inflammation of the paranasal sinuses, Acute bacterial sinusitis, Acute sinusitis in adults, Subacute sinusitis, acute Sinusitis, sinusitis

J06 Acute upper respiratory infections of multiple and unspecified

Frequent colds viral diseases, Infections of the upper respiratory tract, Acute respiratory disease influenza character, for colds Pain, Acute colds, Cold, respiratory infection, Seasonal colds, Pain in infectious and inflammatory diseases of the upper respiratory tract, Bacterial infections of the upper respiratory tract, Bacterial respiratory infections, Viral disease of the respiratory tract, Viral respiratory tract infections, Inflammatory disease of the upper respiratory tract, Inflammation of the upper respiratory tract disease, Inflammation of the upper respiratory tract illness with difficult sputum, Inflammatory airway disease, Secondary infections with colds, Shortness of sputum in acute and chronic respiratory diseases, Upper respiratory tract infection , Infections of the upper respiratory tract, Respiratory Tract Infections, Infections of the respiratory tract and lungs, Infectious-inflammatory diseases of the upper respiratory tract, Infectious-inflammatory diseases of the upper respiratory tract and ENT-organs, Infectious-inflammatory diseases of the upper respiratory tract in children and adults, Infectious-inflammatory diseases of the upper respiratory tract, Infectious inflammation of the airways, respiratory infection, Qatar upper respiratory tract, Catarrh of the upper respiratory tract, Catarrhal disease of the upper respiratory tract, Catarrhal symptoms of the upper respiratory tract, Coughing with a cold, SARS, ARI, ARI with rhinitis phenomena, Acute respiratory infection, Acute infectious and inflammatory disease of the upper respiratory tract, Acute respiratory disease, Sore throat or nose, Respiratory viral infections, Respiratory diseases, Respiratory infections, Recurrent respiratory infections, Secondary infection with influenza, cold in the chest,Feverish condition with flu

J30 Vasomotor and allergic rhinitis

Allergic rinopatiya, Allergic rhinosinusopathy, Allergic respiratory diseases, Allergic rhinitis, nasal allergy, Seasonal Allergic Rhinitis, Vasomotor rhinitis, Long-allergic rhinitis, Perennial allergic rhinitis, Perennial allergic rhinitis, Year-round or seasonal allergic rhinitis, Year-round allergic rhinitis nature, Rhinitis allergic vasomotor, Exacerbation of pollen allergy in the form of Syndrome rinokonyunktivalnogo, Acute allergic rhinitis, Edema of the nasal mucosa, Edema of the nasal mucosa, Swelling of the mucosa of the nasal cavity, Swelling of the nasal mucosa, Swelling of the nasal mucosa, pollen disease, Permanent allergic rhinitis, rhinoconjunctivitis, rhinosinusitis,rhinosinusopathy, Seasonal allergic rhinitis, Seasonal Allergic Rhinitis, Haymarket rhinitis, Chronic allergic rhinitis, Allergic respiratory diseases

J999 * Diagnosis of Respiratory Diseases

bronchography, bronchoscopy, Diagnostic procedures in the nasal passages, Diagnostic Study of the bronchi, laryngoscopy, Preparing for rhinoscopy, Preparing the patient for bronchoscopy and / or bronhografii, Preparing the patient for bronchoscopy or bronhografii, Preparing the patient for diagnostic procedures in the nasal passages, Preparing the patient for diagnostic procedures in the area of the nasal passages, rhinoscopy, Visualization of the chest cavity, Chest X-ray, Mediastinoscopy

Composition

Grippostad C

The capsules 1 caps.

Paracetamol 200 mg

150 mg ascorbic acid

25 mg caffeine

chlorpheniramine maleate 2.5 mg

Excipients: lactose monohydrate; glyceryl tristearate; gelatin

the composition of the capsule shell:

housing - gelatin; water; titanium dioxide

cap - gelatin; quinoline yellow; water; yellow dye "sunset"; titanium dioxide

in blister 10 pcs .; In the paper cartons 1 or 2 blisters.

Grippostad® Reno

Spray for nasal application of 1 ml

Xylometazoline hydrochloride 1 mg

Other ingredients: benzalkonium chloride (50% solution); citric acid; sodium citrate; Glycerol (85% solution); Purified water - up to 1 ml

in vials with 10 ml of spray; In the paper cartons 1 bottle.

Nasal drops 1 ml

Xylometazoline hydrochloride 1 mg

Other ingredients: benzalkonium chloride (50% solution) - 0.4 mg; citric acid monohydrate - 0.5 mg; Sodium citrate dihydrate - 2.6 mg; 85% glycerine (glycerol) - 24 mg; Purified water - 975.5 mg

in vials of amber glass with lid fitted with a pipette, 10 ml; In the paper cartons 1 bottle.

Nasal drops for kids 1 ml

Xylometazoline hydrochloride 0.5 mg

Other ingredients: benzalkonium chloride (50% solution); citric acid monohydrate; sodium citrate dihydrate; 85% glycerin (glycerol); Purified water - up to 1 ml

in vials of amber glass with lid fitted with a pipette, 10 ml; In the paper cartons 1 bottle.

Grippostad®

Powder for solution for oral administration, 1 pack.

paracetamol 0.6 g

ascorbic acid 0.05 g

Excipients: ethyl cellulose; colloidal silicon dioxide (colloidal anhydrous silica); aspartame; citric acid (anhydrous citric acid); sucrose, lemon flavor

bag 5 g; In the paper cartons 5 bags.

Description

Grippostad®C

Opaque hard gelatine capsules size ą1, cap - yellow, body - white. The contents of capsules - powder from white to yellowish.

Grippostad® Reno

Spray, nasal drops and nasal drops for children: a clear, colorless to slightly colored solution, free from visible foreign particles, odorless.

Grippostad®

Homogeneous powder from white to yellowish in color with a characteristic smell of lemon.

Pharmachologic effect
Grippostad®C

Analgesic, antipyretic.

Grippostad® Reno

Decongestant (alpha2-adrenomimeticheskoe).

Grippostad®

Analgesic, antipyretic.

pharmacodynamics

Grippostad®C

Combined medication to relieve symptoms of colds.

Paracetamol has analgesic (painkiller) and antipyretic effect (influence on the thermoregulation center in the hypothalamus).

Ascorbic acid is involved in regulating the redox processes, carbohydrate metabolism, coagulation, regeneration (restoration) of tissues in the synthesis of steroid hormones; It increases the resistance to infections, vascular permeability decreases, and decreases the need for vitamins B1, B2, A, E, folic acid, pantothenic acid. Improves tolerability of paracetamol and extends its operation (elimination deceleration).

Caffeine has spasmolytic (relaxing) effect, dilates the bronchi, tones the brain, stimulates the heart, has a tonic effect.

Chlorpheniramine - antihistamine, has anti-allergic effect: reduces discharge and nasal congestion, watery eyes, sneezing.

The combination of drug components provides better tolerability symptoms of malaise and fever with influenza infections, and other respiratory diseases.

Grippostad® Reno

Xylometazoline - imidazoline derivatives, is an alpha2-agonists. It narrows the blood vessels of the nasal mucosa, thereby reducing the swelling and redness (redness) mucosa. Facilitates nasal breathing in rhinitis (runny nose). The action comes after 5-10 minutes and lasts up to 10 hours.

It does not interfere with the function of ciliated epithelium of the respiratory tract mucosa. Reactive hyperemia after treatment practically does not occur.

Grippostad®

Combined preparation.

Paracetamol has analgesic (painkiller) and antipyretic action.

Ascorbic acid is involved in regulating the redox processes, carbohydrate metabolism, coagulation, regeneration (restoration) of tissues in the synthesis of steroid hormones; It increases the body's resistance to infection, reduces vascular permeability, reduces the need for vitamins B1, B2, A, E, folic acid, pantothenic acid. Improves tolerability of paracetamol and extends its effect (slowing its elimination).

Pharmacokinetics

Grippostad® Reno

When applied topically practically not absorbed, the plasma concentrations are so small that they can not be determined by modern analytical methods.

Indications

Grippostad®C

Grippostad®

feverish syndrome in infectious and inflammatory diseases;

pain of moderate or low severity (headache, migraine, toothache, neuralgia, myalgia, arthralgia, tuberculosis (painful menstrual irregularities).

Grippostad® Reno

acute allergic rhinitis (a runny nose);

Acute respiratory infections with symptoms of rhinitis;

sinusitis (inflammation of the mucosa of the paranasal sinuses);

hay fever (allergic rhinitis caused by pollen);

otitis media (middle ear infection) - to reduce the swelling of the mucous membrane of the nasopharynx;

preparation of the patient for diagnostic procedures in the nasal passages.

Contraindications

With Grippostad®

Grippostad®

hypersensitivity to the drug;

gastrointestinal bleeding;

portal hypertension (increased blood pressure in the portal vein);

alcoholism;

expressed hepatic and / or renal failure;

pregnancy (I and III trimester);

breastfeeding;

children's age (15 years);

deficiency of glucose-6-phosphate dehydrogenase;

angle-closure glaucoma;

prostatic hypertrophy to form residual urine;

severe arrhythmias;

uncontrolled hypertension.

Carefully:

erosive and ulcerative lesions GIT (exacerbation);

liver and / or kidney failure;

congenital hyperbilirubinemia (diseases in which elevated bilirubin levels in the blood - Gilbert syndrome, Dubin-Johnson and Rotor).

Grippostad® Reno

hypersensitivity to the drug;

arterial hypertension;

tachycardia;

expressed atherosclerosis;

glaucoma;

atrophic rhinitis;

hyperthyroidism;

surgical intervention on meninges (in history);

pregnancy;

Children up to age 6 years.

Precautions:

diabetes;

pheochromocytoma;

Ischemic heart disease (angina);

prostatic hyperplasia;

hyperthyroidism;

during breastfeeding.

Pregnancy and breast-feeding

Grippostad®C

Grippostad®

Contraindicated in pregnancy (I and III trimester) and lactation.

Grippostad® Reno

Contraindicated during pregnancy.

Application Grippostad® Reno during lactation is possible only on prescription in cases where the expected benefit to the mother outweighs the potential risk of the child, because Studies confirming the safety of the drug for the child during breast-feeding, have been conducted.

Side effects of Grippostad Rino

Grippostad®C

At therapeutic doses, the drug is generally well tolerated. There may be allergic skin reactions (skin rash, pruritus, urticaria, angioedema); GI function disorders (nausea, epigastric pain, dry mouth); difficulty urinating.

Rarely - blood system disorders (anemia, leukopenia - low blood leukocytes, thrombocytopenia - low platelet count in the blood).

With prolonged use at high doses (. 12 more capsules daily for more than 5 days) - hepatotoxic effects, disorders of the blood system; erosive and ulcerative lesions gastrointestinal tract; renal toxicity (papillary necrosis).

Grippostad® Reno

Frequent (more than 4 times a day) and / or long-term use (more than 7 days) - irritation and / or dryness of the nasal mucosa, burning, stinging, sneezing, hypersecretion.

Grippostad®

Allergic reactions (skin rash, pruritus, urticaria, angioedema), nausea, pain in the epigastric region; anemia, thrombocytopenia (low platelet count in the blood), agranulocytosis (complete or almost complete disappearance of blood granulocytes).

With prolonged use at high doses - hepatotoxic and nephrotoxic effects; hemodyscrasia.

Interaction

Grippostad®C

Grippostad®

Stimulants microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, which determines the possibility of severe intoxication with small overdoses.

Inhibitors of microsomal oxidation (cimetidine) decrease the risk of hepatotoxic action of the drug.

Ethanol contributes to the development of acute pancreatitis.

Reduces the effectiveness of uricosuric drugs.

By reducing the rate of gastric emptying (propantheline) slows down the action of the drug, when accelerating (metoclopramide) - begins to act more quickly.

Increases toxicity of chloramphenicol.

It may increase the effects of anticoagulants

Grippostad® Reno

Incompatible with MAO inhibitors and tricyclic antidepressants.

Grippostad RinoDosage and Administration

Grippostad®C

Inside, squeezed small amounts of liquid, 2 caps. appointment. If necessary - again with the same dose of 3-4 hours 4-6 times a day. The maximum daily dose should not exceed 12 caps.

Grippostad® Reno

Intranasal.

Nasal Spray: adults and children older than 6 years - 1 injection from the sprayer or 2-3 drops in each nostril 3-4 times a day; should not be applied more than 4 times a day.

Nasal drops: adults and children older than 6 years - 2-3 drops of 0.1% solution in each nostril 3-4 times a day, should not be used more than 4 times a day.

Nasal drops for children: nursing and children under the age of 6 years - po1-2 drops 0.05% solution in each nostril 1 or 2 times a day; should not be applied more than 3 times a day.

Grippostad® Reno (all dosage forms) should not be used longer than 5-7 days, with the exception of prescribed physician. Repeated use of the drug is possible in a few days. Duration of therapy is determined by the physician.

Grippostad®

Inside.

paracetamol dose depends on the age and body weight, generally 10-15 mg / kg of body weight once, the maximum daily dose - 60 mg / kg body weight. A single dose (1 pack.) Equivalent to 600 mg of paracetamol.

The drug can be repeated in 6-8 hours, ie, 3-4 pack. per day. The interval between each dose should be at least 6 hours. Do not exceed a single dose of the drug.

If at the same time the patient is taking other medications paratsetamolsoderzhaschie, that should not be exceeded the maximum permissible daily dose of paracetamol (see. Table).

Patients with liver or kidney disease and Gilbert syndrome: dosage should be reduced or increased the interval between doses.

Patients with severe renal insufficiency: in these cases (Cl creatinine <10 ml / min) the interval between doses should be at least 8 hours.

Elderly patients: No special dose adjustment.

Preparation of the solution

Content 1 pack. should be poured into a cup, pour the required amount of hot water, stir and drink immediately received a warm drink.

Application after a meal may delay onset of action of the drug.

Duration of application

The drug should not be used for more than 3 days without a doctor's recommendation. It is necessary to consult a doctor if symptoms persist for more than 3 days.

Overdose

Grippostad®C

Grippostad®

Symptoms (due to paracetamol): pale skin, loss of appetite, nausea, vomiting; gepatonekroz (necrosis severity, due to intoxication, directly depends on the extent of overdose). Toxic effects in adults may, after receiving more than 10-15 g of paracetamol.

Treatment: An Introduction donators of SH-groups and precursors of glutathione, methionine - in 8-9 hours after the overdose and N-acetylcysteine - 12 hours.

The need for additional therapeutic activities (further introduction of methionine / in administering N-acetyl cysteine) is determined depending on the concentration of acetaminophen in the blood, and the time elapsed after administration.

Grippostad® Reno

With the proper use of the drug overdose of the drug can not be, because drug for topical application is practically not absorbed. However, when exceeding the recommended dose or several times if accidentally swallowed increased side effects observed.

special instructions

Grippostad®C

Grippostad®

When hyperthermia, continuing more than 3 days, and the duration of pain more than 5 days require a doctor's consultation.

Ascorbic acid, which is part of Grippostad® C and Grippostad® distorts the results of the laboratory tests that assess the concentration of glucose and uric acid in plasma.

Do not simultaneously use other drugs containing acetaminophen, as well as other non-narcotic analgesics and NSAIDs (metamizole sodium, acetylsalicylic acid, ibuprofen, etc.), and barbiturates, antiepileptic drugs, rifampicin, chloramphenicol. The simultaneous use of other drugs should be agreed with your doctor.

With long-term (more than 5 days) use of the drug is necessary to monitor patterns of peripheral blood and functional state of the liver.

Persons addicted to alcohol, should be before the start of drug treatment to consult a doctor because paracetamol may have a damaging effect on the liver.

Grippostad® Reno

Before use, clean the nasal passages.

Do not use for a long time (more than 7 days) (eg in chronic rhinitis).

Storage conditions of Grippostad Rino

In a dry, dark place, at a temperature no higher than 25 ° C.

Keep out of the reach of children.
Shelf life of Grippostad Rino

powder for oral solution 600 mg + 50 mg to 600 mg + 50 - 4 years.

Capsules - 5 years.

nasal drops for children 0.05% - 4 years.

nasal drops 0.1% - 4 years.

nasal spray 0.1% - 4 years.

Do not use beyond the expiration date printed on the package.