Rinochenylen - instructions for use, dose, side effects, contraindications

Excipients: Polysorbate 20 - 1,000 mg, microcrystalline cellulose and carmellose sodium 8,000 mg, benzalkonium chloride 0.270 mg, phenylethanol 2.550 mg, dextrose monohydrate 51.00 mg, water up to 1 ml.

Description:White, opalescent, homogeneous or slightly sedimented suspension, shattered by shaking.

Pharmacotherapeutic group:Glucocorticosteroid for topical application.

ATX: & nbsp

R.01.A.D.01 Beclomethasone

Pharmacodynamics:

Beclomethasone is a synthetic glucocorticosteroid for topical application, which has anti-inflammatory and antiallergic effect.

Reduces the formation of the chemotaxis substance, inhibits the development of an "immediate" allergic reaction (due to inhibition of the production of arachidonic acid metabolites and a decrease in the release of inflammatory mediators from mast cells) and improves mucociliary transport. Under the influence of beclomethasone, the number of mast cells in the mucous membrane of the nasal cavity and paranasal sinuses decreases, edema decreases, mucus secretion, neutrophil marginal accumulation, inflammatory exudate and production cytokines, the migration of macrophages is inhibited, the intensity of the processes of infiltration and granulation decreases.

Does not have mineralocorticoid activity.The therapeutic effect develops gradually, which requires the use of the drug for several days.

Pharmacokinetics:

When administered intranasally at recommended doses, Rinoclinil does not have systemic activity. Quickly absorbed in the mucous membrane of the nose. Part of the dose, which is unintentionally swallowed, is inactivated by the "first pass" through the liver. In the liver, the process of conversion of beclomethasone dipropionate into beclomethasone monopropionate and then - into polar metabolites. The binding with plasma proteins of the active substance in the systemic circulation is 87 %. The main part of the preparation (35-76%) is excreted within 96 hours through the intestine, mainly in the form of polar metabolites, 10-15% - by the kidneys.

Indications:

Prophylaxis and treatment of seasonal and all-year-round allergic rhinitis, vasomotor rhinitis.

Contraindications:

Hypersensitivity to the active substance and / or excipients of the drug, tuberculosis and viral infections, children under 6 years of age.

Carefully:

Pregnancy, lactation, systemic and local infections (fungal, bacterial), herpes of the eye, glaucoma,ulceration of the nasal septum, recent surgical interventions in the nasal cavity.

Pregnancy and lactation:

Use during pregnancy is allowed only if the expected benefit to the mother exceeds the potential risk to the fetus.

At recommended doses, the drug is not likely to enter the mother's milk. However, the use of the drug Rinoclinil in the period of breastfeeding is allowed only if the expected benefit for the mother exceeds the potential risk for the child.

Dosing and Administration:

Intranasally.

Adults and children over 6 years of age: 2 doses (200 mcg) in each nasal passage 1 time per day.

Children, if necessary, can use 1 dose (100 mcg) in each nasal passage 2 times a day.

The maximum daily dose is 400 mcg.

Directions for proper use

Shake the bottle before each use.

Before using, remove the protective cap, safety ring and spray several times in the air until the aerosol appears.

When applying

1. Thoroughly clean the nasal passages.

2. Remove the protective cap.

3. Remove the safety ring.

4. Spray into the air until the aerosol appears.

5. Place the tip of the dispenser in the nasal cavity as shown. Pinch the other nasal hole with your finger, inhale, while pressing the dispenser. Repeat the procedure with another nasal passage.

6. Place the safety ring and protective cap in place.

Side effects:

When used in therapeutic doses, side effects are rare, among them: change in taste and smell, allergic reactions (rash, urticaria, angioedema), rhinorrhea, conjunctival hyperemia, cough, sneezing, irritation, nose burning, dry nose, nosebleeds , headache, atrophy of the nasal mucosa. It is extremely rare - perforation of the nasal septum and increased intraocular pressure. When developing infections caused by a fungal microflora, appropriate treatment should be prescribed.

Overdose:

With a single application of high doses of beclomethasone, suppression of the function of the hypothalamic-pituitary-adrenal system is possible. In this case, the dose should be reduced to the recommended dose.

Interaction:At present no interactions with other drugs have been identified.

Special instructions:

The use of the drug Rinoclinil for a long time, can in exceptional cases lead to the development of classical systemic effects typical for this drug. In this case, it is necessary to suspend treatment and prescribe appropriate therapy.

There is a risk of worsening of the function of the adrenal glands with the use of the drug Rinoclinil in patients after prolonged treatment with systemic glucocorticosteroids. In children receiving long-term treatment with glucocorticosteroids intranasally, regular growth control is indicated.

It should be noted that in some cases, in the treatment of allergic rhinitis may require additional therapy to eliminate eye symptoms.

To the attention of athletes: the use of the drug for other purposes, other than therapeutic, is regarded as doping; even when used in therapeutic doses, it can cause a doping effect and give a positive response in a doping test.

Effect on the ability to drive transp. cf. and fur:

Usually the drug does not affect the ability to drive vehicles or engage in other potentially hazardous activities.

However, in case of such side effects such as angioedema, coughing, sneezing, nosebleeds, increased intraocular pressure, from practicing potentially dangerous activities, it is necessary to abstain until the termination of these adverse reactions.

Form release / dosage:

Spray nasal dosed with 100 mcg / dose.

Packaging:For 120 or 200 doses of the preparation in a 35 ml plastic bottle with a dispensing sprayer, closed with a protective cap and a safety ring. One bottle with the instruction is placed in a cardboard box.

Storage conditions:

3 years.

Do not use after the date shown on the package.

After the first autopsy, use within 3 months.

Shelf life:

At a temperature of no higher than 25 ° C. Do not freeze.

Keep out of the reach of children.

Terms of leave from pharmacies:On prescription

Registration number:LS-002467

Date of registration:29.12.2011

The owner of the registration certificate:Kiesi Pharmaceuticals SpAKiesi Pharmaceuticals SpA Italy

Manufacturer: & nbsp

CHIESI FARMACEUTICI, S.p.A. Italy

Representation: & nbspKEZI KEZI Italy

Information update date: & nbsp29.12.2011

Illustrated instructions

Instructions

Rinochenenyl (Rinoclenil)