Avamys

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT AVAMIS (AVAMYS)

Composition:

Active substance: fluticasone furoate;

1 dose of the preparation contains fluticasone furoate 27.5 mcg;

Excipients: anhydrous glucose, microcrystalline cellulose, polysorbate 80, benzalkonium chloride solution, disodium edetate, purified water.

Pharmaceutical form. Nasal spray, suspension, metered.

Main physicochemical characteristics: white, homogeneous suspension of fluticasone furoate.

Pharmacotherapeutic group. Anti-inflammatory and other drugs for local use in diseases of the nasal cavity. Corticosteroids. ATC code R01AD12.

Pharmacological properties.

Pharmacodynamics.

Fluticasone furoate is a synthetic fluorinated corticosteroid with a very high affinity for glucocorticoid receptors and strong anti-inflammatory activity.

Pharmacokinetics.

Fluticasone furoate undergoes extensive first-pass metabolism and incomplete absorption in the liver and intestine, resulting in minimal systemic exposure to the drug. Following intranasal administration of 110 μg once daily, plasma concentrations of the drug are typically below the limit of quantification (< 10 pg/mL). The absolute bioavailability of fluticasone furoate following administration of 880 μg three times daily (total daily dose – 2640 μg) is 0.5%.

The plasma protein binding of fluticasone furoate exceeds 99%. The drug is widely distributed, with a mean volume of distribution of 608 L.

Fluticasone furoate is rapidly cleared (total plasma clearance – 58 L/h) from systemic circulation, primarily via hepatic metabolism mediated by the CYP3A4 isoenzyme of cytochrome P450 to an inactive 17β-carboxylic acid metabolite (GW694301X). The primary metabolic pathway involves hydrolysis of the S-fluoromethyl carbamothioate to form the 17β-carboxylic acid metabolite. Following oral and intravenous administration, the drug and its metabolites are excreted predominantly in feces, with evidence of biliary excretion of fluticasone furoate and its metabolites. After intravenous administration, the elimination half-life is 15.1 hours. Renal excretion accounts for approximately 1% and 2% of the dose following oral and intravenous administration, respectively.

Clinical characteristics.

Indications.

Symptomatic treatment of allergic rhinitis.

Contraindications.

Hypersensitivity to any component of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Fluticasone furoate is rapidly eliminated via extensive first-pass metabolism in the liver by cytochrome P450 3A4.

Based on findings from the use of another glucocorticoid, fluticasone propionate, which is also metabolized by CYP3A4, concomitant use with ritonavir is not recommended due to increased systemic exposure to fluticasone furoate.

Fluticasone furoate should be used with caution in combination with strong CYP3A4 inhibitors, including products containing cobicistat, due to an increased risk of systemic adverse reactions. Such combinations should be avoided unless the expected benefit outweighs the potential increased risk of systemic corticosteroid side effects. In such cases, patients should be monitored for the development of systemic adverse effects.

In a clinical drug interaction study of fluticasone furoate with the strong CYP3A4 inhibitor ketoconazole, a higher number of subjects had measurable plasma concentrations of fluticasone furoate in the group receiving ketoconazole (6 out of 20) compared to the placebo group (1 out of 20). This minor increase in systemic exposure did not result in a statistically significant difference in 24-hour serum cortisol levels between the two groups.

Data from enzyme induction and inhibition studies suggest that there is no reason to expect metabolic interactions between fluticasone furoate and other mediators of cytochrome P450 metabolism at the intranasal doses used clinically. Therefore, clinical studies on the interaction of fluticasone furoate with other medicinal products have not been conducted.

Special precautions for use.

Systemic effects may occur with the use of intranasal corticosteroids, particularly when high doses are used over prolonged periods. The likelihood of such effects is lower than with oral corticosteroids and varies depending on the specific corticosteroid and individual patient response. Potential systemic effects may include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma, and, less frequently, a range of psychological or behavioral effects, including psychomotor hyperactivity, sleep disturbances, restlessness, depression, or aggression (particularly in children).

Use of intranasal corticosteroids at doses higher than recommended may lead to clinically significant adrenal suppression. During periods of stress or elective surgery, consideration should be given to the need for additional systemic steroid therapy if there is evidence of use of intranasal corticosteroids at doses exceeding the recommended levels. Administration of fluticasone furoate at a dose of 110 mcg daily has not been associated with suppression of the hypothalamic-pituitary-adrenal (HPA) axis in adults or children. However, the dose of intranasal fluticasone furoate should be reduced to the lowest effective dose that maintains control of allergic rhinitis symptoms. As with other intranasal corticosteroids, when concomitant steroid therapy in any form is used, the total systemic steroid exposure should be taken into account.

Patients showing any signs of adrenal insufficiency should be switched from systemic corticosteroid therapy to intranasal fluticasone furoate with caution.

Visual disturbances

Visual disturbances may occur with both systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, they should be referred to an ophthalmologist for evaluation of possible underlying causes, which may include cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, which has been reported following the use of both systemic and topical corticosteroids.

Growth retardation has been observed in children treated with intranasal corticosteroids at recommended doses. In children treated with fluticasone furoate at a dose of 110 mcg daily over one year (see section "Adverse reactions"), a reduction in growth velocity was observed. Therefore, children should be treated with the lowest effective dose required to maintain adequate symptom control (see section "Dosage and administration"). Regular monitoring of growth in children receiving long-term treatment with intranasal corticosteroids is recommended. If a child's growth is slowed, therapy should be re-evaluated with the aim of reducing the dose, if possible, to the lowest effective dose needed to control disease symptoms. Referral of the patient to a paediatrician should also be considered.

Concomitant use of the drug with ritonavir is not recommended due to an increased risk of systemic effects of fluticasone furoate.

Use during pregnancy or breastfeeding.

Pregnancy

There is insufficient data on the use of the drug during pregnancy. In animal studies, glucocorticoids have been shown to cause fetal malformations, including cleft palate and intrauterine growth retardation. It is unlikely that these effects are relevant to humans when recommended doses are used, resulting in minimal systemic exposure. Fluticasone furoate should be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus or child.

Breastfeeding

It is unknown whether fluticasone furoate is excreted in human milk following intranasal administration. Fluticasone furoate should be used during breastfeeding only if the expected benefit to the mother outweighs the potential risk to the fetus/child.

Fertility

There are no data on the effect on human fertility.

Ability to affect reaction speed when driving or operating machinery.

Avamys has no effect or has a negligible effect on the ability to drive and use machinery.

Method of Administration and Dosage

Avamis is intended for intranasal use only.

Adults and children aged 12 years and older: The recommended initial dose is 2 sprays (27.5 mcg per spray) in each nostril once daily (total daily dose – 110 mcg).

After achieving control of rhinitis symptoms, the maintenance dose may be reduced to 1 spray in each nostril once daily (total daily dose – 55 mcg).

Children aged 6 to 11 years: The recommended initial dose is 1 spray in each nostrid once daily (total daily dose – 55 mcg).

If symptoms of rhinitis are not adequately controlled with 1 spray in each nostril once daily (total daily dose – 55 mcg), the dose may be increased to 2 sprays in each nostril once daily (total daily dose – 110 mcg).

After achieving control of rhinitis symptoms, the dose should be reduced to 1 spray in each nostril once daily (total daily dose – 55 mcg).

Elderly patients: The same dosage as for adults should be used.

Renal impairment: Dose adjustment is not required.

Hepatic impairment: Dose adjustment is not required.

To achieve full therapeutic effect, the medication must be used regularly. Onset of action occurs within 8 hours after the first dose, but maximum therapeutic effect is achieved after several days of treatment. Therefore, patients should be informed that benefits will be observed with regular use of the medication. The duration of treatment should be limited to the allergen exposure period.

Administration

Instructions for Using the Nasal Spray

The nasal metered spray (see figure below) consists of a glass bottle placed inside a plastic housing with a protective cap covering the spray nozzle (a special device at the top of the spray). Small openings are located at the lower part of the housing, through which the presence of the medication in the glass bottle can be observed. You will be able to see the liquid level in the 30-dose bottle, but not in the 120-dose bottle, as the liquid level in the latter is above the opening.

On one side of the plastic housing there is a large dosing button, pressing which releases the medication through the spray nozzle.

Six Important Facts About the Spray You Need to Know

• Avamis is supplied in a dark glass bottle. To check the remaining amount of spray in the bottle, hold the bottle vertically against a bright light. This will allow you to see the liquid level through the opening.

• If the bottle is being used for the first time, shake it well for 10 seconds without removing the cap. This is important because Avamis is a thick suspension that becomes more fluid upon shaking—see figure b. Administration is possible only after the suspension becomes fluid.

• To administer a spray, press the dosing button firmly—see figure c.

• If it is difficult to press the button with one finger, you may use the thumbs of both hands—see figure d.

• Always keep the nasal spray bottle capped when not in use. This helps prevent dust from entering, maintains pressure, and prevents clogging of the spray nozzle. When the cap is in place, the spray button cannot be accidentally pressed.
• Do not attempt to clean the nozzle opening with a needle or other sharp objects. This may damage the device.

Preparation for Use

You must prepare the nasal spray bottle:

• before first use;
• if the cap has been removed for more than 5 days;
• if the nasal spray device has not been used for 30 or more days.

Proper preparation ensures delivery of the correct dose. Follow these steps:

1. Without removing the cap, shake the bottle well for 10 seconds.
2. Remove the cap by firmly squeezing its sides with your thumb and index finger—see figure e.
3. Hold the nasal spray bottle vertically, then tilt and turn the spray nozzle away from yourself.
4. Press the button firmly. Perform at least 6 actuations until a fine mist is released into the air—see figure f.

**

**

The nasal spray is now ready for use.

Using the Nasal Spray

1. Shake the nasal spray bottle vigorously.
2. Remove the cap.
3. Clear your nasal passages, then slightly tilt your head forward.
4. Insert the spray nozzle into one nostril—see figure g. Direct the tip of the nozzle toward the outer wall of the nose, not toward the nasal septum. This ensures proper delivery of the medication.
5. Press the button firmly all the way down while inhaling through the nose—see figure h.

6. Remove the nozzle from the nostril and breathe out through the mouth.
7. If your doctor has instructed you to administer 2 sprays into each nostril, repeat steps 4–6.
8. Repeat steps 4–7 for the second nostril.
9. Replace the cap on the bottle.

Care of the Spray Nozzle

After each use:

1. Wipe the spray nozzle and the inside of the cap with a clean, dry cloth—see figures i and j.

2. Do not use water to clean the nozzle.
3. Do not attempt to clean the nozzle opening with a needle or other sharp objects.
4. Always replace the cap immediately after use.

If your spray nozzle does not work:

• Check the medication level in the bottle by looking through the opening. If the level is very low, there may not be enough liquid for the spray to function.
• Check the device for damage.
• If you suspect the nozzle is clogged, do not use a needle or any other sharp object to clean it.
• Try to reactivate the device by repeating the steps in the section "Preparation for Use".
• If the spray nozzle still does not work or emits a stream instead of a mist, contact your pharmacy or GlaxoSmithKline Pharmaceuticals Ukraine at (044) 585-51-85 or +38 (050) 381-43-49, or email [email protected] for assistance.

Avoid spraying into the eyes. If contact occurs, rinse eyes with water.

Children. Avamis is not recommended for children under 6 years of age, as the efficacy and safety of this medicinal product have not been established in this age group.

Overdose

Clinical studies have shown that intranasal administration of up to 2640 mcg per day for more than 3 days was not associated with adverse effects. Acute overdose is unlikely to require any treatment other than medical observation.

Adverse reactions.

Adverse reactions are categorized by frequency as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), frequency not known (cannot be estimated from available data).

Respiratory system.

Very common: epistaxis (nosebleeds).

Common: nasal ulceration.

Epistaxis was usually mild or moderate in severity. In adults and adolescents, epistaxis occurred more frequently with long-term use (more than 6 weeks) compared to use for up to 6 weeks. In pediatric clinical trials lasting up to 12 weeks, the incidence of epistaxis was similar in the fluticasone furoate-treated group and the placebo group.

Uncommon: nasal pain, discomfort (including burning, irritation, nasal tenderness), nasal dryness.

Very rare: nasal septum perforation.

Immune system.

Rare: hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria.

Nervous system.

Common: headache.

Eye organs.

Frequency not known: transient visual disturbances, blurred vision.

Children.

Musculoskeletal and connective tissue disorders.

Frequency not known: growth retardation.

In a one-year clinical study assessing growth in prepubescent children receiving 110 mcg of fluticasone furoate once daily, a difference in growth rate of -0.27 cm per year was observed compared to the placebo group.

Systemic effects.

Systemic effects may occur, especially with prolonged use of high doses (see section "Special precautions for use"). Cases of growth retardation have been reported in children treated with intranasal corticosteroids.

Shelf life. 3 years. After first opening – 2 months.

Storage conditions.

Store at temperatures not exceeding 30 ºC. Do not store in a refrigerator. Do not freeze. Keep out of reach and sight of children.

Packaging. Amber glass bottles with a metering device, spray pump, and cap. Each bottle contains 120 doses.

Prescription status. Prescription only.

Manufacturer.

Glaxo Operations UK Limited, United Kingdom.

Manufacturer's address and place of business.

Harmire Road, Barnard Castle, DL12 8DT, United Kingdom.

INSTRUCTIONS

for medical use of the medicinal product

AVAMYS

(AVAMYS)

Composition:

Active substance: fluticasone furoate;

1 dose of the medicinal product contains fluticasone furoate 27.5 mcg;

Excipients: anhydrous glucose, dispersed cellulose, polysorbate 80, benzalkonium chloride solution, disodium edetate, purified water.

Pharmaceutical form. Nasal spray, suspension, metered.

Main physicochemical properties: white, homogeneous suspension of fluticasone furoate.

Pharmacotherapeutic group. Anti-inflammatory and other drugs for topical use in nasal cavity disorders. Corticosteroids. ATC code R01AD12.

Pharmacological properties.

Pharmacodynamics.

Fluticasone furoate is a synthetic fluorinated corticosteroid with a very high affinity for glucocorticoid receptors and potent anti-inflammatory activity.

Pharmacokinetics.

Fluticasone furoate undergoes extensive first-pass metabolism and incomplete absorption in the liver and intestine, resulting in minimal systemic exposure. Following intranasal administration of 110 μg once daily, plasma concentrations are typically below the limit of quantification (< 10 pg/mL). The absolute bioavailability of fluticasone furoate following administration of 880 μg three times daily (total daily dose – 2640 μg) is 0.5%.

The plasma protein binding of fluticasone furoate exceeds 99%. The drug is widely distributed, with a mean volume of distribution of 608 L.

Fluticasone furoate is rapidly cleared (total plasma clearance – 58 L/h) from systemic circulation, primarily via hepatic metabolism mediated by the CYP3A4 isoenzyme of the cytochrome P450 system, forming an inactive 17β-carboxylic acid metabolite (GW694301X). The primary metabolic pathway is hydrolysis of the S-fluoromethyl carborthioate to form the 17β-carboxylic acid metabolite. Following oral and intravenous administration, the drug and its metabolites are excreted predominantly in feces, with evidence of biliary excretion of fluticasone furoate and its metabolites. After intravenous administration, the elimination half-life is 15.1 hours. Renal excretion accounts for approximately 1% and 2% of the dose following oral and intravenous administration, respectively.

Clinical characteristics.

Indications.

Symptomatic treatment of allergic rhinitis.

Contraindications.

Hypersensitivity to any component of the medicinal product.

Interaction with other medicinal products and other forms of interactions.

Fluticasone furoate is rapidly eliminated through extensive first-pass metabolism in the liver via cytochrome P450 3A4 (CYP3A4).

Based on findings with another glucocorticoid, fluticasone propionate, which is also metabolized by CYP3A4, concomitant use with ritonavir is not recommended due to increased systemic exposure to fluticasone furoate.

Fluticasone furoate should be used with caution in combination with strong CYP3A4 inhibitors, including products containing cobicistat, due to an increased risk of systemic adverse reactions. Such combinations should be avoided unless the expected benefit outweighs the potential increased risk of systemic corticosteroid side effects. In such cases, patients should be monitored for the development of systemic adverse effects.

In a clinical drug interaction study of fluticasone furoate with the strong CYP3A4 inhibitor ketoconazole, a greater number of subjects had measurable plasma concentrations of fluticasone furoate in the ketoconazole group (6 out of 20) compared to the placebo group (1 out of 20). This minor increase in systemic exposure did not result in a statistically significant difference in 24-hour serum cortisol levels between the two groups.

Data from enzyme induction and inhibition studies suggest that there is no reason to expect metabolic interactions between fluticasone furoate and other mediators of cytochrome P450 metabolism at the intranasal doses used clinically. Therefore, clinical studies investigating interactions between fluticasone furoate and other medicinal products have not been conducted.

Special precautions for use

Systemic effects may occur with the use of intranasal corticosteroids, particularly when high doses are used over prolonged periods. The likelihood of such effects is lower than with oral corticosteroids and varies depending on the specific corticosteroid and individual patient response. Potential systemic effects may include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma, and, less frequently, various psychological or behavioural effects, including psychomotor hyperactivity, sleep disturbances, restlessness, depression, or aggression (particularly in children).

Using intranasal corticosteroids at doses higher than recommended may lead to clinically significant adrenal suppression. During periods of stress or elective surgery, consideration should be given to the need for additional systemic steroid therapy if there is evidence of use of intranasal corticosteroids at doses exceeding the recommended levels. Administration of fluticasone furoate at a dose of 110 μg daily has not been associated with suppression of the hypothalamic-pituitary-adrenal (HPA) axis in adults or children. However, the dose of intranasal fluticasone furoate should be reduced to the lowest effective dose that maintains control of allergic rhinitis symptoms. As with other intranasal corticosteroids, the total systemic impact should be considered when any other forms of steroid therapy are used concomitantly.

Patients showing any signs of adrenal function suppression should be switched from systemic corticosteroid therapy to intranasal fluticasone furoate with caution.

Visual disturbances

Visual disturbances may occur with both systemic and local use of corticosteroids. If a patient develops symptoms such as blurred vision or other visual disturbances, they should be referred to an ophthalmologist to evaluate possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, which has been reported following the use of both systemic and topical corticosteroids.

Cases of growth retardation have been observed in children treated with intranasal corticosteroids at recommended doses. Growth retardation has been observed in children treated with fluticasone furoate at a dose of 110 μg daily over one year (see section "Adverse reactions"). Therefore, children should be treated with the lowest effective dose required to maintain adequate symptom control (see section "Dosage and administration"). Regular monitoring of growth in children receiving long-term treatment with intranasal corticosteroids is recommended. If a child's growth slows, therapy should be reviewed with the aim of reducing the dose, if possible, to the lowest effective dose controlling disease symptoms. Referral of the patient to a paediatrician should also be considered.

Concomitant use of this medicinal product with ritonavir is not recommended due to an increased risk of systemic effects of fluticasone furoate.

Use during pregnancy or breastfeeding

Pregnancy

There are insufficient data on the use of this medicinal product during pregnancy. Animal studies have shown that glucocorticoids can cause malformations, including cleft palate and intrauterine growth retardation. These effects are unlikely to be relevant in humans when recommended doses are used, resulting in minimal systemic exposure. Fluticasone furoate should be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to the foetus or child.

Breastfeeding

It is unknown whether fluticasone furoate passes into breast milk following intranasal administration. Fluticasone furoate should be used during breastfeeding only if the expected benefit to the mother outweighs the potential risk to the foetus/child.

Fertility

There are no data on the effect on human fertility.

Ability to affect reaction speed while driving or operating machinery

Avamys has no effect or has a negligible effect on the ability to drive and use machinery.

Administration and Dosage

Avamis should be used only for intranasal administration.

Adults and children aged 12 years and older: The recommended initial dose is 2 sprays (27.5 mcg per spray) in each nostril once daily (total daily dose – 110 mcg).

After achieving control of rhinitis symptoms, the maintenance dose may be reduced to 1 spray in each nostril once daily (total daily dose – 55 mcg).

Children aged 6 to 11 years: The recommended initial dose is 1 spray in each nostrine once daily (total daily dose – 55 mcg).

If symptoms of rhinitis are not adequately controlled with 1 spray in each nostril once daily (total daily dose – 55 mcg), the dose may be increased to 2 sprays in each nostril once daily (total daily dose – 110 mcg).

After achieving control of rhinitis symptoms, the dose should be reduced to 1 spray in each nostril once daily (total daily dose – 55 mcg).

Elderly patients: The same doses as for adults should be used.

Renal impairment: Dose adjustment is not required.

Hepatic impairment: Dose adjustment is not required.

To achieve full therapeutic effect, the medication must be used regularly. Onset of action occurs within 8 hours after the first dose, but maximum therapeutic effect is achieved after several days of treatment. Therefore, patients should be informed that treatment benefits will be observed with regular use of the medication. The duration of treatment should be limited to the period of allergen exposure.

Administration

Instructions for Use of Nasal Spray

The nasal metered spray (see figure below) consists of a glass bottle placed in a plastic housing with a protective cap covering the spray nozzle (a special device at the top of the spray). Small openings in the lower part of the housing allow visualization of the medication level in the glass bottle. The liquid level can be seen in a 30-dose bottle, but not in a 120-dose bottle, as the liquid level in the latter is above the openings.

On one side of the plastic housing there is a large dosing button, pressing which releases the medication through the spray nozzle.

Six Important Facts About the Spray You Need to Know

• Avamis comes in a dark glass bottle. To check the remaining amount of spray in the bottle, hold the bottle vertically against a bright light. This will allow you to see the liquid level through the opening.

• If the medication bottle is being used for the first time, shake the bottle well for 10 seconds without removing the cap. This is important because Avamis is a thick suspension that becomes more fluid upon shaking—see figure b. The spray should only be used after the suspension has become fluid.

• To administer a spray, press the dosing button firmly—see figure c.

• If you have difficulty pressing the button with one thumb, you may use both thumbs—see figure d.

• Always keep the nasal spray bottle capped when not in use. This helps prevent dust contamination, maintains pressure, and prevents clogging of the spray nozzle. When the cap is in place, the spray button cannot be accidentally pressed.
• Do not attempt to clean the nozzle opening with a needle or other sharp objects. This may damage the device.

Preparation for Use

You must prepare the nasal spray bottle:

• before first use;
• if the cap has been removed for more than 5 days;
• if the nasal spray device has not been used for 30 days or more.

Proper preparation ensures that the correct dose of medication is delivered. Follow these steps:

1. Without removing the cap, shake the bottle well for 10 seconds.
2. Remove the cap by firmly squeezing its sides with your thumb and index finger—see figure e.
3. Hold the nasal spray bottle vertically, then tilt and turn the spray nozzle away from yourself.
4. Press the button firmly. Perform at least 6 actuations until a fine mist is released into the air—see figure f.

**

**

The nasal spray is now ready for use.

Using the Nasal Spray

1. Shake the nasal spray bottle vigorously.

2. Remove the cap.

3. Clear your nasal passages, then slightly tilt your head forward.

4. Insert the spray nozzle into one nostril—see figure g. Direct the tip of the nozzle toward the outer wall of the nose, not toward the nasal septum. This ensures proper delivery of the medication.

5. Press the button firmly all the way down while inhaling through your nose—see figure h.

1. Remove the spray nozzle from the nostril and exhale through your mouth.
2. If your doctor has instructed you to use 2 sprays in each nostril, repeat steps 4–6.
3. Repeat steps 4–7 for the other nostril.
4. Replace the cap on the bottle.

Care of the Spray Nozzle

After each use:

1. Wipe the spray nozzle and the inside of the cap with a clean, dry tissue—see figures i and j.

1. 2. Do not use water to clean the nozzle.
2. 3. Never attempt to clean the nozzle opening with a needle or other sharp objects.
3. Always replace the cap on the bottle immediately after use.

If your spray device is not working:

• Check the medication level in the bottle by looking through the opening. If the level is very low, there may not be enough medication left for the spray to function.
• Check the device for damage.
• If you suspect the spray nozzle is clogged, do not use a needle or any other sharp object to clean it.
• Try to reactivate the device by repeating the steps in the section "Preparation for Use".
• If the spray still does not work or emits a stream of liquid instead of a mist, contact your pharmacy or GlaxoSmithKline Pharmaceuticals Ukraine Ltd. at (044) 585-51-85 or +38 (050) 381-43-49, or email [email protected] for assistance.

Avoid spraying into the eyes. If contact occurs, rinse eyes with water.

Children. Avamis is not recommended for children under 6 years of age, as the efficacy and safety of the medication in this age group have not been established.

Overdose

Clinical studies have shown no adverse effects following intranasal administration of up to 2640 mcg per day for more than 3 days. In the event of acute overdose, treatment beyond medical observation is unlikely to be necessary.

Adverse Reactions

Adverse reactions are categorized by frequency as follows: very common (≥ 1/10), common (≥ 1/100 and < 1/10), uncommon (≥ 1/1,000 and < 1/100), rare (≥ 1/10,000 and < 1/1,000), very rare (< 1/10,000), frequency not known (cannot be estimated from available data).

Respiratory system

Very common: nasal epistaxis.

Common: development of nasal ulcers.

Nasal epistaxis was usually mild or moderate in severity. In adults and adolescents, nasal epistaxis occurred more frequently with long-term use (more than 6 weeks) than with use up to 6 weeks. In pediatric clinical trials lasting up to 12 weeks, the incidence of nasal epistaxis was similar in the group treated with fluticasone furoate and in the placebo group.

Uncommon: nasal pain, discomfort (including burning, irritation, tenderness in the nose), nasal dryness.

Very rare: nasal septal perforation.

Immune system

Rare: hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria.

Nervous system

Common: headache.

Eye organs

Frequency not known: transient visual disturbances, blurred vision.

Children

Musculoskeletal and connective tissue disorders

Frequency not known: growth retardation.

Data from a one-year clinical study assessing growth in prepubertal children receiving 110 mcg of fluticasone furoate once daily showed a difference in growth velocity of -0.27 cm per year compared to the placebo group.

Systemic effects

Systemic effects may occur, particularly with prolonged use of high doses (see section "Special precautions for use"). Cases of growth retardation have been reported in children treated with intranasal corticosteroids.

Shelf life. 3 years. After first opening – 2 months.

Storage conditions.

Store at temperatures not exceeding 30 °C. Do not store in a refrigerator. Do not freeze. Keep out of the reach of children.

Packaging. Amber glass bottles with a metering device, spray pump, and cap. Each bottle contains 120 doses.

Prescription status. Prescription only.

Manufacturer.

Glaxo Wellcome S.A., Spain

Manufacturer's address and place of business.

Avda. de Extremadura, 3, Pol. Ind. Allendeduero, 09400 Aranda de Duero, Burgos, Spain / Avda. de Extremadura, 3, Pol. Ind. Allendeduero, 09400 Aranda de Duero, Burgos, Spain.