Ribuspir

Leaflet accompanying the packaging: information for the user

Ribuspir, 200 micrograms/dose, inhalation aerosol, solution

Package with Jet inhalation chamber
Budesonide

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not mentioned in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Ribuspir and what is it used for
• 2. Important information before using Ribuspir
• 3. How to use Ribuspir
• 4. Possible side effects
• 5. How to store Ribuspir
• 6. Contents of the packaging and other information

1. What is Ribuspir and what is it used for

Ribuspir is available as a solution in an inhalation aerosol, intended for inhalation through the mouth, directly into the lungs. The active substance of the medicine is budesonide, which belongs to a group of medicines called corticosteroids, which are also known as steroids. Medicines in this group have anti-inflammatory effects, reduce swelling and irritation of the mucous membrane of the airways.

Ribuspir is a preventive medicine: it treats inflammation and is used to prevent asthma symptoms. Ribuspir does not interrupt asthma attacks. In such cases, a fast-acting, inhaled bronchodilator should be used, which should always be carried with you.

Ribuspir is indicated for:

Treatment of mild, moderate, and severe chronic asthma.

2. Important information before using Ribuspir

When not to use Ribuspir

You should consult a doctor.

Warnings and precautions

Before starting treatment with Ribuspir, you should discuss it with your doctor:

During therapy, if oral thrush occurs, you should tell your doctor, as antifungal treatment or discontinuation of therapy may be necessary. To reduce the risk of oral thrush, see section 3. How to use Ribuspir.

In the event of paradoxical bronchospasm with wheezing immediately after taking the medicine, treatment should be discontinued immediately.

If you experience blurred vision or other vision disturbances, you should contact your doctor.

Children and adolescents

It is essential to monitor the growth of children treated long-term and inform the doctor.

Ribuspir and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

It is particularly important to inform your doctor about taking medicines such as:

• corticosteroid-containing medicines,
• antifungal medicines, such as ketoconazole and itraconazole,
• medicines containing disulfiram or metronidazole (see "Ribuspir contains glycerol and ethanol"),
• HIV protease inhibitors or other potent CYP3A4 inhibitors,
• estrogens and contraceptive steroids.

Some medicines may enhance the effect of Ribuspir, and your doctor may want to closely monitor your condition while taking such medicines (including some HIV medicines: ritonavir, cobicistat).

If you are taking any of the above medicines, your doctor may recommend taking a different medicine or changing the dose of Ribuspir or other concomitantly used medicines.

If an ACTH stimulation test is performed to diagnose adrenal insufficiency, the results may be false (reduced values).

Your doctor may recommend using other medicines to treat breathing problems. It is crucial to use them regularly and NOT TO INTERRUPT their use or change the dosage when starting to use Ribuspir.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before using this medicine.

If you become pregnant while using Ribuspir, you should immediately inform your doctor.

Global experience with inhaled budesonide has not demonstrated an increased risk of adverse effects in the fetus and newborn associated with the use of budesonide during pregnancy.

Budesonide may be used during breastfeeding.

Driving and using machines

No effects on the ability to drive and use machines have been observed.

Ribuspir contains glycerol and ethanol.

This medicine contains 8.4 mg of alcohol (ethanol) per actuation, which is equivalent to 0.12 mg/kg body weight per actuation in adults and 0.42 mg/kg body weight in children. The amount of alcohol in the actuation of this medicine is equivalent to less than 1 ml of beer or wine. The small amount of alcohol in this medicine is unlikely to cause noticeable effects.

Ethanol may interact with disulfiram or metronidazole in particularly sensitive patients taking this medicine.

This medicine contains glycerol: it may cause headache, stomach upset, and diarrhea.

3. How to use Ribuspir

Ribuspir is intended for inhalation use.

This medicine should always be used as directed by your doctor. If you have any doubts, you should consult a doctor or pharmacist.

Your doctor will recommend regular monitoring of asthma symptoms to ensure that the prescribed dose of Ribuspir is optimal.

Your doctor will adjust the dosage individually for each patient, depending on the severity of asthma symptoms. The doctor will determine the lowest effective dose (maintenance dose) that provides the best control of asthma symptoms. Under no circumstances should the established dosage be changedwithout prior consultation with a doctor.

It is essential to use Ribuspir for as long as your doctor decides. The effect of Ribuspir usually occurs within a few days of starting treatment. Therefore, it is crucial to take the medicine regularly.

Adults and adolescents

The recommended dose is 200 micrograms (one actuation) 2 to 4 times a day. The maintenance dose usually is 200 micrograms (one actuation) per day.

The maximum daily dose of the medicine is 1600 micrograms.

Use in children

Children aged 6 to 12 years

The recommended dose is 200 micrograms (one actuation) per day. The maximum daily dose is 400 micrograms.

If Ribuspir is prescribed for a child, you should ensure that the child uses the medicine correctly. Inhalation in children should always be performed under adult supervision.

Corticosteroid use

If you have just started using Ribuspir instead of taking corticosteroid tablets or if you are taking high doses of inhaled corticosteroids long-term, in stressful situations, you may need to take higher doses of steroids. Stressful situations may include hospitalization after an accident, severe injury, or planned surgery. In such cases, your doctor may decide to administer an additional dose of corticosteroids in tablets or injections.

How to use Ribuspir

See "Inhaler instruction" at the end of the leaflet.

It is recommended to rinse your mouth with water after each inhalation to reduce the risk of oral thrush.

Using a higher than recommended dose of Ribuspir

It is essential to take doses according to the information on the label from the pharmacist or as directed by your doctor. Do not increase or decrease the dose without consulting a doctor. If you have taken a higher dose of Ribuspir than recommended, you should consult a doctor as soon as possible.

Missing a dose of Ribuspir

If you miss a dose of the medicine, you should take the next dose at the usual planned time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Ribuspir

You should not stop using the medicine, even if you feel better, unless your doctor recommends otherwise. Suddenly stopping treatment with Ribuspir may cause worsening of asthma symptoms.

In case of worsening asthma symptoms

If your symptoms worsen or you experience difficulties in controlling them (e.g., more frequent use of inhaled bronchodilators) or if there is no improvement after using a fast-acting inhaled bronchodilator, you should immediately inform your doctor. This may indicate worsening of asthma, and your doctor may decide to change the dosage of Ribuspir or use other treatments.

In case of switching from oral steroids to Ribuspir, despite improvement in breathing, you may experience worsening of your overall condition. You should inform your doctor, but DO NOT STOPtreatment unless your doctor recommends otherwise.

If you have any further doubts about using this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Ribuspir can cause side effects, although not everybody gets them.

The side effects that occur are usually mild and transient. However, some of them may be severe and require medical attention.

Possible side effects are listed below:

Common(may affect up to 1 in 10 people):

Hoarseness, cough, throat irritation, oral thrush, difficulty swallowing.

Uncommon(may affect up to 1 in 100 people):

Anxiety, depression, tremors, cataracts, blurred vision, muscle spasms.

Rare(may affect up to 1 in 1,000 people):

Easy bruising, thinning of the skin, rash or hives, skin inflammation, itching, redness of the skin, anaphylactic reaction, angioedema, excess or deficiency of cortisol in the blood, bronchospasm.

Anxiety, nervousness, irritability, psychiatric disorders, and behavioral changes. These effects are more likely to occur in children.

Very rare(may affect up to 1 in 10,000 people):

Abnormal or decreased taste, nausea, tongue pain, oral mucositis, dryness of the oral mucosa, back pain.

Frequency not known(frequency cannot be estimated from the available data)

Sleep disturbances, aggressive reactions, increased motor activity (mainly in children). Increased intraocular pressure (glaucoma).

Rare but severe allergic reactions:

If, immediately after taking the medicine, you experience itching, an allergic reaction with symptoms such as redness of the skin, facial swelling, very low blood pressure, and irregular heartbeat (anaphylactic reaction), angioedema, or early and late hypersensitivity reactions:

• you should stop taking Ribuspir
• you should immediately contact your doctor.

Difficulty breathing immediately after using Ribuspir:

Rarely, in the case of inhaled medicines, immediately after their administration, bronchospasm (wheezing and shortness of breath) may occur. In this case:

• you should immediately stop using Ribuspir
• you should use a fast-acting inhaled bronchodilator to relieve shortness of breath and wheezing
• you should immediately contact your doctor.

Using inhaled corticosteroids in high doses for a long time may

cause systemic effects: in rare cases, growth retardation in children and adolescents, and adrenal dysfunction (adrenal suppression), very rarely a decrease in bone mineral density (osteoporosis).

Sleep disturbances are more likely to occur in children, but the frequency of their occurrence is unknown.

Reporting side effects

If you experience any side effects, including those not mentioned in this leaflet, you should tell your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych:

Al. Jerozolimskie 181C, 02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Ribuspir

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the month stated.
• Store at a temperature below 25°C.
• The container contains a pressurized solution. Do not pierce the container, do not expose it to heat, even after it has been emptied, do not freeze it, or expose it to direct sunlight.
• Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ribuspir contains:

The active substance of the medicine is budesonide. One dose contains 200 micrograms of budesonide.

The other ingredients of the medicine are: 1,1,1,2-tetrafluoroethane (HFA-134a), anhydrous ethanol, and glycerol.

What Ribuspir looks like and what the pack contains:

Ribuspir is available as a solution for inhalation, contained in an aluminum container under pressure, equipped with a plastic inhaler.

Each pack contains one inhaler, which delivers 200 doses.

Marketing authorization holder and manufacturer

Marketing authorization holder

Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122 Parma, Italy

Manufacturer

Chiesi Farmaceutici S.p.A, Via Palermo 26/A, 43122 Parma, Italy

Chiesi Pharmaceuticals GmbH, Gonzagagasse 16/16, 1010 Vienna, Austria

All-Gen Pharmaceuticals & Generics BV, Rouboslaan 32, 2252 TR Voorschoten, Netherlands

To obtain detailed information about the medicine and its names in the Member States of the European Economic Area, you should contact the local representative of the marketing authorization holder:

Chiesi Poland Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw

Tel.: (22) 620 14 21, Fax: (22) 652 37 79, Email: [email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Italy

Deso

Poland

Ribuspir

Date of leaflet approval:02/2021

INHALER INSTRUCTIONS:

Ribuspir is easy to use. To use the inhaler correctly, you should first read the following instructions.

The effectiveness of the treatment depends on the correct use of the inhaler.

Test the inhaler's proper functioning: before the first use of the inhaler or if the inhaler has not been used for 3 days or longer, you should remove the protective cap from the mouthpiece by gently squeezing its sides and then perform one actuation into the air to ensure the inhaler is working correctly.

Unpacking

After opening the carton, the inhaler mouthpiece should be closed with the protective cap.

Taking a dose of Ribuspir

Figure 1-2 Hold the inhaler between your thumb and index finger, with the mouthpiece facing downwards. Remove the protective cap from the mouthpiece.

Figure 3 a-b Perform a slow exhalation (3a), and then place the mouthpiece firmly between your lips (3b).

Figure 4 a-b-c Perform a deep and slow inhalation through your mouth, simultaneously pressing the canister once (4a). After inhalation, hold your breath for as long as possible (4b). After taking the prescribed number of doses, put the protective cap back on the inhaler mouthpiece (4c).

During inhalation in a child, it may be helpful to squeeze the child's nostrils.

Cleaning the inhaler:

The mouthpiece should always be kept clean. To do this, remove the metal container from the plastic casing, and rinse the mouthpiece with warm water. Let it dry in a warm place.