Ventolin

Leaflet accompanying the packaging: patient information

Ventolin, 1 mg/ml (0.1%), solution for nebulization

Ventolin, 2 mg/ml (0.2%), solution for nebulization

Salbutamol

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 necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Ventolin solution for nebulization and what is it used for
• 2. Important information before using Ventolin solution for nebulization
• 3. How to use Ventolin solution for nebulization
• 4. Possible side effects
• 5. How to store Ventolin solution for nebulization
• 6. Package contents and other information

1. What is Ventolin solution for nebulization and what is it used for

Ventolin solution for nebulization contains a medicine called salbutamol. It belongs to a group of fast-acting bronchodilators.

• They help maintain the patency of the airways, making it easier to breathe.
• They help reduce chest tightness, wheezing, and cough associated with asthma.

Ventolin solution for nebulization is indicated for use in adults, adolescents, and children from 4 years of age, in chronic bronchospastic states that do not usually respond to conventional treatment methods and in the treatment of acute, severe asthma attacks. Use in infants and children under 4 years of age, see section 3 of this leaflet.

Ventolin solution for nebulization is intended for inhalation use only and should not be administered intravenously or orally.

Ventolin solution for nebulization, which is in a plastic ampoule, is intended for inhalation using an appropriate nebulizer, in accordance with the doctor's recommendations.

2. Important information before using Ventolin solution for nebulization

When not to use Ventolin solution for nebulization

• if the patient is allergic to salbutamol sulfate or any of the other ingredients of this medicine (listed in section 6),
• in the case of threatened abortion,
• in the prevention of premature labor.

Warnings and precautions

Before starting to use Ventolin solution for nebulization, the patient should consult their doctor if they:

• have poorly controlled asthma (e.g., frequent symptoms or exacerbations, or reduced physical fitness). The doctor may recommend starting or increasing the dose of a medicine, such as an inhaled corticosteroid, to control the disease.
• have high blood pressure,
• have diabetes,
• have hyperthyroidism,
• have had heart problems in the past, such as irregular or rapid heartbeat or chest pain,
• have low potassium levels in the blood,
• are taking xanthine derivatives (e.g., theophylline) or steroids for asthma,
• are taking diuretics, sometimes used to treat high blood pressure or heart disease,
• are taking other nebulized medicines, such as ipratropium bromide, in addition to salbutamol. Such combined treatment should be used with caution. The eyes should be protected from contact with the medicine.
• are taking medicines such as ephedrine or pseudoephedrine due to nasal congestion or other medicines used to treat asthma.

If the patient is taking any of these medicines, the doctor will recommend monitoring the potassium level in the blood.

Symptoms to watch out for

Using high doses of Ventolin solution for nebulization may, in very rare cases, lead to the development of a condition called lactic acidosis. The patient should pay attention to certain symptoms when using Ventolin solution for nebulization to minimize the risk of any problems. See also "Symptoms to watch out for" in section 4 of this leaflet.

Patients treated at home with Ventolin solution for nebulization should immediately consult a doctor if their response to the previously used dose decreases, or if the duration of action of the medicine shortens. Increasing the dose or frequency of use, due to the increased risk of side effects, is only allowed under the supervision of a doctor.

Ventolin and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.

• Some medicines may affect the action of Ventolin solution for nebulization or increase the risk of side effects. These include:
• beta-adrenergic receptor blockers, such as propranolol, used to treat high blood pressure or other heart conditions.

The doctor will decide whether the patient can use Ventolin solution for nebulization with these medicines.

Using Ventolin solution for nebulization with food and drink

Ventolin solution for nebulization can be used at any time, regardless of meals.

Pregnancy and breastfeeding

Ventolin solution for nebulization is not usually recommended for use during pregnancy. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine. The doctor will assess whether the patient can take Ventolin during this period.

Driving and using machines

No effect on the ability to drive and use machines has been observed.

3. How to use Ventolin solution for nebulization

Ventolin solution for nebulization should always be used in accordance with the doctor's recommendations. In case of doubts, the patient should contact their doctor.

Ventolin solution for nebulization should be used as needed, and not regularly.

If the patient's asthma is active (e.g., frequent symptoms or exacerbations, such as shortness of breath that interferes with speaking, eating, or sleeping, coughing, wheezing, chest tightness, or reduced physical fitness), they should immediately tell their doctor, who may start treatment or increase the dose of a medicine that helps control asthma symptoms, such as an inhaled corticosteroid.

If the patient thinks the medicine is not working as well as usual, they should tell their doctor as soon as possible (e.g., the patient needs larger doses to relieve breathing problems or asthma symptoms do not improve for at least 3 hours after using the nebulizer), as asthma may be worsening and another medicine may be needed.

If the patient uses Ventolin solution for nebulization more frequently than twice a week to relieve asthma symptoms, excluding preventive use before physical exertion, it means that asthma is poorly controlled and the risk of severe asthma attacks (exacerbations) may increase, which can lead to serious complications and even death. The patient should contact their doctor as soon as possible to verify their asthma treatment.

If the patient uses a medicine with anti-inflammatory effects in the lungs, such as an "inhalation corticosteroid", every day, it is essential to continue its regular use, even if the patient feels better.

Adults

Adults (including the elderly): 2.5 mg to 5 mg of salbutamol up to four times a day.

Doses up to 40 mg per day may be used in hospital settings under close medical supervision.

Children and adolescents

Children over 12 years of age: the same dosage as for adults.

Children from 4 to 11 years of age: 2.5 mg to 5 mg up to four times a day.

The efficacy of salbutamol solution for nebulization in infants and children under 18 months of age has not been fully confirmed yet.

In children under 4 years of age, other forms of the medicine may be more suitable.

Ventolin solution for nebulization is intended for inhalation use only through the mouth, under medical supervision, using an appropriate nebulizer.

The solution should not be administered intravenously or orally.

After cutting the foil blister with scissors, the connected ampoules should be removed and one of them separated.

The ampoule with the medicine should be opened by twisting it along the axis.

Ventolin solution for nebulization is intended for use without dilution. However, if the administration time is prolonged (longer than 10 minutes), the solution may be diluted with a 0.9% sodium chloride solution.

Unused solution should be discarded from the nebulizer.

The solution in the nebulizer should be changed daily.

Many nebulizers work on the principle of continuous flow, so it is likely that some of the medicine may escape from the device. For this reason, inhalation with a nebulizer should be performed in a well-ventilated room, especially in hospital wards where several patients use nebulizers at the same time.

If the patient feels that the effect of Ventolin solution for nebulization is too strong or too weak, they should consult their doctor.

Using a higher dose of Ventolin solution for nebulization than recommended

In case of using a higher dose of Ventolin than recommended, the patient should immediately contact their doctor or pharmacist for advice. The patient should have the carton of the medicine with them to show it to the doctor.

The following symptoms may occur:

• faster than usual heartbeat,
• tremors,
• excessive restlessness. These symptoms usually disappear within a few hours. Additionally, the following may occur:
• decreased potassium levels in the blood (hypokalemia)
• abdominal pain, increased ventilation of the lungs (rapid breathing), shortness of breath despite decreased wheezing, cold hands and feet, irregular heartbeat, thirst (symptoms suggesting the development of lactic acidosis).

Missing a dose of Ventolin solution for nebulization

In case of missing a dose of Ventolin solution for nebulization, the patient should take it as soon as possible, and then continue taking the medicine according to the doctor's recommendations. The patient should not take a double dose of the medicine to make up for the missed dose.

If the patient has any further doubts about using the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

If breathing worsens or wheezing increases immediately after taking this medicine, the patient should stop using it and immediately consult their doctor.

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

The following are side effects observed in patients taking Ventolin solution for nebulization.

Symptoms to watch out for

Allergic reactions:These occur very rarely (in less than 1 in 10,000 patients taking the medicine). Symptoms include:

• skin rash (hives) or redness,
• swelling, mainly of the face, lips, tongue, or throat (angioedema),
• worsening of wheezing, coughing, or difficulty breathing,
• sudden feeling of weakness or dizziness (which can lead to falls or loss of consciousness).

The patient should immediately consult their doctor if they experience any of the above symptoms. They should stop using Ventolin solution for nebulization.

The patient should immediately consult their doctor if they experience:

• a faster or stronger than usual heartbeat (palpitations). This is usually not serious and disappears soon after taking the medicine,
• an irregular heartbeat. The patient should not stop using Ventolin solution for nebulization unless their doctor recommends it.

Common side effects(occurring in less than 1 in 10 patients, but more than 1 in 100 patients taking the medicine):

• tremors,
• headache,
• rapid heartbeat.

Uncommon side effects(occurring in less than 1 in 100 patients, but more than 1 in 1,000 patients taking the medicine):

• palpitations,
• irritation of the mucous membrane of the mouth and throat,
• muscle cramps.

Rare side effects(occurring in less than 1 in 1,000 patients, but more than 1 in 10,000 patients taking the medicine):

• peripheral vasodilation,
• decreased potassium levels in the blood.

Very rare side effects(occurring in less than 1 in 10,000 patients taking the medicine):

• allergic reactions (see above),
• excessive restlessness,
• heart rhythm disorders,
• paradoxical bronchospasm. Like other inhaled medicines, paradoxical bronchospasm may occur, which is characterized by wheezing immediately after taking the medicine. In such a situation, the patient should immediately stop using Ventolin solution for nebulization and consult their doctor. The doctor will assess the patient's condition and, if necessary, recommend other treatment.
• abdominal pain, hyperventilation (increased lung ventilation), shortness of breath despite decreased wheezing, cold hands and feet, irregular heartbeat, thirst (symptoms suggesting the development of lactic acidosis).

Side effects with unknown frequency

• myocardial ischemia, which may be manifested by, for example, chest pain.

If any of the side effects worsen or any side effects not listed in the leaflet occur, the patient should tell their doctor or pharmacist.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: [insert website]. Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Ventolin solution for nebulization

• 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 or carton. The expiry date refers to the last day of the month.
• Store in a temperature below 30°C. After opening the foil blister, the product in plastic ampoules, protected from light, is suitable for use for 3 months. Unused solution for nebulization should be discarded from the nebulizer.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Ventolin solution for nebulization contains

• The active substance of the medicine is salbutamol in the form of salbutamol sulfate. 1 ml of solution for nebulization contains 1 mg or 2 mg of salbutamol in the form of salbutamol sulfate.
• The other ingredients are: sodium chloride, sulfuric acid 10%, water for injections.

What Ventolin looks like and what the package contains

Ventolin 1 mg/ml, solution for nebulization -20 plastic ampoules (LDPE) of 2.5 ml each, containing 2.5 mg of salbutamol, in a carton.

Ventolin 2 mg/ml, solution for nebulization- 20 plastic ampoules (LDPE) of 2.5 ml each, containing 5 mg of salbutamol, in a carton.

Marketing authorization holder:

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

D24 YK11

Ireland

Manufacturer:

Aspen Bad Oldesloe GmbH

Industriestrasse 32-36

23843 Bad Oldesloe

Germany

To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:

GSK Services Sp. z o.o.

ul. Rzymowskiego 53

02-697 Warsaw

tel. (22) 576-90-00

Date of last revision of the leaflet: