Ventolin

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Ventolin
100 μg/dose, inhalation aerosol, suspension
Salbutamol
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Ventolin inhalation aerosol, suspension is and what it is used for
2. Important information before using Ventolin inhalation aerosol, suspension
3. How to use Ventolin inhalation aerosol, suspension
4. Possible side effects
5. How to store Ventolin inhalation aerosol, suspension
6. Contents of the pack and other information

1. What Ventolin inhalation aerosol, suspension is and what it is used for

Ventolin inhalation aerosol, suspension contains a medicine called salbutamol. It belongs to a group of medicines known as fast-acting bronchodilators.
Bronchodilators:

• help keep the airways open, making breathing easier,
• help reduce chest tightness, wheezing and coughing associated with asthma.
  Ventolin inhalation aerosol, suspension is used to treat breathing disorders in adults, adolescents and children aged 4 years and older who have asthma or similar conditions, and also to prevent asthma symptoms triggered by physical exertion and exposure to allergens (substances that cause asthma attacks). These include house dust, pollen, cat and dog hair, and cigarette smoke.

2. Important information before using Ventolin, inhalation aerosol, suspension

When not to use Ventolin, inhalation aerosol, suspension

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

Warnings and precautions
Before starting treatment with Ventolin, inhalation aerosol, suspension, consult your doctor if the patient:

• has poorly controlled asthma (e.g. asthma symptoms occur frequently or symptoms worsen, or the patient has reduced physical capacity). The doctor may recommend starting or increasing the dose of another medicine, such as an inhaled corticosteroid, to achieve disease control,
• has high blood pressure,
• has hyperthyroidism,
• has previously had heart problems, such as irregular or rapid heartbeat or chest pain,
• has low blood potassium levels,
• is taking xanthine derivatives (e.g. theophylline) or steroids for asthma treatment,
• is taking diuretics (water tablets), sometimes used to treat high blood pressure or heart disease ➔ If the patient is taking any of these medicines, the doctor may recommend monitoring blood potassium levels.

➔ Consult your doctor to determine whether any of the above conditions apply to the patient.
Consult your doctor if the duration of action of the medicine is shorter than 3 hours.

Ventolin, inhalation aerosol, suspension and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those obtained without a prescription.
Some medicines may affect the action of Ventolin, inhalation aerosol, suspension or increase the risk of side effects. These include:

• beta-blocking agents, such as propranolol, used in the treatment of high blood pressure or other heart conditions.

➔ Your doctor will decide whether the patient can use Ventolin, inhalation aerosol, suspension together with these medicines.

Pregnancy and breastfeeding
Ventolin, inhalation aerosol, suspension is generally not recommended during pregnancy.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine. The doctor will assess whether the patient may take Ventolin, inhalation aerosol, suspension during this period.

Driving and operating machinery
No effects on the ability to drive or operate machinery have been observed.

3. How to use Ventolin, inhalation aerosol, suspension

Ventolin, inhalation aerosol, suspension should always be used as directed by the physician.
In case of doubt, consult the physician.
Ventolin, inhalation aerosol, suspension is intended for oral inhalation only.
Increasing the dose or frequency of administration is permitted only under medical supervision.
Patients who have difficulty coordinating inhalation with actuation of the inhaler may use Ventolin, inhalation aerosol, suspension with a spacer device.
Children under 5 years of age may use Ventolin, inhalation aerosol, suspension with a paediatric spacer device (Babyhaler).
Ventolin, inhalation aerosol, suspension should be used as needed, not on a regular basis.
If asthma is active (for example, frequent symptoms or exacerbations such as breathlessness interfering with speaking, eating or sleeping, coughing, wheezing, chest tightness or reduced physical performance), the patient should inform the physician immediately. The physician may initiate or increase the dose of medication to maintain asthma control, such as an inhaled corticosteroid.
If the patient feels that the medicine is not working as well as usual, they should inform the physician as soon as possible (for example, if higher doses are needed to relieve breathing difficulties, or if asthma symptoms do not resolve within at least 3 hours after using the inhaler), because asthma may be worsening and a different treatment may be required.
If the patient uses Ventolin, inhalation aerosol, suspension more than twice a week to relieve asthma symptoms, excluding prophylactic use before exercise, this indicates poorly controlled asthma and increases the risk of severe asthma attacks (asthma exacerbations), which may lead to serious complications, be life-threatening, or even fatal. The patient should contact the physician promptly to reassess the asthma treatment regimen. If the patient is using a daily anti-inflammatory lung medication, such as an inhaled corticosteroid, it is important to continue regular use, even if symptoms improve.
Inform the physician if the medicine is no longer effective, as this may indicate worsening asthma control and a change in therapy may be necessary.

Adults and adolescents aged 12 years and older

• To relieve acute bronchospasm: 1 to 2 inhalations (100 to 200 micrograms of salbutamol).
• Prophylactically before exercise or anticipated allergen exposure: usually 2 inhalations (2 × 100 micrograms of salbutamol) 10–15 minutes before exercise or allergen exposure.
• Maintenance treatment: 2 inhalations (2 × 100 micrograms of salbutamol) up to 4 times daily.

Maximum daily dose: 800 micrograms (2 inhalations no more than 4 times within 24 hours).

Children under 12 years of age

• To relieve acute bronchospasm: 1 inhalation (100 micrograms of salbutamol). The dose may be increased to 2 inhalations (2 × 100 micrograms) if needed.
• Prophylactically before exercise or anticipated allergen exposure: usually 1 inhalation (100 micrograms of salbutamol) 10–15 minutes before exercise or allergen exposure. The dose may be increased to 2 inhalations (2 × 100 micrograms) if needed.
• Maintenance treatment: up to 200 micrograms 4 times daily.

Maximum daily dose: 800 micrograms (2 inhalations no more than 4 times within 24 hours).

Instructions for using the inhaler
The physician, nurse, or pharmacist should instruct the patient on the correct use of the inhaler.
The medicine is contained in a pressurized canister fitted with a plastic actuator and mouthpiece.

Checking the inhaler
Before first use, check that the inhaler is working. Remove the mouthpiece cap by gently pressing the sides of the cap with the thumb and index finger.

Figure 1
To confirm the inhaler is working, shake it vigorously, point the mouthpiece away from you, and release one puff into the air.
If the inhaler has not been used for one week or longer, remove the mouthpiece cap, shake the inhaler vigorously, and release two puffs into the air.

Using the inhaler
It is important to begin breathing slowly and as deeply as possible before using the inhaler.

1. Use the inhaler while standing or sitting upright.
2. Remove the mouthpiece cap (as shown in Figure 1). Check the mouthpiece inside and out to ensure it is clean and free of foreign objects.
3. Shake the inhaler 4 or 5 times to remove any debris and to ensure the contents are evenly mixed before use.

Figure 2
Do not rush the steps described in points 4–7.

4. Hold the inhaler upright with fingers, placing the thumb at the base of the inhaler, below the mouthpiece. Breathe out fully, as deeply as possible.

Figure 3

5. Place the mouthpiece in the mouth and seal lips tightly around it. Do not bite the mouthpiece.

Figure 4

6. Immediately after starting to inhale slowly through the mouth, press down on the canister to release the dose of Ventolin, inhalation aerosol, suspension, then continue a slow, deep inhalation.

Figure 5

7. Hold your breath, remove the inhaler from the mouth, and remove your finger from the canister. Hold your breath for several seconds, or as long as comfortable, then breathe out slowly.

Figure 6

8. If the physician has prescribed two inhalations, wait about half a minute before repeating steps 3–7.
9. After inhalation, always replace the mouthpiece cap to prevent dust from entering. Push the cap firmly into place. If a clicking sound is not heard when replacing the cap, remove it, turn it over, and try again. Do not use excessive force.

Cleaning the inhaler
To prevent blockage, clean the inhaler at least once a week. To clean:

• Remove the mouthpiece cap.
• Do not remove the metal canister from the plastic casing during cleaning or at any other time.
• Wipe the mouthpiece inside and out, and the outside of the plastic casing, with a dry cloth or tissue.
• Replace the mouthpiece cap. A click should be heard when properly fitted. If no click is heard, remove the cap, turn it over, and try again. Do not use excessive force.

Do not immerse the metal canister in water.

Accidental overdose of Ventolin, inhalation aerosol, suspension
If more Ventolin, inhalation aerosol, suspension has been used than recommended, contact the physician or pharmacist immediately for advice. Keep the original carton of the medicine to show the doctor.
The following symptoms may occur:

• faster than normal heartbeat,
• tremors,
• excessive excitability. These symptoms usually resolve within a few hours. Additionally, the following may occur:
• decreased blood potassium levels (hypokalaemia),
• abdominal pain, increased lung ventilation (rapid breathing), shortness of breath despite reduced wheezing, cold hands and feet, irregular heartbeat, thirst (symptoms suggestive of lactic acidosis).

Missed dose of Ventolin, inhalation aerosol, suspension
If a dose of Ventolin, inhalation aerosol, suspension is missed, take it as soon as possible, then continue taking the medicine as directed by the physician.
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

If breathing worsens or wheezing increases immediately after taking this medicine, stop using the medicine immediately and contact your doctor immediately.
Like all medicines, Ventolin inhalation aerosol, suspension, may cause adverse reactions, although not everyone experiences them.
Below are the adverse symptoms observed in patients taking Ventolin inhalation aerosol, suspension.

Symptoms to be aware of
Allergic reactions: Very rare (occurs in fewer than 1 in 10,000 patients taking the medicine). Symptoms include:

• skin rash (urticaria) or redness,
• swelling, mainly of the face, lips, tongue or throat (angioedema),
• increased wheezing in the airways, cough or difficulty breathing,
• sudden feeling of weakness or dizziness (which may lead to falling or loss of consciousness).

➔ Contact your doctor immediately if any of the above symptoms occur. Discontinue use of Ventolin inhalation aerosol, suspension immediately.
Contact your doctor immediately if the patient experiences:

• sensation of faster or stronger than usual heartbeat (palpitations). This is usually not dangerous and resolves soon after taking the medicine,
• sensation of irregular heartbeat. Do not stop using Ventolin inhalation aerosol, suspension unless otherwise advised by your doctor.

Adverse reactions that are common (occurs in fewer than 1 in 10 patients, but more than 1 in 100 patients taking the medicine):

• tremor,
• headache,
• rapid heartbeat.

Adverse reactions that are uncommon (occurs in fewer than 1 in 100 patients, but more than 1 in 1,000 patients taking the medicine):

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

Adverse reactions that are rare (occurs in fewer than 1 in 1,000 patients, but more than 1 in 10,000 patients taking the medicine):

• decreased blood potassium levels,
• peripheral vasodilation.

Adverse reactions that are very rare (occurs in fewer than 1 in 10,000 patients taking the medicine):

• allergic reactions (see above),
• excessive excitability,
• cardiac arrhythmias,
• paradoxical bronchospasm. As with other inhaled medicines, paradoxical bronchospasm may occur, characterized by wheezing immediately after taking the medicine. In such a case, discontinue administration of Ventolin inhalation aerosol, suspension immediately and contact your doctor. The doctor will assess the patient's condition and, if necessary, recommend alternative treatment.

Adverse reactions with unknown frequency

• myocardial ischemia, which may present as chest pain, for example.

➔ If any adverse reaction worsens or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ventolin, inhalation aerosol, suspension

Keep the medicine out of the sight and reach of children.
Do not store at temperatures above 30°C.
Do not freeze.
Store in the outer packaging to protect from direct sunlight.
The container holds contents under pressure. Do not expose to temperatures above 50°C. Do not pierce, damage, or burn the container, even if it appears to be empty.
As with most inhaled medicines delivered from pressurized containers, the effectiveness of the medicinal product may be reduced if the inhaler is cold.
After inhalation, replace the cap on the mouthpiece. Do not force the cap on.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ventolin, inhalation aerosol, suspension contains

• The active substance is salbutamol in the form of salbutamol sulfate. Each dose of Ventolin, inhalation aerosol, suspension contains 100 μg (micrograms) of salbutamol as salbutamol sulfate.
• The other ingredient is: Norflurane (HFA 134a)

This medicine contains fluorinated greenhouse gases.
Each inhaler contains 18 g of HFC-134a (also known as Norflurane or HFA 134a), which
corresponds to 0.0257 tonnes of CO2 equivalent (global warming potential GWP = 1430).
What Ventolin, inhalation aerosol, suspension looks like and contents of the pack
An aluminium container with 200 doses, closed with a metering valve and fitted with a plastic actuator,
packaged in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Spain, the country of export:
GlaxoSmithKline, S.A.
P.T.M. C/ Severo Ochoa, 2
28760 Tres Cantos (Madrid)
Spain
Manufacturer:
Glaxo Wellcome, S.A., Avda. de Extremadura, 3, 09400 – Aranda de Duero (Burgos), Spain
Glaxo Wellcome Production, Zone Industrielle nº 2, 23 Rue Lavoisier, La Madeleine, 27000 Evreux,
France
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Spain, the country of export: 656706.7
Parallel Import Authorisation Number: 351/25