Ventolin

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Ventolin (Ventilan-Inhaler)
100 µg/inhalation dose, inhalation aerosol, suspension
Salbutamol
Ventolin and Ventilan-Inhaler are different trade names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of 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 with asthma and similar conditions, and to prevent asthma symptoms triggered by physical exertion and exposure to allergens (substances that trigger 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,
• for the prevention of 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. frequent asthma symptoms or exacerbations, or reduced physical performance). The doctor may recommend initiating or increasing the dose of a 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 the treatment of asthma,
• is taking diuretics (water tablets), sometimes used in the treatment of 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 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 with 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 available without a prescription.
Some medicines may affect the action of Ventolin inhalation aerosol, suspension or increase the risk of adverse effects. These include:

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

➔ The 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 for use 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 can take Ventolin during this period.
Driving and operating machinery
No effects on the ability to drive and operate machinery have been observed.

3. How to use Ventolin, inhalation aerosol, suspension

Ventolin, inhalation aerosol, suspension should always be used exactly as directed by your doctor.
If you have any doubts, consult your doctor.
Ventolin, inhalation aerosol, suspension is for inhalation through the mouth only.
Increasing the dose or frequency of use 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 schedule.
If asthma becomes active (for example, frequent symptoms or exacerbations such as breathlessness interfering with speaking, eating, or sleeping, coughing, wheezing, chest tightness, or reduced physical activity), the patient should inform the doctor immediately. The doctor may initiate or adjust treatment, possibly increasing the dose of a controller medication such as an inhaled corticosteroid to maintain asthma under control.
If the patient feels that the medicine is not working as well as usual, they should inform the doctor as soon as possible (for example, if higher doses are needed to relieve breathing difficulties, or 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 aeros, suspension more than twice a week to relieve asthma symptoms (excluding preventive use before physical exertion), this indicates poorly controlled asthma and increases the risk of severe asthma attacks (asthma exacerbations), which may lead to serious complications, can be life-threatening, and may even result in death. The patient should contact the doctor promptly to review the asthma treatment plan. If the patient is using a daily anti-inflammatory lung medication, such as an inhaled corticosteroid, it is important to continue using it regularly, even if they feel better.
Inform the doctor if the medicine no longer works as before, 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: inhale one to two puffs (100 to 200 micrograms of salbutamol).
• For prophylaxis before exercise or anticipated exposure to an allergen: usually two puffs (2 × 100 micrograms of salbutamol) 10–15 minutes before exercise or allergen exposure.
• Maintenance treatment: 2 puffs (2 × 100 micrograms of salbutamol) up to 4 times daily.

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

Children under 12 years of age

• To relieve acute bronchospasm: inhale one puff (100 micrograms of salbutamol). If needed, the dose may be increased to two puffs (2 × 100 micrograms).
• For prophylaxis before exercise or anticipated allergen exposure: usually one puff (100 micrograms of salbutamol) 10–15 minutes before exercise or allergen exposure. If needed, the dose may be increased to two puffs (2 × 100 micrograms).
• Maintenance treatment: up to 200 micrograms 4 times daily.

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

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

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

Figure 1
To ensure 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 steadily as possible even before using the inhaler.

1. Use the inhaler while standing or sitting.
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 foreign particles and to ensure the contents are evenly mixed before use.

Figure 2
It is important not to rush through steps 4–7.

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

Figure 3

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

Figure 4

6. Immediately after starting to inhale through your mouth, press down on the canister to release the Ventolin medication, then continue to inhale slowly and deeply.

Figure 5

7. Hold your breath, remove the inhaler from your mouth, and lift your finger off the canister. Hold your breath for several seconds, or as long as is comfortable without causing discomfort, then breathe out slowly.

Figure 6

8. If your doctor has prescribed two puffs, 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 you do not hear a click when attaching the cap, remove it, turn it around, and try again. Do not use excessive force.

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

• Remove the mouthpiece cap.
• Do not remove the metal canister from the plastic housing during cleaning or at any other time.
• Wipe the mouthpiece inside and out, and the outside of the plastic housing, with a dry cloth or tissue.
• Replace the mouthpiece cap. When properly attached, a click will be heard. If no click is heard, remove the cap, turn it around, 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 is used than recommended, contact your doctor or pharmacist immediately for advice. Keep the cardboard packaging 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 your doctor.
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 doctor or pharmacist.

4. Possible adverse effects

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

Symptoms to watch for
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. Stop using Ventolin inhalation aeros, suspension.
You should contact your doctor immediately if the patient experiences:

• sensation of faster or stronger than usual heartbeat (palpitations). Usually this is not dangerous and resolves shortly after taking the medicine,
• sensation of irregular heartbeat. Do not stop using Ventolin inhalation aerosol, suspension unless your doctor advises otherwise.

Adverse effects occurring frequently (occurs in fewer than 1 in 10 patients, but more frequently than 1 in 100 patients taking the medicine):

• tremors,
• headache,
• increased heart rate.

Adverse effects occurring uncommonly (occurs in fewer than 1 in 100 patients, but more frequently than 1 in 1,000 patients taking the medicine):

• palpitations,
• irritation of the oral and pharyngeal mucosa,
• muscle cramps.

Adverse effects occurring rarely (occurs in fewer than 1 in 1,000 patients, but more frequently than 1 in 10,000 patients taking the medicine):

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

Adverse effects occurring very rarely (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, administration of Ventolin inhalation aerosol, suspension must be stopped immediately and medical advice sought. The doctor will assess the patient's condition and, if necessary, recommend alternative treatment.

Adverse effects with unknown frequency

• myocardial ischaemia, which may manifest as chest pain.

➔ If any adverse effect worsens or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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: https://smz.ezdrowie.gov.pl.
Reporting adverse effects 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.
Store below 30°C.
Protect from light. Do not freeze.
The container holds a pressurized suspension. Do not expose to temperatures above 50°C; protect from direct sunlight. Do not pierce, damage, or burn the container, even if it seems empty.
As with most inhaled medicines in pressurized containers, the effectiveness of the medicine 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 the sewage system 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: 1,1,1,2-tetrafluoroethane (HFA 134a).

This medicine contains fluorinated greenhouse gases.
Each inhaler contains 18 g of HFC-134a (also known as 1,1,1,2-tetrafluoroethane or HFA 134a), equivalent to 0.0257 tonnes of CO₂-equivalent (global warming potential GWP = 1430).

What Ventolin looks like and contents of the pack
An aluminium container containing 200 doses, closed with a metering valve and fitted with a plastic dispenser, in a cardboard box.

For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Portugal, country of export:
Glaxo Wellcome Farmacêutica, Lda.
Rua Dr. António Loureiro Borges, 3
Arquiparque, Miraflores
1495-131 Algés
Portugal

Manufacturer:
Glaxo Wellcome Production
23, Rue Lavoisier - Zone Industrielle nº 2
F-27000 Evreux
France

Glaxo Wellcome, S.A.
Avenida da Extremadura, 3
E-09400 Aranda de Duero - Burgos
Spain

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Portugal, country of export: 8322628
Parallel Import Licence Number: 310/25