Ventolin disk
Poland
Table of Contents
Patient Information Leaflet
Ventolin Disk, 200 µg/inhalation dose, inhalation powder
Salbutamol
Please read this leaflet carefully before using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others.
- It may harm other people, even if their symptoms are the same.
- If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Leaflet Contents:
- What Ventolin Disk is and what it is used for
- What you need to know before using Ventolin Disk
- How to use Ventolin Disk
- Possible side effects
- How to store Ventolin Disk
- Contents of the pack and other information
1. What Ventolin Disk is and what it is used for
Ventolin Disk, inhalation powder, 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 Disk, inhalation powder, is used to treat breathing problems 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 cause breathing difficulties). These include house dust, pollen, cat and dog hair, and cigarette smoke.
2. Important information before using Ventolin Dysk
When not to use Ventolin Dysk
- if the patient is allergic to salbutamol sulfate or any of the other ingredients of this medicine (listed in section 6),
- in threatened miscarriage,
- for prevention of premature labor,
- if the patient has severe allergy to milk proteins.
Warnings and precautions
Before starting treatment with Ventolin Dysk, consult the doctor
in charge if the patient:
- has poorly controlled asthma (e.g. asthma symptoms or exacerbations occur frequently, or reduced physical performance). 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 had heart problems in the past, 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 pills), 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 the doctor in charge whether any of the above conditions apply to the patient.
Consult a doctor if the duration of action of the medicine is shorter than 3 hours.
Ventolin Dysk and other medicines
Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines.
Some medicines may affect the action of Ventolin Dysk or increase the risk of adverse effects. These include:
- beta-adrenergic 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 Dysk with these medicines.
Pregnancy and breastfeeding
Ventolin Dysk is generally not recommended during pregnancy.
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult a doctor before using this medicine. The doctor will assess whether the patient can take Ventolin Dysk during this period.
Driving and operating machinery
No effects on the ability to drive or operate machinery have been observed.
Ventolin Dysk contains monohydrate lactose.
Each dose of Ventolin Dysk contains approximately 12.5 mg of monohydrate lactose (which contains milk proteins). In patients with lactose intolerance, this amount of lactose usually does not cause any problems. However, if the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking the medicine.
3. How to use Ventolin Disk
Ventolin Disk should always be used exactly as directed by your doctor. If you are unsure,
contact your doctor.
Ventolin Disk is for inhalation use only through the mouth.
Before using the medicine, read carefully the instructions for use of the Disk inhaler device provided.
Increasing the dose or frequency of use is permitted only under medical supervision.
Ventolin Disk should be used as needed, not on a regular basis.
If a patient's asthma is active (for example, frequent symptoms or exacerbations such as
shortness of breath making speaking, eating, or sleeping difficult, coughing, wheezing, chest
tightness, or reduced physical activity), they should inform their doctor immediately. The doctor may
initiate treatment or increase the dose of a medicine that helps maintain control of asthma symptoms,
such as an inhaled corticosteroid.
If the patient feels the medicine is not working as well as usual, they should inform their doctor
as soon as possible (for example, if higher doses are needed to relieve breathing problems, or
asthma symptoms do not subside for at least 3 hours after using the inhaler), because asthma
may be worsening and a different treatment may be necessary.
If the medicine does not provide rapid relief of symptoms lasting at least 3 hours after a dose,
seek immediate medical advice.
If the patient uses Ventolin Disk 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 can lead to serious complications,
be life-threatening, and even result in death. The patient should contact their doctor promptly to
review their asthma treatment plan. If the patient is using a lung anti-inflammatory medicine daily,
such as an "inhaled corticosteroid," it is important to continue using it regularly, even if they feel
better.
Adults, adolescents, and children aged 4 years and older
- To relieve sudden bronchospasm, inhale one dose (200 micrograms of salbutamol).
- For preventive use, the usual dose is one inhalation (200 micrograms of salbutamol) 10–15 minutes before physical exertion or anticipated exposure to an allergen.
The maximum dose is 4 inhalations (800 micrograms) per day. Do not use more inhalations or
use the medicine more than 4 times a day. Inform your doctor if the medicine is no longer effective
as before, as this may indicate worsening asthma control and a change in treatment may be needed.
Instructions for using the Disk inhaler device
Your doctor, nurse, or pharmacist should instruct you on how to use the inhaler device correctly.
They should periodically check that you are using the inhaler properly.
When first removed from the packaging, the Disk inhaler is in the closed position.
The Disk inhaler contains Ventolin medicine in the form of individual powder doses for inhalation.
The Disk inhaler is equipped with a dose counter indicating how many doses remain in the device.
The counter displays the dose number down to 0. Numbers from 5 to 0 appear in red as a warning
that only a few doses remain in the inhaler. When the counter shows 0, the inhaler is empty.
Using the Disk inhaler
Follow the steps below:
- OPENING: To open the Disk inhaler, hold the cover with one hand and place the thumb of the other hand in the indentation of the casing. Slide the thumb away from you until you hear a click. After this, a small opening in the mouthpiece becomes visible.
- DOSE PREPARATION: Hold the Disk inhaler with the mouthpiece facing toward you. You may hold it in either your right or left hand. Slide the lever fully away from you until you hear a distinct sound. The Disk inhaler is now ready for use. Each time the lever is moved, the next dose of powder is prepared for inhalation. Do not play with the lever, as this will release the next dose and reduce the number of available doses.
- INHALING: Before inhaling the medicine, carefully read the instructions below.
- Hold the Disk inhaler at a slight distance from your mouth and breathe out calmly and deeply. Do not exhale into the Disk inhaler.
- Place the mouthpiece in your mouth; inhale deeply through your mouth (not through your nose) from the Disk inhaler.
- Hold your breath, then remove the Disk inhaler from your mouth. Hold your breath for about 10 seconds, or as long as comfortable, then breathe out slowly.
- CLOSING:
- To close the Disk inhaler, place your thumb in the indentation and slide it toward you.
- A "click" sound will be heard when closing the Disk inhaler. The dose-setting slider automatically returns to its original position. The Disk inhaler is now ready for reuse.
Cleaning
To clean the mouthpiece of the Disk inhaler, wipe it with a dry, soft cloth.
Use of a higher than recommended dose of Ventolin Disk
If a higher than recommended dose of Ventolin Disk is used, contact your doctor or pharmacist
immediately for advice. Keep the cardboard medicine packaging with you 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 (hypokalemia),
- abdominal pain, increased lung ventilation (rapid breathing), shortness of breath despite reduced wheezing, cold hands and feet, irregular heartbeat, thirst (symptoms suggesting lactic acidosis).
Missed dose of Ventolin Disk
If a dose of Ventolin Disk powder for inhalation is missed, take it as soon as possible, then continue
using 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 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 can cause side effects, although not everyone gets them.
Below are the adverse reactions observed in patients using Ventolin Dysk, inhalation powder.
Symptoms to be aware of
Allergic reactions: Very rare (means occurring 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),
- worsening of wheezing in the airways, cough or difficulty breathing,
- sudden feeling of weakness or dizziness (which may lead to collapse or loss of consciousness).
Contact your doctor immediately if any of the above symptoms occur. Discontinue use of Ventolin Dysk.
Contact your doctor promptly if the patient experiences:
- sensation of faster or stronger than usual heartbeat (palpitations). Usually this is not dangerous and resolves soon after taking the medicine,
- sensation of irregular heartbeat. Do not discontinue use of Ventolin Dysk unless otherwise advised by your doctor.
Common adverse reactions (means occurring in fewer than 1 in 10 patients,
but more than 1 in 100 patients taking the medicine):
- tremor,
- headache,
- increased heart rate.
Uncommon adverse reactions (means occurring in fewer than 1 in 100
but more than 1 in 1,000 patients taking the medicine):
- palpitations,
- irritation of the oral and pharyngeal mucosa,
- muscle cramps.
Rare adverse reactions (means occurring in fewer than 1 in 1,000
but more than 1 in 10,000 patients taking the medicine):
- decreased blood potassium levels,
- peripheral vasodilation.
Very rare adverse reactions (means occurring 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 Dysk, inhalation powder immediately and consult your doctor. The doctor will assess the patient's condition and, if necessary, recommend alternative treatment.
Adverse reactions with unknown frequency:
- myocardial ischaemia, which may manifest as chest pain, for example.
If any of the adverse reactions worsen 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 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
Adverse reactions can also be reported to the marketing authorization holder or its representative.
Reporting adverse reactions helps to gather further information on the safety of the medicine.
5. How to store Ventolin Dysk
- Keep the medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date stated on the label or the cardboard packaging. The "Expiry date (EXP)" refers to the last day of the month. The "Lot" abbreviation indicates the batch number.
- Store below 30 °C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.
6. Contents of the pack and other information
What Ventolin Dysk contains
- The active substance is salbutamol in the form of salbutamol sulfate. Each dose (inhalation) of the medicine contains 200 µg (micrograms) of salbutamol as salbutamol sulfate.
- The other ingredient is lactose monohydrate (which contains milk proteins).
What Ventolin Dysk looks like and contents of the pack
Powder for inhalation.
Pack:
The inhaler device Dysk contains a foil strip with doses placed on it. The foil protects the powder for inhalation from atmospheric conditions.
The Dysk inhaler device containing 60 doses of powder, equipped with a mouthpiece and a dose counter, in a cardboard box.
Marketing Authorisation Holder: Manufacturer:
GlaxoSmithKline Trading Services Limited Glaxo Wellcome Production
12 Riverwalk Zone Industrielle No.2
Citywest Business Campus 23, rue Lavoisier
Dublin 24 27000 Evreux
D24 YK11 France
Ireland
For further information, contact the representative of the Marketing Authorisation Holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel.: (22) 576-90-00