0.1 mg/dose inhalation spray , suspension
salbutamol
What Ventoline Evohaler is and what it is used for
Ventoline Evohaler is a bronchodilator medicine that makes breathing easier.
Ventoline Evohaler is used for symptom relief in:
- asthma
- chronic obstructive pulmonary disease (COPD).
Ventoline Evohaler should be used to relieve acute symptoms.
What you need to know before you use Ventoline Evohaler
Do not take Ventoline Evohaler:
- if you are allergic to salbutamol or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Ventoline Evohaler.
Before starting treatment with Ventoline Evohaler, consult a doctor if you have any of the following diseases:
- cardiovascular disease
- angina pectoris
- increased thyroid function ( hyperthyroidism )
- condition with reduced potassium content in the blood
- diabetes.
If the asthma symptoms increase or if the effect of Ventoline Evohaler worsens, a doctor should be contacted immediately. for example, if a previously effective dose does not provide symptom relief for at least 3 hours, a doctor should be consulted. Repeated inhalations that do not produce an effect in severe asthma attacks may mean that another treatment is needed.
Stop taking Ventoline and contact your doctor immediately if you experience any of the following symptoms
( angioedema ):
- swelling of the face, tongue, or throat
- difficulty swallowing
- hives and difficulty breathing.
Other medicines and Ventoline Evohaler
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of treatment can be affected if Ventoline Evohaler and certain other medicines are taken at the same time. Therefore, consult a doctor before taking other concomitant medication. Some blood pressure-lowering medicines ( beta-blockers ) can cancel out the effect of Ventoline Evohaler.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Limited experience of use during pregnancy. Therefore, consult a doctor when using Ventoline Evohaler during pregnancy.
It is unknown whether salbutamol passes into breast milk. Therefore, consult a doctor before use during breastfeeding.
Driving ability and use of machinery
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
How to use Ventoline Evohaler
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Carefully follow your doctor’s instructions on how many doses (puffs) you should use daily.
Adults and children aged 12 and over
The usual dose is 1-2 inhalations as needed, which should provide relief in an acute asthma attack.
Children (4-11 years)
The usual dose for the relief of acute spasms in the trachea is 1 inhalation. One dose can be increased to 2 inhalations if necessary. The total use when necessary must not exceed 2 inhalations 4 times daily.
The usual dose for chronic treatment of asthma is 2 inhalations four times daily
If the treatment has no effect or if you need several doses per day, contact your doctor. Never increase your dose without consulting your doctor. See the User Manual for more information.
Shake inhalation spray before use.
Ventoline Evohaler inhalation spray can be used together with a breathing container for those who have difficulty coordinating inhalation and spray impression.
For children under 4 years of age, no recommendations can be made for dosage as the effect has not yet been established.
If you have taken too much Ventoline Evohaler
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
In case of overdose, you may experience palpitations, tremors, and headaches.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are divided into the following categories:
very common (affects more than 1 person in 10)
common (affects more than 1 person in 100)
uncommon (affects less than 1 person in 100)
rare (affects less than 1 person in 1,000)
very rare (affects less than 1 person in 10,000)
Common: Tremors. Increased heart rate. Headache. Muscle cramps.
Uncommon: Palpitations. Irritation in the oral cavity and throat.
Rare: Decreased potassium content in the blood. Expansion of superficial blood vessels that can cause redness and a feeling of heat in the skin.
Very rare: Hypersensitivity reaction, e.g. itching and skin rash (hives), swelling of the face, tongue, and/or throat (so-called angioedema ), spasm in the trachea, drop in blood pressure. Overactivity and sleep disorders. Irregular heartbeat. Chest pain (a sign of angina).*
* If chest pain (a sign of angina) should occur, you should talk to your doctor as soon as possible. However, do not stop treatment on your own.
Inhalation treatment can cause spasms in the trachea through unclear mechanisms.
Tremors and palpitations may occur, especially at the beginning of treatment. These usually disappear after a certain period of use.
How to store Ventoline Evohaler
- Keep this medicine out of the sight and reach of children.
- Store at a maximum of 30 °C.
- Always replace the protective hood immediately after use. You don’t need to use much force when the protective hood is pressed into place until a click is heard.
- Inhalation spray must be protected from frost and direct sunlight. Risk of impaired function and effect when it is cold.
- The contents of the metal container are under pressure. Do not expose it to temperatures above 50 °C. Must not be punctured, burned, or exposed to other damage, even if the container appears to be empty.
- Use before the expiry date stated on the packaging after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
As drug residues may remain in the empty packaging, these should not be thrown in the rubbish, but the empty packaging should also be returned to the pharmacy.
Contents of the packaging and other information
Contents declaration
The active substance in Ventoline Evohaler is salbutamol. Each dose contains 0.1 mg of salbutamol (as salbutamol sulfate). Other ingredients are norflurane propellant approx. 75 mg per dose.
Appearance and package sizes of the medicine
Ventoline Evohaler inhalation spray is a (blue) plastic inhaler with an aluminum metal container.
Ventoline Evohaler is packed in a cardboard box with a guarantee seal in a pack size of 1 x 200 doses.
Marketing Authorisation Holder
GlaxoSmithKline AB, Box 516, 169 29 Solna
Phone: 08-638 93 00
Email: info.produkt@gsk.com