2 mg/ml solution for nebulizer
Salbutamol
What Ventoline is and what it is used for
Ventoline is a bronchodilator medicine that makes breathing easier.
Ventolin is used for:
- symptom relief of bronchial contractions in asthma
- relief of severe acute and chronic respiratory conditions (COPD).
What you need to know before using Ventoline
Do not take Ventolin:
- 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.
Before starting treatment with Ventoline, 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 (sugar disease).
In isolated cases, eye problems ( glaucoma with a narrow chamber angle ) have been reported, when Ventoline was combined with ipratropium bromide and the solution got into the eyes. People suffering from glaucoma or showing signs of eye disease should avoid this combination.
Eye irritation and pain, visual phenomena, blurred vision, and red, irritated eyes can be signs of acute angle-closure glaucoma . See an ophthalmologist immediately in such cases.
If the asthma symptoms increase or if the effect of Ventoline worsens, a doctor should be contacted immediately. Do not exceed the prescribed dosage.
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
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 and certain other medicines are taken at the same time. Therefore, consult a doctor before taking other concomitant medication. Certain antihypertensive drugs ( beta blockers ) can cancel out the effect of Ventoline.
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.
No adverse effects on the fetus have been demonstrated when using Ventoline 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
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The dose is determined by the doctor, who adjusts it individually for you.
The medicine is inhaled using a special inhalation device ( nebulizer ). Instructions for how to use this are provided by healthcare personnel.
Adults and children aged 12 and over
For adults and children from 12 years of age, a usual starting dose of salbutamol is 2.5 mg which can be increased to 5 mg if necessary and which is inhaled via nebulizer up to 4 times daily.
Children
For children under 12 years of age, a usual starting dose of salbutamol inhaled via nebulizer is 2.5 mg up to 4 times daily.
For children under 4 years of age, no recommendations can be made for dosage as the effect has not yet been established.
Other forms of preparation may be more appropriate to give to children under 4 years of age.
If you have taken too much Ventoline
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 (may affect more than 1 in 100 people)
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. Lactic acidosis (a condition with increased lactic acid production in the body). 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
- Keep this medicine out of the sight and reach of children.
- Store at a maximum of 30°C.
- Store in the original packaging. Light sensitive.
- Use before the expiry date stated on the packaging after the Expiration date. The expiration date is the last day of the specified month.
- Broken foil packaging of 10 single-dose containers must be used within 3 months. Any remaining contents of the single-dose container are discarded.
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.
Contents of the packaging and other information
Contents declaration
The active substance in the Ventoline solution for the nebulizer is salbutamol. 1 ml of solution contains 2 mg of salbutamol (as salbutamol sulfate). Other ingredients are sodium chloride, and sulfuric acid (for pH adjustment to 4).
The solution does not contain preservatives.
Each single-dose container of 2.5 ml contains 5 mg of salbutamol.
The single-dose container is ready to use without dilution.
Appearance and package sizes of the medicine
Packaging size 60 single-dose containers packed in the foil of 10 pieces.
Marketing Authorisation Holder:
GlaxoSmithKline AB, Box 516, 169 29 Solna
Phone: 08-638 93 00
Email: info.produkt@gsk.com
Manufacturer:
Aspen Bad Oldesloe GmbH
Industriestrasse 32-36, 23843 Bad Oldesloe, Germany