1. What Ventolin is and what it is used for
Ventolin Solution contains the active substance salbutamol, which belongs to a group of medicines called fast-acting bronchodilators. Rapid-acting bronchodilators relax the muscles in the walls of an air small cape our passages in the lungs within a few minutes. Ventolin Solution:
helps the airways in your lungs open and stay open, making your breathing easier;
helps ease the tightness of chest, wheezing, and cough associated with asthma.
Ventolin Solution is used in adults, adolescents and children aged 4 to 11 years to treat breathing problems in people with bronchial asthma and other lung diseases. Its effect includes alleviation and prevention of asthmatic symptoms caused by physical effort or other causes. Common causes include house dust, pollen, cats, dogs, and cigarette smoke.
If your asthma is active (for example, you have frequent symptoms or seizures or limited physical activity), you should tell your doctor about it so that he or she can decide whether to start or increase your asthma medication, such as, for example, inhaled corticosteroids.
Ventolin Solution is usually used to overcome severe forms of the disease - to control severe seizures of bronchial asthma when taking salbutamol in another dosage form does not improve the condition.
The duration of action of salbutamol in most patients is 4-6 hours.
Ventolin The solution should only be administered by inhalation and should be inhaled through the mouth. Apply with a nebuliser or respirator only at the instructions given by the doctor.
The solution should not be injected or ingested.
2. What you need to know before using Ventolin Solution
Do not use Ventolin Solution:
if you are allergic (hypersensitive) to salbutamol or any of the other ingredients of the Ventolin Solution (listed in section 6).
If you think any of the above applies to you, do not use Ventolin Solution before discussing it with your doctor.
Take special care with Ventolin Solution
Before using Ventolin Solution, your doctor needs to know if:
you have high blood pressure ;
you have hyperfunction of the thyroid gland ;
before you have had heart problems such as irregular or rapid heart rhythm or angina (chest pain);
you have low potassium levels in the blood;
take xanthine derivatives (such as theophylline) or steroids to treat asthma;
take diuretics that are sometimes used to treat high blood pressure or heart disease.
If you are taking any of the medicines listed above, your doctor will monitor the level of potassium in your blood.
Talk to your doctor if you think any of the following conditions may apply to you:
You are diabetic.
Use nebulized anticholinergics (such as ipratropium bromide) as well as salbutamol. Make sure that the fine mist of the aerosol does not fall into your eyes (see section 7).
Take medications to relieve runny nose and blocked nose (such as ephedrine or pseudoephedrine) or other medicines to treat asthma.
Conditions you should monitor
In rare cases, high doses of Ventolin may cause a condition known as lactic acidosis. You should check for symptoms associated with this condition while taking Ventolin Solution (see Conditions to be followed in section 4 of this leaflet) to reduce the risk of any problems.
Other medicines and Ventolin Solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Some medicines can affect the way Ventolin Solution works or increase the risk of developing side effects. Such drugs are:
Beta-blockers such as propranolol used to treat high blood pressure or heart disease.
Your doctor or pharmacist will decide whether you should take Ventolin Solution with these medicines.
Pregnancy and breast-feeding
Ventolin Solution is usually not recommended for use during pregnancy. If you are pregnant, think you may be pregnant or planning to become pregnant, do not take Ventolin Solution before consulting your doctor. Your doctor will evaluate the expected benefit of your treatment for the potential risk for the baby when taking Ventolin Solution during pregnancy.
It is not known whether the ingredients of Ventolin Solution pass into breast milk. If you are breast-feeding, you should consult your doctor before taking Ventolin Solution.
Driving and using machines
There is no indication of the effect of Ventolin Solution on the ability to drive or use machines.
3. How to use Ventolin Solution
What dose to take
Intermittent treatment (irregular administration of small doses if necessary):
Intermittent treatment can be given up to four times a day.
The usual starting dose is 0.5 ml to 1 ml (2.5 mg - 5 mg salbutamol);
Some patients may require a dose of up to 2 ml (10 mg of salbutamol).
Children aged 4 to 11 years
The starting dose is usually 0.5 ml (2.5 mg salbutamol);
Some patients may require a dose of up to 1 ml (5 mg of salbutamol).
Children over 12 years of age: the dose is the same as in adults.
Prolonged use (prolonged inhalation):
The usual dose is 1 mg to 2 mg of Ventolin Solution per hour. A dose of 1 mg is achieved by diluting 1 ml of Ventolin Solution with sterile saline to 100 ml. A dose of 2 mg is achieved by diluting 2 ml of Ventolin Solution with sterile saline to 100 ml.
How to use Ventolin Solution
Ventolin Solution should not be injected or ingested
Remember: Ventolin The solution should be inhaled orally by a device called a nebuliser and should not be injected or ingested. The nebulizer converts the drug into an aerosol which is inhaled by a breathing mask or a mouth-applicator.
Care must be taken to ensure that the solution or nebuliser formed by the aerosol does not get into the eyes.
The nebuliser should be used in rooms with good ventilation, as part of the aerosol can get into the air and be inhaled by other people.
Carefully follow the instructions for use listed in section 7.
If you forget to take Ventolin Solution
Do not take a double dose to make up for forgotten.
Inhale the next dose when it is time for this or earlier if wheezing or other symptoms of asthma occur.
If you take too much Ventolin Solution
If you take too much Ventolin Solution, ask your doctor or pharmacist for advice. If possible, show them the pack of Ventolin Solution,
Do not stop taking Ventolin Solution without a doctor's advice
Take Ventolin Solution for as long as your doctor has told you.
Keep taking until your doctor tells you to stop.
4. Possible side effects
If your breathing or wheezing gets worse right after taking this medicine, stop using it immediately and tell your doctor as soon as possible. If you have another fast-acting asthma medication available, apply it as soon as possible.
Like all medicines, Ventolin Solution can cause side effects, although not everyone gets them.
Conditions to Monitor
Allergic reactions: These are very rare in people taking Ventolin Solution. Signs include:
skin rash (urticaria) or redness;
swelling, sometimes on the face or mouth (angioedema);
wheezing, coughing or difficulty in breathing;
a sudden sensation of weakness or fainting (which may lead to collapse or loss of consciousness).
Contact a doctor immediately if you get any of these symptoms. Stop taking Ventolin Solution.
Lactic acidosis: increasing the amount of lactic acid in the blood (lactic acidosis) is a very rare side effect of Ventolin Solution. Most often it affects people with severe kidney disease. Symptoms of lactic acidosis include:
rapid breathing, shortness of breath (despite the possible disappearance of other signs of bronchospasm, such as wheezing);
stomach pain, nausea and vomiting.
Contact your doctor immediately if you experience these symptoms. Stop taking Ventolin Solution.
Common side effects - these may affect up to 1 in 10 people:
increased heart rate.
Uncommon side effects - these may affect up to 1 in 100 people:
irregular heartbeat (palpitations);
irritation in the mouth and throat;
Rare side effects - these may affect up to 1 in 1,000 people:
low potassium levels in your blood;
increased blood flow to your limbs (expansion of the blood vessels).
Very rare side effects - these may affect up to 1 in 10,000 people:
unusual activity, such as anxiety and excitement.
Very rare side effects that may occur in blood tests - these may affect up to 1 in 10,000 people:
Communicating side effects
If you get any side effects, talk to your doctor or pharmacist. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed below. As you report side effects, you can contribute to getting more information on the safety of this medicine.
Executive Agency for Drugs ,
8, Damian Gruev Str.,
tel .: +359 2 8903417,
5. How to store Ventolin Solution
Keep out of the reach and sight of children.
Store below 25 ° C. Keep away from direct sunlight.
Any unused quantities of solution remaining in the nebuliser should be discarded. The remainder of the medicine in the package should not be used if it has been more than 1 month after the bottle has been opened for the first time.
Do not use Ventolin after the expiry date which is stated on the packaging.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Ventolin contains Solution
The active substance is salbutamol (in the form of sulphate). Each 1 ml of solution contains 5 mg of salbutamol in the form of salbutamol sulphate.
The other ingredients are: benzalkonium chloride, dilute sulfuric acid and purified water.
What Ventolin looks like and contents of the pack
Ventolin Solution is a solution that is sprayed before inhalation into a device called nebuliser. Each pack of Ventolin Solution contains a glass bottle with 20 ml of solution.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
GlaxoSmithKline EOOD, Bulgaria.
Glaxo Wellcome Operations, UK.
7. Instructions for use
How to use Ventolin Solution
1. Prepare the nebulizer for filling.
2. Measure the right amount of Ventolin Solution and put it in the Nebulizer Cup.
3. Add the correct amount of sterile saline. To dilute the Ventolin Solution use only sterile saline solution.
4. Put the cap on the nebuliser cup and shake it gently to mix the contents.
5. Assemble the nebulizer and use it as instructed for use.
6. After use, discard unused amounts of solution remaining in the nebuliser cup. Clean the nebulizer as recommended in its instructions for use.
8. Information for the physician
Duration of use (continuous inhalation):
Ventolin The solution is diluted with sterile saline until concentrations of 50 to 100 micrograms of salbutamol per ml (1 ml to 2 ml of Ventolin solution are diluted to 100 ml with diluent ). The diluted solution is administered as an aerosol by a suitable nebuliser. The usual rate of administration is 1 mg to 2 mg per hour.
Precautions for disposal and handling
Ventolin The solution may be diluted with sterile saline. Any unused quantities of solution remaining in the nebuliser should be discarded.