100 micrograms/dose inhalation powder
salbutamol
What Ventilastin Novolizer is and what it is used for
Ventilastin Novolizer 100 micrograms/dose, inhalation powder is approved for adults, adolescents, and children between 6 and 12 years of age.
The active substance in Ventilastin Novolizer is an asthma medicine that dilates the airways ( beta stimulator ).
Ventilastin Novolizer is used for
- Symptomatic treatment of conditions with accompanying reversible narrowing of the airways, e.g. asthma or chronic obstructive pulmonary disease (COPD), when the symptoms are characterized by substantial reversibility.
- Prevention of asthma attacks triggered by exertion or allergen exposure.
The salbutamol contained in Ventilastin Novolizer may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Ventilastin Novolizer
Do not use Ventilastin Novolizer
if you are allergic (hypersensitive) to salbutamol, lactose, and/or milk protein that is part of lactose.
Warnings and precautions
Talk to your doctor or pharmacist before using Ventilastin Novolizer.
Be especially careful when using Ventilastin Novolizer,
if you have any of the following conditions:
- Severe heart disease, especially if you have had a recent heart attack
- Coronary artery disease, a certain chronic heart muscle disease ( hypertrophic obstructive cardiomyopathy ), and heart rhythm disorders characterized by a rapid pulse ( tachyarrhythmia )
- High blood pressure (severe, untreated hypertension )
- Abnormal enlargement of a blood vessel ( aneurysm )
- Over function of the thyroid gland ( hyperthyroidism )
- Intractable diabetes
- A certain disease of the adrenal medulla ( phaeochromocytoma )
Before you start taking this medicine, tell your doctor if you have previously had any heart disease or angina pectoris. Contact your doctor if you experience chest pain or other symptoms of worsening of your heart disease.
Caution should be exercised when treating acute asthma attacks or exacerbations of severe asthma as elevated levels of serum lactate (increased levels of lactate in the blood), and on rare occasions, lactic acidosis (a condition of increased lactic acid production in the body), have been reported following the use of high doses of salbutamol. This is transient by reducing the dose of salbutamol.
Before using the Novolizer powder inhaler for the first time, your doctor should have given you instructions on how to use the device correctly.
The treatment is about the severity of the disease.
If you have permanent (persistent) asthma, the treatment must not consist only of Ventilastin Novolizer. Increased need for bronchodilator medication such as Ventilastin Novolizer is a sign of worsening of the disease. Doctors should be contacted to adjust the treatment schedule. Sudden and progressive worsening of asthma symptoms can be life-threatening, and in such cases, a doctor should be contacted immediately.
Excessive use (especially of single doses for acute attacks as well as of the daily dosage ) should be avoided as it may entail risks due to the drug’s effect on the heart. Other side effects can also get worse.
An important part of the treatment consists of daily self-monitoring of the symptoms according to the instructions given by the attending physician. This is needed to assess how the disease develops and to evaluate the treatment with Ventilastin Novolizer and other medicines that you use for your disease. This check can take place e.g. by regular measurement of forced exhalation using a PEF meter.
If you have diabetes
Large doses of inhaled Ventilastin Novolizer can raise blood sugar levels. Therefore, the blood sugar of diabetics must be monitored closely.
Other medicines and Ventilastin Novolizer
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those without a prescription.
- Treatment with salbutamol can cause hypokalaemia (low potassium in the blood) which can be worsened by some other medicines. This includes other medicines for asthma, such as xanthine derivatives (e.g. theophylline) or steroids (e.g. prednisolone ), or medicines for other diseases, e.g. diuretics ( eg furosemide ) or digoxin. You must tell your doctor if you are using any of these medicines. The doctor may then want to take a blood test to check the potassium level in your blood.
- You should also tell your doctor if you are taking beta-blockers (eg atenolol) for high blood pressure or angina pectoris (angina pectoris) or medicines to treat depression (eg moclobemide, phenelzine, amitriptyline, clomipramine or imipramine).
- Some anesthetics can also affect or be affected by salbutamol and cause breathing difficulties. If you are going to undergo an operation, it is therefore important that you tell the healthcare staff that you are taking Ventilastin Novolizer.
Please note that this may also apply to medicines that you have recently used.
Pregnancy, breastfeeding, and fertility
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.
During pregnancy, and especially during the first three months of pregnancy and towards the end of pregnancy, you should use Ventilastin Novolizer only if your doctor has specifically prescribed it and even then only if your doctor considers it necessary.
Inhaled salbutamol preparations are not suitable for the treatment of premature labor. They should also not be used in case of threatened miscarriage.
Salbutamol, the active substance in Ventilastin Novolizer, can pass into breast milk. Therefore, Ventilastin Novolizer may be used by breastfeeding women only if a doctor has expressly prescribed this.
Driving ability and use of machinery
No studies have been performed.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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 a doctor or pharmacist if you are unsure.
Ventilastin Novolizer contains milk sugar (lactose),
11.42 mg lactose monohydrate per inhalation. Normally, the amount of lactose in a single dose does not cause problems for people with lactose intolerance. If you suspect you are lactose intolerant, discuss this with your doctor.
Lactose contains small amounts of milk protein.
How to use Ventilastin Novolizer
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Your doctor will give you detailed instructions on how to use Ventilastin Novolizer correctly. Children may use this medicine only under the supervision of an adult and by the doctor’s instructions.
The recommended dose depends on the nature, severity, and course of the disease.
If you think that Ventilastin Novolizer has too strong or too weak an effect, discuss this with your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the following dosage is recommended for adults (including elderly patients and adolescents):
For acute treatment of sudden spasms of the trachea or attack of shortness of breath: take one (1) inhalation (100 micrograms).
For the prevention of exercise-induced asthma or in case of allergen contact: take two (2) inhalations (200 micrograms) about 10-15 minutes before provocation
The maximum dosage during 24 hours must not exceed 8 inhalations (equivalent to 800 micrograms).
Children (6–12 years)
For acute treatment of sudden spasms of the trachea or attack of shortness of breath: take one (1) inhalation (100 micrograms).
For prevention of exercise-induced asthma or allergen exposure: take one (1) inhalation (100 micrograms) approximately 10-15 minutes before the challenge and one (1) additional dose as needed (total dose: 200 micrograms).
The maximum dosage during 24 hours must not exceed 4 inhalations (equivalent to 400 micrograms).
Children under 6 years
Ventilastin Novolizer is not recommended for children under 6 years of age due to insufficient data regarding safety and efficacy.
All patients
In an acute attack of shortness of breath, a single inhalation often provides rapid symptom relief. If the symptoms do not noticeably improve within 5-10 minutes after one inhalation, another inhalation can be taken. At least four hours must pass between each dose (where a dose is defined as 1 or 2 inhalations ).
If a severe attack of shortness of breath does not subside after the second inhalation or if the patient is unable to dose with the Ventilastin Novolizer inhaler during an asthma attack, contact a doctor immediately.
If salbutamol treatment is needed daily to relieve symptoms when needed, consideration should be given to supplementing the treatment with regular anti-inflammatory treatment.
When any other salbutamol inhaler is replaced with the Ventilastin Novolizer inhaler, the amount of salbutamol reaching the lungs may vary. In these cases, the doctor may need to adjust the treatment schedule.
Dosage method
For inhalation.
Inhale according to the instructions in the instructions for use.
If you have taken too much Ventilastin Novolizer
If you have ingested too much medicine or if, for example, If a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Overdose produces symptoms and signs similar to the side effects described below. The side effects then appear quickly and probably with greater intensity.
Typical signs and symptoms of overdose are palpitations, irregular and/or rapid pulse, strong tremors especially in the hands, restlessness, sleep disturbances, and chest pain.
If these problems occur, seek medical attention immediately.
If you forget to take Ventilastin Novolizer
Do not take a double dose to make up for a missed dose
If you stop using Ventilastin Novolizer
Do not stop treatment with Ventilastin Novolizer without first talking to your doctor, as this may lead to the worsening of the disease.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If shortness of breath immediately worsens after an inhalation, contact a doctor immediately.
Under certain conditions, some of the side effects mentioned below can be life-threatening (e.g. dangerously fast heart rate ). Therefore, a doctor must be consulted immediately if such a side effect occurs suddenly and/or if it has an unexpected intensity.
Common side effects (which may occur in up to 1 in 10 users) are i.a. altered sense of taste (bad, unpleasant, unusual taste), irritation in the mouth and throat as well as a burning sensation on the tongue, cough, trembling fingers or hands ( tremor ), dizziness, nausea, sweating, restlessness, and headache. These side effects may subside within 1–2 weeks with continued treatment.
Rare side effects (may affect up to 1 in 1,000 users):
The heart and blood vessels:
Rapid pulse, heart rhythm disturbances (including atrial fibrillation ), extra heartbeats, palpitations, altered blood pressure (low or high), and blood vessel dilation ( peripheral vasodilatation ).
Metabolism/electrolytes:
Low potassium content in the blood ( hypokalemia ), high blood sugar ( hyperglycemia ), increased levels of insulin, free fatty acids, glycerol, and ketone bodies
Nervous system and mental disorders:
Overactive behavior (especially in children up to 12 years old)
Musculoskeletal system:
Muscle aches and muscle cramps
Respiratory tract:
Coughing and attacks of shortness of breath during/after inhalation (paradoxical bronchospasm )
In very rare cases (which may affect up to 1 in 10,000 users), the following side effects may occur:
- 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. Contact a doctor immediately if you experience any of these reactions.
- Decreased number of platelets ( thrombocytopenia )
- Inflammation of the kidneys (nephritis)
- Collapse
- Overactivity and sleep disorders. Delusions (hallucinations) (especially in children up to 12 years of age).
In very rare cases, some people may experience chest pain (as a sign of angina). Tell your doctor as soon as possible but do not stop taking your medicine unless you are told to.
Lactose monohydrate contains smaller amounts of milk proteins and can therefore cause allergic reactions.
How Ventilastin Novolizer should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label, carton, and cassette container. The expiration date is the last day of the specified month.
Store at a maximum of 30 ºC. Moisture sensitive.
Store the refill cartridge in the original packaging until first use.
Replace the cartridge 6 months after opening the package.
Do not use the powder inhaler for longer than 1 year.
Note: The Novolizer inhaler has been tested and found to work for at least 2,000 individual dosing years. Thus, a maximum of 10 cartridges of 200 doses can be used with this inhaler (within one year) before it is replaced.
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 is salbutamol.
- One dose ( inhalation ) contains 100 micrograms of salbutamol (as sulfate).
- The second ingredient is lactose monohydrate.
Appearance and package sizes of the medicine
Ventilastin Novolizer inhalation powder is a white powder in a cassette and is available in the following pack sizes:
Original packaging:
1 cassette with 200 doses, filled with at least 2.308 g of the powder packed in a plastic container sealed with aluminum foil and 1 powder inhaler (= Novolizer).
Refill packs:
1 cassette of 200 doses, filled with at least 2.308 g of the powder packed in a plastic container sealed with aluminum foil.
2 cassettes of 200 doses each, filled with at least 2.308 g of the powder packed in plastic containers sealed with aluminum foil.
Hospital packaging:
Packaging with 10 original packagings.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Viatris AB
Box 23033
104 35 Stockholm
Manufacturer
McDermott Laboratories T/A Mylan Dublin
Respiratory
Unit 25 Baldoyle Industrial Estate
Grange Road, Baldoyle
Dublin 13
Ireland