VENTOLIN 100 MICROGRAMMI Aerozol ciśnieniowy do inhalacji

Treść ulotki

1. Ventolin 100 micrograms pressurized suspension
   1. What is Ventolin pressurised suspension and what it is used for
   2. What you need to know before using Ventolin pressurised suspension
   3. How to use Ventolin pressurized suspension
   4. Possible side effects
2. Ventolin 2 mg/10 ml Syrup
   1. What is Ventolin Syrup and what it is used for
   2. What you need to know before using Ventolin Syrup
   3. How to use Ventolin Sciroppo
   4. Possible side effects
   5. How to store Ventolin Syrup
   6. Package Contents and Other Information
3. Ventolin 500 micrograms/1 ml Injectable Solution
   1. What is Ventolin injectable solution and what is it used for
   2. What you need to know before using Ventolin injectable solution
   3. How to use Ventolin injectable solution
   4. Possible side effects
4. Ventolin 100 micrograms/5 ml Injectable Solution
   1. What is Ventolin injectable solution and what it is used for
   2. What you need to know before using Ventolin injectable solution
   3. How to use Ventolin injectable solution
   4. Possible side effects
   5. How to store Ventolin
   6. Contents of the pack and other information

Ventolin 100 micrograms pressurized suspension

salbutamol sulfate

Read this leaflet carefully before you start to take this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you want any further information or advice, ask your doctor, pharmacist or nurse.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Ventolin pressurized suspension is and what it is used for
• 2. What you need to know before you use Ventolin pressurized suspension
• 3. How to use Ventolin pressurized suspension
• 4. Possible side effects
• 5. How to store Ventolin pressurized suspension
• 6. Contents of the pack and other information

1. What is Ventolin pressurised suspension and what it is used for

Ventolin pressurised suspension contains a medicinal product called salbutamol. It belongs
to a group of medicines called bronchodilators.

• Bronchodilators help the airways in the lungs to stay open. This makes it easier for air to enter and exit.
• They help to relieve chest tightness, wheezing and coughing.

Ventolin pressurised suspension is used for the treatment of serious breathing problems in people with
asthma and similar conditions.
This includes the relief and prevention of asthma caused by exercise or other " trigger". Triggers
are factors that can trigger asthma symptoms in some people.
Common triggers include house dust, pollen, cats, dogs and cigarette smoke.
Ventolin Evohaler contains a propellant called HFA 134a. This is less harmful to the environment
than older inhalers. Older inhalers may have a different taste than Ventolin suspension
pressurised. This will not make any difference to how the medicine works.

2. What you need to know before using Ventolin pressurised suspension

Do not use Ventolin pressurised suspension

• if you are allergic to salbutamol sulfate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult a doctor, nurse or pharmacist before taking Ventolin suspension
pressurisedif:

• Your asthma is active (for example if you have frequent symptoms or exacerbations or limited physical performance). The doctor may start you on, or increase the dose of, an asthma control medicine such as an inhaled corticosteroid.
• if you have high blood pressure
• have an overactive thyroid gland
• if you have a history of heart disease characterised by irregular or fast heartbeat or angina.
• If you are taking xanthine derivatives (such as theophylline) or steroids for the treatment of asthma.
• If you are taking diuretics, sometimes used to treat high blood pressure or a heart condition.

If you think this medicine is not working as well as it should for you
If the medicine seems not to be working as well as usual, tell your doctor as soon as possible. Your chest problems may be getting worse and you may need different medicine. Do not take further
doses of Ventolin pressurised suspension unless your doctor tells you to do so.

Other medicines and Ventolin pressurised suspension
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might
take any other medicines, including those obtained without a prescription. This includes herbal
remedies. If you need to go to hospital remember to take this medicine with you.
In particular, tell your doctor, nurse or pharmacist if you are taking any of the following:

• medicines for irregular or fast heartbeat
• other medicines for asthma.

Ventolin pressurised suspension with food and drink
You can use Ventolin pressurised suspension at any time of day, with or without
food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor, nurse or pharmacist for advice before using this medicine.

Driving and using machines
It is unlikely that Ventolin will affect your ability to drive or operate machinery.

For athletes
The use of the drug without therapeutic need constitutes doping and may still result in a positive
doping test.

3. How to use Ventolin pressurized suspension

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor,
nurse or pharmacist.

Adults and adolescents aged 12 years and over

• to relieve asthma - one or two inhalations
• to prevent asthma - two inhalations 10-15 minutes before exercise or exposure to a “ trigger”
• for regular treatment - two inhalations up to 4 times a day
• the maximum dose is 8 inhalations within 24 hours.

Children under 12 years of age

• to relieve asthma - one spray. Two inhalations if necessary.
• to prevent asthma - one spray 10-15 minutes before exercise or exposure to a “ trigger”. Two inhalations if necessary.
• for regular treatment - two inhalations up to 4 times a day
• the maximum dose is 8 inhalations within 24 hours.

Instructions for use

• Ventolin pressurized suspension produces a fine mist, which is inhaled into the lungs through the mouth. The doctor, nurse or pharmacist must show you how to use the inhaler. If you are not sure, ask your doctor, nurse or pharmacist.
• Each pressurized suspension canister provides 200 inhalations.

Do not use the inhaler more often than your doctor has told you to. Tell your doctor if the
medicine does not seem to work as well as usual, as your chest tightness problems
may worsen and you may need different medicine. Your doctor may have told you to
take additional doses since this is an emergency treatment in case your shortness of breath or
breathing worsens. It is very important to take the medicine according to your doctor's instructions on how
many inhalations to take and how often to use the inhaler.

a Checking the inhaler is working 1 When using the inhaler for the first time, i test if it is working. Remove the cap z from the mouthpiece by gently pressing the sides with the n thumb and index finger and pull it off. 2 To make sure it works, shake well, e point the mouthpiece away from you and spray one dose into the air. If you haven't used the inhaler for g 5 days or more, shake it well and spray into the air for two times.

A Using the inhaler Before using the inhaler it is important to start to breathe as slowly as possible. 1 When using the inhaler remain standing or sitting upright.

2 Remove the mouthpiece cap (as shown in the first image). Check inside and outside that the mouthpiece is clean and free from objects.	o
3 Shake the inhaler 4 or 5 times to make sure that any objects are removed and that the contents of the inhaler are mixed evenly.	a r m a c
4 Hold the inhaler in an upright position with the thumb on the base, under the mouthpiece. Exhale until you are comfortable. Do not inhale yet.	d e l F
5 Place the mouthpiece in your mouth between your teeth. Close your lips around it. Do not a bite it. i l a	n a
t 6 Inhale through your mouth. Immediately after I starting to inhale, press down on the canister cap to release a spray of medicine. Do this while inhaling steadily and deeply. i z
n 7 Hold your breath; remove the inhaler from your mouth and your finger from the top of the inhaler. e Continue to hold your breath for a few seconds or longer if you are comfortable. g
A 8 If your doctor has told you to take two inhalations, wait about half a minute before inhaling another dose repeating steps 3 to 7.
9 After use, replace the mouthpiece cap to prevent dust from settling on it. Close the cap firmly by pressing it until you hear the snap when it is in place.

For the first few times, practice in front of a mirror. If you see a 'mist' coming from the
top of the inhaler or from the sides of your mouth, you must start over.
Younger children may need help and their parents may have to use
the inhaler for them.
Encourage the child to exhale and use the inhaler only after the child starts to inhale.
Practice the technique together. You can try the Volumatic® spacer device, with a mask, or the Babyhaler® device may be useful if you need to administer Ventolin pressurized suspension
to a child under 5 years of age - talk to your doctor if you think you may
need to use one of these devices.
Older children or people with weak hands may find it easier to hold the inhaler with
both hands. Place both index fingers on top of the inhaler and both thumbs on the bottom
under the mouthpiece. Your doctor, nurse or pharmacist will be able to advise you.

Cleaning the inhaler
To prevent the inhaler from becoming blocked, it is important to clean it at least once a week.
To clean the inhaler:

• Remove the metal canister from the plastic casing.
• Rinse the plastic casing with plenty of lukewarm running water.
• Dry the plastic casing thoroughly inside and out.
• Replace the canister in the plastic casing and put the mouthpiece cap back in place. Do not put the metal container in water.

If you use more Ventolin pressurized suspension than you should
If you use more than you should, consult your doctor as soon as possible.
You may have the following effects:

• your heart beats faster than usual
• you feel tremors
• you are hyperactive These effects usually disappear within a few hours.

If you forget to use Ventolin pressurized suspension

• If you forget a dose, take it as soon as you remember.
• However, if it is already time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a missed dose.

If you stop taking Ventolin pressurized suspension
Do not stop taking Ventolin pressurized suspension without first consulting your doctor.
If you have any doubts about using this medicine, ask your doctor, nurse or pharmacist.

4. Possible side effects

If your breathing or wheezing gets worse immediately after taking this medicine, stop using it
immediately, and inform your doctor as soon as possible.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with this medicine:

Allergic reactions(may affect up to 1 in 10,000 people)
If you have an allergic reaction, stop using Ventolin pressurized suspension and seek immediate
medical attention.
The signs of an allergic reaction include: swelling of the face, lips, mouth, tongue or throat which may
cause difficulty swallowing or breathing, itchy rash, feeling of faintness and
dizziness, and collapse.

See your doctor as soon as possible if:

• you feel your heart beating faster or stronger than usual (palpitations). This is usually a harmless symptom, and usually stops after using the medicine for a while.
• you can feel an irregular heartbeat or an extra beat (these effects may affect up to 1 in 10 people).

If any of these effects occur, see your doctor as soon as possible. Do not stop using the
medicine unless you are told to do so.
Tell your doctor if you have any of the following side effects that may also occur with this
medicine:
Common(may affect up to 1 in 10 people)

• tachycardia
• feeling of tremor
• headache.

Uncommon(may affect up to 1 in 100 people)

• palpitations
• irritation to the mouth and throat
• muscle cramps

Rare(may affect up to 1 in 1,000 people)

• low levels of potassium in the blood
• increased blood flow to the extremities (peripheral vasodilation).

Very rare(may affect up to 1 in 10,000 people)

• unusual or irregular heartbeats
• hyperactivity
• paradoxical bronchospasm

The following effects may occur very rarely:

• chest pain, due to heart problems such as angina. Tell your doctor, nurse or pharmacist if this happens. Do not stop using the medicine unless you are told to do so.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. Side effects can also be reported directly through the
reporting system for side effects contributes to providing more information on the safety of this
medicine.

5How to store Ventolin

• Keep this medicine out of the sight and reach of children.
• Do not store above 30°C. Protect from frost and direct sunlight.
• If the inhaler is very cold, remove the metal canister from the plastic container and warm it between your hands for a few minutes before use. Do not use anything else to warm it.
• The metal canister contains a liquid under pressure. Do not expose to temperatures above 50°C. Do not puncture, break or burn the inhaler even when it is empty.
• Do not use this medicine after the expiry date which is stated on the label and carton after 'EXP'. The expiry date refers to the last day of that month.

Do not dispose of any medicine via water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. These will help to protect the environment.

6Contents of the pack and other information
What Ventolin pressurized suspension contains

• The active ingredient is salbutamol sulfate.
• The other ingredient is HFA 134a.

Description of Ventolin pressurized suspension and contents of the pack
Ventolin pressurized suspension comprises an aluminium alloy canister sealed with a
valve stem, an actuator and a dust cap.
Each canister contains 200 doses of 100 micrograms of salbutamol (as salbutamol sulfate).

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A.
Viale dell’Agricoltura, 7
37135 Verona, Italy

Manufacturer
Glaxo Wellcome Production - 23 Rue Lavoisier - Zone Industrielle, 2 - Evreux - France
Glaxo Wellcome S.A. - Avenida de Extremadura, 3 - Aranda de Duero (Burgos) – Spain

Ventolin 2 mg/10 ml Syrup

salbutamol sulfate

Read this leaflet carefully before you start to take this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you want more information or advice, ask your doctor, nurse or pharmacist.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, nurse or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Ventolin Syrup is and what it is used for
• 2. What you need to know before you use Ventolin Syrup
• 3. How to use Ventolin Syrup
• 4. Possible side effects
• 5. How to store Ventolin Syrup
• 6. Contents of the pack and other information

4. What is Ventolin Syrup and what it is used for

Ventolin Syrup contains an active ingredient called salbutamol. It belongs to a group of
medicines called short-acting bronchodilators.

• Bronchodilators help the airways in the lungs to stay open. This makes it easier for air to pass through.
• They help to relieve chest tightness, wheezing and coughing.

Ventolin Syrup is used for the treatment of breathing problems in people with asthma and similar
conditions. The syrup is used when children and adolescents between the ages of 3 and 12 years and
adults cannot use an inhaler device.

5. What you need to know before using Ventolin Syrup

Do not use Ventolin Syrup

• if you are allergic to salbutamol sulfate or any of the other ingredients of this medicine (listed in section 6)
• if you have an unexpected threat of abortion.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Ventolin Syrupif:

• you have high blood pressure
• you are diabetic
• you have hyperthyroidism (overactive thyroid)
• you have low levels of potassium in your blood (hypokalaemia)
• you have glaucoma (high pressure inside the eye)
• you have a pheochromocytoma (adrenal gland tumor that causes the release of substances into the body that increase blood pressure)
• you have thyrotoxicosis (illness due to excess thyroid hormones in the blood)
• you have prostatic hypertrophy (enlarged prostate)
• you have a history of heart problems, such as irregular or fast heartbeat or angina.

Other medicines and Ventolin Syrup
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines, including those obtained without a prescription. This includes herbal
medicines. Remember to take this medicine with you if you need to go to hospital.
In particular, tell your doctor, nurse or pharmacist if you are taking any of the following:

• medicines for irregular or fast heartbeat
• other beta-blockers (such as propranolol)
• xanthine medicines (used to help with breathing)
• steroid medicines
• diuretic medicines
• medicines for diabetes that lower blood sugar
• other medicines for asthma.

If you think this medicine is not working as well as it should
If the medicine seems to be not working as well as usual, tell your doctor as soon as possible. Your chest
problems may get worse and you may need a different medicine. Do not take further
doses of Ventolin Syrup unless your doctor tells you to do so.

Ventolin Syrup with food and drink
You can use Ventolin Syrup at any time of day, with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor, nurse or pharmacist for advice before using this medicine.

Driving and using machines
It is unlikely that Ventolin Syrup will affect your ability to drive or operate
machinery.

Ventolin Syrup contains sodium
Ventolin Syrup contains 11.2 mg of sodium (the main component of table salt) per each 10 ml dose
of syrup. This is equivalent to 0.56% of the recommended maximum daily intake with the
diet of an adult.

Ventolin Syrup contains benzoate
Ventolin Syrup contains 20 mg of benzoate per 10 mL. Benzoate may increase jaundice
(yellowing of the skin and eyes) in newborns up to 4 weeks.

Ventolin Syrup contains benzyl alcohol
Ventolin Syrup contains 0.00006737 mg of benzyl alcohol per unit dose of 10 mL.
Benzyl alcohol can cause allergic reactions. Do not use for more than one week in young children (under
3 years of age) unless otherwise recommended by your doctor or pharmacist. Ask your doctor
or pharmacist if you are pregnant or breastfeeding or if you have a liver or kidney condition. This
is because large amounts of benzyl alcohol can accumulate in the body and cause adverse effects (such as
metabolic acidosis).

Ventolin Syrup contains propylene glycol
This medicine contains 3.79 mg of propylene glycol per 10 ml dose. If the child is
less than 4 weeks old, talk to your doctor or pharmacist before giving this medicine, in
particular if the child is taking other medicines containing propylene glycol or alcohol.
Ventolin Syrup does not contain sugar.

For athletes
The use of the drug without therapeutic necessity constitutes doping and may still result in a positive
doping test.

6. How to use Ventolin Sciroppo

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor,
nurse or pharmacist.

Children aged between 3 and 6 years

• The usual dose is ½-1 teaspoon (1-2 mg), 3 or 4 times a day.

Children aged between 6 and 12 years

• The usual dose is 1 teaspoon (2 mg), 3 or 4 times a day.

Children over 12 years of age

• as for adults.

Adults (over 18 years of age)

• The usual dose is 1 to 2 teaspoons (2-4 mg), 3 or 4 times a day.

Elderly (over 65 years of age)

• 1 teaspoon (2 mg), 3 or 4 times a day.

If you use more Ventolin Sciroppo than you should
If you use more than you should, consult your doctor as soon as possible.
You may experience the following effects:

• your heart beats faster than usual
• you feel tremors
• you are hyperactive
• acid builds up in your body and this can cause faster breathing.

These effects usually disappear within a few hours.

If you forget to use Ventolin Sciroppo

• If you forget a dose, take it as soon as you remember.
• However, if it is already time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a missed dose.

If you stop taking Ventolin Sciroppo
Do not stop taking Ventolin Sciroppo without first consulting your doctor.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With this medicine, the following side effects may occur:

Allergic reactions(may affect up to 1 in 10,000 people)
If you have an allergic reaction, stop using Ventolin Syrup and seek immediate medical attention.
Signs of an allergic reaction include: swelling of the face, lips, mouth, tongue or throat which may
cause difficulty swallowing or breathing, itchy rash, bronchospasm, low blood pressure and collapse.

See your doctor as soon as possible if:

• you feel your heart beating faster or harder than usual (palpitations). This is usually a harmless symptom and usually stops after using the medicine.
• you can feel your heartbeat is irregular or an extra beat
• these effects may affect up to 1 in 10 people.

If any of these effects occur, see your doctor as soon as possible. Do not stop using the
medicine unless your doctor tells you to.
Tell your doctor if you have any of the following side effects which can also occur with this
medicine:
Very common(may affect more than 1 in 10 people)

• tremors.

Common(may affect up to 1 in 10 people)

• headache
• tachycardia (increased heart rate per minute)
• palpitations (feeling of increased heartbeats)
• muscle cramps.

Rare(may affect up to 1 in 1,000 people)

• low levels of potassium in the blood
• increased blood flow to the extremities (peripheral vasodilation).
• heart arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystole.

Very rare(may affect up to 1 in 10,000 people)
or myocardial ischemia (when the blood flow to the heart decreases)

• hyperactivity
• muscle tension.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through the website
Reporting side effects can help provide more information on the safety of this
medicine.

5. How to store Ventolin Syrup

• Keep this medicine out of the sight and reach of children.
• Protect from light.
• Do not use Ventolin Syrup after the expiry date which is stated on the bottle and carton label after 'EXP'. The expiry date refers to the last day of that month.
• If you need to stop taking this medicine, return unused Ventolin Syrup to your pharmacist for disposal.

Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help to protect the environment.

6. Package Contents and Other Information

What Ventolin Syrup Contains

• The active ingredient is salbutamol sulfate.
• The other ingredients are water, sodium citrate, citric acid monohydrate, hypromellose, sodium saccharin, salt (sodium chloride), the preservative sodium benzoate (E211), propylene glycol (E 1520), benzyl alcohol and orange flavour.

Description of the appearance of Ventolin Syrup and package contents
Ventolin Syrup is contained within an amber glass bottle. This is sealed with a
child-resistant plastic cap.
Each bottle contains 200 ml of syrup.
Each bottle contains 2 mg of salbutamol per 10 ml of syrup.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A. – Viale dell’Agricoltura, 7– 37135 Verona (Italy).

Manufacturer
Farmaclair – 440 Avenue du Général De Gaulle - Hérouville Saint Clair – France

Ventolin 500 micrograms/1 ml Injectable Solution

salbutamol sulfate

Read this leaflet carefully before you start to use this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you want more information or advice, ask your doctor, nurse or pharmacist.
• If any side effects occur, including any not listed in this leaflet, tell your doctor, nurse or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Ventolin injectable solution is and what it is used for
• 2. What you need to know before you use Ventolin injectable solution
• 3. How to use Ventolin injectable solution
• 4. Possible side effects
• 5. How to store Ventolin injectable solution
• 6. Contents of the pack and other information

7. What is Ventolin injectable solution and what is it used for

Ventolin injectable solution contains an active substance called salbutamol.
It belongs to a group of medicines called short-acting bronchodilators.

• Bronchodilators help the airways in the lungs to stay open. This makes it easier for air to pass through.
• They help to relieve chest tightness, wheezing and coughing.

Ventolin injectable solution is used for the treatment of severe breathing problems in adults with asthma and
similar conditions.

8. What you need to know before using Ventolin injectable solution

Do not use Ventolin injectable solution

• If you are allergic to salbutamol sulfate or any of the other ingredients of this medicine (listed in section 6).
• If you have an unexpected threat of miscarriage.

Warnings and precautions
Consult a doctor, nurse or pharmacist before receiving an injection of Ventolin solution
injectableif:

• you have high blood pressure
• you have low levels of potassium in your blood (hypokalaemia)
• you have glaucoma (high pressure inside the eye)
• you have a pheochromocytoma (a tumour of the adrenal gland that causes the release into the body of substances that increase blood pressure)
• you have thyrotoxicosis (a condition caused by too much thyroid hormone in the blood)
• you are diabetic
• you have hyperthyroidism (overactive thyroid)
• you have a history of heart disease characterised by shortness of breath, palpitations or angina.

Other medicines and Ventolin injectable solution
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might
take any other medicines, including those obtained without a prescription. This includes herbal
medicines. Ventolin injectable solution can affect the way some
medicines work, and some medicines can affect the way Ventolin injectable solution works.
In particular, tell your doctor, nurse or pharmacist if you are taking any of the following:

• medicines for irregular or fast heartbeat
• other beta-blockers (such as propranolol)
• xanthine medicines (used to help breathing)
• steroid medicines
• diuretics
• medicines for diabetes that lower blood sugar (such as insulin, metformin or glibenclamide)
• other medicines for asthma.

Ventolin injectable solution must not be infused in the same syringe or infusion with other medicines.
If you are on the list for surgery under general anaesthesia, your doctor will stop giving you
Ventolin injectable solution 6 hours before the operation, where possible, to protect you from unwanted effects
(e.g. irregular heartbeat).

If you think this medicine is not working as well as it should
If the medicine seems not to be working as well as usual, tell your doctor as soon as possible. Your chest problems could
get worse and you may need a different medicine.

Ventolin injectable solution with food and drink
You can use Ventolin injectable solution at any time of day, with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor, nurse or pharmacist for advice before using this medicine.

Driving and using machines
It is unlikely that Ventolin will affect your ability to drive or operate machinery.

For athletes
The use of the drug without therapeutic necessity constitutes doping and may still result in a positive
doping test.

Ventolin contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) in a 1 mL vial, i.e. it is essentially
“sodium-free”.

9. How to use Ventolin injectable solution

How the injectable solution is administered
Ventolin injectable solution is usually administered by a doctor or nurse. It can be
administered directly into a vein or muscle (intravenously or intramuscularly). You should never
expect to self-administer this medicine. It will always be administered to you by a
person who is qualified to do so.
The vials are provided with a Break Point, which is an opening system and must be opened with the
following instructions:

• hold the lower part of the vial with one hand
• place the other hand on the upper part of the vial, position your thumb over the colored point and press.

Intramuscular route
The usual dose is 8 micrograms per kilogram of body weight (500 micrograms) to be repeated, if
necessary every four hours.

Intravenous route

• The usual dose is 4 micrograms per kilogram of body weight (from 100 micrograms to 250 micrograms) administered slowly (3-5 minutes).
• It is injected slowly and can be repeated, if necessary.
• Ventolin injectable solution can be diluted with 10 ml of water for injectable preparations.

Infusion route

• In status asthmaticus and other forms of severe bronchospasm, the usual dosage of Ventolin Injectable Solution is equal to 10 micrograms/ml of solution.
• The infusion rate can vary from 3 to 20 micrograms per minute, however, if you suffer from respiratory failure, higher administration rates can be used successfully.
• An initial dose of 5 micrograms/minute is recommended with appropriate dosage adjustments based on your clinical response.

Children
Currently, there is insufficient data to recommend Ventolin injectable solution in children.

If you receive more Ventolin injectable solution than you should
Ventolin injectable solution will always be carefully administered to you under controlled conditions. However,
if you think that you are being given more than you should, talk to your doctor or
nurse as soon as possible.
You may experience the following effects:

• the heart beats faster than usual
• you experience tremors
• you are hyperactive
• the build-up of acid in the body can cause your breathing to speed up.

These effects generally disappear within a few hours.

If you stop using Ventolin injectable solution
Do not stop using Ventolin injectable solution without first consulting your doctor.
If you have any doubts about the use of this medicine, ask your doctor, nurse or pharmacist.

4. Possible side effects

If your breathing or shortness of breath worsens immediately after taking this medicine, stop using it
immediately, and inform your doctor as soon as possible.
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur with this medicine:

Allergic reactions(may affect up to 1 in 10,000 people)
If you have an allergic reaction, stop using Ventolin injectable solution and seek immediate medical attention.
The signs of an allergic reaction include: swelling of the face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing, itchy rash, bronchospasm, low blood pressure and collapse.

See a doctor as soon as possible if:

• you feel your heart beating faster or stronger than usual (palpitations). This symptom is usually harmless, and usually stops after using the medicine.
• you can feel your heartbeat is irregular or an extra beat. These effects may affect less than 1 in 10 people.

If any of these effects happen to you, tell your doctor as soon as possible . Do not stop using this
medicine unless you are told to do so.
Tell your doctor if you have any of the following side effects that may also occur with this
medicine:
Very common(may affect more than 1 in 10 people)

• tremors
• tachycardia (increased heart rate per minute)
• palpitations (feeling of increased heartbeats).

Common(may affect up to 1 in 10 people)

• headache
• muscle cramps

Uncommon(may affect up to 1 in 100 people)

• fluid accumulation in the lungs (pulmonary edema) which can cause difficulty breathing *
• myocardial ischemia (when blood flow to the heart decreases)*

*in the treatment of preterm labor with salbutamol by injection.

Rare(may affect up to 1 in 1,000 people)

• hypokalemia (low levels of potassium in the blood)
• unusual or irregular heartbeats
• increased fluid flow to the extremities (peripheral vasodilation)

Very rare(may affect up to 1 in 10,000 people)

• lactic acidosis (a condition that can cause stomach pain, hyperventilation, shortness of breath, cold hands and feet, irregular heartbeat and thirst)
• hyperactivity
• myocardial ischemia (when blood flow to the heart decreases)
• nausea, vomiting
• mild pain or burning following intramuscular injection of undiluted solution.

Very rarely in some patients, chest pain may appear (due to heart problems such as
angina). Inform your doctor as soon as possible, avoiding interrupting therapy unless advised.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the website
Reporting side effects can help provide more information on the safety of this
medicine.

5How to store Ventolin

• Keep this medicine out of the sight and reach of children.
• Keep the vials in the outer carton to protect them from light.
• Use the medicine within 24 hours of mixing with other liquids.
• Do not use this medicine after the expiry date which is stated on the vial label and the carton after 'EXP'. The expiry date refers to the last day of that month.

Do not dispose of any medicine in water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. These will help protect the environment.

6Contents of the pack and other information
What Ventolin injectable solution contains

• The active ingredient is salbutamol sulfate.
• The other ingredients are water, salt (sodium chloride), sodium hydroxide, sulfuric acid and nitrogen.

Description of the appearance of Ventolin injectable solution and contents of the pack
Ventolin injectable solution is contained in a glass vial of 1 ml in a plastic tray containing 5.
Each 1 ml glass vial contains 0.1 mg of salbutamol. Each pack contains 10 vials.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A.
Viale dell’Agricoltura, 7
Verona
Italy

Manufacturer
GlaxoSmithKline Manufacturing S.p.A.
San Polo di Torrile
Parma
Italy

INSTRUCTIONS FOR OPENING THE VIAL
The vials are equipped with a safety breakaway and must be opened as follows:

• hold the lower part of the vial with one hand as shown in figure 1;
• place the other hand on the top positioning the thumb above the COLOURED SPOT and apply pressure as shown in figure 2.

Ventolin 100 micrograms/5 ml Injectable Solution

salbutamol sulfate

Read this leaflet carefully before you start to use this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you want more information or advice, ask your doctor, nurse or pharmacist.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, nurse or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Ventolin injectable solution is and what it is used for
• 2. What you need to know before you use Ventolin injectable solution
• 3. How to use Ventolin injectable solution
• 4. Possible side effects
• 5. How to store Ventolin injectable solution
• 6. Contents of the pack and other information

1. What is Ventolin injectable solution and what it is used for

Ventolin injectable solution contains an active ingredient called salbutamol.
It belongs to a group of medicines called short-acting bronchodilators.

• Bronchodilators help the airways in the lungs to stay open. This makes it easier for air to pass through.
• They help to relieve chest tightness, wheezing and coughing.

Ventolin injectable solution is used for the treatment of severe breathing problems in adults with asthma and
similar conditions.

2. What you need to know before using Ventolin injectable solution

Do not use Ventolin injectable solution

• If you are allergic to salbutamol sulfate or any of the other ingredients of this medicine (listed in section 6).
• If you have an unexpected threat of miscarriage.

Warnings and precautions
Consult a doctor, nurse or pharmacist before receiving an injection of Ventolin solution
injectableif:

• you have high blood pressure
• you have low levels of potassium in the blood ( hypokalaemia)
• you have glaucoma (high pressure inside the eye)
• you have a pheochromocytoma (a tumor of the adrenal gland that causes the release into the body of substances that increase blood pressure);
• you have hyperthyroidism (disease due to excess thyroid hormones in the blood)
• you are diabetic
• you have hypothyroidism (overactive thyroid)
• you have a history of heart disease characterized by shortness of breath, palpitations or angina.

Other medicines and Ventolin injectable solution
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might
take any other medicines, including those obtained without a prescription. This includes
herbal medicines. Ventolin injectable solution may affect the way some
medicines work, and some medicines may affect the way Ventolin injectable solution works.
In particular, tell your doctor, nurse or pharmacist if you are taking any of the following:

• medicines for irregular or fast heartbeat
• other beta-blockers (such as propranolol)
• xanthine medicines (used to help with breathing)
• steroid medicines
• diuretics
• medicines for diabetes that lower blood sugar (such as insulin, metformin or glibenclamide)
• other medicines for asthma.

Ventolin injectable solution must not be infused in the same syringe or given in infusion with other
medicines.
If you are on the list for surgery under general anesthesia, your doctor will stop giving you
Ventolin injectable solution 6 hours before the operation, if possible, to protect you from unwanted effects
(e.g. irregular heartbeat).

If you think this medicine is not working as well as it should
If the medicine seems not to be working as well as usual, tell your doctor as soon as possible. Your chest problems could get worse and you may need a different medicine.

Ventolin injectable solution with food and drink
You can use Ventolin injectable solution at any time of the day, with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor, nurse or pharmacist for advice before using this medicine.

Driving and using machines
It is unlikely that Ventolin will affect your ability to drive or operate machinery.

For athletes
The use of the drug without therapeutic need constitutes doping and may still result in a positive doping test.

Ventolin contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) in a 5 mL vial, i.e. it is essentially
“sodium-free”.

3. How to use Ventolin injectable solution

How the injectable solution is administered
Ventolin injectable solution is usually administered by a doctor or nurse. It may be
administered subcutaneously (subcutaneous injection) or directly into a vein or muscle (via
intravenous or intramuscular route). You should never expect to self-administer this medication. It will always be
administered by a person who is qualified to do so.
The vials are provided with a Break Point, which is an opening system and must be opened with the
following instructions:

• hold the lower part of the vial with one hand
• place the other hand on the upper part of the vial, position your thumb over the colored point and press.

Intramuscular route
The usual dose is 8 micrograms per kilogram of body weight (500 micrograms) to be repeated, if
necessary, every four hours.

Intravenous route

• The usual dose is 4 micrograms per kilogram of body weight (from 100 micrograms to 250 micrograms) administered slowly (3-5 minutes).
• It is injected slowly and can be repeated, if necessary.
• Ventolin injectable solution can be diluted with 10 ml of water for injectable preparations.

Infusion route

• In status asthmaticus and other forms of severe bronchospasm, the usual dosage of Ventolin injectable solution is 10 micrograms/ml of solution.
• The infusion rate may vary from 3 to 20 micrograms per minute, however, if you suffer from respiratory failure, higher administration rates can be used successfully.
• An initial dose of 5 micrograms/minute is recommended with appropriate dosage adjustments based on your clinical response.

Children
Currently, there is not enough data to recommend Ventolin injectable solution in children.

If you receive more Ventolin injectable solution than you should
Ventolin injectable solution will always be carefully administered to you under controlled conditions. However,
if you think that you are being given more than you should, talk to your doctor or
nurse as soon as possible.
You may experience the following effects:

• the heart beats faster than usual
• you experience tremors
• you are hyperactive
• the build-up of acid in the body can cause your breathing to speed up. These effects usually disappear within a few hours.

If you stop taking Ventolin injectable solution
Do not stop taking Ventolin injectable solution without first consulting your doctor.
If you have any doubts about the use of this medicine, ask your doctor, nurse or pharmacist.

4. Possible side effects

If your breathing or shortness of breath worsens immediately after taking this medicine, stop using it
immediately, and inform your doctor as soon as possible.
Like all medicines, this medicine can cause side effects, although not everyone will experience them. The following side effects may occur with this medicine:

Allergic reactions(may affect up to 1 in 10,000 people)
If you have an allergic reaction, stop using Ventolin injectable solution and seek immediate medical attention.
The signs of an allergic reaction include: swelling of the face, lips, mouth, tongue or throat that may cause difficulty swallowing or breathing, itchy rash, bronchospasm, low blood pressure and collapse.

See your doctor as soon as possible if:

• you feel your heart beating faster or stronger than usual (palpitations). This symptom is usually harmless, and usually stops after you have used the medicine
• you can feel your heartbeat being irregular or an extra beat. These effects may affect less than 1 in 10 people.

If any of these effects happen to you, tell your doctor as soon as possible . Do not stop using this
medicine unless you are told to do so.
Tell your doctor if you have any of the following side effects that may also occur with this
medicine:
Very common(may affect more than 1 in 10 people)

• tremors
• tachycardia (increased heart rate per minute)
• palpitations (feeling of increased heartbeats)

Common(may affect up to 1 in 10 people)

• headache
• muscle cramps

Uncommon(may affect up to 1 in 100 people)

• fluid accumulation in the lungs (pulmonary edema) which may cause difficulty breathing*
• myocardial ischemia (when blood flow to the heart decreases)* *in the treatment of preterm labor with salbutamol by injection.

Rare(may affect up to 1 in 1,000 people)

• low levels of potassium in the blood
• unusual or irregular heartbeats
• increased fluid flow to the extremities (peripheral vasodilation)

Very rare(may affect up to 1 in 10,000 people)

• lactic acidosis (a condition that can cause stomach pain, hyperventilation, shortness of breath, cold hands and feet, irregular heartbeat and thirst)
• hyperactivity
• myocardial ischemia (when blood flow to the heart decreases)
• nausea, vomiting
• mild pain or burning following intramuscular injection of undiluted solution

Very rarely, some patients may experience chest pain (due to heart problems such as
angina). Inform your doctor as soon as possible, avoiding interrupting therapy unless you are
advised to do so.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor, pharmacist or nurse. You can also report side effects directly through the website
https://www.aifa.gov.it/web/content/segnalazioni-reazioni-avverse . By reporting side effects you can
contribute to providing more information on the safety of this medicine.

5. How to store Ventolin

• Keep this medicine out of the sight and reach of children.
• Keep the vials in the outer packaging to protect them from light.
• Use the medicine within 24 hours of mixing with other liquids.
• Do not use this medicine after the expiry date which is stated on the vial label and the pack after 'EXP'. The expiry date refers to the last day of that month.

Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ventolin injectable solution contains

• The active ingredient is salbutamol sulfate.
• The other ingredients are water, salt (sodium chloride), sodium hydroxide and sulfuric acid.

Description of the appearance of Ventolin injectable solution and contents of the pack
Ventolin injectable solution is contained in a glass vial of 5 ml in a plastic tray containing 5.
Each glass vial of 5 ml contains 0.1 mg of salbutamol. Each pack contains 10 vials.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A.
Viale dell’Agricoltura, 7
Verona
Italy

Manufacturer
GlaxoSmithKline Manufacturing S.p.A.
San Polo di Torrile
Parma
Italy

INSTRUCTIONS FOR OPENING THE VIAL
The vials are equipped with a safety break and must be opened as follows:

• hold the lower part of the vial with one hand as shown in figure 1;
• place the other hand on the upper part positioning the thumb above the COLOURED SPOT and apply pressure as shown in figure 2.