VENTOLIN DISKUS

Patient leaflet in accordance with the Pharmacists' Regulations (Preparations) - 1986

The medicine is dispensed according to a physician's prescription only

Ventolin

™

Diskus

™

Each dose contains 200 micrograms salbutamol (as sulfate) inhalation powder

Ventolin Diskus contains 60 measured doses.

List of the additional ingredients listed in section 6.

Read the entire leaflet carefully before using the medicine. This leaflet contains concise information about the medicine. If you

have any other questions, refer to the physician or the pharmacist.

This medicine has been prescribed for the treatment of your illness. Do not give it to others. It

may harm them even if it seems to you that their illness is similar.

1. What is the medicine intended for?

Ventolin Diskus contains a medicine called salbutamol. This belongs to a group of medicines

called fast-acting bronchodilators.

Bronchodilators help the airways in your lungs to stay open. This makes it easier for air to get

in and out.

They help to relieve chest tightness, wheezing and cough.

Ventolin Diskus is used to treat breathing problems in people with asthma and similar conditions.

Including relieving and preventing asthma brought on by exercise or other “triggers” such as house

dust, pollen, cats, dogs and cigarette smoke.

Therapeutic group:

adrenoceptor agonist.

2. Before using the medicine

Do not use the medicine if:

you are sensitive (allergic) to salbutamol sulfate or to any of the additional ingredients contained in the medicine as listed in

section 6.

you unexpectedly go into early labour (premature labour) or threatened abortion.

you have a severe milk-protein allergy.

Special warnings regarding the use of the medicine

Talk to your physician or pharmacist before taking Ventolin Diskus if:

your asthma is active (for example you have frequent symptoms or flare ups or limited physical ability). Your physician may start

or increase the treatment in order to control your asthma such as an inhaled corticosteroid.

you have high blood pressure

you have an overactive thyroid gland

you have a history of heart problems such as an irregular or fast heartbeat or angina.

you are taking xanthine derivatives (such as theophylline) or steroids to treat asthma.

you are taking water tablets (diuretics), sometimes used to treat high blood pressure or a heart condition.

If you are taking, have recently taken or might take other medicines including non-prescription medicines and food supplements,

tell the physician or the pharmacist. Don’t forget to take this medicine with you if you have to go to hospital. Especially inform the

physician or the pharmacist if you are taking:

medicines for an irregular or fast heartbeat (especially from the beta blockers group such as propranolol)

other medicines for your asthma.

Using the medicine and food

You can use Ventolin Diskus at any time of day, with or without food.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your physician or pharmacist

for advice before taking this medicine.

Driving and using machines

Ventolin is not likely to affect you being able to drive or use any tools or machines.

Important information about some ingredients of the medicine

This medicine contains lactose. If you have been told by your physician that you have an intolerance to some sugars, contact your

physician before taking this medicinal product.

3. How should you use the medicine?

Always use according to the physician's instructions.

You should check with the physician or the pharmacist if you are unsure.

The dosage and treatment will be determined only by the physician. The usual dosage is:

Adults and children:

For immediate relief, one inhalation (200 micrograms).

For chronic treatment, one inhalation (200 micrograms) up to 4 times a day.

For prevention as a result of physical activity or exposure to an allergen, one inhalation (200 micrograms), 10-15 minutes before the

exposure or the physical activity.

The maximum dose is one inhalation (200 micrograms) 4 times a day.

Do not exceed the recommended dose

Follow the Instructions for use at the end of the leaflet

If you accidently have taken a higher dosage you should talk to a physician as soon as possible.

The following effects may happen:

your heart beating faster than usual

you feel shaky

hyperactivity.

These effects usually wear off in a few hours.

If you forgot to take the medicine

If you forget a dose, take it as soon as you remember it

However, if it is time for the next dose, skip the forgotten dose

Do not take a double dose to make up for a forgotten dose.

Persist with the treatment as recommended by the physician.

If you stop taking the medicine

Do not stop taking Ventolin Diskus without talking to your physician.

Do not take medicines in the dark! Check the label and the dose each time you take a medicine. Wear glasses if you need them.

If you have any further questions regarding the use of the medicine, consult the physician or the pharmacist.

4. Side effects

If your breathing or wheezing gets worse straight after taking this medicine, stop using it immediately, and tell your physician

as soon as possible.

As with any medicine, use of Ventolin Diskus may cause side effects in some of the users. Do not be alarmed by reading the list of

side effects. You may not experience any of them.

The following side effects may happen with this medicine:

Allergic Reactions (very rare, may affect up to 1 in 10,000 people)

If you have an allergic reaction, stop taking Ventolin and see a physician straight away. Signs of an allergic reaction include:

swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, itchy rash, feeling faint and

light-headed, and collapse.

Refer to the physician as soon as possible if:

you feel your heart is beating faster or stronger than usual (palpitations). This is usually harmless, and usually stops after you have

used the medicine for a while

you may feel your heartbeat is uneven or it gives an extra beat

these may affect up to 1 in 10 people (common).

If any of these happen to you, talk to your physician as soon as possible. Do not stop using this medicine unless told to do so.

Additional side effects

Tell your physician if you have any of the following side effects which may also happen with this medicine:

Common side effects (may affect up to 1 in 10 people)

feeling shaky

headache.

Uncommon side effects (may affect up to 1 in 100 people)

mouth and throat irritation

muscle cramps.

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

a low level of potassium in your blood

increased blood flow to your extremities (peripheral dilatation).

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

changes in sleep patterns and changes in behavior, such as restlessness and excitability (hyperactivity).

The following side effects can also happen but the frequency of these are not known:

chest pain, due to heart problems such as angina. Tell your physician or pharmacist if this occurs. Do not stop using this medicine

unless told to do so.

If a side effect has appeared, if any of the side effects gets worse or when you suffer from side effect not mentioned in the leaflet,

you should consult the physician.

If you think this medicine is not working well enough for you

If your medicine does not seem to be working as well as usual, talk to your physician as soon as possible. Your chest problem may

be getting worse and you may need a different medicine. Do not take extra doses of Ventolin Diskus unless your physician tells

you to.

Adverse Reactions Reporting

Adverse events can be reported to the Ministry of Health via the on-line form for adverse events reporting, that is located on the

Ministry of Health home page

www.health.gov.il

or by entering the link:

https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il.

5. How to store the medicine?

Avoid poisoning! This medicine and any other medicine should be kept in a closed place out of the sight and reach of children

and/or infants in order to avoid poisoning. Do not induce vomiting without an explicit instruction from the physician.

Do not use the medicine after the expiry date (exp. date) appearing on the package. The expiry date refers to the last day of that

month.

Do not store above 30°C. Keep in the original package.

6. Additional information

In addition to the active ingredient the medicine also contains: lactose monohydrate.

What does the medicine look like and what is the content of the package: Ventolin Diskus contains 60 doses of 200 micrograms

of salbutamol (as sulfate).

License Holder: GlaxoSmithKline (Israel) Ltd., 25 Basel St., Petach Tikva.

Manufacturer: Glaxo Wellcome Production, Evreux, France.

This leaflet was checked and approved by the Ministry of Health in: August 2015.

Registration number of the medicine in the National Drug Registry of the Ministry of Health 126-97-30674

Instructions for use:

Your physician or pharmacist will show you how to use your diskus. They will check how you use it from time to time. Not using

the Ventolin Diskus properly or as prescribed may mean that it will not help your asthma as it should.

The Ventolin Diskus device holds blisters containing Ventolin as a powder.

There is a counter on top of the Ventolin Diskus which tells you how many doses are left. It counts down to 0. The numbers 5 to

0 will appear in red to warn you when there are only a few doses left. Once the counter shows 0, your diskus is empty.

Do not use your diskus more often than the physician told you to. Tell your physician if your medicine does not seem to be working

as well as usual, as your chest problem may be getting worse and you may need a different medicine.

Your physician may have told you to take more than the usual dose as an emergency treatment if your wheezing or breathing gets

very bad. It is very important that you keep to your physician's instructions as to how many inhalations to take and how often to

use your diskus.

Using your Diskus

1. To open the Ventolin Diskus, hold the outer case in one hand and put the thumb of your other

hand on the thumbgrip. Push your thumb away from you as far as it will go. You will hear a click.

This will open a small hole in the mouthpiece.

2. Hold your Ventolin Diskus with the mouthpiece towards you. You can hold it in either your right

or left hand. Slide the lever away from you as far as it will go. You will hear a click. This places a

dose of your medicine in the mouthpiece.

Every time the lever is pushed back a blister is opened inside and the powder is made ready for

you to inhale. Do not play with the lever as this opens the blisters and wastes medicine.

3. Hold the Ventolin Diskus away from your mouth; breathe out as far as is comfortable. Do not

breathe out into your Ventolin Diskus. Do not breathe in yet.

4. Put the mouthpiece to your lips; breathe in steadily and deeply through the Ventolin Diskus with

your mouth, not through your nose.

Remove the Ventolin Diskus from your mouth. Hold your breath for about 10 seconds or for as

long as is comfortable.

Breathe out slowly.

5. To close the Ventolin Diskus, slide the thumbgrip back towards you until you will hear a click.

The lever will return to its original position and is reset.

Your Diskus is now ready for you to use again.

Cleaning your diskus

Wipe the mouthpiece of the Diskus with a dry tissue to clean it.

The format of this leaflet was determined by the Ministry of Health and its content was

checked and approved in August 2015

Ventolin

™

Diskus

™

1.

Name of the Medicinal Product

Ventolin Diskus

2.

Qualitative and Quantitative Composition

Ventolin Diskus is a plastic inhaler device containing a foil strip with 60 regularly spaced blisters

each containing a mixture of 200 micrograms of microfine salbutamol (as sulfate) and larger

particle lactose.

Excipients with known effect: Contains Lactose monohydrate 12.5 mg/blister (see section 4.4).

For the full list of excipients see section 6.1.

3.

Pharmaceutical Form

Multi-dose dry powder inhalation device.

4.

Clinical Particulars

4.1

Therapeutic

Indications

Ventolin Diskus is indicated in adults, adolescents and children.

Ventolin Diskus can be used for relief of bronchospasm in broncial asthma of all types, chronic

bronchitis and emphysema.

Ventolin Diskus is particularly suitable for the relief of asthma symptoms. It should be used to

relieve symptoms when they occur, and to prevent them in those circumstances recognised by the

patient to precipitate an asthma attack (e.g. before exercise or unavoidable allergen exposure).

Ventolin Diskus is particularly valuable as relief medication in mild, moderate

or severe asthma, provided that reliance on it does not delay the introduction and use of regular

inhaled corticosteroid therapy.

4.2

Posology and

Method

of

Administration

Adults (including the elderly)

For the relief of acute asthma symptoms including bronchospasm, 100 micrograms may be

administered (with Ventolin Inhaler CFC Free) as a single minimum starting dose. This may be

increased to 200mcg if necessary.

To prevent allergen or exercise-induced symptoms, 200mcg should be taken 10-15 minutes before

challenge.

For chronic therapy, 200mcg up to four times a day.

Children

For the relief of acute asthma symptoms including bronchospasm, or before allergen exposure or

exercise, 100mcg (with Ventolin Inhaler CFC Free), or 200mcg if necessary.

For chronic therapy, 200mcg up to four times a day.

On-demand use of Ventolin Diskus should not exceed four times daily (800mcg in any 24 hours).

Reliance on such frequent supplementary use, or a sudden increase in dose, indicates poorly

controlled or deteriorating asthma (see section 4.4).

4.3

Contraindications

Hypersensitivity to the active substance or any of the excipients listed in section 6.1.

Non-IV formulations of salbutamol must not be used to arrest uncomplicated premature labour or

threatened abortion.

Ventolin Diskus is contraindicated in patients with severe milk-protein allergy.

4.4

Special warnings and precautions for use

Bronchodilators should not be the only or main treatment in patients with severe or unstable

asthma. Severe asthma requires regular medical assessment, including lung-function testing, as

patients are at risk of severe attacks and even death. Physicians should consider using the

maximum recommended dose of inhaled corticosteroid and/or oral corticosteroid therapy in these

patients.

The dosage or frequency of administration should only be increased on medical advice.

Increasing use of bronchodilators, in particular short-acting inhaled

-agonists to relieve

symptoms, indicates deterioration of asthma control. The patient should be instructed to seek

medical advice if short-acting relief bronchodilator treatment becomes less effective, or more

inhalations than usual are required. In this situation the patient should be assessed and

consideration given to the need for increased anti-inflammatory therapy (e.g. higher doses of

inhaled corticosteroid or a course of oral corticosteroid).

Severe exacerbations of asthma must be treated in the normal way.

Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol. There is

some evidence from post-marketing data and published literature of rare occurrences of

myocardial ischaemia associated with salbutamol. Patients with underlying severe heart disease

(e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving salbutamol

should be warned to seek medical advice if they experience chest pain or other symptoms of

worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea

and chest pain, as they may be of either respiratory or cardiac origin.

Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis.

Potentially serious hypokalaemia may result from

-agonist therapy, mainly from parenteral and

nebulised administration. Particular caution is advised in acute severe asthma as this effect may

be potentiated by hypoxia and by concomitant treatment with xanthine derivatives, steroids and

diuretics. Serum potassium levels should be monitored in such situations.

As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate

increase in wheezing after dosing. This should be treated immediately with an alternative

presentation or a different fast-acting inhaled bronchodilator. Ventolin Diskus should be

discontinued immediately, the patient assessed, and if necessary a different fast-acting

bronchodilator instituted for on-going use.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or

glucose-galactose malabsorption should not take this medicine.

4.5

Interaction with other medicaments and other forms of interaction

Salbutamol and non-selective

-blocking drugs such as propranolol, should not usually be

prescribed together.

4.6

Fertility, pregnancy and lactation

Pregnancy:

Administration of drugs during pregnancy should only be considered if the expected benefit to the

mother is greater than any possible risk to the fetus. As with the majority of drugs, there is little

published evidence of the safety of salbutamol in the early stages of human pregnancy, but in

animal studies there was evidence of some harmful effects on the fetus at very high dose levels.

Breast-feeding:

As salbutamol is probably secreted in breast milk, its use in nursing mothers requires careful

consideration. It is not known whether salbutamol has a harmful effect on the neonate, and so its

use should be restricted to situations where it is felt that the expected benefit to the mother is

likely to outweigh any potential risk to the neonate.

Fertility:

There is no information on the effects of salbutamol on human fertility. There were no adverse

effects on fertility in animals (see section 5.3).

4.7

Effect on ability to drive and use machines

None reported.

4.8

Undesirable effects

Adverse events are listed below by system organ class and frequency. Frequencies are defined as:

very

common

1/10),

common

1/100

1/10),

uncommon

1/1000

1/100),

rare

1/10,000 to

1/1000) and very rare (

1/10,000) including isolated reports. Very common and

common events were generally determined from clinical trial data. Rare, very rare and unknown

events were generally determined from spontaneous data.

Immune system disorders

Very rare:

Hypersensitivity

reactions

including

angioedema,

urticaria,

bronchospasm,

hypotension and collapse

Metabolism and nutrition disorders

Rare:

Hypokalaemia.

Potentially serious hypokalaemia may result from beta

agonist therapy.

Nervous system disorders

Common:

Tremor, headache.

Very rare:

Hyperactivity.

Cardiac disorders

Common:

Tachycardia.

Uncommon:

Palpitations.

Very rare:

Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and

extrasystoles

Unknown:

Myocardial ischaemia* (see section 4.4)

Vascular disorders

Rare:

Peripheral vasodilatation.

Respiratory, thoracic and mediastinal disorders

Very rare:

Paradoxical bronchospasm.

Gastrointestinal disorders

Uncommon:

Mouth and throat irritation.

Musculoskeletal and connective tissue disorders

Uncommon:

Muscle cramps.

* reported spontaneously in post-marketing data therefore frequency regarded as unknown

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare

professionals are asked to report any suspected adverse reactions to the Ministry of Health

according to the National Regulation by using an online form

http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.health.gov.il

) or

by email

adr@moh.health.gov.il

Additionally, you should also report to GSK Israel

il.safety@gsk.com

4.9

Overdose

The most common signs and symptoms of overdose with salbutamol are transient beta agonist

pharmacologically mediated events, including tachycardia, tremor, hyperactivity and metabolic

effects including hypokalaemia (see sections 4.4 and 4.8).

Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be

monitored. Lactic acidosis has been reported in association with high therapeutic doses as well as

overdoses of short-acting beta-agonist therapy, therefore monitoring for elevated serum lactate

and consequent metabolic acidosis (particularly if there is persistence or worsening of tachypnea

despite resolution of other signs of bronchospasm such as wheezing) may be indicated in the

setting of overdose.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Andrenergics, inhalants. Selective beta-2-andrenoreceptor agonists

ATC code: R03AC02

Salbutamol is a selective

-adrenoceptor agonist. At therapeutic doses it acts on the

adrenoceptors of bronchial muscle, with little or no action on the

-adrenoceptors of cardiac

muscle.

Salbutamol provides short-acting (4-6 hour) bronchodilation with a fast onset (within 5 minutes)

in reversible airways obstruction.

5.2

Pharmacokinetic properties

Salbutamol administered intravenously has a half-life of 4 to 6 hours and is cleared partly renally,

and partly by metabolism to the inactive 4'-O-sulfate (phenolic sulfate) which is also excreted

primarily in the urine. The faeces are a minor route of excretion. After administration by the

inhaled route between 10 and 20% of the dose reaches the lower airways. The remainder is

retained in the delivery system or is deposited in the oropharynx from where it is swallowed. The

fraction deposited in the airways is absorbed into the pulmonary tissues and circulation, but is not

metabolised by the lung. On reaching the systemic circulation it becomes accessible to hepatic

metabolism and is excreted, primarily in the urine, as unchanged drug and as the phenolic sulfate.

The swallowed portion of an inhaled dose is absorbed from the gastrointestinal tract and

undergoes considerable first-pass metabolism to the phenolic sulfate. Both unchanged drug and

conjugate are excreted primarily in the urine. Almost all of a dose of salbutamol given

intravenously, orally or by inhalation is excreted within 72 hours. Salbutamol is bound to plasma

proteins to the extent of 10%.

5.3

Preclinical safety data

In common with other potent selective

-receptor agonists, salbutamol has been shown to be

teratogenic in mice when given subcutaneously. In a reproductive study, 9.3% of fetuses were

found to have cleft palate at 2.5 mg/kg, 4 times the maximum human oral dose. In rats, treatment

at the levels of 0.5, 2.32, 10.75 and 50 mg/kg/day orally throughout pregnancy resulted in no

significant fetal abnormalities. The only toxic effect was an increase in neonatal mortality at the

highest dose level as the result of lack of maternal care. A reproductive study in rabbits revealed

cranial malformations in 37% of fetuses at 50 mg/kg/day, 78 times the maximum human oral

dose.

In an oral fertility and general reproductive performance study in rats at doses of 2 and

50 mg/kg/day, with the exception of a reduction in number of weanlings surviving to day 21 post

partum at 50 mg/kg/day, there were no adverse effects on fertility, embryofetal development, litter

size, birth weight or growth rate.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Lactose monohydrate (which contains milk protein)

6.2

Incompatibilities

None reported.

6.3

Shelf life

The expiry date of the product is indicated on the label and packaging.

6.4

Special precautions for storage

Do not store above 30

C. Keep in the original container

6.5

Nature and contents of container

The powder mix of salbutamol (as sulfate) and lactose is filled into a blister strip consisting of a

formed base foil with a peelable foil laminate lid. The foil strip is contained within the Diskus

device.

6.6

Special precautions for disposal and other handling

The powdered medicine is inhaled through the mouth into the lungs.

The Diskus device contains the medicine in individual blisters which areopened as the device is

manipulated.

For detailed instructions for use refer to the Patient Information Leaflet in every pack.

7.

Manufacturer

Glaxo Wellcome

Production, Evreux, France.

8.

License Holder and Importer

GlaxoSmithKline

(Israel) Ltd., 25 Basel St., Petach Tikva.

9.

License number

126-97-30674

Ven Dis DR v3