Consumer medicine information

VENTOLIN ROTACAPS

Salbutamol

BRAND INFORMATION

Brand name

Ventolin Rotacaps Powder for Inhalation

Active ingredient

Salbutamol

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using VENTOLIN ROTACAPS.

What is in this leaflet?

Please read this leaflet carefully before you use Ventolin Rotacaps.

This leaflet answers some common questions about Ventolin Rotacaps. It does not contain all of the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the expected benefits of you taking Ventolin Rotacaps against the risks this medicine could have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What are Ventolin Rotacaps used for?

Ventolin Rotacaps are capsules which contain a medicine called salbutamol sulfate. This medicine belongs to a group of medicines called beta-2 adrenoceptor agonists. The medicine is a very fine powder mixed with lactose (which contains milk protein). Each capsule contains the equivalent of 200 micrograms of salbutamol.

Ventolin Rotacaps are used in a plastic device called a Ventolin Rotahaler. When used in your Ventolin Rotahaler, your Ventolin Rotacaps provide a measured amount of medicine for you to breathe into your lungs. Your Ventolin Rotacaps help you to breathe more easily. When you are having difficulty breathing, or your chest is tight, or when you are wheezing, Ventolin Rotacaps open up the breathing tubes in your lungs to help with breathing. Because the medicine in your Ventolin Rotacaps gives fast relief from your chest symptoms, it is often called a 'reliever'.

Some people start wheezing or their chest starts to feel tight when they exercise. This is called exercise-induced asthma. If you have exercise-induced asthma, your doctor may tell you to inhale one or two Ventolin Rotacaps before you exercise. This can help prevent the symptoms of exercise-induced asthma.

This medicine is only one part of a plan to help you manage your asthma or other chest condition. You should discuss this plan with your doctor. Ask your doctor to check your treatment regularly.

The medicine in Ventolin Rotacaps is not addictive.

Before you take Ventolin Rotacaps

Do not take:

  • if you have ever had an allergic reaction to salbutamol sulfate, lactose or milk protein
  • to stop a miscarriage or premature labour
  • if the expiry date (EXP) printed on the pack has passed
  • if the packaging is torn or shows signs of tampering.

Tell your doctor if:

You must tell your doctor if:

  • you are allergic to foods, dyes, preservatives or any other medicines
  • you have had to stop taking this or any other asthma medicine
  • you are having treatment for a thyroid condition
  • you are having treatment for high blood pressure
  • you have a heart problem
  • you have a liver problem
  • you have a kidney problem
  • you have sugar diabetes
  • you are taking any other medicines, including medicines you buy without a prescription
  • you are breastfeeding, pregnant or trying to become pregnant.

How do I take Ventolin Rotacaps?

How much to take

The pharmacist's label will usually tell you how many capsules to use and how often to use your Ventolin Rotacaps with the Rotahaler. If you are not sure, ask your doctor or pharmacist.

Adults: one or two Rotacaps (200-400 micrograms) inhaled via Rotahaler 3 or 4 times daily. The maximum dose is 12 Rotacaps in a 24 hour period.

Children (to 12 years): one Rotacap (200 micrograms) inhaled via Rotahaler 3 or 4 times daily. The maximum dose is 6 Rotacaps in a 24 hour period.

Initial doses in the elderly may be lower than the recommended adult dose.

If your breathing condition suddenly gets worse, your doctor may tell you to use extra capsules. If you use extra capsules and do not get relief, tell your doctor immediately.

If you forget to take a dose, do not worry. Just take the next dose at the normal time or earlier if you become wheezy or feel tight in the chest.

How to take it

Do not swallow your Ventolin Rotacaps. The medicine in your Ventolin Rotacaps is taken by inhalation only, using your Ventolin Rotahaler. The Rotahaler opens the capsule and releases the powder. Make sure that you have a Ventolin Rotahaler and can use it properly.

More instructions on how to use your Ventolin Rotacaps with your Ventolin Rotahaler are provided inside your pack of Ventolin Rotacaps. Follow the instructions carefully.

You should visit your doctor or pharmacist regularly to check that you are using your Ventolin Rotahaler in the right way. If you are not breathing the medicine in correctly, the medicine may not be helping you as much as it could.

How long to take it for

Do not stop taking Ventolin Rotacaps, or change the dose without first checking with your doctor.

What do I do if I take too much? (Overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, if you think you or anyone else may have taken too much of your medicine, even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep telephone numbers for these places handy.

If you are not sure what to do, contact your doctor or pharmacist.

While you are taking Ventolin Rotacaps

Things you must do

Tell your doctor if, for any reason, you have not taken your medicine exactly as directed.

Otherwise, your doctor may think that it was not working as it should and change your treatment unnecessarily.

If your breathing suddenly becomes more difficult just after you have used your Ventolin Rotacaps, tell your doctor immediately.

Tell your doctor if your Ventolin Rotacaps medicine does not seem to be working as well as usual as your asthma may be getting worse and you may need a different medicine.

These may be signs that your breathing condition is getting worse.

Your doctor may decide to add another medicine to your treatment if your Ventolin Rotacaps are not having the same effect as before.

Things you must not do

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Do not use Ventolin Rotacaps to treat any other complaints unless your doctor says to.

What are the side effects?

Check with your doctor as soon as possible if you think you are experiencing any side effects or allergic reactions due to taking Ventolin Rotacaps, even if the problem is not listed below.

Like other medicines, Ventolin Rotacaps can cause some side effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.

The most commonly reported side effects are:

  • headache
  • nausea
  • shaky or tense feeling
  • heart beating faster than usual
  • 'warm' feeling
  • mouth or throat irritation.

Some rare side-effects are:

  • muscle cramps
  • restlessness.

Stop using your Ventolin Rotacaps and tell your doctor immediately if you notice any of the following:

  • skin rash, angioedema (sudden swelling under the skin) or faint or dizzy feeling. These could be symptoms of an allergic reaction.

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

In some people, the medicine in Ventolin Rotacaps may affect their blood potassium levels. Your doctor may do tests to check this.

How do I store Ventolin Rotacaps?

Keep this medicine where children cannot reach it, such as in a locked cupboard.

Keep your Ventolin Rotacaps in a cool, dry place away from heat (store below 30°C). Do not leave in a car, on window sill or in bathroom.

Do not load a capsule into your Rotahaler until you are ready to take a dose.

You will find an expiry (or use by) date printed on the manufacturer's label on the cardboard box. Do not use your Ventolin Rotacaps after this date.

Return any unused or expired medicine to your pharmacist.

Product description

What Ventolin Rotacaps look like

The capsule shell is made of gelatin. One half of the capsule shell is transparent and the other half is pale blue in colour. Printed on the capsule shell is either "Ventolin 200" in light red once on the body and once on the cap or "Ventolin 200" in light red once on the cap and an arrow on the body.

Not all pack sizes may be available.

Ventolin Rotacaps are available in boxes of either 100 or 128 capsules per box.

Ingredients

Ventolin Rotacaps contains the active ingredient salbutamol sulfate.

Ventolin Rotacaps also contain lactose (which contains milk protein) as a non-active ingredient.

Supplier

Your Ventolin Rotacaps are supplied by:

GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street,
Abbotsford, Victoria 3067
Australia

Where to go for further information

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition. You may also be able to find general information about your disease and its treatment from patient information groups and from books, for example in public libraries.

This leaflet was prepared on 21 March 2016.

The information provided applies only to: Ventolin Rotacaps®

Ventolin, Rotacaps and Rotahaler are registered trademarks of the GSK group of companies.

© 2016 GSK group of companies. All rights reserved.

Ventolin Rotacaps: AUST R 12530

Version 6.0

BRAND INFORMATION

Brand name

Ventolin Rotacaps Powder for Inhalation

Active ingredient

Salbutamol

Schedule

S3

 

Name of the medicine

Salbutamol (as sulfate) BP.

Excipients.

Lactose (which contains milk protein).

Description

Chemical name: 1-(4-hydroxy-3- hydroxymethylphenyl)-2- (tert-butylamino)ethanol sulfate. Molecular formula: (C13H21NO3)2H2SO4. MW: 576.7. CAS: 51022-70-9. Salbutamol sulfate is a white or almost white odourless powder. It is soluble in 4 parts of water; slightly soluble in 95% alcohol, chloroform and solvent ether. Ventolin Rotacaps contain microfined salbutamol sulfate in a hard gelatin shell.

Pharmacology

Salbutamol is a relatively selective beta2-adrenoreceptor stimulant. It is more specific than both isoprenaline and orciprenaline for adrenergic beta2-receptors.
After oral and parenteral administration, stimulation of the beta-receptors in the body, both beta1 and beta2, occurs because (a) beta2 selectivity is not absolute, and (b) higher concentrations of salbutamol occur in the regions of these receptors with these modes of administration. This results in the beta1 effect of cardiac stimulation, though not so much as with isoprenaline, and beta2 effects of peripheral vasodilatation and hypotension, skeletal muscle tremor and uterine muscle relaxation.
Metabolic effects such as hyperinsulinaemia and hyperglycaemia also may occur, although it is not known whether these effects are mediated by beta1 or beta2-receptors. The serum potassium levels have a tendency to fall.

Pharmacokinetics.

Following inhalation, salbutamol acts topically on bronchial smooth muscle and initially the drug is undetectable in the blood. After 2 to 3 hours, low concentrations are seen, due presumably to the portion of the dose which is swallowed and absorbed in the gut.
The elimination half-life of inhaled or oral salbutamol is between 2.7 and 5 hours.
Salbutamol is not metabolised in the lung but is converted to the 4'-ο-sulfate ester in the liver. Salbutamol is excreted in the urine as free drug and as the metabolite. After oral administration 58-78% of the dose is excreted in the urine in 24 hours, approximately 60% as metabolites. A small fraction is excreted in the faeces.
Impairment of liver or renal function may necessitate a reduction in dosage (see Dosage and Administration).

Indications

For the relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease, and for acute prophylaxis against exercise induced asthma or in other situations known to induce bronchospasm.
Ventolin Rotacaps are indicated for the above conditions in those patients unable to use a pressurised aerosol bronchodilator satisfactorily. Patients most likely to benefit from the use of Rotacaps are the following.
1) Children from 3 to 6 years of age who are too young to operate a metered aerosol.
2) Patients who have difficulty synchronising deep inhalation with actuation of a metered aerosol.
3) Patients who are sensitive to freon propellants.

Contraindications

Salbutamol dry powder inhaler formulations are contraindicated in patients with severe milk protein allergy or who have a history of hypersensitivity to salbutamol or any of its components (see Excipients).
Nonintravenous formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion.

Precautions

The management of asthma should follow a stepwise programme, and patient response should be monitored clinically and by lung function tests. Increasing use of short acting inhaled beta2-agonists to control symptoms indicates deterioration of asthma control. Under these conditions, the patient's therapy plan should be reassessed. Sudden and progressive deterioration in asthma control is potentially life threatening and consideration should be given to starting or increasing corticosteroid therapy. In patients considered at risk, daily peak flow monitoring may be instituted.
In the event of a previously effective dose of inhaled salbutamol failing to give relief for at least three hours, the patient should be advised to seek medical advice in order that any necessary additional steps may be taken.
If patients with an acute attack of asthma fail to respond to a dry powder inhaler of beta2-agonists they should be advised to follow their personal asthma action plan. Failure to respond to beta2-agonists in general can be due to various reasons related to drug administration or the disease itself. Particularly in children 5 years or younger, and exceptionally in other cases, inspiratory flow through a dry powder inhaler may not be sufficient for optimal drug delivery. If a nonresponse occurs, medical help should be sought while beta2-agonist treatment is continued. In such a situation, and if available, a nebuliser or pressurised metered dose inhaler with spacer should be used.
Animal studies suggest that cardionecrotic effects may occur with high dosages of some sympathomimetic amines. On this evidence the possibility of the occurrence of myocardial lesions cannot be excluded subsequent to long-term treatment with these drugs.
Care should be taken with patients who are known to have received large doses of salbutamol or other sympathomimetic drugs, or who are suffering from hypertension, hyperthyroidism, myocardial insufficiency or diabetes mellitus.
Salbutamol should be administered cautiously to patients with thyrotoxicosis.
Excessive use may induce a nonresponsive state leading to a worsening of hypoxaemia.
Potentially serious hypokalaemia may result from beta2-agonist therapy mainly from parenteral and nebulised administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics and hypoxia. It is recommended that serum potassium levels are monitored in such situations.
The possibility of cardiac arrhythmias arising as a consequence of salbutamol induced hypokalaemia should be borne in mind, especially in digitalised patients, following the administration of Ventolin injection.
As with other inhalation therapy, paradoxical bronchospasm may occur, resulting in an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast acting inhaled bronchodilator, if immediately available. The specific salbutamol presentation should be discontinued, and if necessary a different fast acting bronchodilator instituted for ongoing use.

Effects on fertility.

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

Use in pregnancy.

(Category A)
Salbutamol is known to cross the placental barrier in humans. Safety for use in pregnancy has not been demonstrated, therefore the drug should not be used in pregnant women, or those likely to become pregnant, unless the expected benefit outweighs any potential risk.
Oral administration of salbutamol to rats and rabbits during pregnancy showed no teratogenic effects in offspring.
During worldwide marketing experience, rare cases of various congenital anomalies, including cleft palate and limb defects have been reported in the offspring of patients being treated with salbutamol.
Although intravenous salbutamol and occasionally salbutamol tablets are used in the management of uncomplicated premature labour, Ventolin presentations should not be used for threatened abortion during the first or second trimesters of pregnancy. Intravenous salbutamol is contraindicated in cases of antepartum haemorrhage because of the risk of further haemorrhage from an atonic uterus and there is the risk of the same problem arising inadvertently in asthmatics using salbutamol. Profuse uterine bleeding following spontaneous abortion has been reported after the use of salbutamol. Special care is required in pregnant diabetic women.

Use in lactation.

It is not known whether salbutamol is excreted in breast milk nor whether it has a harmful effect on the newborn. Therefore it is not recommended for nursing mothers unless the expected benefits outweigh any potential risk.

Interactions

Beta-adrenergic blocking drugs inhibit the bronchodilator action of salbutamol and other sympathomimetic bronchodilators. However, such drugs should not be used in asthmatic patients as they may increase airway resistance.
Care is recommended if it is proposed to administer salbutamol in concomitant therapy with other sympathomimetic amines as excess sympathetic stimulation may occur.
Animal studies have shown that large doses of salbutamol may interact with imipramine, chlordiazepoxide and chlorpromazine but any practical significance of these results in man remains to be established.

Adverse Effects

A fine tremor of skeletal muscle has been reported in some patients when salbutamol is administered orally or by inhalation and in about 20% of patients receiving Ventolin Injection; the hands being the most obviously affected, with a few patients feeling tense. These effects are dose related and are caused by a direct action on skeletal muscle and not by direct CNS stimulation.
With higher doses than those recommended, or in patients who are unusually sensitive to beta-adrenergic stimulants, dilatation of some peripheral arterioles may occur, leading to a small reduction in arterial pressure; a compensatory increase in cardiac output may then occur.
Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) have been reported. Peripheral vasodilation and a compensatory small increase in heart rate may occur in some patients. Tachycardia may occur in some patients.
Other reactions which may occur are headaches, nausea, palpitations and sensations of warmth. Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely. There have been very rare reports of muscle cramps. Mouth and throat irritation may occur with inhaled salbutamol.

Note.

The incidence and severity of particular side effects depends on the dosage and route of administration. Ventolin does not cause difficulty in micturition because, unlike sympathomimetic drugs such as ephedrine, therapeutic doses have no alpha-adrenergic receptor stimulant activity.
Potentially serious hypokalaemia may result from beta2-agonist therapy.
As with other inhalation therapy, paradoxical bronchospasm may occur, resulting in an immediate increase in wheezing after dosing.
As with other beta2-agonists, hyperactivity has been reported rarely in children.

Dosage and Administration

Ventolin Rotacaps are for inhalation use only using a Ventolin Rotahaler inhaler.
Increasing use of beta2-agonists may be a sign of worsening asthma. Under these conditions a reassessment of the patient's therapy plan may be required and concomitant glucocorticosteroid therapy should be considered.
Studies in asthmatics have shown that the use of one 200 microgram Ventolin Rotacap will produce bronchodilatation of a similar order to that produced by the use of one (100 microgram) puff of Ventolin Inhaler.

Adults.

The contents of one or two Rotacaps (200-400 microgram of salbutamol) to be inhaled 3 or 4 times daily.

Children to the age of 12 years.

The contents of one Rotacap (200 microgram of salbutamol) to be inhaled 3 or 4 times daily.
The total amount of salbutamol administered by Rotahaler in any 24 hour period should not exceed 12 Rotacaps for an adult or 6 Rotacaps for a child.

Note 1.

Failure to obtain relief from Rotacaps may be a medical emergency. Other appropriate treatment must be instituted without delay.

Note 2.

It is important that the patient be instructed in the proper use of the Rotahaler.

Geriatric.

Initial doses of salbutamol in the elderly should be lower than the recommended adult dosage. The dose may then be gradually increased if sufficient bronchodilatation is not achieved.

In impaired liver function.

As about 60% of orally administered salbutamol (this includes not only tablet and syrup preparations but also approximately 90% of an inhaled dose) is metabolised to an inactive form, impairment of liver function may result in accumulation of unchanged salbutamol.

In impaired renal function.

About 60-70% of salbutamol administered by inhalation or intravenous injection is excreted in urine unchanged. Impairment of renal function may therefore require a reduction in dosage to prevent exaggerated or prolonged effects.

Overdosage

For information on the management of overdose, contact the Poisons Information Centre on 131 126 (Australia).
The most common signs and symptoms of overdose with salbutamol are transient beta-agonist pharmacologically mediated events (see Precautions and Adverse Effects). The signs of salbutamol overdosage are significant tachycardia and/or significant muscle tremor.
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.
Consideration should be given to discontinuation of treatment and appropriate symptomatic treatment such as a cardioselective beta-blocking agent given by intravenous injection, in patients presenting with cardiac symptoms (e.g. tachycardia, palpitations). Beta-blocking drugs should be used with caution as they may cause bronchospasm in sensitive individuals.
In treating overdosage with Ventolin Rotacaps it is to be remembered that twenty 200 microgram Rotacaps contain as much salbutamol as one 4 mg Ventolin tablet.

Presentation

Rotacaps.

Capsules, salbutamol sulfate ≡ salbutamol 200 microgram (microfined powder, hard gelatin shell, clear/pale blue, marked Ventolin 200 in light red on cap and body, or Ventolin 200 in light red on cap and arrow on body*): 100's*, 128's (foil pack in carton).
*Not currently marketed in Australia.
A 10% overage is included for wastage in the Rotahaler.
Ventolin Rotacaps contain a powder for inhalation and should be used in conjunction with the Ventolin Rotahaler. The Rotahaler breaks the Rotacap in halves. These halves are rotated and agitated to release the drug powder when the patient inhales.
The Rotacaps must only be inserted into the Rotahaler immediately prior to use. Failure to observe this instruction will affect the delivery of the drug.

Storage

Ventolin Rotacaps have a shelf life of 3 years when stored below 30°C. Avoid storage areas of high humidity.

Poison Schedule

S3.