Consumer medicine information

What is in this leaflet

Please read this leaflet carefully before you use your medicine.

This leaflet answers some common questions about Salbutamol Cipla cipules. It does not contain all 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 risks of you taking Salbutamol Inhalation Solution against the benefits they expect it will 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 Salbutamol Cipla cipules are used for

Salbutamol Cipla Cipules contains the active substance, salbutamol which is known as a bronchodilator. It helps you breathe more easily. When your chest is tight or when you are wheezing, Salbutamol Cipla Cipules opens up the breathing tubes in your lungs.

Because the medicine in your Salbutamol Cipla Cipules gives fast relief from your chest symptoms, it is often called a 'reliever'. There are other types of medicines that prevent wheezing or chest tightness. These medicines are called 'preventers' and must be used every day. Your doctor may tell you to use a 'preventer' in addition to your Salbutamol Cipla Cipules.

Salbutamol inhalation solution are not the only form of salbutamol available. Your doctor will decide which form of salbutamol is right for you.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

Before you use Salbutamol Cipla cipules

When you must not be given it

Do not use Salbutamol Inhalation Solution if you have an allergy to salbutamol sulfate or any other ingredients in Salbutamol Cipla Cipules (see Ingredients)

Do not take Salbutamol Cipla Cipules to stop a miscarriage or premature labour.

Do not take this medicine after the expiry date printed on the pack has passed or if the packaging is torn or shows signs of tampering. If it has expired or if the packaging is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

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 for any reason
• you have been diagnosed with a thyroid condition
• you have been diagnosed with high blood pressure
• you have a heart condition
• you have a liver condition
• you have a kidney condition
• you have diabetes

Tell your doctor if you are pregnant or plan to become pregnant or are breast- feeding. The ingredients of Salbutamol Cipla Cipules are known to cross the placenta during pregnancy. Your doctor can discuss with you the risks and benefits involved.

It is not known whether the ingredients of Salbutamol Cipla Cipules can pass into breast milk. If you are breast- feeding, you must check with your doctor before you take Salbutamol Cipla Cipules.

If you have not told your doctor about any of the above, tell him/ her before you start taking Salbutamol Cipla Cipules.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with salbutamol. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take Salbutamol Cipla cipules properly

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much to take

Take Salbutamol Cipla Cipules as directed by your doctor or pharmacist. The pharmacist's label will usually tell you how many Salbutamol Cipla Cipules should be taken. If you are not sure, ask your doctor or pharmacist.

Adults: one 5 mg cipule via nebuliser every 4-6 hours as necessary.

Children (4 -12 years): one 2.5 mg cipule via nebuliser every 4-6 hours as necessary.

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

If your condition suddenly gets worse, your doctor may tell you to increase your dose.

How to take it

Salbutamol Cipla Cipules must only be used by inhalation from a nebuliser and must not be injected or swallowed.

The nebuliser produces a fine mist which you breathe in through a face mask or a mouthpiece. Make sure you know how to use it properly. If you have problems ask your doctor or pharmacist.

Do not let the liquid, or the mist produced by the nebuliser get into your eyes. You can wear glasses or goggles to protect them.

Use your nebuliser in a well ventilated room as some of the mist will be released into the air and may be breathed in by others

The nebuliser should be assembled and used as directed by your doctor. Any solution remaining in the nebuliser should be discarded after use. Follow the manufacturer's instructions on how to clean your nebuliser.

How long to take it

Your doctor will decide how often and for how long you have to take Salbutamol Cipla Cipules. The pharmacist's label will usually tell you how often to take Salbutamol Cipla Cipules. If you are not sure, ask your doctor or pharmacist.

Do not stop taking Salbutamol Cipla Cipules, or change the dose without first checking with your doctor.

If you forget to take it

Do not take an extra dose to make up for a missed dose.

This may increase the chance of you getting unwanted side effects.

Just take your next dose at the usual time. If you become wheezy or develop other symptoms of an asthma attack you may need to take your next dose earlier.

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

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (In Australia call 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too many Salbutamol Cipla Cipules. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of an overdose may include:

• rapid heart beat
• significant muscle tremor
• increased acid in the blood, which may cause an increased rate of breathing.

While you are using Salbutamol inhalation

Things you must do

If you are about to be started on any new medicine, remind your doctor or pharmacist that you are taking Salbutamol Cipla Cipules.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.

If you become pregnant while taking this medicine, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.

Keep all of your doctor's appointments so that your progress can be checked.

If your Salbutamol Cipla Cipules do not help your breathing as much as usual, tell your doctor as soon as possible.

If the effect of your Salbutamol Cipla Cipules does not last as long as usual, tell your doctor as soon as possible. These may be signs that your chest condition is getting worse.

If your Salbutamol Cipla Cipules are not having the same effect as before, your doctor may decide to prescribe other forms of salbutamol, or another medicine, for you to use.

This medicine is only one part of a general 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.

Things you must not do

Do not take salbutamol to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or lower the dosage without checking with your doctor. If you stop taking it suddenly, your condition may worsen or you may have unwanted side effects.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Salbutamol Cipla cipules.

Like other medicines Salbutamol Cipla cipules may have unwanted side effects in a few people. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following side effects and they worry you.

Common side effects:

• headache
• nausea
• shaky or tense feeling
• irregular or fast heart beat
• 'warm' feeling or flushing

Rare side effects:

• mouth and throat irritation
• muscle cramps
• restlessness in children.

Very rare side effects:

• feeling unusually active, such as restlessness and excitability.

If your breathing or wheezing gets worse straight after taking this medicine, stop using it immediately, and tell your doctor immediately. If available, try a different fast-acting asthma medicine as soon as possible.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital. Allergic reactions have been very rarely reported. These symptoms may include a skin rash, angioedema (sudden swelling under the skin) or a faint or dizzy feeling.

Other side effects not listed above may also occur in some people.

Some of these side effects such as changes to blood potassium levels have been seen rarely and can only be found when your doctor does tests from time to time to check your progress.

After using Salbutamol Cipla Cipules

Storage

Keep your medicine in the pack until it is time to take them. If you take the medicine out of the pack they may not keep well.

Salbutamol Cipla Cipules should be kept in a cool, dry place where the temperature stays below25°C. Cipule must be protected from light.

Do not store in direct sunlight or heat. Do not leave in the car on hot days.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

Do not use after the expiry date on the carton.

Once you have opened each foil pack, you need to note down the date of opening the foil lid. Add three months to this date and write it down in the space provided on the foil pack. Do not use the Salbutamol Cipla Cipules left in the tray after this date.

A locked cupboard at least one-and-a half metres above the ground is a good place to store medicines. Do not store Salbutamol Cipla Cipules or any other medicine in the bathroom or near a sink.

Disposal

If your doctor tells you to stop using Salbutamol Cipla or it has passed its expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

Salbutamol Cipla Cipules contain salbutamol solution for inhalation. It is a clear colourless, preservative free solution and comes in plastic unit dose ampoules.

Salbutamol Cipla Cipules comes in two strengths.

AUST R 115652 2.5mg Salbutamol Sulphate in 2.5ml of solution, 30 (6X5)

AUSTR 115657 5 mg Salbutamol Sulphate in 2.5ml of solution, 30(6X5)

Ingredients

Cipules contains the active ingredient Salbutamol Sulfate BP.

Your medicine also contains sodium chloride and water.

The solution is sterile and preservative free.

Supplier

Cipla Australia Ply Ltd
Level 1, 132-136 Albert Road
South Melbourne, VIC 3205
drugsafety@Cipla.com
Phone: 1 800 569 074.

This leaflet was prepared on Mar 2021.

Published by MIMS May 2021

1 Name of Medicine

Salbutamol sulfate.

2 Qualitative and Quantitative Composition

Each ampoule contains salbutamol 2.5 mg/2.5 mL or 5 mg/2.5 mL as salbutamol sulfate.
Salbutamol sulfate 1.2 mg is approximately equivalent to salbutamol 1 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Conventional inhalation.
Clear colourless to pale yellow solution.

4 Clinical Particulars

4.1 Therapeutic 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.

4.2 Dose and Method of Administration

Increasing use of beta-2 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.
Salbutamol Cipla ampoule/s are to be used under the direction of a doctor.
The solution must not be injected or ingested.
Salbutamol Cipla ampoule/s 2.5 mg/2.5 mL and 5 mg/2.5 mL may be delivered from any efficient nebulising device.
Salbutamol Cipla ampoule/s may be used to achieve bronchodilatation as part of an inhalation therapy regime or for patients requiring assisted ventilation.
There is a large safety margin between therapeutic effects and unpleasant side effects. Nevertheless, because of the possibility of uncontrolled dosage associated with continuous administration, intermittent administration of appropriate amounts of Salbutamol Cipla ampoule/s is preferred.

Use in adults and children.

Important.

Use in the elderly.

Use in hepatic impairment.

Use in renal impairment.

4.3 Contraindications

Hypersensitivity to any of the ingredients.
Non-i.v. formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion.

4.4 Special Warnings and Precautions for Use

The management of asthma should normally follow a stepwise programme, and patient response should be monitored clinically and by lung function tests. Increasing use of short-acting inhaled beta-2 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.
Patients should be warned that if either the usual relief is diminished or the usual duration of action reduced, they should seek medical advice at the earliest opportunity after increasing the dose.
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.
In common with other beta-adrenoceptor agonists, salbutamol can induce reversible metabolic changes, for example increased blood sugar levels. The diabetic patient may be unable to compensate for this and the development of ketoacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.
Excessive use may induce a non-responsive state leading to a worsening of hypoxaemia.
Potentially serious hypokalaemia may result from beta-2-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 salbutamol injection.
Addition of other active substances to Salbutamol Cipla ampoule/s cannot be recommended.
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.

Lactic acidosis.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of 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.
A small number of cases of acute angle closure glaucoma have been reported in patients treated with a combination of nebulised salbutamol and ipratropium bromide. A combination of nebulised salbutamol with nebulised anticholinergics should therefore be used cautiously.
Patients should receive adequate instruction in correct administration and be warned not to let the solution or mist enter the eye.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Adverse events are described according to the CIOMS classification: Very common > 10%; Common > 1% and < 10%; Uncommon > 0.1% and < 1%; Rare > 0.01% and < 0.1%; Very rare < 0.01%.

Very common.

Note.

Reporting suspected adverse effects.

4.9 Overdose

For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).
The most common signs and symptoms of overdose with salbutamol are transient beta agonist pharmacologically mediated events (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)). The signs of salbutamol overdosage are significant tachycardia and/or significant muscle tremor.
Hypokalaemia may occur following overdosage 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 cardio-selective 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.
During continuous administration of Salbutamol Cipla ampoule/s, any signs of overdosage can usually be counteracted by withdrawal of the drug.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride, sulphuric acid (for pH adjustment), water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
3 months when removed from foil overwrap.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light.

6.5 Nature and Contents of Container

Salbutamol Cipla is available in plastic ampoules; Pack sizes: cartons of 30 x 2.5 mL ampoules.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Salbutamol sulfate is a white or almost white, crystalline, odourless powder with a slightly bitter taste. It is freely soluble in water, slightly soluble in alcohol, chloroform and ether, very slightly soluble in methylene chloride.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes