SALBUTAMOL 2.5 MG / 2.5ML NEBULISER SOLUTION - patient leaflet, side effects, dosage

Salbutamol 2.5mg/2.5ml and 5mg/2.5ml Nebuliser Solutions

(Salbutamol)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

  What is in this leaflet:

  • 1. What Salbutamol Nebuliser Solution is and what it is used for

  • 2. What you need to know before you take Salbutamol Nebuliser Solution

  • 3. How to use Salbutamol Nebuliser Solution

  • 4. Possible side effects

  • 5. How to store Salbutamol Nebuliser Solution

  • 6. Contents of the pack and other information

Information on sodium content

This medicine contains less than 1mmol sodium (23mg) per dose, that is to say essentially ‘sodium-free’.

3 HOW TO USE SALBUTAMOL NEBULISER SOLUTION

1 WHAT SALBUTAMOL NEBULISER SOLUTION IS AND WHAT IT IS USED FOR

Always use Salbutamol Nebuliser Solution exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor may tell you to use your nebuliser at regular times every day or only when you are wheezy or short of breath. Allow 3–6 hours between doses. You should always follow your doctor’s instruc­tions.

Adults and adolescents aged 12 years and over and children aged 4 to 11 years

• the usual starting dose is 2.5mg up to four times daily. Your doctor may increase this to 5mg up to four times daily.

2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE SALBUTAMOL NEBULISER SOLUTION

Do not take Salbutamol Nebuliser Solution

• If you are allergic (hypersensitive) to salbutamol or any of the other ingredients of this medicine (listed in section 6).
• you unexpectedly go into early labour (premature labour) or threatened abortion.

Other pharmaceutical forms may be available that are more appropriate for children under 4 years old. The effect of Salbutamol Nebuliser Solution in infants under 18 months is uncertain. Please speak to your doctor for further information.

Children under 18 years should only use a nebuliser to take reliever medications under the care of a doctor with expertise in the management of asthma so that deterioration in asthma control can be detected and treated without delay.

Warnings and precautions

Talk to your doctor or pharmacist before using Salbutamol Nebuliser Solution if you:

• have active asthma (e.g. frequent symptoms or flare ups or limited physical ability). Your doctor may start or increase a medicine such as an inhaled corticosteroid to control your asthma
• have diabetes
• have a heart condition or have recently had a heart attack
• have high blood pressure
• have an overactive thyroid gland
• have a history of heart problems such as an irregular or fast heartbeat or angina
• suffer from glaucoma (excessive pressure inside your eyes)
• are taking steroids including prednisolone
• are taking medicines called xanthines such as theophylline
• are taking water tablets (diuretics), sometimes used to treat high blood pressure or a heart condition
• are taking another nebuliser solution e.g. ipratropium bromide (for asthma).

Other medicines and Salbutamol Nebuliser Solution

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including any of the following as they may interact with Salbutamol Nebuliser Solution:

• medicines for an irregular or fast heartbeat such as propranolol
• other medicines for asthma.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you become pregnant whilst taking this medicine you should tell your doctor as soon as possible.

Driving and using machines

Salbutamol Nebuliser Solution has no known effects on the ability to drive and use machines.

General instructions:

Your medicine should be used with a power operated nebuliser. The “mist” produced is then inhaled through a face mask or mouthpiece. Do not let the solution or the mist produced by the nebuliser get in your eyes. You can wear glasses or goggles to protect them. Your doctor, nurse or pharmacist should show you how to use your medicine.

Only use the nebuliser recommended by your doctor and supervise your child while they are using the nebuliser.

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.

Do not inject or swallow the liquid. Salbutamol Nebuliser Solution should only be inhaled using your nebulizer.

Instructions for use:

• 1. Prepare your nebuliser following the manufacturer’s n instructions and/or the dosing instructions given by M your doctor.

• 2. Take a strip of ampoules from the foil sachet. Remove one or two ampoules (depending on your dose) [Diagram 1] and put the rest back in the foil sachet and replace the foil sachet in the carton. Never use an ampoule that has been opened already or if the

solution is discoloured.

• 3. Hold the ampoule upright and open it by twisting off the top. [Diagram 2].

• 4. Unless otherwise instructed by your doctor, squeeze all of the liquid from the plastic ampoule into the nebuliser chamber.

• 5. Throw away the opened plastic ampoule, even if there is liquid left over.

• 6. If your doctor has told you to dilute the solution, this should be carried out using ONLY sterile sodium chloride 0.9% solution. Use the amount which your

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doctor has told you to use. Do not dilute the contents

unless told to do so by your doctor.

• 7. Turn on the nebuliser and breathe in the “mist” calmly and deeply using a face mask or mouthpiece. If you are using a face mask, make sure it is fitted correctly.

Protect your eyes from the mist produced as it can cause pain or discomfort if it gets into them. This is especially important if you suffer from glaucoma.

• 8. The length of time it takes your nebuliser to turn your medicine into a mist will depend on the type of equipment you use. You will know when your treatment is complete because the fine mist will stop coming out of your mask or mouthpiece.

• 9. You must wash your nebuliser, face mask and/or mouthpiece in warm soapy water and rinse well after each use.

In most people, Salbutamol Nebuliser Solution will start to give relief from wheezing and chest tightness within about 5 minutes and the effects should last for about 4–6 hours. After using your nebuliser a few times you will know how long the effects normally last for you.

Contact your doctor immediately if:

• You are not getting relief from your current dose or you are having to take more inhalations
• Your breathing is not improving or is getting worse
• Your chest feels tight.

These are signs that your condition is not being controlled and you may need different or additional treatment.

Your doctor may also prescribe a second type of nebuliser solution to use at the same time as this medicine. Follow your doctor’s advice on how to use the nebuliser properly. If you are in any doubt, ask your doctor.

If you use more Salbutamol Nebuliser Solution than you should

Call your doctor immediately or go to the nearest hospital casualty department. You may feel your heart is beating faster than usual, shaky, or hyperactive. These effects usually wear off in a few hours. If you feel shaky you should not drive. Take this leaflet or an ampoule with you so the hospital will know what you have taken.

If you forget to use Salbutamol Nebuliser Solution

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

If you stop using Salbutamol Nebuliser Solution

This may make your condition worse. Do not stop taking your medicine unless your doctor tells you to do so.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4 possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor or go to the nearest hospital casualty department immediately if you experience any of the following serious side effects: Common (may affect up to 1 in 10 people):

• your heart is beating much faster than usual (tachycardia).

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

• low blood potassium (hypokalaemia) which can make you feel generally unwell and over-tired. You may also experience frequent urination (passing water). If you notice any of these effects, your doctor may arrange for you to have a blood test
• some people may occasionally experience chest pain, due to heart problems such as angina. Tell your doctor as soon as possible if you develop these symptoms, but do not stop using this medicine unless told to do so.

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

• an allergic reaction (such as sudden wheeziness, difficulty in breathing, swelling of the eyelids, face, lips or throat, or a rash or itching especially affecting the whole body, feeling faint and collapsing)
• inhaled medicines such as salbutamol can cause coughing, acute wheezing, shortness of breath (bronchospasm). If this occurs, stop using your medicine immediately and seek medical help
• an abnormally fast heart rate, irregular heart rhythm or chest pain (arrhythmia).

Not known (frequency cannot be estimated from the available data):

• restricted blood flow to the heart (myocardial ischemia) can cause chest, jaw or shoulder pain which may be accompanied with shortness of breath when physically active, nausea and vomiting, sweating, fatigue
• a condition known as lactic acidosis may cause stomach pain, hyperventilation, shortness of breath even though there may be improvement in your wheezing, cold feet and hands, irregular heartbeat or thirst.

Tell your doctor if you notice any of the following side effects, they get worse or you notice any other effects not listed:

Common (may affect up to 1 in 10 people):

• tremor (shaking), headache.

Uncommon (may affect up to 1 in 100 people):

• an awareness of your heartbeat (palpitations), mouth and throat irritation, muscle cramps.

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

• increased blood flow or pain in the arms and legs.

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

• hyperactive behaviour.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5 how to store salbutamol nebuliser solution

Keep this medicine out of the sight and reach of children.

Store the product below 25°C. Store in the original package.

Do not use this medicine after the expiry date which is stated on the carton and ampoule after Exp. The expiry date refers to the last day of that month.

Open one foil pack at a time and use all 10 ampoules before opening the next foil pack. Always replace the foil pack in the carton after use. When first opening a foil pack, note the date of opening and add 6 months to this date which will be the “Do not use after” date. Unused ampoules remaining in an opened foil pack after the “Do not use after” date should not be used, but should be returned to your pharmacist.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6 contents of the pack and other information

What Salbutamol Nebuliser Solution contains

• The active substance is Salbutamol 2.5mg/2.5ml or 5mg/2.5ml (as salbutamol sulfate).
• The other ingredients are sodium chloride, water for injections and sulfuric acid.

What Salbutamol Nebuliser Solution looks like and contents of the pack

Salbutamol Nebuliser Solutions are clear, colourless to pale yellow solutions in clear plastic ampoules.

Salbutamol Nebuliser Solutions are packed in cartons containing 20 or 60 ampoules in foil wrapped strips of 10. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Accord, Barnstaple, EX32 8NS, UK.

Manufacturer:

Laboratoire Unither,

Espace lndustriel Nord

151 rue Andre Durouchez- CS 28028

80084 AMIENS CEDEX 2

France.

This leaflet was last revised in June 2021.

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