iMedi.co.uk

Salbutamol 2.5mg Inhalation Solution

Document: leaflet MAH BRAND_PL 20046-0093 change

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Salbutamol Inhalation Solution 2.5mg and 5.0mg

[Salbutamol Sulphate 2.5mg/2.5ml and 5.0mg/2.5ml)

Read all of this leaflet carefully before you start using this medicine.

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 symptoms are the same as yours.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Salbutamol Inhalation Solution is and what it is used for

2.    Before you use Salbutamol Inhalation Solution

3.    Howto use Salbutamol Inhalation Solution

4.    Possible side effects

5.    How to store Salbutamol Inhalation Solution

6.    Further information

1.WHAT SALBUTAMOL INHALATION SOLUTION IS AND WHAT IT IS USED FOR

the active substance in Salbutamol Inhalation Solution is called salbutamol sulphate. Salbutamol sulphate belongs to a group of medicines known as bronchodilators. It is used to treat asthma and breathing difficulties associated with wheezing, coughing, chest tightness or shortness of breath. It works by opening up the air passages in your lungs so that you can breathe more easily. Salbutamol Inhalation Solution is usually prescribed to people who suffer severe cases of these conditions where alternative treatment has not proved sufficient. It is also given to treat severe attacks of asthma.

2. BEFORE YOU USE SALBUTAMOL INHALATION SOLUTION

Do not use Salbutamol Inhalation Solution

if you are allergic (hypersensitive) to salbutamol sulphate or any of the other ingredients of Salbutamol Inhalation Solution if you are pregnant and go into premature labour if you have a history of miscarriages Talk to your doctor before using this product if this applies to you. Take special care with Salbutamol Inhalation Solution if you are pregnant

if there is a chance you might become pregnant if you are breast-feeding if you suffer from an overactive thyroid gland if you suffer from heart problems, irregular heart rhythm, high blood pressure or angina

if you suffer from diabetes (you may need some additional blood sugar tests)

If any of the above apply to you, it is important that you tell your doctor or pharmacist before using Salbutamol Inhalation Solution and they will decide what to do. It may still be safe for you to use Salbutamol Inhalation Solution.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any of the following medicines:

Digoxin (used to treat heart failure and other heart problems): this medicine may not work as well and your doctor may need to change your dose.

Seta blockers such as propranolol (useO to treat high bloo pressure): taking beta blockers and salbutamol together ma make these medicines less effective and they may not work properly.

Taking any of the following medicines with Salbutamol Inhalation Solution can result in low levels of potassium in your blood, which can make your muscles feel weak or give you muscle aches or cramps:

•    Diuretics (water tablets), including acetazolamide (used in the treatment of glaucoma, epilepsy and excess water retention) and other diuretics (used to treat high blood pressure).

•    Theophylline or corticosteroids (used in the treatment ol asthma).

Your doctor may therefore ask you to have a blood test from time to time to check your potassium levels.

If you are using another nebuliser solution e.g. ipratropium bromide, at the same time as Salbutamol Inhalation Solution, ask your doctor or pharmacist to advise you on how to make sure that the mist does not get into your eyes Please also tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

Using Salbutamol Inhalation Solution with food and drink

Food and drink have no known influence.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before using Salbutamol Inhalation Solution if you are pregnant, thinking ol becoming pregnant or breast-feeding.

Driving and using machines Salbutamol Inhalation Solution has no known influence on your ability to drive and use machines

3.HOW TO USE SALBUTAMOL INHALATION SOLUTION

Always use Salbutamol Inhalation Solution exactly as your doctor has told you. You should check with your doctor or pharmacist i you are not sure.

First use of Salbutamol Inhalation Solution

The first time you use Salbutamol Inhalation Solution should be under close medical supervision.

Adults (including the elderly and children over 12 years)

The usual dose is 2.5mg to 5mg up to four times daily. However your doctor may increase the dose to 1 Omg up to four times dail if necessary. In these severe cases, you will require strict medica supervision in hospital.

Children (aged 4 to 11 years)

The usual dose is 2.5mg to 5mg up to four times daily.

Salbutamol Inhalation Solution must only be administered b inhalation from a suitable nebuliser. (This product should not be injected or swallowed). A nebuliser is a machine which turns the nebuliser solution into a fine spray which you can then inhale usually through a mask.

Preparing the nebuliser and Salbutamol Inhalation Solution:

1.    Make sure that you are fully familiar with the operation of your nebuliser. Your doctor will instruct you in how to correctly use the nebuliser and Salbutamol Inhalation Solution. You should also carefully read the instructions provided with the nebuliser.

2.    Prepare the nebuliser for use.

3.    Separate an ampoule from the strip by carefully pulling and twisting (Figure 1). Never use one that is already open

4.    Hold the ampoule upright and twist off the tab (Figure 2). Use the contents of the ampoule immediately after opening.

5.    Squeeze all the ampoule contents into the nebuliser reservoir (Figure 3). Salbutamol Inhalation Solution should be used undiluted. However, if dilution is necessary (e.g. if a prolonged delivery time is required), this should be carried out using ont sterile normal saline solution as instructed by your doctor.

6.    Assemble the nebuliser and use it as instructed by your doctor Care should be taken to ensure that the nebuliser mist (or the solution) does not enter your eyes.

7.    After nebulisation throw away any solution remaining in the nebuliser and clean the nebuliser as instructed.

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Separation    Opening    Squeezing into

nebuliser reservoir

If your treatment is less effective than usual

If your treatment is less effective than usual or the effect does not last as long as usual, do not attempt to exceed your prescribed dose. You should contact your doctor immediately to discuss the situation.

If you use more Salbutamol Inhalation Solution than you should

If you have taken a slightly larger dose than recommended, you may feel short of breath, develop an increased heart rate, feel shaky or feel muscle weakness and cramps. This usually wears off after a few hours. However, if you have taken a much larger dose, you should contact your nearest casualty department or tell your doctor immediately. Take this leaflet and any remaining medicine with you.

If you forget to use Salbutamol Inhalation Solution

If you forget an inhalation, take it when you remember. The next dose should be after your normal interval between doses. Do not take a double dose to make up for a forgotten dose.

If you stop using Salbutamol Inhalation Solution

Your doctor will advise you when to stop using Salbutamol Inhalation Solution. Follow your doctor's instructions.

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

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4. POSSIBLE SIDE EFFECTS

Like all medicines, Salbutamol Inhalation Solution can cause side effects, although not everybody gets them.

If you experience any of the following very rare side effects (affecting fewer than 1 in 10,000 people) whilst taking your medicine, contact your doctor immediately and stop taking this medicine:

•    Severe allergic reaction. You may have a red lumpy skin rash, difficulty breathing, swelling of face, lips or eyelids, unexplained high temperature (fever) and feel faint. If the swelling affects your throat and makes breathing and swallowing difficult, go to hospital straight away.

•    Your breathlessness gets worse.

Although it is not known exactly how often this happens, some people may occasionally experience chest pain (due to heart problems such as angina). Tell your doctor if you develop these symptoms whilst receiving treatment with salbutamol, but do not stop using this medicine unless told to do so. the following side effects have also been reported:

Common side effects (affecting up to 1 in 10 people)

•    Headache

•    Increase in heart rate

•    Trembling

Uncommon side effects (affecting fewer than 1 in 100 people)

•    Mouth and throat irritation

•    Muscle cramps

•    Pounding of the heart

Rare side effects (affecting fewer than 1 in 1000 people)

•    Flushing of the skin

•    Decrease in the body's potassium level (which may make your muscles feel weak, or you may experience muscle aches and/or cramps)

Very rare side effects (affecting fewer than 1 in 10,000 people)

•    Uneven heartbeat, or an extra heartbeat

In children, the following very rare side effects have been reported:

•    Sleep and behaviour disturbances

•    Over excitability


Other side effects (frequency unknown)

•    A condition called lactic acidosis which may make you hyperventilate and feel short of breath

•    A condition called acute angle-closure glaucoma which mav cause sudden eye pain, redness of the eyes and blurred visior

If any of the side effects above get serious, or if you notice an> side effects not listed in this leaflet, please tell your doctor or pharmacist.

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5.    HOW TO STORE SALBUTAMOL INHALATION SOLUTION

Keep out of the reach and sight of children.

Do not use Salbutamol Inhalation Solution after the expiry date which is stated on the carton, foil bag and plastic ampoules. The expiry date refers to the last day of that month.

Store the product below 25°C. Keep the Inhalation Solution ampoules in the foil bag within the carton in order to protect the product from light and moisture.

Do not use Salbutamol Inhalation Solution if you notice that the packaging or any of the plastic ampoules are damaged, or if the solution in the plastic ampoules is no longer clear and colourless or slightly yellow.

Do not keep or use an ampoule which has been opened previously - throw it away.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose ol medicines no longer required. These measures will help to protect the environment.

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6. FURTHER INFORMATION

What Salbutamol Inhalation Solution contains

The active substance is called salbutamol sulphate. Each 2.5m ampoule contains either 2.5mg or 5.0mg of salbutamol as salbutamol sulphate.

The other ingredients in the Inhalation Solution are: sodium chloride, dilute sulphuric acid, sodium hydroxide solution and water for injections.

What Salbutamol Inhalation Solution looks like and the contents of the pack

Each carton of Salbutamol Inhalation Solution contains 20 plastic ampoules packed in strips of 10 ampoules. Each strip is individually wrapped in a foil bag. Each ampoule contains 2.5m of a clear and colourless or slightly yellow solution for use onl> through a nebuliser.

Marketing Authorisation Holder Focus Pharmaceuticals Limited, Unit 5, Faraday Court, First Avenue, Centrum 100, Burton upon Trent, Staffordshire, DEI 4 2WX

Manufacturer Almac Pharma Services Limited, Almac House, 20

Seagoe Industrial Estate, Craigavon, BT63 5QD, UK

For any information about this medicinal product, please

contact the Marketing Authorisation Holder, details provided

above.

For information in large print, audio CD or Braille, please telephone 00 44 (0)1283 495 280 or email medinfo@focuspharma.co.uk

This leaflet was last revised in 12/2012.