Medine.co.uk

Terbutaline Sulfate 2.5mg/Ml Nebuliser Solution

200 MM

CODE 39


PACKAGE LEAFLET: INFORMATION FOR THE USER

Terbutaline Sulfate 2.5mg/ml Nebuliser Solution

Read all of this leaflet carefully before you start taking 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 Terbutaline Sulfate Nebuliser Solution is and what it is used for

2.    Before you use Terbutaline Sulfate Nebuliser Solution

3.    How to use Terbutaline Sulfate Nebuliser Solution

4.    Possible side effects

5.    How to store Terbutaline Sulfate Nebuliser Solution

6.    Further information


1. WHAT TERBUTALINE SULFATE NEBULISER SOLUTION IS AND WHAT IT IS USED FOR


3. HOWTO USE TERBUTALINE SULFATE NEBULISER SOLUTION


280 MM


Terbutaline Sulfate Nebuliser Solution belongs to a group of medicines called 'bronchodilators' which help to open up the air passages in your lungs so that you can breathe more easily.

Terbutaline Sulfate Nebuliser Solution helps to make breathing easier in patients who have asthma, bronchitis and other chest illnesses.


2. BEFORE YOU USE TERBUTALINE SULFATE NEBULISER SOLUTION


Do not use Terbutaline Sulfate Nebuliser Solution:

•    If you are allergic (hypersensitive) to terbutaline sulfate

•    If you are allergic to any of the other ingredients of Terbutaline Sulfate Nebuliser Solution (see section 6 Further Information)

•    If you have a heart condition called cardiomyopathy (this is when your heart does not work properly due to inflammation of the heart muscles).

Take special care with Terbutaline Sulfate Nebuliser Solution:

Talk to your doctor if any of the following apply to you:

•    If you have diabetes

•    If you have an overactive thyroid gland

•    If you have a heart condition, abnormal heart rhythm, or disease of the heart

•    If you have high blood pressure

•    If you have low levels of potassium in the blood (hypokalaemia).

Taking other medicines

Tell your doctor if you are taking any of the following as they may interact with your medicine:

•    Medicines for treating high blood pressure such as propranolol

•    Other medicines which help you to breathe.

If you are already taking other medicines prescribed by your doctor for your asthma, make sure you keep taking these unless your doctor tells you otherwise.

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, think you are pregnant or are breast-feeding, tell your doctor before using this medicine. If you become pregnant whilst taking this medicine you should tell your doctor as soon as possible.

Driving and using machines

If you are taking high doses of this medicine, you should not drive or use machinery.

If you are unsure, talk to your doctor.


Always use Terbutaline Sulfate Nebuliser Solution exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults (including the elderly):

The usual dose is one or two ampoules (5mg or 10mg) taken two to four times each day.

Children weighing more than 25 kg:

The usual dose is one ampoule (5mg) taken two to four times each day. This medicine is not recommended for children weighing less than 25 kg General instructions:

Open each foil sachet one at a time and use all the ampoules inside before opening the next foil sachet. Always return any remaining ampoules to the foil sachet and place the sachet back in the carton after use. Since the ampoules do not contain a preservative, it is important to use them as soon as they are opened.

Instructions for use:

1.    Prepare your power-operated nebuliser following the manufacturer's instructions and/or the dosing instructions given by your doctor.

2.    Take a strip of ampoules from the foil sachet Remove one or two ampoules (depending on your dose) and put the rest back in the foil sachet and replace the foil sachet in the carton. [Diagram 1], 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 plastic ampoule.

6.    Turn on the nebuliser and breathe in the "mist” calmly and deeply using the face mask or mouthpiece. If you are using a face mask make sure that it is fitted correctly. Be sure to 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.

7.    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.

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


Diagram 1



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5. HOW TO STORE TERBUTALINE SULFATE NEBULISER SOLUTION


In most people, Terbutaline Sulfate Nebuliser Solution gives relief of wheezing and chest tightness for up to 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 as much relief from your current dose

•    Your breathing 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.

If you use more Terbutaline Sulfate Nebuliser Solution than you should you may feel shaky, anxious or dizzy, get a headache and feel that your heart is beating faster than usual.

Call your doctor immediately or go to the nearest hospital casualty department. If you feel shaky you should not drive. Take this leaflet or an ampoule of your medicine with you so that the hospital will know what you have taken.

If you forget to use your Terbutaline Sulfate Nebuliser Solution

If you forget to take your Terbutaline sulfate Nebuliser Solution take the next dose when it is due or before you become wheezy. Do not take a double dose to make up for the one you missed.

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

4. POSSIBLE SIDE EFFECTS_

Like all medicines, Terbutaline Sulfate Nebuliser Solution can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor immediately if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).

Rarely, inhaled drugs such as terbutaline can cause acute wheezing and/or shortness of breath. If this occurs, stop using your medicine immediately and seek medical advice.

The following side effects have been reported. If they do occur, they usually go away within the first week of starting treatment. Tell your doctor if any of these side effects become troublesome:

•    Trembling or shaking    •    Cramps or feeling    tense

•    Headache    •    Mouth and throat    irritation

•    Nausea (feeling sick)    •    Feeling tense.

Rarely, you may experience muscle weakness, thirst and pins and needles (caused by the effects of low levels of potassium in the blood).

Changes in sleeping patterns and changes in behaviour, such as agitation, hyperactivity and restlessness have sometimes been seen.

Rarely, fast heart beats occur with medicines of this type. Other heart problems such as unusual heartbeats have also occurred, although this is usually only seen in susceptible patients.

Keep out of the reach and sight of children.

Do not use after the expiry date which is stated on the carton, foil sachet and ampoule after "Exp”. The expiry date refers to the last day of that month.

Store the ampoules in their foil sachet and their original carton.

Once the foil sachet has been opened, the ampoules inside should be used within 6 months.

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

6. FURTHER INFORMATION

What Terbutaline Sulfate Nebuliser Solution contains

•    The active substance is terbutaline sulfate

•    The other ingredients are sodium chloride, disodium edetate, water for injections and sulfuric acid.

Terbutaline Sulfate Nebuliser Solution contains 5mg of terbutaline sulfate (2.5mg/ml) as the active substance in each 2ml ampoule.

What Terbutaline Sulfate Nebuliser Solution looks like and contents of the pack

Your medicine comes in the form of plastic ampoules containing 2mI of a colourless to yellow solution to be nebulised (made into a fine mist for inhalation).

Each carton contains 20 ampoules in foil wrapped strips of 5 or 10. Marketing Authorisation Holder:

Breath Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom.

Manufacturer:

Laboratoire Unither, Espace Industriel Nord,

151 rue Andre Durouchez - CS 28028,

80084 AMIENS CEDEX 2, France.

This leaflet was last revised in November 2015

280 MM


Reporting of side effects

13 MM


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: www.mhra.gov.uk/yellowcard

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

AAAI5265