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Salbutamol Tablets Bp 2mg

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Document: label-leaflet MAH BRAND_PL 00142-0485 change

30x115mm 18pp label leaflet Profile (BST)


Braille reads:-salbutamol tablets 2 mg


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Height    Height

30mm    30mm


Salbutamol    28 tablets

tablets

Each tablet contains 2.4mg salbutamol sulfate equivalent to 2mg salbutamol.

For oral administration.

Also contains lactose, E122-see leaflet for details.

Use as directed by physician. Keep out of the reach and sight of children. Store below 25°C in a dry place.

PL 0142/0485

50868511 AAAI3481    Actavis, Barnstaple, EX32 8NS, UK


Base Label -115mm


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PEEL HERE.

~ DO NOT REMOVE LEAFLET.

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• Braille /frtvtork only* *

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Salbutamol 2mg tablets

Salbutamol sulfate

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.

Index

1.    What Salbutamol tablets are and what they are used for

2.    Before you take

3.    How to take

4.    Possible side effects

5.    How to store

6.    Further information

1. What Salbutamol tablets are and what they are used for

Salbutamol tablets belong to a group of medicines called selective beta-2-adrenergic agonists, which can be used to relax the muscles of the airways and womb. Salbutamol tablets may be used in:

*    asthma, to relieve the narrowing of the airways

*    chronic bronchitis

*    emphysema

2. Before you take

Do not take Salbutamol tablets and tell your doctor if you:

*    are allergic (hypersensitive) to salbutamol or any other ingredients in Salbutamol tablets (see section 6).

*    have threatened abortion (potential miscarriage) during the first six months of pregnancy.

*    are taking beta-blockers such as propranolol.

Check with your doctor or pharmacist before taking Salbutamol tablets if you have:

an overactive thyroid gland (thyrotoxicosis). diabetes.

a history of heart disease, irregular heart rhythm or angina. Although it is not known exactly how often this happens, some people occasionally experience chest pain (due to heart problems such as angina). Tell your doctor/midwife if you develop these symptoms whilst receiving treatment with salbutamol, but do not stop using this medicine unless told to do so.


Taking other medicines

* theophylline (for breathing problems).

Sugar intolerance

Please tell your doctor or pharmacist if you are taking or have recently

* inhaled anaesthetics (advise your doctor or dentist if you are undergoing

f you have been told you have an intolerance to some sugars, contact your

taken any other medicines, including medicines obtained without a

any dentistry or surgery)

doctor before taking this medicine, as it contains a sugar called lactose.

prescription. Especially:

* digoxin (for heart problems)

Ingredients warning

Salbutamol tablets contain carmoisine (E122) which may cause allergic reactions.

Tests

f you have severe asthma, your doctor may monitor you more closely by carrying out certain tests.

* diuretics, guanethidine, reserpine or methyldopa (to treat high blood pressure)

*    xanthines such as theophylline, aminophylline (for asthma)

*    medicines for diabetes

*    monoamine oxidase inhibitors e.g. tranylcypromine (for depression)

*    tricyclic antidepressants e.g. amitriptyline (for depression)

*    beta-blockers such as propranolol

*    corticosteroids

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or are breastfeeding tell your doctor or pharmacist before taking this medicine.


3. How to take

Always take Salbutamol tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Swallow the tablets with water

If you notice the tablets are not working as well as before, contact your doctor for advice.

* Adults:

Usual dose is 4mg three or four times a day. Your doctor may increase this


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gradually up to a maximum of 8mg three or four times a day. Some patients may be treated successfully with 2mg three or four times a day. ' Elderly or patients known to be sensitive to this product or other similar drugs:

Initially 2mg three or four times a day should be given.

' Children 2-6 years:

1-2mg three or four times a day.

' Children 6-12 years:

2mg three or four times a day.


*    Children over 12 years:

2-4mg three or four times a day.

*    Children under 2 years:

Not recommended.

If you take more than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include low levels of potassium in the blood which may cause


muscle twitching or weakness and an irregular heart beat.

If you forget to take the tablets

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

4. Possible side effects

Stop taking Salbutamol tablets and contact your doctor at once if you

experience


*    an allergic reaction such as swelling of the face, lips, throat or tongue, pale or red irregular raised patches with severe itching (hives), difficulty breathing, low blood pressure, collapse

*    chest, jaw or shoulder pain (which may be accompanied with shortness of breath, feeling or being sick)

Tell your doctor if you notice any of the following effects or if you notice any not listed:

*    increased lactic acid in the body: rapid breathing, being sick, stomach pain.


low blood potassium: muscle twitching or weakness, an irregular heart beat.

other: headaches, increased blood sugar levels, slight shaking (usually of the hands), a tense feeling, widening of blood vessels which can cause an increase in heart function and heart rate, an irregular heart beat, muscle spasm, fluid on the lungs. An increase in the amount of acid in the body (ketoacidosis) may occur in diabetics.

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store

Keep out of the reach and sight of children.

Store below 25°C in a dry place.

Do not use Salbutamol tablets after the expiry date stated on the

label/carton/bottle. The expiry date refers to the last day of that month.


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 Salbutamol tablets contain

*    The active substance (the ingredient that makes the tablets work) is salbutamol sulfate. Each tablet contains 2.4mg of the active ingredient equivalent to 2mg salbutamol.

*    The other ingredients are maize starch, lactose monohydrate, dispersed


pink (erythrosine (E127), carmoisine (E122), titanium dioxide (E171), sodium starch glycollate, talc, magnesium stearate.

What Salbutamol tablets look like and contents of the pack

Salbutamol tablets are pink, circular, flat bevelled edge, uncoated tablets.

Pack size is 28.

Marketing Authorisation Holder and Manufacturer

Actavis, Barnstaple, EX32 8NS, UK.

This leaflet was last revised in October 2015


Salbutamol

28 tablets

tablets    For oral use

Each tablet contains 2.4mg salbutamol sulfate equivalent to 2mg salbutamol.

For oral administration.

Also contains lactose, E122-see leaflet for details. Use as directed by physician. Keep out of the reach and sight of children. Store below 25°C in a dry place. PL 0142/0485 |pQM|

50868511 AAAI3481


5 11012617 008923

^3Cf3Vfa

Actavis, Barnstaple, EX32 8NS, UK



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