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The product code for this leaflet is: PL 00142/0486

 

Salbutamol Tablets BP 4mg

Company Details

Actavis UK Ltd


Whiddon ValleyBarnstapleDevonEX32 8NS
Telephone:
Fax:
Medical Information Direct Line:
Medical Information e-mail:medinfo@actavis.co.uk
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PATIENT INFORMATION LEAFLET

Salbutamol 4mg tablets

Salbutamol sulphate

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

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

Salbutamol tablets belong to a group of medicines called selective beta-2-androgenic 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
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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

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

Especially:

  • guanethidine, reserpine or methyldopa (to treat high blood pressure)
  • monoamine oxidase inhibitors e.g. tranylcypromine (for depression)
  • tricyclic antidepressants e.g. amitriptyline (for depression)
  • beta-blockers such as propranolol
  • corticosteroids
  • theophylline (for breathing problems).

Pregnancy and breast-feeding

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

Sugar intolerance

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a sugar called lactose.

Ingredients warning

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

Tests

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

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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 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.

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4. Possible side effects

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

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

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

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6. Further information

What Salbutamol tablets contain

  • The active substance (the ingredient that makes the tablets work) is salbutamol sulphate. Each tablet contains 4.8mg of the active ingredient equivalent to 4mg 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
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This leaflet was last revised in December 2013


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