Salbutamol Syrup 2mg/5ml
PATIENT INFORMATION LEAFLET Salbutamol Syrup 2mg/5ml
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 symptoms are the same as yours.
• If any of the side effects gets 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 is and what it is used for
2. What you need to know before you take Salbutamol
3. How to take Salbutamol
4. Possible side effects
5. How to store Salbutamol
6. Contents of the pack and other information
1. What Salbutamol is and what it is used for
The active ingredient of this medicine is salbutamol which belongs to a group of medicines known as oronchodilators. Salbutamol is used to rapidly treat asthma, bronchospasm and reversible airways obstruction oy widening the airways of the lungs. It is suitable for children or adults who prefer liquid medicines or are unable to use an inhaler device.
2. What you need to know before you take Salbutamol Do NOT take Salbutamol if you:
• have an allergy (hypersensitivity) to Salbutamol Sulphate or any of the other ingredients of Salbutamol (see Section 6 and end of section 2).
• are in premature labour or threatened miscarriage.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Salbutamol if you:
• are diabetic, as this product may cause an increase in blood sugar levels. This effect may be further increased if you are also taking corticosteroids.
• have an irregular heartbeat / heart rhythm, including a very fast pulse.
• have an overactive thyroid.
• have acute severe asthma; your potassium levels should be monitored
• have unstable asthma; you may need additional treatment and regular monitoring
• need to use your asthma medication(s) more frequently to control your symptoms
• have an enlarged prostate, as Salbutamol may cause difficulty in passing water.
Taking other medicines
3lease tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, but especially the following:
• medicines for the treatment of high blood pressure: propranolol, guanethidine, reserpine and methyldopa
• tricyclic antidepressants
If you are going to have an operation requiring general anaesthetic (for example chloroform, cyclopropane or nalothane) please tell the medical staff you are taking Salbutamol.
Pregnancy and breast-feeding
Salbutamol should only be used in pregnancy and when breast-feeding if considered to be essential by the doctor. Ask your doctor or pharmacist for advice before taking any medicine during pregnancy, or if you are oreast-feeding.
Driving and using machines
Salbutamol has no known effect on your ability to drive or use machines.
Important information about some of the ingredients of Salbutamol
Your medicine contains:-
Ethanol: This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 5ml.
3. How to take Salbutamol
Always take the product exactly as advised. You should check with your doctor or pharmacist if you are not sure. Only to be taken by mouth. Shake the bottle well before measuring the dose in the 5ml plastic spoon provided.
For doses less than 5 ml
When measuring a (1 mg) half 5ml dose, the spoon should be filled up to the 2.5ml mark indicated on the spoon. Please see diagram below. An oral syringe may be used to measure doses less than 5ml.
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The usual dose is:
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Adults: |
Two 5ml spoonfuls (10ml), 3 or 4 times per day, which may be increased to a maximum of four 5ml spoonfuls (20ml), 3 or 4 times per day. Minimum starting dose is one 5ml spoonful (5ml), 3 or 4 times per day. |
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Children aged 2-6 years: |
Half to one 5ml spoonful (2.5-5ml), 3 or 4 times per day. |
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Children aged 6-12 years: |
One 5ml spoonful (5ml), 3 or 4 times per day. |
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Children over 12 years: |
One to two 5ml spoonfuls (5-10ml), 3 or 4 times per day. |
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Elderly patients and patients unusually sensitive to this class of medicine: |
Start treatment with one 5ml spoonful (5ml), 3 or 4 times per day. |
If the medicine does not seem to be working as well as usual, TELL YOUR DOCTOR AS SOON AS POSSIBLE. It may be that your chest condition is getting worse and you need a different medicine. DO NOT TAKE EXTRA SYRUP unless told to by your doctor.
If you take more Salbutamol than you should:
If you or someone else takes too much Salbutamol, you should contact your doctor or pharmacist who will •ecommend what action you should take.
The following effects may happen:
your heart beating faster than usual hyperactivity
These effects usually wear off in a few hours.
If you forget to take Salbutamol
If you miss a dose, take it as soon as you remember and take any remaining doses for that day at evenly spaced times. Do not take a double dose to make up for the forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Salbutamol can cause side effects, although not everybody gets them.
Allergic reactions (affects less than 1 in 10,000 people)
You should STOP using Salbutamol and seek advice from your doctor if you experience a rare allergic reaction, ncluding skin rashes, difficulty breathing, dizziness or collapse.
Talk to your doctor as soon as possible if:
you feel your heart is beating faster or stronger than usual (palpitations). This is usually harmless and usually stops after you have used the medicine for a while you feel your heartbeat is uneven or it gives an extra beat these affect less than 1 in 10 people.
If any of these happen to you, talk to your doctor as soon as possible. Do not stop using this medicine unless told to do so.
Tell your doctor if you have any of the following side effects which may also happen with this medicine:
Very common (may affect more than 1 in 10 people) feeling shaky
Common (may affect up to 1 in 10 people)
headache • muscle cramps
Rare (may affect up to 1 in 1,000 people)
changes in the salt balance of your body • a low level of potassium in your blood increased blood flow to your extremities (peripheral dilation)
Very rare (may affect up to 1 in 10,000 people)
changes in sleep patterns and changes in behaviour, such as restlessness and excitability muscle tension
The following side effects can also happen but the frequency of these are not known:
chest pain, due to heart problems such as angina. Tell your doctor, pharmacist or nurse if this occurs. Do not stop using this medicine unless told to do so.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed n 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 Salbutamol
Keep out of the reach and sight of children. Do not store above 25 C. Do not use Salbutamol after the expiry date which is stated on the label or carton. The expiry date refers to the last day of that month. Keep container in :he outer carton. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist now to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information What Salbutamol contains:
The active substance is Salbutamol Sulphate equivalent to 2mg Salbutamol per 5ml.
The other ingredients are xanthan gum (E415), glycerol (E422), sodium citrate, saccharin sodium (E954), sodium benzoate (E211), citric acid monohydrate, raspberry cola flavour (which contains: ethanol, propylene glycol (E1520), polysorbate (E423), nutmeg oil, safrole and cinnamic aldehydes) and purified water. (See end of section 2 for information on ethanol).
What Salbutamol looks like and contents of the pack
Salbutamol is a raspberry cola flavoured sugar-free syrup, available in 100ml and 150ml HDPE bottles, or in 100ml, 150ml and 200ml amber glass bottles.
Marketing Authorisation Holder and Manufacturer
3inewooa Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland. PL 04917/0033
This leaflet was last revised 07/2016.
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you feel shaky
acid build up in your body which may cause breathing to become fastei