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Salbutamol Syrup 2mg/5ml

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Document: leaflet MAH BRAND_PL 04917-0033 change

PATIENT INFORMATION LEAFLET


SALAPIN Salbutamol Syrup 2mg/5ml Salbutamol 2mg/5ml


Read all of this leaflet carefully 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 Salapin is and what it is used for

2.    Before you take Salapin


3.    How to take Salapin

4.    Possible side effects

5.    How to store Salapin

6.    Further information


1.    WHAT SALAPIN IS AND WHAT IT IS USED FOR

The active ingredient of Salapin is salbutamol which belongs to a group of medicines known as bronchodilators. Salapin is used to rapidly treat asthma, bronchospasm and reversible airways obstruction by 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.    BEFORE YOU TAKE SALAPIN Do NOT take Salapin if you:

•    have an allergy (hypersensitivity) to Salbutamol Sulphate or any of the other ingredients of Salapin (see Section 6 and end of section 2).

•    are in premature labour or threatened miscarriage.

•    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.

Take special care with Salapin and talk to your doctor or pharmacist if you:

•    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 Salapin may cause difficulty in passing water.

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, but especially the following:

•    medicines for the treatment of high blood pressure: propanolol, guanethidine, reserpine and methyldopa

•    tricyclic antidepressants

If you are going to have an operation requiring general anaesthetic (for example chloroform, cyclopropane or halothane) please tell the medical staff you are taking Salapin.

Pregnancy and breast-feeding

Salapin 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 breast-feeding.

Driving and using machines

Salapin has no known effect on your ability to drive or use machines.

Important information about some of the ingredients of Salapin

Your medicine contains:-

Ethanol: This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 5ml.

3.    HOW TO TAKE SALAPIN

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 (1mg) 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.


5 ml


2.5 ml



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The usual dose is:

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.

Children aged 2 - 6 years:

Half to one 5ml spoonful (2.5-5ml), 3 or 4 times per day.

Children aged 6 - 12 years:

One 5ml spoonful (5ml), 3 or 4 times per day.

Children over 12 years:

One to two 5ml spoonfuls (5-10ml), 3 or 4 times per day.

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 Salapin than you should:

If you or someone else takes too much Salapin, you should contact your doctor or pharmacist who will recommend what action you should take.

If you forget to take Salapin

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

Li ke all medicines, Salapin can cause side effects, although not everybody gets them.

You should STOP using Salapin and seek advice from your doctor if you experience a rare allergic reaction, including skin rashes, difficulty breathing, dizziness or collapse.

Common side effects:

You may notice the following more common side effects:

•    tremor of the hands

•    tension, restlessness and a rapid heartbeat Very rare side effects:

There have been occasional reports of headache, and very rare reports of muscle cramps.

Rare side effects:

As with other drugs in this class, rare reports of hyperactivity in children have been received.

Potentially serious low potassium levels in your blood may occur with use of products such as Salapin. Additional monitoring should be performed.

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.

5.    HOW TO STORE SALAPIN

Keep out of the reach and sight of children. Do not store above 25°C.

Do not use Salapin 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 the outer carton.

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 Salapin 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 Salapin looks like and contents of the pack

Salapin 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

Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.

PL 04917/0033

This leaflet was last revised 08/2009.


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