When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
SUMMARY OF SPC CHANGES (IN RED)
1. NAME OF THE MEDICINAL PRODUCT
Ventolin Syrup 2mg/5ml Oral Solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml of liquid solution contains 2mg salbutamol as salbutamol sulphate. Excipients: Contains approximately 5.61mg sodium per 5ml dose. For a full list of excipients, see section 6.1. 6.2 Incompatibilities Dilution of Ventolin Syrup with Syrup BP or Sorbitol Solution is not recommended as this may result in precipitation of the cellulose thickening agent. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. 6.3 Shelf life 3 years Diluted solution: 4 weeks. Discard any unused diluted solution. 6.4 Special Precautions for Storage Do not store above 25°C. Store in the original container to protect from light. For storage of the diluted product, see section 6.3 and protect from light. 6.5 Nature and Contents of Container It is supplied in Type III amber glass bottles with aluminium screw-caps or HDPE child resistant closures, containing 150ml of Syrup Oral Solution. Not all pack sizes may be marketed. 6.6 Instructions for Use and Handling Salbutamol Syrup Oral Solution may be diluted by the pharmacist with an equal volume of Purified Water BP (50% v/v). The resulting mixture contains 1mg/5ml salbutamol. The resulting mixture should be stored in a glass bottle, protected from light and used within 28 days 4 weeks. Do not store above 25oC. A 50% v/v dilution of salbutamol Syrup Oral Solution has been shown to be adequately preserved against microbial contamination. Admixture of salbutamol Syrup Oral Solution with other liquid preparation is not recommended.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of liquid solution contains 2mg salbutamol as salbutamol sulphate.
Excipients: Contains approximately 5.61mg sodium per 5ml dose.
For a full list of excipients, see section 6.1.
6.2 Incompatibilities
Dilution of Ventolin Syrup with Syrup BP or Sorbitol Solution is not recommended as this may result in precipitation of the cellulose thickening agent.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 Shelf life
3 years
Diluted solution: 4 weeks. Discard any unused diluted solution.
6.4 Special Precautions for Storage
Do not store above 25°C.
Store in the original container to protect from light.
For storage of the diluted product, see section 6.3 and protect from light.
6.5 Nature and Contents of Container
It is supplied in Type III amber glass bottles with aluminium screw-caps or HDPE child resistant closures, containing 150ml of Syrup Oral Solution.
Not all pack sizes may be marketed.
6.6 Instructions for Use and Handling
Salbutamol Syrup Oral Solution may be diluted by the pharmacist with an equal volume of Purified Water BP (50% v/v). The resulting mixture contains 1mg/5ml salbutamol. The resulting mixture should be stored in a glass bottle, protected from light and used within 28 days 4 weeks. Do not store above 25oC.
A 50% v/v dilution of salbutamol Syrup Oral Solution has been shown to be adequately preserved against microbial contamination.
Admixture of salbutamol Syrup Oral Solution with other liquid preparation is not recommended.
4.9 Overdose
The preferred antidote for overdosage with salbutamol is a cardioselective â-blocking agent. However,
Symptoms and Signs
The most common signs and symptoms of overdose with salbutamol are transient beta agonist pharmacologically mediated events (see Special Warnings and Precautions for Use and Undesirable Effects).
Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored.
Nausea, vomiting and hyperglycaemia have been reported, predominantly in children and when salbutamol overdose has been taken via the oral route.
Treatment
Consideration should be given to discontinuation of treatment and appropriate symptomatic therapy such as cardio-selective beta-blocking agents in patients presenting with cardiac symptoms (e.g. tachycardia, palpitations).
Beta-blocking drugs should be used with caution in patients with a history of bronchospasm.
No special requirements.
Salbutamol syrup may be diluted with Purified Water BP (50% v/v). The resulting mixture should be protected from light and used within 28 days.
A 50% v/v dilution of salbutamol syrup has been shown to be adequately preserved against microbial contamination.
Admixture of salbutamol syrup with other liquid preparation is not recommended.
4.4 Special Warnings and Precautions for Use
Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol. There is some evidence from post-marketing data and published literature of myocardial ischaemia associated with salbutamol. Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving salbutamol should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.
4.8 Undesirable Effects
Unknown: Myocardial ischaemia* (see section 4.4).
* reported spontaneously in post-marketing data therefore frequency regarded as unknown
Patient Leaflet additional wording – Respiratory indication only
(Ventolin Diskus, Evohaler, Nebules, Syrup & Respirator Solution)
Tell your doctor before starting this medicine:
· If you have a history of heart disease, irregular heart rhythm or angina.
Side effects:
Although it is not known exactly how often this happens, some people may 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.
Ventolin Syrup may cause a fine tremor of skeletal muscle, usually the hands are most obviously affected. This effect is dose related and is common to all
A few patients experience a feeling of tension; this is also due to the effects on skeletal muscle and not to direct CNS stimulation.
Occasionally headaches have been reported.
Peripheral vasodilation and a compensatory small increase in heart rate may occur in some patients.
Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely.
There have been very rare reports of muscle cramps.
Potentially serious hypokalaemia may result from
As with other
Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) may occur, usually in susceptible patients.
Tachycardia may occur in some patients.
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (1/10), common (1/100 and <1/10), uncommon (1/1000 and <1/100), rare (1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports. Very common and common events were generally determined from clinical trial data. Rare and very rare events were generally determined from spontaneous data.
Immune system disorders
Very rare: Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse.
Metabolism and nutrition disorders
Rare: Hypokalaemia.
Potentially serious hypokalaemia may result from beta-2 agonist therapy.
Nervous system disorders
Very common: Tremor.
Common: Headache.
Very rare: Hyperactivity.
Cardiac disorders
Common: Tachycardia, palpitations.
Rare: Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles.
Vascular disorders:
Rare: Peripheral vasodilatation.
Musculoskeletal and connective tissue disorders
Common: Muscle cramps.
Very rare: Feeling of muscle tension.