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.
4.2 Posology and method of administration
Oral administration only.
Do not exceed the stated dose.
Should not be used with other cough and cold medicines. Removal of dosing for children under 12.
4.3 Contraindications Hypersensitivity to any of the ingredients.
Contraindicated in patients with a history of hypersensitivity to guaifenesin, treacle, glucose or to any of the excipients. Addition of contraindication for children under 12
4.4 Special warnings and precautions for use
Warning not to give to children under 12 Removal of instruction to consult doctor/pharmacist for use in children under 6. Contains 4.8mg sodium per 5ml. This should be taken into consideration in patients on a controlled sodium diet.
Contains 3.34g of sugars per 5ml. This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
4.6 Pregnancy and lactation Use during pregnancy and lactation is not contraindicated. However caution should be exercised and use during pregnancy should be on the advice of a doctor. Pregnancy The safety of guaifenesin during pregnancy has not been established. Medical advice should be sought before use in pregnancy and this medicine should not be used unless the potential benefit to the mother outweighs the possible risk to the developing foetus. Lactation No relevant data available. Should not be used whilst breastfeeding without medical advice.
4.8 Undesirable effects Very occasionally, gastrointestinal discomfort has been reported with guaifenesin. Hypersensitivity reactions ranging from pruritus urticaria and swelling have been reported. There have been isolated reports of anaphylaxis. Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Adverse events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by System Organ Class. As these reactions are reported voluntarily from a population of uncertain size, the frequency of these events is unknown but likely to be rare. Immune system disorders: Unknown: allergic reactions, angioedema, anaphylactic reactions Respiratory, thoracic and mediastinal disorders: Unknown: dyspnoea* *dyspnoea has been reported in association with other symptoms of hypersensitivity Gastrointestinal disorders Unknown: nausea, vomiting, abdominal discomfort Skin and subcutaneous disorders: Unknown: rash, urticaria
"Hypersensitivity reactions ranging from pruritus to urticaria have been reported. There have been isolated reports of anaphylaxis." In Section 10 (Date of Revision of Text), October 2008 has been changed to September 2009
The following has been added:
Section 4.2
Directions for use
Shake the bottle before use.
Recommended Dose and Dosage Schedule
Adults (including elderly) and children aged 12 years and over:
Fill the measure cup to the 10ml mark (two 5ml teaspoonfuls) and repeat every 2 - 3 hours.
Children 6 – under 12 years:
Fill the measure cup to the 5ml mark (one 5ml teaspoonful) and repeat every 2 - 3 hours.
Children 3 – under 6 years:
If your child is older than 3 years and under 6 years consult your doctor or pharmacist before use. Fill the measure cup to the 5ml mark or take one 5ml teaspoonful every 2 - 3 hours.
Not more than 4 doses should be given in any 24 hours.
Not to be given to children under 3 years of age.
Section 4.3
Hypersensitivity to any of the ingredients.
Contraindicated in children under 3 years of age.
Section 4.4
Do not take with any other cough and cold medicine.
Keep out of the reach of children.
If symptoms persist consult your doctor.
This product should only be used when clearly necessary.
Do not give to children under 3 years of age.
Consult a pharmacist or other healthcare professional before use in children under 6 years.
Section 10
May 2008
Section 1:
Veno's Expectorant, Oral Solution
Guaifenesin 100mg/5ml
Liquid glucose 3g/5ml
Treacle 1.35g/5ml
Section 2:
Active Constituents Quantity/5ml
Guaifenesin 100.00 mg
Liquid glucose 3.00 g
Treacle 1.35 g
Excipients: contains 2.5 mg/5ml sodium metabisulphate.
For full list of excipients, see section 6.1.
Section 6.2 and 6.3
Full stops to be added at the end of each line.
Section 6.5
the following sentence to be added:
Not all pack sizes may be marketed.
Section 6.6
No special requirements.
Section 7
To delete coma in first line of the address.
Section 9
The date of the first authorisation is 10th November 1987.
February 2008