1. Name Of The Medicinal Product
Galpseud Plus Linctus OR Vantage Galpseud Plus Linctus
2. Qualitative And Quantitative Composition
Active Ingredients:
Per 5ml Dose:
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For excipients, see 6.1
3. Pharmaceutical Form
Oral liquid.
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of allergic rhinitis.
4.2 Posology And Method Of Administration
For oral administration.
Adults:
Two 5ml spoonfuls three times daily.
Children:
Under 2 years: Not recommended.
2 – 6 years: 2.5ml three times daily.
6 – 12 years: 5ml three times daily.
Not more than 3 doses should be given in any 24 hours
4.3 Contraindications
Contra-indicated in patients with a known hypersensitivity to pseudoephedrine hydrochloride or chlorphenamine maleate or any of the other ingredients. Contra-indicated in epileptics because of the antihistamine content and in patients currently taking or within 2 weeks of stopping monoamine oxidase inhibitors. Contra-indicated in hypertension or in patients receiving antihypertensive therapy.
Not recommended for children under 2 years.
4.4 Special Warnings And Precautions For Use
Asthmatics should consult a medical practitioner before using this product. Caution should be exercised in patients with renal impairment, urinary retention, diabetes, hyperthyroidism, glaucoma, hepatic impairment or cardiovascular disease and those taking other sympathomimetic agents, such as decongestants, amphetamine-like psychostimulants and appetite suppressants. The effects of single dose of Galpseud Plus/Vantage Galpseud Plus on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment. As with other sympathomimetic agents, caution should be exercised in patients with prostatic enlargement or bladder dysfunction.
In severe hepatic or renal dysfunction, a single dose of Galpseud Plus/Vantage Galpsud Plus should be given, and the patient's response used as a guide to the dosage requirement for further administration.
If symptoms persist consult your doctor.
Do not exceed the stated dose.
Do not take with other cough and cold medicine.
Consult a pharmacist or other healthcare professional before use in children under 6 years.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
The antibacterial agent furazolidone is known to cause progressive inhibition of monoamine oxidase and although there are no reports of a hypertentive crisis having occurred, it should not be administered concurrently with Galpseud Plus/Vantage Galpseud Plus.
There may be an increased risk of arrythmias if pseudoephedrine is given to patients receiving cardiac glycosides or tricyclic antidepressants. Pseudoephedrine may reduce the hypotensive effect of antihypertensives with sympathomimetic activity. Concurrent use of pseudoephedrine with monoamine oxidase inhibitors may cause a hypertensive crisis. Chlorphenamine may enhance the sedative effects of CNS depressants, including alcohol, barbiturates, hypnotics, anxiolytics, sedatives and anti-psychotics. As chlorphenamine possesses anticholinergic activity the effects of some anticholinergics may be potentiated.
4.6 Pregnancy And Lactation
Not to be used during pregnancy and lactation without prior consultant with a medical practitioner. Pseudoephedrine is excreted in breast milk in small amounts.
4.7 Effects On Ability To Drive And Use Machines
May cause drowsiness, if affected do not drive or operate machinery. The drowsiness may be potentiated by alcohol or other central sedatives.
4.8 Undesirable Effects
Pseudoephedrine may cause anxiety, tremor, cardiac arrhythmias, palpitations, tachycardia, hypertension, nausea, vomiting, headache and may occasionally cause insomnia and urinary retention in men. Rarely sleep disturbance and hallucinations have been reported.
There have been rare cases of psychosis following misuse of pseudoephedrine.
Chlorphenamine may cause drowsiness, nausea, vomiting, headaches, blurred vision, anorexia and dryness of the mouth.
The administration of antihistamines has also been associated with rash, angioedema, convulsions, parasthesias, dizziness and constipation.
4.9 Overdose
Symptoms of overdose may include restlessness, drowsiness, tetany, hallucinations, excitement, ataxia, convulsions, fever, nausea, vomiting, difficulty in micturition, flushing, palpitations, tachycardia, cardiac arrhythmias and respiratory difficulties. Overdose should be treated by general symptomatic and supportive means. In the event of gross overdose the stomach may be emptied by airways protective gastric lavage. If consciousness is impaired or if respiration or circulatory difficulties are evident, appropriate supportive measures should be taken to maintain a patient's airway and to stabilise cardiovascular function. Convulsions should be controlled by immediate appropriate measures.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pseudoephedrine has direct and indirect sympathomimetic activity and is an orally effective upper respiratory tract decongestant.
Pseudoephedrine is substantially less potent than ephedrine in producing both tachycardia and elevation in systolic blood pressure and considerably less potent in causing stimulation of the central nervous system.
Chlorphenamine is one of the most potent anti-histamines. It is useful in the control of symptoms which are allergic in origin. It helps to provide relief from nasal stuffiness and watering of the eyes.
5.2 Pharmacokinetic Properties
Pseudoephedrine hydrochloride is readily and completely absorbed from the gastro-intestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted unchanged in the urine.
Chlorphenamine maleate is readily absorbed from the gastro-intestinal tract. It is extensively metabolised in the liver and excreted in the urine.
5.3 Preclinical Safety Data
None stated.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Citric acid monohydrate BP (E330)
Sodium hydroxybenzoates (E215, E217, E219)
Ethanol 96% BP
Amaranth (E123)
Carmellose sodium BP (E466)
Saccharin sodium BP
Menthol BP
Condensed milk flavour (F12516)
Orange flavour (17.40.7040)
Glycerol BP (E422)
Purified Water Ph.Eur.
6.2 Incompatibilities
None stated.
6.3 Shelf Life
Two years from the date of manufacture.
6.4 Special Precautions For Storage
Protect from light.
Store below 25°C.
6.5 Nature And Contents Of Container
Amber HDPE 2 litre Winchester with a polypropylene cap.
Amber glass bottle with a 28mm tamper evident child resistant closure with a low density polyethylene plug
Pack size: 150, 200, 300 and 500ml.
6.6 Special Precautions For Disposal And Other Handling
None stated.
7. Marketing Authorisation Holder
Thornton & Ross Ltd.
Linthwaite
Huddersfield
HD7 5QH
United Kingdom
8. Marketing Authorisation Number(S)
PL 00240/0108
9. Date Of First Authorisation/Renewal Of The Authorisation
8 July 2002
10. Date Of Revision Of The Text
12th Feb 2010
11 DOSIMETRY
Not Applicable
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Not Applicable
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