- Approval Id
- d15e11dcccdfeb56
- Drug Approval Emc Name
- Iglu Sugar Free Pastilles
- Drug Name
- Iglu Sugar Free Pastilles
- Company Name
- Diomed Developments Limited
- Company Address
- Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR
- Company Website
- //www.diomedgroup.co.uk
- Company Telephone
- +44 (0)1462 458 866
- Legal Category
- General Sales List
- Authorisation Holder
- Ernest Jackson & Co Ltd
High Street
Crediton
Devon EX17 3AP
UK
- Authorisation Number
- PL 00094/5016R
- Authorisation Date
- 11/10/1989 / 01/05/08
- Instruction Authorisation Holder
- Ernest Jackson & Co Ltd
High Street
Crediton
Devon EX17 3AP
UK
- Instruction Authorisation Number
- PL 00094/5016R
- Instruction Authorisation Date
- 11/10/1989 / 01/05/08
- Instruction Composition
- Benzalkonium Chloride Solution 1.11 mg per pastille
Compound Benzoin Tincture 8.06 mg per pastille (0.75% v/w)
\*\*Excipient(s) with known effect\*\*
Sorbitol liquid 363.3 mg per pastille
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Pastille
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
For the relief of mouth ulcers and sore gums4.2 Posology and method of administration
Adults, the elderly and children of 3 years and above: Dissolve one pastille in the mouth at 2 hourly intervals.
Do not take more than 8 pastilles per day.4.3 Contraindications
Hypersensitivity to benzalkonium chloride, benzoin or any of the other ingredients.
Contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.4.4 Special warnings and precautions for use
None4.5 Interaction with other medicinal products and other forms of interaction
None known4.6 Fertility, pregnancy and lactation
\*Pregnancy\*
There is no or inadequate evidence of the safety of the active ingredients in this medicine in human pregnancy. The potential risk for humans is unknown.
In the absence of sufficient data, the use during pregnancy is not recommended.
\*Lactation\*
It is not known whether the active ingredients of this product are excreted in human breast milk.
In the absence of sufficient data, the use during lactation is not recommended.
\*Fertility\*
Studies of the effects on fertility have not been investigated4.7 Effects on ability to drive and use machines
None known4.8 Undesirable effects
Sensitivity to benzalkonium chloride may occur in some people.
\*\*Reporting of suspected adverse reactions\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.4.9 Overdose
Symptoms of overdose are unlikely unless the recommended dosage is grossly exceeded, when nausea and vomiting may be seen. Treat by discontinuation, giving milk and egg whites and observation.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Benzalkonium chloride is an antiseptic detergent.
Benzoin tincture is included as a mild antiseptic and a mucosal protective.5.2 Pharmacokinetic properties
The product is used by being allowed to dissolve in the mouth, and its action is therefore dependent on local distribution in the buccal cavity and contact with the affected areas.5.3 Preclinical safety data
None specific to the product.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Sorbitol liquid, non crystallising
Acacia
Peppermint Oil
Simethicone Antifoam (water, polydimethyl siloxane and silica mix, polyoxyethylene 20 sorbitan monostearate, glyceryl monostearate, sodium carboxymethyl cellulose, methyl-4-hydroxybenzoate, propyl-4-hydroxybenzoate, hydrogen chloride)
Vegetable oil
Carnauba wax
Water6.2 Incompatibilities
None known6.3 Shelf life
36 months6.4 Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from moisture.6.5 Nature and contents of container
24 pastilles, blister packed and contained in a printed carton
45 g pastilles contained in a laminate bag integral with a printed carton.6.6 Special precautions for disposal and other handling
None specific to packs
- Instruction Content
- ## Composition
Benzalkonium Chloride Solution 1.11 mg per pastille
Compound Benzoin Tincture 8.06 mg per pastille (0.75% v/w)
\*\*Excipient(s) with known effect\*\*
Sorbitol liquid 363.3 mg per pastille
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Pastille
## Clinical Particulars
4.1 Therapeutic indications
For the relief of mouth ulcers and sore gums4.2 Posology and method of administration
Adults, the elderly and children of 3 years and above: Dissolve one pastille in the mouth at 2 hourly intervals.
Do not take more than 8 pastilles per day.4.3 Contraindications
Hypersensitivity to benzalkonium chloride, benzoin or any of the other ingredients.
Contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.4.4 Special warnings and precautions for use
None4.5 Interaction with other medicinal products and other forms of interaction
None known4.6 Fertility, pregnancy and lactation
\*Pregnancy\*
There is no or inadequate evidence of the safety of the active ingredients in this medicine in human pregnancy. The potential risk for humans is unknown.
In the absence of sufficient data, the use during pregnancy is not recommended.
\*Lactation\*
It is not known whether the active ingredients of this product are excreted in human breast milk.
In the absence of sufficient data, the use during lactation is not recommended.
\*Fertility\*
Studies of the effects on fertility have not been investigated4.7 Effects on ability to drive and use machines
None known4.8 Undesirable effects
Sensitivity to benzalkonium chloride may occur in some people.
\*\*Reporting of suspected adverse reactions\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.4.9 Overdose
Symptoms of overdose are unlikely unless the recommended dosage is grossly exceeded, when nausea and vomiting may be seen. Treat by discontinuation, giving milk and egg whites and observation.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Benzalkonium chloride is an antiseptic detergent.
Benzoin tincture is included as a mild antiseptic and a mucosal protective.5.2 Pharmacokinetic properties
The product is used by being allowed to dissolve in the mouth, and its action is therefore dependent on local distribution in the buccal cavity and contact with the affected areas.5.3 Preclinical safety data
None specific to the product.
## Pharmaceutical Particulars
6.1 List of excipients
Sorbitol liquid, non crystallising
Acacia
Peppermint Oil
Simethicone Antifoam (water, polydimethyl siloxane and silica mix, polyoxyethylene 20 sorbitan monostearate, glyceryl monostearate, sodium carboxymethyl cellulose, methyl-4-hydroxybenzoate, propyl-4-hydroxybenzoate, hydrogen chloride)
Vegetable oil
Carnauba wax
Water6.2 Incompatibilities
None known6.3 Shelf life
36 months6.4 Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from moisture.6.5 Nature and contents of container
24 pastilles, blister packed and contained in a printed carton
45 g pastilles contained in a laminate bag integral with a printed carton.6.6 Special precautions for disposal and other handling
None specific to packs
