- Approval Id
- 93b779d59e987033
- Drug Approval Emc Name
- Simple Linctus Sugar Free
- Drug Name
- Simple Linctus Sugar Free
- Company Address
- Linthwaite, Huddersfield, West Yorks, HD7 5QH
- Company Website
- http://www.thorntonandross.co.uk
- Company Medical Info Direct Line
- +44 (0) 1484 848164
- Company Medical Info Email
- thorntonross@medinformation.co.uk
- Company Customer Care Direct Line
- +44(0)1484 848200
- Atc Code
- R05
- Legal Category
- General Sales List
- Authorisation Holder
- L.C.M. Ltd
Linthwaite Laboratories
Huddersfield
HD7 5QH
- Authorisation Number
- PL 12965/0050
- Authorisation Date
- 02/07/2010
- Instruction Authorisation Holder
- L.C.M. Ltd
Linthwaite Laboratories
Huddersfield
HD7 5QH
- Instruction Authorisation Number
- PL 12965/0050
- Instruction Authorisation Date
- 02/07/2010
- Instruction Composition
- Citric acid monohydrate (E330) 125mg per 5ml.
\*\*Excipients with known effects\*\*
Excipients: Each 5ml contains:
Liquid Maltitol (E965) 4.2g (contains Sorbitol 840mg)
Sodium benzoate (E211) 2.5mg
For the full list of excipients see section 6.1
- Instruction Dosage Form
- Oral Solution
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
For relief of the symptoms of coughs.4.2 Posology and method of administration
Oral.
\*\*Recommended doses\*\*
Adults, the elderly and children over 12 years: one 5ml spoonful, repeated up to four times per day.
Children under 12 years: not recommended.4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.4.4 Special warnings and precautions for use
This medicinal product is not recommended for the use in children below the age of 12 years due to lack of data on safety and efficacy.
This medicine contains 840mg sorbitol in each 5ml dose. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.
This medicine also contains 4.2g of maltitol liquid (E965) per 5ml dose. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
This medicine contains less than 1mmol sodium (23mg) per 5ml dose, that is to say essentially 'sodium-free'. This medicine contains 2.5mg sodium benzoate per 5ml dose.4.5 Interaction with other medicinal products and other forms of interaction
None known.4.6 Pregnancy and lactation
No adverse effects are known for the product, however as with all medicines use should be avoided during pregnancy unless recommended by a doctor.4.7 Effects on ability to drive and use machines
Simple Linctus Sugar Free has no influence on the ability to drive and use machines.4.8 Undesirable effects
\*\*Tabulated list of adverse reaction(s)\*\*
Adverse reactions frequency are defined using the following convention:
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
| | | |
| --- | --- | --- |
| \*\*System organ class (MedDRA)\*\* | \*\*Frequency\*\* | \*\*Adverse event\*\* |
| \*\*Immune System Disorders\*\* | Not known | Hypersensitivity |
\*\*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 or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
Overdose with this preparation is unlikely to occur due to the low concentrations of the active substance, however in the event of an overdose, treatment should be symptomatic.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Cough and Cold Preparations
ATC Code: R055.2 Pharmacokinetic properties
None stated5.3 Preclinical safety data
None.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Aniseed Flavour (contains propylene glycol) PHL-090803
Glycerol (E422)
Liquid Maltitol (E965) (contains Sorbitol)
Sodium Benzoate (E211)
Purified water6.2 Incompatibilities
Not Applicable.6.3 Shelf life
36 months unopened. Discard 2 months after first opening.6.4 Special precautions for storage
Do not store above 25°C6.5 Nature and contents of container
| | |
| --- | --- |
| | |
| 200ml: | Amber glass bottle with plastic cap and liner or white 28mm cap with tamper evident band and EPE Saranex liner |
| | |
| | |6.6 Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
- Instruction Content
- ## Composition
Citric acid monohydrate (E330) 125mg per 5ml.
\*\*Excipients with known effects\*\*
Excipients: Each 5ml contains:
Liquid Maltitol (E965) 4.2g (contains Sorbitol 840mg)
Sodium benzoate (E211) 2.5mg
For the full list of excipients see section 6.1
## Pharmaceutical Form
Oral Solution
## Clinical Particulars
4.1 Therapeutic indications
For relief of the symptoms of coughs.4.2 Posology and method of administration
Oral.
\*\*Recommended doses\*\*
Adults, the elderly and children over 12 years: one 5ml spoonful, repeated up to four times per day.
Children under 12 years: not recommended.4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.4.4 Special warnings and precautions for use
This medicinal product is not recommended for the use in children below the age of 12 years due to lack of data on safety and efficacy.
This medicine contains 840mg sorbitol in each 5ml dose. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.
This medicine also contains 4.2g of maltitol liquid (E965) per 5ml dose. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
This medicine contains less than 1mmol sodium (23mg) per 5ml dose, that is to say essentially 'sodium-free'. This medicine contains 2.5mg sodium benzoate per 5ml dose.4.5 Interaction with other medicinal products and other forms of interaction
None known.4.6 Pregnancy and lactation
No adverse effects are known for the product, however as with all medicines use should be avoided during pregnancy unless recommended by a doctor.4.7 Effects on ability to drive and use machines
Simple Linctus Sugar Free has no influence on the ability to drive and use machines.4.8 Undesirable effects
\*\*Tabulated list of adverse reaction(s)\*\*
Adverse reactions frequency are defined using the following convention:
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
| | | |
| --- | --- | --- |
| \*\*System organ class (MedDRA)\*\* | \*\*Frequency\*\* | \*\*Adverse event\*\* |
| \*\*Immune System Disorders\*\* | Not known | Hypersensitivity |
\*\*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 or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
Overdose with this preparation is unlikely to occur due to the low concentrations of the active substance, however in the event of an overdose, treatment should be symptomatic.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Cough and Cold Preparations
ATC Code: R055.2 Pharmacokinetic properties
None stated5.3 Preclinical safety data
None.
## Pharmaceutical Particulars
6.1 List of excipients
Aniseed Flavour (contains propylene glycol) PHL-090803
Glycerol (E422)
Liquid Maltitol (E965) (contains Sorbitol)
Sodium Benzoate (E211)
Purified water6.2 Incompatibilities
Not Applicable.6.3 Shelf life
36 months unopened. Discard 2 months after first opening.6.4 Special precautions for storage
Do not store above 25°C6.5 Nature and contents of container
| | |
| --- | --- |
| | |
| 200ml: | Amber glass bottle with plastic cap and liner or white 28mm cap with tamper evident band and EPE Saranex liner |
| | |
| | |6.6 Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
- Company Detail Path
- /organization/thornton-and-ross-ltd
