Summary of medicine characteristics - SIMPLE LINCTUS
1 NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
4.3 Contra-Indications
None Known.
4.4 Special Warnings and Special Precautions For Use
Keep out of the reach of children.
Not suitable for children under 12 years.
This product contains 4g of sucrose per dose. To be taken into account in people with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicine contains less than 1mmol sodium (23 mg) per 5ml dose, that is to say essentially ‘sodium-free’. This medicine contains 2.5mg sodium benzoate per 5ml dose.
4.5 Interactions 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
None known.
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 ingredients, however, in the event, treatment should be symptomatic.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic Properties
5.2 Pharmacokinetic Properties
None stated.
5.3 Preclinical Safety Data
5.3 Preclinical Safety DataNone.
6 PHARMACEUTICAL PARTICULARS
6 PHARMACEUTICAL PARTICULARS6.1 List of excipients
Anise flavour (contains propylene glycol)
Sodium benzoate (E211)
Glycerol (E422)
Purified water
Syrup (sucrose)