This information is intended for use by health professionals

1. Name of the medicinal product

Simple Linctus

2. Qualitative and quantitative composition

Citric Acid Monohydrate BP 125mg per 5ml.

3. Pharmaceutical form

Linctus

4. 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

None Known.

4.4 Special warnings and precautions for use

Keep out of the reach of children.

Not suitable for children under 12 years.

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

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

None stated.

5.2 Pharmacokinetic properties

None stated.

5.3 Preclinical safety data

None.

6. Pharmaceutical particulars
6.1 List of excipients

Anise flavour (contains propylene glycol)

Sodium benzoate (E211)

Glycerol (E422)

Purified water

Syrup

6.2 Incompatibilities

None.

6.3 Shelf life

24 months unopened. Discard 2 months after first opening.

6.4 Special precautions for storage

Store below 25°C.

6.5 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

None.

7. Marketing authorisation holder

L.C.M. Ltd

Linthwaite Laboratories

Huddersfield

HD7 5QH

8. Marketing authorisation number(s)

PL 12965/0032

9. Date of first authorisation/renewal of the authorisation

21.04.1999

10. Date of revision of the text

12/07/2019