Cold and Flu Relief Powder for Oral Solution – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Cold and Flu Relief Powder for Oral Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet contains:

1.2 g of extract (as dry extract) from Isatis root (Isatis tinctoria L.) (equivalent to 6.3-7.5 g of Isatis root).

Extraction solvent: water

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Powder for oral solution.

White powder with brown speckles.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used to relieve the symptoms of the common cold, mild upper respiratory tract infections and flu-like illness; such as sore throat, based on traditional use only.

4.2 Posology and method of administration

Posology

Adults (including elderly): One sachet three times a day This product is not recommended for use in children or adolescents under 18 years of age. (See ' section 4.4 special warnings and precautions for use').

Method of administration

For oral administration only.

Pour contents of one sachet into a mug. Fill it with 150-200ml of hot (not boiling) water, stir until dissolved (to a clear, caramel brown colour solution) and drink.

Start at first signs of a cold or flu.

Do not use the product for more than 10 days.

If symptoms worsen during the use of the product or persist for more than 10 days, a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active ingredient or any plants of the Cruciferae family or to any of the excipients listed in section 6.1.

Hypersensitivity to aspirin or other NSAIDs.

Hypersensitivity to sulfonylureas and sulphonamide antibiotics

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

The product should be discontinued at least 2 weeks prior to elective surgery due to the potential increased risk of bleeding (see Section 4.5 Interaction with other medicinal products and other forms of interaction’).

This product should be used with caution in patients taking anticoagulant or antiplatelet medicines. (See ‘Section 4.5 Interaction with other medicinal products and other forms of interaction.’)

This medicinal product is not suitable for children under 18 years because data is not sufficient and medical advice should be sought. If the symptoms worsen, or if high fever occurs during the use of the product, or if symptoms persist after 10 days, a doctor or qualified healthcare practitioner should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction

This product should not be used in combination with aspirin or other NSAIDs. This product has antiplatelet activity and may increase the risk of bleeding when taken with medicines that affect coagulation and bleeding eg. anticoagulants such as warfarin, , acenocoumarol, phenindione apixaban, edoxaban, dabigatran, rivaroxaban, heparin, dalteparin, enoxaparin and tinzaparin; antiplatelet drugs such as clopidogrel, and non-steroidal anti-inflammatory drugs such as aspirin, ibuprofen and naproxen

4.6 Fertility, pregnancy and lactation

The safety of this product during pregnancy and lactation has not been established. In the absence of sufficient data the use during pregnancy and lactation is not recommended.

Studies on the effects on fertility have not been performed.

4.7 Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

4.8 Undesirable effects

The following terms and frequencies are applied: very common (1/10), common (1/100 to <1/10), uncommon (1/1000 to <1/100), rare (1/10,000 to <1/1000), and very rare (<1/10,000), not known (cannot be estimated from the available data).

If other adverse reactions occur, a doctor or a qualified healthcare practitioner should be consulted.

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

No cases of overdose have been reported. Treatment should be supportive.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended

5.2 Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended

5.3 Preclinical safety data

Isatis was shown to be non-mutagenic in a bacterial reverse mutation test and non-clastogenic and non-aneugenic in an in vitro Human Lymphocyte micronucleus test.

Studies on carcinogenicity have not been performed

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Maltodextrin

Citric Acid Anhydrous

Stevia R-A 98%

Honey Flavouring

Lemon Flavouring

6.2 Incompatibilities

Not applicable

6.3 Shelf life

2 years

6.4 Special precautions for storage

Do not store above 25°C. Store in the original container.

6.5 Nature and contents of container

Each sachet contains 4.0g of powder.

The sachet is made of 45CCPaper/12PE/15Alu/25Surlyn 10, 15 or 20 sachets packed in a boxboard carton.

Appearance after reconstitution

A clear, caramel brown colour solution.

6.6 Special precautions for disposal

No special requirements

7 MARKETING AUTHORISATION HOLDER

INNOVABRIDGE LTD

11 Wilde Court

47 West Way

Oxford

England

OX2 0FH

UK

8 MARKETING AUTHORISATION NUMBER(S)

THR 62517/0001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

14/07/2017

10 DATE OF REVISION OF THE TEXT

11/08/2026