SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Esberisin Coated Tablets.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains:

12 mg Gentian root (Gentiana lutea L.),

36 mg Verbena herb (Verbena officinalis L.),

36 mg Sorrel herb (Rumex acetosa L.),

36 mg Elder flower (Sambucus nigra L.),

36 mg Primula flower with calyx (Primula veris L.).

Excipient:

One coated tablet contains 145 mg sucrose and 3.924 mg glucose in the coating.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Coated tablets.

White, convex, round coated tablets.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used to relieve nasal congestion and sinusitis based on traditional use only.

4.2 Posology and method of administration

For oral administration.

The tablets should be swallowed whole with a glass of water. Do not chew the tablets.

Adults, the elderly and children over 12 years of age

One coated tablet three times a day.

Children under 12 years of age

The use in children under 12 years of age is not recommended (see section 4.4 'Special warnings and precautions for use').

Duration of use

If the symptoms worsen, or persist for more than 7 days a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to any of the active ingredients or to Primula species or to any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If the symptoms worsen, or persist for more than 7 days, a doctor or a qualified healthcare practitioner should be consulted.

If dyspnoea, fever or purulent sputum occurs, a doctor or a qualified health care practitioner should be consulted.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

The use in children under 12 years of age is not recommended because no data on safety is available.

4.5 Interaction with other medicinal products and other forms of interaction

None reported.

4.6 Fertility, Pregnancy and lactation

Safety during during pregnancy and lactation has not been established. In the absence of sufficient data, use during pregnancy or lactation is not recommended. No studies on the effects on fertility have been performed.

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

The evaluation of undesirable effects is based on the following incidence data: 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)

Gastrointestinal complaints (e.g. stomach pain, nausea) are uncommon. Hypersensitivity reactions of the skin (skin rash, reddening of the skin, itching) as well as severe allergic reactions (angioedema, dyspnoea, swelling of the face) are rare.

Discontinue immediately if hypersensitivity occurs.

If other adverse reactions not mentioned above occur, a doctor or a qualified health care 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.

Supportive and symptomatic treatment should be provided as appropriate.

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

The non-clinical toxicology data available are limited.

Reverse mutation assays (Ames test) on bacteria indicated that the product was not mutagenic in Salmonella typhimurium (strains TA 1535, TA 100 and TA 102) mutation assays with or without metabolic activation. The product was positive in TA 1537, TA 98 with or without metabolic activation, however, this was considered to be due to the presence of quercetin. Further investigations in a mammalian cell system, i.e. the mouse lymphoma assay (MLA) showed negative results indicating the absence of a mutagenic potential.

Adequate tests on reproductive toxicity have not been performed. Tests on carcinogenicity have not been performed.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet core

Colloidal anhydrous silica Cellulose powder Maltodextrin Croscarmellose sodium Magnesium stearate (vegetable)

Tablet coating Hypromellose Sucrose Talc

Calcium carbonate

Tragacanth

Acacia

Titanium dioxide E 171 Anhydrous glucose Shellac

White beeswax Carnauba wax

6.2 Incompatibilities

None known.

6.3 Shelf life

3 years.

6.5 Nature and contents of container

PVC/PVDC-Al blister strips in cardboard carton. Packs of 20, 40 and 60 coated tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

There are no special instructions

7 MARKETING AUTHORISATION HOLDER

Schaper & Brummer GmbH & Co. KG,

BahnhofstraBe 35,

38259 Salzgitter,

Germany

8    MARKETING AUTHORISATION NUMBER(S)

THR 26548/0001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

24/09/2015

10 DATE OF REVISION OF THE TEXT

24/09/2015