SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Potter’s Catarrh & Congestion Relief

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains:

30 mg Garlic Powder 1 mg Garlic Oil

13.2 mg of extract (as dry extract) from Echinacea angustifolia root (100:22) (Equivalent to 60mg Echinacea angustifolia (D.C.))

Extraction Solvent: Water

For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Tablet

An olive-green round biconvex sugar-coated tablet

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used to relieve the symptoms of catarrh, rhinitis and nasal congestion, based on traditional use only.

4.2 Posology and method of administration

For oral use only.

Adults and the elderly: Take two tablets three times a day. Children and adolescents over 12 years: Take half the adult dose.

Not recommended for children under 12 years of age. (See section 4.4 ‘Special warnings and precautions for use’.)

Duration of use:

Do not use for more than 10 days.

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

4.3 Contraindications

Hypersensitivity to the active ingredients, other plants of the Asteraceae (Compositae) family or any of the excipients.

Because of its immunostimulating activity, Echinacea must not be used in cases of

progressive systemic disorders (tuberculosis, sarcoidosis), autoimmune diseases (e.g.

collangenoses, multiple sclerosis), immunodeficiencies (e.g. HIV infection, AIDS),

immunosuppression (e.g. onocological cytostatic therapy, history of organ or bone

marrow transplant) and diseases of the white blood cell system (e.g. agranulocytosis, leukaemias) and allergic diathesis (e.g. urticaria, atopic dermatitis, asthma).

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If the symptoms worsen or persist for more than 10 days, a doctor or a qualified health care practitioner should be consulted.

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

There is a possible risk of allergic reactions in sensitive individuals. Those patients should consult their doctor before using Echinacea.

There is a possible risk of anaphylactic reactions in atopic patients. Atopic patients should consult their doctor before using Echinacea.

Not recommended for children under 12 years of age because data are not sufficient and medical advice should be sought.

This medicinal product contains sucrose.

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

4.5 Interaction with other medicinal products and other forms of interaction

Not to be used concomitantly with immunosuppressant medications such as ciclosporin and methotrexate.

4.6 Fertility, Pregnancy and lactation

The safety of this product during pregnancy and lactation has not been established, therefore the use of this product during pregnancy and lactation is not recommended.

Limited data (several hundreds of exposed pregnancies) indicate no adverse effects of

Echinacea on pregnancy or on the health of the foetus/newborn child. Data concerning the immune system of the newborn child are not available. To date, no

other relevant epidemiological data are available. The potential risk for

humans is

unknown.

Studies on fertility have not been performed.

4.7 Effects on ability to drive and use machines

No studies have been conducted on the effects on the ability to drive or use machines.

4.8 Undesirable effects

Hypersensitive reactions (skin reactions, rash, urticaria, Stevens-Johnson Syndrome,

angiodema of the skin, Quincke’s oedema, bronchospasm with obstruction, asthma

and anaphylactic shock) have been reported.

Echinacea can trigger reactions in atopic patients. Association with autoimmune

diseases (encephalitis disseminate, erythema nodosum, immunothrombocytopenia,

Evans Syndrome, Sjogren Syndrome with renal tubular dysfunction) has been reported. Leucopenia may occur in long-term use (more than 8 weeks).

The frequency is not known.

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.

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

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Maltodextrin

Calcium hydrogen phosphate Charcoal Powder Sucrose

Acacia, spray-dried Stearic Acid Talc

Magnesium Stearate

Croscarmellose Sodium Colloidal anhydrous Silica Shellac

Calcium Carbonate Light Titanium Dioxide (E171)

Black Iron Oxide (E172)

Yellow Iron Oxide (E172)

Wax polish (beeswax, shellac, carnauba wax)

6.2 Incompatibilities

None known.

6.3 Shelf life

Three years.

6.4 Special precautions for storage

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

6.5 Nature and contents of container

Tamper evident polyethylene/polypropylene pot packed in a cardboard box: 30, 60, 84, 100, 126 and 168 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

There are no special precautions for disposal.

7 MARKETING AUTHORISATION HOLDER

Soho Flordis UK Limited 1 Botanic Court,

Martland Park,

Wigan,

WN5 0JZ,

UK.

Trading as: Potters, Wigan WN5 0JZ

MARKETING AUTHORISATION NUMBER(S)

THR 44893/0006

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

20/12/2012

DATE OF REVISION OF THE TEXT

28/09/2015