SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Lobelina Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains:

60 mg of Lobelia herb (Lobelia inflata L.)

30 mg of soft extract from dried Squill (Urginea maritima L.) bulb (2:1). Extraction solvent: water

Excipients:

Each tablet contains 30 mg of lactose and 222 mg of sucrose.

Each tablet contains 120 micrograms Sodium methyl hydroxybenzoate.

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Coated tablet.

Pale yellow biconvex coated tablet.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the relief of coughs, blocked sinuses and catarrh, based on traditional use only.

4.2 Posology and method of administration

For oral use only.

Adults, the elderly and children over 12 years One tablet three times a day

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

If symptoms worsen or persist after 7 days, a doctor or qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to any of the active ingredients or any of the excipients. Patients with any type of heart condition.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

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

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

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

Contains lactose and sucrose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Contains sodium methyl hydroxybenzoate. This may cause allergic reactions (possibly delayed).

4.5 Interaction with other medicinal products and other forms of interaction

No studies have been carried out to determine if drug interactions occur with this product.

In view of the potential for Squill to interact with other medicines administered concurrently, the product should not be taken with digoxin or any medicine for heart conditions (see section 4.3).

4.6 Fertility, pregnancy and lactation

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

Studies on the effects on fertility have not been carried out.

4.7 Effects on ability to drive and use machines

No studies on the effect of this product on the ability to drive or use machinery have been performed.

4.8 Undesirable effects

Lobelia can cause similar effects to nicotine and include nausea, vomiting, diarrhoea, coughing, tremors and dizziness.

The frequency is not known.

Squill may cause gastric irritation. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner should be consulted.

4.9 Overdose

No case of overdose has been reported.

Overdose of Lobelia could produce nausea, vomiting or diarrhoea, profuse diaphoresis, paresis, hypotension and coma. High doses could be cardioactive. If symptoms arise, 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

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

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Other Core Ingredients Sucrose

Sodium Starch Glycollate Purified Talc Magnesium Stearate Lactose Cayenne

Coating Ingredients Titanium Dioxide (E171)

Sucrose Purified Talc Kaolin Light

Iron Oxide (yellow) (E172)

6.2 Incompatibilities

None Stated

6.3 Shelf life

3 years

6.4 Special precautions for storage

Store below 25°C. Store in the original package.

6.5 Nature and contents of container

100ml HDPE polythene tablet container and tamper evident cap closure.

Pack contains 60 tablets.

6.6 Special precautions for disposal

There are no special precautions for disposal. When the container is empty the label should be removed and the container placed in a recycling bin.

7 MARKETING AUTHORISATION HOLDER

Kerbina Limited T/A Bio Health Culpeper Close Medway City Estate Rochester Kent

ME2 4HU

8    MARKETING AUTHORISATION NUMBER(S)

THR 00904/0006

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19/11/2012

10 DATE OF REVISION OF THE TEXT

19/11/2012