SEVEN SEAS JOINTCARE COMFRELIEVE CREAM,NATURES BEST COMFREY CREAM - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Seven Seas JointCare Comfrelieve Cream

Nature’s Best Comfrey Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

3   PHARMACEUTICAL FORM

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the symptomatic treatment of joint pain, sprains, inflammation and strains associated with restricted joint mobility.

4.2 Posology and method of administration

For cutaneous use

Application may only be made to intact skin.

Wash hands before and after using the cream.

Adults, children aged 12 years and older and the elderly:

If not otherwise prescribed, depending on the size of the joint to be treated and the severity of the symptoms, apply a thread of cream of 2 – 6 cm in length four times daily for 8 days.

Treatment duration should not exceed 21 days.

Apply the cream to the parts of the body to be treated and massage in carefully.

Not recommended in children under 12 years of age

4.3 Contraindications

Hypersensitivity to any of the ingredients, peanut or soya.

4.4 Special warnings and precautions for use

For cutaneous use.

The preparation should not be applied to the eyes, mucous membranes or open wounds. Do not apply to broken or irritated skin.

Discontinue use if skin becomes irritated, red or dry.

Contains arachis oil (peanut oil). Patients allergic to peanut or soya, should not use this product (see Section 4.3 Contraindi­cations)

Contains methyl (E218), ethyl (E214), propyl (E216), butyl 4-hydroxybenzoate and isobutyl-4-hydroxybenzoate (parabens), which may cause allergic reactions (possibly delayed).

Contains benzyl benzoate, which may cause mild irritation to the skin, eyes and mucous membranes.

Contains cetostearyl alcohol, which may cause localised skin reactions (e.g. contact dermatitis).

Patients using the cream for the first time, should apply the product on a small area e.g. on the wrist to test tolerance prior to use.

Patients with allergic predisposition may be more prone to suffer from hypersensitivity reactions

Rosemary oil can trigger hypersensitivity reactions (including dyspnoea) in patients sensitized correspondingly.

The use in children under 12 years old has not been established and medical advice should be sought.

If symptoms worsen or persist a doctor or pharmacist should be consulted.

Articular pain accompanied by swelling of the joints, redness or fever should be examined by a doctor.

4.5 Interaction with other medicinal products and other forms of interaction

None known to date

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 is not recommended.

Studies on the effects of fertility have not been performed.

4.7 Effects on ability to drive and use machines

The product has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

The following side effects may occur. The frequency of these effects occurring is not known.

Localised skin reactions may occur due to the content of excipients. The application of the cream may result in hypersensitivity reactions.

Hypersensitivity reactions may manifest as application site skin reactions. Also, systemic hypersensitivity reactions may occur (see below)

Adverse drug reactions are listed below by system organ class:

Immune system disorders:

– systemic hypersensitivity reactions involving e.g. the skin (not restricted to application site), the gastrointestinal system, the eyes or the respiratory system – hypersensitivity reactions on application site e.g. reddening, nodules and blisters with itching may occur.

Skin and subcutaneous tissue disorders:

– contact dermatitis, pain, eczema, pruritus, rash, skin burning sensation, erythema

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 case of overdose has been reported.

This medicinal product is only intended for topical application. Application of doses larger than recommended (see section 4.2) is not advised.

Information on swallowing the product is limited. In case of accidental oral ingestion an irritation of the mucous membranes may occur.

The remains of the cream must be removed from the oral cavity or from nasopharyngeal spa­ce.

The patient should be carefully observed and given supportive treatment if necessary.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

M02AX16

Topical anti-inflammatory drug on a plant base

The Symphytum officinale root extract in the product has an anti-inflammatory and analgesic action and promotes granulation and tissue regeneration. Allantoin, mucopolysaccharides and tannins can be mentioned as the constituents responsible for efficacy.

5.2 Pharmacokinetic properties

No data available

5.3 Preclinical safety data

Pyrrolizidine alkaloids and their N-oxides are to be found in many plant species.

Particularly in the Asteraceae and the Boraginaceae, to which Symphytum officinale also belongs, they are widespread. They are also taken up by domesticated animals with their feed and can therefore be detected in certain foodstuffs (e.g. milk, honey). The pyrrolizidine alkaloids intermedin, symphytine and symviridine, usually in the form of N-oxides, can be detected in Symphytum officinale.

In investigations on acute toxicity, liver damage was induced in rats with dried leaf drug.

In long-term experiments on rats, a tumorigenic and carcinogenic action was observed.

The main alkaloid symphytine appears to be responsible for this effect, whereby symphytine has also proved to be mutagenic. A special procedure is applied to remove over 99% of the pyrrolizidine alkaloids contained in Symphytum officinale (specification: <0.35ppm in the finished drug). The amounts of pyrrolizidine alkaloids occurring in the normal doses of the preparation are thus below the amount of 10 llg/day toxicologically recognised as tolerable for topical drugs. As no negative effects have been observed at this content of pyrrolizidine alkaloids according to the data available in the literature, restrictions on the duration of administration are not necessary.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Cetostearyl alcohol

Glycerol-1-stearate

Sodium laurilsulfate

Arachis oil, refined

Lavender oil

Spruce needle oil

Purified water

Phenonip

(containing: Phenoxyethanol

Ethyl-4-hydroxybenzoate (E214)

Propyl-4-hydroxybenzoate (E216)

Methyl-4-hydroxybenzoate (E218)

Butyl-4-hydroxybenzoate

Isobutyl-4-hydroxybenzoate)

Perfume oil R07338 Spezial PH

(containing: Benzyl acetate

Benzyl benzoate

Eugenol

Heliotropin

Hydroxycitronellal

Lavender oil

Lemon oil

Pettigrain oil

Rosemary oil

Phenylethyl alcohol

Linalyl acetate

Linalool)

Eumulgin L Sodium hydroxide

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 years

After first opening the container: 1 year

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

Store in the original package.

6.5 Nature and contents of container

Aluminium tube with HDPE screw cap, in pack sizes of 25, 50, 100 and 150 g. Not all pack sizes may be marketed.

6.6 Special precautions for disposal

None

7 MARKETING AUTHORISATION HOLDER

Lamberts Healthcare Limited

1 Lamberts Road

Tunbridge Wells

Kent TN2 3EH

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 34425/0012

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE