1 NAME OF THE MEDICINAL PRODUCT

Seven Seas JointCare Comfrelieve Cream Nature’s Best Comfrey Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

100 g Seven Seas JointCare “Comfrelieve Cream” contains:

35 g of liquid extract (1:2) from Comfrey root (Symphytum officinale) (Extraction solvent: Ethanol 60 / (v/v)).

Excipients

100 g Seven Seas JointCare “Comfrelieve Cream” also contains:

Arachis (peanut) oil, refined		14.000 g
Cetostearyl Phenonip	alcohol	6.100 g
(containing:	Ethyl parahydroxybenzoate (E214)	0.024 g
	Propyl parahydroxybenzoate (E216)	0.012 g
	Methyl parahydroxybenzoate (E218)	0.096 g
Fragrance	Butyl-4-hydroxybenzoate)	0.036 g
(containing:	Benzyl benzoate)	0.341 g*

* varies from batch to batch

For full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Beige coloured cream

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.

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 Seven Seas JointCare “Comfrelieve 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 constituents (including the parabens)

Seven Seas JointCare “Comfrelieve Cream” should not be applied to open wounds

Contains Arachis oil (peanut oil). Do not use if hypersensitive to peanut or soya.

4.4 Special warnings and precautions for use

For external use only

The preparation should not be applied to the eyes, mucous membranes or open wounds.

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) and butyl 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

4.5    Interaction with other medicinal products and other forms of interaction

None known to date

4.6    Pregnancy, lactation and fertility

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

Seven Seas JointCare “Comfrelieve Cream” has no or negligible influence on the ability to drive and use machines.

4.8    Undesirable effects

Localised skin reactions such as contact dermatitis, pain, skin burning sensation and eczema may occur due to the content of excipients.

Seven Seas JointCare “Comfrelieve Cream” can lead to hypersensitivity reactions. They occur in the form of reddening, and the development of nodules and blisters, usually with itching, at the site of treatment. Also systemic hypersensitivity reactions may occur, involving e.g. the skin (not confined on application site), the gastrointestinal system, the eyes or the respiratory system.

The frequency is not known.

If other adverse reactions occur, a doctor or pharmacist 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 case of overdose has been reported.

In case of accidental oral ingestion an irritation of the mucous membranes may occur.

The remains of the ointment must be removed from the oral cavity or from nasopharyngeal space and in addition, emptying of the stomach (forced vomiting,gastric lavage) should be considered.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

M02AX16

Topical anti-inflammatory drug on a plant base

The Symphytum officinale root extract in Seven Seas JointCare “Comfrelieve Cream” has an anti-inflammatory and analgesic action and promotesgranulation 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 pg/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 lauryl sulphate

Arachis oil, refined Lavender oil Pine needle oil Purified water Phenonip

(containing:    Phenoxyethanol

Ethyl parahydroxybenzoate (E214) Propyl parahydroxybenzoate (E216) Methyl parahydroxybenzoate (E218) Butyl-4-hydroxybenzoate)

Other perfume

(containing:    Aldehyde C10

Benzyl acetate Benzyl benzoate Eugenol Hellotropin Hydroxycitronellal Lavender oil Lemon oil Methyl anthranilate Pettigrain oil Phenoxyethanol Rosemary oil Vanillin)

6.2    Incompatibilities

Not applicable

6.3    Shelf life

3 years

Seven Seas JointCare “Comfrelieve Cream” should not be used after the expiry date.

After first opening the container: 1 year

6.4    Special precautions for storage

No special precautions for storage

6.5    Nature and contents of container

Tube containing 25g cream Tube containing 50g cream Tube containing 100g cream Tube containing 150g cream

6.6    Special precautions for disposal

None

7    MARKETING AUTHORISATION HOLDER

Seven Seas Limited

Trading As Merck Consumer Healthcare Limited

Hedon Road

Marfleet

Hull

HU9 5NJ

8    MARKETING AUTHORISATION NUMBER

PL 01932/0056

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

31/05/2007

10 DATE OF REVISION OF THE TEXT

23/02/2015