Seven Seas Jointcare Comfrelieve Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Seven Seas JointCare Comfrelieve Cream Nature’s Best Comfrey Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 g of cream contains:
35 g of liquid extract (1:2) from Comfrey root (Symphytum officinale L) (Extraction solvent: Ethanol 60 % (v/v)).
Excipients with known effect:
Also contains arachis oil (peanut oil), cetostearyl alcohol, methyl (E218), ethyl (E214), propyl (E216) hydroxybenzoates, butyl-4-hydroxybenzoate, isobutyl-4-hydroxybenzoate (parabens) and benzyl benzoate (see section 4.4 Special warnings and precautions for use)
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.
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 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.
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 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 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
Not
Aluminium tube with HDPE screw cap, in pack sizes of 25, 50, 100 and 150 g. all pack sizes may be marketed.
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Seven Seas Limited Bedfont Cross Stanwell Road Feltham Middlesex TW14 8NX United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 01932/0056
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
31/05/2007
10 DATE OF REVISION OF THE TEXT
14/06/2016