Seven Seas Jointcare Comfrelieve Cream
Out of date information, search another1 NAME OF THE MEDICINAL PRODUCT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
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