Phytocold
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
PHYTOCOLD
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 250 mg of Echinacea purpurea root (Echinacea purpurea (L.) Moench).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsules, hard.
Colourless and transparent hard capsules containing clear yellow to beige powder.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Traditional herbal medicinal product used to relieve the symptoms of the common cold and influenza-type infections based on traditional use only
4.2 Posology and method of administration
For oral use only.
For adults, elderly and children over 12 years: one to two capsules to be taken with a glass of water before meals three times daily.
Start at the first signs of a common cold.
Do not use for more than 10 days.
The use in children below 12 years of age is not recommended (see section 4.4 Special warnings and precautions for use).
If symptoms worsen or persist for more than 10 days or if the patient gets a high fever, a doctor or a qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active substance or to plants of the Asteraceae (Compositae) family or to the excipient.
Because of Echinacea’s immunostimulating activity, PHYTOCOLD must not be used in cases of progresive systemic disorders (tuberculosis, sarcoidosis), autoimmune diseases (e.g.: collagenosis, multiple sclerosis), immunodeficiencies (e.g.: HIV infection, AIDS), immunosuppression (e.g.: oncological cytostatic therapy, history of organ or bone marrow transplant), diseases of the white blood cell system (e.g.: agranulocytosis, leukaemias) and allergic diathesis (e.g.: urticaria, atopic dermatitis, asthma).
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If symptoms worsen or persist for more than 10 days or if a high fever occurs, a doctor or a qualified healthcare practitioner should be consulted.
The use of this product in children under 12 years of age is not recommended because data are not sufficient and medical advice should be sought.
There is a possible risk of anaphylactic reactions in atopic patients. Atopic patients should consult their doctor or qualified healthcare practitioner before using Echinacea.
4.5 Interaction with other medicinal products and other forms of interaction
Not to be used concomitantly with immunosuppressant medications such as ciclosporin or methotrexate.
4.6 Fertility, pregnancy and lactation
Safety during pregnancy and lactation has not been established. Due to the lack of sufficient data, use during pregnancy and lactation is not recommended.
Limited data (several hundreds of exposed pregnancies) indicate no adverse effects of Echinacea on pregnancy or on the health of the foetus/newborn child. Data concerning the immune system of the newborn child are not available.
To date, no other relevant epidemiological data are available. The potential risk for humans is unknown.
Studies on the effects on fertility have not been performed.
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
No studies on the effects on the ability to drive or operate machines have been performed.
4.9 Overdose
No cases of overdose have been reported.
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 carcenogenicity have not been performed.
6
PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Capsule shell : Hypromellose.
6.2 Incompatibilities
None known.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store below 30°C.
Store in the original package.
6.5 Nature and contents of container
Brown, poly (vinyl chloride) container with a security caps made of low density polyethylene.
Container with 45 and/or 150 capsules.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Laboratoires ARKOPHARMA
Lid de Carros Le Broc - 1ere avenue, 2709 m
06510 CARROS
FRANCE
Tel.: +33 (0)4 93 29 11 28 Fax.:+33 (0)4 93 29 11 62
8 MARKETING AUTHORISATION NUMBER(S)
THR 12297/0019
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
05/03/2013
10 DATE OF REVISION OF THE TEXT
05/03/2013