Coldandflu_packHRI Cold & Flu – SPC

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1. Name of the medicinal product
HRI Cold and Flu Echinacea Tablets
2. Qualitative and quantitative composition
Each film coated tablet contains 56mg of extract (as dry extract) from Echinacea purpurea root (equivalent to 338mg-450mg of Echinacea Purpurea (L). Moench, root).
Extraction Solvent: Ethanol 75% v/v.
For full list of excipients, see section 6.1.
3. Pharmaceutical form
Film Coated tablet.
Pale pink round circular biconvex.
4. Clinical particulars
4.1. Therapeutic indications
A 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 administration.
Adults, elderly and children over 12 years: the recommended dosage is 1-2 tablets twice a day. The tablet formulation is not intended for children below 12 years. (See section 4.4 special warnings and precautions for use).
Start at first signs of common cold. Do not use the medicinal product for more than 10 days. If symptoms worsen during the use of the product or persist for more than 10 days, 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.
Because of its immunostimulating activity, Echinacea must not be used in cases of progressive systemic disorders (tuberculosis, sarcoidosis), autoimmune diseases (e.g.: collagenoses, 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, leukemias) and allergic diathesis (e.g.: urticaria, atopic dermatitis, asthma).
4.4. Special warnings and precautions for use
Do not exceed the stated dose.
If the condition worsens or high fever occurs during the use of the product or if symptoms persist for more than 10 days, consult a doctor or qualified healthcare practitioner.
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 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 and methotrexate.
4.6. Pregnancy and lactation
In the absence of sufficient data the use in 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.
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8. Undesirable effects
Hypersensitivity reactions (rash, urticaria, Stevens-Johnson Syndrome, angioedema of the skin, Quincke edema, bronchospasm with obstruction, asthma and anaphylactic shock) may occur.
Echinacea can trigger allergic reactions in atopic patients.
Association with autoimmune diseases (encephalitis disseminata, erythema nodosum, immunothrombocytopenia, Evans Syndrome, Sjögren syndrome with renal tubular dysfunction) has been reported.
Leucopenia may occur in long-term use (more than 8 weeks). The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a pharmacist should be consulted.
4.9. Overdose
No case of overdose has been reported.
5. Pharmacological properties
5.1. Pharmacodynamic properties
Not required as per Artilce 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
5.2. Pharmacokinetic properties
Not required as per Artilce 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
5.3. Preclinical safety data
Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6. Pharmaceutical particulars
6.1. List of excipients
Herbal Extract
• Malodextrin
• Colloidal anhydrous silica
Tablet Core
• Dicalcium Phosphate
• Microcrystalline Cellulose
• Croscarmellose Sodium
• Colloidal Anhydrous Silica
• Magnesium Stearate
• Stearic Acid
Tablet Coating
• Hypromellose
• Red Iron Oxide (E172)
• Black iron Oxide (E172)
• Titanium Dioxide (E171)
• Purified Talc
6.2. Incompatibilities
None known.
6.3. Shelf life
24 Months.
6.4. Special precautions for storage
Do not store above 25 °C. Store in the original packaging.
6.5. Nature and contents of container
Tablets are packed into PVC aluminium foil blister stips of 15 tablets.
Pack sizes: 30’s, 60’s, 90’s
Not all pack Sizes may be marketed.
6.6. Instructions for Use/Handling
No special requirements.
7. Traditional registration holder
8. Marketing Authorisation number
THR 02231/0001
9. Date of first authorisation/renewal of the authorisation
27th July 2011
10. Date of revision of the text
Sept 2010