Summary of Product Characteristics (SmPC) - Pollinosan Hayfever tablets
1 NAME OF THE MEDICINAL PRODUCT
Pollinosan Hayfever tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet (250 mg) contains:
Ammi visnaga 1x
Aralia racemosa 2x
Cardiospermum halicacabum 2x
Larrea mexicana 2x
Luffa operculata 6x
Okoubaka aubrevillei 2x
Galphimia glauca 3x
Contains lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Slightly yellowish, biconvex tablet with a triangular stamp.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A homeopathic medicinal product used within the homeopathic tradition to relieve the symptoms of hayfever and other forms of allergic rhinitis.
4.2 Posology and method of administration
Adults, the elderly and children over 12 years: Take 2 tablets 3 times daily before meals.
Maximum recommended daily dose is 6 tablets.
This product should not be used in children under 12 years.
For oral use only.
4.3 Contraindications
Hypersensitivity to any of the active ingredients or to any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If the condition worsens, or if symptoms persist for more than 7 days, consult a doctor or qualified healthcare practitioner.
This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.
This product is not recommended for use in children under 12 years of age due to a lack of data on safety.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
Pregnancy: There is no evidence of the safety of the product in human pregnancy, nor is there any evidence from animal studies.
The use of the product during pregnancy and lactation should be avoided unless under the guidance of a doctor.
Studies on the effects on fertility have not been performed.
4.7 Effects on ability to drive and use machines
Pollinosan has no influence on the ability to drive or use machines.
4.8 Undesirable effects
Frequency not known
Gastrointestinal disturbances e.g. nausea, stomach upset. Allergic reactions e.g. rash
If symptoms worsen, or persist for more than 7 days, or if other adverse reactions not mentioned above occur, a doctor, pharmacist or a qualified healthcare practitioner should be consulted.
4.9 Overdose
None known.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not applicable.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose monohydrate
Pregelatinised starch
Magnesium stearate
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
60 months.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
Amber glass bottles (Type III glass) sealed with coated aluminium foil and closed with pilfer proof screw caps fitted with a polyethylene liner
Pack sizes: 80 tablets
120 tablets
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
A.Vogel Ltd
2 Brewster Place
Irvine, Ayrshire
KA11 5DD, United Kingdom
Tel: 01294 277344
enquiries@avogel.co.uk
8 MARKETING AUTHORISATION NUMBER(S)
NR 13668/0208
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
19/02/2013
10 DATE OF REVISION OF THE TEXT
19/02/2013