Olbas Blackcurrant Pastilles
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olbas Blackcurrant Pastilles
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
|
Ingredients |
%w/w |
mg per pastille |
|
Eucalyptus Oil |
1.160 |
19.70 |
|
Peppermint Oil |
1.120 |
19.00 |
|
Levomenthol |
0.100 |
1.70 |
|
Juniper Oil |
0.067 |
1.14 |
|
Methyl Salicylate |
0.047 |
0.80 |
|
Clove Oil |
0.002 |
0.03 |
Excipients: Aspartame, Maltitol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pastille
Purple, oval, ribbed, oiled pastille.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the symptomatic relief of colds, coughs, catarrh, sore throats, influenza, catarrhal headache and nasal congestion.
4.2 Posology and method of administration
For oropharyngeal use.
Adults, the elderly and children aged 16 and over: Dissolve 1 pastille slowly in the mouth when required.
Do not take more than 8 pastilles in any 24 hour period.
Not recommended for children under 16 years old.
Contraindications
4.3
Hypersensitivity to the active substances or to any of the excipients.
Olbas Blackcurrant Pastilles should not be used in children and adolescents under the age of 16.
4.4 Special warnings and precautions for use
Aspartame is a source of phenylalanine. May be harmful for people with phenylketonuria.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
If symptoms worsen or do not improve after 7 days, a doctor should be contacted.
Do not exceed the stated dose.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6 Pregnancy and lactation
There are no or limited amount of data from the use of Olbas Blackcurrant Pastilles in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Olbas Blackcurrant Pastilles should not be used during pregnancy unless potential benefits outweigh any risks.
It is unknown whether Olbas Blackcurrant Pastilles/metabolites are excreted in human or animal milk. However, at therapeutic doses of Olbas Blackcurrant Pastilles no effects on the breastfed newborns/infants are anticipated. Nevertheless it is not recommended that Olbas Blackcurrant Pastilles be used during breast feeding.
4.7 Effects on ability to drive and use machines
Olbas Blackcurrant Pastilles have no influence on the ability to drive and use machines.
4.8 Undesirable effects
No undesirable effects are likely with this product because of the low concentrations of the active ingredients. Methyl Salicylate may cause heartburn, wheezing, dyspnoea and the worsening of asthma.
4.9 Overdose
Overdose due to abuse of the product can result in gastric upset causing abdominal pain, nausea, vomiting and diarrhoea. In very large doses the symptoms may include renal damage and irritation of the kidneys, bladder and urethra, dizziness and CNS depression or stimulation. Treatment would be symptomatic.
Salicylate toxicity can result if the stated dose is exceeded.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other Cold Combination Preparations, ATC code: R05X
Peppermint Oil, Eucalyptus Oil, Juniperberry Oil and Clove Oil render secretions more fluid and relieve congestion. Levomenthol relieves symptoms of bronchitis and sinusitis. Methyl Salicylate has analgesic properties.
5.2 Pharmacokinetic properties
The product is intended for local effect on the oropharynx.
Excretion of essential oils takes place through the lungs, skin and kidneys. After absorption, Levomenthol is excreted in the urine and bile as glucuronide.
5.3 Preclinical safety data
Clove Oil, Eucalyptus Oil, Juniper Oil and Levomenthol are mild to moderate irritants of human skin. Clove Oil and Peppermint Oil are irritant to mucous membranes at concentrations >3%. There are no other non-clinical data available that are of relevance to the prescriber that are not mentioned in other sections of the Summary of Product Characteristics.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Acesulfame Potassium
Anthocyanin Extract E163
Aspartame
Bittermask DA40248
Blackcurrant Flavour 517589E
Gelatin
Malic Acid
Maltitol Solution
Silicone Antifoam
Vegetable Oil/Carnauba wax
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25 °C.
Do not use if sealed inner pouch is cut or torn.
6.5 Nature and contents of container
40g (equivalent to a minimum of 21 pastilles) and 45g pastilles (equivalent to a minimum of 24 pastilles) contained in an aluminium/LDPE foil bag integral with a carton.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Any unused product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
G. R. Lane Health Products Limited
Sisson Road
Gloucester
GL2 0GR
United Kingdom
Tel: +44 (0)1452 524012
Fax: +44 (0)1452 507930
Email: info@laneshealth.com
8 MARKETING AUTHORISATION NUMBER
PL 01074/0009
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 10 October 2000
Date of latest renewal: 25 November 2005
10
DATE OF REVISION OF THE TEXT
24/12/2015