Land: Malta
Taal: Engels
Bron: Medicines Authority
PEPPERMINT OIL, CAJUPUT OIL, EUCALYPTUS OIL, LEVOMENTHOL
LanesHealth (Ireland) Limited Suite 7, The Courtyard, Carmanhall Road, Sandyford, Dublin 18, D18 NW62, Ireland
R01AX
PEPPERMINT OIL 20 % (W/W) CAJUPUT OIL 20 % (W/W) EUCALYPTUS OIL 20 % (W/W) LEVOMENTHOL 40 % (W/W)
NASAL STICK
PEPPERMINT OIL 20 % (W/W) CAJUPUT OIL 20 % (W/W) EUCALYPTUS OIL 20 % (W/W) LEVOMENTHOL 40 % (W/W)
OTC
NASAL PREPARATIONS
Authorised
2005-12-23
NASAL STICK _inhaler_ _inhaler_ _Olbas_ _Olbas_ The pure plant remedy for symptomatic relief of coughs, colds and catarrh. Olbas Inhaler contains essential oils which have decongestant properties. Before you use Olbas Inhaler Do not use if you are allergic to any of the ingredients. How to use Olbas Inhaler Adults and children aged 7 and over: Unscrew outer cover from stick, close one nostril, place inhaler in other nostril, and inhale deeply. After use, wipe stick with a tissue and replace cover. Not recommended for children under 7 years old. Do not use more than 4 times an hour. If symptoms persist, talk to your doctor. Possible side effects Like all medicines, Olbas Inhaler can cause side effects although not everybody gets them. If you notice any side effect, please tell your doctor or pharmacist. How to store Olbas Inhaler Keep out of the reach and sight of children. Do not use after the expiry date below. Do not store above 25°C. Keep the container tightly closed. Further information Active ingredients w/w: Cajuput Oil 20%, Eucalyptus Oil 20%, Levomenthol 40%, Peppermint Oil 20%. Marketing authorisation holder: LanesHealth (Ireland) Limited, Suite 7, The Courtyard, Carmanhall Road, Sandyford, Dublin 18, D18 NW62, Ireland. Manufacturer (EU QP Release Site): Elara Pharmaservices Europe Limited, 239 Blanchardstown Corporate Park, Ballycoolin, Dublin, D15 KV21, Ireland. NASAL STICK 335 Cutter Nasal stick containing 695mg Approved: Mar 2019 PA 22702/2/3 1006-01 P U R E P L A N T O I L S P U R E P L A N T O I L S C O N T A I N S NASAL STICK _inhaler_ _inhaler_ Immediate relief for stuffy noses _Olbas_ _Olbas_ P U R E P L A N T O I L S P U R E P L A N T O I L S C O N T A I N S 1006-01 BREXIT EIRE inhaler card Date:05/03/19 Amends author: GW Brief Description: Licence Change Size: 150mm x 210mm Colours: Pantone 335 Pantone 353 Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Olbas Inhaler Nasal Stick 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ingredients %w/w Cajuput Oil 20 Levomenthol 40 Peppermint Oil 20 Eucalyptus Oil 20 3. PHARMACEUTICAL FORM Nasal stick. White tube closed with a white cap and containing a wad dosed with Olbas Inhaler oil. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For the symptomatic relief of blocked up sinuses, catarrh, hay fever, colds and influenza. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION For nasal use. Adults and children aged 6 and over: Insert into each nostril in turn and inhale whilst keeping the other nostril closed. Do not use more than four times per hour. Not recommended for children under 6 years old. 4.3. CONTRAINDICATIONS Hypersensitivity to the active substances. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE If symptoms worsen or do not improve after 7 days, a doctor should be contacted. 4.5. INTERACTIONS 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 Inhaler in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Olbas Inhaler should not be used during pregnancy unless potential benefits outweigh any risks. It is unknown whether Olbas Inhaler/metabolites are excreted in human or animal milk. However, at therapeutic doses of Olbas Inhaler no effects on the breastfed newborns/infants are anticipated. Nevertheless it is not recommended that Olbas Inhaler be used during breast feeding. 4.7. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Olbas Inhaler has 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. However, local hypersensitivity, contact dermatitis and irritant effects of Levomenthol are listed in the literature. 4.9. OVERDOSE Reports of an over Lees het volledige document