Country: Israel
Language: English
Source: Ministry of Health
DIMETINDENE MALEATE; PHENYLEPHRINE
GSK CONSUMER HEALTHCARE, ISRAEL LTD
R06AB03
NASAL SOLUTION
DIMETINDENE MALEATE 0.025 %W/V; PHENYLEPHRINE 0.25 %W/V
NASAL
Not required
GSK CONSUMER HEALTHCARE SARL, SWITZERLAND
DIMETINDENE
DIMETINDENE
Symptomatic treatment of common cold, nasal congestio, acute rhinitis, seasonal (hay fever) and non seasonal allergic rhinitis, acute sinusitis. Adjunctive therapy in case of acute otitis media.
2022-10-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS ’ REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed without a doctor's prescription VIBROCIL MICRODOSER 0.25% W/V + 0.025% W/V METERED-DOSE NASAL SPRAY ACTIVE INGREDIENTS AND THEIR QUANTITY IN A DOSING UNIT: DIMETHINDENE MALEATE 0.025% W/V PHENYLEPHRINE 0.25% W/V Inactive ingredients and allergens in the preparation, please see section 6 and section 2 under the title “ Important information about some of the ingredients of the medicine ” . READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have additional questions, refer to the doctor or the pharmacist. Use the preparation according to the instructions in the dosage section of this leaflet. Consult the pharmacist if you need more information. Refer to the doctor if signs of the ailment (symptoms) worsen or do not improve after 7 days. 1. WHAT IS THE MEDICINE INTENDED FOR? Vibrocil Microdoser is intended for temporary relief of nasal congestion and common cold, acute rhinitis, seasonal allergic rhinitis (hay fever), non-seasonal allergic rhinitis and acute sinusitis. Vibrocil Microdoser is also used as an adjunctive therapy for otitis media (inflammation of the middle ear). THERAPEUTIC CLASS: Dimethindene maleate – an anti-allergic agent. Phenylephrine – a sympathomimetic agent, a capillary constrictor. 2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredients or to any of the other components the medicine contains (please see section 6 and section 2). • You are taking or have taken during the last 14 days antidepressants of the monoamine oxidase inhibitors group (MAO inhibitors). • You have Atrophic Rhinitis/Ozena that has caused your nasal mucous membranes to become thinner. • You have narrow angle glaucoma. • You have undergone resection of the pituitary gland or surgery via the nose or the mouth in which the hard, outermost membrane of the cen Read the complete document
1. VIBROCIL MICRODOSER _2. _ _COMPOSITION _ _Active ingredients:_ Dimetindene maleate 0.025% W/V, Phenylephrine 0.25% W/V. _3. _ _PHARMACEUTICAL FORM AND AMOUNT OF ACTIVE INGREDIENT PER UNIT _ _Microdoser_ 1 mL contains: Dimetindene maleate 0.25 mg, phenylephrine 2.5 mg. 1 spray (=0.14 mL) contains 0.035 mg dimethindene maleate and 0.35 mg phenylephrine. A standardized valve enables exact dosing (mean value: 140 µL solution per spray). _4. _ _INDICATIONS/APPLICATIONS _ _4.1_ Indication: Symptomatic treatment of common cold, nasal congestion, acute rhinitis, seasonal (hay fever) and non seasonal allergic rhinitis, acute sinusitis. Adjunctive therapy in case of acute otitis media. _4.2 DOSING REGIMEN/USE _ Do not exceed the indicated dosage and frequency of use. The lowest effective dosage should always be used, and the treatment kept as short as possible. _Children older than 6 years (under adult supervision) and adults:_ 1 to 2 sprays into each nostril 3 to 4 times a day. Using the microdoser 1. Thoroughly clean your nose ( e.g. by blowing it ) before use. 2. Be careful not to get the spray into your eyes. 3. Remove the protective cap. Before first use, actuate the pump 5 times to prime it. The microdoser is now ready for further use. If the product has not been used for some time, the pump must be actuated 5 times again before use. 4. Insert the microdoser into one nostril and breathe in through your nose as you spray once, pressing down firmly on the pump. Repeat the process in the other nostril. 5. Wipe and dry the nozzle tip before putting the protective cap back on. Do not share your bottle of Vibrocil metered-dose spray with other people to avoid any possible spread of infection. _4.3 CONTRAINDICATIONS _ Hypersensitivity to one of the active substances (phenylephrine, dimetindene maleate) or one of of the excipients listed in section 6.1. Contraindicated in: simple atrophic rhinitis, ozena ( rhinitis atrophicans cum foetore) patients who are on MAO inhibitors or who have taken them in the preceding Read the complete document