Marketing Authorisation Holder
Telfast 120mg & 180mg: Sanofi Consumer Healthcare 87 Yarraman Place, Virginia, QLD 4014 Australia
Telfast-D: Sanofi Consumer Healthcare 87 Yarraman Place,Virginia, QLD 4014 Australia
Naselfast: Opella Healthcare UK Limited 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, United Kingdom
Full Prescribing Information
Full prescribing information is available upon request at : Opella Healthcare International SAS First Floor, Office 101, Building 25, Dubai Healthcare City, Dubai, United Arab Emirates For further medical information, please contact the following:
For UAE: 800 OPELLAAE (800 67355223) Direct Line (+971522163940) For all Gulf Countries: CHCMedical-Information.ME@sanofi.com
To report adverse events, please call +971522164011 or contact Opella Country Safety Head at CHCPVME@sanofi.com For UAE only you may also contact MOHAP PV department at: PV@mohap.gov.ae
For any Product Technical Complaint please contact CHC.me.quality@sanofi.com
CONSULT YOUR DOCTOR BEFORE TAKING THE PRODUCT.
Telfast 120mg
Active ingredient: Fexofenadine hydrochloride 120 mg. Indication: Relieve the symptoms of hay fever (seasonal allergic rhinitis) such as sneezing, itchy, watery or red eyes and itchy, blocked or runny nose in adults and children aged 12 years or older. Dosage: This medicine is for adults and children over 12 years of age only. The dosage is one tablet daily. Contra-indications: Do not take Telfast if you are pregnant, intend to become pregnant, or if you are breastfeeding, unless advised to do so by a Doctor or Pharmacist. Do not take Telfast if you have had an allergic reaction allergy to fexofenadine, terfenadine or any of the other ingredients in Telfast. These are listed at the end of this leaflet. Do not give Telfast to children under 12 years of age. Do not take Telfast after the expiry date (EXP.) printed on the pack or if the packaging is damaged or shows signs of tampering. Common Side Effects: All medicines can cause side effects. Sometimes they are serious, but most of the time they are not. You may need medical treatment if you get some of the side effects. Although most people will not experience any, some of the side effects that may occur with Telfast are: headache, tiredness, nausea, indigestion, dizziness, drowsiness.
Telfast 180mg
Active ingredient: Fexofenadine hydrochloride 180 mg. Indication: Relieve the symptoms of hay fever (seasonal allergic rhinitis) such as sneezing, itchy, watery or red eyes and itchy, blocked or runny nose as well as the symptoms of urticaria otherwise known as hives or itchy rash in adults and children aged 12 years or older. Dosage: This medicine is for adults and children over 12 years of age only. The dosage is one tablet daily. Contra-indications: Do not take Telfast if you are pregnant, intend to become pregnant, or if you are breastfeeding, unless advised to do so by a Doctor or Pharmacist. Do not take Telfast if you have had an allergic reaction allergy to fexofenadine, terfenadine or any of the other ingredients in Telfast. These are listed at the end of this leaflet. Do not give Telfast to children under 12 years of age. Do not take Telfast after the expiry date (EXP.) printed on the pack or if the packaging is damaged or shows signs of tampering. Common Side Effects: All medicines can cause side effects. Sometimes they are serious, but most of the time they are not. You may need medical treatment if you get some of the side effects. Although most people will not experience any, some of the side effects that may occur with Telfast are: headache, tiredness, nausea, indigestion, dizziness, drowsiness.
Telfast-D
Active Ingredients: 60mg fexofenadine HCl & 120mg pseudoephedrine HCl. Telfast D Indication: Indication: For the relief of the symptoms of seasonal &perennial AR (including hay fever) with sinus/nasal congestion. Symptoms include : Nasal & sinus congestion, Sneezing, Itchy, runny nose, Watery, itchy eyes & Itchy throat. Common side effects (usually mild and short-lived) : Headache, nausea, fatigue, dry mouth, anorexia, drowsiness, difficulty sleeping, nervousness, excitability, restlessness, dizziness, fear or anxiety, rapid hearth beat, tremor, hallucinations. Contra-indications: very high blood pressure, severe coronary artery disease, narrow angle glaucoma, urinary retention, a sensitivity to adrenergic events (symptoms include insomnia, dizziness, weakness, tremor, or irregular hear beat), or if you have taken monoamine oxidase inhibitors (medicines used to treat depression) in the last 14 days.
Naselfast®
Naselfast® 55 micrograms/dose, nasal spray suspension is indicated to treat the nasal symptoms of allergic rhinitis in adults and children. The recommended dose: Adults and children (over 12 years) 2 sprays in each nostril daily. Once the symptoms of allergy are under control lower the dose to 1 spray in each nostril each day. Children (2 to 12 years) The usual dose is 1 spray in each nostril daily. If the symptoms do not go away, increase to 2 sprays in each nostril each day. This medicine is not recommended for use in children under 2 years of age. Common side effects: Runny nose, headache, sore throat and/or cough, Nosebleeds, Inflammation/irritation of the airways (bronchitis) , Heartburn or indigestion, Flu-like symptoms (fever, muscle pain, weakness and/or fatigue), Problems with teeth.