Ebastine 10 mg Film-Coated Tablets

    Ebastine 10 mg Film-Coated Tablets

    S2

    API: Ebastine | Company: Adcock Ingram

    1. WHAT EBASTINE 10 MG ADCO IS AND WHAT IT IS USED FOR

    Ebastine 10 mg Adco contains active ingredient ebastine which belongs to a group of medicines called antihistamines.

    Ebastine 10 mg Adco is used for the symptomatic treatment of seasonal and perennial allergic rhinitis (runny or stuffy nose) and idiopathic chronic urticaria.

    2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EBASTINE 10 MG ADCO

    Do not take Ebastine 10 mg Adco

    If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

    Children and adolescents

    This medicine should not be given to children under 12 years of age.

    Warnings and precautions:

    Take special care with Ebastine 10 mg Adco:

    • If you develop a sudden emergency allergic reaction 1 to 3 hours after taking Ebastine 10 mg Adco.
    • If you have heart disease.
    • If your doctor told you that you have low levels of potassium in the blood.

    Do not exceed the usual daily dose of 10 mg if you have severe liver disease.

    Ebastine 10 mg Adco contains lactose

    If your doctor has told you that you have intolerance to certain sugars, check with him or her before taking Ebastine 10 mg Adco.

    Other medicines and Ebastine 10 mg Adco:

    Always tell your health care provider if you are taking any other medicine (This includes all complementary or traditional medicines).

    Ebastine 10 mg Adco active ingredients ebastine can interfere with the results of allergic skin tests, so it is advisable not to perform these tests until 5-7 days after treatment has been discontinued.

    Special caution is recommended when taking Ebastine 10 mg Adco with some antibiotics like erythromycin and medicines used to treat fungal infection like ketoconazole.

    Ebastine 10 mg Adco with food:

    Ebastine 10 mg Adco can be taken with or without food.

    Pregnancy, breastfeeding:

    Safety in pregnancy has not been established. Do not use Ebastine 10 mg Adco while breast feeding your baby. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine.

    Driving and using machinery

    Ebastine 10 mg Adco lacks significant sedative effects. Patients should, however, be warned that they may experience sedation. This effect may be compounded by the simultaneous intake of alcohol or other central nervous system depressants. Patients should therefore be advised to determine individual response before driving or performing complicated tasks.

    3. HOW TO TAKE EBASTINE 10 MG ADCO

    Do not share your medicine with any other person

    Always take Ebastine 10 mg Adco exactly as described in this leaflet or as your doctor/pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

    The usual dose for adults and children over 12 years old: 1 tablet (10 mg) once daily

    Do not use this medicine for more than 10 days

    Method of administration:

    Ebastine 10 mg Adco tablets are administered orally. The tablets should be swallowed whole, without chewing or breaking them up, with a glass of liquid, preferably water. Ebastine 10 mg Adco can be taken at any time of the day regardless of food intake.

    If you take more Ebastine 10 mg Adco than you should

    In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

    If you forgot to take Ebastine 10 mg Adco

    If you miss a dose, wait for the next one. Do not take a double dose to make up for a forgotten dose.

    4. POSSIBLE SIDE EFFECTS

    Ebastine 10 mg Adco can cause side effects.

    Not all side effects reported for Ebastine 10 mg Adco are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Ebastine 10 mg Adco, please consult your healthcare provider for advice.

    Tell your doctor if you notice any of the following:

    The following side effects have been reported frequently:

    • headache
    • drowsiness
    • dry mouth
    • pharyngitis
    • runny or stuffy nose
    • weakness, lack of energy and strength (asthenia)

    The following side effects have been reported less frequently:

    • abdominal pain
    • indigestion (dyspepsia)
    • digestive discomfort
    • nosebleed
    • nausea
    • insomnia (lack of sleep or having difficulty to sleep)

    The following side effects have been reported but the frequency is unknown:

    • weight gain
    • increased appetite

    If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

    Reporting of side effects

    If you get side effects, talk to your health care provider. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 . By reporting side effects, you can help provide more information on the safety of Ebastine 10 mg Adco.

    May also report to Adcock Ingram Limited using the following email: [email protected]

    5. HOW TO STORE EBASTINE 10 MG ADCO

    Store all medicines out of reach of children. Store at or below 25 ºC. Store in the original container.

    Keep the blister in the outer carton

    Do not use after the expiry date stated on the blister label or carton. Return all unused medicine to your pharmacist.

    Do not dispose of unused medicine in drains or sewerage systems e.g. (toilets).

    Important Disclaimer

    The Ebastine 10 mg Film-Coated Tablets professional information leaflet below is the property of Adcock Ingram and is provided on Somayeza exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Somayeza serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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