Allevia Hayfever Allergy Tablets, Prescription Strength 120mg Fexofenadine, 24hr Relief Acts Within 1 Hour, Including Sneezing, Watery Eyes, Itchy & Runny Nose, 30 Tablets

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b) Used for the relief of symptoms associated with seasonal allergic rhinitis (hay fever) in adults and children aged 12 years and over

The usual dose for treating hives is 180mg once a day for adults and children aged 12 years and over. There may be a small risk of incorrect use in children under the age of 12 years or to treat the symptoms of CIU. This is due to other antihistamines that are available as P and GSL medicines which can be used in children less than 12 years and to treat both seasonal allergic rhinitis and chronic idiopathic urticaria. However, the clear labelling and leaflet of Allevia 120mg tablets are likely to be sufficient to reduce this risk. 5.3 POM Criteria 3 5.3.1 Activity and/or adverse reactions require further investigation The Medicines and Healthcare products Regulatory Agency ( MHRA) is the UK Government agency responsible for regulating medicines and medical devices. We continually review the safety of medicines and vaccines in the UK, and inform healthcare professionals and the public of the latest updates through several means, including public reclassification reports. Allevia 120mg Tablets can be used for the relief of symptoms associated with seasonal allergic rhinitis ( SAR) in adults and children aged 12 years and over. Allergic rhinitis is inflammation of the inside of the nose caused by an allergen. An allergen is a substance that causes an allergic response. ‘Seasonal’ allergic rhinitis is when symptoms occur at the same time each year in response to a seasonal allergen, for example grass and tree pollen allergens. It is also known as hay fever.If you're breastfeeding or planning to breastfeed, talk to your doctor or pharmacist, as other antihistamines called loratadine and cetirizine might be better while you're breastfeeding. A Prescription Only Medicine ( POM) must be prescribed by a doctor or other authorised health professional and it must be dispensed from a pharmacy or from another specifically licensed place. mg twice daily for the relief of symptoms associated with SAR in paediatric patients aged 6 to 11 years It is likely that the symptoms of seasonal allergic rhinitis would be easily recognised as there are already a number of medicines available as non-prescription medicines to treat this condition. The Commission considered that the POM criteria had not been met and the GSL criterion had been met, and therefore advised that Allevia 120mg tablets, containing 120mg fexofenadine hydrochloride, could be approved for General Sales List ( GSL) availability based on the conditions outlined in section 3. 10. Conclusion

Hayfever symptoms shouldn’t get in the way of your day-to-day activities. With Allevia 120 mg Tablets, it doesn’t have to. Allevia provides relief that lasts all day from sevenIf you forget to give a dose to a child who is taking fexofenadine twice a day, you can give the dose if it's within 4 hours of when they should have had it. There are no adequate data from the use of fexofenadine hydrochloride in pregnant women. Limited animal studies do not indicate direct or indirect harmful effects with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Allevia 120 mg should not be used during pregnancy unless on the advice of a doctor..

Try to take fexofenadine tablets at about the same time every day. Choose a time that is easy to remember. The application contained a risk management plan ( RMP). RMPs are documents that contain information on a medicine’s safety profile and one or more of the following: b) Used for the relief of symptoms associated with seasonal allergic rhinitis (hay fever) in adults and children aged 12 years and over any medicine that makes you drowsy, gives you a dry mouth, or makes it difficult for you to pee – taking fexofenadine might make these side effects worse There is very little information available, but it shows that only tiny amounts get into breast milk. It is unlikely to cause any side effects in your baby.

plans for studies and other activities to gain more knowledge about the safety and efficacy of the medicine

There's very little information about taking herbal remedies and supplements with fexofendadine. There might be a problem taking some herbal remedies and supplements with it, especially ones that cause sleepiness or a dry mouth, or make it difficult to pee.

Human histamine wheal and flare studies following single and twice daily doses of fexofenadine hydrochloride demonstrate that the medicinal product exhibits an antihistaminic effect beginning within one hour, achieving maximum at six hours and lasting 24 hours. There was no evidence of tolerance to these effects after 28 days of dosing. A positive dose-response relationship between doses of 10 mg to 130 mg taken orally was found to exist. In this model of antihistaminic activity, it was found that doses of at least 130 mg were required to achieve a consistent effect that was maintained over a 24 hour period. Maximum inhibition in skin wheal and flare areas were greater than 80%. Clinical studies conducted in seasonal allergic rhinitis have shown that a dose of 120 mg is sufficient for 24 hour efficacy. There is limited data regarding the use of fexofenadine in pregnancy. Over 20 years, there have only been 13 serious cases reported which is considered to be low. Women who are pregnant or breastfeeding are also advised to talk to a doctor or pharmacist before taking this product. Fexofenadine has been available as a POM for over 20 years and therefore its activity and safety profile are well established, and no further investigation of the side effects is required. 5.4 POM Criteria 4 5.4.1 Is normally prescribed as an injection Additional side effects (frequency not known: cannot be estimated from the available data) which may occur are: