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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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 Additional side effects (frequency not known: cannot be estimated from the available data) which may occur are: Furthermore, the elderly, individuals with impaired kidney or liver function, or individuals with a history of heart disease are all advised to seek advice from their doctor or pharmacist before taking this product. This is suitable as currently the POM product is prescribed ‘with care’ to these populations, which implies that some level of healthcare professional input is required. Any indirect dangers associated with the above-mentioned excluded populations (e.g. individuals with a history of heart disease) from taking the product is considered to be low. As a P medicine, pharmacists would be able to advise these individuals that the product can only be taken on the advice of a doctor. 5.2 POM Criteria 2 5.2.1 Incorrect Use Opticrom Hayfever 2% w/v Eye Drops, solution contains sodium cromoglicate. For the relief of hayfever eye symptoms.

Fexofenadine hydrochloride is a non-sedating H 1 antihistamine. Fexofenadine is a pharmacologically active metabolite of terfenadine. very common ≥1/10; common ≥1/100 and <1/10; uncommon ≥1/1,000 and <1/100; rare ≥1/10,000 and <1/1,000; very rare <1/10,000 and not known (frequency cannot be estimated from the available data). 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. Indirect dangers” are considered to be when treatment might mask an underlying condition that requires medical attention. A clinical drug-drug interaction study showed that co-administration of apalutamide (a weak inducer of P-gp) and a single oral dose of 30 mg fexofenadine resulted in a 30 % decrease in AUC of fexofenadine.plans for studies and other activities to gain more knowledge about the safety and efficacy of the medicine If you think that you need to take fexofenadine in pregnancy, talk to your doctor or pharmacist who will help you decide, or who may recommend other medicines for you. Fexofenadine and breastfeeding There are no data on the content of human milk after administering fexofenadine hydrochloride. However, when terfenadine was administered to nursing mothers fexofenadine was found to cross into human breast milk. Therefore Allevia 120 mg is not recommended for mothers breast-feeding their babies. Breast-feeding women should only use Allevia 120 mg if advised to do so by a doctor. mg once daily for the relief of symptoms associated with chronic idiopathic urticaria ( CIU) in adults and adolescents aged 12 years or older. CIU, also known as hives, is an itchy, raised rash that appears on the skin, usually for more than 6 weeks. mg twice daily for the relief of symptoms associated with SAR in paediatric patients aged 6 to 11 years

Aventis Pharma Limited proposed to make Allevia 120mg Tablets available through general retail outlets with the following terms of reclassification:You may only need to take fexofenadine on a day you have symptoms, such as when you've been exposed to something you're allergic to, like animal hair. Hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis. 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 If you often forget doses, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine. What if I take too much?

There are currently other antihistamines which are available as a pharmacy medicine that are also used to treat the symptoms of hay fever. 5.1.2 Indirect Danger If you remember more than 4 hours after, do not give the missed dose. Instead, wait until the next dose and carry on as normal. Consult your doctor or pharmacist if you have an underlying medical condition, are taking any other medication or complementary therapy, or if symptoms persist serious allergic reactions which can cause swelling of the face, lips, tongue or throat, flushing, chest tightness, and difficulty breathing.

Fexofenadine hydrochloride is rapidly absorbed into the body following oral administration, with Tmax occurring at approximately 1-3 hours post dose. The mean Cmax value was approximately 427 ng/mL following the administration of a 120 mg dose once daily.

e) Strength: Each tablet contains 120mg of fexofenadine hydrochloride 4. Prescription Only Medicine ( POM) Criteria If 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. 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. 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.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 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. The MHRA secondly assessed the application against the GSL criterion as stated in section 5 to ascertain whether the product could be supplied without the supervision of a pharmacist in other retail outlets. 7.1 Hazard the health If your doctor or health visitor says your baby is healthy, you can take fexofenadine while breastfeeding. b) Used for the relief of symptoms associated with seasonal allergic rhinitis (hay fever) in adults and children aged 12 years and over