Direct danger’ means that a danger may be present if the product causes adverse reactions that are important. Fexofenadine is a P-glycoprotein (P-gp) and organic-anion-transporting polypeptide (OATP) substrate. Concomitant use of fexofenadine with P-gp inhibitors or inducers can affect the exposure to fexofenadine. Coadministration of fexofenadine hydrochloride with P-gp inhibitors, erythromycin or ketoconazole has been found to result in a 2-3 times increase in the level of fexofenadine in plasma. The changes were not accompanied by any effects on the QT interval and were not associated with any increase in adverse reactions compared to the medicinal products given singly.

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 Indirect dangers” are considered to be when treatment might mask an underlying condition that requires medical attention. 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 Opticrom Allergy 2% w/v Eye Drops, solution contains sodium cromoglicate. For the symptomatic relief of eye allergies. 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

5. Side effects

Overall, none of the POM criteria have been met, and therefore this product could suitably be classified as a P medicine. 6. General Sales List ( GSL) Criterion Hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis. In adults, the following undesirable effects have been reported in clinical trials, with an incidence similar to that observed with placebo: General Sales List ( GSL) medicines can be sold or supplied in other retail outlets other than pharmacies by someone who is not a pharmacist.

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

This criterion is set out in the Human Medicines Regulations 2012, regulation 62 (5). 7. Assessment of suitability for General Sales List availabilityAdditional side effects (frequency not known: cannot be estimated from the available data) which may occur are: Opticrom Hayfever 2% w/v Eye Drops, solution contains sodium cromoglicate. For the relief of hayfever eye symptoms. 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. 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.