PAR: Reclassification of Allevia 120mg tablets from Prescription Only Medicine (POM) to General Sales List (GSL)

Public Assessment Report

Prescription Only Medicine to General Sales List Reclassification

Allevia 120mg Tablets

Fexofenadine Hydrochloride 120mg

PL 04425/0667 – 0042

AVENTIS PHARMA LIMITED

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.
Suspected side effects to any drug or vaccine can be reported to the MHRA by both healthcare professionals and members of the public via the Yellow Card scheme.

1. Introduction

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.

Each tablet contains 120 milligrams of fexofenadine hydrochloride.

The licence holder, Aventis Pharma Limited, applied to change the legal status of this product from Prescription Only Medicine (POM) to a General Sales List (GSL) medicine (see Background for definition).

The Medicines and Healthcare Products Regulatory Agency (MHRA) considers this product sufficiently safe to be sold on general sale. This report outlines the evidence that the MHRA reviewed and which led to the decision to approve the application.

2. Background

Fexofenadine hydrochloride is an antihistamine which works by blocking the effects of a substance called histamine in your body. In hay fever, histamine is released in response to allergens which can cause symptoms such as sneezing, itchy and watery eyes or blocked nose.

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.

Pharmacy (P) medicines can be supplied without prescription only from pharmacies, by or under the supervision of a pharmacist.

General Sales List (GSL) medicines can be sold or supplied in other retail outlets other than pharmacies by someone who is not a pharmacist.

Fexofenadine hydrochloride was first approved in 1996 as a prescription product in the UK.

In in the UK, Fexofenadine is also currently available in the following preparations as prescription only medicines:

  • 180 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.
  • 30 mg twice daily for the relief of symptoms associated with SAR in paediatric patients aged 6 to 11 years

3. Proposed Terms of Reclassification

Aventis Pharma Limited proposed to make Allevia 120mg Tablets available through general retail outlets with the following terms of reclassification:

a) Pack size: 30 tablets

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

c) Dose: (Adults and children aged 12 years and over): One tablet daily before a meal

d) Route of administration: Tablet for oral use

e) Strength: Each tablet contains 120mg of fexofenadine hydrochloride

4. Prescription Only Medicine (POM) Criteria

To be reclassified from POM to P, a medicine must:

  • be unlikely to be a direct or indirect danger to human health when used without the
    supervision of a doctor, even if used correctly
  • be generally used correctly (i.e. not frequently or to a wide extent used correctly)
  • not contain substances or preparations of substances where the activity of the product or
    its side effects require further investigation
  • not normally be prescribed by a doctor for injection (parenteral administration)

These criteria are set out in the Human Medicines Regulations 2012, regulation 62(3).

5. Assessment of suitability for Pharmacy availability

The MHRA firstly assessed the application against the POM criteria as stated in section 4 to ascertain whether the product could be supplied without a prescription in a pharmacy setting under the supervision of a pharmacist.

5.1 POM Criteria 1

5.1.1 Direct Danger

‘Direct danger’ means that a danger may be present if the product causes adverse reactions that are important.

The safety profile of Allevia 120mg Tablets is considered to be well established, and there has been extensive use of the medicine for over 20 years. The most common side effects are shared amongst many other non-prescription medicines and are considered to be self-limiting. In comparison to older antihistamines, fexofenadine is unlikely to cause sleepiness or drowsiness and is therefore unlikely to impair the ability to drive or operate machinery.

Fexofenadine is unlikely to cause harmful effects by interacting with other medicines. Indigestion remedies containing aluminium and magnesium may affect the action of fexofenadine and therefore it is recommended to leave 2 hours between the time that an Allevia 120mg tablet and an indigestion remedy is taken.

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.

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.

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

“Indirect dangers” are considered to be when treatment might mask an underlying condition that requires medical attention.

The risk of masking an underlying condition is expected to be low as there are already other medicines available from pharmacies to treat the symptoms of hay fever, and therefore the condition is already easily diagnosed, especially as hay fever often occurs at the same time each year. Some symptoms of hay fever such as a runny nose or a blocked nose are similar to other minor illnesses such as a common cold. However, these symptoms are self-limiting, and it is likely that if symptoms persisted, medical advice would be sought.

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.

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

There is no evidence that Allevia 120mg tablets are frequently and to a very wide extent used incorrectly. The risk of intentional misuse related to the use of fexofenadine is low. There is no evidence to indicate that fexofenadine has any abuse potential.

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

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

This product is for oral use only, so this criterion does not apply.

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

To be reclassified from P to GSL, a medicine must meet the GSL criterion which is defined as medicines which can, with reasonable safety, be sold or supplied otherwise than by or under the supervision of a pharmacist.

The term “with reasonable safety” has been defined as: “where the hazard to health, the risk of misuse, or the need to take special precautions in handling is small and where wider sale would be a convenience to the purchaser.”

This criterion is set out in the Human Medicines Regulations 2012, regulation 62 (5).

7. Assessment of suitability for General Sales List availability

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

This has been considered under the POM criteria 1 (section 5.1).

7.2 Risk of Misuse

This has been considered under the POM criteria 2 (section 5.2).

7.3 Special precautions in handling

There are no special handling requirements for Allevia 120mg tablets that would prevent its availability as a GSL medicine.

7.4 Wider sale would be a convenience to the purchaser

The GSL availability of Allevia 120mg is considered to be appropriate. The increased access of this medicine would be advantageous particularly to individuals who may have previously been prescribed Fexofenadine and wish to continue use without the barriers associated with a prescription medicine. The increase in choice of antihistamines for seasonal allergic rhinitis is also considered to be of benefit to the public. Limiting Allevia 120mg tablets to P legal status would unnecessarily limit the availability of the product.

8. Further details on the application

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:

  • how any risks identified in the safety profile will be prevented or minimised in patients
  • plans for studies and other activities to gain more knowledge about the safety and efficacy of the medicine
  • risk factors for side effects
  • measuring the effectiveness of measures taken to prevent or minimise risks.

The RMP for Allevia 120mg tablets identified the main risks associated with the product and proposed how these would be managed through routine pharmacovigilance (monitoring and reporting of adverse events for a medicine, for which there are no special safety concerns) and via the product information (SPC, labelling and patient information leaflet). No additional risk minimisation measures were proposed for the product.

9. Advice from the Commission on Human Medicines

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

The MHRA has taken the decision to approve GSL legal status for the Allevia 120mg tablets under the following conditions:

a) Pack size: 30 tablets

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

c) Dose: (Adults and children aged 12 years and over): One tablet daily before a meal

d) Route of administration: Tablet for oral use

e) Strength: Each tablet contains 120mg of fexofenadine hydrochloride

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