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Desloratadine 5 mg film-coated tablets – patient leaflet, side effects, dosage

Last updated: · Text from the MHRA, as of · About this document

Medicine status: Prescription only (POM) Details

Medicine strength:
5 mg
Other strengths and forms:
Contains active substance:

Patient leaflet - Desloratadine 5 mg film-coated tablets

1. WHAT DESLORATADINE IS AND WHAT IT IS USED FOR

Desloratadine tablets contain the active substance desloratadine which is an antihistamine. How Desloratadine works

Desloratadine is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.

When Desloratadine should be used

Desloratadine relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults and adolescents 12 years of age and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.

Desloratadine is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives.

Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESLORATADINE

Do not take Desloratadine

if you are allergic to desloratadine, or any of the other ingredients of this medicine (listed in section 6) or to loratadine.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Desloratadine: if you have poor kidney function.

if you have medical or familial history of seizures.

Children and adolescents

Do not give this medicine to children less than 12 years of age.

Other medicines and Desloratadine

There are no known interactions of Desloratadine with other medicines. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Desloratadine with food, drink and alcohol

Desloratadine may be taken with or without a meal.

Use caution when taking Desloratadine with alcohol.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, or pharmacist for advice before taking this medicine. Taking Desloratadine is not recommended if you are pregnant or nursing a baby. There is no data available on male/female fertility.

Driving and using machines

At the recommended dose, this medicine is not expected to affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended not to engage in activities requiring mental alertness, such as driving a car or operating machinery until you have established your own response to the medicine.

Desloratadine contains lactose

Desloratadine contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicine.

3. HOW TO TAKE DESLORATADINE

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Use in adults and adolescents 12 years of age and over

The recommended dose is one tablet once a day with water, with or without food. This medicine is for oral use.

Swallow the tablet whole.

Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Desloratadine. If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your physician will recommend you a treatment schedule that will depend on the evaluation of the history of your disease.

If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more than 4 weeks), your physician may recommend you a longer term treatment. For urticaria, the duration of treatment may be variable from patient to patient and therefore you should follow the instructions of your physician.

If you take more Desloratadine than you should

Take Desloratadine only as it is prescribed for you. No serious problems are expected with accidental overdose. However, if you take more Desloratadine than you were told to, tell your doctor, pharmacist or nurse immediately.

If you forget to take Desloratadine

If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten dose. If you stop taking Desloratadine

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. During the marketing of Desloratadine, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely. If you notice any of these serious side effects, stop taking the medicine and seek urgent medical advice straight away.

(Continued overleaf)

As stated in design

Package leaflet

TBA

TW271762 (MAT) UK

All

NA

TBA

9 pts (Reg text)

NA 24/06/2026

Black C

In clinical studies in adults, side effects were about the same as with a dummy tablet. However, fatigue, dry mouth and headache were reported more often than with a dummy tablet. In adolescents, headache was the most commonly reported side effect. In clinical studies with Desloratadine, the following side effects were reported as: Common: the following may affect up to 1 in 10 people

fatigue

dry mouth

headache

During the marketing of Desloratadine, the following side effects were reported as: Very rare: the following may affect up to 1 in 10,000 people

severe allergic reactions

rash

pounding or irregular heartbeat

fast heartbeat

stomach ache

feeling sick (nausea)

vomiting

upset stomach

diarrhoea

dizziness

drowsiness

inability to sleep

muscle pain

hallucinations

seizures

restlessness with increased body movement

liver inflammation

abnormal liver function tests

Not known: frequency cannot be estimated from the available data unusual weakness

yellowing of the skin and/or eyes

increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to UV lights of a solarium

changes in the way the heart beats

abnormal behaviour

aggression

weight increased, increased appetite

Children

Not known: frequency cannot be estimated from the available data slow heartbeat

change in the way the heart beats

abnormal behaviour

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE DESLORATADINE

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Desloratadine contains

The active substance is desloratadine

Each tablet contains 5 mg desloratadine

The other ingredients are

Tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, maize starch, talc, zinc stearate.

Film coating: Opadry II Blue (33B505002) containing: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), macrogol (E1521), Indigo Carmine Aluminum Lake (E132)). What Desloratadine looks like and contents of the pack

Desloratadine film-coated tablets 5 mg are presented as light blue to blue, round biconvex, film coated tablets debossed with “5” on one side and plain on other side. Desloratadine 5 mg film-coated tablets are packed in Alu hard tempered foil – Alu plain cold formable foil blister pack.

Desloratadine 5 mg film-coated tablets are available in packs containing 30 tablets. Marketing Authorisation Holder

Tillomed Laboratories Limited

220 Butterfield, Great Marlings

Luton, LU2 8DL, United Kingdom

Manufacturer

Manx Healthcare Ltd

Unit 2, Bosworth Avenue, Tournament Fields, Warwick, CV34 6UQ, UK Other formats

To request a copy of this leaflet in Braille, large print or audio, please call 0800 970 6115.

This leaflet was last revised in June 2026

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About this document

Source: MHRA - Medicines and Healthcare products Regulatory Agency (products.mhra.gov.uk) · Marketing authorisation: PL 11311/0808

Last revision stated in the text: June 2026 · MHRA data as of 13 October 2026

Found a mistake? Tell us on the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Facts about Desloratadine 5 mg film-coated tablets

Prescription needed? Yes, prescription-only medicine (POM)
Active substance Desloratadine
Strength 5 mg
Pharmaceutical form Oral tablet
Light blue to blue, round biconvex, film coated tablet debossed with “5” on one side and plain on other side with approximate 6.1 mm in diameter.
How is it taken Oral
Excipients Calcium hydrogen phosphate dihydrate, Microcrystalline cellulose, Maize starch, Talc, Zinc stearate, Hypromellose (E464), Lactose monohydrate, Titanium dioxide (E171), Macrogol (E1521), Indigo Carmine Aluminum Lake (E132)
Is it available? Listed as available (NHS Dictionary of Medicines and Devices – not a record of current supplies)
Shelf life 48 months
Storage This medicinal product does not require any special storage condition
Drug group (ATC) Antihistamines – H1 antagonist
  1. R Respiratory system drugs
    1. R06 Antihistamines for systemic use
      1. R06A Antihistamines for systemic use
        1. R06AX Other antihistamines for systemic use
          1. R06AX27 desloratadine
Marketing authorisation PL 11311/0808 (first authorised 26 April 2024)
Marketing authorisation holder Tillomed Laboratories Limited 220 Butterfield
Codes BNF 03040100

Sources: the MHRA product information (products.mhra.gov.uk) and the NHS Dictionary of Medicines and Devices (dm+d), release 10.2.0 of 19 October 2026, NHS Business Services Authority. Contains public sector information licensed under the Open Government Licence v3.0.