Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Desloratadine 5 mg film-coated tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Desloratadine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for 2. What you need to know before you take Desloratadine 3. How to take Desloratadine 4. Possible side effects 5. How to store Desloratadine 6. Contents of the pack and other information
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What Desloratadine is Desloratadine 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 or 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.
What you need to know before you take it
e Desloratadine Do not take Desloratadine:
- if you are allergic to desloratadine or to 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.
Use in 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 in 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. Fertility 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 medicinal product. Desloratadine contains lactose Desloratadine tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
How to take it
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. 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 or 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, 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 or pharmacist or nurse.
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. 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.
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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 Adults 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
- pounding or irregular heartbeat
- fast heartbeat
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Leaflet folded on middle with visibly first side (title); PhC that comes out of the middle of leaflet must be visible!/ Navodila prepognjena na sredini z vidno prvo stranjo (naslovom); pharma kodi, ki izhajata iz sredine navodila, morata biti vidni!
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iKRKk Šifra/Article No.: xxxxxx Emb. mat./Article name.: xx PL. Desloratadine 5 mg
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- stomach ache
- feeling sick (nausea)
- vomiting
- upset stomach
- diarrhoea
- dizziness
- drowsiness
- inability to sleep
- muscle pain
- hallucinations
- seizures
- restlessness with increased body movement
- rash
- liver inflammation
- abnormal liver function tests
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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
- change 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
- aggression
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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.
How to store it
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 packaging after EXP. The expiry date refers to the last day of that month. Do not store above 30°C. Store in the original package in order to protect from moisture. Do not use this medicine if you notice any change in the appearance of the tablets. 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.
- The other ingredients in the film coating are: hypromellose (E464), macrogol, lactose monohydrate, titanium dioxide (E171) and indigo carmine aluminium lake (E132). What Desloratadine looks like and contents of the pack Light blue, round, film-coated tablets with bevelled edges (diameter 6.5 mm). Desloratadine is available in carton boxes of 7, 10, 20, 30, 50, 90 and 100 film-coated tablets in blisters and in plastic tablet containers of 250 film-coated tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia Manufacturers KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany This leaflet was last revised in March 2023.
Contents of the pack and other information
What Desloratadine contains
- The active substance is desloratadine. Each film-coated tablet contains 5 mg desloratadine.
- The other ingredients in the tablet core are: microcrystalline cellulose (E460), hypromellose (E464), hydrochloric acid (E507), sodium hydroxide (E524), maize starch, lactose monohydrate and talc (E553b).
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Frequently asked questions about Desloratadine 5 mg film-coated tablets
How do I take Desloratadine 5 mg film-coated tablets?
Desloratadine 5 mg film-coated tablets comes as tablet containing 5mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Desloratadine 5 mg film-coated tablets?
The active substance in Desloratadine 5 mg film-coated tablets is desloratadine.
Are there equivalent medicines to Desloratadine 5 mg film-coated tablets?
Medicines with the same active substance, strength and form include: Neoclarityn 5 mg film-coated tablets, Desloratadine Glenmark 5 mg Tablets, Desloratadine Mylan 5 mg film-coated tablets. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Desloratadine 5 mg film-coated tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Desloratadine 5 mg film-coated tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: desloratadine
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Desloratadine is indicated in adults and adolescents aged 12 years or older for the relief of symptoms associated with: - allergic rhinitis (see section 5.1), - urticaria (see section 5.1).
4.2. Posology and method of administration
Posology
Adults and adolescents (12 years of age and over)
The recommended dose of desloratadine is one tablet once a day.
Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4 weeks) should be managed in accordance with the evaluation of patient's disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance.
In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods.
Paediatric population
There is limited clinical trial efficacy experience with the use of desloratadine in adolescent s 12 through 17 years of age (see sections 4.8 and 5.1).
The safety and efficacy of desloratadine film-coated tablets in children below the age of 12 years have not been established.
Method of administration
Oral use.
The dose can be taken with or without food.
4.3. Contraindications
Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to loratadine.
4.4. Special warnings and precautions for use
In the case of severe renal insufficiency, desloratadine should be used with caution (see section 5.2).
Desloratadine should be administered with caution in patients with medical or familial history of seizures, and mainly young children (see section 4.8), being more susceptible to develop new seizures under desloratadine treatment. Healthcare providers may consider discontinuing desloratadine in patients who experience a seizure while on treatment.
Desloratadine contains lactose. Patients with rare hereditary problems of galactose intolerance, the
Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5. Interaction with other medicinal products and other forms of interaction
No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which erythromycin or ketoconazole were co-administered (see section 5.1).
Paediatric population
Interaction studies have only been performed in adults.
In a clinical pharmacology trial, desloratadine tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1). However, cases of alcohol intolerance and intoxication have been reported during postmarketing use. Therefore, caution is recommended if alcohol is taken concomitantly.
4.6. Fertility, pregnancy and lactation
Pregnancy
A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformative nor foeto/neonatal toxicity of desloratadine.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of desloratadine during pregnancy.
Breast-feeding
Desloratadine has been identified in breastfed newborns/infants of treated women. The effect of desloratadine on newborns/infants is unknown. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from desloratadine therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility
There are no data available on male and female fertility.
4.7. Effects on ability to drive and use machines
Desloratadine has no or negligible influence on the ability to drive and use machines based on clinical trials. Patients should be informed that most people do not experience drowsiness. Nevertheless, as there is individual variation in response to all medicinal products, it is recommended that patients are advised not to engage in activities requiring mental alertness, such as driving a car or using machines, until they have established their own response to the medicinal product.
4.8. Undesirable effects
Summary of the safety profile
In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria,
at the recommended dose of 5 mg daily, undesirable effects with desloratadine were reported in
3 % of patients in excess of those treated with placebo. The most frequent of adverse reactions reported in excess of placebo were fatigue (1.2 %), dry mouth (0.8 %) and headache (0.6 %).
Paediatric population
In a clinical trial with 578 adolescent patients, 12 through 17 years of age, the most common adverse event was headache; this occurred in 5.9% of patients treated with desloratadine and 6.9% of patients receiving placebo.
Tabulated list of adverse reaction
The frequency of the clinical trial adverse reactions reported in excess of placebo and other undesirable effects reported during the post-marketing period are listed in the following table. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
System Organ Class
Frequency
Adverse reactions seen with
Metabolism and nutrition disorders
Not known
Increased appetite desloratadine
Psychiatric disorders
Very rare
Hallucinations
Nervous system disorders
Common
Very rare
Headache
Dizziness, somnolence, insom
Cardiac disorders
Very rare
psychomotor hyperactivity, Tachycardia, palpitations
Gastrointestinal disorders
Common
Very rare
Dry mouth
Abdominal pain, nausea, vomiting,
Hepatobiliary disorders
Very rare
Elevations of liver enzymes, increased bilirubin, hepatitis
Skin and subcutaneous tissue disorders
Not known
Photosensitivity
Musculoskeletal and connective tissue
Very rare
Myalgia
General disorders and administration site conditions
Common
Very rare
Fatigue
Hypersensitivity reactions (su as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria)
Investigations
Not known
Weight increased
Paediatric population
Other undesirable effects reported during the post-marketing period in paediatric patients with an unknown frequency included QT prolongation, arrhythmia, bradycardia, abnormal behaviour, and aggression.
A retrospective observational safety study indicated an increased incidence of new-onset seizure in patients 0 to 19 years of age when receiving desloratadine compared with periods not receiving desloratadine. Among children 0-4 years old, the adjusted absolute increase was 37.5 (95% Confidence Interval (CI) 10.5-64.5) per 100,000 person years (PY) with a background rate of new onset seizure of 80.3 per 100,000 PY. Among patients 5-19 years of age, the adjusted absolute increase was 11.3 (95% CI 2.3-20.2) per 100,000 PY with a background rate of 36.4 per 100,000 PY. (See section 4.4.)
Rep orting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
The adverse event profile associated with overdosage, as seen during post-marketing use, is similar to that seen with therapeutic doses, but the magnitude of the effects can be higher.
Treatment
In the event of overdose, consider standard measures to remove unabsorbed active substance. Symptomatic and supportive treatment is recommended.
Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal dialysis.
Symptoms
Based on a multiple dose clinical trial, in which up to 45 mg of desloratadine was administered (nine times the clinical dose), no clinically relevant effects were observed.
Paediatric population
The adverse event profile associated with overdosage, as seen during post-marketing use, is similar to that seen with therapeutic doses, but the magnitude of the effects can be higher.
💬 Ask about this leaflet
Ask anything about Desloratadine 5 mg film-coated tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.