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.
Loratadine 10 mg 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 Loratadine 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
What Loratadine Tablets are Loratadine tablets contain the active substance loratadine which belongs to the class of medicines called "anti-histamines." How Loratadine Tablets work Loratadine tablets help to reduce your allergy symptoms by stopping the effects of asubstance called "histamine",which is produced in the body when you are allergic to something. When Loratadine Tablets should be taken Loratadine tablets relieves symptoms associated with allergic rhinitis (for example, hay fever) and perennial allergic rhinitis (year round allergy symptoms). Symptoms of these conditions can include sneezing, runny nose, nasal itching, in addition to burning, itching and watering of the eyes. Loratadine tablets may also be used to help relieve symptoms of chronic idiopathic urticaria (itching and redness) which is often known as hives or nettle rash. You must talk to a doctor if you do not feel better or if you feel worse after 7 days. 2.
What you need to know before you take it
e Loratadine Tablets
Do not take Loratadine Tablets:
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if you are allergic to loratadine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions Talk to your doctor, pharmacist, or nurse before taking Loratadine tablets if:
- you have severe liver problems
- you are due to have any skin tests for allergies. Do not take Loratadine Tablets for two days before having these tests. This is because it may affect the test results. If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist, or nurse before taking Loratadine Tablets. Children and adolescents Do not give Loratadine tablets to children younger than 6 years old or to children who weigh 30 kg or less. There are other formulations more suitable for children younger than 6 years or with a body weight of 30 kg or less. Children under 2 years of age: The safety and efficacy of Loratadine tablets have not been established. No data are available. Other medicines and Loratadine Tablets The side effects of Loratadine Tablets may increase when used together with medicines that alter the performance of sorne enzymes responsible for drug-metabolism in the liver. However, in clinical studies, no increase inside effects of loratadine was seen with products that altered the performance of these enzymes. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines taken without a prescription. Loratadine Tablets with alcohol Loratadine Tablets have not been shown to add to the effects of an alcoholic drink. Pregnancy and breast-feeding 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. As a precautionary measure, it is preferable to avoid the use of Loratadine tablets during pregnancy. Do not take Loratadine if you are breast-feeding as this treatment passes into the mother's milk. . Driving and using machines In clinical trials that assessed driving ability, no impairment was observad in patients receiving loratadine. At the recommended dose, Loratadine Tablets are not expected to cause you to be drowsy or less alert. However, very rarely some people experience drowsiness, which may affect their ability to drive or use machines. Loratadine Tablets contain lactose
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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 it
Loratadine Tablets Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Adults and children over 6 years of age with a body weight greater than 30 kg: Take 1 tablet 1 time daily with a glass of water, with or without food. Children who weigh 30 kg or less: Do not give Loratadine 10 mg tablets. There are other presentations more appropriate for children under 6 years of age who weigh 30 kg or less. Children aged less than 2 years of age: Not recommended for children under 2 years old. Adults and children with severe liver problems: Adults and children weighing more than 30 kg: Take 1 tablet 1 time a day and every other day with a glass of water, with or without food. However, you should talk to your doctor, pharmacist or nurse before taking this medicine. If worsens, or symptoms persist after 7 days of treatment, you should see a doctor. Taking this medicine The tablet should be swallowed whole with a drink of water. It may be taken with or without food. To help you to remember to take your medicine, try to get into the habit of taking it at the same time every day. If you take more Loratadine Tablets than you should If you take more Loratadine Tablets than you should, talk to your doctor or pharmacist straight away. No serious problems are expected however, you may get a headache, have a rapid heartbeat or feel sleepy. If you forget to take Loratadine Tablets If you forget to take Loratadine Tablets, take one as soon as you remember, then go on as before. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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The most commonly reported side effects in adults and children over 12 years are:
- drowsiness
- headache
- increased appetite
- difficulty sleeping. The most commonly reported side effects in children aged from 6 to 12 years are:
- headache
- nervousness
- tiredness. The following very rare side effects (may affect up to 1 in 10,000 people) have also been seen during the marketing of loratadine:
- severe allergic reaction (including swelling)
- dizziness
- fit (convulsion)
- rapid heartbeat, palpitations (awareness of heart beat/racing)
- nausea (feeling sick)
- dryness of the mouth
- irritation of the stomach lining (gastritis)
- rash
- hair loss
- abnormal liver function
- tiredness. Frequency not known:
- Weight increased 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 at: 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 it
Loratadine Tablets
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 foil after 'EXP'. The expiry date refers to the last day of that month. Store in the original package. 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.
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6.
Contents of the pack and other information
What Loratadine Tablets contain The active substance is loratadine. Each tablet contains 10 mg loratadine. The other ingredients are: lactose monohydrate, maize starch, pre-gelatinised maize starch and magnesium stearate. What Loratadine Tablets look like and contents of the pack Loratadine 10 mg Tablets are white to off-white, round, uncoated tablets debossed with "R" on one side and "10" on the other. Loratadine 10 mg Tablets are available as blister strips in pack sizes of 7, 10, 14, 20, 21, 30 or 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder SUN PHARMA UK LIMITED 6-9 The Square, Stockley Park, Uxbridge, UB11 1FW United Kingdom Manufacturers Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87 2132 JH Hoofddorp The Netherlands Alkaloida Chemical Company Zrt. 4440 Tiszavasvári Kabay János u. 29 Hungary This leaflet was last revised in November 2023.
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Frequently asked questions about Loratadine 10 mg Tablets
How do I take Loratadine 10 mg Tablets?
Loratadine 10 mg Tablets comes as tablet containing 10mg. 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 Loratadine 10 mg Tablets?
The active substance in Loratadine 10 mg Tablets is loratadine.
Are there equivalent medicines to Loratadine 10 mg Tablets?
Medicines with the same active substance, strength and form include: Boots One-a-Day Allergy Relief 10mg Tablets (P & GSL), Brown & Burk Once-A-Day Hayfever & Allergy 10mg Tablets, Clarityn Allergy 10mg Tablets (GSL). In total there are 6 equivalent products. 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 Loratadine 10 mg 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 Loratadine 10 mg 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: loratadine
- 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
Loratadine 10mg Tablets is indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.
4.2. Posology and method of administration
Adults: one tablet once daily
Paediatric population
Children 6 years of age and older with a body weight greater than 30 kg:
One tablet once daily.
For appropriate dosing in children younger than 6 years or with body weight of 30 kg or less, there are other formulations more suitable.
Children under 2 years of age:
Safety and efficacy of loratadine tablets have not been established. No data are available.
Patients with hepatic impairment
Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine. An initial dose of 10mg every other day is recommended for adults and children weighing more than 30kg.
Patients with renal impairment
No dosage adjustments are required in patients with renal insufficiency.
Elderly
No dosage adjustments are required in the elderly.
Method of administration
Oral use. The tablet may be taken without regard to mealtime.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Loratadine 10 mg Tablets should be administered with caution in patients with severe liver impairment (see section 4.2).
The administration of Loratadine 10 mg Tablets should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.
This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption should not take this medicine.
4.5. Interaction with other medicinal products and other forms of interaction
When administered concomitantly with alcohol, Loratadine 10 mg Tablets has no potentiating effects as measured by psychomotor performance studies.
Potential interaction may occur with all known inhibitors of CYP3A4 or CYP2D6 resulting in elevated levels of loratadine (see Section 5.2), which may cause an increase in adverse events.
Increase in plasma concentrations of loratadine has been reported after concomitant use with ketoconazole, erythromycin, and cimetidine in controlled trials, but without clinically significant changes (including electrocardiographic).
Paediatric population
Interaction studies have only been performed in adults.
4.6. Fertility, pregnancy and lactation
Pregnancy
A large amount of data on pregnant women (more than 1000 exposed outcomes) indicate no malformative nor feto/ neonatal toxicity of loratadine. 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 Loratadine 10mg Tablets during pregnancy.
Breast-feeding
Loratadine is excreted in breast milk, therefore the use of loratadine is not recommended in breast-feeding women.
Fertility
There are no data available on male and female fertility.
4.7. Effects on ability to drive and use machines
In clinical trials that assessed driving ability, no impairment occurred in patients receiving loratadine. Loratadine has no or negligible influence on the ability to drive and use machines. However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.
4.8. Undesirable effects
Summary of the safety profile
In clinical trials involving adults and adolescents in a range of indications including allergic rhinitis (AR) and chronic idiopathic urticaria (CIU), at the recommended dose of 10mg daily, adverse reactions with loratadine were reported in 2% of patients in excess of those treated with placebo. The most frequent adverse reactions reported in excess of placebo were somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%).
Tabulated list of adverse reactions
The following adverse reactions reported during the post-marketing period are listed in the following table by System Organ Class. 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 Experience Term
Immune system disorders
Very rare
Hypersensitivity reactions (including angioedema and anaphylaxis)
Nervous system disorders
Very rare
Dizziness, convulsion
Cardiac disorders
Very rare
Tachycardia, palpitation
Gastrointestinal disorders
Very rare
Nausea, dry mouth, gastritis
Hepatobiliary disorders
Very rare
Abnormal hepatic function
Skin and subcutaneous tissue disorders
Very rare
Rash, alopecia
General disorders and administration site conditions
Very rare
Fatigue
Investigations
Not known
Weight increased
Paediatric population
In clinical trials in a paediatric population, children aged 2 through 12 years, common adverse reactions reported in excess of placebo were headache (2.7%), nervousness (2.3%), and fatigue (1%).
Reporting 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, website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Overdosage with loratadine increased the occurrence of anticholinergic symptoms. Somnolence, tachycardia, and headache have been reported with overdoses.
In the event of overdosage, general symptomatic and supportive measures are to be instituted and maintained for as long as necessary. Administration of activated charcoal as a slurry with water may be attempted. Gastric lavage may be considered. Loratadine is not removed by haemodialysis and it is not known if loratadine is removed by peritoneal dialysis. Medical monitoring of the patient is to be continued after emergency treatment.
💬 Ask about this leaflet
Ask anything about Loratadine 10 mg 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.