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.

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Clarityn Allergy 1mg/ml Syrup

⚠ 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.

Active substance: Loratadine
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for The full name of your medicine is Clarityn Allergy Syrup. What Clarityn Allergy Syrup is Clarityn Allergy Syrup contains the active substance loratadine which belongs to a class of medicines called "antihistamines". How Clarityn Allergy Syrup works Clarityn Allergy Syrup helps to reduce your allergy symptoms by stopping the effects of a substance called "histamine", which is produced in the body when you are allergic to something. When Clarityn Allergy Syrup should be taken Clarityn Allergy Syrup relieves symptoms associated with allergic rhinitis (for example, hayfever), such as sneezing, runny or itchy nose and burning or itchy eyes in adults and children over the age of 2 years. The syrup may also be used to help relieve symptoms of urticaria (itching and redness), which is often known as hives or nettle rash. The effect of Clarityn Syrup will last a whole day and should help you to continue your normal daily activities and sleep. You must talk to a doctor if you do not feel better or if you feel worse.

What you need to know before you take it

e Clarityn Allergy Syrup Do not take Clarityn Allergy Syrup

  • if you are allergic (hypersensitive) to loratadine or any of the other ingredients of this medicine (listed in section 6)
  • if you are pregnant or breast-feeding Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Clarityn Allergy Syrup:
  • if you have liver disease
  • if you are scheduled to have any skin tests for allergies. Do not take Clarityn Allergy Syrup for two days before having these tests. This is because it may affect test results. If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Clarityn Allergy Syrup.

Children Do not give Clarityn Allergy Syrup to children younger than 2 years old. Other medicines and Clarityn Allergy Syrup The side effects of Clarityn Allergy Syrup may increase when used together with medicines that alter the performance of some enzymes responsible for drug-metabolism in the liver. However, in clinical studies, no increase in side effects of loratadine was seen with products that altered the performance of these enzymes. Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription. Clarityn Allergy Syrup with alcohol Clarityn Allergy Syrup has not been shown to add to the effects of an alcoholic drink. Pregnancy and breast-feeding If you are pregnant, 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 Clarityn Allergy Syrup during pregnancy. Do not take Clarityn Allergy Syrup if you are breast-feeding. Loratadine is excreted in breast milk. Driving and using machines In clinical trials that assessed driving ability, no impairment was observed in patients receiving loratadine. At the recommended dose, Clarityn Allergy Syrup is 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. Clarityn Allergy Syrup contains: Maltitol liquid: This medicine contains 3g maltitol liquid in each 5ml of syrup which is equivalent to 600.69mg/ml. If you have been told by your doctor that you (or your child) have an intolerance to some sugars, contact your doctor before taking this medicine. Sorbitol: This medicine contains 700mg sorbitol in each 5ml of syrup which is equivalent to 140mg/ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before taking this medicine. Propylene glycol: This medicine contains 250mg propylene glycol in each 5ml of syrup which is equivalent to 50mg/ml. Sodium benzoate: This medicine contains 2.5mg sodium benzoate in each 5ml of syrup which is equivalent to 0.5mg/ml. Sodium: This medicine contains less than 1mmol sodium (23mg) per 5ml of syrup, that is to say essentially 'sodium-free'.

How to take it

Clarityn Allergy Syrup Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure. Taking this medicine

  • Water or other liquid is not needed to swallow the syrup.
  • The syrup may be taken with or without food.

Giving this medicine to children: It is important to know how much your child weighs to make sure that you give the correct amount of medicine. For example, a 9 year old child weighs about 30kg (4st 7lb). If in doubt weigh your child and then follow the instructions in the table. Do not give to children under 2 years. How much to take: The recommended dose is: Age How much to take How often to take Children of 2 to 12 5ml Once daily years who weigh 30kg (measuring cup (4st 7lb) or less filled to 5ml line) Children of 2 to 12 10ml Once daily years who weigh more (measuring cup than 30kg (4st 7lb) filled to 10ml line) Adults and children over 10ml Once daily 12 years (measuring cup filled to 10ml line) If you have severe liver problems your doctor or pharmacist may advise you to take the recommended amount every other day. If this applies to you follow their instructions. If you take more syrup than you should If you take more Clarityn Allergy Syrup 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 your syrup If you forget to take your dose, take it as soon as you remember, then continue to take it as usual.

  • 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, pharmacist or nurse.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The most commonly reported side effects in adults and children over 12 years of age are:

  • drowsiness
  • headache
  • increased appetite
  • difficulty sleeping The most commonly reported side effects in children aged 2 through 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
  • convulsion
  • fast or irregular heartbeat
  • nausea (feeling sick)
  • dry mouth
  • upset stomach
  • liver problems
  • hair loss
  • rash
  • tiredness The frequency of the following side effect is not known:
  • weight gain

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: http://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

Clarityn Allergy Syrup

  • Keep this medicine out of the sight and reach of children.
  • Do not freeze. Keep the bottle in the outer carton in order to protect from light.
  • Do not use this medicine after the expiry date which is stated on the bottle after 'EXPIRY'. The expiry date relates to the last day of that month.
  • Clarityn Allergy Syrup is to be used within 1 month after opening.
  • Do not use this medicine if you notice any changes in the appearance of the syrup.
  • 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 to protect the environment.

Contents of the pack and other information

What Clarityn Allergy Syrup contains

  • The active substance is loratadine. Each 10ml of the syrup contains 10mg loratadine.
  • The other ingredients are disodium edetate (E386), sodium dihydrogen phosphate dihydrate (E339), maltitol liquid (E965), propylene glycol (E1520), glycerol (E422), phosphoric acid (E338), sodium benzoate (E211), sorbitol liquid (E420), sucralose (E955), artificial mixed berries flavour and purified water. What Clarityn Allergy Syrup looks like and contents of the pack Clarityn Allergy Syrup is a clear, colourless to light yellow syrup. Clarityn Allergy Syrup is available in white opaque plastic bottles of 60ml with a tamper-evident, childproof plastic cap. A measuring cup with 5ml and 10ml dosing lines is included. Not all bottle sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Bayer plc 400 South Oak Way Reading RG2 6AD United Kingdom Manufacturer: BerliMed S.A. Poligono Industrial Santa Rosa Calle Francisco Alonso No.7 28806 Alcalá de Henares (Madrid) Spain This leaflet was last revised in June 2020.

Frequently asked questions about Clarityn Allergy 1mg/ml Syrup

How do I take Clarityn Allergy 1mg/ml Syrup?

Clarityn Allergy 1mg/ml Syrup comes as oral solution containing 1mg/ml. 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 Clarityn Allergy 1mg/ml Syrup?

The active substance in Clarityn Allergy 1mg/ml Syrup is loratadine.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Clarityn Allergy 1mg/ml Syrup, 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 Clarityn Allergy 1mg/ml Syrup 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.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Loratadine (10 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Clarityn Allergy Syrup is indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria in adults and children over the age of 2 years.

4.2. Posology and method of administration

Adults and children over 12 years of age:

10ml (10mg) of the syrup once daily.

Paediatric population

Children 2 to 12 years of age are dosed by weight:

Body weight more than 30kg : 10ml (10mg) of the syrup once daily.

Body weight 30kg or less: 5ml (5mg) of the syrup once daily.

The safety and efficacy of Clarityn Allergy Syrup in children under 2 years of age has 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 and for children weighing 30kg or less, 5ml (5mg) every other day is recommended.

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 syrup may be taken without regard to meal time.

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

Clarityn Allergy Syrup should be administered with caution in patients with severe liver impairment (see section 4.2).

This medicinal product contains maltitol and sorbitol; thus patients with rare hereditary problems of fructose intolerance should not take this medicine.

The administration of Clarityn Allergy Syrup should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.

4.5. Interaction with other medicinal products and other forms of interaction

When administered concomitantly with alcohol, Clarityn Allergy Syrup 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 Clarityn Allergy Syrup during pregnancy.

Breast-feeding

Loratadine is excreted in breast milk. Therefore, the use of Clarityn Allergy Syrup 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 was observed in patients receiving loratadine. Clarityn Allergy Syrup 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 urticarial (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).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

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 increase

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..

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 overdose, 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.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

  • CLARITINE 1 mg/ml prescriptionLORATADINUM · taken by mouth
  • FLONIDAN 10 mg over the counterLORATADINUM · taken by mouth
  • CLARITINE 10 mg over the counterLORATADINUM · taken by mouth
  • PROACTIN 10 mg prescriptionLORATADINUM · taken by mouth
  • LORASTAMIN 10 mg over the counterLORATADINUM · taken by mouth
  • LORATADINA ARENA 10 mg over the counterLORATADINUM · taken by mouth

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

  • Loratadyna GalenaLoratadinum · taken by mouth
  • ClaritineLoratadinum · taken by mouth
  • FlonidanLoratadinum · taken by mouth
  • Loratadyna PyloxLoratadinum · taken by mouth
  • LoratanLoratadinum · taken by mouth
  • Claritine AllergyLoratadinum · taken by mouth

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →

💬 Ask about this leaflet

Ask anything about Clarityn Allergy 1mg/ml Syrup. 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.

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