Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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.
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.
e Clarityn Allergy Syrup Do not take 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'.
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
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.
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:
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.
Clarityn Allergy Syrup
What Clarityn Allergy Syrup contains
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.
The active substance in Clarityn Allergy 1mg/ml Syrup is loratadine.
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.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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.
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.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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.
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.
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.
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.
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..
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.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
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 →
Medicines sold in Poland with the same active substance: W Polsce znany jako
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 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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