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.
Clarityn Allergy 10mg Tablets (GSL)
⚠ 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 2. What you need to know before you take Clarityn Allergy Tablets
3, How to take Clarityn Allergy Tablets 4, Possible side effects 5. How to store Clarityn Allergy Tablets 6. Contents of the pack and other information
1. WHAT CLARITYN ALLERGY TABLETS 'ARE AND WHAT THEY ARE USED FOR The full name of your medicine is Ciarityn Allergy 10 mg Tablets. 'What Clarityn Allergy Tablets are Gaarityn Allergy Tablets contain the active substance loratadine which belongs to a class of
medicines called "antihistamines". How Clarityn Allergy Tablets work Clarityn Allergy Tablets help 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 Ciarityn Allergy Tablets should be
taken Carityn Alergy Tabkets relieves symptoms associated with allergic rhinitis (for example, hay fever), such as sneezing, runny or itchy nose, and burning or itchy eyes. Gaarityn Allergy Tablets may also be used to help Telieve symptoms of urticaria (itching and redness)
Which is often known as hives or nettle rash. 'The effect of Clarityn Allergy Tablets 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 TABLETS Do not take Clarityn Allergy Tablets it:
- You are allergic (hypersensitive) to loratadine or any of the other ingredients of this medicine
(listed in section 6). + You are pregnant or breastfeeding
Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Clarityn Alergy Tablets if:
- You have liver disease.
- You are scheduled to have any skin tests for allergies. Do not take Clarityn Allergy Tablets for 'two days before having these tests. This is because it may affect the test results. If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Carityn Allergy Tablets.
Children Do not give Clarityn Allergy 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 Clarityn Allergy Tablets
have not been established. No data are available. Other medicines and Clarity Allergy Tablets The side effects of Clarityn Allergy Tablets 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 increasein 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 takenor might take any other
'medicines. This includes medicines taken withouta prescription. Clarityn Allergy Tablets with alcohol Clarityn Allergy Tablets have not been shown to
'add to the effects of an alcoholic drink. Pregnancy and breast-feeding Ifyou 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. Asa precautionary measure, itis preferable to avoid the use of Clarityn Allergy Tablets during
pregnanoy.
'Do not take Clarityn Allergy Tablets 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 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. Clarityn Allergy Tablets contains lactose Clarityn Allergy Tablets contains lactose; thusif you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take it
CLARITYN ALLERGY TABLETS 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.
Reporting of side effects Ifyou get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
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Giving this medicine to children Itis 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
side effects not listed in this leaflet. You can also
about 30kg (4st 7Ib). If in doubt weigh your child
United Kingdom: Yellow Card Scheme Website:
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The score line of the tablet is only there to help you break the tablet if you have difficulty swallowing it
whole,
and then follow the instructions in the table, Do not give to children who weigh 30 kg (4st 7Ib) or
less. There are other formulations more suitable for children younger than 6 years or with a body weight of 30 kg or less. Not recommended for children under 2 years old.
How much to take: 'Age and weight Adults and children6 'years and older who weal
How much totake |1 xtablet
|How often [to take /Once daily
hore than 30kg (Ast) Children who weigh
| Not recommended.
30kg (4st 7Ib) or less Ifyou have severe liver problems your doctor or pharmacist may advise you to fake the recommended amount every other day. I this apples to you follow thelr instructions. If you take more Clarityn Allergy Tablets than you should Ifyou take more Clarityn Allergy Tablets than you should, talk to your doctor or pharmacist straight away. No serious problems are expected however, you may get a headache, havea rapid heartbeat or feel sleepy. If you forget to take Clarityn Allergy Tablets
- Ifyou forgetto 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 fora forgotten dose. Ifyou have any further questions on the use of this
product, ask your doctor, pharmacist or nurse.
Possible side effects
Like all medicines, this medicine can cause side
Teport side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. 'www.mhra.gov.uk/yellowcard 'Malta: ADR Reporting, The Medicines Authority, Post-Licensing Directorate, 203 Level 3, Rue
D'Argens, G2R-1368 Gzira Website: www.medicinesauthority.gov.mt, e-mail: [email protected]
How to store it
CLARITYN ALLERGY TABLETS
- This medicinal product does not require any special storage conditions. + 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 blister after Exp. The expiry date refers to the last day of the month. + Do notuse this medicine if you notice any change in the appearance of the tablet. + 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 Tablets contain
- The active substance is loratadine. Each tablet
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contains 10 mg loratadine.
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+ The other ingredients are lactose monohydrate, maize starch, magnesium stearate.
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What Clarityn Allergy Tablets looks like and contents of the pack Clarityn Alergy tablets are white, to off-white, oval 'tablets with a score on one side and plain on the
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other side,
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effects, although not everybody gets them.
Charityn Alergy tablets are available in pack sizes of
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'The most commonly reported side effects in adults and children over 12 years of age are:
7,10, 14, 20, 30, or 60 tablets.
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Not all pack sizes may be marketed.
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- drowsiness
- headache
- increased appetite © difficulty sleeping. The most commonly reported side effects in children aged 2 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
- convulsion
Marketing Authorisation Holder and
Manufacturer
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Marketing Authorisation Holder: Bayer ple
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400 South Oak Way
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Reading
RG2GAD United Kingdom
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Manufacturer: Bayer Bitterfeld GmbH OT Greppin
Salegaster Chaussee 1 06803 Bitterfeld-Wotfen Germany
« 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
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This leaflet was last revised in
July 2018,
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'Due to regulatory changes, the content of the following Patient Information| Leafet may the one found In date' your towards medicine thepack. 'compare the varyLeafletfrom prepared/revised end ofPlease the leaflet to establish if there have been any changes. If you have any doubts or queries about your medication, please contact your doctor or pharmacist,
@ seer tevcare
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Frequently asked questions about Clarityn Allergy 10mg Tablets (GSL)
How do I take Clarityn Allergy 10mg Tablets (GSL)?
Clarityn Allergy 10mg Tablets (GSL) 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 Clarityn Allergy 10mg Tablets (GSL)?
The active substance in Clarityn Allergy 10mg Tablets (GSL) is loratadine.
Are there equivalent medicines to Clarityn Allergy 10mg Tablets (GSL)?
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 (P). 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 Clarityn Allergy 10mg Tablets (GSL), 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 10mg Tablets (GSL) 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
Clarityn Allergy Tablets are indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.
4.2. Posology and method of administration
Posology
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 Clarityn Allergy 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 10 mg every other day is recommended for adults and children weighing more than 30 kg.
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
Clarityn Allergy Tablets should be administered with caution in patients with severe liver impairment (see section 4.2).
This medicinal product contains lactose; thus patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
The administration of Clarityn Allergy Tablets 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 Tablets have 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 Tablets during pregnancy.
Breast-feeding
Loratadine is excreted in breast milk. Therefore, the use of Clarityn Allergy Tablets 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 studies that assessed driving ability, no impairment was observed in patients receiving loratadine. Clarityn Allergy Tablets 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.
💬 Ask about this leaflet
Ask anything about Clarityn Allergy 10mg Tablets (GSL). 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.