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 5 mg/5 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.
What it is and what it is used for
FOR Loratadine 5 mg/5 ml Syrup ('Loratadine') belongs to a group of medicines called antihistamines. It works by counteracting the effects of histamine which is produced naturally by your body's defence system, but may be over-produced in allergic reactions. Loratadine is used to relieve the symptoms of hayfever (allergic rhinitis) in adults and children over the age of 2 years, which include:
- sneezing
- irritated, runny or blocked nose
- itchy, red and watering eyes It is also used to relieve the symptoms of skin allergies in adults and children (over the age of 2 years), which include:
- rash, itching and urticaria (hives).
How to take it
LORATADINE Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Loratadine is to be taken only by mouth, and is not to be taken by children aged under 2 years. The spoon provided holds 5 ml of your medicine. Shake the bottle well before use. The usual dose is:
2. BEFORE YOU TAKE LORATADINE DO NOT TAKE Loratadine if you are:
- allergic to Loratadine, or any of the other ingredients of Loratadine 5 mg/5 ml Syrup (see Section 6 and end of Section 2).
- pregnant or planning to become pregnant.
- breast-feeding, as Loratadine can pass into breast milk. Take special care with Loratadine if:
- you have severe liver problems
- you have an hereditary intolerance to some sugars. Loratadine should not be taken for 48 hours before a skin test, since it may affect the results. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
Adults and children over 12 years:
Two 5 ml spoonfuls once daily
Children aged 2 to 12 years: weighing more than 30 kg weighing less than 30 kg
Two 5 ml spoonfuls once daily One 5 ml spoonful once daily
Patients with severe liver problems: Adults and children more than 30 kg Children weighing less than 30 kg
Two 5 ml spoonfuls on alternate days One 5 ml spoonful on alternate days 23LF01528PW
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Customer
Product
Item Code
Part No.
Pinewood Loratadine Syrup
23LF01528PW
210
x
Pharmacode/ 2D/Barcode Colours FRONT (or cover)
Black
Colours BACK (or inner)
Black
148
1981
Pages 2 pp
GSM 60
Drawing 148X210/F/D/1 2 UP
1110111110
Operator Date
VERSION
1ST BAR
LAST BAR
181640 Dims (mm)
A
Paul Yarnold 01/02/2018 08:30:15
Attention: The colours displayed in this proof are for electronic representational purposes only. Please refer to the PANTONE® colour guides for accurate colour matching. By approving this file, you are signifying full approval of design and text. To ensure accurate viewing and printing of this PDF file, Overprint Preview must be activated for accurate colour representation. MPS Leaflets PDF files are designed to work with Adobe Acrobat 6 or higher and are PDF/X -01a-2001 compliant.
LAST BAR
1ST BAR
POSITION AS 23LF01182PW
02100148P00260148L01-M060UPINT
HEAD
>> READ DIRECTION
you can help provide more information on the safety of this medicine.
Do not exceed the stated dose If you take more Loratadine than you should: If you or your child may have taken too much of this medicine, talk to a doctor or pharmacist immediately. You or the child may feel drowsy, have a headache or rapid heartbeat. If you forget to take Loratadine If you forget to take a dose, take it as soon as you remember, unless it is nearly time for the next dose. Do not take a double dose to make up for the forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Loratadine can cause side effects, although not everybody gets them. Swelling of the face, mouth, lips or throat can be signs of an allergic reaction. If this happens to you, STOP taking Loratadine and tell your doctor immediately, or go to your nearest hospital. Take the bottle with you if you can. 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
- dizziness
- fast or irregular heartbeat
- nausea (feeling sick)
- dry mouth
- upset stomach
- liver problems
- hair loss
- rash
- tiredness The following not known side effect (cannot be estimated from the available data) has also been seen during the marketing of loratadine:
- weight increased 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 www.mhra.gov.uk/yellowcard. By reporting side effects
23LF01528PW << READ DIRECTION
Customer
Product
Item Code
Part No.
Pinewood Loratadine Syrup
23LF01528PW
210
x
Pharmacode/ 2D/Barcode Colours FRONT (or cover)
Black
Colours BACK (or inner)
Black
148
1981
Pages 2 pp
GSM 60
Drawing 148X210/F/D/1 2 UP
1110111110
Operator Date
VERSION
1ST BAR
LAST BAR
181640 Dims (mm)
A
Paul Yarnold 01/02/2018 08:30:15
Attention: The colours displayed in this proof are for electronic representational purposes only. Please refer to the PANTONE® colour guides for accurate colour matching. By approving this file, you are signifying full approval of design and text. To ensure accurate viewing and printing of this PDF file, Overprint Preview must be activated for accurate colour representation. MPS Leaflets PDF files are designed to work with Adobe Acrobat 6 or higher and are PDF/X -01a-2001 compliant.
How to store it
LORATADINE Keep out of the sight and reach of children, and do not store above 25 ̊C. Do not use Loratadine after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Use within 6 months after opening. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Loratadine contains
- The active ingredient is Loratadine: 5 mg in each 5 ml of syrup.
- The other ingredients are: sucrose, glycerol (E422), propylene glycol, sodium benzoate (E211), citric acid monohydrate, peach flavour and purified water (see end of Section 2 for further information). What Loratadine looks like and contents of the pack Loratadine is a colourless solution, with the taste of peach. It is available in pack sizes of 60 ml, 100 ml and 150 ml amber glass bottles, and includes a 5 ml spoon. Marketing Authorisation Holder and Manufacturer Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland. PL 04917/0067 This leaflet was last updated in 11/2017.
Frequently asked questions about Loratadine 5 mg/5 ml Syrup
How do I take Loratadine 5 mg/5 ml Syrup?
Loratadine 5 mg/5 ml Syrup comes as oral solution containing 5mg / 5ml. 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 5 mg/5 ml Syrup?
The active substance in Loratadine 5 mg/5 ml Syrup is loratadine.
Are there equivalent medicines to Loratadine 5 mg/5 ml Syrup?
Medicines with the same active substance, strength and form include: Boots 2 Years Plus Hayfever & Allergy Relief 5 mg/5 ml Oral Solution. 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 5 mg/5 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 Loratadine 5 mg/5 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.
- 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 5mg/5ml Syrup is indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticarial in adults and children over the age of 2 years.
4.2. Posology and method of administration
Posology
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.
Efficacy and safety of Loratadine 5mg/5ml Syrup in children under 2 years of age has not been established.
Patients with severe liver 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 severe renal impairment
No dosage adjustments are required in the elderly or in patients with renal insufficiency.
Elderly
No dosage adjustments are required in the elderly.
Method of administration
For oral administration.
4.3. Contraindications
Loratadine 5mg/5ml Syrup is contraindicated in patients who are hypersensitive to the active substance or to any of the excipients in this formulation (see section 6.1).
4.4. Special warnings and precautions for use
Loratadine 5mg/5ml Syrup should be administered with caution in patients with severe liver impairment (see section 4.2).
This medicinal product contains sucrose; patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
The administration of Loratadine 5mg/5ml 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, Loratadine 5mg/5ml 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 Loratadine 5mg/5ml Syrup 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. 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
a. Summary of the safety profile
In clinical trials involving adults and adolescents in a range of indications including AR and CIU, at the recommended dose of 10mg daily, adverse reactions with loratadine were reported in 2% of patients in excess of those treated with the 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%).
b. 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 Reaction
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
Hepato-biliary 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
c. 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 at 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 Loratadine 5 mg/5 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.