Loratadine 5mg/5ml
143 mm
210 mm
Hayfever Relief
All Day 5 mg/5 ml Oral Solution
(Loratadine)
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.
Keep this leaflet, you may need to read it again Ask your pharmacist if you need more information or advice
You must contact a pharmacist or doctor if your symptoms worsen or do not improve If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
What this medicine is for
This medicine contains Loratadine which belongs to a group of medicines called antihistamines, which act to relieve the symptoms of allergies.
It can be used to relieve the symptoms of hayfever (e.g. sneezing, runny and itchy nose and eye irritation). It can also be used to treat raised, red itchy skin (symptoms of urticaria, which is often known as hives or nettle rash).
Before you take this medicine
This medicine can be taken by adults and children aged 2 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.
jK Do not take:
• If you are allergic to loratadine or any of the ingredients in this medicine (see "What is in this medicine")
• If you have an intolerance to some sugars,
unless your doctor tells you to (this medicine contains sucrose)
• If you are pregnant or breastfeeding
f Talk to your pharmacist or doctor:
• If you have severe liver problems
(you may need a smaller amount of this . .medicine)___________________________
Other important information
If you are having skin patch testing to identify allergies, stop taking this medicine 48 hours before the tests.
Driving and using machines: This medicine does not normally cause drowsiness in the majority] of people taking it. Therefore it will not normally affect your ability to drive or operate machines. However, very occasionally some people do report drowsiness after taking loratadine. If affected do not drive or use machines.
Information about some of the ingredients:
This medicine contains 3 g of sucrose per 5 ml spoonful. This should be taken into account if you suffer from sugar diabetes.
If you take other medicines
This medicine is not expected to affect any other medicines that you may be taking. However, some medicines may affect the way that the active ingredient in this medicine is broken down in the body.
If you are unsure about interactions with any medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.
/How to take this medicine
Check the cap seal is not broken before first use. If it is, do not take the medicine.
Shake the bottle well before use. Use the spoon provided.
Giving this medicine to children:
It is important to know how much your child weighs to make sure you give them the correct amount of medicine. As a guide a child of 9 years of age will weigh about 30 kg. If in doubt weigh your child, then follow the instructions in the table on the back of this leaflet.
23LF01341PW
lA
" Do nof give fo children under 2 years.
Adults and children of 12 years and over
Two 5 ml spoonfuls
Once a day
Children of 2 to 12 years who weigh more than 30 kg
Two 5 ml spoonfuls
Once a day
Children of 2 to 12 years who weigh less than 30 kg_
One 5 ml spoonful
Once a day
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.
This medicine should be swallowed.
Do not take more than the amount recommended above.
If symptoms do not go away talk to your pharmacist or doctor.
f If you take too much: Talk to a doctor straight away. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.
Possible side effects
Most people will not have problems, but some may get some. If you have any unwanted side effects you should seek advice from your doctor, pharmacist or other healthcare professional.
f If you get any of these serious side effects, stop taking this medicine. See a doctor at once:
• Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)
If you get any of the following side effects see your pharmacist or doctor:
• Headache, nervousness, tiredness in children
• Drowsiness, headache, increased appetite, difficulty in sleeping in adults
• Fast or irregular heart rate, dizziness, tiredness
• Feeling sick, dry mouth, stomach pain, liver problems, rash, hair loss
• Convulsion
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 alsol report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
How to store this medicine
Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.
Use by the date on the end flap of the carton, or 6 months after first opening. After this date return any unused product to your nearest pharmacy for safe disposal.
What is in this medicine
Each 5 ml of oral solution contains Loratadine 5 mg, which is the active ingredient.
As well as the active ingredient, the oral solution also contains propylene glycol, glycerol (E422), sodium benzoate (E211), citric acid monohydrate, sucrose, purified water, peach flavouring (artificial). The pack contains 100 ml of clear, colourless oral solution.
Who makes this medicine
Manufactured for The Boots Company PLC Nottingham NG2 3AA by the Marketing Authorisation holder Pinewood Laboratories Limited Ballymacarbry Clonmel Co. Tipperary Ireland.
Leaflet prepared November 2015 If you would like any further information about this medicine, please contact The Boots Company PLC Nottingham NG2 3AA.
Other formats
To request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name: Boots Hayfever Relief All Day
5 mg/5 ml Oral Solution
Reference number: 04917/0067
This is a service provided by the Royal National
Institute of Blind People.
23LF01341PW
Hayfever Relief
All Day 5 mg/5 ml Oral Solution
(Loratadine)
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.
Keep this leaflet, you may need to read it again Ask your pharmacist if you need more information or advice
You must contact a pharmacist or doctor if your symptoms worsen or do not improve If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
What this medicine is for
This medicine contains Loratadine which belongs to a group of medicines called antihistamines, which act to relieve the symptoms of allergies.
It can be used to relieve the symptoms of hayfever (e.g. sneezing, runny and itchy nose and eye irritation). It can also be used to treat raised, red itchy skin (symptoms of urticaria, which is often known as hives or nettle rash).
Before you take this medicine
This medicine can be taken by adults and children aged 2 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.
jk Do not take:
• If you are allergic to loratadine or any of the ingredients in this medicine (see "What is in this medicine")
■ If you have an intolerance to some sugars,
unless your doctor tells you to (this medicine contains sucrose)
• If you are pregnant or breastfeeding
f Talk to your pharmacist or doctor:
• If you have severe liver problems
(you may need a smaller amount of this _ .medicine)___________________________
Other important information
If you are having skin patch testing to identify allergies, stop taking this medicine 48 hours before the tests.
Driving and using machines: This medicine does not normally cause drowsiness in the majority; of people taking it. Therefore it will not normally affect your ability to drive or operate machines. However, very occasionally some people do report drowsiness after taking loratadine. If affected do not drive or use machines.
Information about some of the ingredients:
This medicine contains 3 g of sucrose per 5 ml spoonful. This should be taken into account if you suffer from sugar diabetes.
If you take other medicines
This medicine is not expected to affect any other medicines that you may be taking. However, some medicines may affect the way that the active ingredient in this medicine is broken down in the body.
If you are unsure about interactions with any medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.
/How to take this medicine
Check the cap seal is not broken before first use. If it is, do not take the medicine.
Shake the bottle well before use. Use the spoon provided.
Giving this medicine to children:
It is important to know how much your child weighs to make sure you give them the correct amount of medicine. As a guide a child of 9 years of age will weigh about 30 kg. If in doubt weigh your child, then follow the instructions in the table on the back of this leaflet.
23LF01341PW
' Do nof give to children under 2 years.
Adults and children of 12 years and over
Two 5 ml spoonfuls
Once a day
Children of 2 to 12 years who weigh more than 30 kg
Children of 2 to 12 years who weigh less than 30 kg_
Two 5 ml spoonfuls
One 5 ml spoonful
Once a day
Once a day
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.
This medicine should be swallowed.
Do not take more than the amount recommended above.
If symptoms do not go away talk to your pharmacist or doctor.
f If you take too much: Talk to a doctor straight away. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.
Possible side effects
Most people will not have problems, but some may get some. If you have any unwanted side effects you should seek advice from your doctor, pharmacist or other healthcare professional.
f If you get any of these serious side effects, stop taking this medicine. See a doctor at once:
• Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)
If you get any of the following side effects see your pharmacist or doctor:
• Headache, nervousness, tiredness in children
• Drowsiness, headache, increased appetite, difficulty in sleeping in adults
• Fast or irregular heart rate, dizziness, tiredness
• Feeling sick, dry mouth, stomach pain, liver problems, rash, hair loss
• Convulsion
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 you can help provide more information on the safety of this medicine.
How to store this medicine
Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.
Use by the date on the end flap of the carton, or 6 months after first opening. After this date return any unused product to your nearest pharmacy for safe disposal.
What is in this medicine
Each 5 ml of oral solution contains Loratadine 5 mg, which is the active ingredient.
As well as the active ingredient, the oral solution also contains propylene glycol, glycerol (E422), sodium benzoate (E211), citric acid monohydrate, sucrose, purified water, peach flavouring (artificial). The pack contains 100 ml of clear, colourless oral solution.
Who makes this medicine
Manufactured for The Boots Company PLC Nottingham NG2 3AA by the Marketing Authorisation holder Pinewood Laboratories Limited Ballymacarbry Clonmel Co. Tipperary Ireland.
Leaflet prepared November 2015 If you would like any further information about this medicine, please contact The Boots Company PLC Nottingham NG2 3AA.
Other formats
To request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name: Boots Hayfever Relief All Day
5 mg/5 ml Oral Solution
Reference number: 04917/0067
This is a service provided by the Royal National
Institute of Blind People.
ARTWORK ONLY
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Category: |
Healthcare |
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Sub-Category: |
Allergy |
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Brand: |
Core |
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Pack Type: |
Leaflet |
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Variant: |
Hayfever Relief All Day 5 mg/5 ml Oral Solution |
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Action: |
B |
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Date: |
19/11/15 |
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Country: |
UK |
Com ponent Code: 23LF01341 P W
Item Code: 1 6-17-257
CAD Ref No: 148 mm width x 210 mm height
Printer:
Substrate: White Paper
23LF01341 PW
TECHNICAL INFO:
Barcodes MUST be checked for format/style at repro stage prior to printing, Trident have created it as a "ITF no check" @ 28% magnification to fit into the 16mm gap but we are unsure if this is correct. Customer is aware of this.
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Barcode Type: |
N/A |
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Barcode Number: |
N/A |
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Magnification: |
N/A |
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Barcode Truncated By: N/A (smallest bar) | |
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Edgemark Position: |
N/A |
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Pharmacode No/NE: |
N/A |
Technical ft Non Printing Items Cutter ^ Guides
Colours
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PANTONE 290 C | |
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= | |
ARTWORK TEXT SIZE
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Main Headings: |
13pt |
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Sub Headings: |
11pt |
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Body Copy: |
9pt |
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PACK MOCK LIP | ||
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Product Name: Hayfever Relief All Day 5 mg/5 mi Oral Solution Product Licence No.: 04917/00G7 Wording Ref: MHRA Approved VI dated 27/01/2014 (BTC 122624 vf) Status: internally Approved Pack Details: Type III Amber Glass with a tamper evident child resistant closure having a polypropylene outer layer and polyethylene inner layer. Measuring device provided. | ||
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Pack Size: |
100 ml. | |
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Version No. |
Date Issued |
Reason For Change |
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1 |
18/11/15 |
Addition of ADR Reporting statement on SPC and PIL Furthermore, deletion of previous side effect reporting text and update of product code. |
STUDIO USE ONLY vl.O