Mylan Travel Sickness 15 Mg Tablets
240 mm
Information for the user
Motion Sickness 15 mg Tablets
(Cinnarizine)
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
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet
• You must contact a pharmacist or doctor if your symptoms worsen or do not improve
What this medicine is for
This medicine contains Cinnarizine, a type of antihistamine medicine, which acts to treat disorders of the inner ear that may affect balance.
It can be used to relieve the symptoms of travel (motion) sickness such as feeling sick and being sick.
Before you take this medicine
This medicine can be taken by adults and children of 5 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.
XDo not take:
• If you are allergic to any of the ingredients in this medicine (see “What is in this medicine”)
• If you are pregnant or breastfeeding
f Talk to your pharmacist or doctor:
• If you have liver or kidney problems
• If you have Parkinson’s disease as this medicine may make your condition worse
• If you you have porphyria (a rare blood disease)
Other important information
If you are having any allergy tests, stop taking this medicine 4 days before the test.
Driving and using machines: This medicine may make you feel drowsy. Do not drive or use machinery until you are sure you are not affected.
Do not drink alcohol (wine, beer, spirits) whilst taking this medicine. Alcohol increases the risk of side effects occurring and may make you feel more drowsy.
Information about some of the ingredients in this medicine: This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
If you take other medicines
Before you take these tablets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:
• Medicines that make you sleepy or feel drowsy (e.g. medicines for mental health conditions and strong painkillers)
• Medicines for depression (e.g. tricyclic antidepressants)
If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor or medicine you have bought for yourself, including herbal and homeopathic remedies.
/How to take this medicine
Check the foil is not broken before use. If it is, do not take that tablet.
Take the tablets after food to reduce the risk of stomach upset.
|
Age |
How many to take and how often |
|
Adults and children of 12 years and over |
Take 2 tablets two hours before your journey begins and then take 1 tablet every eight hours during the journey, if you need to. |
|
Children of 5 to 12 years |
Give 1 tablet two hours before their journey begins and then give half a tablet every eight hours during the journey, if you neeato. |
The tablet can be sucked, chewed or swallowed whole with water.
Do not give to children under 5 years.
Do not take more than the amount recommended above.
If symptoms do not go away talk to your doctor.
If you forget to take the tablets, take them as soon as you remember. Do not make up for the missed tablets by taking more than the amount recommended in the table.
f If you take too many tablets: Talk to your doctor straight away or go to your nearest casualty department. Take your medicine and this leaflet with you.
430118
LT1925AB
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 the tablets. See a doctor at once:
• Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)
• A red, lumpy, itchy rash which may have silvery scales on areas of the skin that have been exposed to sunlight
If you get any of the following side effects see your pharmacist or doctor:
Common side effects: (may affect up to 1 in 10 people)
• Drowsiness
Side effects with an unknown frequency:
• Headache
• Movement disorders including trembling and shaking of the hands and fingers, uncontrollable twitching or twisting movements or restless legs
• Tremors, slow, jerky or uncoordinated movement
• Muscle stiffness
• Skin rash with patches of spots, red or pinkish skin or with a crust
• Dry mouth, stomach discomfort
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.aov.uk/vellowcard. 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 foil or the end flap of the carton. After this date return any unused product to your nearest pharmacy for safe disposal.
What is in this medicine
Each tablet contains Cinnarizine 15 mg, which is the active ingredient.
As well as the active ingredient, the tablet also contains maize starch, lactose, mannitol, magnesium stearate, talc.
This pack contains 4, 6, 8,10,15, 20, 84 or 100 white, flat bevel edged tablets marked ‘G’ on both sides.
Not all pack sizes may be marketed.
Who makes this medicine
Manufactured for The Boots Company PLC Nottingham NG2 3AA by Gerard Laboratories, 35/36, Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland. Marketing Authorisation held by Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Leaflet prepared January 2015
If you would like any further information about this product, 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: 0800198 5000 (UK only)
Please be ready to give the following information: Product name: Boots Motion Sickness 15 mg Tablets Reference number: 04569/0599 This is a service provided by the Royal National Institute of Blind People.
430118
LT1925AB
ARTWORK TEXT SIZE
Main Headings: 13pt
Sub Headings: 11 pt
Body Copy: 9pt
Information for the user
Motion Sickness 15 mg Tablets
(Cinnarizine)
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
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet
• You must contact a pharmacist or doctor if your symptoms worsen or do not improve
What this medicine is for
This medicine contains Cinnarizine, a type of antihistamine medicine, which acts to treat disorders of the inner ear that may affect balance.
It can be used to relieve the symptoms of travel (motion) sickness such as feeling sick and being sick.
Before you take this medicine
This medicine can be taken by adults and children of 5 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.
XDo not take:
• If you are allergic to any of the ingredients in this medicine (see “What is in this medicine”)
• If you are pregnant or breastfeeding
f Talk to your pharmacist or doctor:
• If you have liver or kidney problems
• If you have Parkinson’s disease as this medicine may make your condition worse
• If you you have porphyria (a rare blood disease)
Other important information
If you are having any allergy tests, stop taking this medicine 4 days before the test.
Driving and using machines: This medicine may make you feel drowsy. Do not drive or use machinery until you are sure you are not affected.
Do not drink alcohol (wine, beer, spirits) whilst taking this medicine. Alcohol increases the risk of side effects occurring and may make you feel more drowsy.
Information about some of the ingredients in this medicine: This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
If you take other medicines
Before you take these tablets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:
• Medicines that make you sleepy or feel drowsy (e.g. medicines for mental health conditions and strong painkillers)
• Medicines for depression (e.g. tricyclic antidepressants)
If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor or medicine you have bought for yourself, including herbal and homeopathic remedies.
/How to take this medicine
Check the foil is not broken before use. If it is, do not take that tablet.
Take the tablets after food to reduce the risk of stomach upset.
|
Age |
How many to take and how often |
|
Adults and children of 12 years and over |
Take 2 tablets two hours before your journey begins and then take 1 tablet every eight hours during the journey, if you need to. |
|
Children of 5 to 12 years |
Give 1 tablet two hours before their journey begins and then give half a tablet every eight hours during the journey, if you neea to. |
The tablet can be sucked, chewed or swallowed whole with water.
Do not give to children under 5 years.
Do not take more than the amount recommended above.
If symptoms do not go away talk to your doctor.
If you forget to take the tablets, take them as soon as you remember. Do not make up for the missed tablets by taking more than the amount recommended in the table.
f If you take too many tablets: Talk to your doctor straight away or go to your nearest casualty department. Take your medicine and this leaflet with you.
430118
LT1925AB
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 the tablets. See a doctor at once:
• Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)
• A red, lumpy, itchy rash which may have silvery scales on areas of the skin that have been exposed to sunlight
If you get any of the following side effects see your pharmacist or doctor:
Common side effects: (may affect up to 1 in 10 people)
• Drowsiness
Side effects with an unknown frequency:
• Headache
• Movement disorders including trembling and shaking of the hands and fingers, uncontrollable twitching or twisting movements or restless legs
• Tremors, slow, jerky or uncoordinated movement
• Muscle stiffness
• Skin rash with patches of spots, red or pinkish skin or with a crust
• Dry mouth, stomach discomfort
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.aov.uk/vellowcard. 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 foil or the end flap of the carton. After this date return any unused product to your nearest pharmacy for safe disposal.
What is in this medicine
Each tablet contains Cinnarizine 15 mg, which is the active ingredient.
As well as the active ingredient, the tablet also contains maize starch, lactose, mannitol, magnesium stearate, talc.
This pack contains 4, 6, 8,10,15, 20, 84 or 100 white, flat bevel edged tablets marked ‘G’ on both sides.
Not all pack sizes may be marketed.
Who makes this medicine
Manufactured for The Boots Company PLC Nottingham NG2 3AA by Gerard Laboratories, 35/36, Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland. Marketing Authorisation held by Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Leaflet prepared January 2015
If you would like any further information about this product, 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: 0800198 5000 (UK only)
Please be ready to give the following information: Product name: Boots Motion Sickness 15 mg Tablets Reference number: 04569/0599 This is a service provided by the Royal National Institute of Blind People.
430118
LT1925AB
ARTWORK ONLY
ARTWORK TEXT SIZE
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Main Headings: |
13pt |
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Sub Headings: |
11 pt |
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Body Copy: |
9pt |
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PACK 1VIOCK LIP | ||
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Product Name: Motion Sickness 15 mg Tablets | ||
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Product Licence No.: 04569/0599 Wording Ref: MHRA Approved dated 27/11/2013 (BTC130616 vsC) | ||
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Status: |
Internally Approved | |
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Pack Details |
PVdC coated PVC blister strips with aluminium foil lidding | |
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Pack Size: |
N/A | |
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Version No. |
Date Issued |
Reason For Change |
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1 |
28/05/2014 |
change of PL number from 04569/0476 to PL 04569/0599 (same dossier), to remove Meniere’s disease as indication for product. |
|
2 |
05/01/2015 |
RFI issued by MHRA regarding warnings |
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Category: |
Healthcare |
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Sub-Category: |
Travel |
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Brand: |
Core |
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Pack Type: |
Leaflet |
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Variant: |
Motion Sickness 15 mg Tablets |
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Action: |
E |
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Date: |
07/01/15 |
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Country: |
UK |
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Component Code: |
430118/LT1925AB |
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Item Code: |
17-48-688 |
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CAD Ref No: |
170 mm width x 240 mm height |
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Printer: | |
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Substrate: |
White Paper |
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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 | |
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(smallest bar) | |
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Edgemark Position: |
n/a |
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Pharmacode No/NE: |
10100(51) |
Technical & Non Printing Items Cutter | Guides
Colours
TECHNICAL INFO: PRINTER PLEASE NOTE
Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.
STUDIO USE ONLY v1.0