Mylan Travel Sickness 15 Mg Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
• 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. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse.
Package leaflet: Information for the user
MYLANTRAVEL SICKNESS 15 mg TABLETS
cinnarizine
What is in this leaflet
1. What Mylan Travel Sickness Tablets is and what it is used for
2. What you need to know before you take Mylan Travel Sickness Tablets
3. How to take Mylan Travel Sickness Tablets
4. Possible side effects
5. How to store Mylan Travel Sickness Tablets
6. Contents of the pack and other information
1. What Mylan Travel Sickness Tablets is and what it is used for
Mylan Travel Sickness Tablets contain the active ingredient cinnarizine, which belongs to a group of medicines called anti-histamines. Mylan Travel Sickness Tablets are taken to control travel sickness.
This medicine is for adults and children aged 5 years and over.
The product will be referred to Cinnarizine for the remaining portion of this leaflet.
2. What you need to know before you take Mylan Travel Sickness Tablets
Do not take Cinnarizine
• if you are allergic to cinnarizine or any of the other ingredients of this medicine (listed
in section 6). An allergic reaction may be recognised as a rash, itching or swelling of the face, lips, tongue, neck or throat or difficulty breathing.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Cinnarizine if:
• you have Parkinson's disease as this medicine may make your condition worse
• you suffer from liver or kidney problems
• you have a blood condition called 'porphyria'
Whilst taking Cinnarizine
If you have a skin (allergy) test, tell the doctor you are taking these tablets, as the tablets can affect skin test results. You will need to stop taking Cinnarizine 4 days before the test.
Other medicines and Cinnarizine Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially any of the following:
• medicines called tricyclic antidepressants or hypnotics used to treat depression, anxiety or difficulty sleeping
• medicines that makes you feel drowsy e.g. tranquillisers or certain pain killers
Cinnarizine with alcohol
Alcohol can make you feel more drowsy than normal. Do not drink alcohol whilst taking Cinnarizine.
Pregnancy and breast-feeding
You should not take this medicine during
pregnancy or if you are breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Do not drive or operate machinery if you feel drowsy while taking these tablets.
Cinnarizine contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicine.
3. How to take Mylan Travel Sickness Tablets
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.
Cinnarizine should be taken after food to reduce the risk of stomach upset. The tablets may be sucked, chewed or swallowed whole with water.
Use in adults, elderly and children over 12 years:
The recommended dose is two tablets to be taken two hours before the journey and, if necessary, one tablet taken every eight hours during the journey.
Use in children 5-12 years old:
The recommended dose is one tablet to be taken two hours before the journey and, if necessary, half a tablet taken every eight hours during the journey.
Cinnarizine should not be given to children under 5 years.
If you take more Cinnarizine than you should
If you accidentally take too many tablets or if a young child takes this medicine by accident, contact your doctor or go to your nearest hospital emergency department immediately taking this leaflet and pack with you. You may be sick, feel sick or have an upset stomach, be shaking, have uncontrollable muscle spasms, weakness or floppy muscles, become drowsy or lose consciousness. Young children may also experience seizures.
If you forget to take Cinnarizine
Take the next dose as soon as you remember unless it is almost time for your next dose.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Cinnarizine and seek medical help immediately if you have any of the following:
Not known (cannot be estimated from the available data)
• allergic reactions such as rash, itching or swelling of the face, lips, tongue, neck or throat or difficulty breathing
• red, lumpy, itchy rash which may also have some silvery scales on areas of skin exposed to sunlight
Other possible side effects:
Common (may affect up to 1 in 10 people)
• feeling drowsy
Not known (cannot be estimated from the available data)
• headache
• dry mouth
• problems with your gut
• unusual movements, including trembling and shaking of the hands and fingers, uncontrollable twitching or twisting movements or restless legs
• skin rash with patches of spots, red or pinkish skin, with a crust
• muscle stiffness
• shaking, stiff posture, slow movements with a shuffling, unbalanced walk
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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.
5. How to store Mylan Travel Sickness Tablets
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 packaging after 'EXP'. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. 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 protect the environment.
6. Contents of the pack and other information
What Cinnarizine contains
Each tablet contains 15 mg of the active ingredient, cinnarizine.
The other ingredients are maize starch, lactose anhydrous (see section 2 'Cinnarizine contains lactose'), mannitol, magnesium stearate and talc.
What Cinnarizine looks like and contents of the pack
Cinnarizine tablets are white, flat with a bevel edge and marked 'G' on both sides. Cinnarizine is available in plastic containers and blister packs of 4, 6, 8, 10, 15, 20, 84 and 100. Not all pack sizes may be marketed. _
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
Manufacturer
Gerard Laboratories,
35/36 Baldoyle Industrial Estate, Grange road,
Dublin 13, Ireland
This leaflet was last
revised in 10/2014 479904