Loratadine 10mg Tablets
Package Leaflet: Information for the user
Loratadine 10mg Tablets Loratadine
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, pharmacist or nurse has 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
- You must talk to a doctor if you do not feel better, if you feel worse or if your symptoms change. See section 4.
What is in this leaflet
1. What Loratadine 10 mg Tablets are and what they are used for
2. What you need to know before you take Loratadine 10 mg Tablets
3. How to take Loratadine 10 mg Tablets
4. Possible side effects
5. How to store Loratadine 10 mg Tablets
6. Contents of the pack and other information
1. What Loratadine 10 mg Tablets are and what they are used for
The full name of your medicine is Loratadine 10 mg Tablets.
What Loratadine 10 mgTablets are
Loratadine 10 mg Tablets contain the active substance loratadine which belong to a class of medicines known as anti-histamines.
How Loratadine 10 mg Tablets work
Loratadine 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 RoletraTablets should be taken
Loratadine 10 mg Tablets relieves symptoms associated with seasonal allergic rhinitis (for example, hay fever) such as sneezing, runny or itchy nose, and burning or itchy eyes in adults and children over the age if 2 years who weigh more than 30kg.
Loratadine tablets may also be used to relieve symptoms of urticaria (itching and redness) which is often known as hives or nettle rash.
The effect of Loratadine 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.
2. What you need to know before you take Loratadine 10 mg Tablets
Do not take Loratadine 10 mg Tablets if:
• 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 Loratadine tablets if:
• you have liver disease
• you are scheduled to have any skin tests for allergies. Do not take Loratadine 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 nursebefore taking Loratadine tablets.
Children
Do not give Loratadine tablets to children younger than 2 years old or to children 2 to 12 years old who weigh less than 30kg. There are other formulations more suitable for children 2 to 12 years old who weigh less than 30kg.
Other medicines and Loratadine tablets
Tell your doctor or pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines taken without a prescription.
Loratadine Tablets with alcohol
Loratadine tablets have not been shown to add to the effects of an alcoholic drink.
Pregnancy and breast-feeding
Do not take Loratadine tablets if you are pregnant.
Do not take Loratadine tablets if you are breast-feeding. Loratadine is excreted in breast milk.
Driving and using machines
At the recommended dose, Loratadine 10 mg 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 machinery.
Loratadine 10 mg Tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Loratadine 10 mg 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.
Giving this medicine to children
Loratadine syrup may be preferable for children. It is 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 about 30kg (4st 7lb). If in doubt weigh your child and then follow the instructions in the table.
Do not give to children under 2 years or who weigh 30 kg (4st 7lb) or less.
How much to take:
|
Age |
How much to take |
How often to take |
|
Adults and children over 12 years |
1 x tablet |
Once daily |
|
Children of 2 to 12 years who weigh more than 30kg (4st 7lb) |
1 x tablet |
Once daily |
|
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. | ||
The tablet should be swallowed whole with a drink of water.
If you have taken more Loratadine 10 mg Tablets than you should
If you take more Loratadine tablets than you should, talk to your doctor of pharmacist straight away. No serious problems are expected however, you may get a headache, have a rapid heartbeat or feel sleepy.
If you forget to take Loratadine 10 mg Tablets
• If you forget to 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 for a forgotten dose.
If you have any further questions on the use of this medicine ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Stop taking loratadine Tablets and talk to a doctor straight away, if you notice the following:
• severe allergic reaction
This is a very rare side effect (may affect up to 1 in 10,000 people).
Other side effects
The side effects reported in adults and children over 12 years of age are:
Common (may affect up to 1 in 10 people)
• drowsiness
Uncommon (may affect up to 1 in 100 people)
• headache
• increased appetite
• difficulty sleeping
The commonly (may affect up to 1 in 10 people) 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:
• dizziness
• fit (convulsion)
• rapid heartbeat, palpitations (awareness of heart beat/raching)
• nausea (feeling sick)
• dry mouth
• irritation of the stomach lining (gastritis)
• liver problems
• hair loss
• rash
• tiredness
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 Loratadine 10 mg 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 carton and foil after ‘EXP’. The expiry date refers to the last day of that month.
Store in the original package.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer use. These measures will help protect the environment
6. Contents of the pack and other information
What Loratadine 10 mg Tablets contains
The active substance is loratadine.
The other ingredients are: lactose monohydrate, maize starch, pre-gelatinised maize starch and magnesium stearate.
What Loratadine 10 mg Tablets look like and contents of the pack
Loratadine 10 mg Tablets are white to off-white round uncoated tablets debossed with "R" on one side and "10" on the other.
Loratadine 10 mg Tablets are available as blister strips in pack sizes of 7, 10, 14, 15, 21 and 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ranbaxy (UK) Limited
5th floor, Hyde Park, Hayes 3
11 Millington Road
Hayes, UB3 4AZ
United Kingdom
Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87 2132 JH Hoofddorp The Netherlands
Alkaloida Chemical Company Zrt.
4400 Tiszavasvari Kabay Janos u. 29 Hungary
This leaflet was last revised in August 2016.
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