Loratadine 10 Mg Tablets
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Information for the user
Loratadine 10 mg 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. See section 4.
- You must talk to a doctor if you do not feel better, if you feel worse
What is in this leaflet
1. What Loratadine Tablets are and what they are used for
2. What you need to know before you take Loratadine Tablets
3. How to take Loratadine Tablets
4. Possible side effects
5. How to store Loratadine Tablets
6. Contents of the pack and other information
1. What loratadine tablets are and what they are used for
This medicine contains the active substance loratadine which belongs to a class of medicines called "antihistamines".
Loratadine Tablets relieve symptoms associated with allergic rhinitis (for example, hay fever), such as sneezing, runny or itchy nose, and burning or itchy eyes.
Loratadine tablets may also be used to help relieve symptoms of urticaria (itching, redness and number and size of hives).
Relief of these symptoms lasts a full day and helps you to resume 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 Tablets.
DO NOT TAKE Loratadine Tablets
- if you are allergic (hypersensitive) to loratidine or any of the other ingredients of this medicine (listed in section 6)
- if you are pregnant or planning to become pregnant
- if you are breast-feeding currently.
Children under 2 years of age and/or under 30 kg
of weight should not take this medicine.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
- if you have severe liver problems
- if 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 test results.
If any of the above applies to you, please tell your doctor or pharmacist.
Other medicines and loratadine Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes taken without a prescription.
This is particularly important if you are taking
- Cimetidine (for stomach problems)
- Erythromycin (an antibiotic)
- Ketoconazole or fluconazole (for fungal infections)
Loratadine Tablets with alcohol
Loratadine Tablets has not been shown to add to the effects of an alcoholic drink.
Pregnancy and 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.
Pregnancy: Do not take Loratadine Tablets if you are pregnant.
Breast feeding: 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 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 machines. Please make sure you are not drowsy before performing these activities.
Loratadine Tablets contains lactose
Loratadine Tablets contain lactose ; thus if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take loratadine tablets
Always take Loratadine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Try to get into the habit of taking your medicine at the same time every day. This will make it easier for you to remember.
The Central breakline of the tablet is only there to help you the break the tablet if you have difficulty swallowing it whole.
Giving this medicine to children:
A loratadine syrup formulation may be preferable for children. It is important to know how much your child weights to make sure that you give the
PACKAGING DEVELOPMENT
Product Name : Loratadine 10mg 30’s
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The usual dose is
|
Age |
Dose |
|
Adults and children over 12 years of age |
10 mg once daily (swallow one tablet daily with water) |
|
Children aged 2 to 12 years and weighing over 30 kg |
10 mg once daily (swallow one tablet daily with water) |
|
Children who are aged over 2 years old but do not weigh more than 30 kg |
Should not take this medicine |
|
Children under 2 years of age |
Should not take this medicine |
|
Patients with severe liver problems |
Your doctor may prescribe a different dose for patients with severe liver problems |
If you take more Loratadine Tablets than you should
correct amount of the medicine. For example, a 9 year old child weight about 30 kg (4st 7lbs). if in doubt weigh your child and then follow the instructions in the table.
If you may have taken more Loratadine than you should, talk to your doctor or pharmacist immediately. Overdose may cause sleepiness or a faster heart beat. Immediate medical attention should be sought in the event of an overdose; take your tablets along to show to your doctor, if possible.
If you forget to take Loratadine Tablets
If you have forgotten to take your tablet, take it as soon as you remember and continue 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 product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 which cause difficulty in breathing or dizziness.
- rapid heartbeat
- palpitation (awareness of heartbeat/racing)
- gastritis (abdominal pain, burning feeling in the stomach between meals or at night and nausea (with or without vomiting)
- feeling tired
- skin rashes
- abnormal liver function (can be detected by laboratory tests)
- hair loss
- fainting,
- nausea
- dry mouth
- serious allergic reaction which causes swelling of the face or throat
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
5. How to store loratadine tablets
- Keep out of the sight and reach of children.
- Do not take Loratadine Tablets after the expiry date which is stated on the carton 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 you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Loratadine Tablets contain
- The active substance is loratadine.
- The other ingredients are lactose monohydrate, maize starch, colloidal anhydrous silica, croscarmellose sodium, talc and magnesium stearate.
What Loratadine Tablets look like and contents of the pack
Loratadine Tablets are white coloured, circular, flat beveled uncoated tablets, with central breakline on one side and ‘L’ on other side.
Loratadine Tablets are available in blister strips in pack size of 20, 30, 50 and 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom.
Manufacturer:
Cipla (EU) Limited, 4th Floor, 1 Kingdom Street, London, W2 6BY, United Kingdom.
This leaflet was last revised in Month of Variation approval.
Cipla