Teva Loratadine 10mg Tablets
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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 or if you feel worse.
What is in this leaflet:
1. What Teva Loratadine Tablets areand what they are used for
2. What you need to know before you take Teva Loratadine Tablets
3. How to take Teva Loratadine Tablets
4. Possible side effects
5. How to store Teva Loratadine Tablets
6. Content of the pack and other information
1. What Teva Loratadine Tablets are and what they are used for The full name of your medicine is Teva Loratadine 10 mg Tablets
What Teva Loratadine Tablets are
Teva Loratadine Tablets contain the active substance loratadine_which belongs to a class of medicines known as “antihistamines”.
How Teva Loratadine Tablets work
Teva 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 Teva Loratadine Tablets should be taken
Teva Loratadine Tablets relieves symptoms associated with 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 of 2 years who weight more than 30 kg.
Teva Loratadine Tablets may also be used to help relieve symptoms of urticaria (itching and redness) which is often known as hives or nettle rash.
The effect of Teva Loratadine Tablets will last a whole day and should help you to continue your normal 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_Teva Loratadine Tablets
Do not take Teva Loratadine Tablets:
- If you are allergic to loratadine or any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Teva Loratadine Tablets:
• If you have liver disease
• If you are scheduled to have any skin tests for allergies. Do not take Teva 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 nurse before taking Teva Loratadine Tablets.
Children
Do not give Teva Loratadine Tablets to children younger than 2 years old or to children 2 to 12 years old who weight less than 30 kg. There are other formulations more suitable for children 2 to 12 years old who weight less then 30 kg.
Other medicines and Teva 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.
Teva Loratadine Tablets with alcohol
Teva Loratadine Tablets have 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.
Do not take Teva Loratadine Tablets if you are pregnant.
Do not take Teva Loratadine Tablets if you are breast-feeding. Loratadine is excreted in breast milk.
Driving and using machine s
At the recommended dose, Teva 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.
Teva Loratadine Tablets contain lactose.
Teva 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 Teva Loratadine Tablets
Always take this medicine exactly as your doctor or pharmacist or nurse has told you. Check with your doctor or pharmacist or nurse if you are not sure.
Use in 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 less than 30 kg (4st 7lb).
The recommended dose is:
|
Age |
How much to take |
How often to take |
|
Children of 2 to 12 years who weigh more than 30 kg (4st 7lb) |
1 x tablet |
Once daily |
|
Adults and children over 12 years |
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 score line is only there to help you break the tablet if you have difficulty swallowing it whole.
If you take more Teva Loratadine Tablets than you should
If you take more Teva Loratadine Tablets than you should, talk to your doctor or 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 Teva Loratadine Tablets
• If you forget to take your dose on time, 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.
Stop taking Teva Loratadine tablets and contact your doctor immediately if you notice signs of:
• Allergic reaction: swelling of the face, lips, tongue or throat, narrowing of the airways causing difficulty breathing, shock, collapse, rash, itching.
• Fast or irregular heartbeat
• Changes in the way your liver works (this may show up in a blood test)
Other side effects:
Very common (may affect more than 1 in 10 people) in adults and children over 12 years of age are:
• Drowsiness
• Headache
• Increased appetite
• Difficulty sleeping
Very common (may affect more than 1 in 10 people) in children aged 2 to 12 years are:
• Headache
• Nervousness
• Tiredness
Very rare (may affect up to 1 in 10,000 people) have also been seen during the marketing of loratadine:
• Dizziness
• Fit or seizure
• Nausea (feeling sick)
• Dry mouth
• Upset stomach
• 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 national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Teva Loratadine Tablets
Keep this medicine out of the sight and reach of children.
Do not transfer the tablets to another container.
Do not use this medicine after the expiry date which is stated on the blister after Exp. The expiry date refers to the last day of that month.
Do not use this medicine if you notice any change in the appearance of the tablet.
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.
This medicinal product does not require any special storage conditions.
6. Contents of the pack and other information
What Teva Loratadine Tablets contain
- The active substance is loratadine.
- The other ingredients are lactose monohydrate, maize starch, pregelatinised starch and magnesium stearate.
What Teva Loratadine Tablets look like and contents of the pack
Teva Loratadine 10 mg Tablets are white, oval tablets, scored on one side and plain on the other side, debossed “L” and “10” on each side of the scoreline
The product is available in pack sizes of 5, 7, 10, 15, 20, 28, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
To be completed nationally
This medicinal product is authorised in the Member States of the EEA under the following names:
To be completed nationally This leaflet was last revised in
To be completed nationally
This is a representation of an electronic record that was signed electronically and this
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE
Teva India 1.3 pil-eu clean
Approvals
|
Signed by |
Meaning of Signature |
Server Date |
|
Bhushan Gugale |
Regulatory Affairs Approval |
19-Jan-2015 11:09:05 AM |
REG0151288 Version 0.1 Approved Page 7 of 7