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TEVA LORATADINE 10MG TABLETS

Active substance(s): LORATADINE

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Package leaflet: Information for the user
Teva 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 or if you feel worse.
What is in this leaflet:
1.
What Teva Loratadine Tablets are and 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.
Contents 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 doctoror 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 machines
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 1 x tablet
weigh more than 30 kg (4st
7lb)

Once daily

Adults and children over 12 1 x tablet
years

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 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 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 the 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:
Marketing Authorisation Holder:
Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem The Netherlands.
The company responsible for manufacture include:
Pharmachemie BV, Swensweg 5, P O Box 552, 2003 Rn Haarlem, Netherlands
Or
TEVA Pharmaceutical Works Co. Ltd., Pallagi Street 13, Debrecen, H-4042, Hungary
This leaflet was last revised in March 2016
PL 14776/0062

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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