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LORATADINE 10MG ALLERGY RELIEF FILM-COATED TABLETS

Active substance(s): LORATADINE

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PACKAGE LEAFLET

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Package leaflet: Information for the patient
Loratadine 10 mg Allergy Relief Film-Coated 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, 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 a doctor if you do not feel better or if your symptoms feel worse.
What is in this leaflet
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What Loratadine is and what it is used for
What you need to know before you take Loratadine
How to take Loratadine
Possible side effects
How to store Loratadine
Contents of the pack and other information

1.

What Loratadine is and what it is used for

Loratadine belongs to a group of medicines called antihistamines.
This medicine is used to treat the symptoms of allergies. These allergies can happen all year round or they
can be seasonal eg. hayfever. The symptoms include sneezing, itchy runny nose and itchy skin. Loratadine
10 mg Allergy Relief Film-Coated Tablets can also be used to relieve itchy, burning eyes.
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What you need to know before you take Loratadine

Do not take Loratadine if:
 If you are allergic to loratadine or any of the other ingredients in this medicine (listed in see section
6 above).
 you are pregnant or are breast-feeding
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Loratadine if:
 you haveliver problems
 you are going to have a skin (allergy) test, tell the doctor you are taking Loratadine, as
antihistamines can effect skin test results. You will need to stop treatment 48 hours before the test.
Long term treatment with Loratadine can cause dry mouth, so good oral hygiene is important. Brush your
teeth regularly.
If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before
taking Loratadine.
Children
Do not give Loratadine to children under 2 years of age or with a bodyweight less than 30 kg.
There are other formulations that are more suitable for children under 2 years of age or weighing less than
30 kg.

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Other Medicines and Loratadine
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other
medicines. This includes medicines taken without a prescription.
 Cimetidine , to treat heartburn or stomach ulcers
 Antibiotics such as Erythromycin,
 Antifungals such as Fluconazole and Ketoconazole
 Quinidine, to treat a heart condition
 Fluoxetine, to treat depression
 Amfebutamone/ Buproprion as an aid to stop smoking.
Pregnancy and breast-feeding
Do not take Loratadine if you are pregnant.
Do not take Loratadine if you are breast-feeding. Loratadine is excreted in breast milk.
Driving and using machines
Loratadine is not expected to cause drowsiness. However, very rarely some people experience drowsiness,
which may affect their ability to drive of use machines.
Loratadine contains lactose
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

Always 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.
Swallow the tablet whole with a glass of water.
The recommended dose is:
For adults and children over 12 years old: Take one 10 mg tablet per day.
For children under 12 years who weigh more than 30 kg: Take one 10 mg tablet per day.
Loratadineshould not be given to children under 2 years or with a bodyweight less than 30 kg.
For patients with severe liver problems: Your dose may need to be reduced, discuss this with
your doctor before taking these tablets.
If you take more Loratadine than you should
If you take more Loratadine than you should, talk to your doctor or nearest hospital casualty department
straight away. Symptoms of an overdose include drowsiness, a very fast heartbeat and headache.
If you forget to take Loratadine
Take the recommended dose as soon as you remember. Wait at least 24 hours before taking another tablet.
Do not take a double dose to make up for a forgotten tablet.
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 Loratadine immediately and see a doctor or go to a hospital straight away if you have the
following side effects:

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Very Rare (may affect up to 1 in 10,000 people)
 Severe allergic reaction, symptoms include itching, skin rashes, swelling of the face, lips, tongue or
throat, or difficulty breathing or swallowing, narrowing of airways.
The following side effects may be seen with Loratadine:
Common (may affect more than 1 in 10 people):
 Headache
 Drowsiness
 Nervousness
Uncommon (may affect up to 1 in 100 people):
 Increased appetite
 Difficulty sleeping
Very Rare (may affect up to 1 in 10,000 people):
 Fits
 Dizziness
 Fast or irregular heart beat
 Palpitations
 Feeling sick
 Inflammation of the stomach which can cause stomach pain and sickness
 Dry mouth
 Changes in the way your liver works
 Rash
 Hair loss
 Tiredness
 Nose bleeds
 Sore throat
In children aged between 2 and 12 years, common side effects include tiredness, headache and feeling
nervous.
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

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 label, carton and blister 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 to protect the environment.
6.

Contents of the pack and other information

What Loratadine contains
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The active substance is loratadine. Each film-coated tablet contains 10 mg of loratadine.
The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, pregelatinized
starch, hydrated colloidal silica, magnesium stearate, carnauba wax and talc.
The film-coat contains hypromellose and macrogol 400 and 6000.
What Loratadine looks like and contents of the pack
Loratadine tablets are white round biconvex shape with ‘LR 10’ on one side. Loratadine is available in
blister packs of 7 tablets.
Marketing Authorisation Holder and Manufacturer
Mylan,
Potters Bar,
Hertfordshire,
EN6 1TL,
United Kingdom
This leaflet was last revised in 05/2015.

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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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