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Active substance(s): LORATADINE

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Warnings and Precautions

Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
This medicine is available without prescription.
However you still need to take Loratadine
carefully to get the best results from it.
• Keep this leaflet. You may need to
read it again.
• Ask your pharmacist if you need
more information or advice.
• You must talk to a doctor if you do not feel
better or if you feel worse.
• If any of the side effects get serious, or if you
notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
This includes any side effects not listed in
the leaflet. See section 4.

Pharma code 581

1. What Loratadine is and what it is used for
2. What you need to know before you take
3. How to take Loratadine
4. Possible side effects
5. How to store Loratadine
6. Contents of the pack and other information


What Loratadine is and what
it is used for

Loratadine belongs to a group of drugs
called antihistamines which help to relieve
the symptoms of some allergies.
Your medicine is used to relieve symptoms
such as sneezing, runny nose and burning,
itchy eyes due to hayfever and other
Loratadine tablets can also be taken
to relieve symptoms due to skin allergies
such as rash, itching or urticaria (hives).


What you need to know before
you take Loratadine

Do NOT take Loratadine if you:
• are allergic (hypersensitive) to
Loratadine or any of the other
ingredients of this medicine. See section 6.

Other precautions you should take
This product may prevent a response to
allergens in skin allergy testing; therefore you
should stop taking this medicine at least 2 days
before any such testing.
Pregnancy and breast-feeding
Do not take Loratadine if you are pregnant or
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines:
• Loratadine may make you feel
drowsy. Do not drive or operate any
tools or machines if affected.
Loratadine contains Lactose
Patients who are intolerant to lactose should
note that Loratadine tablets contain a small
amount of 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.


How to take Loratadine

If your doctor has prescribed this medicine,
always take Loratadine exactly as your doctor
has told you. Otherwise follow the instructions
below. You should check with your doctor or
pharmacist if you are not sure.
The tablets should be swallowed, preferably
with a drink of water.
The usual dose is:
Adults and Children over 12 years of age
One 10 mg tablet once daily.
Children aged 2 - 12 years of age are dosed by
Bodyweight more than 30kg: 10mg once daily
(one tablet once daily).
Loratadine tablets are not suitable for children
with a body weight of less than 30kg.
Children under 2 years of age
Loratadine is not recommended for children
under 2 years of age.
Patients with severe liver problems
Adults and Children over 2 years of age:
Bodyweight more than 30kg: 10mg (one tablet)
every other day.
If you take more Loratadine than you should
If you (or someone else) swallow a lot of the
tablets all together, or if you think a child has
swallowed any of the tablets, contact your
nearest hospital casualty department or your
doctor immediately. Overdose may cause

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Talk to your doctor or pharmacist before you
start taking this medicine if you:
• have severe liver problems (see
section 3, ‘How to take Loratadine’).

sleepiness, fast heart rate and headache.
Please take this leaflet, any remaining tablets
and the container with you to the hospital or
doctor so that they know which tablets were

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:

If you forget to take Loratadine
If you forget to take a dose, take one as soon
By reporting side effects you can help provide
as you remember, unless it is nearly time to
take the next one. Do not take a double dose to more information on the safety of this
make up for a forgotten dose.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.


How to store Loratadine

Keep this medicine out of the sight and reach
of children. This medicinal product does not
require any special storage conditions. Do not
Like all medicines, Loratadine can cause side
transfer the tablets to another container. Do
effects, although not everybody gets them.
not use Loratadine after the expiry date that is
stated on the outer packaging. The expiry date
If the following happens, stop taking
refers to the last day of that month.
Loratadine and tell your doctor
immediately or go to the casualty department Do not throw away any medicines via
wastewater or household waste. Ask your
at your nearest hospital:
pharmacist how to throw away medicines you
• a severe allergic reaction (swelling of the
face, lips, mouth or throat which may cause no longer use. These measures will help
protect the environment.
difficulty swallowing or breathing).
This is a very serious but very rare side effect.
You may need urgent medical attention or
Contents of the pack and other


Possible side effects


The following side effects have been reported
at the approximate frequencies shown:
Children aged 2 to 12 years:
Common (affects less than 1 in 10 patients
receiving the medicine):
• headache
• nervousness
• tiredness (fatigue).
Adults and children over 12 years:
Common (affects less than 1 in 10 patients
receiving the medicine):
• drowsiness (somnolence).
Uncommon (affects less than 1 in 100 patients
receiving the medicine):
• headache
• increased appetite
• difficulty sleeping (insomnia).
Very rare (affects less than 1 in 10,000 patients
receiving the medicine):
• dizziness
• convulsions
• fast or uneven heartbeat (tachycardia,
• feeling sick (nausea), dry mouth,
inflammation of the stomach, which
may lead to stomach pain, being
sick, or loss of appetite (gastritis)
• abnormal liver function (shown by
blood test results)
• rash, hair loss (alopecia)
• tiredness (fatigue)

What Loratadine tablets contain:
• The active ingredient is loratadine
10 mg.
• The other ingredients are lactose, maize
starch, pregelatinised starch and magnesium stearate.
What Loratadine tablets look like and contents
of the pack:
• White, oval tablets, scored on one side and
plain on the other, debossed “L” and “10”
on each side of the scoreline.
• The product is available in packs of 5, 7, 10,
14, 15, 20, 28, 30, 50, and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company
responsible for manufacture: TEVA UK Limited,
BN22 9AG.
This leaflet was last revised: January 2015
PL 00289/0371


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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.