LORATADINE 10 MG TABLETS

Active substance: LORATADINE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Children under 2 years of age and/or under 30 kg
of weight should not take this medicine.

Loratadine 10 mg
Tablets

Take special care with Loratadine Tablets
-

Read all of this leaflet carefully because it
contains important information for you.
This medicine is available without prescription.
However, you still need to take Loratadine 10 mg
tablets 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 contact a doctor if your symptoms
worsen or do not improve.
- If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

if you have severe liver problems

-

Loratadine

if you have been told that you have an
intolerance to some sugars.

-

if you are due to have skin tests since
Loratadine could affect the results.

If any of the above applies to you, please tell your
doctor or pharmacist.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Laboratory tests:
Antihistamines may prevent response to allergens
in skin allergy testing, therefore this medicine
should be stopped two days prior to such testing.

In this leaflet:
1. What Loratadine 10 mg Tablets are and what
they are used for
2. Before you take Loratadine Tablets
3. How to take Loratadine Tablets

Taking Loratadine Tablets with food and drink

4. Possible side effects

This medicine may be taken with or without food.

5. How to store Loratadine Tablets
Pregnancy and breast-feeding

6. Further information
1. WHAT LORATADINE 10 MG TABLETS
ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Loratadine 10 mg
Tablets. It will be referred to as Loratadine Tablets
throughout this leaflet.
Loratadine Tablets belong to a class of medicines
known as antihistamines. Antihistamines help
to reduce allergic symptoms by preventing the
effects of a substance called histamine, which is
produced in the body.

Ask your doctor or pharmacist for advice before
taking any medicine.
Pregnancy: the safe use of loratadine during
pregnancy has not been established. The use of
Loratadine during pregnancy is therefore not
recommended.
Breast feeding: loratadine, the active substance in
this medicine is excreted in breast milk; therefore
the use of loratadine is not recommended in
breast-feeding women.
Driving and using machines

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.

2. BEFORE YOU TAKE LORATADINE
TABLETS

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.
Important information about some of the
ingredients of Loratadine tablets
Loratadine Tablets contain lactose (milk sugar). If
you have been told by your doctor that you have
intolerance to some sugars, contact your doctor
before taking this medicinal product.

DO NOT TAKE Loratadine Tablets
if you are allergic (hypersensitive) to
Loratadine or any of the other ingredients of
Loratadine Tablets. An allergic reaction can
include skin rash, itching, swelling or
breathing difficulties.

-

if you are pregnant or planning to become
pregnant

-

if you are breast-feeding currently.
Loratadine
10 mg Tablets
Loratadine

PHARMACODE
AREA

PHARMACODE
AREA

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Loratadine
10 mg Tablets
Loratadine

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PACKAGING DEVELOPMENT
Product Name : Loratadine 10mg Tab. (PIL)
Cordinator : P

Item Code : XXXXX
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Date : 01-11-12 (06-11-12)
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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 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
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.

However, check with your doctor if they
continue or are bothersome:
- nausea (feeling sick)
- fatigue
- headache
- nervousness
- dryness of the mouth, nose and throat
- hair loss
In addition, other side effects that have been
reported when taking Loratadine Tablets are:
- dizziness
- rapid heartbeat
- palpitation (awareness of heartbeat/racing)
- irritation of the stomach lining (gastritis)
- increased appetite
- insomnia
- skin rashes
- abnormal liver function.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5. HOW TO STORE LORATADINE TABLETS
Keep your tablets out of the reach and sight 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.
- Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION

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, Loratadine can cause side
effects, although not everybody gets them.
You must stop taking Loratadine Tablets
immediately and consult your doctor if you
develop any allergic reaction to this medicine.
This can consist of
- skin rash or eruptions (including inside the mouth)
- itching
- swelling of the face, tongue, lips, hands, feet
- breathing difficulties
Other side effects
- The following side effects have been reported
rarely with loratadine use. They are generally
non serious and may go away on their own.

What Loratadine Tablets contain
- The active substance is Loratadine 10 mg.
- The other ingredients are lactose monohydrate,
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 30 tablets.
Marketing Authorisation Holder
Cipla (EU) Limited, Hillbrow House, Hillbrow
Road, Esher, Surrey, KT10 9NW.
Manufacturer:
APC Pharmaceuticals & Chemicals (Europe) Ltd.,
9th floor, C.P. House, 97-107 Uxbridge Road,
Ealing, London , W5 5TL
Distributed By:
APC Pharmaceuticals & Chemicals (Europe) Ltd.,
9th floor, C.P. House, 97-107 Uxbridge Road,
Ealing, London, W5 5TL
This leaflet was last revised in 10/2012.

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If you forget to take Loratadine Tablets

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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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