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BROWN & BURK ONCE-A-DAY HAYFEVER & ALLERGY 10MG TABLETS

Active substance(s): LORATADINE

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2) Strength

: Brown & Burk Once-A-Day Hayfever & Allergy
Tablets - BBUK
: 10 mg

3) Component

: Leaflet

4) No. of Colours

: 1

5) Dimension

: 120 x 224 mm

6) Artwork Code

: NA

7) Pharma Code

: NA

8) Font Type and Size

: Arial Narrow, 9pt

1) Product

MICRO LABS LIMITED
Bangalore, INDIA

Colours used

Black

Colours not for printing
Keylines

9) Technical Specification: NA
WOA

Code No. :

WA

Reason for Change
Approved
by

Regulatory
Affairs

Contract Giver/
PL holder

NA

Revision: 00

NA

Date : 24-06-2016
Packaging
Development

Head Production/
Packing (Site)

Head QC
(Site)

Head QA
(Site)

Sign/
Date

120 mm

Package Leaflet : Information for the patient
Brown & Burk Once-A-Day Hayfever
& Allergy 10mg 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 or pharmacist
has told you.
This medicine is available without prescription,
for you to treat a mild illness without a doctor's
help. You still need to use this medicine carefully
to get the best results from them.
- 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
or pharmacist. 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 after 5 days.
What is in this leaflet
1. What this medicine is and what it is used for
2. What you need to know before you take this
medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
1. What this medicine is and what it is used
for
Loratadine is one of a group of medicines called
non-sedating antihistamines used to relieve the
symptoms of some allergies.
This medicine are used in adults and children to
relieve allergy symptoms such as sneezing,
runny nose, and itchy and/or burning eyes
whether these are due to hayfever or whether
they occur at other times of the year. This
medicine may also be used to relieve the
symptoms associated with chronic idiopathic
urticaria such as rash, itching and hives.
2. What you need to know before you take
this medicine:

Warnings and precautions
Talk to your doctor or pharmacist before
taking this medicine if:
- you have liver disease
- you have been told by your doctor that you
have an intolerance to some sugars.
Patients with some types of intolerance to
sugars should not take this medicine.
- you are going to have allergy tests. You
should stop taking this medicine 2 days
before you are due to have the test.
Other medicines and this medicine:
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, even
those not prescribed.
This medicine with food, drink and alcohol:
This medicine should not be affected by food or
drink.
You do not have to avoid alcohol whilst taking
this medicine.
Pregnancy
Ask your doctor or pharmacist for advice before
taking any medicine.
This medicine should not be taken if you are
pregnant or think you may be pregnant.
Breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.
This medicine should not be taken by women
who are breastfeeding because the active
ingredient, Loratadine, passes into breast milk.
Driving and using machines:
Very rarely this medicine can cause drowsiness
which may affect your ability to drive and operate
machinery whilst taking this medicine. If you are
unsure ask your pharmacist.

Pharmacode

By reporting side effects you can help provide
more information on the safety of this medicine.
If the child weighs less than 30 kg, the 10mg
strength tablet is not recommended.
If you are unsure ask your doctor or pharmacist
for advice.
This medicine are not recommended in children
under 2 years.
If you take more this medicine than you
should:
If you (or someone else) have accidentally taken
more this medicine than you/they should,
contact your doctor or pharmacist immediately,
or go to the nearest Accident and Emergency
hospital department.
If you forget to take this medicine:
Take your 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 missed doses.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If the following happens, stop taking the tablets
and tell your doctor immediately or go
immediately to the accident and emergency
department at your nearest hospital:
- An allergic reaction (angioedema): swelling
of the face, lips, tongue or throat, or difficulty
breathing or swallowing.
This is a very serious but very rare side effect.
You may need urgent medical attention or
hospitalisation.
The most commonly reported side effects are
tiredness, difficulty sleeping, headache,
nervousness, increased appetite and
drowsiness.

The following section contains instructions on
how many tablets to take and when.
Do not exceed the dose stated below.
Adults, the elderly, children aged 12 years and
over:
One tablet to be swallowed once daily.

If you notice any of these effects, or any side
effects not mentioned in this leaflet, please
inform your doctor or pharmacist.

Children aged 2 to 12 years:
If the child weighs more than 30 kg, one tablet
taken once daily is recommended.

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:

Do not take this medicine if:
- you are hypersensitive (allergic) to
Loratadine, or any of the other ingredients
of the tablets (check by reading the

Size: 120 x 224 mm Front Side

Pharmacode

5. How to store this medicine:
Keep this medicines out of the sight and reach of
children. Your medicine may harm them.
There are no special storage recommendations
for this medicine. However, do not store your
medicine in a very damp or very hot place, such
as the bathroom or kitchen.
Do not use after the expiry date stated on the
outer carton/blister strip after EXP. The expiry
date refers to the last day of that month.
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.
If there is anything about this medicine you
do not understand or are unsure about, your
doctor or pharmacist will be able to help or
advise you.

4. Possible side effects

Very rarely reported effects include dizziness,
heart palpitations, fast heart beats, dry mouth
and feeling sick, skin rashes, hair loss, changes
in liver function and upper abdominal pain or
discomfort.

3. How to take this medicine:

www.mhra.gov.uk/yellowcard

6. Contents of the pack and other
information
-

The active substance in your tablets is
loratadine. Each this medicine contains
10mg of loratadine.

-

The other ingredients in your tablets are
lactose monohydrate, microcrystalline
cellulose, maize starch, magnesium
stearate.

This medicine are white or almost white, 8mm
round, flat tablets, debossed with letter 'L' on
one side and with a score line on other.
This medicine are available in packs of 7, 14 and
30 tablets from your pharmacist.
Marketing Authorisation Holder &
Manufacturer
Brown & Burk UK Ltd, 5 Marryat Close,
Hounslow West, Middlesex, TW4 5DQ
United Kingdom
Marketing Authorisation Number
PL 25298/0117
This leaflet was last revised in: May 2016

Pharmacode
BBUK CODE

Size: 120 x 224 mm Back Side

224 mm

224 mm

list of ingredients above).
you are (or think you may be) pregnant, or
are breastfeeding

-

Artwork code

Pharmacode

120 mm

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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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