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

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Bangalore, INDIA

1) Product

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

Colours used Black

2) Strength

: 10 mg

3) Component

: Leaflet

4) No. of Colours


5) Dimension

: 120 x 224 mm

6) Artwork Code

: NA

7) Pharma Code

: NA

Colours not for printing

8) Font Type and Size

: Arial Narrow, 9pt


9) Technical Specification: NA


Code No. :



Revision: 00

Reason for Change


Date : 24-06-2016



Contract Giver/ PL holder





Head Production/ Packing (Site)

Head QC (Site)

Head QA (Site)



120 mm


120 mm


224 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.

list of ingredients above).

-    you are (or think you may be) pregnant, or are breastfeeding

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.


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.


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.

3. How to take this medicine:

2. What you need to know before you take this medicine:

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

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.

Children aged 2 to 12 years:

If the child weighs more than 30 kg, one tablet taken once daily is recommended.







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.

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

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.

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.

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

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:

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


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224 mm

Size: 120 x 224 mm Front Side

Size: 120 x 224 mm Back Side