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Loratadine 10 Mg Tablets

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Document: leaflet MAH GENERIC_PL 25298-0019 change

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Patient Information Leaflet Loratadine 10mg Tablets Read all of this leaflet carefully before you start taking this medicine.

This medicine is available without prescription, for you to treat a mild illness without a doctors help. You still need to use Loratadine 10mg Tablets 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.

-You must see a doctor if your symptoms worsen or do not improve after 5 days.


MICRO LABS LIMITED

Bangalore, INDIA

1) Product

: Loratadine Tablets - BBUK

Colours used

2) Strength

: 10 mg

Black

3) Component

: Leaflet

4) No of colours

:1

5) Dimension

: NA

6) Artwork Code

: NA

7) Pharma code

: NA

Colours not for printing

8) Font type and Size

: Arial Narrow, 9pt

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9) Technical specification : na

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Code No. : -

WA

NA

Revision: 00

Reason for change

NA

Date : 20-01-2015


Contract Giver/ PL holder


Regulatory

Affairs


Packaging

Development


Production Head (Site)


Head QC (Site)


Head QA (Site)


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. Loratadine 10mg Tablets may also be used to relieve the symptoms associated with chronic idiopathic urticaria such as rash, itching and hives.


2. BEFORE YOU TAKE LORATADINE 10MG TABLETS:


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10mg Tablets.


HOW TO TAKE LORATADINE 10MG TABLETS:


In this leaflet:

1.    What Loratadine 10mg Tablets are and what they are used for

2.    Before you take Loratadine 10mg Tablets

3.    How to take Loratadine 10mg Tablets

4.    Possible side effects

5.    Storing Loratadine 10mg Tablets

-    The active substance in your tablets is loratadine. Each Loratadine 10mg Tablet contains 10mg of loratadine.

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

Manufacturer

Morningside Pharmaceutical Ltd.

5 Pavilion Way, Loughborough LE 115GW, United Kingdom

Marketing Authorisation Holder

Brown & Burk UK Ltd, 5 Marryat Close, Hounslow West, Middlesex, TW4 5DQ United Kingdom

Marketing Authorisation Number PL25298/0019


Do not take Loratadine 10mg Tablets if:

-    you are hypersensitive (allergic) to Loratadine, or any of the other ingredients of the tablets (check by reading the list of ingredients above).

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

Talk to your doctor or pharmacist before taking

Loratadine 10mg Tablets 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 Loratadine 10 mg tablets 2 days before you are due to have the test.


1. WHAT LORATADINE 10MG TABLETS ARE AND WHAT THEY ARE USED FOR


Loratadine 10mg Tablets are white or almost white, 8mm round, flat tablets, embossed with a letter 'L' on one side and a score line on the other.

Loratadine 10mg Tablets are available in packs of 7 tablets from your pharmacist.

Loratadine is one of a group of medicines called nonsedating antihistamines used to relieve the symptoms of some allergies.

Loratadine 10mg Tablets are used in adults and children to


Taking Loratadine 10mg Tablets with food and drink:

Loratadine 10mg Tablets should not be affected by food or drink.

Pregnancy

Ask your doctor or pharmacist for advice before taking any medicine.

Loratadine 10mg Tablets 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.

Loratadine 10mg Tablets should not be taken by women who are breastfeeding because the active ingredient, Loratadine, passes into breast milk.

Driving and using machines:

Very rarely Loratadine 10mg Tablets can cause drowsiness which may affect your ability to drive and operate machinery whilst taking this medicine. If you are unsure ask your pharmacist.

Taking other medicines:

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

You do not have to avoid alcohol whilst taking Loratadine


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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.

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.

Loratadine 10 mg tablets are not recommended in children under 2 years.

If you take more Loratadine 10mg Tablets than you should:

If you (or someone else) have accidentally taken more Loratadine 10mg Tablets 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 Loratadine 10mg Tablets:

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.


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: www.mhra.gov.uk/yellowcard


5. STORING LORATADINE 10MG TABLETS:


Keep all medicines out of the reach and sight of children. Your medicine may harm them.

There are no special storage recommendations for Loratadine 10mg Tablets. 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.

Please return any unused medicine to your pharmacist for safe disposal.

If there is anything about Loratadine Tablets you do not understand or are unsure about, your doctor or pharmacist will be able to help or advise you.

Date of preparation: January 2015


4. POSSIBLE SIDE EFFECTS


Like all medicines, Loratadine 10mg Tablets can have some side effects.

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:

D 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.


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