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Loratadine 10 Mg Tablets

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Document: leaflet MAH GENERIC_PL 20117-0069 change

Patient Information Leaflet: Information forthe user

Loratadine 10mg Tablets

Loratadine


1005


Read all ofthis leaflet carefully before you start taking this medicine because it contains important information foryou.

This medicine is available without prescription, for you to treat a mild illness without a doctor's help. You still need to use Loratadine 10mg Tablets carefully to get the best results from them.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

•    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 after 5 days.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet

In this leaflet:

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

2.    What you need to know before you take Loratadine 10mg Tablets

3.    How to take Loratadine 10mg Tablets

4.    Possible side effects

5.    How to store Loratadine 10mg Tablets

6.    Contents of the pack and other information.


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


Loratadine is one of a group of medicines called non-sedating antihistamines used to relieve the symptoms of some allergies. Loratadine 10mg Tablets 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 ofthe year. Loratadine 10mg Tablets 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 Loratadine 10mg Tablets


Do not take Loratadine 10mg Tablets if:

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

•    you are (or think you may be) pregnant, or are breastfeeding.


Warnings and precautions

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.

Other medicines and Loratadine 10mg Tablets:

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

Loratadine 10mg Tablets with food, drink and alcohol:

Loratadine 10mg Tablets should not be affected by food or drink. You do not have to avoid alcohol whilst taking Loratadine 10mg Tablets

Pregnancy and Breast-feeding

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.

Loratadine 10mg tablets contain lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before you take this medicine.


3. How to take Loratadine 10mg Tablets


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 2to12 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.

Ifyou take more Loratadine 10mg Tablets than you should:

Ifyou (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.

Ifyou 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.

4. Possible side effects

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

Ifthe following happens, stop taking the tablets and tell yourdoctor immediately or go immediately to the accident and emergency department at your nearest hospital:

An allergic reaction (angioedema or anaphylaxis): 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, convulsions, heart palpitations, fast heart beats, dry mouth and feeling sick, skin rashes, hair loss, changes in liver function and upper abdominal pain or discomfort.

Reporting ofside effects

Ifyou get any side effects, talk to your doctor or pharmacist. 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. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Loratadine 10mg Tablets

Keep all medicines out of the sight and reach 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.

6. Contents ofthe pack and other information

What Loratadine 10mg Tablets contain:

•    The active substance in your tablets is loratadine.

Each Loratadine 10mg Tablet contains 10mg ofloratadine.

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

What Loratadine 10mg Tablets look like and contents of the pack

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

Loratadine 10mg Tablets are available in pack sizes of 7 tablets.

Manufacturer

Morningside Pharmaceuticals Ltd.

5 Pavilion Way, Loughborough LE11 5GW, UK

Marketing Authorisation Holder

Morningside Healthcare Ltd,

115 Narborough Road,

Leicester, UK

This leaflet was last revised in January 2015

500 r