PACKAGE LEAFLET: INFORMATION FOR THE USER

Loratadine 10 mg Tablets

Loratadine

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.

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

4.    Possible side effects

5.    How to store Loratadine Tablets

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.

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

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

Take special care with Loratadine Tablets

-    if you have severe liver problems

-    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.

Taking Loratadine Tablets with food and drink

This medicine may be taken with or without food.

Pregnancy and breast-feeding

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

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.

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

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.

If you forget to take Loratadine Tablets

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

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

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.

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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

APTIL Pharma Limited,

9th floor, C.P.House,97-107 Uxbridge Road, Ealing,London W5 5TL

Manufacturer:

APC Pharmaceuticals & Chemicals (Europe) Ltd., 9th floor, C.P. House, 97-107 Uxbridge Road, Ealing, London , W5 5TL

This leaflet was last revised in 06/2012.

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