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ALLERGY RELIEF 10 mg TABLETS LORATADINE

PATIENT INFORMATION LEAFLET

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

This medicine is available without prescription. However you still need to take Loratadine 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 talk to a doctor if you do not feel better or if you feel worse.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. This includes any side effects not listed in the leaflet. See section 4.

WHAT IS IN THIS LEAFLET:

1.    What Loratadine is and what it is used for

2.    What you need to know before you take Loratadine

3.    How to take Loratadine

4.    Possible side effects

5.    How to store Loratadine

6.    Contents of the pack and other information

OWhat Loratadine is and what it is used for

• Loratadine belongs to a group of drugs called antihistamines which help to relieve the symptoms of some allergies.

• Your medicine is used to relieve symptoms such as sneezing, runny nose and burning, itchy eyes due to hayfever and other allergies.

Loratadine tablets can also be taken to relieve symptoms due to skin allergies such as rash, itching or urticaria (hives).

What you need to know before you take Loratadine

Do NOT take Loratadine if you:

• are allergic (hypersensitive) to Loratadine or any of the other ingredients of this medicine. See section 6.

Warnings and Precautions

Talk to your doctor or pharmacist before you start taking this medicine if you:

•    have severe liver problems (see section 3, 'How to take Loratadine').

Other precautions you should take This product may prevent a response to allergens in skin allergy testing; therefore you should stop taking this medicine at least 2 days before any such testing.

Pregnancy and breast-feeding

Do not take Loratadine if you are pregnant or

breast-feeding.

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

Driving and using machines:

•    Loratadine may make you feel drowsy. Do not drive or operate any tools or machines if affected.

Loratadine contains Lactose Patients who are intolerant to lactose should note that Loratadine tablets contain a small amount of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

a How to take Loratadine

If your doctor has prescribed this medicine, always take Loratadine exactly as your doctor has told you. Otherwise follow the instructions below.You should check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed, preferably with a drink of water.

The usual dose is:

Adults and Children over 12 years of age One 10 mg tablet once daily.

Children aged 2 - 12 years of age are dosed by weight:

Bodyweight more than 30kg: 10mg once daily (one tablet once daily).

Loratadine tablets are not suitable for children with a body weight of less than 30kg.

Children under 2 years of age

Loratadine is not recommended for children under 2 years of age.

Patients with severe liver problems Adults and Children over 2 years of age:

Bodyweight more than 30kg: 10mg (one tablet) every other day.

If you take more Loratadine than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Overdose may cause

sleepiness, fast heart rate and headache.

Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Loratadine

If you forget to take a dose, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. | Possible side effects

Like all medicines, Loratadine can cause side effects, although not everybody gets them.

If the following happens, stop taking Loratadine and tell your doctor immediately or go to the casualty department at your nearest hospital:

•    a severe allergic reaction (swelling of the face, lips, mouth or throat which may cause difficulty swallowing or breathing).

This is a very serious but very rare side effect. You may need urgent medical attention or hospitalisation.

The following side effects have been reported at the approximate frequencies shown:

Children aged 2 to 12 years:

Common (affects less than 1 in 10 patients receiving the medicine):

•    headache

•    nervousness

•    tiredness (fatigue).

Adults and children over 12 years:

Common (affects less than 1 in 10 patients receiving the medicine):

•    drowsiness (somnolence).

Uncommon (affects less than 1 in 100 patients receiving the medicine):

•    headache

•    increased appetite

•    difficulty sleeping (insomnia).

Very rare (affects less than 1 in 10,000 patients receiving the medicine):

•    dizziness

•    convulsions

•    fast or uneven heartbeat (tachycardia, palpitations)

•    feeling sick (nausea), dry mouth, inflammation of the stomach, which may lead to stomach pain, being sick, or loss of appetite (gastritis)

•    abnormal liver function (shown by blood test results)

•    rash, hair loss (alopecia)

•    tiredness (fatigue)

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 By reporting side effects you can help provide more information on the safety of this medicine.

[5 How to store Loratadine

Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage conditions. Do not transfer the tablets to another container. Do not use Loratadine after the expiry date that is stated on the outer packaging. 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.

©Contents of the pack and other information

What Loratadine tablets contain:

• The active ingredient is loratadine 10 mg.

• The other ingredients are lactose, maize starch, pregelatinised starch and magnesium stearate.

What Loratadine tablets look like and contents of the pack:

• White, oval tablets, scored on one side and plain on the other, debossed 'X and "10" on each side of the scoreline.

• The product is available in packs of 5, 7, 10, 14, 15, 20, 28, 30, 50, and 100 tablets.

Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufac-

Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne,

BN22 9AG.

This leaflet was last revised: January 2015 PL 00289/0371

V10-150312

86844-V