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Package leaflet:

Information for the user

SelarizlO mg 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, pharmacist, or nurse has told you

-    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, pharmacist, or nurse. 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, if you feel worse.

What is in this leaflet:

1.    What Selariz Tablets are and what they are used for

2.    What you need to know before you take Selariz Tablets

3.    How to take Selariz Tablets

4.    Possible side effects

5.    How to store Selariz Tablets

6.    Contents of the pack and other information

l. What selariz tablets are and what they are used for

This medicine contains the active substance loratadine which belongs to a class of medicines called "antihistamines".

Selariz Tablets relieve symptoms associated with allergic rhinitis (for example, hay fever), such as sneezing, runny or itchy nose, and burning or itchy eyes.

Selariz 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.

You must talk to a doctor if you do not feel better or if you feel worse.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Selariz Tablets

-    if you have severe liver problems

-    if you are scheduled to have any skin tests for allergies. Do not take Selariz tablets for two days before having these tests. This is because it may affect test results.

If any of the above applies to you, please tell your doctor or pharmacist.

Other medicines and Selariz Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes taken without a prescription.

This is particularly important if you are taking

-    Cimetidine (for stomach problems)

-    Erythromycin (an antibiotic)

-    Ketoconazole or fluconazole (for fungal infections)

Selariz Tablets with alcohol

Selariz Tablets has not been shown to add to the effects of an alcoholic drink.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy: Do not take Selariz Tablets if you are pregnant.

Breast feeding: Do not take Selariz Tablets if you are breast-feeding. Loratadine is excreted in breast milk.

Driving and using machines

At the recommended dose, Selariz Tablets are not expected to cause you to be drowsy or less alert. However, very rarely some patients experience drowsiness, which may affect their ability to drive or use machines. Please make sure you are not drowsy before performing these activities.

Selariz Tablets contains lactose

Selariz Tablets contain lactose; thus if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

2. What you need to know before you take Selariz Tablets

DO NOT TAKE Selariz Tablets

-    if you are allergic (hypersensitive) to loratidine or any of the other ingredients of this medicine (listed in section 6)

-    if you are pregnant or planning to become pregnant

-    if you are breast-feeding currently.

Children under 2 years of age and/or under 30 kg

of weight should not take this medicine.

3. How to take selariz tablets

Always take this medicine exactly as as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Try to get into the habit of taking it at the same time every day. This will make it easier for you to remember.

The Central breakline of the tablet is only there to help you the break the tablet if you have difficulty swallowing it whole.

Giving this medicine to children:

A loratadine syrup formulation may be preferable for children. It is important to know how much your child weights to make sure that you give the

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correct amount of the medicine. For example, a 9 year old child weight about 30 kg (4st 7lbs). if in doubt weigh your child and then follow the instructions in the table.

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 Selariz 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

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

The most commonly reported side effects in adults and children over 12 years of age are:

-    drowsiness

-    headache

- increased appetite

- difficulty sleeping

The most commonly reported side effects in children aged 2 through 12 years are:

-    headache

-    nervousness

-    tiredness

The following very rare side effects (may affect up to 1 in 10,000 people) have also been seen during the marketing of loratadine:

-    severe allergic reaction which cause difficulty in breathing or dizziness.

-    rapid heartbeat

-    palpitation (awareness of heartbeat/racing)

-    gastritis (abdominal pain, burning feeling in the stomach between meals or at night and nausea (with or without vomiting)

-    feeling tired

-    skin rashes

- hair loss

-    fainting,

-    nausea

-    dry mouth

-    serious allergic reaction which causes swelling of the face or throat

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 selariz tablets

-    Keep out of the sight and reach of children.

-    Do not take Selariz 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.

-    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 to protect the environment.

6. Contents of the pack and other information

What Selariz Tablets contain

-    The active substance is loratadine.

-    The other ingredients are lactose monohydrate, maize starch, colloidal anhydrous silica, croscarmellose sodium, talc and magnesium stearate.

What Selariz Tablets look like and contents of the pack

Selariz Tablets are white coloured, circular, flat beveled uncoated tablets, with central breakline on one side and ‘L’ on other side.

Selariz Tablets are available in blister strips in pack size of 7, 10,14, 20 and 30 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Cipla (EU) Limited, Hillbrow House, Hillbrow

Road, Esher, Surrey, KT10 9NW, United Kingdom.

Manufacturer:

Cipla (EU) Limited,

20 Balderton Street, London W1K 6TL,

United Kingdom

Cipla Europe NV

Uitbreidingstraat 80, 2600 Antwerp, Belgium This leaflet was last revised in 08/2016.

Cipla