Document: leaflet MAH GENERIC_PL 00289-0388 change

• leaflet MAH GENERIC_PL 00289-0388
• leaflet MAH GENERIC_PL 16363-0464
• leaflet MAH GENERIC_PL 36390-0043

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TEVA UK Ref: 231-30-50005-D LEA CETIRIZINE 10mg TAB TUK (GSL) Version: 3    17 November 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

CETIRIZINE HYDROCHLORIDE 10 mg FILM-COATED TABLETS

Patient Information Leaflet

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 or pharmacist have told you.

-    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 you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in the leaflet. See section 4.

The name of this medicine is Cetirizine Hydrochloride 10 mg Film-coatedTablets but will be referred to as Cetirizine in the rest of the leaflet.

What is in this leaflet

1.    What Cetirizine is and what it is used for

2.    What you need to know before you take Cetirizine

3.    How to take Cetirizine

4.    Possible side effects

5.    How to store Cetirizine

6.    Contents of the pack and other information

OWHAT CETIRIZINE IS AND WHAT IT IS USED FOR

• Cetirizine is an antihistamine. Antihistamines help to relieve the symptoms of some allergies.

• In adults and children 6 years and above, Cetirizine is used

• to relieve the nasal symptoms of hay fever, seasonal rhinitis (runny and itchy nose)

• to relieve the symptoms of other allergies e.g. pet or house dust mite allergies.

• for skin allergies such as rash, itching and urticaria (hives).

OWHAT YOU NEED TO KNOW BEFORE YOU TAKE CETIRIZINE

Do not take Cetirizine if you:

• Are allergic to cetirizine or similar products e.g. hydroxyzine, cyclizine, meclozine or to any of the other ingredients of this medicine (listed in section 6).

• Are undergoing dialysis for kidney problems

• Have a hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

Warnings and precautions

Talk to your doctor or pharmacist before taking Cetirizine if you:

• Have liver problems • Have kidney problems, as the dose may need to be adjusted.

• Are epileptic or at risk of convulsions • Have urinary retention problems.

Allergy tests: If you are going to have an allergy skin test, stop taking this medicine 3 days before the test.

If you take Cetirizine for a long time, there is an increased risk of tooth decay due to mouth dryness. It is important to brush your teeth regularly whilst taking Cetirizine.

Children and adolescents

•    Not recommended in children aged less than 6 years of age.

Other medicines and Cetirizine

Due to the profile of cetirizine, no interactions with other drugs are expected. Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Cetirizine with food, drink and alcohol

•    Do not take large amounts of alcohol whilst taking Cetirizine, as this medicine may increase the effects of alcohol.

Pregnancy, breast-feeding and fertility

If you are pregnant or are planning to become pregnant or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines:

•    When taken at the recommended dose, Cetirizine is not expected to affect your ability to drive or operate machinery. However, there are exceptions and you should take care when using this medicine for the first time.

•    If this product makes you feel drowsy,

DO NOT drive or operate machinery. This effect will be worse if you are also taking sedatives or drinking alcohol.

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

^ HOW TO TAKE CETIRIZINE

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. Cetirizine should be swallowed with a drink of water.

The recommended dosage is given below:

•    Adults and adolescents aged 12 years and over:

One tablet (10 mg) once daily.

•    Children aged from 6 to 12 years:

Half a tablet (5 mg) twice daily.

•    Children under 6 years of age:

Cetirizine is not recommended for children under this age.

If you have kidney problems, you should talk to your doctor or pharmacist for advice before taking these tablets, as a lower dose may be required.

If you take more Cetirizine than you should

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

The effects of an overdose may cause confusion, diarrhoea, dizziness, tiredness, headache, a general feeling of being unwell, restlessness, feeling sleepy, a state of semi-unconsciousness, faster heartbeat, shaking or problems urinating.

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.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

If you forget to take Cetirizine

If you forget to take a tablet, 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 tablet or dose.Take the remaining doses at the correct time.

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

^ POSSIBLE SIDE EFFECTS

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

Stop taking the tablets and tell your doctor

immediately or go to the casualty department at your nearest hospital if the following happens:

•    a severe allergic reaction (swelling of the face, lips, mouth or throat leading to severe difficulty in breathing or swallowing; skin rash or hives).

This is a very serious but rare side effect.

You may need urgent medical attention or hospitalisation.

In very rare cases people have thoughts about committing suicide and if you feel this way then stop taking these tablets and see your doctor.

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

Common (may affect up to 1 in 10 people):

•    tiredness or sleepiness

•    dizziness or headache

•    nausea or diarrhoea

•    dry mouth or difficulty in swallowing accompanied by earache and swollen glands, sore throat

•    runny and itchy nose.

Uncommon (may affect up to 1 in 100 people):

•    agitation

•    abdominal pain

•    lethargy or feeling weak and/or unwell

•    pins and needles

•    skin itchiness or rashes.

Rare (may affect up to 1 in 1,000 people):

•    rapid heartbeat

•    water retention

•    liver problems (diagnosed by blood and/or urine tests)

•    weight gain

•    fits or unusual movements of your arms and/or legs

•    aggression or depression

•    confusion

•    hallucinations

•    difficulty in sleeping

•    red and/or blotchy skin rash.

Very rare (may affect up to 1 in 10,000 people):

•    bleeding and bruising easily (could indicate problems with your blood)

•    sight problems including difficulty focusing and blurred vision

•    unusual movements of the eyeball

•    fainting

•    decreased sense of taste

•    bed wetting

•    pain in passing water

•    inflammatory skin eruption

•    unusual movements or contractions in the face

•    abnormal muscle rigidity or movements

•    shaking.

Not known (frequency cannot be estimated from the available data):

•    Amnesia - partial or total loss of memory, memory impairment

•    Increased appetite

•    Vertigo

•    Urinary retention.

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.

HOW TO STORE CETIRIZINE

Keep this medicine out of sight and reach of children.

There are no special storage conditions.

Do not transfer to another container.

Do not take Cetirizine after the expiry date which is stated on the outer packaging. The expiry date refers to the last day of that month.

Do not take this medicine if you notice any defects or signs of deterioration in the tablets such as broken tablets.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer take. These measures will help protect the environment.

©CONTENTS OF THE PACK AND OTHER INFORMATION

What Cetirizine contain

• The active ingredient is cetirizine dihydrochloride 10 mg (also known as cetirizine hydrochloride).

• The other ingredients are microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate (E572), hypromellose (E464), macrogol, titanium dioxide (E171) and polydextrose. What Cetirizine look like and contents of the pack

• CetirizineTablets are white to off white, capsule-shaped tablets, debossed with C10 on one side and a deep breakline on the other.

• The product is available in pack sizes of 7, 14, 15, 20, 28 and 30 tablets.

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

TEVA UK Limited, Eastbourne, BN22 9AG. This leaflet was last revised:

November 2015

PL 00289/0388

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50005-D 160x323