Patient Information Leaflet

Cetirizine Hydrochloride 1 mg/ml Oral Solution

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 Cetirizine 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

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

1.    WHAT CETIRIZINE IS AND WHAT IT IS USED FOR

Cetirizine is an antihistamine. Antihistamines help to relieve the symptoms of some allergies. In children 2 to 6 years, Cetirizine is used:

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

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

•    to relieve the nasal symptoms of hay fever and non-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).

In adults and children 12 years and above Cetirizine is also used:

•    to relieve the symptoms of allergic eye conditions.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETIRIZINE DO NOT take Cetirizine and talk to your doctor if you:

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

•    are undergoing dialysis for kidney problems

•    have a hereditary fructose intolerance.

Warnings and precautions

Tell your doctor before you start to take this medicine if you:

•    have kidney problems, as the dose may need to be adjusted

•    are epileptic or at risk of convulsions.

•    have urinary retention problem

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

Not recommended in children aged less than 2 years of age.

Other medicine and Cetirizine

Talk to your doctor if you are taking any of the following:

Due to the profile of cetirizine, no interactions with other drugs are expected.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Important information about some of the ingredients of Cetirizine

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

•    Propyl parahydroxybenzoate E216 and methyl parahydroxybenzoate E218 may cause allergic reactions (possibly delayed).

Cetirizine with food and drink

•    DO NOT take large amounts of alcohol whilst taking Cetirizine, as Cetirizine may increase the effects of alcohol.

Pregnancy, breast-feeding and fertility

•    If you are pregnant or planning to become pregnant, ask your doctor for advice before taking this medicine.

•    DO NOT take Cetirizine if you are breast-feeding.

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.

3. HOW TO TAKE CETIRIZINE

If your doctor has prescribed this medicine, always take Cetirizine exactly as your doctor has told you. Otherwise, follow the instructions below. If you are not sure how to take this medicine talk to your doctor or pharmacist.

Use the spoon provided to make sure you have the correct dose.

The usual dosage instructions are given below:

•    Adults and children over 12 years of age

10 mg once daily as 10 ml oral solution (two full measuring spoons) once daily.

•    Children aged 6 - 12 years (for hay fever, runny and itchy nose due to allergy and skin allergies)

5 mg twice daily as 5 ml oral solution (one full measuring spoon) twice daily.

•    Children aged 2 - 6 years (for hay fever only)

2.5 mg twice daily as 2.5 ml oral solution (a half-measuring spoon) twice daily.

•    Children under 2 years of age

Cetirizine is not recommended for use.

•    Patients with moderate to severe kidney problems

In patients with kidney impairment, the dose may need to be reduced as recommended by a doctor. Please talk to you doctor or pharmacist.

If you take more Cetirizine than you should

If you (or someone else) swallow a lot of the solution all together, or if you think a child has accidentally swallowed any of the solution, 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, dilated pupils, itching, restlessness, drowsiness, sleepiness, a state of semi unconsciousness, faster heartbeat, shaking or problems urinating. Please take this leaflet, any remaining solution and the container with you to the hospital or doctor so that they know which solution was taken.

If you forget to take Cetirizine

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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

Stop taking the solution 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.

The following side effect has been reported with Cetirizine. Tell your doctor if you notice the following:

•    abnormal liver function tests (diagnosed by blood and/or urine tests).

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

Common (affecting fewer than one person in 10 but more than one person in 100)

•    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 (affecting less than one person in 100 but more than one person in 1,000):

•    agitation

•    abdominal pain

•    lethargy or feeling weak and/or unwell

•    pins and needles

•    skin itchiness or rashes.

Rare (affecting less than one person in 1,000 but more than one person in 10,000):

•    rapid heartbeat

•    water retention

•    liver problems

•    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 (affecting less than one person in 10,000):

•    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.

Side effects with frequency not known

•    Partial or total loss of memory

•    Increased appetite

•    Vertigo

•    Urinary retention

In very rare cases people have thought about committing suicide and if you feel this way then stop taking the oral solution and see your doctor.

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.

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 CETIRIZINE

Keep out of the sight and reach of children. There are no special storage conditions. Do not transfer to another container. Do not use Cetirizine after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.

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.    CONTENTS OF THE PACK AND OTHER INFORMATION What Cetirizine solution contains:

• The active ingredient is cetirizine hydrochloride. Each 1 ml of solution contains 1 mg of cetirizine hydrochloride.

The other ingredients are glycerol, propylene glycol, sorbitol solution (E420), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium acetate, glacial acetic acid, saccharin sodium, banana flavour and purified water.

What Cetirizine solution looks like and contents of the pack:

•    Cetirizine solution is a clear, colourless solution with a banana flavour.

•    The product is available in pack sizes of 70 ml, 75 ml, 100 ml, 150 ml and 200 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.

Or¹

Marketing Authorisation holder:

TEVA UK Limited, Eastbourne, BN22 9AG.

Company responsible for manufacture: Teva Czech Industries s.r.o., Opava, Czech Republic.

This leaflet was last revised: July 2014 PL 00289/0416

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Only the company responsible for batch release will be shown on the mock-up.