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PACKAGE LEAFLET: INFORMATION FOR THE USER Cetirizine Dihydrochloride 10 mg Film-coated Tablets

(Cetirizine dihydrochloride)

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Cetirizine 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 after 3 days.

-    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 Cetirizine Tablets are and what they are used for

2.    Before you take Cetirizine Tablets

3.    How to take Cetirizine Tablets

4.    Possible side effects

5.    How to store Cetirizine Tablets

6.    Further information

1.    WHAT CETIRIZINE TABLETS ARE AND WHAT THEY ARE USED FOR

The name of this medicine is Cetirizine Dihydrochloride 10 mg Film-coated Tablets (referred to as Cetirizine Tablets or Cetirizine throughout this leaflet).

Cetirizine dihydrochloride is the active ingredient of Cetirizine Tablets. Cetirizine is an antiallergic medication. In adults and children aged 6 year and above, Cetirizine is indicated

-    for the relief of hayfever (allergic rhinitis) and year round allergies such as dust or pet allergies (perennial allergic rhinitis)

-    for the relief of swelling, redness and itchiness of the skin

2.    BEFORE YOU TAKE CETIRIZINE TABLETS

Do not take Cetirizine Tablets

•    if you are known to be allergic (hypersensitive) to the active substance of Cetirizine, to any of its excipients (other constituents), to hydroxyzine or to piperazine derivatives (closely related active substances of other medicines).

•    if you have a severe kidney disease (severe kidney failure with creatinine clearance below 10 ml/min).

•    if you have hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

•    if you are breast-feeding

Take special care with Cetirizine Tablets

-    If you are a patient with renal insufficiency, that is, when the kidneys fail to function properly, please ask your doctor for advice. If necessary, you will take a lower dose. The new dose will be determined by your doctor.

-    If you are an epileptic patient or a patient at risk of experiencing fits, you should ask your doctor for advice.

No noticeable interactions have been observed between alcohol (at a level of 0.5 per millilitre in the blood, which is equivalent to one glass of wine) and cetirizine used at the normal doses. As with all antihistamines, it is recommended to avoid excessive alcohol consumption when taking Cetirizine.

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.

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

Taking Cetirizine with food and drink

Food does not noticeably affect the absorption of cetirizine.

Pregnancy and breast-feeding

Ask your doctor for advice before taking any medicine.

As with other drugs, use of Cetirizine Tablets should be avoided in pregnant women. Accidental use of the drug by a pregnant woman should not produce any harmful effects on the foetus. Nevertheless, the administration of the medicine should be discontinued.

Do not take Cetirizine Tablets during breast-feeding because cetirizine passes into breast milk.

Driving and using machines

Antihistamines can cause drowsiness in some patients.

Although this has not been reported with cetirizine at the recommended dose, please be cautious whilst driving or operating machinery.

Important information about some of the ingredients of Cetirizine

Cetirizine tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicinal product.

3.    HOW TO TAKE CETIRIZINE TABLETS

How and when should you take Cetirizine?

These guidelines apply unless your doctor has given you different instructions on how to use Cetirizine tablets. Please follow these instructions; otherwise Cetirizine tablets may not be fully effective.

Tablets need to be swallowed with a glass of liquid.

Dosage

-    Adults and adolescents above 12 years old: 10 mg once daily as 1 tablet.

-    Children between 6 and 12 years old: 10 mg once daily (1 tablet).

-    Patients with moderate to severe kidney failure: Patients with moderate kidney failure are recommended to take 5 mg once daily (half a tablet).

If you feel that the effect of Cetirizine tablets is too weak or too strong, please consult your doctor.

If you take more Cetirizine Tablets than you should

If you think you have taken an overdose of Cetirizine Tablets, please inform your doctor. Your doctor will then decide what measures, if any, should be taken.

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