PACKAGE LEAFLET: INFORMATION FOR THE USER

Cetirizine 10mg Film-coated Tablets

cetirizine dihydrochloride

Read all of this leaflet carefully before you start taking this medicine.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    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 is and what it is used for

2.    Before you take Cetirizine

3.    How to take Cetirizine

4.    Possible side effects

5.    How to store Cetirizine

6.    Further information

1.    WHAT CETIRIZINE IS AND WHAT IT IS USED FOR

Cetirizine dihydrochloride is the active ingredient of Cetirizine. Cetirizine is an antiallergic medication.

In adults and children aged 6 year and above, Cetirizine is indicated

-    for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.

-    for the relief of chronic nettle rash (chronic idiopathic urticaria).

2.    BEFORE YOU TAKE CETIRIZINE Do not take Cetirizine

-    if you have a severe kidney disease (severe renal failure with creatinine clearance below 10ml/min);

-    if you are known to be 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).

You should not take Cetirizine 10 mg tablets:

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

Take special care with Cetirizine

If you are a patient with renal insufficiency, 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 convulsions, you should ask your doctor for advice.

No interactions susceptible to have a noticeable impact have been observed between alcohol (at the blood level of 0.5 per mille corresponding to one glass of wine) and cetirizine used at the normal doses. However, as it is the case with all antihistamines, it is recommended to avoid concurrent consumption of alcohol.

If you need a skin (allergy) test, tell the doctor you are taking these tablets, as antihistamines can affect skin test results. You will need to stop treatment three days before the test.

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 affect noticeably the absorbtion of cetirizine.

Pregnancy and breast-feeding

Ask your doctor for advice before taking any medicine.

As with other drugs, use of Cetirizine 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.

You should not take Cetirizine during breast feeding because cetirizine passes into breast milk.

Driving and using machines

Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking Cetirizine at the recommended dose.

If you are intending to drive, engage in potentially hazardous activities or operate machinery, you should not exceed the recommended dose. You should closely observe your response to the drug.

If you are a sensitive patient, you may find that the simultaneous use of alcohol or other nervous depressant agents may additionally affect your attention and ability to react.

Important information about some of the ingredients of Cetirizine

Cetirizine film-coated tablets contains 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

How and when should you take Cetirizine?

These guidelines apply unless your doctor has given you different instructions on how to use Cetirizine.

Please follow these instructions, otherwise Cetirizine may not be fully effective.

Tablets need to be swallowed with a glass of liquid.

Adults and adolescents above 12 years old:

10 mg once daily as 1 tablet.

Children between 6 and 12 years old:

5 mg twice daily as a half tablet twice daily.

Patients with moderate to severe renal impairment

Patients with moderate renal impairment are recommended to take 5 mg once daily.

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

Duration of treatment:

The duration of treatment depends on the type, duration and course of your complaints and is determined by your doctor.

If you take more Cetirizine than you should

If you think you have taken an overdose of Cetirizine please inform your doctor.

Your doctor will then decide what measures, if any, should be taken.

After an overdose, the side effects described below may occur with increased intensity. Adverse effects such as confusion, diarrhoea, dizziness, tiredness, headache, ailing, dilating of pupil, itching, restlessness, sedation, somnolence, stupor, abnormal rapid heart rate, tremors and urinary retention have been reported.

If you forget to take Cetirizine

Do not take a double dose to make up for forgotten dose.

If you stop taking Cetirizine

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.

Following side effects have been reported in post marketing experience. Frequencies are defined as follows: Very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data)

-    Blood and lymphatic disorders:

very rare: thrombocytopenia (low levels of blood platelets)

-    Body as a whole: common: fatigue

-    Cardiac disorders:

rare: tachycardia (heart beating too fast)

-    Eye disorders:

very rare: accommodation disorder, blurred vision, oculogyration (eyes having uncontrolled circular movements)

-    Gastro-intestinal disorders: common: dry mouth, nausea, diarrhoea uncommon:, abdominal pain

-    General disorders and administration site conditions: uncommon: asthenia (extreme fatigue), malaise rare: oedema (swelling)

-    Immune system disorders:

rare: allergic reactions, some severe (very rare)

-    Hepatobiliary disorders: rare: liver function abnormal

-    Investigations:

rare: weight increased

-    Nervous system disorders: common: dizziness, headache

uncommon: paresthesia (abnormal feelings of the skin) rare: convulsions

very rare: syncope, tremor, dysgeusia (altered taste) not known: amnesia, memory impairment.

- Psychiatric disorders:

common: somnolence uncommon: agitation

rare: aggression, confusion, depression, hallucination, insomnia very rare: tic

-    Renal and urinary disorders:

very rare: abnormal elimination of urine

-    Respiratory system disorders: common: pharyngitis, rhinitis

-    Skin and subcutaneous tissue disorders: uncommon: pruritus, rash

rare: urticaria

very rare: oedema, fixed drug eruption

If you develop one of the side effects described above, please inform your doctor. At the first signs of a hypersensitivity reaction, stop taking Cetirizine. Your doctor will then assess the severity and decide on any further measures that may be necessary.

If you think you have any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5.    HOW TO STORE CETIRIZINE

Keep out of the reach and sight of children.

Do not use Cetirizine after the expiry date which is stated on the box and blister.

This medicine does not require any special storage conditions.

6.    FURTHER INFORMATION What Cetirizine contains

-    The active substance of Cetirizine is cetirizine dihydrochloride. One film-coated tablet contains 10 mg cetirizine dihydrochloride.

-    The other ingredients are lactose monohydrate, pregelatinised maize starch, povidone, magnesium stearate, hydroxypropylmethyl cellulose (E464), macrogol, titanium dioxide (E171) and talc.

What Cetirizine looks like and contents of the pack

The tablets are white and capsule-shaped with ‘CZ 10’on one side and ‘G’ on the other. All tablets have a breakline.

Packed in bottles of 30, 100 and 250 tablets and blister packs of 7, 10, 14, 15, 20, 30, 50, 60, 90 and 100 tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder

Generics [UK] Limited t/a Mylan

Station Close

Potters Bar

Hertfordshire

EN6 1TL

United Kingdom

Manufacturer

McDermott Laboratories Limited t/a Gerard 35-36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria: Cetirizindihydrochlorid “Arcana” 10mg Filmtabletten Belgium: Cetirizine Mylan 10mg filmomhulde tabletten Denmark: Cetirizin Mylan NM Germany: Cetidura 10mg Filmtabletten

Italy: Cetirizina Mylan Generics 10mg compresse rivestite con film Luxumbourg: Cetirizine-Mylan 10mg

Netherlands: Cetirizine diHCl Mylan 10mg filmomhulde tabletten Norway: Cetirizin Mylan NM

Portugal: Cetirizine Mylan Genericos 10mg comprimidos revestidos Spain: Cetirizina Mylan 10mg, comprimidos recubiertos Sweden: Cetirizin Mylan 10 mg filmdragerad tablett United Kingdom: Cetirizine 10mg Tablets

This leaflet was last approved in 04/2011