Cetirizine diHCl PCH 10 mg, filmomhulde tabletten

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 urticaria.

You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

Do not take Cetirizine

• if you are allergic (hypersensitive) to the active substance of Cetirizine or any of the other ingredients of Cetirizine (listed in section 6), to hydroxyzine or to piperazine derivatives (closely related active substances of other medicines).
• if you have a severe kidney disease (severe renal failure with creatinine clearance below 10 ml/min); Cetirizine

Warnings and precautions

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 have problems passing urine (like spinal cord problems or prostate or bladder problems), please ask your doctor for advice.

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

If you are going to have an allergy skin test please tell your doctor that you currently take Cetirizine. . Usually you will need to stop taking any medicines for a period of 3 days before the allergy skin test.

No clinically significant interactions have been observed between alcohol (at the blood level of 0.5 per mille (g/l) corresponding to one glass of wine) and cetirizine used at the recommended doses. However, there are no data available on the safety when higher doses of cetirizine and alcohol are taken together. Therefore, as it is the case with all antihistamines, it is recommended to avoid taking /../ with alcohol.

Other medicines and Cetirizine

Tell your doctor or pharmacist if you are taking/using or have recently taken/used or might take/use any other medicines.

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

Taking Cetirizine with food

Food does not affect noticeably the absorption of cetirizine.

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.

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.

Cetirizine 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.

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.

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 renal impairment

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

If you suffer from severe kidney disease, please contact your doctor or pharmacist who may adjust the dose accordingly.

If your child suffers from kidney disease, please contact your doctor or pharmacist who may adjust the dose according to your child’s needs.

The tablet can be divided into equal doses.

Direction for use

If your treatment with /.../ stipulates that you have to split tablets, you should ideally do so as follows. Place the tablet on a hard, flat surface (such as a table top or plate) with the score line facing upwards. Then press with both of your index fingers (or thumbs) at the same time briefly and firmly on the outer edges to the left and right of the score line as shown in the graphical representation below.

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 a forgotten dose.

If you stop taking Cetirizine

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

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

Following side effects have been reported in post marketing experience.

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

• fatigue,
• dry mouth, nausea, diarrhoea,
• dizziness, headache,
• somnolence (sleepiness),
• pharyngitis, rhinitis (in children)

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

• abdominal pain,
• asthenia (extreme fatigue), malaise,
• paresthesia (abnormal feelings of the skin),
• agitation,
• pruritus (itchy skin), rash

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

• tachycardia (heart beating too fast),
• allergic reactions,
• oedema (swelling),
• liver function abnormal,
• weight increased,
• convulsions,

• aggression, confusion, depression, hallucination, insomnia,
• urticaria (hives)

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

• thrombocytopenia (low levels of blood platelets),
• accommodation disorder (difficulty focusing), blurred vision, oculogyration (eyes having uncontrolled circular movements),
• syncope, dyskinesia (involuntary movements), dystonia (abnormal prolonged muscular contractions),tremor, dysgeusia (altered taste),
• tic (habit spasm),
• abnormal elimination of urine (bed wetting, pain and/or difficulty passing water),
• angioedema (serious allergic reaction which causes swelling of the face or throat), fixed drug eruption
• severe allergic reactions,

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

• amnesia, memory impairment
• increased appetite,
• suicidal ideation (recurring thoughts of or preoccupation with suicide)
• vertigo (sensation of rotation or movement)
• urinary retention (inability to completely empty the urinary bladder)

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

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.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the box and blister after {abbreviation used for expiry date}.The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 protect the environment.

What /.../ contains

The active substance is cetirizine dihydrochloride.

One film-coated tablet contains 10 mg cetirizine dihydrochloride.

The other ingredients are lactose monohydrate, microcrystalline cellulose, colloidal silica, magnesium stearate, titanium dioxide (E171), hypromellose (E464) and macrogol.

What CETIRIZINE looks like and contents of the pack

The	film-coated tablet is white to almost white, round, biconvex with breakscore on
one	side and approximately 6,5 mm in diameter.

The tablet can be divided into equal doses.

PVC//PVDC/alu blisters.

Blister with 7, 14, 28, 30, 50x1, 60 and 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Nederland B.V.

Swensweg 5

2031 GA Haarlem

Nederland

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3

D-89143 Blaubeuren

Duitsland

TEVA SANTE

Rue Bellocier

89100 Sens

Frankrijk

In het Register ingeschreven onder

Cetirizine diHCl PCH 10 mg, filmomhulde tabletten: RVG 111430

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

Denmark: Zynor

France: CETIRIZINE RATIO CONSEIL 10 mg, comprimé pelliculé sécable Ireland: Zynor Allergy 10mg Film-coated Tablets Italy: TICERIN

Italy: TICERIN

Sweden: Cetirizine Teva 10mg filmdragerade tabletter United Kingdom: Cetirizine 10 mg Film-Coated Tablets

Netherland: Cetirizine diHCl PCH 10 mg, filmomhulde tabletten

This leaflet was last revised in juni 2013.