CETIRIZIN

CETIRIZIN AbZ 10 mg film-coated tablets

Important information (mandatory information)

Cetirizin AbZ 10 mg film-coated tablets. Active ingredient: Cetirizine dihydrochloride. Indications: for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis and/or for the relief of chronic hives (chronic idiopathic urticaria).

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Cetirizin AbZ 10 mg film-coated tablets for children from 6 years and adults
Active ingredient: Cetirizine dihydrochloride

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as instructed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after 3 days, contact your doctor.

What is in this package leaflet

1. WHAT IS CETIRIZIN ABZ AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETIRIZIN ABZ?
3. HOW TO TAKE CETIRIZIN ABZ?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE CETIRIZIN ABZ?
6. CONTENTS OF THE PACK AND FURTHER INFORMATION

1. WHAT IS CETIRIZIN ABZ AND WHAT IS IT USED FOR?

Cetirizine dihydrochloride is the active ingredient of Cetirizin AbZ. Cetirizin AbZ is an antiallergic medicine. In adults and children from 6 years of age, Cetirizin AbZ is indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis and/or for the relief of chronic hives (chronic idiopathic urticaria).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETIRIZIN ABZ?

Do not take Cetirizin AbZ:

• if you are allergic to cetirizine dihydrochloride, any of the other ingredients of this medicine listed in section 6, to hydroxyzine or other piperazine derivatives (closely related active substances of other medicines).
• if you have severe kidney disease (severe impairment of kidney function with a creatinine clearance below 10 ml/min).

Warnings and precautions

Please talk to your doctor or pharmacist before taking Cetirizin AbZ. If you suffer from impaired kidney function, please ask your doctor for advice; if necessary, you will take a lower dose. Your doctor will determine the new dose. If you have difficulty urinating (e.g. due to problems with the spinal cord, prostate or urinary bladder), please ask your doctor for advice. If you are an epileptic patient or are at risk of seizures, please ask your doctor for advice.

No clinically significant interactions between alcohol (at a blood level of 0.5 per mille (g/l), which corresponds to about one glass of wine) and cetirizine at recommended dosages have been observed. However, there is no safety data when higher cetirizine dosages and alcohol are taken together. Therefore, as with all antihistamines, it is recommended to avoid the concomitant use of Cetirizin AbZ and alcohol.

If you are scheduled for an allergy test, please ask your doctor if you should stop taking Cetirizin AbZ for a few days before the test, as this medicine could affect the result of an allergy test.

Children

Do not give this medicine to children under 6 years of age, as the required dose cannot be adjusted with the tablets.

Taking Cetirizin AbZ with other medicines

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

Taking Cetirizin AbZ with food and drink

Food has no influence on the absorption of Cetirizin AbZ.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Cetirizin AbZ should be avoided during pregnancy. Accidental intake of the medicine by pregnant women should not lead to harmful effects on the fetus. Nevertheless, the medicine should only be taken if necessary and after medical advice. Cetirizine passes into breast milk. Therefore, you should not take Cetirizin AbZ during breastfeeding until you have consulted your doctor.

Driving ability and ability to operate machinery

In clinical studies, cetirizine dihydrochloride at the recommended dose did not lead to any signs of impairment of attention, alertness and driving ability. If you intend to drive, work without a secure footing or operate machinery, you should carefully observe your reaction to the medicine after taking Cetirizin AbZ. You should not use more than the recommended dose.

Cetirizin AbZ contains lactose

Please take Cetirizin AbZ only after consulting your doctor if you know that you suffer from a sugar intolerance.

Cetirizin AbZ contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, i.e. it is almost "sodium-free".

3. HOW TO TAKE CETIRIZIN ABZ?

Always take this medicine exactly as described in this package leaflet or exactly as instructed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The tablets should be swallowed whole with a glass of liquid. The tablet can be divided into equal doses.

Adults and adolescents over 12 years

The recommended dose is 10 mg (1 tablet) once daily.

Children between 6 to 12 years

The recommended dose is 5 mg (half a tablet) twice daily.

Patients with renal impairment

Patients with moderate renal impairment are recommended to take 5 mg once daily. If you suffer from severe kidney disease, please talk to your doctor or pharmacist, who can adjust your dose accordingly. If your child suffers from severe kidney disease, please talk to your doctor or pharmacist, who can adjust the dose according to the child's needs.

If you have the impression that the effect of Cetirizin AbZ is too weak or too strong, please contact your doctor.

Duration of use

The duration of use depends on the type, duration and course of your symptoms. Please ask your doctor or pharmacist for advice.

If you have taken a larger quantity of Cetirizin AbZ than you should

If you think you have taken an overdose of Cetirizin AbZ, please tell 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, fatigue, headache, malaise, pupillary dilation, itching, restlessness, sedation, drowsiness, somnolence, accelerated heartbeat, tremor and urinary retention have been reported.

If you forget to take Cetirizin AbZ

Do not take a double dose if you have forgotten the previous dose.

If you stop taking Cetirizin AbZ

If you stop taking Cetirizin AbZ, pruritus (intense itching) and/or urticaria (hives) may recur in rare cases.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects occur rarely or very rarely. If you notice these side effects, you must stop taking the medicine immediately and contact your doctor: Allergic reactions, including severe allergic reactions and angioedema (severe allergic reaction that causes swelling of the face and throat). These reactions can occur shortly after you