Zyrtec

ZYRTEC 10 mg film-coated tablets

Important notes (mandatory information)

Zyrtec 10 mg film-coated tablets. Active ingredient: Cetirizine dihydrochloride. Areas of application: for the relief of nasal and eye symptoms in seasonal and perennial allergic rhinitis and for the relief of hives (urticaria).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Zyrtec 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 leaflet or exactly as your doctor or pharmacist has told you.

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

What this leaflet contains

1. WHAT IS ZYRTEC AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ZYRTEC?
3. HOW TO TAKE ZYRTEC?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE ZYRTEC?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS ZYRTEC AND WHAT IS IT USED FOR?

Cetirizine dihydrochloride is the active ingredient in Zyrtec. Zyrtec is an antiallergic. In adults and children from the age of 6, Zyrtec 10 mg film-coated tablets are indicated for the relief of nasal and eye symptoms in seasonal and perennial allergic rhinitis and for the relief of hives (urticaria).

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ZYRTEC?

Zyrtec must not be taken:

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

Warnings and precautions

If you have impaired kidney function, please consult 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 bladder), please consult your doctor for advice. If you are an epilepsy patient or at risk of seizures, please consult your doctor for advice. No clinically significant interactions between alcohol (at a blood level of 0.5 per mille (g/l), equivalent to about one glass of wine) and cetirizine have been observed at recommended dosages. However, there is no safety data when higher doses of cetirizine and alcohol are taken together. Therefore, as with all antihistamines, it is recommended to avoid taking Zyrtec and alcohol at the same time. If you are going to have an allergy test, please ask your doctor whether you should stop taking Zyrtec 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 tablets cannot be used to adjust the required dose.

Taking Zyrtec with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. Taking Zyrtec with food and drink Food has no effect on the absorption of Zyrtec.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor for advice before taking this medicine. Zyrtec should be avoided during pregnancy. Accidental ingestion 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 consulting a doctor. Cetirizine passes into breast milk. Therefore, until you have consulted your doctor, you should not take Zyrtec while breast-feeding.

Driving and using machines

In clinical studies, Zyrtec at the recommended dose did not lead to any signs of impaired attention, alertness and driving ability. If you intend to participate in road traffic, work without a safe hold or operate machinery, you should carefully observe your reaction to the medicine after taking Zyrtec. You should not use more than the recommended dose.

Zyrtec contains lactose

Therefore, please only take Zyrtec after consulting your doctor if you are aware that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE ZYRTEC?

Always take this medicine exactly as described in this leaflet or exactly as agreed with 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 two equal doses.

Adults and adolescents over 12 years of age

The recommended dose is: 10 mg once a day as 1 tablet.

Children between 6 and 12 years of age

The recommended dose is: 5 mg twice a day as half a tablet twice a day.

Patients with kidney impairment

Patients with moderate kidney impairment are recommended to take 5 mg once a day. If you have severe kidney disease, please talk to your doctor or pharmacist, who can adjust your dose accordingly. If your child has 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 Zyrtec 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 complaints. Please consult your doctor or pharmacist for advice.

If you have taken more Zyrtec than you should

If you think you have taken an overdose of Zyrtec, please tell your doctor. Your doctor will then decide what measures, if any, need to be taken. After an overdose, the side effects described below may occur with increased intensity. Undesirable effects such as confusion, diarrhoea, dizziness, fatigue, headache, malaise, pupil dilation, itching, restlessness, sedation, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, drowsiness, 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