CETIRIZIN-ratiopharm for allergies 10 mg film-coated tablets.

Important notes (mandatory information)

Cetirizine-ratiopharm for allergies film-coated tablets. Active ingredient: Cetirizine dihydrochloride 10 mg. Areas of application: for adults and children from the age of 6 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

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

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 directed 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 experience 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 even worse after 3 days, contact your doctor.

What this leaflet contains

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

1. WHAT IS CETIRIZINE-RATIOPHARM AND WHAT IS IT USED FOR?

Cetirizine dihydrochloride is the active ingredient of Cetirizine-ratiopharm. Cetirizine-ratiopharm is an antiallergic. In adults and children from the age of 6, Cetirizine-ratiopharm is 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 CETIRIZINE-RATIOPHARM?

Cetirizine-ratiopharm must not be taken:

• if you are allergic to cetirizine dihydrochloride, any of the other ingredients of this medicine listed in section 6, hydroxyzine or other piperazine derivatives (closely related active ingredients 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 Cetirizine-ratiopharm. 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 are at risk of seizures, please consult your doctor for advice. No clinically significant interactions between alcohol (at a blood alcohol level of 0.5 per mille (g/l), equivalent to about one glass of wine) and cetirizine have been observed at recommended doses. However, there are no safety data when higher doses of cetirizine and alcohol are taken together. Therefore, as with all antihistamines, it is recommended to avoid taking Cetirizine-ratiopharm and alcohol at the same time. If you are scheduled to have an allergy test, please ask your doctor if you should stop taking Cetirizine-ratiopharm for a few days before the test, as this medicine could affect the results 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 Cetirizine-ratiopharm with other medicines

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

Taking Cetirizine-ratiopharm with food and drink

Food has no effect on the absorption of Cetirizine-ratiopharm.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Cetirizine-ratiopharm 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, you should not take Cetirizine-ratiopharm while breast-feeding until you have consulted your doctor.

Driving and using machines

In clinical studies, cetirizine dihydrochloride at the recommended dose did not show any signs of impairing attention, alertness and driving ability. If you intend to participate in road traffic, work without a secure hold or operate machinery, you should carefully observe your reaction to the medicine after taking Cetirizine-ratiopharm. You should not use more than the recommended dose.

Cetirizine-ratiopharm contains lactose

Please only take Cetirizine-ratiopharm after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

Cetirizine-ratiopharm contains sodium

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

3. HOW TO TAKE CETIRIZINE-RATIOPHARM?

Always take this medicine exactly as described in this leaflet or exactly as directed 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 of age

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

Children between 6 and 12 years of age

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

Patients with renal impairment

Patients with moderate renal 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 Cetirizine-ratiopharm 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 Cetirizine-ratiopharm than you should

If you think you have taken an overdose of Cetirizine-ratiopharm, 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, diarrhea, dizziness, fatigue, headache, malaise, dilated pupils, 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, drowsiness, 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