CETIRIZIN

CETIRIZIN-ratiopharm Saft

Important notes (mandatory information)

Cetirizine-ratiopharm syrup. Active ingredient: Cetirizine dihydrochloride. Areas of application: for adults and children from the age of 2 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 syrup 1 mg/ml oral solution for children from 2 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 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 SYRUP AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING CETIRIZINE-RATIOPHARM SYRUP?
3. HOW TO TAKE CETIRIZINE-RATIOPHARM SYRUP?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE CETIRIZINE-RATIOPHARM SYRUP?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

Cetirizine dihydrochloride is the active ingredient in Cetirizine-ratiopharm syrup. Cetirizine-ratiopharm syrup is an antiallergic. In adults and children from the age of 2, Cetirizine-ratiopharm syrup 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 SYRUP?

Cetirizine-ratiopharm syrup must not be taken:

• if you are allergic to cetirizine dihydrochloride, any of the other ingredients listed in section 6 of this medicine, methyl(4-hydroxybenzoate), propyl(4-hydroxybenzoate), to 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 syrup. 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 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 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 Cetirizine-ratiopharm syrup and alcohol at the same time. If you are going to have an allergy test, please ask your doctor if you should stop taking Cetirizine-ratiopharm syrup for a few days before the test, as this medicine could affect the result of an allergy test.

Taking Cetirizine-ratiopharm syrup 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 syrup with food and drink

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

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 syrup 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 syrup while breast-feeding until you have consulted your doctor.

Driving and using machines

In clinical studies, cetirizine dihydrochloride 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 secure hold or operate machinery, you should carefully observe your reaction to the medicine after taking Cetirizine-ratiopharm syrup. You should not use more than the recommended dose.

Cetirizine-ratiopharm syrup contains methyl(4-hydroxybenzoate), propyl(4-hydroxybenzoate), propylene glycol, sodium and sorbitol

This medicine contains methyl(4-hydroxybenzoate) and propyl(4-hydroxybenzoate) which may cause allergic reactions, including delayed reactions. This medicine contains 490 mg propylene glycol in 10 ml oral solution. This medicine contains less than 1 mmol sodium (23 mg) per 10 ml oral solution, i.e. it is essentially "sodium-free". This medicine contains 4.5 g sorbitol per 10 ml. Sorbitol is a source of fructose. Talk to your doctor before you (or your child) take (or receive) this medicine if your doctor has told you (or your child) that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI) - a rare, inherited condition in which a person cannot break down fructose. Sorbitol can cause gastrointestinal discomfort and may have a mild laxative effect. 10 ml Cetirizine-ratiopharm syrup contains 4.5 g sorbitol (a source of 1.13 g fructose).

Note for diabetics

The calorific value is 2.6 kcal/g sorbitol.

3. HOW TO TAKE CETIRIZINE-RATIOPHARM SYRUP?

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 solution can be taken undiluted. Please use the enclosed measuring cup for dosing.

Adults and adolescents over 12 years of age

The recommended dose is: 10 ml solution (= 10 mg) once daily.

Children between 6 and 12 years of age

The recommended dose is: 5 ml solution (= 5 mg) twice daily.

Children between 2 and 6 years of age

The recommended dose is: 2.5 ml solution (= 2.5 mg) twice daily.

Patients with renal impairment

Patients with moderate renal impairment are recommended to take 5 ml solution (= 5 mg) once daily. 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 syrup 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 consult your doctor or pharmacist for advice.

If you have taken more Cetirizine-ratiopharm syrup than you should

If you think you have taken an overdose of Cetirizine-ratiopharm syrup, 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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