Rolinoz oral drops solution 10 mg/ml bottle 20 ml

• 1 ml of solution contains cetirizine dihydrochloride 10 mg;
• Excipients: glycerin; propylene glycol; sodium saccharin; methylparaben (E 218); propylparaben (E 216); sodium acetate, trihydrate; glacial acetic acid; purified water.

Hypersensitivity to the active substance, other components of the drug, to hydroxyzine or to any piperazine derivatives in history; severe renal impairment with creatinine clearance less than 10 ml/min.

The drug is intended for oral use.

Adults and children over 12 years of age – the drug should be used at a dose of 10 mg (20 drops) once a day.

Children aged 6 to 12 years – the drug should be used at a dose of 5 mg (10 drops) 2 times a day.

Children aged 2 to 6 years – use the drug at a dose of 2.5 mg (5 drops) 2 times a day.

For children with impaired renal function, the dosage should be adjusted individually, depending on the patient’s creatinine clearance, age, and body weight.

Antihistamines, including cetirizine, suppress the response to skin allergy testing, so before conducting it, the drug should be discontinued 3 days before the study (withdrawal period).

Pruritus and/or urticaria have been reported to occur after discontinuation of cetirizine, even when these symptoms were not previously observed. In some cases, they may be severe enough to require re-introduction of cetirizine. The need for re-introduction of treatment depends on the symptoms that occur.

No clinically significant interactions with alcohol have been observed when cetirizine is used in therapeutic doses (at blood alcohol levels of 0.5 g/l). However, caution should be exercised in case of concomitant use.

Pregnant women

During pregnancy, the drug should be used with caution when, in the opinion of the doctor, the benefit of use for the woman outweighs the potential risk to the fetus.

Children

The drug is prescribed for children from 2 years of age.

Drivers

Patients who drive vehicles or operate machinery should not exceed recommended doses and should take into account their own body’s response to the drug.

Patients who experience drowsiness should refrain from driving or operating machinery.

In sensitive patients, simultaneous administration of the drug with other agents that depress the central nervous system may cause additional deterioration in attention.

Symptoms observed after significant overdose of cetirizine are mainly related to effects on the central nervous system or to effects that may indicate anticholinergic activity. Adverse reactions reported after doses exceeding at least 5 times the recommended daily dose include: confusion, diarrhea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, sedation, drowsiness, stupor, tachycardia, tremor, urinary retention.

On the mental side – drowsiness.

From the nervous system – dizziness, headache.

On the part of the respiratory system, chest organs and mediastinum – pharyngitis.

On the part of the digestive tract – abdominal pain, dry mouth, nausea.

General disorders – increased fatigue.

Store at a temperature not exceeding 25 °C out of the reach of children.