XYZAL sol 5mg/ml 20 ml
KSIZAL solution 5 mg/ml. 20 ml.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Xyzal 5 mg/ml oral drops, solution
levocetirizine dihydrochloride
Read all of this leaflet carefully because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious or you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
1. WHAT KSYZAL IS AND WHAT IT IS USED FOR
The active substance of Xyzal is levocetirizine dihydrochloride. Xyzal is an antiallergic drug.
For the treatment of disease manifestations (symptoms) associated with:
allergic rhinitis (including persistent allergic rhinitis);
hives (urticaria).
2. BEFORE YOU TAKE XYZAL
Do not take Xyzal:
if you are allergic (hypersensitive) to the active substance, levocetirizine dihydrochloride, or to antihistamines or to any of the other ingredients of Xyzal (see "What Xyzal contains");
if you have severe kidney impairment (severe renal failure and creatinine clearance below 10 ml/min).
Take special care when using Xyzal
The use of Xyzal is not recommended in children under 2 years of age due to lack of experience in this age group.
If you are unable to empty your bladder due to a spinal cord injury or an enlarged prostate, please consult your doctor.
Use of other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Xyzal with food and drink
Caution is required when taking Xyzal and alcohol at the same time.
In sensitive patients, wakefulness may be affected by the concomitant administration of cetirizine or levocetirizine with alcohol or other drugs acting on the brain.
Xyzal can be taken with or without food.
Pregnancy and breastfeeding
Tell your doctor if you are pregnant, trying to become pregnant, or breastfeeding.
Consult your doctor or pharmacist before using any medicine.
Driving and using machines
Some patients taking Xyzal may experience drowsiness/sleepiness, fatigue and exhaustion. Be careful when driving or operating machinery until you know how the medicine affects you. Specific studies conducted in healthy people, after using levocetirizine at the recommended dose, did not reveal any impairment of concentration, reactions and the ability to drive.
Important information about some of the ingredients of Xyzal
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed), such as headache, stomach upset and diarrhoea.
3. HOW TO TAKE XYZAL
Always take Xyzal exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Dosage:
The usual dose is:
Adults and children over 6 years of age: 20 drops once daily.
Children aged 2 to 6 years: 5 drops twice daily.
The use of Xyzal is not recommended in newborns and young children under 2 years of age due to lack of experience in this age group.
Special instructions for use in special patient groups:
Patients with impaired kidney function should take a lower dose according to the severity of their kidney disease. In children, the dose should be based on their body weight. Your doctor will determine this dose.
Patients with severe renal impairment should not take Xyzal.
Patients who have only impaired liver function should take the usual prescribed dose.
Patients who have both kidney and liver problems may need a lower dose, depending on the severity of their kidney disease. In children, the dose should be based on their body weight. Your doctor will determine this dose.
Patients with hepatic impairment should take the usual prescribed dose.
Elderly patients do not need to change the dose if their renal function is normal.