KSISAL DROPS 5 mg x 20 ml

XYZAL salt. 5 mg/ml 20 ml indications:
Antiallergic agent (antihistamine for systemic use). 
For the treatment of disease manifestations (symptoms) associated with allergic conditions such as: 
allergic rhinitis (including persistent allergic rhinitis); 
chronic hives of unknown origin (chronic idiopathic urticaria). 
XYZAL salt. 5 mg/ml 20 ml dosage and administration:
The usual dose is: 
Adults and children over 6 years of age: 20 drops daily 
Children from 2 to 6 years of age: 5 drops twice daily. 
XYZAL salt. 5 mg/ml 20 ml ingredients:
The active substance is levocetirizine dihydrochloride. 
1 ml of oral solution contains 5 mg levocetirizine dihydrochloride. 
The other ingredients are: sodium acetate, acetic acid, propylene glycol, glycerol 85%, 
methyl parahydroxybenzoate, propyl parahydroxybenzoate, saccharin sodium, purified water. 
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. This medicine is available without a prescription for adults and children over 12 years of age and on prescription for children from 2 to 12 years of age. However, to get the best results from the treatment, you should carefully follow the instructions for use of the medicinal product. – Keep this leaflet. You may need to read it again. – If you need further information or advice, ask your pharmacist. – You should seek medical advice if your symptoms worsen or do not improve after 3 days. – If any of the side effects become serious, or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Xyzal is and what it is used for 2. Before you take Xyzal 3. How to take Xyzal 4. Possible side effects 5. How to store Xyzal 6. Further information 1. WHAT Xyzal IS AND WHAT IT IS USED FOR Antiallergic agent (antihistamine for systemic use). For the treatment of the symptoms associated with allergic conditions such as: • allergic rhinitis (including persistent allergic rhinitis); • chronic hives of unknown origin (chronic idiopathic urticaria). 2. BEFORE YOU TAKE Xyzal Do not take Xyzal • if you are allergic (hypersensitive) to levocetirizine dihydrochloride, to other 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 with Xyzal The use of Xyzal is not recommended in children under 2 years of age, due to lack of experience in this age group. Using other medicines Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those 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, the simultaneous use of cetirizine or levocetirizine with alcohol or other medicines acting on the central nervous system may have an effect. However, data from cetirizine do not show an increase in the effects of alcohol. Xyzal can be taken with or without food. Pregnancy and breast-feeding Ask your doctor or pharmacist before taking any medicine. As with other medicines, the use of Xyzal during pregnancy should be avoided. Accidental use by pregnant women should not lead to harm to the fetus, but the use of the medicine should nevertheless be discontinued. Xyzal is contraindicated in nursing mothers, since the racemate (cetirizine) is excreted in breast milk. Driving and using machines Some patients may experience drowsiness, fatigue and exhaustion when taking Xyzal. If you intend to drive, perform potentially hazardous activities or operate machinery, we recommend that you wait to establish the effects of the medicine. Special studies conducted in healthy people, after the use of levocetirizine at the recommended dose, have not found any impairment of attention, reactions and ability to drive. Important information about some of the ingredients of Xyzal Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause an allergic reaction (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 is 20 drops daily – Children from 2 to 6 years of age are 5 drops twice daily. The use of Xyzal is not recommended in 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 the kidney disease. In children, the dose should be adjusted to their weight. Patients with liver impairment should take the usual prescribed dose. Application: If no drops are coming out or the required amount has not been reached, stand the bottle upright and turn it upside down again, continue counting the drops. The drops should be taken orally with a spoon or diluted with water. When diluting the drops, it should be borne in mind, especially when administered to children, that the volume of water to which the drops are added should be adapted depending on the amount of water that the patient can swallow. The diluted solution should be taken immediately. When counting the drops, the bottle should be held vertically (with the bottom up). If no drops are coming out or the required amount has not been reached, stand the bottle upright and turn it upside down again, continue counting the drops. If you have taken more than the required dose of Xyzal Significant overdose can cause drowsiness in adults. In children, initial excitement and restlessness are possible, followed by drowsiness. If you think you have taken more than the required dose of Xyzal, please inform your doctor, he will decide what action to take. If you forget to take Xyzal If you forget to take Xyzal, or you have taken a lower dose than prescribed by your doctor, do not take a double dose to make up for the missed one; wait for the scheduled time for the next dose and take the usual dose prescribed by your doctor. If you stop taking Xyzal Stopping treatment with Xyzal earlier than expected does not lead to any other harmful consequences, except that the symptoms of the disease will progressively return, and their strength will not be higher than that before treatment with Xyzal. If you have any further questions related to the use of this product, please ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Xyzal can cause side effects, although not everybody gets them. Common (1 % to 10%) side effects are: dry mouth, headache, fatigue and drowsiness. Uncommon (0.1% to 1%) side effects are: fatigue and abdominal pain. Other side effects are: palpitations, tachycardia (rapid heartbeat), convulsions, allergic reactions, some of which are severe, visual impairment, edema, pruritus (itching), rash, urticaria (swelling, redness and itching of the skin), shortness of breath, weight gain, muscle pain, aggressive or overexcited behavior, hallucinations, depression, hepatitis, abnormal liver function tests and nausea. At the first sign of a hypersensitivity reaction, stop using Xyzal and tell your doctor. Symptoms of a hypersensitivity reaction include: swelling of the mouth, face and/or throat, difficulty breathing or swallowing (tightness in the chest or wheezing), hives, an unexpected drop in blood pressure leading to collapse or shock, which may be fatal. If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE Ksizal Keep out of the reach and sight of children. Do not use Ksizal after the expiry date which is stated on the carton after „EXP“. The expiry date refers to the last day of that month. Store in the original package and protect from light. The shelf life after first opening is 3 months. 6. FURTHER INFORMATION What Xyzal contains – The active substance is levocetirizine dihydrochloride 1 ml of oral solution contains 5 mg of levocetirizine dihydrochloride. – The other ingredients are: sodium acetate, acetic acid, propylene glycol, glycerol 85%, methyl parahydroxybenzoate, propyl parahydroxybenzoate, saccharin sodium, purified water. What Xyzal looks like and contents of the pack Xyzal is packaged in dark glass bottles, with a dropper made of natural low-density polyethylene and closed with a white polypropylene child-resistant stopper. Capacity of 20 ml oral drops, solution. Each carton contains 1 bottle and a leaflet. Marketing authorisation holder: UCB GmbH, Alfted-Nobel-Str. 10, 40789 Monheim, Germany Manufacturer: UCB Pharma SpA, Via Praglia 15, 1-10044 Pianezza (TO), Italy For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: UCB Bulgaria EOOD tel: (02) 962 99 20