Xyzal 5 mg x7 tablets UCB Pharma

XYZAL / XYZAL TABLET 5MG X 7 tablets.
For the treatment of symptoms associated with allergic conditions such as: – seasonal allergic rhinitis (including ocular symptoms) – perennial allergic rhinitis – chronic idiopathic urticaria 
 
Dosage and administration:
Adults and children over 12 years of age, one tablet daily. 
Children – 6-12 years: 1 tablet daily 
In children under 6 years of age, accurate dosing is not possible.
 
Ingredients:
Levocetirizine. Antiallergic agent.
 
PACKAGE LEAFLET: INFORMATION FOR THE USER Xyzal 5 mg film-coated tablets levocetirizine dihydrochloride (levocetirizine dihydrochloride) Read all of this leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, to get the best results from your 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. 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 The active substance of Xyzal is levocetirizine dihydrochloride. Xyzal is an antiallergic medicine. For the treatment of the 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 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 for children under 6 years of age, as the film-coated tablets do not allow dose adjustment. If you cannot empty your bladder due to spinal cord injury or an enlarged prostate, please consult your doctor. 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. Pregnancy and breast-feeding Ask your doctor or pharmacist before taking any medicine. Tell your doctor if you are pregnant, planning to become pregnant or breastfeeding. Driving and using machines Some patients taking Xyzal may experience drowsiness, fatigue and exhaustion. If you intend to drive, perform potentially dangerous activities or operate machinery, we recommend that you wait to establish the effects of the medicine. Specific studies conducted in healthy people, after using 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 These tablets contain lactose. If your doctor has told you that you have an intolerance to some sugars, contact him before taking this product. 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. The recommended dose for adults and children aged 6 years and over is one tablet daily. Patients with impaired renal function should take a lower dose, taking into account the severity of their kidney disease. Patients with liver impairment should take the usual recommended dose. Patients with impaired renal and liver function may take a lower dose, taking into account the severity of their kidney disease. In children, the dose should be adjusted to their weight. Your doctor will determine the dose. Xyzal is not suitable for children under 6 years of age. Administration The tablets should be swallowed whole with water; they can be taken with or without food. If you take more Xyzal than you should A significant overdose may cause drowsiness in adults. In children, initial agitation and restlessness are possible, followed by drowsiness. If you think you have taken more Xyzal than you should, 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 next dose at the appointed time 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 before treatment with Xyzal. If you have any further questions on 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. The following, mostly mild to moderate side effects, have been observed frequently (1% to 10%): dry mouth, headache, tiredness and drowsiness. Uncommon (0.1% to 1%) side effects are: fatigue and abdominal pain. Other side effects have been reported, such as: palpitations, seizures, tingling, dizziness, syncope, tremor, dysgeusia (taste disturbance), feeling of spinning or moving, visual impairment, blurred vision, painful or difficult urination, inability to completely empty the bladder, edema, pruritus (itching), rash, urticaria (swelling, redness and itching of the skin), skin rash, shortness of breath, weight gain, muscle pain, aggressive or overexcited behavior, hepatitis, altered liver function, increased appetite 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 can 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 XYZAL Keep out of the reach and sight of children. Do not use Xyzal after the expiry date which is stated on the carton after „EXP“. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. 6. FURTHER INFORMATION What Xyzal contains The active substance is: 5 mg levocetirizine dihydrochloride. Each film-coated tablet contains 5 mg levocetirizine dihydrochloride. The other ingredients are: cellulose, microcrystalline; lactose monohydrate; silica, colloidal anhydrous; magnesium stearate; hypromellose (E464), titanium dioxide (E171) and macrogol 400. What Xyzal looks like and contents of the pack Xyzal are white to off-white film-coated tablets, oval, with the code „Y“ on one side. They are available in blisters in packs of 7, 10, 14, 20 and 30 tablets. Not all pack sizes may be marketed. Marketing authorisation holder and manufacturer Marketing authorisation holder: UCB Pharma GmbH, Germany. Manufacturer: UCB Pharma sa, Italy.