Xazal 5 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the patient
Xazal 5 mg film-coated tablets
For adults and children aged 6 years and older
Levocetirizine dihydrochloride
Read all of this leaflet carefully before you start taking this medicine 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 only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Xazal is and what it is used for
- What you need to know before you take Xazal
- How to take Xazal
- Possible side effects
- How to store Xazal
Pack contents and additional information
1. What Xazal is and what it is used for
The active substance of Xazal is levocetirizine dihydrochloride. Xazal is an antiallergy medicine.
For the treatment of signs of disease (symptoms) associated with:
- Allergic rhinitis (including persistent allergic rhinitis);
Urticaria.
2. What you need to know before taking Xazal
Do not take Xazal
- If you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or any of the other ingredients of Xazal (listed in section 6).
- If you have severe kidney disease requiring dialysis.
Warnings and precautions
Talk to your doctor or pharmacist before taking Xazal.
If you have any condition that impairs your ability to empty the urinary bladder (such as spinal cord damage or enlarged prostate), please inform your doctor.
If you have epilepsy or are at risk of seizures, please consult your doctor, as the use of Xazal may worsen seizures.
If you are scheduled to undergo allergy testing, ask your doctor whether you should stop taking Xazal several days before the test. This medicine may affect the results of allergy testing.
Children
The use of Xazal is not recommended in children under 6 years of age, as the film-coated tablets do not allow for dose adjustment.
Other medicines and Xazal
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taking Xazal with food, drinks, and alcohol
Caution is advised when taking Xazal together with alcohol or other agents acting on the central nervous system. In sensitive patients, taking Xazal simultaneously with alcohol or other central nervous system agents may cause additional reduction in attention capacity and performance.
Xazal can be taken either on an empty stomach or with food.
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Some patients treated with Xazal may experience drowsiness/sedation, fatigue, and exhaustion. Be cautious when driving or operating machinery until you know how this medication affects you. However, in specific studies conducted in healthy individuals, no impairments in attention, reaction ability, or driving skills were detected after taking levocetirizine at the recommended dose.
Xazal contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Xazal
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose for adults and children aged 6 years and older is one tablet daily.
Special dosing instructions for specific populations:
Renal and hepatic impairment
Patients with renal impairment should receive a reduced dose according to the severity of their kidney disease, and in children the dose will also be selected based on body weight; the dose will be determined by your doctor.
Patients with severe kidney disease requiring dialysis must not take Xazal.
Patients with hepatic impairment alone should take the standard prescribed dose.
Patients with both hepatic and renal impairment should take a reduced dose according to the severity of their kidney disease, and in children the dose will be based on body weight; the dose will be determined by your doctor.
Patients aged 65 years and older
Dosage adjustment is not necessary in elderly patients if renal function is normal.
Use in children
The use of Xazal is not recommended in children under 6 years of age.
How and when should you take Xazal?
For oral use only.
Xazal tablets should be swallowed whole with water and may be taken either on an empty stomach or with food.
How long should your treatment with Xazal last?
The duration of treatment depends on the type, duration, and course of symptoms, and must be determined by your doctor.
If you take more Xazal than you should
If you take more Xazal than you should, somnolence may occur in adults. In children, initial agitation and restlessness may occur, followed by somnolence.
In case of overdose or accidental ingestion of Xazal, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone number: 915 620 420.
If you forget to take Xazal
If you forget to take Xazal, or if you take a lower dose than prescribed by your doctor, do not take a double dose to make up for the missed doses. Continue taking your normal dose at the next scheduled time.
If you stop taking Xazal
Discontinuation of treatment should not have negative effects. However, pruritus (intense itching) may rarely occur when stopping Xazal, even if these symptoms were not present at the start of treatment. Symptoms may resolve spontaneously. In some cases, symptoms may be severe and require restarting treatment. Symptoms usually resolve when treatment is restarted.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Common: may affect up to 1 in 10 people
Dry mouth, headache, fatigue and drowsiness.
Uncommon: may affect up to 1 in 100 people
Exhaustion and abdominal pain.
Frequency not known: cannot be estimated from available data
Other adverse effects that have also been reported include palpitations, increased heart rate (tachycardia), seizures, tingling, dizziness, fainting, tremor, dysgeusia (altered sense of taste), sensation of rotation or movement, visual disturbances, blurred vision, oculogyric crisis (uncontrolled circular eye movements), pain or difficulty urinating, inability to urinate, edema, pruritus (itching), rash, urticaria (swelling, redness and itching of the skin), skin rash, shortness of breath, weight gain, muscle pain, joint pain, aggressive or agitated behavior, hallucinations, depression, insomnia, recurrent thoughts or concerns about suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea and diarrhea.
Pruritus (intense itching) when treatment is discontinued.
At the first signs of a hypersensitivity reaction, stop taking Xazal and inform your doctor immediately. Symptoms of a hypersensitivity reaction may include: swelling of the mouth, tongue, face and/or neck, difficulty breathing or swallowing (chest tightness or whistling sounds), hives, sudden drop in blood pressure which may lead to collapse or shock, any of which may be fatal.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Xazal
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the container and label after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point in your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of Xazal
- The active substance is levocetirizine dihydrochloride.
- Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride.
- The other components are microcrystalline cellulose, monohydrate lactose, anhydrous colloidal silica, magnesium stearate, hypromellose (E464), titanium dioxide (E171), and macrogol 400.
Appearance of the product and contents of the pack
The film-coated tablets are white or almost white, oval-shaped, with the mark "Y" engraved on one side.
They are packaged in blisters containing 1, 2, 4, 5, 7, 10, 2x10, 10x10, 14, 15, 20, 21, 28, 30, 40, 50, 60, 70, 90 and 100 tablets. Not all pack sizes may be commercially available.
Marketing Authorization Holder
UCB Pharma, S.A.
Plaza de Manuel Gómez Moreno, s/n,
Edificio Bronce, Planta 5
28020 Madrid, Spain
Manufacturer
Aesica Pharmaceuticals S.r.l
Via Praglia 15, I-10044 Pianezza (TO)
Italy
<UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom>
<ExtractumPharma Co.Ltd, IV Korzet 6, Kunfeherto, 6413, Hungary>
<Phoenix Pharma Polska Sp. z o.o., ul. Rajdowa 9 Konotopa, 05-850 Ozarów Mazowiecki, Poland>
<UCB Pharma AS, Haakon VIIs gate 6, NO-0161 Oslo, Norway>
<UCB Pharma B.V., Hoge Mosten 2 A1, 4822 NH, Breda, Netherlands>
<UCB Nordic A/S, Edvard Thomsens Vej 14, DK-2300 København S, Denmark>
<UCB Pharma SA, Chemin Du Foriest 1, Braine-L’alleud, 1420, Belgium>
This medicinal product is authorized in the European Economic Area member states under the following names:
Austria: Xyzall
Belgium: Xyzall
Cyprus: Xyzal
Czech Republic: Xyzal
Denmark: Xyzal
Estonia: Xyzal
Finland: Xyzal
France: Xyzall
Germany: Xusal
Greece: Xozal
Hungary: Xyzal 5 mg filmtabletta
Ireland: Xyzal
Italy: Xyzal
Latvia: Xyzal
Lithuania: Xyzal
Luxembourg: Xyzall
Malta: Xyzal
Netherlands: Xyzal
Norway: Xyzal
Poland: Xyzal
Portugal: Xyzal
Slovakia: Xyzal
Slovenia: Xyzal
Spain: Xazal
United Kingdom: Xyzal
Date of the most recent revision of this leaflet: 07/2022
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es