XYZALL film-coated Allergic rhinitis, hives (urticaria) tablets

Active ingredient

Levocetirizine dihydrochloride

Allergic rhinitis, hives (urticaria) Important information (mandatory information):

Xyzall 5 mg film-coated tablets. Active ingredient: Levocetirizine dihydrochloride. Indications: For the treatment of signs (symptoms) of allergic rhinitis (including persistent allergic rhinitis) and hives (urticaria).

For risks and side effects, read the package leaflet and ask your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Xyzall 5 mg film-coated tablets for adults and children 6 years and older
Active ingredient: Levocetirizine dihydrochloride

Read the entire package leaflet carefully before you start taking this medicine because it contains important information.

• Keep this leaflet. You may want to read it again later.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not share it with anyone else. It may harm others, even if they have the same symptoms as you.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. WHAT IS XYZALL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING XYZALL?
3. HOW SHOULD I TAKE XYZALL?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD XYZALL BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS XYZALL AND WHAT IS IT USED FOR?

The active ingredient in Xyzall is levocetirizine dihydrochloride. Xyzall is a medicine used to treat allergies. It is indicated for the treatment of signs (symptoms) of allergic rhinitis (including persistent allergic rhinitis) and hives (urticaria).

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING XYZALL?

Do not take Xyzall:

• if you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine or any of the other ingredients of this medicine listed in section 6.
• if your kidney function is severely impaired (severe renal insufficiency with a creatinine clearance below 10 ml/min).

Warnings and precautions:
Please talk to your doctor or pharmacist before taking Xyzall. If you are prone to problems emptying your bladder (with conditions such as spinal cord injuries or enlarged prostate), please ask your doctor for advice. If you suffer from epilepsy or are at risk of seizures, please consult your doctor, as taking Xyzall may make seizures worse. If allergy tests are planned, please ask your doctor if you need to stop taking Xyzall for a few days before the tests are carried out. This medicine may affect the results of allergy tests.

Children:
Xyzall film-coated tablets are not recommended for children under 6 years of age, as the film-coated tablet form does not allow for dose adjustment.

Taking Xyzall with other medicines:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Taking Xyzall with food, drink, and alcohol:
Caution is advised when taking Xyzall at the same time as alcohol or other brain-acting substances. In sensitive patients, taking Xyzall with alcohol or other brain-acting substances could result in additional impairment of alertness and performance. Xyzall can be taken with or without food.

Pregnancy, breast-feeding, and fertility:
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

Driving and using machines:
Some patients may experience drowsiness/drowsiness, tiredness, and fatigue during treatment with Xyzall. Be careful when driving or operating machinery until you know your personal reaction to the medicine. However, special tests have shown that no impairment of alertness, reaction time, or driving ability was observed in healthy volunteers taking levocetirizine at the recommended dosage.

Xyzall contains lactose:
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, please consult your doctor before taking Xyzall.

3. HOW TO TAKE XYZALL

Always take this medicine exactly as your doctor or pharmacist has told you. Consult your doctor or pharmacist if you are not sure. The recommended dose for adults and children 6 years and older is one film-coated tablet daily.

Specific dosage recommendations for special patient groups:

• Impaired kidney and liver function: Patients with impaired kidney function may receive a lower dose, depending on the severity of their kidney disease and, in children, their body weight. The dose will be determined by your doctor.
• Patients with severely impaired kidney function should not take Xyzall.

Patients with only impaired liver function should take the usual recommended dose.

• Patients with both impaired liver and kidney function may receive a lower dose, depending on the severity of the kidney disease and, in children, on body weight. The dose will be determined by your doctor.
• Elderly patients aged 65 years and over: No dose adjustment is required in elderly patients provided renal function is normal.

Use in children:
Xyzall is not recommended for children under 6 years of age.

How and when should you take Xyzall?
For oral use only. Xyzall film-coated tablets must be swallowed whole with water. They can be taken with or without food.

How long should you take Xyzall?
The duration of treatment depends on the type, duration, and progression of your symptoms and will be determined by your doctor.

If you take more Xyzall than you should:
If you take more Xyzall than you should, adults may feel drowsy. Children may initially experience excitement and restlessness, followed by drowsiness. If you take more Xyzall, contact your doctor, pharmacist, or the Poison Control Center (070/245.245) immediately. They will then decide on any necessary measures.

If you forget to take Xyzall:
Do not take a double dose to make up for a forgotten dose or if you have taken a lower dose than prescribed by your doctor. Continue taking the medicine and take the next dose at the scheduled time.

If you stop taking Xyzall:
Stopping treatment is not expected to have any harmful effects. However, pruritus (intense itching) can sometimes occur when you stop taking Xyzall, even if these symptoms were not experienced before treatment began. Symptoms may disappear spontaneously. In some cases, symptoms may be intense and require restarting treatment. Symptoms should disappear when treatment is restarted.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common - may affect up to 1 in 10 people:
dry mouth, headache, fatigue, and drowsiness/drowsiness.

Uncommon - may affect up to 1 in 100 people:
exhaustion and abdominal pain.

Not known - frequency cannot be estimated from the available data:
Other side effects such as palpitations, rapid heartbeat, seizures, tingling and prickling, dizziness, fainting, tremors, taste disturbances, sensation of spinning or movement, visual disturbances, blurred vision, oculogyration (uncontrollable, circular movement of the eyes), pain or difficulty urinating, inability to completely empty the bladder, swelling of the skin due to fluid retention, pruritus (itching), temporary rash, urticaria (swelling, redness, and itching of the skin), rash, shortness of breath, weight gain, muscle pain, joint pain, aggressive or agitated behavior, hallucinations, depression, insomnia, recurrent thoughts of or preoccupation with suicide, nightmare, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea have also been reported. Pruritus (intense itching) after discontinuation of treatment.

Stop taking Xyzall at the first sign of a hypersensitivity reaction and tell your doctor. Symptoms of a hypersensitivity reaction may include: swelling of the mouth, tongue, face, and/or throat; difficulty breathing or swallowing (chest tightness or wheezing); hives; sudden drop in blood pressure, which may lead to collapse or shock, which can be fatal.

Reporting of side effects:
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, Germany; website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD XYZALL BE STORE?

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after ###Exp.###. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Xyzall contains:
The active ingredient is levocetirizine dihydrochloride. Each film-coated tablet contains 5 mg levocetirizine dihydrochloride. The other ingredients are microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, magnesium stearate, hypromellose (E464), titanium dioxide (E171), and macrogol 400.

What Xyzall looks like and contents of the pack:
The film-coated tablets are white to off-white, oval, with ###Y### engraved on one side. They are available in packs of 1, 2, 4, 5, 7, 10, 2 x 10, 10 x 10, 14, 15, 20, 21, 28, 30, 40, 50, 60, 70, 90, and 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
UCB Pharma SA
Allée de la Recherche 60
B-1070 Brussels
Belgium

Manufacturer:
Aesica Pharmaceuticals Srl
Via Praglia 15
I-10044 Pianezza (TO)
Italy

UCB Pharma Ltd.
208 Bath Road, Slough
Berkshire, SL1 3WE
United Kingdom

Phoenix Pharma Polska Sp. z oo
ul. Opiotek 26
01-940 Warsaw
Poland

ExtractumPharma Co. Ltd.
6413 Kunfehérto
IV. körzet 6.
Hungary

Movianto Polska Sp. z oo
ul., Artura i Franciszka Radziwiiiow 5
05-850 Ozarow Mazowiecki
Poland

This leaflet was last revised in August 2024.

Source: Information from the package leaflet.
Version: 01/2025

Active ingredient: Levocetirizine dihydrochloride. Indications: For the treatment of signs (symptoms) of allergic rhinitis (including persistent allergic rhinitis) and hives (urticaria).

 Allergic rhinitis, hives (urticaria)