Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Xyzal tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What Xyzal is used for
Xyzal belongs to the antihistamine group of drugs and contains an antihistamine called levocetirizine. Xyzal is used to treat symptoms associated with allergic conditions such as:
- Hay fever (seasonal allergic rhinitis), including associated eye complaints
- Year round allergies such as dust or pet allergies (perennial allergic rhinitis), and
- Hives (urticaria).
Antihistamines relieve the symptoms and discomfort associated with the above conditions, such as sneezing, irritated, runny nose, itchy, red and watering eyes and skin rashes.
Your doctor, however, may prescribe Xyzal for another purpose.
Ask your pharmacist if you have any questions about Xyzal
There is no evidence that Xyzal is addictive.
Before you take Xyzal
When you must not take it
Do not take Xyzal tablets if you have any hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Xyzal tablets contain lactose. If you have been told by your doctor that you have an intolerance to lactose or other sugars, you should not take Xyzal tablets.
Do not take Xyzal if you have ever had an allergic reaction to Xyzal, cetirizine hydrochloride or hydroxyzine (other antihistamines related to levocetirizine) or any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction to Xyzal may include:
- Shortness of breath, wheezing or difficulty breathing
- Swelling of the face, lips, tongue or other parts of the body
- Rash, itching or hives on the skin.
Do not take Xyzal if the expiry date marked on the packaging has passed, even though the tablets may look alright. If you take this medicine after the expiry date has passed, it may not work as well.
Do not take Xyzal if the packaging is torn or shows signs of tampering If this is the case, take the tablets to your pharmacist.
If you are not sure whether you or your child should start taking Xyzal, talk to your doctor or pharmacist.
Before you start to take it
Tell your doctor or pharmacist if you have allergies to:
- Any other medicines
- Any other substances such as foods, preservatives or dyes
Tell your doctor or pharmacist if you have or have had any medical conditions, especially the following:
- Epilepsy (fits/seizures/convulsions)
- Kidney problems.
Patients with impaired kidney function may be given a lower dose according to the severity of their kidney disease. Your doctor or pharmacist will determine the dose for you.
Tell your doctor or pharmacist if you are pregnant or intend to become pregnant. Xyzal is not recommended for use during pregnancy. If there is a need to consider Xyzal during your pregnancy, your doctor or pharmacist will discuss with you the benefits and risks of using it.
Tell your doctor or pharmacist you are breastfeeding or wish to breastfeed. Xyzal should not be taken during breast feeding as it passes into breast milk and may affect your baby.
If you have a predisposing factor to urinary retention (like spinal cord lesion or prostatic hyperplasia), please ask your doctor for advice before taking Xyzal.
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Xyzal.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and Xyzal may interfere with each other. Your doctor or pharmacist can advise you about other medicines you might need to be careful with while taking Xyzal.
How to take Xyzal
Follow all directions given to you by your doctor or pharmacist. They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
How much to take
The usual dose of Xyzal for adults and adolescents (12 years and older) is one tablet daily.
Xyzal tablets should not be given to children under 12 years of age.
Tell your doctor or pharmacist if you have impaired kidney function before taking Xyzal. Patients with impaired kidney function may be given a lower dose.
How to take it
Swallow the tablet whole with a glass of water.
Xyzal can be taken with or without food.
How long to take it
The duration of treatment depends on the type and duration of your complaint. Continue taking Xyzal until your symptoms disappear. If the symptoms reappear you may commence taking Xyzal again.
If you are not sure how long to take Xyzal for, ask your doctor or pharmacist.
If your symptoms persist, see your doctor or pharmacist for advice.
If you forget to take it
If you forget to take a dose of Xyzal, take one as soon as you remember, but wait at least 24 hours before taking the next dose.
Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency (Casualty) at your nearest hospital if you think you or anyone else may have taken too much Xyzal, even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Keep telephone numbers for these places handy.
Taking too many tablets may cause increased sleepiness in adults. In children, an overdose may cause initially agitation and restlessness, followed by drowsiness.
While you are taking Xyzal
Things you must do
Tell all doctors, dentists and pharmacists who are treating you that you are taking Xyzal.
If you are about to be started on any new medicines, tell your doctor or pharmacist that you are taking Xyzal.
Tell your doctor if you become pregnant while taking Xyzal.
Things you must not do
Do not use Xyzal to treat any other complaints unless your doctor says to.
Things to be careful of
Be careful driving or operating machinery until you know how Xyzal affects you. Although Xyzal tablets are unlikely to affect your ability to drive or operate machinery, some people may be impaired and care should be taken.
Avoid drinking alcohol while taking Xyzal tablets. The combined used of Xyzal tablets and alcohol may have effects on your alertness, ability to drive and use machinery. Caution is advised if Xyzal is taken with alcohol.
Side effects
Xyzal helps most people with hayfever and allergy symptoms, but it may have unwanted side effects in a few people. All medicines have side effects. Sometimes they are serious, most of the time they are not.
You may need medical treatment if you get some of the side effects.
Ask you doctor or pharmacist any questions you may have.
Tell your doctor immediately, or go to your nearest hospital if you notice any of the following:
- Signs of allergy such as rash or hives( more severe than the condition being treated), swelling of the face, lips or tongue, wheezing or difficulty breathing.
If you experience any of these symptoms, stop taking Xyzal. These symptoms are usually rare but may be serious and need urgent medical attention.
Tell your doctor if you experience any of the following and they worry you:
- Dry mouth,
- Headache,
- Tiredness, sleepiness, exhaustion,
- Abdominal pain.
This is not a complete list of all possible side effects. Other side effects not listed above may occur in some patients.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
After taking Xyzal
Storage
Keep your tablets where young children cannot reach them. A locked cupboard at least one and a half metres above the ground is a good place to store medicines.
Keep your Xyzal tablets in a cool dry place where the temperature stays below 30°C.
Do not store Xyzal or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.
Keep your tablets in their blister pack until it is time to take them. If you take your tablets out of the pack they may not keep as well.
Disposal
When you have stopped taking Xyzal, or if the tablets have passed their expiry date, ask your pharmacist what to do with any left over.
Product description
What it looks like
Xyzal 5 mg tablets are white to off-white, oval, film-coated tablet with a Y logo on one side. They are available in blister packs of 10 and 30 tablets.
Ingredients
Active ingredients:
Xyzal tablets contain 5 mg levocetirizine dihydrochloride.
Other ingredients
Xyzal tablets contain the following inactive ingredients:
- microcrystalline cellulose
- lactose
- colloidal anhydrous silica
- magnesium stearate
- hypromellose (E464)
- titanium dioxide (E171)
- macrogol 400.
Xyzal tablets do not contain gluten.
Sponsor
UCB Pharma (a division of UCB Australia Pty Ltd)
Level 1, 1155 Malvern Road
Malvern VIC 3144
Australian Registration Numbers:
Xyzal 5 mg tablets; AUST R 150854
This leaflet was prepared in November 2011
Published by MIMS March 2012
