Xusal 5 mg film-coated tablets, 50 pcs

Important notes (compulsory information):

Xusal 5 mg film-coated tablets. Active substance: Levocetirzine hydrochloride. Areas of application: for the treatment of disease signs (symptoms) in allergic runs (including persistent allergic sniffs); Hives (urticaria).Warning: Contains lactose.

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


LEAFLET: INFORMATION FOR THE USER

1. What is Xusal and what is it used for?

Levocetirizindihydrochloride is the active ingredient of Xusal.
Xusal serves to treat allergies.

For the treatment of disease signs (symptoms) at:

• allergic sniffs (including persistent allergic sniffs);
• Hives (urticaria).

2. What do you need to consider before taking Xusal?

Xusal must not be taken,

• if you are hypersensitive (allergic) against Levocetirizin, an antihistamine or any of the other ingredients of Xusal (see "What contains Xusal")
• if your renal function is severely limited (heavy renal insufficiency with creatinine clearance under 10 ml / min)

Special care when taking Xusal is required:
For children under 6 years, the use of Xusal film-coated tablets is not recommended because no dose adjustment is possible with the film-coated tablets.

If you may not be able to completely empty your bubble (such as a spinal cord infringement or an enlarged prostate), please ask your doctor for advice.

When taking Xusal with other medicines:
Please inform your doctor or pharmacist if you take / use other medicines or recently taken / have applied, even if it is non-prescription medicines.

Taking Xusal together with food and beverages:
Caution is required when Xusal is taken together with alcohol.
With sensitive patients, the simultaneous administration of cetirizine or levocetirizine and alcohol or other centrally attenuating agents could affect the central nervous system, although the Razemat Cetirizin was shown that the effect of alcohol is not enhanced.

Pregnancy and breast feeding period:
Ask your doctor or pharmacist for advice before taking all medicines.
Inform your doctor if you want to be pregnant or breastfeeding.

Driveion and use of machines:
Some patients can occur under the therapy with xusal drowsiness / dizziness, fatigue and deferredness. Caution is required when driving or serving machines until you know how this medicine works with you.
However, special investigations did not detect any impairment of attention, responsiveness and driving of healthy test persons by taking levocetirizin in the recommended dosage.

Important information about certain other ingredients of Xusal:
This medicine contains lactose. Please take Xusal only after consulting your doctor if you are familiar with any intolerance to certain sugars.

3. How to take Xusal?

Always take Xusal exactly as your doctor has told you. Please ask your doctor or pharmacist if you are not sure.

Dosage:
If nothing differently prescribed by the doctor, the usual dose is:
The normal dose for adults and children from 6 years is 1 Film tablet daily.

Special dosage instructions for specific patient groups:
Patients with impaired kidney function optionally receive a lower dose, which is aimed at the severity of kidney disease and in children in addition to the body weight. The dose is determined by your doctor.

Patients with strong restricted renal function may not take Xusal.

Patients with exclusive liver function should take the normal prescribed dose.

Patients with at the same time restricted liver and renal function optionally receive a lower dose, which is aimed for the severity of kidney disease and in children in addition to the body weight. The dose is determined by your doctor.

For children under 6 years, the use of Xusal film-coated tablets is not recommended.

If the renal function is normal, no dose adjustment is required in older patients.

How and when should you take Xusal?
The film-coated tablets should be occupied with water. The intake can be done or independently of meals.

If you take a greater amount of Xusal than you should:
If you take a larger amount of Xusal than you should, adult drowsiness may occur. In children, it can first come to excitation and restlessness and then drowsiness.

If there is suspected overdose with Xusal, please notify your doctor. This will decide on the measures necessary if necessary.

If you forget to take Xusal:
If you forget to take Xusal or have a lower dose than you have dedicated from your doctor, do not take a double dose. Wait until the time you should take the next dose and then take the normal dose prescribed by your doctor.

If you cancel the taking Xusal:
The termination of taking should not have harmful effects. The symptoms of the disease can recur, but they should not be worse than before the treatment.

If you have further questions about the application of the medicine, ask your doctor or pharmacist.

4. Which side effects are possible?

Like all medicines, Xusal can have side effects that do not have to occur each other.

Common side effects: can concern up to 1 of 10 treated
Mouth dryness, headache, fatigue and drowsiness / dizziness

Random side effects: can concern up to 1 out of 100 treated
Failure and abdominal pain

Unknown: Frequency on the basis of the available data is not estimable
Further side effects such as palpitations, accelerated heartbeat / cardiac wounds, cramps, tingling, dizziness, sudden consciousness loss, trembling, disturbed taste sensation, tillwheel, vision disorder, blurred see, complicated or painful urination, incomplete bladder emptying, increased water accumulation in the tissue (edema), Swelling of skin and mucous membrane, especially in the face and throat area (angioneurotic edema), itching, fleeting rash, hives (swelling, redness and itching of the skin), at the same point rash (fixed drug extraneous), shortness of weight, weight gain, muscle aches, Aggressive or excited behavior, see or listening to things that are not really (hallucination), Depression, insomnia, frequent thoughts on or employment with self-service, hepatitis (hepatitis), abnormal liver function values, vomiting, appetizing and nausea were also reported.

In the first signs of a hypersensitivity reaction, take the intake of Xusal and inform your doctor. Symptoms of a hypersensitivity reaction may be: swelling in the area of the mouth, the tongue, facial and / or neck, difficulty in breathing or swallowing (sensing in breast or pending breathing), nettle rash, sudden blood pressure drop, which leads to collapse or shock, What can be deadly.

Please inform your doctor or pharmacist if one of the listed side effects will significantly affect it or notice side effects that are not specified in this document formation.

5. How to keep Xusal?

Store drug out of reach of children.
You may be Xusal after the on the blister strip and outer carton "Usable until" specified expiry date no longer apply. That Expiry date refers to the last day of the month.
This medicinal product does not require special storage conditions.

6. Further information

What Xusal includes:
The active substance is 5 mg Levocetirizindihydrochlorid
One tablet contains 5 mg Levocetirizindihydrochlorid.

The other ingredients are:
Microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate (Ph.Eur.), Hypromellose (E464) Titanium dioxide (E171), Macrogol 400

How Xusal looks like and contents of the pack:
The tablets are white, white to almost oval and have a Y logo on one side.
They are x in blister packs 1, 2, 4, 5, 7, 10, 2 x 10, 10 10, 14, 15, 20, 21, 28, 30, 40, 50, 60, 70, 90 and 100 tablets packaged.
Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer:
Pharmaceutic entrepreneur:
UCB Pharma GmbH
Alfred-Nobel-Straße 10
40789 Monheim
Phone: 02173 / 48-4848
Fax: 02173 / 48-4841

Manufacturer:
Aesica Pharmaceuticals S.r.l.
Via Praglia, 15
I-10044 Pianezza (TO)
Italy

This leaflet was last in July 2013 revised.

Source: Information of the leaflet
Date: 04/2020