PATIENT INFORMATION LEAFLET

Levocetirizine Tarbis 5mg film-coated tablets

Levocetirizine dihydrochloride

In this leaflet:

1.What Levocetirizine Tarbis is and what it is used for

2.Before taking Levocetirizine Tarbis

3.How to take Levocetirizine Tarbis

4.Possible side effects

5Storage of Levocetirizine Tarbis

6.Additional information

The active ingredient of Levocetirizina Tarbis is levocetirizine dihydrochloride. Levocetirizina Tarbis is an antihistamine medication.

For the treatment of signs of disease (symptoms) associated with:

-Allergic rhinitis (including persistent allergic rhinitis);

-Chronic urticaria (idiopathic chronic urticaria).

Do not take Levocetirizina Tarbis

• if you are allergic (hypersensitive) to levocetirizine dihydrochloride or to an antihistamine or to any of the other components of Levocetirizina Tarbis (See “What Levocetirizina Tarbis contains?”).
• if you have a severe impairment of renal function (severe renal impairment with a creatinine clearance of less than 10 ml/min).

Be especially careful with Levocetirizina Tarbis

• Levocetirizina Tarbis is not recommended for use in children under 6 years old as the film-coated tablets do not allow for dose adjustment.

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Taking Levocetirizina Tarbis with food and drinks

Use caution if you take Levocetirizina Tarbis and at the same time as alcohol.

In sensitive patients, the simultaneous intake of cetirizine or levocetirizine and alcohol or other central-acting agents may have effects on the central nervous system, although the racemic cetirizine has shown that it does not potentiate the effect of alcohol.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking a medicine.

Inform your doctor if you are pregnant, trying to become pregnant or are breastfeeding.

Driving and operating machinery

Some patients treated with Levocetirizina Tarbis may experience drowsiness, fatigue and exhaustion. If you are going to drive, perform potentially hazardous activities or use machinery, it is recommended that you wait and observe your response to the medication. Nevertheless, in special tests performed on healthy individuals, no alterations in attention, reaction time and driving ability were detected after taking levocetirizine at the recommended dose.

Important information about some of the components of Levocetirizina Tarbis

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Follow exactly the administration instructions for Levocetirizina Tarbis provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

The usual dose for adults and children aged 6 years and above is one tablet per day.

Patients with renal insufficiency should receive a lower dose according to the severity of their renal disease.

Patients with liver insufficiency only should take the normal prescribed dose.

Patients with both liver and renal insufficiency should take a lower dose based on the severity of their renal disease, and in children the dose will be based on body weight; your doctor will determine the dose to be taken.

Levocetirizina Tarbis is not recommended for use in children under 6 years of age.

How and when should I take Levocetirizina Tarbis?

The tablets should be swallowed whole with water and can be taken either on an empty stomach or with food.

If you take more Levocetirizina Tarbis than you should

A significant overdose can cause drowsiness in adults. In children, it may initially cause agitation and restlessness followed by drowsiness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone 915 620 420.

If you forget to take Levocetirizina Tarbis

If you have forgotten to take Levocetirizina Tarbis, or if you take a dose lower than prescribed by your doctor, do not take a double dose to compensate, simply wait until the next scheduled time and take the normal dose prescribed by your doctor.

If you stop taking Levocetirizina Tarbis

Stopping treatment with Levocetirizina Tarbis before the scheduled time should not have any adverse effects, as the symptoms of the disease should reappear gradually with a severity not greater than that before starting treatment with Levocetirizina Tarbis.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, Levocetirizina Tarbis may have adverse effects, although not all people may experience them.

Frequent adverse effects (between 1% and 10%) have been described, mostly mild to moderate, such as dry mouth, headache, fatigue, and drowsiness. Less frequent adverse effects (between 0.1% and 1%) have been observed, such as exhaustion and abdominal pain. Other adverse effects have also been described, including palpitations, seizures, visual disturbances, edema, pruritus (itching), skin rash, urticaria (skin swelling, redness, and itching), shortness of breath, weight gain, muscle pain, aggressive or agitated behavior, hepatitis, abnormal liver function, and nausea.

Additionally, an adverse effect of unknown frequency (cannot be estimated from available data) has been described: ocular crisis (uncontrolled circular eye movements).

At the first signs of hypersensitivity reaction, stop taking Levocetirizina Tarbis and see your doctor immediately. Symptoms of hypersensitivity reaction may include: swelling of the mouth, tongue, face, and/or neck, difficulty breathing or swallowing along with hives (angioedema), sudden drop in blood pressure that can lead to collapse or shock, which can be fatal.

If you notice adverse effects not mentioned in this prospectus or if you experience one of the described adverse effects severely, inform your doctor or pharmacist.

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is

possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Do not use Levocetirizina Tarbis after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

What is Levocetirizina Tarbis?

• The active ingredient is 5 mg of levocetirizine dihydrochloride.

Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride.

• The other components are: tablet core: microcrystalline cellulose, anhydrous colloidal silica, lactose monohydrate, hydroxypropyl cellulose, and magnesium stearate. Coating: hypromellose, titanium dioxide, lactose monohydrate, macrogol 3350, and triacetin.

Appearance of the product and contents of the package

The film-coated tablets are white to off-white, round, slightly biconvex, with the mark “E” on one face and “281” on the other face.

They are packaged in blisters of 20, 21, and 100 tablets. Not all package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Responsible manufacturer:

EGIS Pharmaceuticals PLC

Bökényföldi út 118-120

1165 Budapest (Hungary)

This leaflet was approved in May 2018.

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/