LEVOCETIRIZINE TARBIS 5 MG FILM-COATED TABLETS EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Levocetirizine Tarbis 5 mg film-coated tablets EFG

Levocetirizine dihydrochloride

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

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

5. Storage of Levocetirizine Tarbis

6. Further information

1. What LEVOCETIRIZINE TARBIS is and what it is used for

The active substance in Levocetirizine Tarbis is levocetirizine dihydrochloride. Levocetirizine Tarbis is an antiallergic medicine.

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

• Allergic rhinitis (including persistent allergic rhinitis);
• Chronic urticaria (chronic idiopathic urticaria).

2. Before taking LEVOCETIRIZINE TARBIS

Do not take Levocetirizine Tarbis

• if you are allergic (hypersensitive) to levocetirizine dihydrochloride or to any antihistamine or to any of the other components of Levocetirizine Tarbis (see “What does Levocetirizine Tarbis contain?”).
• if you have severe impairment of kidney function (severe renal insufficiency with creatinine clearance less than 10 ml/min).

Take special care with Levocetirizine Tarbis

• The use of Levocetirizine Tarbis is not recommended in children under 6 years of age, as the film-coated tablets do not allow for dose adjustment.

Use of other medicines

Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those not requiring a prescription.

Taking Levocetirizine Tarbis with food and drink

Caution is advised when taking Levocetirizine Tarbis together with alcohol.

In sensitive patients, concomitant intake of cetirizine or levocetirizine and alcohol or other agents acting on the central nervous system may affect the central nervous system, although the racemate cetirizine has been shown not to potentiate the effects of alcohol.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

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

Driving and using machines

Some patients treated with Levocetirizine Tarbis may experience drowsiness, fatigue, and exhaustion. If you are driving, performing potentially hazardous activities, or operating machinery, you are advised to wait and observe your response to the medication first. However, in special tests conducted in healthy individuals, no impairments in attention, reaction ability, or driving skills have been detected after taking levocetirizine at the recommended dose.

Important information about some of the components of Levocetirizine Tarbis

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take LEVOCETIRIZINE TARBIS

Follow exactly the instructions for use of Levocetirizine 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 older is one tablet daily.

Patients with renal impairment should receive a reduced dose according to the severity of their kidney disease.

Patients with hepatic impairment only should take the normal prescribed dose.

Patients with both hepatic and renal impairment should take a reduced dose based on the severity of their kidney disease, and in children the dose will depend on body weight; the appropriate dose will be determined by your doctor.

Use of Levocetirizine Tarbis is not recommended in children under 6 years of age.

How and when should you take Levocetirizine Tarbis?

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

If you take more Levocetirizine Tarbis than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915 620 420.

If you forget to take Levocetirizine Tarbis

If you have forgotten to take Levocetirizine Tarbis, or if you have taken a lower dose than prescribed by your doctor, do not take a double dose to make up for it. Simply wait until the next scheduled dose and take the normal prescribed dose.

If you stop taking Levocetirizine Tarbis

Premature discontinuation of treatment with Levocetirizine Tarbis should not have harmful effects; however, symptoms of the condition being treated should gradually reappear, with severity no greater than that observed before starting treatment with Levocetirizine Tarbis.

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

4. Possible adverse effects

Like all medicines, Levocetirizine Tarbis may have adverse effects, although not everyone experiences them.

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

An adverse effect with unknown frequency (cannot be estimated from available data) that has also been reported is oculogyric crisis (uncontrolled circular movements of the eyes).

At the first signs of hypersensitivity reaction, stop taking Levocetirizine Tarbis and seek immediate medical attention. Symptoms of hypersensitivity reaction may include swelling of the mouth, tongue, face, and/or throat, difficulty breathing or swallowing along with hives (angioedema), sudden drop in blood pressure that may lead to collapse or shock, which can be fatal.

If you notice adverse effects not listed in this leaflet, or if you experience any of the described adverse effects severely, inform your doctor or pharmacist.

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not mentioned in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. LEVOCETIRIZINE TARBIS Storage

Keep out of the reach and sight of children.

Do not use Levocetirizine Tarbis after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Additional information

What does Levocetirizine Tarbis contain?

• The active substance is 5 mg of levocetirizine dihydrochloride.

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

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

Appearance of the product and contents of the pack

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

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer:

EGIS Pharmaceuticals PLC

Bökényföldi út 118-120

1165 Budapest (Hungary)

This leaflet was approved in May 2018.

Detailed and up-to-date 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/