LEVOCETIRIZINE STADA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levocetirizine STADA 5 mg film-coated tablets EFG

Levocetirizine dihydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What you need to know before you take Levocetirizine Stada
2. How to take Levocetirizine Stada
3. Possible side effects

1. Storage of Levocetirizine Stada

1. Contents of the pack and further information

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

The active substance of Levocetirizine Stada is levocetirizine dihydrochloride.

Levocetirizine dihydrochloride is an antiallergic medicine.

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

• Allergic rhinitis (including persistent allergic rhinitis);
• Urticaria.

2. What you need to know before you take Levocetirizine Stada

Do not take Levocetirizine Stada:

• if you are allergicto levocetirizine dihydrochloride, to cetirizine, to hydroxyzine or to any of the other components of this medicine (listed in section 6).
• if you have severe kidney impairment(severe renal insufficiency with a creatinine clearance of less than 10 ml/min).

Warnings and precautions

Consult your doctor or pharmacist before taking Levocetirizine Stada.

If you have any condition that makes it difficult for you to empty your urinary bladder (such as damaged spinal cord or enlarged prostate), please inform your doctor.

If you are epileptic or have a risk of convulsions, please consult your doctor as the use of levocetirizine dihydrochloride may worsen the crises.

If you are going to undergo any allergy testing, ask your doctor if you should stop taking levocetirizine dihydrochloride a few days before. This medicine may affect the results of the allergy test.

Children

Levocetirizine Stada is not recommended for use in children under 6 years of age since the film-coated tablets do not allow for dose adjustment.

Other medicines and Levocetirizine Stada

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

Taking Levocetirizine Stada with food, drinks and alcohol

Caution is recommended if you take this medicine at the same time as alcohol or other agents that act on the brain.

In sensitive patients, taking levocetirizine with alcohol or other agents that act on the brain may cause additional decreased attention and decreased performance

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Some patients treated with levocetirizine dihydrochloride may experience somnolence or drowsiness, fatigue and exhaustion. If you are going to drive, perform potentially hazardous activities or use machinery, you are advised to wait and observe your response to the medication. However, in special tests performed in healthy people, no alterations in attention, reaction capacity and ability to drive were detected after taking levocetirizine at the recommended dose.

Levocetirizine Stada contains lactose

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

3. How to take Levocetirizine Stada

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Posology:

The normal dose for adults and children from 6 years of age is one tablet per day.

Special dosing instructions for specific populations:

Patients with renal insufficiency should receive a lower dose according to the severity of their kidney disease and in children the dose will be based on body weight; the dose to be taken will be determined by your doctor.

Patients with severe kidney impairment should not take this medicine.

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

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

No dose adjustment is necessary in elderly patients, provided their renal function is normal.

Use in children

Levocetirizine Stada is not recommended for use in children under 6 years of age.

How and when should you take Levocetirizine Stada?

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

How long should your treatment with Levocetirizine Stada last?

The duration of treatment depends on the type, duration and course of the symptoms and it is your doctor who must determine it.

If you take more Levocetirizine Stada than you should

If you take more levocetirizine dihydrochloride than you should, it may 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 Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Levocetirizine Stada

If you have forgotten to take levocetirizine dihydrochloride, or if you take a lower dose than prescribed by your doctor, do not take a double dose to make up for the forgotten doses; simply wait until the next scheduled intake and take the normal dose prescribed by your doctor.

If you stop taking Levocetirizine Stada

Stopping treatment should not have harmful effects. However, rarely, intense itching (pruritus) may appear when stopping levocetirizine dihydrochloride, even when these symptoms were not present at the start of treatment. The symptoms may disappear spontaneously. In some cases, the symptoms may be intense and require restarting treatment. The symptoms usually 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, drowsiness/drowsiness

Uncommon: may affect up to 1 in 100 people

Exhaustion and abdominal pain

Frequency not known: frequency cannot be estimated from the available data

Other side effects have also been reported, such as palpitations, increased heart rate, convulsions, tingling, dizziness, syncope, tremor, dysgeusia (alteration of taste), sensation of movement, including sensation of spinning, visual disturbances, blurred vision, pain or difficulty urinating, inability to urinate, edema, pruritus (itching), rash, urticaria (swelling, redness and itching of the skin), skin eruption, shortness of breath, weight gain, muscle pain, joint pain, aggressive or agitated behavior, hallucinations, depression, insomnia, recurrent thoughts of concern with suicidal ideation, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, diarrhea, and oculogyric crisis (uncontrolled circular movements of the eyes). Intense itching (pruritus) when stopping treatment.

In case of the first signs of hypersensitivity reaction, stop taking levocetirizine dihydrochloride and see your doctor immediately. The symptoms of the hypersensitivity reaction may include: swelling of the mouth, tongue, face and/or throat, difficulty breathing or swallowing (chest tightness or wheezing), urticaria (rash on the skin), sudden decrease in blood pressure that 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, even if it is possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levocetirizine Stada

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 carton after EXP. The first two digits indicate the month and the last four digits indicate the year. The expiry date is the last day of the month indicated.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Levocetirizine Stada

• The active substance is levocetirizine. Levocetirizine is present in the form of levocetirizine dihydrochloride (5 mg), corresponding to 4.2 mg of levocetirizine.
• The other components are microcrystalline cellulose, lactose monohydrate, magnesium stearate (core) and hypromellose (E464), titanium dioxide (E171), and macrogol 400 (coating).

Appearance of the product and contents of the pack

The film-coated tablets are white or almost white, oval, biconvex, and have the marking “L9CZ” engraved on one side and “5” on the other side.

They are packaged in blisters of 7, 10, 14, 20, 21, 28, 30, 90 and 100 tablets per pack and unit-dose blisters containing 30 x 1 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

Synthon BV

Microweg 22,

6545 Nijmegen

Netherlands

or

Synthon Hispania SL

Castelló 1, Polígono Las Salinas,

08830 Sant Boi de Llobregat

Spain

or

STADA Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

or

LAMP SAN PROSPERO S.p.A.

Via della Pace, 25/A

41030 San Prospero (Modena)

Italy

or

STADA Arzneimittel GmbH

Muthgasse 36

A-1190 - Wien

Austria

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: September 2018

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/