Package Insert: Information for the User

Levocetirizine STADA 5 mg Film-Coated Tablets EFG

Levocetirizine dihydrochloride

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

5. Storage of Levocetirizine Stada

1. Contents of the package and additional information

The active ingredient of Levocetirizina Stada is levocetirizine dihydrochloride.

Levocetirizine dihydrochloride is an antihistamine medication.

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

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

Do not take Levocetirizina Stada:

• if you areallergicto levocetirizine dihydrochloride, cetirizine, hydroxyzine, or any of the other ingredients of this medication (listed in section 6).
• if you have asevere kidney function impairment(severe renal insufficiency with a creatinine clearance of less than 10 ml/min).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Levocetirizina Stada.

If you have any condition that prevents you from emptying your bladder (such as spinal cord damage or enlarged prostate), please inform your doctor.

If you are epileptic or at risk of seizures, please consult your doctor as the use of levocetirizine dihydrochloride may exacerbate seizures.

If you are to undergo an allergy test, ask your doctor if you need to stop taking levocetirizine dihydrochloride several days beforehand. This medication may affect the results of the allergy test.

Children

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

Other medications and Levocetirizina Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Taking Levocetirizina Stada with food, drinks, and alcohol

Caution is advised if this medication is taken at the same time as alcohol or other central nervous system agents.

In sensitive patients, taking levocetirizine with alcohol or other central nervous system agents may cause additional decreased attention capacity and decreased performance.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

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

Levocetirizina Stada contains lactose

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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

Dosage:

The normal dose for adults and children over 6 years old is one tablet per day.

Special dosage instructions for specific populations:

Patients with renal insufficiency should receive a lower dose according to the severity of their renal 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 renal function impairment should not take this medication.

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

Patients with 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; the dose to be taken will be determined by your doctor.

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

Use in children:

Levocetirizina Stada is not recommended for use in children under 6 years old.

How and when to take Levocetirizina Stada:

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

How long should your treatment with Levocetirizina Stada last?

The duration of treatment depends on the type, duration, and course of symptoms, and will be determined by your doctor.

If you take more Levocetirizina 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 Toxicological Information Service at 915 620 420, indicating the medication and the amount ingested.

If you forget to take Levocetirizina Stada:

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

If you interrupt treatment with Levocetirizina Stada:

Stopping treatment should not have any adverse effects. However, rarely, intense itching may occur when stopping levocetirizine dihydrochloride, even if these symptoms were not present at the start of treatment. Symptoms may disappear spontaneously. In some cases, symptoms may be intense and require restarting treatment. Symptoms usually disappear when treatment is restarted.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Frequent: may affect up to 1 in 10 people

Dry mouth, headache, fatigue, drowsiness/drowsiness

Rare: may affect up to 1 in 100 people)

Exhaustion and abdominal pain

Unknown frequency: the frequency cannot be estimated from the available data

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

At the first signs ofhypersensitivity reaction, stop taking levocetirizine dihydrochloride and see your doctor immediately. The symptoms of a hypersensitivity reaction may include: swelling of the mouth, tongue, face, and/or throat, difficulty breathing or swallowing (chest tightness or wheezing), urticaria (hives on the skin), sudden drop in blood pressure that can lead to collapse or shock, which can be fatal.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them through the Spanish System of Pharmacovigilance of Medicines for Human Use. https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The first two digits indicate the month and the last four digits indicate the year. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Levocetirizine Stada

• The active ingredient is levocetirizine. Levocetirizine is present in the form of dihydrochloride of levocetirizine (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 package

The film-coated tablets are white or off-white, oval, biconvex, and have the mark “L9CZ” engraved on one face and “5” on the other face.

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder

STADA Laboratorio, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing:

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 (Módena)

Italy

or

STADA Arzneimittel GmbH

Muthgasse 36

A-1190 - Wien

Austria

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:September 2018

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/