LEVOCETIRIZINE CINFA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levocetirizine Cinfa 5 mg film-coated tablets EFG

Levocetirizine dihydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Levocetirizine Cinfa and what is it used for
2. What you need to know before taking Levocetirizine Cinfa
3. How to take Levocetirizine Cinfa
4. Possible side effects
5. Storage of Levocetirizine Cinfa

Contents of the pack and further information

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

The active substance of Levocetirizine Cinfa is levocetirizine dihydrochloride. This medication is an antiallergic.

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

• Allergic rhinitis (including persistent allergic rhinitis)

• Urticaria.

2. What you need to know before taking Levocetirizine Cinfa

Do not take Levocetirizine Cinfa

• if you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or any of the other components of this medication (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 starting to take Levocetirizine Cinfa.

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

If you are epileptic or have a risk of seizures, please consult your doctor, as the use of Levocetirizine Cinfa may worsen seizures.

If you are going to undergo any allergy testing, ask your doctor if you need to stop taking Levocetirizine Cinfa several days in advance. This medication may affect the results of the allergy test.

Children

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

Taking Levocetirizine Cinfa with other medications

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

Taking Levocetirizine Cinfa with food, drinks, and alcohol

Cautious use is recommended if you take Levocetirizine Cinfa at the same time as alcohol or other agents that act on the brain. In sensitive patients, taking Levocetirizine Cinfa with alcohol or other agents that act on the brain may cause additional decreased attention and decreased performance.

Levocetirizine Cinfa can be taken both on an empty stomach and with food.

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 using this medication.

Driving and using machines

Some patients treated with Levocetirizine Cinfa may experience drowsiness/drowsiness, fatigue, and exhaustion. Be careful if you are going to drive or use machinery until you know how this medication affects you. However, in special tests performed on healthy individuals, no alterations in attention, reaction capacity, and driving ability were detected after taking Levocetirizine Cinfa at the recommended dose.

Levocetirizine Cinfa contains lactose

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

3. How to take Levocetirizine Cinfa

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

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

Special dosing instructions for specific populations

Renal and hepatic insufficiency

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

Patients with severe renal insufficiency should not take Levocetirizine Cinfa.

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

Patients with both 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.

Patients 65 years of age or older

In elderly patients, it is not necessary to adjust the dose if their kidney function is normal.

Use in children

The use of Levocetirizine Cinfa is not recommended in children under 6 years of age.

How and when should you take Levocetirizine Cinfa?

For oral use only.

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 Cinfa 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 Levocetirizine Cinfa than you should

If you take more Levocetirizine Cinfa than you should, in adults, it may cause drowsiness. 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 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Levocetirizine Cinfa

If you have forgotten to take Levocetirizine Cinfa, or if you take a lower dose than prescribed by your doctor, do not take a double dose to make up for the missed doses. Continue taking your normal dose when it is due.

If you stop taking Levocetirizine Cinfa

Stopping treatment with Levocetirizine Cinfa should not have negative effects. However, rarely, intense itching (pruritus) may appear when stopping Levocetirizine Cinfa, 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 other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Common: may affect up to 1 in 10 people

Dry mouth, headache, fatigue, and drowsiness.

Uncommon: may affect up to 1 in 100 patients

Exhaustion and abdominal pain.

Frequency not known: cannot be estimated from available data

Other side effects have also been reported, such as palpitations, increased heart rate (tachycardia), seizures, tingling, dizziness, syncope, tremors, dysgeusia (altered sense of taste), sensation of rotation or movement, visual disturbances, blurred vision, oculogyric crisis (uncontrolled circular movements of the eyes), 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, hallucination, depression, insomnia, recurrent thoughts or concerns about suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea.

Intense itching (pruritus) when stopping treatment.

If you experience the first signs of a hypersensitivity reaction, stop taking Levocetirizine Cinfa and inform your doctor immediately. The symptoms of a hypersensitivity reaction may include: swelling of the mouth, tongue, face, and/or neck, difficulty breathing or swallowing (or pressure in the chest or wheezing), hives, sudden decrease in blood pressure that may lead to collapse or shock, which can be fatal.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Levocetirizine Cinfa

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Levocetirizine Cinfa

• The active substance is levocetirizine dihydrochloride.

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

• The other components are microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropylcellulose, colloidal silica, magnesium stearate, hypromellose (E464), titanium dioxide (E171), talc, and macrogol 6000.

Appearance of the product and contents of the pack

Levocetirizine Cinfa 5 mg is presented in the form of white or almost white, round, biconvex, and serigraphed (marked "LC") film-coated tablets, which are packaged in packs of 20 tablets.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the last revision of this package leaflet:November 2018

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

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/73155/P_73155.html

QR code to: https://cima.aemps.es/cima/dochtml/p/73155/P_73155.html