Levocetirizine Cinfa 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

levocetirizine cinfa 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What levocetirizine cinfa is and what it is used for
2. What you need to know before taking levocetirizine cinfa
3. How to take levocetirizine cinfa
4. Possible side effects
5. How to store levocetirizine cinfa

Contents of the pack and other information

1. What levocetirizine cinfa is and what it is used for

The active substance of levocetirizine cinfa is levocetirizine dihydrochloride. This medicine is an antiallergenic.

For the treatment of disease signs (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 ingredients of this medicine (listed in section 6).
• if you have severe impairment of kidney function (severe renal insufficiency with a creatinine clearance below 10 ml/min).

Warnings and precautions

Talk to your doctor or pharmacist before starting 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 have epilepsy or are at risk of seizures, please consult your doctor, as the use of levocetirizine cinfa may worsen seizures.

If you are scheduled for any allergy testing, ask your doctor whether you need to stop treatment with levocetirizine cinfa several days in advance. This medicine may affect the results of allergy tests.

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 medicines

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

Taking levocetirizine cinfa with food, drinks and alcohol

Caution is advised when taking levocetirizine cinfa together with alcohol or other agents acting on the brain. In sensitive patients, taking levocetirizine together with alcohol or other central nervous system-acting agents may cause an additional decrease in attention capacity and reduced performance.

Levocetirizine can be taken either on an empty stomach or with food.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Some patients treated with levocetirizine may experience drowsiness/sedation, fatigue, and exhaustion. Exercise caution when driving or operating machinery until you know how this medicine affects you. However, in specific studies conducted in healthy individuals, no impairments in attention, reaction ability, or driving skills were detected after taking levocetirizine at the recommended dose.

levocetirizine cinfa contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take levocetirizine cinfa

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose for adults and children aged 6 years and older is one tablet daily.

Special dosing instructions for specific populations

Renal and hepatic impairment

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

Levocetirizine cinfa must not be taken by patients with severe renal impairment.

Patients with hepatic impairment alone should take the standard prescribed dose.

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

Patients aged 65 years and older

In elderly patients, dose adjustment is not necessary if renal function is normal.

Use in children

Levocetirizine cinfa is not recommended for use 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 may be taken either on an empty stomach or 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 should be determined by your doctor.

If you take more levocetirizine cinfa than you should

If you take more levocetirizine cinfa 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take levocetirizine cinfa

If you forget 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 dose. Continue taking your normal dose at the next scheduled time.

If you stop taking levocetirizine cinfa

Stopping treatment with levocetirizine cinfa should not have negative effects. However, pruritus (intense itching) may rarely occur when stopping levocetirizine cinfa, even when these symptoms were not present at the start of treatment. Symptoms may resolve spontaneously. In some cases, symptoms may be severe and require restarting treatment. Symptoms usually resolve when treatment is restarted.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Frequent: may affect up to 1 in 10 people
Dry mouth, headache, fatigue and somnolence.

Uncommon: may affect up to 1 in 100 people
Exhaustion and abdominal pain.

Frequency not known: cannot be estimated from the available data
Other adverse effects that have also been reported include palpitations, increased heart rate (tachycardia), seizures, tingling sensations, dizziness, syncope, tremor, dysgeusia (altered sense of taste), sensation of rotation or movement, visual disturbances, blurred vision, oculogyric crisis (uncontrolled circular eye movements), pain or difficulty urinating, inability to urinate, edema, pruritus (itching), rash, 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, recurrent thoughts or concerns about suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea and diarrhea.

Pruritus (intense itching) when treatment is discontinued.

At the first signs of a hypersensitivity reaction, stop taking levocetirizine cinfa and inform your doctor immediately. Symptoms of a hypersensitivity reaction may include: swelling of the mouth, tongue, face and/or neck, difficulty breathing or swallowing (or chest tightness or whistling sounds), hives, sudden drop in blood pressure which may lead to collapse or shock, any of which could be fatal.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it involves possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of levocetirizine cinfa

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other 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 silicon dioxide, magnesium stearate, hypromellose (E464), titanium dioxide (E171), talc and macrogol 6000.

Description of the product and pack contents

levocetirizine cinfa 5 mg is presented as white or almost white, round, biconvex film-coated tablets, printed with the mark "LC", available 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 most recent revision of this leaflet: November 2018

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. 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