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Patient Information Leaflet

Levocetirizine Krka 5 mg Film-Coated Tablets

levocetirizine dihydrochloride

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• 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 only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

The active ingredient of Levocetirizina Krka is levocetirizine dihydrochloride.

Levocetirizina Krka is an antihistamine medication.

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

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

Do not takeLevocetirizina Krka

• if you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or any other antihistamine or any of the other ingredients in this medication (listed in section 6),

• if you have a severe kidney disease that requires dialysis.

Warnings and precautions

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

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 Levocetirizina Krka may worsen the seizures.

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

Children

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

Other medications and Levocetirizina Krka

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

TakingLevocetirizina Krka with food, drinks, and alcohol

Caution is advised if you takeLevocetirizina Krkaat the same time as alcohol or other agents that act on the brain.

In sensitive patients, concurrent use of Levocetiricina Krka and alcohol or other agents that act on the brain may cause additional reductions in attention and reduced ability.

Levocetirizina can be taken with or without food.

Pregnancy and breastfeeding

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

Driving and operating machines

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

Levocetirizina Krka containslactose

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

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

The recommended dose for adults and children aged 6 years and above 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 renal diseaseand 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 disease requiring dialysis should not take levocetirizine.

Patients with only hepatic insufficiency should take the prescribed dose.

Patients with both renal and hepatic 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.

Patients aged 65 years and above

No dose adjustment is necessary in elderly patients with normal renal function.

Children

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

How and when to take Levocetirizine Krka?

For oral use only.

Swallow the tablets wholewith water and can be taken either on an empty stomach or with food.

How long to take Levocetirizine Krka?

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

If you take moreLevocetirizine Krkathan you should

If you take more levocetirizine than you should, in adults it may cause drowsiness.In children it may initially cause restlessness and agitation 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.

If you forget to takeLevocetirizine Krka

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

If you interrupt the treatment withLevocetirizine Krka

Discontinuation of treatment should not have negative effects. However, rarely, intense itching may occur when stoppinglevocetirizine, 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 medicationcan produce adverse effects, although not all people will experience them.

Frequent Adverse Effects (affects 1 in 10 patients):

Dry mouth, headache, fatigue, and drowsiness.

Less Frequent Adverse Effects (affects 1 in 100 patients):

Exhaustion and abdominal pain.

Unknown Frequency (cannot be estimated from available data):

Other adverse effects that have been described includepalpitations, increased heart rate (tachycardia), seizures, paresthesia, dizziness, syncope, tremor, dysgeusia (alteration of the sense of taste), sensation of rotation or movement, seizures, visual disturbances, blurred vision,ocular crisis(uncontrolled circular movements of the eyes),pain or difficulty urinating, inability to urinate, edema, pruritus (itching), urticaria (skin swelling, redness, and itching), skin rash, labored breathing, weight gain, muscle pain, joint pain, aggressive or agitated behavior, hallucinations, depression, insomnia, recurring thoughts or concern about suicide,nightmares,hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea.Intense pruritus when treatment is interrupted.

Stop taking Levocetirizina Krka and see your doctor immediately if you experience the first signs ofhypersensitivity reaction. Symptoms of a hypersensitivity reaction may include: swelling of themouth, tongue, face, and/or neck, difficulty breathing or swallowing(chest tightness or wheezing),angioedema, 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 not listed in this prospectus. You can also report them directly through the national notification system: Spanish System for Pharmacovigilance of Medicinal Products for Human Use: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 medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointofthe pharmacy. Incase of doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofLevocetirizine Krka

• The active ingredient is levocetirizine dihydrochloride.

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

• The other components are lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate in the tablet core and lactose monohydrate, hypromellose 6cP, titanium dioxide (E171), macrogol 3000, and triacetin in the coating. See section 2 “Levocetirizine Krka contains lactose”.

Appearance of the productand contents of the pack

The film-coated tablets are white, round, biconvex, and have beveled edges.

They are available in blisters of 7, 10, 14, 20, 28, 30, 50, 60, 90, 98, and 100 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Or

TAD Pharma GmBH, Heinz-Lohman-Strasse 5, 27472 Cuxhaven, Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Krka Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

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

Last review date of this leaflet:March 2024

More detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es/.