Leaflet: information for the user

levocetirizine dihydrochloride 5 mg film-coated tablets EFG

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as 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.

Contents of the pack and additional information

The active ingredient of levocetirizine cinfa is levocetirizine dihydrochloride. This medication is an antihistamine.

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

• Allergic rhinitis (including persistent allergic rhinitis)

• Urticaria.

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 a severe kidney impairment (severe renal impairment 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 a condition that prevents you from emptying your bladder (such as spinal cord damage or an 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 the seizures.

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

Children

Levocetirizine cinfa is not recommended for children under 6 years old 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 taken recently or may need to take any other medicine.

Taking levocetirizine cinfa with food, drinks and alcohol

Caution is advised if levocetirizine cinfa is taken at the same time as alcohol or other agents that act on the brain. In sensitive patients, the simultaneous intake of levocetirizine with alcohol or other agents that act on the brain may cause additional decrease in attention capacity and reduce performance.

Levocetirizine cinfa 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 intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

Some patients treated with levocetirizine 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 at the recommended dose.

levocetirizine cinfa contains lactose

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

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.

The recommended dose for adults and children aged 6 years and older 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 disease, and in children the dose will also be chosen based on their body weight; the dose will be determined 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 renal and hepatic insufficiency should take a lower dose according to the severity of their renal disease, and in children the dose will be based on their body weight; the dose to be taken will be determined by your doctor.

Patients aged 65 years and older

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

Use in children

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

How and when to take levocetirizine cinfa

For oral use only.

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 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

Exceeding the recommended dose in adults 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 at 91 562 04 20, indicating the medication and amount ingested.

If you forget to take levocetirizine cinfa

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

If you interrupt treatment with levocetirizine cinfa

Stopping treatment with levocetirizine cinfa should not have negative effects. However, rarely, intense itching may occur when stopping treatment, even if these symptoms were not present at the start of treatment. Symptoms may disappear spontaneously. In some cases, symptoms may be severe 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, and drowsiness.

Rare: may affect up to 1 in 100 patients

Exhaustion and abdominal pain.

Unknown frequency: cannot be estimated from available data

Other adverse effects that have been described include palpitations, increased heart rate (tachycardia), seizures, paresthesia, dizziness, syncope, tremor, dysgeusia (alteration of the sense of taste), sensation of rotation or movement, visual disturbances, blurred vision, ocular crisis (uncontrolled circular movements of the eyes), pain or difficulty urinating, inability to urinate, edema, pruritus (itching), urticaria (hives, 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 or concern about suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea.

Intense itching when treatment is interrupted.

In the event of the first signs of hypersensitivity reaction, stop taking levocetirizine cinfa and immediately inform your doctor. The symptoms of hypersensitivity reaction may include: swelling of the mouth, tongue, face, and/or neck, difficulty breathing or swallowing (or chest pressure or buzzing), sudden drop in blood pressure that can lead to collapse or shock, which can be fatal.

Reporting Adverse Effects

Ifyou 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 directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.esBy 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.

No special storage conditions are required.

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

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 pointat the pharmacy. If in doubt, 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 cinfa

• The active ingredient 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 packaging

levocetirizine cinfa 5 mg is presented in the form of film-coated tablets, white or almost white, round, biconvex, and printed (mark “LC”) that are presented in packs of 20 tablets.

Holder of the marketing authorization and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet:November 2018

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your 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