Label: information for the patient

LevocetirizinePharma Combix5mgcomprimidos recubiertosconpelícula EFG

Levocetirizinadihidrocloruro

Please read this label carefully, and keep it for future reference, as it contains important information for you.

• Read this label carefully, and keep it for future reference, and return it to the pharmacist.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed for your use only, and should not be given to other persons who have the same symptoms as you, and who may be pregnant.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Contents of the label:

1. What is Levocetirizine Pharma Combix and how it is used.
2. What you need to know before starting to take Levocetirizine Pharma Combix.
3. How to take Levocetirizine Pharma Combix.
4. Possible adverse effects.
5. Advice on the use of Levocetirizine Pharma Combix.
6. Contents of the package and additional information.

The active ingredient of Levocetirizina Pharma Combixis levocetirizine dihydrochloride. Levocetirizina Pharma Combixis an antihistamine medication.

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

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

Do not take LevocetirizinaPharma Combix

• if you areallergicto levocetirizine dihydrochloride, an antihistamine, or any of the other ingredients in this medication (listed in section 6)
• if you have asevere 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 LevocetirizinaPharma Combix.

LevocetirizinaPharma Combixis not recommended for children under 6 years old as the film-coated tablets do not allow for dose adjustment.

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.

Use of LevocetirizinaPharmaCombixwith other medications

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

Administration of LevocetirizinaPharmaCombixwith food, drinks, and alcohol

Use caution if you take this medication and at the same time consume alcohol.

In sensitive patients, the simultaneous intake of cetirizine or levocetirizine and alcohol or other central-acting agents may have effects on the central nervous system, although the racemic cetirizine has shown that it does not potentiate the effect of alcohol.

Pregnancy and lactation

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

Driving and operating machinery

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

LevocetirizinaPharmaCombixcontains lactose.If your doctor has indicated that you have an intolerance 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.

Dosage

The usual dose for adults and children aged 6 years and above 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 chosen 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 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.

Levocetirizina Pharma Combix is not recommended for use in children under 6 years of age.

In elderly patients, no dose adjustment is necessary, provided their renal function is normal.

How and when to take Levocetirizina Pharma Combix

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

If you take more Levocetirizina Pharma Combix than you should

If you take more Levocetirizina Pharma Combix 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, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Levocetirizina Pharma Combix

If you have forgotten to take Levocetirizina Pharma Combix, or if you take a dose lower than prescribed by your doctor, do not take a double dose to compensate for the missed doses, simply wait until the next scheduled time and take the normal dose prescribed by your doctor.

If you interrupt treatment with Levocetirizina Pharma Combix

Discontinuation of treatment should not have negative effects. Symptoms may reappear, but they should not be worse than the previous symptoms before treatment.

If you have any other doubts 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.

Common adverse effects (may affect up to 1 in 10 people):

Dry mouth, headache, fatigue, and drowsiness.

Less common adverse effects (may affect up to 1 in 100 people):

Exhaustion and abdominal pain.

Unknown frequency (frequency cannot be estimated from available data)

Other adverse effects have also been described, such as palpitations, increased heart rate (tachycardia), seizures, numbness, dizziness, syncope, tremors, dysgeusia (alteration of the sense of taste), sensation of rotation or movement, visual disturbances, ocular crisis (uncontrolled circular movements of the eyes), blurred vision, painful or difficult urination, inability to urinate, edema, pruritus (itching), urticaria (skin swelling, redness, and itching), skin rash, interrupted breathing, weight gain, muscle pain, aggressive or agitated behavior, hallucinations, depression, insomnia, recurring thoughts or concern about suicide, hepatitis, abnormal liver function, vomiting, increased appetite, and nausea.

At the first signs ofhypersensitivity reaction, stop taking levocetirizine and immediately inform your doctor. The symptoms of a hypersensitivity reaction may include: swelling of the mouth, tongue, face, and/or neck, difficulty breathing or swallowing (chest tightness or wheezing), hives, sudden decrease in blood pressure that may 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 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.

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. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in 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 of LevocetirizinePharmaCombix

• The active ingredient is levocetirizine in the form of levocetirizine dihydrochloride.

Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride, which is equivalent to 4.2 mg of levocetirizine.

• The other components (excipients) are:

Tablet core: Lactose monohydrate, microcrystalline cellulose (E460i), crospovidone, magnesium stearate (E470b), and anhydrous colloidal silica (E551).

Tablet coating: Opadry white 03B180001 (hydroxypropylmethylcellulose (E464), titanium dioxide (E171), and macrogol 400 (E1521)).

Appearance of the product and contents of the package

White or off-white film-coated tablet, oval, biconvex, with beveled edges and smooth on both faces.

OPA/Al/PVC-Aluminum blisters and PVC/PVDC-Aluminum blisters (standard or perforated).

Packages of 20 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

LaboratoriesCombix,S.L.U.

C /Badajoz2,Edificio2

28223PozuelodeAlarcón(Madrid)

Spain

Responsible for manufacturing

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Flavine Pharma France

3 Voie d’Allemagne

13127 Vitrolles

France

Last review date of this prospectus: June 2018

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