


Ask a doctor about a prescription for LEVOCETIRIZINE PHARMA COMBIX 5 mg FILM-COATED TABLETS
Package Leaflet: Information for the Patient
LevocetirizinePharma Combix5mgcomprimidos recubiertos con película EFG
Levocetirizine dihydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Contents of the pack and other information
The active substance of Levocetirizine Pharma Combix is levocetirizine dihydrochloride. Levocetirizine Pharma Combix is an antiallergic medicine.
For the treatment of symptoms associated with:
Do not take Levocetirizine Pharma Combix
Warnings and precautions
Consult your doctor or pharmacist before taking Levocetirizine Pharma Combix.
Levocetirizine Pharma Combix is not recommended for use in children under 6 years of age, as the film-coated tablets do not allow for dose adjustment.
If you have any condition that makes it difficult for you to empty your urinary bladder (such as spinal cord injury or enlarged prostate), please inform your doctor.
Use of Levocetirizine Pharma Combix with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Taking Levocetirizine Pharma Combix with food, drinks and alcohol
Cautions should be taken if you take this medicine and alcohol at the same time.
In sensitive patients, the simultaneous intake of cetirizine or levocetirizine and alcohol or other centrally acting agents may have effects on the central nervous system, although the racemate cetirizine has shown that it does not potentiate the effect of alcohol.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Some patients treated with levocetirizine may experience somnolence, fatigue and tiredness. If you are going to drive, perform potentially hazardous activities or use machinery, it is advisable to wait and observe your response to this medication. However, in special tests performed in healthy individuals, no alterations in attention, reaction capacity and ability to drive were detected after taking levocetirizine at the recommended dose.
Levocetirizine Pharma Combix contains lactose.If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.
Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.
Dosage
The normal dose for adults and children from 6 years of age is one tablet per day.
Special dosage instructions for specific populations
Patients with renal impairment should receive a lower dose according to the severity of their kidney disease, and in children, the dose will be chosen based on body weight; the dose to be taken will be decided by your doctor.
Patients with severe renal impairment should not take this medicine.
Patients with only hepatic impairment should take the normal prescribed dose.
Patients with hepatic and renal impairment 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.
Levocetirizine Pharma Combix is not recommended for use in children under 6 years of age.
In elderly patients, no dose adjustment is necessary, provided that their renal function is normal.
How and when to take Levocetirizine Pharma Combix?
The tablets should be swallowed whole with water and can be taken with or without food.
If you take more Levocetirizine Pharma Combix than you should
If you take more Levocetirizine Pharma Combix than you should, it may cause somnolence in adults. In children, it may initially cause agitation and restlessness followed by somnolence.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Levocetirizine Pharma Combix
If you have forgotten to take Levocetirizine Pharma Combix, or if you have taken a lower dose than prescribed by your doctor, do not take a double dose to make up for the forgotten doses, simply wait until the next scheduled dose and take the normal dose prescribed by your doctor.
If you stop taking Levocetirizine Pharma Combix
Stopping treatment should not have negative effects. The symptoms may reappear, but they should not be worse than the symptoms before treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people):
Dry mouth, headache, fatigue and somnolence.
Uncommon side effects (may affect up to 1 in 100 people):
Exhaustion and abdominal pain.
Frequency not known (frequency cannot be estimated from the available data)
Other side effects have also been reported, such as palpitations, increased heart rate (tachycardia), convulsions, tingling, dizziness, syncope, tremor, dysgeusia (alteration of taste), sensation of rotation or movement, visual disturbances, oculogyric crisis (uncontrolled circular movements of the eyes), blurred vision, difficulty or pain when 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, aggressive or agitated behavior, hallucination, depression, insomnia, recurrent thoughts or concern with suicide, hepatitis, abnormal liver function, vomiting, increased appetite and nausea.
At the first signs of a hypersensitivity reaction, stop taking levocetirizine and inform your doctor immediately. The symptoms of a hypersensitivity reaction may include: swelling of the mouth, tongue, face and/or throat, difficulty breathing or swallowing (chest tightness or wheezing), hives, sudden drop in blood pressure that can lead to collapse or shock, which can be fatal.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
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 which is stated on the carton after EXP. The expiry date is the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Place the empty cartons and any remaining medicines in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the cartons and any remaining medicines. This will help protect the environment.
Composition of Levocetirizine Pharma Combix
Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride, which is equivalent to 4.2 mg of levocetirizine.
Core of the tablet: Lactose monohydrate, microcrystalline cellulose (E460i), crospovidone, magnesium stearate (E470b) and anhydrous colloidal silica (E551).
Coating of the tablet: Opadry white 03B180001 (hypromellose (E464), titanium dioxide (E171) and macrogol 400 (E1521)).
Appearance of the product and contents of the pack
White or almost white, oval, biconvex, film-coated tablet with beveled edges and smooth surfaces on both sides.
OPA/Al/PVC-Aluminum and PVC/PVDC-Aluminum blisters (standard or perforated).
Packs of 20 tablets.
Marketing authorization holder and manufacturer
Marketing authorization holder
Laboratorios Combix, S.L.U.
C / Badajoz 2, Edificio 2
28223 Pozuelo de Alarcón (Madrid)
Spain
Manufacturer
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
Date of last revision of this leaflet: June 2018
Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
The average price of LEVOCETIRIZINE PHARMA COMBIX 5 mg FILM-COATED TABLETS in November, 2025 is around 5.9 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
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