LEVOCETIRIZINE PHARMA COMBIX 5 mg FILM-COATED TABLETS

Introduction

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.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What Levocetirizine Pharma Combix is and what it is used for.
2. What you need to know before you take Levocetirizine Pharma Combix.
3. How to take Levocetirizine Pharma Combix.
4. Possible side effects.
5. Storage of Levocetirizine Pharma Combix.
6. Contents of the pack and further information.

1. What Levocetirizine Pharma Combix is and what it is used for

The active substance of Levocetirizine Pharma Combix is levocetirizine dihydrochloride. Levocetirizine Pharma Combix is an antiallergic medicine.

For the treatment of symptoms associated with:

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

2. What you need to know before you take Levocetirizine Pharma Combix

Do not take Levocetirizine Pharma Combix

• if you are allergicto levocetirizine dihydrochloride, to an antihistamine or to any of the other ingredients of this medicine (listed in section 6)
• if you have severe kidney disease(severe renal impairment with a creatinine clearance below 10 ml/min).

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.

3. How to take Levocetirizine Pharma Combix

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.

4. Possible side effects

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.

5. Storage of Levocetirizine Pharma Combix

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.

6. Contents of the pack and further information

Composition of Levocetirizine Pharma Combix

• The active substance 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 ingredients (excipients) are:

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/