Levocetirizine Pharma Combix 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levocetirizine Pharma Combix 5 mg film-coated tablets EFG

Levocetirizine dihydrochloride

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Levocetirizine Pharma Combix is and what it is used for.
2. What you need to know before taking Levocetirizine Pharma Combix.
3. How to take Levocetirizine Pharma Combix.
4. Possible side effects.
5. How to store Levocetirizine Pharma Combix.
6. Contents of the pack and other 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 medicinal product.

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

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

2. What you need to know before taking Levocetirizina Pharma Combix

Do not take Levocetirizina Pharma Combix

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Levocetirizina Pharma Combix.

The use of Levocetirizina Pharma Combix is not recommended in children under 6 years of age, as the film-coated tablets do not allow for dose adjustment.

If you have any condition that impairs your ability to empty the urinary bladder (such as spinal cord damage or enlarged prostate), please inform your doctor.

Taking Levocetirizina Pharma Combix with other medicines

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

Taking Levocetirizina Pharma Combix with food, drinks and alcohol

Caution is recommended if you take this medicine together with alcohol.

In sensitive patients, concomitant use of cetirizine or levocetirizine with alcohol or other centrally acting agents may affect the central nervous system, although the cetirizine racemate has been shown not to potentiate the effect of alcohol.

Pregnancy and breastfeeding

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

Driving and using machines

Some patients treated with levocetirizine may experience drowsiness, fatigue, and exhaustion. If you intend to drive, perform potentially hazardous activities, or operate machinery, it is advisable to wait and observe your response to this medication first. However, in special tests conducted in healthy individuals, no impairment of attention, reaction ability, or driving skills has been observed after taking levocetirizine at the recommended dose.

Levocetirizina Pharma Combix contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Levocetirizine Pharma Combix

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

The usual dose for adults and children aged 6 years and older is one tablet daily.

Special dosage instructions for specific populations

Patients with renal impairment should receive a reduced dose according to the severity of their kidney disease. In children, the dose will be selected based on body weight; your doctor will determine the appropriate dose.

Patients with severe renal impairment must not take this medicine.

Patients with hepatic impairment alone may take the standard prescribed dose.

Patients with both hepatic and renal impairment should take a reduced dose based on the severity of their kidney disease, and in children the dose will depend on body weight; your doctor will determine the appropriate dose.

The use of Levocetirizine Pharma Combix is not recommended in children under 6 years of age.

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

How and when to take Levocetirizine Pharma Combix

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

If you take more Levocetirizine Pharma Combix than you should

If you take more Levocetirizine 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Levocetirizine Pharma Combix

If you forget to take Levocetirizine Pharma Combix, or if you take a lower dose than prescribed by your doctor, do not take a double dose to make up for the missed dose. Simply wait until the time of your next scheduled dose and take the normal prescribed dose.

If you stop taking Levocetirizine Pharma Combix

Stopping treatment should not have negative effects. Symptoms may reappear, but they should not be worse than the symptoms experienced before treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Dry mouth, headache, fatigue, and drowsiness.

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

Exhaustion and abdominal pain.

Frequency not known (frequency cannot be estimated from available data):

Other adverse effects that have also been reported include palpitations, increased heart rate (tachycardia), seizures, tingling sensations, dizziness, fainting, tremor, dysgeusia (altered sense of taste), sensation of spinning or movement, visual disturbances, oculogyric crisis (involuntary circular eye movements), blurred vision, pain or difficulty urinating, inability to urinate, edema, pruritus (itching), rash, urticaria (swelling, redness, and itching of the skin), skin rash, shortness of breath, weight gain, muscle pain, aggressive or agitated behavior, hallucinations, depression, insomnia, recurrent thoughts or preoccupation with suicide, hepatitis, abnormal liver function, vomiting, increased appetite, and nausea.

At the first signs of hypersensitivity reaction, stop taking levocetirizine and inform your doctor immediately. Symptoms of hypersensitivity reaction may include: swelling of the mouth, tongue, face and/or neck, difficulty breathing or swallowing (chest tightness or whistling sounds), hives, sudden drop in blood pressure which may lead to collapse or shock, which can be fatal.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levocetirizine PharmaCombix

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

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

• The other components (excipients) are:

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

Tablet coating: Opadry White 03B180001 (hydroxypropylmethylcellulose (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 bevelled edges and smooth surfaces on both sides.

Blister packs made of OPA/Al/PVC-Aluminum and blister packs made of PVC/PVDC-Aluminum (standard or perforated).

Pack sizes 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 the most recent review of this leaflet: June 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Health Products (AEMPS) http://www.aemps.gob.es/