Prospecto: information for thepatient

Levocetirizina Sandoz 5 mg film-coated tablets EFG

Levocetirizine (as dihydrochloride)

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. (See section 4).

1.What is Levocetirizina Sandoz and what is it used for

2.What you need to knowbeforestarting totake Levocetirizina Sandoz

3.How to take Levocetirizina Sandoz

4.Possible adverse effects

5Storage of Levocetirizina Sandoz

6.Contents of the package and additional information

Levocetirizina Sandoz contains the active ingredient levocetirizine, it is an antihistamine medication. It is used to treat symptoms associated with allergic states such as:

• allergic rhinitis (including persistent allergic rhinitis),

• chronic urticaria (idiopathic chronic urticaria).

Do not take Levocetirizina Sandoz:

-if you areallergic to levocetirizine hydrochloride, cetirizine, or hydroxyzine or to any of the other ingredientsof this medication (listed in section 6),

-if you havesevere kidney impairment(severe kidney impairment with a creatinine clearance below 10 ml/min).

Warnings and precautions

Consult your doctor orpharmacist before starting to take Levocetirizina Sandoz.

If you have any condition that prevents you from emptying your bladder (such as spinal cord damage or an enlarged prostate), please inform your doctor.

If you have epilepsy or are at risk of seizures, ask your doctor for advice as the use of levocetirizine may worsen seizures.

If you have an appointment for an allergy test, consult your doctor if you should stop taking levocetirizine for several days before the test. This medication may affect the test results.

Children

The use of levocetirizine tablets is not recommended in children under 6 years old as the tablets do not allow for dose adjustment.

Taking Levocetirizina Sandoz withother medications

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may have to take any other medication.

Taking Levocetirizina Sandoz with food, drinks, and alcohol

It is recommended to be cautious if levocetirizine is taken with alcohol or with other agents that act on the brain.

In sensitive patients, the concurrent administration of levocetirizine and alcohol or other agents that act on the brain may produce additional reduction in alertness and decreased performance.

Levocetirizine can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consultyour doctor or pharmacist before using this medication.

Driving and operating machinery

In some patients, levocetirizine may cause drowsiness, fatigue, and exhaustion.

If you intend to drive, engage in any potentially hazardous activity, or operate machinery, it is recommended to wait and observe your response to this medication first.

However, certain special tests conducted in healthy individuals after taking levocetirizine at the recommended dose have shown that there is no impairment of mental alertness or ability to react while driving.

Levocetirizina Sandoz contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose for adults and children aged 6 years and above is one tablet per day.

Renal and hepatic insufficiency

Patients with renal insufficiency and those with both renal and hepatic insufficiency should be administered a lower dose according to the severity of their renal disease, and in children the dose should also be chosen based on body weight, the dose will be determined by your doctor.

Patients with severe renal insufficiency should not take levocetirizine.

Patients with only hepatic insufficiency should take the normal recommended dose prescribed by your doctor.

Patients aged 65 years and above

No dose adjustment is necessary in elderly patients, provided their renal function is normal.

Use in children

Levocetirizine Sandoz is not recommended for children under 6 years of age since the film-coated tablets do not allow for dose adjustment.

How and when to take Levocetirizine Sandoz

The tablets should be swallowed whole with water and can be taken with or without food.

The duration of treatment will be determined by your doctor based on the type, duration, and course of symptoms.

If you take more Levocetirizine Sandoz than you should

If you take more levocetirizine than you should, drowsiness may occur in adults. In children, it may initially cause excitement and fatigue followed by drowsiness.

If you have taken more Levocetirizine Sandoz than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Levocetirizine Sandoz

If you forget to take your medication or take a dose less than prescribed by your doctor, do not take a double dose to compensate for the missed doses. Take the next dose as prescribed by your doctor.

If you interrupt treatment with Levocetirizine Sandoz

Interrupting treatment should not have negative effects. However, pruritus (intense itching) may rarely occur if you stop taking levocetirizine, even if this symptom was not present.

This symptom may resolve spontaneously. In some cases, symptoms may be intense and may require restarting treatment. Symptoms should resolve when treatment is restarted.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop taking levocetirizine and consult your doctor immediately with the first signs of an allergic reaction. Allergic reaction symptoms may include: swelling of the mouth, tongue, face, and/or throat, difficulty swallowing or breathing (chest tightness or urticaria (angioedema), sudden drop in blood pressure leading to collapse or shock, which can be fatal.

Common side effects,may affect up to 1 in 10 people:

• dry mouth,
• headache,
• fatigue,
• drowsiness/dizziness.

Less common side effects,may affect up to 1 in 100 people

• exhaustion,
• abdominal pain.

Side effects of unknown frequency(cannot be estimated from available data)

• palpitations,
• increased heart rate.
• seizures,
• tingling and pins and needles,
• dizziness,
• syncope,
• tremor,
• distortion of taste (dysgeusia),
• sensation of rotation or movement,
• visual disturbances,
• blurred vision,
• ocular crisis (uncontrolled circular eye movements),
• pain or difficulty urinating,
• inability to completely empty the bladder,
• swelling,
• pruritus (itching), also after discontinuation,
• eruption,
• urticaria (swelling, redness, and itching of the skin),
• skin eruption,
• shortness of breath,
• weight gain,
• muscle pain,
• joint pain,
• agitated or aggressive behavior,
• hallucinations,
• depression,
• insomnia,
• recurring thoughts or concern about suicide,
• nightmares,
• hepatitis,
• abnormal liver function,
• vomiting,
• increased appetite,
• nausea,
• diarrhea.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https;//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine

Keep this medication out of the sight and reach of children.

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.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Levocetirizina Sandoz

-The active ingredient is levocetirizine. Each tablet contains 5 mg of levocetirizine (as dihydrochloride), corresponding to 4.2 mg of levocetirizine.

-The other components are: microcrystalline cellulose, lactose monohydrate, magnesium stearate (E572), hypromellose (E464), titanium dioxide (E171) and macrogol (400).

Appearance of the product and contents of the package

The film-coated tablets are white or off-white, oval, biconvex, and have the marks ‘L9CZ’ on one face and ‘5’ on the other.

The tablets are packaged in PVC/PE/PVDC/Al blisters inserted into a cardboard package.

Package sizes:7, 10, 14, 15, 20, 21, 28, 30, 40, 50, 56, 60, 70, 90, 100, 112 or 120tablets and single-dose blisters containing 30x1 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

c/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Salutas Pharma GmBH

Otto von Guericke-Alle 1,

39179 Barleben

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria:Levocetirizin Hexal 5 mg – Filmtabletten

Bulgaria:Bezaleria

Czech Republic:Volnostin

Finland:Levocetirizine Sandoz 5 mg tabletti,kalvopäällysteinen

Greece:Levocetirizine Sandoz

Hungary:Sefaller 5 mg filmtabletta

Portugal:Levocetirizina Sandoz

Poland:Votrezin

Slovakia:Levocetirizin Sandoz 5 mg filmom obalené tablety

Romania:Levocetirizina Sandoz 5 mg comprimate Filmate

Spain:Levocetirizina Sandoz 5 mg comprimidos recubiertos con película EFG.

Last review date of thisleaflet:December 2018.

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/