LEVOCETIRIZINE TEVA-RATIOPHARM 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levocetirizine Teva-ratiopharm 5 mg film-coated tablets EFG

For adults and children from 6 years of age

levocetirizine dihydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 is Levocetirizine Teva-ratiopharm and what is it used for
2. What you need to know before you take Levocetirizine Teva-ratiopharm
3. How to take Levocetirizine Teva-ratiopharm
4. Possible side effects
5. Storing Levocetirizine Teva-ratiopharm
6. Contents of the pack and other information

1. What is Levocetirizine Teva-ratiopharm and what is it used for

Levocetirizine Teva-ratiopharm 5 mg contains the active substance levocetirizine dihydrochloride. Levocetirizine Teva-ratiopharm is an antiallergic medicine.

Levocetirizine is used for the treatment of symptoms associated with:

• allergic rhinitis (including persistent allergic rhinitis)
• urticaria

Antihistamines like levocetirizine relieve the discomfort associated with the above-mentioned conditions, such as sneezing, irritation, secretion and nasal congestion, itching, redness of the eyes with tearing and skin rash.

2. What you need to know before you take Levocetirizine Teva-ratiopharm

Do not take Levocetirizine Teva-ratiopharm:

• If you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or any of the other ingredients of this medicine (listed in section 6).
• If you have severe kidney failure that requires dialysis

Warnings and precautions

Consult your doctor or pharmacist before taking Levocetirizine Teva-ratiopharm.

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.

If you are epileptic or have a risk of convulsions, please consult your doctor as the use of Levocetirizine Teva-ratiopharm may worsen the crises.

If you are going to undergo any allergy testing, ask your doctor if you should stop taking Levocetirizine Teva-ratiopharm a few days before. This medicine may affect the results of the allergy test.

Children

The use of Levocetirizine Teva-ratiopharm is not recommended in children under 6 years of age since the film-coated tablets do not allow for dose adjustment.

Other medicines and Levocetirizine Teva-ratiopharm

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

Using Levocetirizine Teva-ratiopharm 5 mg with food, drinks and alcohol

Caution is recommended if you take Levocetirizine Teva-ratiopharm 5 mg with alcohol or other agents that act on the brain. In sensitive patients, taking Levocetirizine Teva-ratiopharm with alcohol or other agents that act on the brain may cause additional decreased attention and decreased performance.

Levocetirizine Teva-ratiopharm can be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 Teva-ratiopharm may experience drowsiness/sedation, fatigue and exhaustion. Be careful if you are going to drive or use machinery until you know how this medication affects you. However, in special tests performed in healthy people, no alterations in attention, reaction capacity, and ability to drive were detected after taking levocetirizine at the recommended dose.

Levocetirizine Teva-ratiopharm contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Levocetirizine Teva-ratiopharm

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults and children from 6 years of age

The recommended dose for adults and children from 6 years of age is one tablet per day.

Special dosing instructions for specific populations:

Kidney and liver failure

Patients with kidney failure should receive a lower dose according to the severity of their kidney disease, and in children, the dose will also be chosen based on body weight; the dose to be taken will be determined by your doctor.

Patients with severe kidney failure that requires dialysis should not take levocetirizine.

Patients with only liver failure should take the recommended prescribed dose.

Patients who have both liver and kidney function impaired may receive a lower dose depending on the severity of the kidney disease, and in children, the dose will also be chosen based on body weight; the dose will be determined by your doctor.

Patients from 65 years of age

In elderly patients, it is not necessary to adjust the dose if their kidney function is normal.

Use in children

The use of levocetirizine is not recommended in children under 6 years of age.

How and when should you take Levocetirizine Teva-ratiopharm?

Only for oral use.

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

How long should your treatment with Levocetirizine Teva-ratiopharm last?

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

If you take more Levocetirizine Teva-ratiopharm than you should

If you take more levocetirizine than you should, in adults it may cause drowsiness. In children, it may initially cause agitation and restlessness followed by drowsiness. In case of overdose or accidental ingestion, consult your doctor immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Levocetirizine Teva-ratiopharm

If you have forgotten to take levocetirizine, continue taking your usual dose when it is due. Do not take a double dose to make up for forgotten doses.

If you stop taking Levocetirizine Teva-ratiopharm

Stopping treatment should not have negative effects. However, rarely, intense itching (pruritus) may appear when stopping levocetirizine, even when these symptoms were not present at the start of treatment.

The symptoms may disappear spontaneously. In some cases, the symptoms may be intense and require that the treatment be restarted. The symptoms usually disappear when treatment is restarted.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

At the first signs of hypersensitivity reaction, stop taking Levocetirizine Teva-ratiopharm and see your doctor immediately. The symptoms of a hypersensitivity reaction may include: swelling of the mouth, tongue, face and/or throat, difficulty breathing or swallowing along with hives (angioedema), sudden decrease in blood pressure that can lead to collapse or shock, which can be fatal.

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

• dry mouth
• headache
• fatigue
• drowsiness.

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

• exhaustion
• abdominal pain.

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

• increased appetite
• aggressive or agitated behavior, hallucinations, depression, insomnia, recurrent thoughts or concern with suicide, nightmares
• seizures, tingling, dizziness, syncope, tremor, dysgeusia (alteration of the sense of taste),
• sensation of rotation or movement
• visual disturbances, blurred vision, oculogyric crisis (uncontrolled circular movements of the eyes)
• palpitations, increased heart rate,
• shortness of breath
• nausea. Vomiting, diarrhea
• hepatitis, abnormal liver function
• pain or difficulty urinating, inability to empty the bladder completely
• skin rash, itching (pruritus), hives, urticaria (swelling, redness, and itching of the skin)
• intense itching (pruritus) when stopping treatment
• muscle pain, joint pain
• edema
• weight gain

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Levocetirizine Teva-ratiopharm

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Levocetirizine Teva-ratiopharm 5 mg

• The active substance is levocetirizine dihydrochloride. Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride.
• The other ingredients are microcrystalline cellulose, lactose monohydrate, anhydrous colloidal silica, magnesium stearate, hypromellose, titanium dioxide (E171), and macrogol 400.

Appearance of the product and contents of the pack

Levocetirizine Teva-ratiopharm 5 mg: white to off-white, oval, film-coated tablets; one side is marked with “LC5”. The other side of the tablet is smooth.

It is available in blister packs of 7, 10, 14, 15, 20, 21, 28, 30, 40, 50, 60, 90, and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Teva Pharma, S.L.U.

C/ Anabel Segura, nº 11, Edificio Albatros B 1ª planta

28108 Alcobendas – Madrid

Spain

Manufacturer:

Teva Pharmaceuticals Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Pharmachemie B.V.

Swensweg 5, Postbus 552, 2003 RN Haarlem

Netherlands

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany: Levocetirizin Teva 5 mg Filmtabletten

Belgium: Levocetiriteva 5 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten

Denmark: Levocetirizindihydrochlorid Teva

Spain: Levocetirizina Teva-ratiopharm 5 mg comprimidos recubiertos con película EFG

France: Levocetirizine teva 5 mg, comprime pellicule

Hungary: Novocetrin 5 mg filmtabletta

Ireland: Levocetirizine Teva 5 mg film coated tablets

Italy: Levocetirizina Teva 5 mg compresse rivestite con film

Malta: Levocetirizine Teva 5 mg film coated tablets

Netherlands: Levocetirizine diHCl 5 PCH, filmomhulde tabletten 5mg

Slovakia: Levocetirizine Teva 5 mg filmom obalene tablety

United Kingdom (Northern Ireland): Levocetirizine 5mg Film coated tablets

Date of last revision of this leaflet: March 2024

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70601/P_70601.html