LEVOCETIRIZINE TEVA-RATIOPHARM 5 MG FILM-COATED TABLETS EFG

Package leaflet: Information for the user

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 the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Leaflet contents:

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

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

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

Levocetirizine is used to treat the signs of illness (symptoms) associated with:

• allergic rhinitis (including persistent allergic rhinitis)
• urticaria

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

2. What you need to know before starting to 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 renal impairment requiring dialysis

Warnings and precautions

Talk to your doctor or pharmacist before taking Levocetirizine Teva-ratiopharm.

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.

If you have epilepsy or are at risk of seizures, please consult your doctor, as the use of Levocetirizine Teva-ratiopharm may worsen seizures.

If you are scheduled to undergo allergy testing, ask your doctor whether you need to stop treatment with Levocetirizine Teva-ratiopharm several days beforehand. This medicine may affect the results of allergy testing.

Children

The use of Levocetirizine Teva-ratiopharm is not recommended in children under 6 years of age, as 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 need to take any other medicines.

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

Caution is advised when taking Levocetirizine Teva-ratiopharm 5 mg together with alcohol or other agents acting on the central nervous system. In sensitive patients, concomitant use of Levocetirizine Teva-ratiopharm with alcohol or other central nervous system-acting agents may cause additional impairment of attention and reduced performance.

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

Pregnancy and breastfeeding

If you are pregnant or 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 Teva-ratiopharm may experience drowsiness, fatigue, or tiredness. Exercise caution when driving or operating machinery until you know how this medicine affects you. However, in specific studies conducted in healthy individuals, no impairment of attention, reaction ability, or driving skills was observed after taking levocetirizine at the recommended dose.

Levocetirizine Teva-ratiopharm contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Levocetirizine Teva-ratiopharm

Follow exactly the instructions for use of this medicine as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist again.

Adults and children aged 6 years and older

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

Special dosage instructions for specific populations:

Renal and hepatic impairment

Patients with renal impairment should receive a reduced dose according to the severity of their kidney disease, and in children the dose will also be selected based on body weight; the dose will be determined by your doctor.

Patients with severe renal impairment requiring dialysis must not take levocetirizine.

Patients with hepatic impairment alone should take the recommended prescribed dose.

Patients with both impaired hepatic and renal function may receive a lower dose depending on the severity of the renal disease, and in children the dose will also be selected based on body weight; the dose will be determined by your doctor.

Patients aged 65 years and older

In elderly patients, dose adjustment is not necessary if renal 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?

For oral use only.

The tablets should be swallowed whole with water and may 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 symptoms, and should be determined by your doctor.

If you take more Levocetirizine Teva-ratiopharm than you should

If you take more levocetirizine 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, consult your doctor immediately or call the Toxicology Information Service at telephone number 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, take your usual dose at the next scheduled time. 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, pruritus (intense itching) may occur when stopping levocetirizine, even when these symptoms were not present at the start of treatment.

Symptoms may disappear spontaneously. In some cases, symptoms may be severe and require restarting treatment. Symptoms usually resolve when treatment is restarted.

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

4. Possible adverse effects

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

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

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

• dry mouth
• headache
• fatigue
• drowsiness.

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

• exhaustion
• abdominal pain.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This 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 components are microcrystalline cellulose, lactose monohydrate, colloidal anhydrous 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.

Available in blisters 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 Authorization Holder and Manufacturer

Marketing Authorization 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
The Netherlands

This medicinal product is authorized 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 pelicula 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
The 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 the most recent revision of this leaflet: March 2024

Other sources of information

Detailed information on this medicinal product 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 up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70601/P_70601.html