Prospect: Information for the User

Levocetirizine Teva-ratiopharm 5 mg Film-Coated Tablets EFG

For adults and children aged 6 years and above

levocetirizine dihydrochloride

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, 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 not listed in this prospect. See section 4.

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

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

3. How to take Levocetirizine Teva-ratiopharm

4. Possible adverse effects

5. Storage of Levocetirizine Teva-ratiopharm

6. Contents of the pack and additional information

Levocetirizina Teva-ratiopharm 5 mg contains the active ingredient levocetirizine dihydrochloride. Levocetirizina Teva-ratiopharm is an antihistamine medication.

Levocetirizine is used for the treatment of the symptoms associated with:

• allergic rhinitis (including persistent allergic rhinitis)
• urticaria

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

Do not take Levocetirizina Teva-ratiopharm:

• If you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or any of the other components of this medication (listed in section 6).
• If you havesevere renal insufficiency requiring dialysis

Warnings and precautions

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

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

If you are epileptic or at risk of seizures, please consult your doctor as the use of Levocetirizina Teva-ratiopharm may exacerbate seizures.

If you are to undergo an allergy test, ask your doctor if you need to stop taking Levocetirizina Teva-ratiopharm several days beforehand. This medication may affect the results of the allergy test.

Children

Levocetirizina Teva-ratiopharm is not recommended for children under 6 yearsas the film-coated tablets do not allow for dose adjustment.

Other medications and Levocetirizina Teva-ratiopharm

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

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

Caution is advised if Levocetirizina Teva-ratiopharm 5 mg is taken with alcohol or other central nervous system agents.In sensitive patients, simultaneous use of Levocetirizina Teva-ratiopharm with alcohol or other central nervous system agents may cause additional decreased attention and performance.

Levocetirizina Teva-ratiopharm can be taken both on an empty stomach and with food.

Pregnancy and breastfeeding

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

Driving and operating machinery

Some patients treated with Levocetirizina Teva-ratiopharm may experience drowsiness/drowsiness, fatigue, and exhaustion. Be careful if you are driving or operating machinery until you know how this medication affects you. However, in special tests conducted on healthy individuals, no alterations in attention, reaction time, and driving ability were detected after taking levocetirizine at the recommended dose.

Levocetirizina Teva-ratiopharm contains lactose

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

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

Adults and children 6 years or older

The recommended dose for adults and children 6 years or older is one tablet per day.

Special dosing instructions for specific populations:

Renal and hepatic insufficiency

Patients with renal insufficiency should receive a lower dose according to the severity of their renal 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 renal insufficiency requiring dialysis should not take levocetirizine.

Patients with only hepatic insufficiency should take the recommended prescription dose.

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

Patients 65 years of age or older

No dose adjustment is necessary in elderly patients with normal renal function.

Use in children

Levocetirizine is not recommended for use in children under 6 years.

How and when to take Levocetirizine Teva-ratiopharm?

For oral use only.

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 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 medication 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 compensate for the missed doses.

If you interrupt treatment with Levocetirizine Teva-ratiopharm

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

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

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

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

If you experience the first signs ofallergic reaction, stop taking Levocetirizina Teva-ratiopharm and see your doctor immediately. Symptoms of an allergic reaction may include: swelling of the mouth, tongue, face, and/or neck, difficulty breathing or swallowing along with hives (angioedema), sudden drop in blood pressure that may lead to collapse or shock, which can be fatal.

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

• dry mouth
• headache
• fatigue
• drowsiness.

Less common side effects(may affect up to 1 in 100 patients):

• exhaustion
• abdominal pain.

Unknown frequency(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, syncope, tremor, disgeusia (alteration of the sense of taste),
• sensation of rotation or movement
• visual disturbances, blurred vision, ocular crisis (uncontrolled circular eye movements)
• palpitations, increased heart rate,
• labored breathing
• nausea. Vomiting, diarrhea
• hepatitis, abnormal liver function
• pain or difficulty urinating, inability to completely empty the bladder
• skin rash, pruritus (itching), urticaria (swelling, redness, and itching of the skin)
• pruritus (intense itching) upon discontinuation of treatment
• muscle pain, joint pain
• edema
• weight gain

Reporting side effects

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

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

Medications 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 Teva-ratiopharm 5 mg

- The active ingredient is levocetirizine dihydrochloride. Each coated tablet contains 5 mg of levocetirizine dihydrochloride.

- The other components 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 package

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

It is presented in blisters of 7, 10, 14, 15, 20, 21, 28, 30, 40, 50, 60, 90, and 100 coated tablets.

You may not have all package sizes available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

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

28108 Alcobendas – Madrid

Spain

Responsible for manufacturing:

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 authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland)with 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

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

Last review date of this leaflet: March 2024

Other sources of information

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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