LEVOCETIRIZINE TEVA

Patient Information Leaflet

LEVOCETIRIZINE TEVA 5 mg film-coated tablets

For adults and children from 6 years of age
Levocetirizine dihydrochloride
Generic medicine
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

The active substance of Levocetirizine Teva is levocetirizine dihydrochloride.
Levocetirizine Teva is an antiallergic medicinal product.
Levocetirizine Teva is used to treat the signs (symptoms) associated with:

• allergic rhinitis (including persistent allergic rhinitis);
• urticaria. Antihistamines such as Levocetirizine Teva relieve the unpleasant symptoms and discomfort associated with the following conditions, such as sneezing, irritated, runny or blocked nose, itching, redness and watering of the eyes, and skin rashes.

2. What you need to know before taking Levocetirizine Teva

Do not take Levocetirizine Teva

• if you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine 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 creatinine clearance less than 10 ml/min).

Warnings and precautions
Talk to your doctor or pharmacist before taking Levocetirizine Teva.
Consult your doctor if you think you may be unable to empty your bladder (in conditions such as spinal cord injury or enlarged prostate).
If you suffer from epilepsy or are otherwise at risk of experiencing epileptic seizures, consult your doctor.
If you are due to have an allergy test, ask your doctor whether you should stop taking Levocetirizine Teva for a few days before the test. This medicine may alter the results of allergy testing.
Children
Levocetirizine Teva is not recommended for use in children under 6 years of age, as the film-coated tablets do not allow for dose adjustment.
Other medicines and Levocetirizine Teva
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Levocetirizine Teva with food, drinks and alcohol
Caution is advised if Levocetirizine Teva is taken together with alcohol or other substances acting on the brain.
In sensitive individuals, concomitant use of Levocetirizine Teva and alcohol or other substances acting on the brain may cause further reduction in alertness and impaired performance.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Some patients treated with Levocetirizine Teva may experience drowsiness, fatigue and weakness. Caution is advised when driving or operating machinery until you know how this medicine affects you. However, specific tests conducted in healthy volunteers have not shown any reduction in alertness, reaction ability or driving capacity following administration of levocetirizine at the recommended dose.
Levocetirizine Teva contains lactose
If you have been diagnosed by your doctor with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Levocetirizine Teva

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

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

Special dosing instructions for specific populations

Renal and hepatic impairment
Levocetirizine Teva must not be taken by patients with severe renal impairment (severe kidney failure with creatinine clearance less than 10 ml/min).
Patients with impaired renal function and patients with both impaired renal and hepatic function may be given a lower dose according to the severity of their kidney disease. In children, the dose will be selected based on body weight; the dose will be determined by the doctor.
Patients with impaired hepatic function only should take the usual prescribed dose.

Patients aged ≥ 65 years
No dose adjustment is necessary in elderly patients, provided their renal function is normal.

Use in children
Levocetirizine Teva is not recommended for children under 6 years of age.

How and when to take Levocetirizine Teva
For oral use only.
The tablets should be swallowed whole with water and may be taken with or without food.

How long should you take Levocetirizine Teva
The duration of treatment depends on the type, duration and course of your condition and will be determined by your doctor.

If you take more Levocetirizine Teva than you should
If you take more Levocetirizine Teva than recommended, drowsiness may occur in adults. Children may initially show signs of excitation and restlessness, followed by drowsiness.
If you think you have taken an excessive dose of Levocetirizine Teva, inform your doctor, who will decide what actions need to be taken.

If you forget to take Levocetirizine Teva
If you forget to take Levocetirizine Teva, do not take a double dose to make up for the missed dose. Take the next dose at the scheduled time.

If you stop taking Levocetirizine Teva
Stopping treatment with Levocetirizine Teva does not cause any harmful effects. However, if you discontinue treatment with Levocetirizine Teva, itching (intense pruritus) may rarely occur, even if this symptom was not present before starting treatment.
These symptoms may resolve spontaneously. In some cases, symptoms may be severe and restarting treatment may be necessary. These symptoms should resolve when treatment is restarted.

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

4. Possible side effects

Like all medicines, Levocetirizina Teva can cause side effects, although not everyone experiences them.
At the first signs of a hypersensitivity reaction, stop taking Levocetirizina Teva and contact your doctor.
Symptoms of a hypersensitivity reaction may include: swelling of the mouth, tongue, face and/or throat,
difficulty breathing or swallowing (chest tightness or wheezing), urticaria, sudden drop in blood pressure leading
to collapse or shock, which could be fatal.

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

• dry mouth;
• headache;
• fatigue;
• drowsiness/lethargy.

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

• asthenia;
• abdominal pain.

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

• increased appetite;
• aggressive or agitated behaviour, hallucinations, depression, insomnia, recurring suicidal thoughts or ideation;
• seizures, paraesthesia, dizziness, syncope, tremor, dysgeusia (altered taste);
• sensation of spinning or movement;
• visual disturbances, blurred vision, oculogyric crisis (eyes with uncontrollable circular movements);
• palpitations, increased heart rate;
• shortness of breath;
• nausea, vomiting, and diarrhoea;
• hepatitis, abnormal liver function tests;
• painful urination or difficulty urinating, inability to completely empty the bladder;
• fixed drug eruption, pruritus, rash, urticaria (swelling, redness, and itching of the skin);
• pruritus (intense itching) following discontinuation of treatment;
• muscle pain, joint pain;
• oedema;
• weight gain.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levocetirizine Teva

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the carton or blister. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Levocetirizina Teva contains

• The active substance is levocetirizine dihydrochloride. Each film-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.

Description of the appearance of Levocetirizina Teva and package contents
Levocetirizina Teva film-coated tablets are white to almost white and oval-shaped; on one side of the tablet is imprinted “LC5”. The other side of the tablet is smooth.
Levocetirizina Teva is available in blisters containing 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 Italia S.r.l., Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy

Manufacturers
Teva Pharmaceutical Works Private Limited Company - Pallagi st. 13 - H-4042 Debrecen (Hungary)
Teva Pharmaceutical Works Private Limited Company - Tàncsics Mihàly st. 82 - 2100 Gödöllő (Hungary)
Teva UK Ltd. - Brampton Road - Hampden Park – BN 22 9AG Eastbourne – East Sussex (United Kingdom)
Pharmachemie B.V. - Swensweg 5 – P.O. Box 552 - 2003 RN Haarlem (The Netherlands)
GALIEN LPS 98 Rue Bellocier, 89100 Sens, France

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium: Levocetiriteva 5 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten
Denmark: Levocetirizindihydrochlorid Teva
France: Levocetirizine teva 5 mg, comprime pellicule
Germany: Levocetirizin Teva 5 mg Filmtabletten
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
Slovakia: Levocetirizin Teva 5 mg filmom obalene tablety
Spain: Levocetirizina Teva 5 mg comprimidos recubiertos con pelicula EFG
The Netherlands: Levocetirizine diHCl 5 PCH, filmomhulde tabletten 5mg
United Kingdom: Levocetirizine 5mg Film coated tablets