Levocetirizine Aurobindo
Italy
Table of Contents
Package leaflet: Information for the user
Levocetirizine Aurobindo 5 mg film-coated tablets
Read all of this leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Levocetirizine Aurobindo is and what it is used for
- What you need to know before taking Levocetirizine Aurobindo
- How to take Levocetirizine Aurobindo
- Possible side effects
- How to store Levocetirizine Aurobindo
- Contents of the pack and other information
1. What Levocetirizina Aurobindo is and what it is used for
The name of your medicine is Levocetirizina Aurobindo film-coated tablets and it contains the active substance
levocetirizine dihydrochloride.
Levocetirizina Aurobindo is an antiallergic medicine.
It is used to treat the signs (symptoms) associated with:
- allergic rhinitis (including perennial allergic rhinitis);
- urticaria.
2. What you need to know before taking Levocetirizine Aurobindo
Do not take Levocetirizine Aurobindo
- If you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or to any of the other ingredients of Levocetirizine Aurobindo (listed in section 6).
- If you have severe renal impairment (severe kidney failure with creatinine clearance less than 10 ml/min).
- If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Levocetirizine Aurobindo.
If you are unable to empty your bladder (due to medical conditions such as spinal cord injury or enlarged prostate), consult your doctor.
If you suffer from epilepsy or are at risk of seizures, consult your doctor, as the use of Levocetirizine Aurobindo may worsen seizure episodes.
If you are due to have an allergy test, ask your doctor whether you should stop taking Levocetirizine Aurobindo a few days before the test. This medicine may alter the results of allergy testing.
Children
The use of Levocetirizine Aurobindo is not recommended in children under 6 years of age, as the film-coated tablets do not allow dose adjustment.
Other medicines and Levocetirizine Aurobindo
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
Levocetirizine Aurobindo with food, drinks and alcohol
Caution is advised if Levocetirizine Aurobindo is taken together with alcohol or other substances acting on the brain. In sensitive patients, concomitant use of Levocetirizine Aurobindo and alcohol or other central nervous system-acting substances may further reduce alertness and impair performance.
Levocetirizine may be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Some patients may experience drowsiness, fatigue, or tiredness after treatment with levocetirizine. Exercise caution when driving or operating machinery until you know how this medicine affects you. However, specific studies conducted in healthy volunteers have not shown any reduction in alertness, reaction ability, or driving capacity following the recommended dose of levocetirizine.
Levocetirizine Aurobindo contains lactose
These tablets contain lactose; if your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
3. How to take Levocetirizine Aurobindo
Take this medicine exactly as directed by your physician. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults and children aged 6 years and older is one tablet per day.
Special dosage instructions for specific populations:
Renal and hepatic impairment
Patients with impaired renal function may be given a lower dose according to the severity of their kidney disease, and in children the dose will be selected based on body weight; the dose will be determined by the doctor.
Patients with severe renal impairment must not take Levocetirizine Aurobindo.
Patients with impaired hepatic function alone should take the usual prescribed dose.
For patients with both impaired hepatic and renal function, a lower dose may be given 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 the doctor.
Patients aged 65 years and older
No dose adjustment is necessary in elderly patients, provided their renal function is normal.
Use in children
Levocetirizine Aurobindo is not recommended for children under 6 years of age.
How and when to take Levocetirizine Aurobindo?
For oral use only.
The Levocetirizine Aurobindo film-coated tablets should be swallowed whole with water and may be taken with or without food.
How long should you take Levocetirizine Aurobindo?
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 Aurobindo than you should
If you take more levocetirizine than you should, drowsiness may occur in adults. Children may initially show signs of excitement and restlessness, followed by drowsiness. If you think you have taken an excessive dose of Levocetirizine Aurobindo, inform your doctor, who will decide what actions should be taken.
If you forget to take Levocetirizine Aurobindo
If you forget to take Levocetirizine Aurobindo, or if you take a lower dose than prescribed by your doctor, 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 Aurobindo
Stopping treatment should not have negative effects. However, if you discontinue treatment with Levocetirizine Aurobindo, you may rarely experience pruritus (intense itching), even if this symptom was not present before starting treatment. This symptom may resolve spontaneously. In some cases, the symptom may be severe and it may be necessary to restart treatment. The symptom should resolve once treatment is resumed.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Common: may affect up to 1 in 10 people
Dry mouth, headache, tiredness and drowsiness/somnolence.
Uncommon: may affect up to 1 in 100 people
Weakness and abdominal pain.
Not known: frequency cannot be estimated from the available data
Other side effects reported include palpitations, increased heart rate, convulsions, tingling, dizziness, fainting (syncope), tremor, dysgeusia (altered sense of taste), sensation of spinning or movement, visual disturbances, blurred vision, oculogyric crisis (eyes with uncontrollable circular movements), pain or difficulty urinating, inability to completely empty the bladder, oedema, itching, rash, urticaria (skin swelling, redness and itching), skin eruption, shortness of breath, weight gain, muscle pain, joint pain, aggressive or agitated behaviour, hallucination, depression, insomnia, recurring thoughts of suicide or suicidal ideation, hepatitis, abnormal liver function, vomiting, increased appetite, nausea and diarrhoea. Itching (intense pruritus) following discontinuation of treatment.
Discontinue Levocetirizina Aurobindo at the first signs of a hypersensitivity reaction and contact your doctor immediately. 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 which may lead to collapse or shock, which can be fatal.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Levocetirizine Aurobindo
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “EXP”.
The expiry date refers to the last day of the month.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.
6. Package contents and other information
What Levocetirizine Aurobindo contains
- The active substance is levocetirizine. Each tablet contains 5 mg of levocetirizine dihydrochloride, equivalent to 4.2 mg of levocetirizine.
- The excipients are microcrystalline cellulose, lactose monohydrate, magnesium stearate (core), and hypromellose (E464), titanium dioxide (E171) and macrogol 400 (coating).
Description of the appearance of Levocetirizine Aurobindo and package contents
Film-coated tablets, white to off-white in colour, oval-shaped, biconvex, with "L9CZ" engraved on one side and "5" on the other.
Blister packs containing 7, 10, 14, 15, 20, 21, 28, 30, 40, 50, 56, 60, 70, 90, 100, 112 or 120 tablets per carton are available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 - Saronno (VA)
Manufacturer
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal
This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Belgium Levocetirizin AB 5 mg filmomhulde tabletten
France Levocetirizine Arrow 5 mg comprimé pelliculé
Germany Levocetirizin-Actavis 5 mg Filmtableten
Italy Levocetirizina Aurobindo
Netherlands Levocetirizine 2HCl Aurobindo 5 mg, filmomhulde tabletten
United Kingdom Levocetirizine dihydrochloride 5 mg tablets