Levocetirizine Doc Generici
Italy
Table of Contents
Package leaflet: Information for the patient
LEVOCETIRIZINE DOC Generics 5 mg film-coated tablets
Equivalent Medicine
Please read this leaflet carefully before using this medicine as 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 their symptoms are the same as yours, as it may be harmful. If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What LEVOCETIRIZINE DOC Generics is and what it is used for
- What you need to know before taking LEVOCETIRIZINE DOC Generics
- How to take LEVOCETIRIZINE DOC Generics
- Possible side effects
- How to store LEVOCETIRIZINE DOC Generics
- Contents of the pack and other information
1. What LEVOCETIRIZINA DOC Generici is and what it is used for
Levocetirizine dihydrochloride is the active substance in LEVOCETIRIZINA DOC Generici.
LEVOCETIRIZINA DOC Generici is an antiallergic medicinal product.
It is used for the treatment of signs of disease (symptoms) associated with:
- Allergic rhinitis (including perennial allergic rhinitis)
- Skin rash (Urticaria)
2. What you need to know before taking LEVOCETIRIZINA DOC Generici
Do not take LEVOCETIRIZINA DOC Generici
- if you are allergic to levocetirizine, cetirizine dihydrochloride, hydroxyzine, or to any of the excipients of this medicine (listed in section 6).
- if you have severe renal function impairment (severe renal insufficiency with creatinine clearance below 10 ml/min)
Warnings and precautions
Talk to your doctor or pharmacist before taking LEVOCETIRIZINA DOC Generici.
If you are likely to be unable to empty your bladder (due to 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 LEVOCETIRIZINA DOC Generici may worsen seizures.
If you are scheduled to undergo allergy testing, ask your doctor whether you should stop taking LEVOCETIRIZINA DOC Generici a few days before the test. This medicine may affect the results of your test.
Children
The use of LEVOCETIRIZINA DOC Generici is not recommended in children under 6 years of age, as the film-coated tablets do not allow dose adjustment.
Other medicines and LEVOCETIRIZINA DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
LEVOCETIRIZINA DOC Generici with food, drinks and alcohol
Caution is advised if LEVOCETIRIZINA DOC Generici is taken concomitantly with alcohol or other agents acting on the central nervous system. In sensitive patients, the concomitant administration of LEVOCETIRIZINA DOC Generici and alcohol or other central nervous system agents may cause additional reduction in alertness and impair performance.
LEVOCETIRIZINA DOC Generici may be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Some patients taking LEVOCETIRIZINA DOC Generici may experience drowsiness, fatigue, and weakness. Exercise caution when driving or operating machinery until you know how you respond to this medicine. However, specific tests have not detected impairment of mental alertness, reaction ability, or driving performance in healthy subjects tested after taking levocetirizine at the recommended doses.
LEVOCETIRIZINA DOC Generici 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 DOC Generici
Take this medicine exactly as directed by your doctor or pharmacist.
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.
Dosage instructions for specific populations:
Renal and hepatic impairment
A lower dose may be given to patients with impaired renal function, depending on the severity of the kidney disease. In children, the dose will also be determined based on body weight; your doctor will decide the appropriate dose.
LEVOCETIRIZINE DOC Generici must not be taken by patients with severe renal impairment.
Patients with impaired liver function alone should take the normal prescribed dose.
For patients with both impaired liver and kidney function, a lower dose may be given depending on the severity of the kidney disease, and in children, the dose will also be determined based on body weight; your doctor will decide the appropriate dose.
Patients aged 65 years and older
Dose adjustment is not required in elderly patients, provided their renal function is normal.
Use in children
LEVOCETIRIZINE DOC Generici is not recommended for children under 6 years of age.
How and when to take LEVOCETIRIZINE DOC Generici?
For oral use only.
LEVOCETIRIZINE DOC Generici tablets must be swallowed whole with water and may be taken with or without food.
How long should you take LEVOCETIRIZINE DOC Generici?
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 DOC Generici than you should
If you take more than the prescribed amount, drowsiness may occur in adults. In children, initial excitability and restlessness may occur, followed by drowsiness. If you think you have taken an overdose of LEVOCETIRIZINE DOC Generici, inform your doctor, who will decide what action should be taken.
If you forget to take LEVOCETIRIZINE DOC Generici
If you forget to take LEVOCETIRIZINE DOC Generici or take a lower dose than prescribed by your doctor, do not take a double dose to make up for the missed dose. Take your next dose at the usual time.
If you stop taking LEVOCETIRIZINE DOC Generici
Stopping treatment should not have any negative effects. However, if you discontinue treatment with LEVOCETIRIZINE DOC Generici, itching (intense pruritus) may rarely occur, even if these symptoms were not present before starting treatment. Symptoms may resolve spontaneously. In some cases, symptoms may be severe and may require resumption of treatment. Symptoms should resolve once treatment is restarted.
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 everybody gets them.
At the first signs of recurring thoughts or concerns about suicide, or an allergic reaction, stop taking LEVOCETIRIZINE DOC Generici and inform your doctor. Symptoms of an allergic reaction may include: swelling of the mouth, tongue, face and/or throat, difficulty breathing or swallowing (tightness in the chest or wheezing), hives, sudden drop in blood pressure leading to collapse or shock, which may be fatal.
Common: may occur in up to 1 in 10 people
Dry mouth, headache, fatigue and drowsiness
Uncommon: may occur in up to 1 in 100 people
Weakness and abdominal pain
Not known: frequency cannot be estimated from the available data
Other side effects that have also been reported include palpitations, increased heart rate, convulsions, tingling, dizziness, fainting, tremor, dysgeusia (altered sense of taste), sensation of spinning or movement, visual disturbances, blurred vision, oculogyric crisis (eyes with uncontrollable circular movements), painful or difficult urination, inability to completely empty the bladder, swelling, itching (pruritus), rash, urticaria (swelling, redness and itching of the skin), skin eruption (red spots recurring in the same area of the skin), shortness of breath, weight gain, muscle pain, joint pain, aggressive or agitated behaviour, hallucinations, depression, insomnia, nightmares, hepatitis, abnormalities in liver function, vomiting, increased appetite, nausea and diarrhoea.
Itching (intense itching) following discontinuation.
Reporting of side effects
If you experience any side effects, 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 the website:
https://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 DOC Generici
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 label and on the
pack after the word EXP. The first two digits indicate the month, the last four
the year.
The expiry date refers to the last day of the month.
Store the medicine in its original packaging to protect it 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 LEVOCETIRIZINA DOC Generici contains
- The active substance is levocetirizine. Levocetirizine is present as levocetirizine dihydrochloride (5 mg), equivalent to 4.2 mg of levocetirizine.
- The excipients are: microcrystalline cellulose, lactose monohydrate (see section 2, “LEVOCETIRIZINA DOC Generici contains lactose”), magnesium stearate (core), and hypromellose (E464), titanium dioxide (E171) and macrogol 400 (coating).
Description of the appearance of LEVOCETIRIZINA DOC Generici and the contents of
the pack
Film-coated tablets, white to almost white, oval-shaped, biconvex, with 'L9CZ' engraved on one side and '5' on the other.
Available in blister packs containing 6, 7, 10, 14, 15, 18, 20, 21, 28, 30, 40, 50, 56, 60, 70, 90, 100, 112 or 120 tablets each.
Single-dose blisters containing 30x1 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer:
DOC Generici Srl, Via Turati 40, 20121 Milano
Manufacturers:
- Synthon BV, Microweg 22, 6545 CM Nijmegen, Netherlands
- Synthon Hispania S.L., Castelló 1, Polígono Las Salinas, 08830 Sant Boi de Llobregat, Spain
- betapharm Arzneimittel GmbH, Kobelweg 95, 86156 Augsburg, Germany
This medicinal product is authorized in the Member States of the European Economic Area
under the following names:
Germany - Levocetirizin beta 5 mg Filmtabletten
Netherlands - Cetirmar 5 mg tabletten
United Kingdom - Levocetirizine dihydrochloride 5 mg film-coated tablets