Levocetirizine PensA
Italy
Table of Contents
Patient Information Leaflet: Information for the User
Levocetirizine PENSA 5 mg film-coated tablets
Levocetirizine dihydrochloride
Generic Medicine
Please read 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, 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 side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Levocetirizine PENSA is and what it is used for
- What you need to know before taking Levocetirizine PENSA
- How to take Levocetirizine PENSA
- Possible side effects
- How to store Levocetirizine PENSA
- Contents of the pack and other information
1. What Levocetirizine PENSA is and what it is used for
Levocetirizine dihydrochloride is the active substance in Levocetirizine PENSA.
Levocetirizine PENSA is an antiallergic medicine.
This medicine is used to treat the signs (symptoms) associated with:
- inflammation of the nasal airways caused by an allergy (allergic rhinitis, including persistent allergic rhinitis);
- chronic urticaria (chronic idiopathic urticaria).
2. What you need to know before taking Levocetirizine PENSA
Do not take Levocetirizine PENSA:
- if you are allergic to levocetirizine dihydrochloride, to other antihistamine medicines, or to any of the other ingredients of this medicine (listed in section 6);
- if you have severe kidney function problems (severe renal impairment with creatinine clearance less than 10 ml/min).
Warnings and precautions
Talk to your doctor or pharmacist before taking Levocetirizine PENSA.
Consult your doctor:
- if you suffer from conditions such as spinal cord injury or enlarged prostate that prevent you from emptying your bladder;
- if you have epilepsy or are at risk of seizures, since the use of Levocetirizine PENSA may worsen seizures;
- if you have renal impairment. You may require a lower dose and should discuss your condition with your doctor.
If you need to undergo an allergy test, ask your doctor whether you should stop taking Levocetirizine PENSA for a few days before the test. This medicine may alter the results of allergy testing.
Children
The use of Levocetirizine PENSA is not recommended in children under 6 years of age, as the tablets do not allow for dose adjustment.
Other medicines and Levocetirizine PENSA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effects of other medicines may be influenced by Levocetirizine PENSA, or in turn may influence the effects of Levocetirizine PENSA.
Levocetirizine PENSA and alcohol
In sensitive individuals, concomitant use of levocetirizine and alcohol or other centrally-acting agents may further reduce alertness and impair performance. Caution is recommended when taking Levocetirizine PENSA together with alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Some patients treated with Levocetirizine PENSA may experience drowsiness/somnolence, fatigue, and weakness. If you intend to drive, perform potentially hazardous activities, or operate machinery, you should wait and observe your response to the medicine first. However, specific tests conducted in healthy volunteers have not shown any reduction in alertness, reaction ability, or driving capacity after taking levocetirizine at the recommended dose.
Levocetirizine PENSA contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
3. How to take Levocetirizine PENSA
Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The tablet must be swallowed whole with water and can be taken with or without food.
The recommended dose for adults and children aged 6 years and older is 1 tablet per day.
Special dosage instructions for specific patients
Patients with impaired renal function may be given a lower dose depending on the severity of their kidney disease. The dose will be determined by the doctor.
Patients with severe kidney problems must not take Levocetirizine PENSA.
Patients who have only hepatic impairment should take the usual prescribed dose.
Patients with both hepatic and renal impairment may be given a reduced dose based on the severity of the renal disease.
Use in children
Levocetirizine tablets are not recommended for children under 6 years of age.
For children aged between 2 and 6 years, a paediatric formulation is recommended.
In children with reduced renal function, the dose will be calculated based on renal function and body weight; the dose will be determined by the doctor.
Elderly patients
No dose adjustment is necessary in elderly patients, provided their renal function is normal.
If you take more Levocetirizine PENSA than you should
If you take more Levocetirizine PENSA than recommended, you may experience drowsiness.
Children may initially show signs of excitation and restlessness, followed by drowsiness.
If you think you have taken an excessive dose of Levocetirizine PENSA, inform your doctor, who will decide what actions to take.
If you forget to take Levocetirizine PENSA
If you forget to take your dose of this medicine, or if you take a lower dose than prescribed by your doctor, do not take a double dose to make up for the missed tablet.
Take the next dose at the usual time, as prescribed by your doctor.
If you stop taking Levocetirizine PENSA
Stopping treatment should not cause negative effects. Symptoms may reappear, but they should not be worse than before treatment began.
However, if you stop treatment with Levocetirizine PENSA, 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 intense and restarting treatment may be necessary. This symptom should resolve once treatment is resumed.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking this medicine or contact your doctor immediately if you experience any of the following signs of an allergic reaction while taking Levocetirizine PENSA:
- swelling of the mouth, tongue, face and/or throat
- difficulty breathing or swallowing (chest tightness or wheezing)
- hives
- sudden drop in blood pressure leading to collapse or shock, which may be fatal.
Other possible side effects include:
Common (may affect up to 1 in 10 people):
- dry mouth, headache, fatigue and drowsiness/sedation
Uncommon (may affect up to 1 in 100 people):
- weakness and abdominal pain
Not known (frequency cannot be estimated from the available data):
- palpitations (irregular heartbeat), tachycardia (increased heart rate)
- seizures, paresthesia (altered sensation), dizziness, fainting, tremor, dysgeusia (altered sense of taste)
- vertigo (sensation of spinning or movement)
- visual disturbances, blurred vision
- dysuria (pain or difficulty urinating), urinary retention (inability to completely empty the bladder)
- edema (swelling)
- angioedema (rapid swelling of the skin, mucosa and submucosal tissues), drug eruption, pruritus, rash, urticaria (swelling, redness and itching of the skin)
- dyspnea (altered breathing rhythm or rate, shortness of breath)
- weight gain
- myalgia (muscle pain)
- aggressive or agitated behavior, hallucinations, depression, insomnia, recurring suicidal thoughts or suicidal ideation
- hepatitis (inflammation of the liver), changes in liver function tests
- increased appetite
- nausea and vomiting
Following the instructions provided in this leaflet reduces the risk of side effects.
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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
5. How to store Levocetirizine PENSA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp". The expiry date refers to the last day of that month.
This medicine requires no special storage precautions.
Do not dispose of medicines 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 PENSA contains
The active substance is levocetirizine dihydrochloride.
Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride.
The other components are:
Tablet core: microcrystalline cellulose, monohydrate lactose, anhydrous colloidal silica, and
magnesium stearate.
Coating: hypromellose, titanium dioxide (E 171), polysorbate 80, macrogol-400 (PEG-400), and
purified water.
Description of the appearance of Levocetirizina PENSA and package contents
White, round, biconvex film-coated tablets, marked with '161' on one side and “H” on the other.
Levocetirizina PENSA is available in blister packs containing 20, 40, or 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan - Italy
Manufacturer responsible for batch release:
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola - PLA 3000 - MALTA