Levocetirizine Hasco

Package Leaflet: Information for the Patient

Levocetirizine Hasco, 0.5 mg/mL, Oral Solution

Levocetirizine Dihydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Levocetirizine Hasco and What is it Used For
• 2. Important Information Before Taking Levocetirizine Hasco
• 3. How to Take Levocetirizine Hasco
• 4. Possible Side Effects
• 5. How to Store Levocetirizine Hasco
• 6. Contents of the Package and Other Information

1. What is Levocetirizine Hasco and What is it Used For

The active substance of Levocetirizine Hasco is levocetirizine dihydrochloride.
Levocetirizine Hasco is an antiallergic medication.
Levocetirizine Hasco is used to treat symptoms associated with:

• allergic rhinitis (including chronic allergic rhinitis);
• urticaria.

Levocetirizine Hasco in the form of an oral solution is indicated for use in adults, adolescents, and children from 2 years of age.

2. Important Information Before Taking Levocetirizine Hasco

When Not to Take Levocetirizine Hasco

Warnings and Precautions

Before starting treatment with Levocetirizine Hasco, discuss it with your doctor or pharmacist.
1/6
If you may have difficulty emptying your bladder (in conditions such as spinal cord injury or prostate enlargement), consult your doctor.
Levocetirizine Hasco may exacerbate seizure attacks, so consult your doctor if you have epilepsy or a risk of seizures.
If you are scheduled to undergo allergy testing, ask your doctor if you should stop taking Levocetirizine Hasco a few days before the test. Levocetirizine Hasco may affect the results of allergy tests.

Children

It is not recommended to give Levocetirizine Hasco to infants and young children under 2 years of age.

Levocetirizine Hasco and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.

Levocetirizine Hasco with Food, Drink, and Alcohol

Caution should be exercised when taking Levocetirizine Hasco with alcohol or other substances that affect brain function.
Sensitive patients, when taking Levocetirizine Hasco with alcohol or other substances that affect brain function, may experience additional decreased alertness and reaction ability.
Levocetirizine Hasco can be taken during or between meals.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.

Driving and Operating Machines

Some patients treated with Levocetirizine Hasco may experience drowsiness, fatigue, and exhaustion. Exercise caution when driving or operating machinery until you know your reaction to the medication. However, special tests conducted with healthy individuals after taking levocetirizine at the recommended dose did not show an effect on attention, reaction ability, or driving ability.

Levocetirizine Hasco Contains Maltitol Liquid (E 965)

If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medication.

Levocetirizine Hasco Contains Sodium Benzoate (E 211)

The medication contains 1.15 mg of sodium benzoate in 1 mL of solution.
Levocetirizine Hasco Contains Propylene Glycol(derived from the aroma)
The medication contains 0.8111 mg of propylene glycol in 1 mL of solution.

Levocetirizine Hasco Contains Sodium

The medication contains less than 1 mmol (23 mg) of sodium in 1 mL of solution, which means the medication is considered "sodium-free".

3. How to Take Levocetirizine Hasco

Always take this medication exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
2/6
The recommended dose is:
Adults and adolescents over 12 years: 10 mL of solution once a day.

Dosing in Special Patient Groups:

Kidney and Liver Impairment
In patients with kidney impairment, it may be necessary to reduce the dose of the medication depending on the severity of the kidney disease; in children, the dose should also be adjusted according to body weight; the dose of the medication will be determined by the doctor.
Patients with severe kidney impairment should not take Levocetirizine Hasco.
Patients with liver impairment only should take the usual recommended dose of the medication.
In patients with both liver and kidney impairment, it may be necessary to use a lower dose depending on the severity of the kidney disease; in children, the dose should also be adjusted according to body weight; the dose of the medication will be determined by the doctor.
Elderly Patients (65 Years and Older)
In elderly patients, there is no need to adjust the dose if kidney function is normal.

Administration in Children

Children from 6 to 12 years: 10 mL of solution once a day.
Children from 2 to 6 years: 2.5 mL of solution twice a day.
It is not recommended to give Levocetirizine Hasco to infants and young children under 2 years of age.

How and When to Take Levocetirizine Hasco

This medication is for oral use only.
A measuring cup is included with the packaging. The solution can be taken undiluted or diluted in a glass of water. The solution should be drunk immediately after dilution.
Levocetirizine Hasco can be taken during or between meals.
Instructions for use:

• Open the bottle.
• Insert the plug into the neck of the bottle using the measuring cup (figure 1).
• Turn the bottle upside down (figure 2).
• Fill the measuring cup with a small amount of solution by pulling the plunger down (figure 3a), press the plunger to remove air bubbles (figure 3b), then pull the plunger down until the mark on the measuring cup corresponds to the dose of solution in milliliters (mL) prescribed by the doctor (figure 3c).
• Turn the bottle right side up. Remove the measuring cup from the plug.
• Press the plunger to empty the measuring cup, pouring the measured dose of solution into a glass of water (figure 4). The solution can also be taken undiluted.
• Give to drink.
• Close the plastic bottle with the cap.
• Wash the measuring cup immediately after use with warm or cold water. If necessary, use a mild detergent, then rinse thoroughly with water. For thorough cleaning, it is recommended to remove the plunger from the cylinder. After drying, put the plunger back into the cylinder (figure 5).

3/6

How Long to Take Levocetirizine Hasco

The treatment period depends on the type, duration, and severity of the disease symptoms and is determined by the doctor.
4/6

Overdose of Levocetirizine Hasco

In adults, in case of taking a higher dose of Levocetirizine Hasco than recommended, drowsiness may occur. In children, initially, there may be excitement and restlessness, especially motor, and then drowsiness.
In case of suspected overdose of Levocetirizine Hasco, consult a doctor who will decide what actions should be taken.

Missed Dose of Levocetirizine Hasco

In case of missing a dose of Levocetirizine Hasco or taking a dose lower than recommended by the doctor, do not take a double dose to make up for the missed dose.
Take the next dose at the usual time.

Stopping Treatment with Levocetirizine Hasco

Stopping treatment with Levocetirizine Hasco should not cause harmful effects. However, in rare cases, itching (intense itching) may occur after stopping treatment with Levocetirizine Hasco, even if these symptoms did not occur before starting treatment. These symptoms may resolve on their own. In some cases, these symptoms may be intense and it may be necessary to resume treatment.
These symptoms should resolve after resuming treatment.
If you have any further questions about taking this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Levocetirizine Hasco can cause side effects, although not everybody gets them.

In Case of the First Symptoms of Hypersensitivity Reaction, Stop Taking Levocetirizine Hasco and Inform Your Doctor. Hypersensitivity Reaction Symptoms (Frequency Not Known) May Include:

Swelling of the Lips, Tongue, Face, and (or) Throat,
Difficulty Breathing or Swallowing (Chest Tightness or Wheezing),
Hives, Sudden Drop in Blood Pressure Leading to Fainting or Shock, Which
May Lead to Death.
Common: May Occur in Less Than 1 in 10 Patients
Dry Mouth, Headache, Fatigue, and Drowsiness
Uncommon: May Occur in Less Than 1 in 100 Patients
Exhaustion and Abdominal Pain
Frequency Not Known: Cannot be Estimated from the Available Data
Other side effects have also been reported, such as: palpitations, increased heart rate, seizures, tingling, dizziness, fainting, tremors, taste disturbances (altered taste perception), feeling of spinning or swaying, vision disturbances, blurred vision, rotational eye movements (uncontrolled circular eye movement), painful or difficult urination, inability to fully empty the bladder, swelling, itching, rash, hives (swelling, redness, and itching of the skin), skin eruptions, shortness of breath, weight gain, muscle pain, joint pain, excitement and aggressive behavior, hallucinations, depression, insomnia, recurring suicidal thoughts or interest in suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea. Itching (intense itching) after stopping treatment with Levocetirizine Hasco.
5/6

Reporting Side Effects

If you experience any side effects, including any not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
phone: 22 49 21 301, fax: 22 49 21 309.
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medication.

5. How to Store Levocetirizine Hasco

Store in a temperature below 25°C. Store in the original packaging.
Shelf life after first opening the bottle: 6 months.
Keep the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the packaging. The expiration date refers to the last day of the given month.
Medications should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Levocetirizine Hasco Contains

• The active substance of Levocetirizine Hasco is levocetirizine dihydrochloride. 1 mL of oral solution contains 0.5 mg of levocetirizine dihydrochloride.
• The other ingredients (excipients) are: glycerol (E 422), maltitol liquid (E 965), sodium acetate trihydrate (E 262), glacial acetic acid (E 260), sodium saccharin (E 954), sodium benzoate (E 211), Tutti-Frutti flavor (containing flavoring substances, including geraniol and linalol and propylene glycol), purified water.

What Levocetirizine Hasco Looks Like and What the Package Contains

Levocetirizine Hasco is a clear and colorless solution placed in a 200 mL brown glass bottle (type III) containing at least 200 mL of product. The bottle is closed with a high-density polyethylene cap with a polyethylene insert and a tamper-evident seal. The packaging includes a 10 mL polypropylene oral measuring cup with a high-density polyethylene plunger in a set with a polyethylene plug.

Marketing Authorization Holder and Manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medication Information
phone: 22 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of the Last Revision of the Package Leaflet:

6/6