Levocetirizine hasco

Package leaflet: Information for the patient

Levocetirizine Hasco, 0.5 mg/mL, oral solution
Levocetirizini dihydrochloridum
Read the entire leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Levocetirizine Hasco is and what it is used for
2. Important information before taking/using Levocetirizine Hasco
3. How to take Levocetirizine Hasco
4. Possible side effects
5. How to store Levocetirizine Hasco
6. Contents of the pack and other information

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

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

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

Levocetirizine Hasco oral solution is indicated for use in adults, adolescents, and children aged 2 years and older.

2. Important information before using Levocetirizine Hasco

When not to use Levocetirizine Hasco

• if the patient is allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, any other piperazine derivatives (substances with similar structure), or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe renal impairment (severe renal failure with creatinine clearance less than 10 mL/min).

Warnings and precautions

Before starting treatment with Levocetirizine Hasco, discuss it with your doctor or pharmacist.
If the patient has difficulty emptying the bladder (e.g. due to spinal cord injury or benign prostatic hyperplasia), consult a doctor.
Levocetirizine Hasco may increase the frequency of epileptic seizures; therefore, consult a doctor if the patient has epilepsy or is at risk of seizures.
If the patient has planned allergy testing, ask the doctor whether the patient should stop taking Levocetirizine Hasco a few days before the tests. Levocetirizine Hasco may affect the results of allergy tests.

Children

Levocetirizine Hasco is not recommended for infants and children under 2 years of age.

Levocetirizine Hasco with other medicines

Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Levocetirizine Hasco with food, drink, and alcohol

Exercise caution when taking Levocetirizine Hasco together with alcohol or other substances affecting brain function.
In sensitive patients, concomitant administration of Levocetirizine Hasco with alcohol or other substances affecting brain function may additionally reduce alertness and reaction ability.
Levocetirizine Hasco may be taken during or between meals.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery

Somnolence, fatigue, and exhaustion may occur in some patients treated with Levocetirizine Hasco. Exercise caution when driving or operating machinery until the patient's response to the medicine is known. However, specific tests conducted in healthy subjects taking levocetirizine at the recommended dose did not show any effect of the medicine on attention, reaction ability, or driving performance.

Levocetirizine Hasco contains maltitol liquid (E 965)

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking the medicine.

Levocetirizine Hasco contains sodium benzoate (E 211)

The medicine contains 1.15 mg of sodium benzoate in 1 mL of solution.

Levocetirizine Hasco contains propylene glycol (from flavoring)

The medicine contains 0.8111 mg of propylene glycol in 1 mL of solution.

Levocetirizine Hasco contains sodium

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

3. How to use Levocetirizine Hasco

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
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Recommended dose:
Adults and adolescents aged 12 years and older: 10 mL of solution once daily.

Dosing in special patient groups:
Renal and hepatic impairment
In patients with impaired renal function, a dose reduction may be necessary depending on the severity of renal disease. In children, the dose should also be adjusted according to body weight; the prescribing doctor will determine the appropriate dose.
Levocetirizine Hasco must not be used in patients with severe renal impairment.
Patients with hepatic impairment alone should usually receive the standard recommended dose.
In patients with both hepatic and renal impairment, a lower dose may be necessary depending on the severity of renal disease. In children, the dose should also be adjusted according to body weight; the prescribing doctor will determine the appropriate dose.

Elderly patients (aged 65 years and above)
No dose adjustment is required in elderly patients if renal function is normal.

Use in children
Children aged 6 to 12 years: 10 mL of solution once daily.
Children aged 2 to 6 years: 2.5 mL of solution twice daily.
Levocetirizine Hasco is not recommended for use in infants and young children under 2 years of age.

How and when to take Levocetirizine Hasco
For oral use only.
An oral syringe with a stopper is supplied with the pack. The solution may be taken undiluted or diluted in a glass of water. The solution should be consumed immediately after dilution.
Levocetirizine Hasco may be taken during or between meals.

Instructions for use:

• Open the bottle.
• Insert the stopper into the neck of the bottle using the syringe (Figure 1).
• Turn the bottle upside down (Figure 2).
• Partially fill the dosing syringe with a small amount of solution by pulling the plunger down (Figure 3 a), then press the plunger to expel any air bubbles (Figure 3 b). Continue pulling the plunger down until the mark corresponding to the prescribed dose in millilitres (mL) is reached (Figure 3 c).
• Turn the bottle upright. Remove the dosing syringe from the stopper.
• Press the plunger to empty the measured dose of solution into a glass of water (Figure 4). The undiluted solution may also be taken directly.
• Drink immediately.
• Close the bottle with the plastic cap.
• Wash the dosing syringe with lukewarm or warm water immediately after use. 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, reinsert the plunger into the cylinder (Figure 5).

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How long to take Levocetirizine Hasco
The duration of treatment depends on the type, duration, and severity of the symptoms and is determined by the doctor.
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Taking more than the recommended dose of Levocetirizine Hasco
In adults, taking more than the recommended dose of Levocetirizine Hasco may cause drowsiness. In children, initial symptoms may include excitation and restlessness, particularly motor restlessness, followed by drowsiness.
If an overdose of Levocetirizine Hasco is suspected, consult a doctor, who will decide on the necessary actions.

Missed dose of Levocetirizine Hasco
If a dose of Levocetirizine Hasco is missed or a lower-than-recommended dose is taken, do not take a double dose to make up for the missed dose. Take the next dose at the usual time.

Stopping Levocetirizine Hasco
Discontinuation of the medicine should not cause harmful effects. However, in rare cases, itching (intense pruritus) may occur after stopping Levocetirizine Hasco, even if these symptoms were not present before starting treatment. These symptoms may resolve spontaneously. In some cases, symptoms may be severe and re-initiation of treatment may be necessary.
These symptoms should resolve upon resumption of treatment.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the first symptoms of hypersensitivity reactions occur, discontinue use of Levocetirizine Hasco
immediately and inform your doctor. Symptoms of hypersensitivity reactions (frequency unknown)
may include: swelling of the lips, 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 may result in 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 available data
Other adverse reactions reported include: palpitations, increased heart rate, seizures, tingling sensations, dizziness, fainting, tremor, taste disturbances (altered taste perception), sensation of spinning or swaying, visual disturbances, blurred vision, rotatory eye movements (involuntary circular eye movements), painful or difficult urination, inability to completely empty the bladder, swelling, itching, rash, urticaria (swelling, redness, and itching of the skin), skin eruptions, shortness of breath, weight gain, muscle pain, joint pain, restlessness and aggressive behavior, hallucinations, depression, insomnia, recurrent suicidal thoughts or suicidal ideation, nightmares, hepatitis, liver function abnormalities, vomiting, increased appetite, nausea, and diarrhea. Itching (intense pruritus) after discontinuation of the medicine.
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Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
tel.: 22 49 21 301, fax: 22 49 21 309.
Website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Levocetirizine Hasco

Store below 25°C. Store in the original packaging.
Shelf life after first opening of the bottle: 6 months.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Levocetirizine Hasco contains

• The active substance 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 flavour (containing flavouring substances including geraniol and linalool, and propylene glycol), purified water.

What Levocetirizine Hasco looks like and contents of the pack
Levocetirizine Hasco is a clear, colourless solution contained in a 200 mL amber glass bottle (Type III) with a nominal capacity of 200 mL, containing not less than 200 mL of product. The bottle is closed with a high-density polyethylene screw cap with a polyethylene insert and a tamper-evident seal. A 10 mL polypropylene oral syringe with a high-density polyethylene plunger is included in the pack, together with a polyethylene cap.
Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information on the medicinal product
tel.: 22 742 00 22
e-mail: [email protected]
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