Package leaflet: information for the patient

Alcetyr, 5 mg, coated tablets
Levocetirizini dihydrochloridum
Please read this leaflet carefully before using 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, please 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 someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Alcetyr is and what it is used for
Important information before taking Alcetyr
How to take Alcetyr
Possible side effects
How to store Alcetyr
Contents of the pack and other information

1. What Alcetyr is and what it is used for

The active substance of Alcetyr is levocetirizine dihydrochloride.
Alcetyr is an antiallergic medicinal product.
The medicine is used to treat symptoms associated with:

allergic rhinitis (including perennial allergic rhinitis);
urticaria.

2. Information before using Alcetyr

When not to use Alcetyr:

if the patient is allergic (hypersensitive) to levocetirizine dihydrochloride, cetirizine, hydroxyzine, any other piperazine derivatives, or any of the other ingredients of Alcetyr (listed in section 6),
if the patient has severe renal function impairment (severe renal failure with creatinine clearance less than 10 ml/min).

Warnings and precautions
Before starting treatment with Alcetyr, discuss with your doctor or pharmacist:

if the patient has problems with urination (due to spinal cord injury or benign prostatic hyperplasia),
if the patient has epilepsy or a risk of seizures, as Alcetyr may increase the frequency of epileptic seizures,
if the patient is scheduled for allergy testing. Alcetyr may affect the results of skin allergy tests; therefore, the patient should consult the doctor whether to discontinue Alcetyr a few days before the tests.

Children
Use of Alcetyr is not recommended in children under 6 years of age, as the coated tablets do not allow for appropriate dose adjustment.

Alcetyr with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient intends to use.

Alcetyr with food, drink and alcohol
Caution is advised when taking Alcetyr together with alcohol or other substances affecting brain function.
In sensitive patients, concomitant use of cetirizine or levocetirizine with alcohol or other substances acting on the central nervous system may additionally reduce alertness and reaction ability.
Alcetyr 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 become pregnant, she should consult a doctor before using this medicine.

Driving and using machines
Some patients taking Alcetyr may experience drowsiness, somnolence, fatigue, or exhaustion. Caution should be exercised when driving or operating machinery until the patient knows how this medicine affects them. However, specific tests conducted in healthy volunteers receiving levocetirizine at the recommended dose did not show any effect of the drug on attention, reaction ability, or driving performance.

Alcetyr contains lactose
This medicine contains lactose. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before using Alcetyr.

3. How to use Alcetyr

This medicine should always be used as directed by the physician. In case of doubt, consult a doctor or pharmacist.
The recommended dose for adults, adolescents, and children over 6 years of age is one coated tablet per day.
Use in children
The recommended dose for children aged 6 years and older is one coated tablet per day. Alcetyr is not recommended for children under 6 years of age.
Dosing recommendations for special patient groups:
In patients with renal function impairment, the dose may be reduced depending on the severity of kidney disease; in children, the dose will be adjusted according to body weight; the physician will determine the appropriate dose.
Patients with severe renal impairment should not take Alcetyr.
Patients with hepatic dysfunction alone should usually receive the standard recommended dose.
In patients with both hepatic and renal function impairment, a lower dose may be necessary depending on the severity of kidney disease. In children, the dose will be adjusted based on body weight; the physician will determine the appropriate dose.
Dose adjustment is not required in elderly patients, provided their renal function is normal.
When and how to take Alcetyr?
For oral use only.
Tablets should be swallowed whole with water. Alcetyr can be taken with or without food.
How long should Alcetyr be taken?
The duration of treatment depends on the type, duration, and severity of disease symptoms and is determined by the physician.
Overdose of Alcetyr
If more than the recommended dose is taken, somnolence may occur in adults.
In children, initial excitation and restlessness, especially motor restlessness, may occur, followed by somnolence.
If an overdose is suspected, consult a doctor, who will decide what actions should be taken.
Missed dose of Alcetyr
If a dose of Alcetyr 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.
Discontinuation of Alcetyr
Stopping treatment with Alcetyr should not have any negative effects. In rare cases, itching (intense pruritus) may occur after discontinuation, even if these symptoms were not present before starting treatment. These symptoms may resolve spontaneously.
In some cases, symptoms may be severe and treatment may need to be resumed. 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common: may occur in less than 1 in 10 people
Dry mouth, headache, fatigue and drowsiness or lethargy.
Uncommon: may occur in less than 1 in 100 people
Feeling of exhaustion and abdominal pain.
Frequency not known: frequency cannot be estimated from the available data
Other side effects such as: palpitations, rapid heartbeat, convulsions, tingling,
dizziness, fainting, tremor, taste disturbances (disturbances in taste perception), sensation
of spinning or swaying, visual disturbances, blurred vision, rotatory eye movements
(uncontrolled circular movements of the eyeballs), painful or difficult urination,
inability to completely empty the urinary bladder, swelling, itching, rash,
urticaria (swelling, redness and itching of the skin), skin eruptions, shortness of breath, weight gain,
muscle pain, joint pain, aggressive behaviour or agitation, hallucinations, depression,
insomnia, recurring suicidal thoughts or interest in suicide, nightmares,
hepatitis, liver function disorders, vomiting, increased appetite, nausea, diarrhoea
have also been reported.
Itching (intense itching) after discontinuation of the medicine.

If the first symptoms of hypersensitivity reactions occur, treatment with Alcetyr should be discontinued and medical advice should be sought immediately. Symptoms of hypersensitivity reactions may include:
swelling of the lips, tongue, face and (or) throat, difficulty breathing or swallowing (chest tightness or wheezing) together with urticaria, sudden drop in blood pressure leading to circulatory collapse or shock, which may lead to death.

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects 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:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: (22) 49 21 301, fax: (22) 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Alcetyr

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following: EXP.
The expiry date refers to the last day of the specified month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Alcetyr contains

The active substance is levocetirizine dihydrochloride. Each coated tablet contains 5 mg of levocetirizine dihydrochloride.
The other ingredients are: monohydrate lactose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, hypromellose (15 cP), titanium dioxide (E 171), talc, polyethylene glycol 400.

What Alcetyr looks like and contents of the pack
White or almost white, oval, biconvex film-coated tablets, printed on one side with the number "5", the other side being smooth.
PVC/PVDC/Aluminium blister packs in a cardboard box.
The pack contains 28 film-coated tablets.
Marketing Authorisation Holder:
Artespharm Sp. z o.o.
ul. Solec 81 B, lok. A-51,
00-382 Warsaw, Poland
Importer:
Mako Pharma Sp. z o.o.
ul. Wiśniowa 9,
05-092 Kiełpin