Package leaflet: Information for the user

Cetoalergedd
10 mg, film-coated tablets
Cetirizini dihydrochloridum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor, pharmacist, or nurse.

Keep this leaflet as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 3 days, or if you feel worse, contact your doctor.

Contents of the leaflet

What Cetoalergedd is and what it is used for
What you need to know before taking Cetoalergedd
How to take Cetoalergedd
Possible side effects
How to store Cetoalergedd
Contents of the pack and other information

1. What Cetoalergedd is and what it is used for

The active substance in Cetoalergedd is cetirizine dihydrochloride. Cetoalergedd is an antihistamine medicine.
Cetoalergedd 10 mg film-coated tablets are indicated in adults and children aged 6 years and older:

for the relief of nasal and ocular symptoms associated with seasonal and perennial allergic rhinitis,
for the relief of symptoms of urticaria.

If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before using Cetoalergedd

When not to take Cetoalergedd:

if the patient has end-stage renal failure (severe kidney failure requiring dialysis),
if the patient is allergic to cetylpyridinium dichloride or any of the other ingredients of this medicine (listed in section 6), hydroxyzine, or piperazine derivatives (active substances with similar structure contained in other medicines).

Warnings and precautions
Before starting treatment with Cetoalergedd, discuss it with your doctor or pharmacist.
If the patient has kidney impairment, consult a doctor before using this medicine, as a lower dose may be required. The doctor will determine the new dose.
If the patient has problems with urination (e.g. due to spinal cord, prostate, or bladder issues), consult a doctor.
If the patient has epilepsy or is at risk of seizures, medical advice should be sought.
Clinically significant interactions between alcohol (at a blood concentration of 0.5 g/l, equivalent to one glass of wine) and cetyryzine administered at recommended doses have not been observed. However, there are no data on the safety of concomitant use of higher doses of cetyryzine and alcohol. Therefore, as with other antihistamine medicines, it is recommended to avoid taking Cetoalergedd together with alcohol.
If an allergy test is planned, ask your doctor whether you should stop taking the tablets a few days before the test. This medicine may affect the results of allergy testing.
Children
This medicine should not be given to children under 6 years of age, as the tablet form does not allow appropriate dose adjustment.
Cetoalergedd and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines the patient intends to take.
Cetoalergedd with food and drink
Food does not affect the absorption of cetyryzine.
Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, is breastfeeding, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Cetyryzine should be avoided in pregnant women. Accidental intake of the medicine during pregnancy is unlikely to have harmful effects on the fetus. However, this medicine should only be used if clearly necessary and after consultation with a doctor.
Cetyryzine passes into breast milk. The occurrence of adverse effects in breastfed infants cannot be ruled out. Therefore, Cetoalergedd should not be used during breastfeeding unless otherwise decided by a doctor.
Driving and operating machinery
Clinical studies have not shown impairment of reaction ability, concentration, or driving skills after administration of cetyryzine at the recommended dose.
The patient should carefully observe their body's response to Cetoalergedd after taking it, especially if planning to drive, perform potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.
Cetoalergedd contains lactose; if the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before using this medicine.

3. How to use Cetoalergedd

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

The tablets should be swallowed whole with a glass of liquid.
The tablet may be divided into 2 equal doses.

Adults and adolescents over 12 years of age:
The recommended dose is 10 mg (1 tablet) once daily.
Other formulations of this medicine may be more suitable for children. Consult a doctor or pharmacist.
Children aged 6 to 12 years:
The recommended dose is 5 mg twice daily (half a tablet twice daily).
Other formulations of this medicine may be more suitable for children. Consult a doctor or pharmacist.
Patients with impaired kidney function
For patients with moderate kidney impairment, the recommended dose is 5 mg (half a tablet) once daily.
If a patient has severe kidney disease, consult a doctor, who will adjust the dose accordingly.
If a child has kidney disease, consult a doctor, who will adjust the dose according to the child's needs.
If you feel that the effect of Cetoalergedd is too strong or too weak, consult your doctor.
Duration of treatment
The duration of treatment depends on the type, duration and course of symptoms, and is determined by the doctor.
If there is no improvement after 3 days, or if symptoms worsen, consult a doctor.
Do not use Cetoalergedd for longer than 10 days without consulting a doctor.
Taking more Cetoalergedd than recommended
If you have taken more than the recommended dose of Cetoalergedd, contact a doctor.
The doctor will decide whether any action is needed and what measures to take.
After an overdose, the adverse reactions listed below may occur with increased intensity.
The following adverse reactions have been reported: confusion, diarrhoea, dizziness, fatigue, headache, malaise, pupil dilation, itching, motor restlessness, sedation, drowsiness, stupor, increased heart rate, tremor, and urinary retention (difficulty completely emptying the bladder).
Missed dose of Cetoalergedd
Do not take a double dose to make up for a missed dose.
Stopping Cetoalergedd
In rare cases, itching (intense pruritus) and/or urticaria may recur after discontinuation of Cetoalergedd.
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 everybody will get them.
The following adverse reactions are rare or very rare; however, you should stop taking the medicine and immediately inform your doctor if any of the following occur:

allergic reactions, including severe reactions and angioedema (a severe allergic reaction causing swelling of the face and throat).

These reactions may occur immediately after the first dose of the medicine or may occur later.
Frequently occurring adverse reactions (may affect fewer than 1 in 10 patients)

drowsiness
dizziness, headache
sore throat, mucositis (nasal discharge, sensation of nasal congestion) (in children)
diarrhoea, nausea, dry mouth
fatigue

Uncommonly occurring adverse reactions (may affect fewer than 1 in 100 patients)

restlessness
paresthesia (sensory disturbances)
abdominal pain
itching, rash
asthenia (extreme tiredness), malaise

Rarely occurring adverse reactions (may affect fewer than 1 in 1,000 patients)

allergic reactions, sometimes severe (very rare)
depression, hallucinations, aggressive behaviour, disorientation, insomnia
seizures
tachycardia (rapid heartbeat)
abnormal liver function
urticaria
swelling
weight gain

Very rarely occurring adverse reactions (may affect fewer than 1 in 10,000 patients)

thrombocytopenia (low number of blood platelets)
tics (habitual spasms)
fainting, dyskinesia (involuntary movements), dystonia (abnormal, prolonged muscle contractions), tremor, taste disturbances
blurred vision, accommodation disorders (visual focus disturbances), nystagmus (uncontrolled, circular eye movements)
angioedema (severe allergic reaction causing swelling of the face or throat), drug eruption
urinary disorders (bedwetting, pain and/or difficulty in passing urine)

Adverse reactions with unknown frequency (frequency cannot be determined from available data)

increased appetite
suicidal behaviour (recurrent suicidal thoughts or interest in suicide), nightmares
memory disturbances, memory loss
dizziness (sensation of spinning or loss of balance)
urinary retention (inability to completely empty the bladder)
itching (intense pruritus) and/or urticaria after discontinuation of the medicine
arthralgia (joint pain), myalgia (muscle pain)
acute generalized exanthematous pustulosis (rash with pustules containing purulent fluid)
hepatitis

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. 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: Al. Jerozolimskie 181C, 02-222 Warsaw, tel: + 48 22 49 21 301, fax: + 48 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 to provide more information on the safety of the medicine.

5. How to store Cetoalergedd

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.

6. Contents of the pack and other information

What Cetoalergedd contains

The active substance is cetylpyridinium chloride dihydrochloride. Each coated tablet contains 10 mg of cetylpyridinium chloride dihydrochloride.
The other ingredients (excipients) are: tablet core: monohydrate lactose, corn starch, pregelatinized corn starch, talc, magnesium stearate; coating: hypromellose, titanium dioxide (E 171), talc and macrogol 6000.

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a physician before taking this medicine.

What Cetoalergedd looks like and contents of the pack

Cetoalergedd is a white or almost white, film-coated tablet in an oval shape, with a break line on one side and an embossed mark "10" on the other.
Cetoalergedd is available in blisters, packs containing 10 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
tel.: 22 32 16 240

Manufacturer/Importer:
PharmaS d.o.o.
Industrijska cesta 5
44317 Potok, Popovača
Croatia
Micro Labs GmbH
Lyoner Straße 20
60528 Frankfurt am Main
Germany
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
Poland

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Cetirizin Micro Labs 10 mg Filmtabletten
Poland: Cetoalergedd
Portugal: Cetirizina IPCA 10 mg comprimidos revestidos por película