Cetoalergedd

Package Leaflet: Information for the User

Cetoalergedd

10 mg, coated tablets
Cetirizine dihydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor, pharmacist, or nurse.

• You should keep this leaflet, you may need to read it again.
• If you need advice or further information, you should speak to your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

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

1. What is Cetoalergedd and what is it used for

The active substance of Cetoalergedd is cetirizine dihydrochloride. Cetoalergedd is an antiallergic medicine.
Cetoalergedd, 10 mg, coated tablets are indicated for adults and children aged 6 years and above:

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

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

2. Important information before taking Cetoalergedd

When not to take Cetoalergedd:

• -if you have severe kidney failure (requiring dialysis),
• -if you are allergic to cetirizine dihydrochloride or any of the other ingredients of this medicine (listed in section 6), hydroxyzine or piperazine derivatives (active substances with a similar structure, present in other medicines).

Warnings and precautions

Before taking Cetoalergedd, you should discuss it with your doctor or pharmacist.
If you have kidney problems, you should consult your doctor before taking the medicine, a lower dose may be necessary. Your doctor will determine the new dose of the medicine.
If you have problems with urination (e.g., spinal cord or prostate problems, or bladder problems), you should consult your doctor.
If you have epilepsy or are at risk of seizures, you should consult your doctor.
No clinically significant interactions have been observed between alcohol (at a blood concentration of 0.5 g/l, equivalent to one glass of wine) and cetirizine at the recommended dose. However, there are no data on the safety of concomitant use of higher doses of cetirizine and alcohol. Therefore, as with other antihistamines, it is recommended to avoid taking Cetoalergedd with alcohol.
If you are planning an allergy test, you should ask your doctor whether you should stop taking the tablets a few days before the test. This medicine may affect the results of the allergy test.

Children

This medicine should not be given to children under 6 years of age, as the tablet form does not allow for appropriate dose adjustment.

Cetoalergedd and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Cetoalergedd with food and drink

Food does not affect the absorption of cetirizine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Cetirizine should be avoided in pregnant women. Accidental use of the medicine by a pregnant woman should not have a harmful effect on the fetus. However, this medicine should only be used if necessary and after consulting a doctor.
Cetirizine passes into breast milk. It cannot be excluded that it may cause side effects in breastfed infants. Therefore, Cetoalergedd should not be used during breastfeeding, unless your doctor decides otherwise.

Driving and using machines

Clinical studies have not shown any impairment of reaction time, concentration, or the ability to drive after taking cetirizine at the recommended dose.
You should carefully observe your body's reaction to Cetoalergedd after taking it and if you plan to drive, perform potentially hazardous activities, or operate machinery. You should not take a higher dose of the medicine than recommended.
Cetoalergedd contains lactose; if you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Cetoalergedd

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

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

Adults and adolescents over 12 years:

The recommended dose is 10 mg (1 tablet) once daily.
Other forms of this medicine may be more suitable for children. You should consult your doctor or pharmacist.

Children from 6 to 12 years:

The recommended dose is 5 mg twice daily (half a tablet twice daily).
Other forms of this medicine may be more suitable for children. You should consult your doctor or pharmacist.

Patients with renal impairment

In patients with moderate renal impairment, a dose of 5 mg (half a tablet) once daily is recommended.
If you have severe kidney disease, you should consult your doctor, who will adjust the dose accordingly.
If your child has kidney disease, you should consult your doctor, who will adjust the dose according to your child's needs.
If you feel that the effect of Cetoalergedd is too strong or too weak, you should consult your doctor.

Duration of treatment

The duration of treatment depends on the type, duration, and course of symptoms and is determined by your doctor.
If after 3 days there is no improvement or you feel worse, you should contact your doctor.
You should not take Cetoalergedd for more than 10 days without consulting your doctor.

Taking a higher dose of Cetoalergedd than recommended

If you have taken a higher dose of Cetoalergedd than recommended, you should contact your doctor.
Your doctor will decide what actions to take.
After an overdose, the following side effects may occur with increased intensity: disorientation, diarrhea, dizziness, fatigue, headache, malaise, dilated pupils, itching, restlessness, sedation, somnolence, stupor, accelerated heart rate, tremor, and urinary retention (difficulty emptying the bladder).

Missing a dose of Cetoalergedd

You should not take a double dose to make up for a missed dose.

Stopping treatment with Cetoalergedd

In rare cases, itching (intense itching) and/or urticaria may recur after stopping treatment with Cetoalergedd.
If you have any further questions about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cetoalergedd can cause side effects, although not everybody gets them.

The following side effects are rare or very rare, but you should stop taking the medicine and inform your doctor immediately if you experience:

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

These reactions may occur immediately after the first dose or may occur later.
Common side effects(may affect up to 1 in 10 people)

• drowsiness
• dizziness, headache
• pharyngitis, rhinitis (runny nose, stuffy nose) (in children)
• diarrhea, nausea, dry mouth
• fatigue

Uncommon side effects(may affect up to 1 in 100 people)

• agitation
• paresthesia (abnormal sensations)
• abdominal pain
• itching, rash
• asthenia (extreme fatigue), malaise

Rare side effects(may affect up to 1 in 1,000 people)

• allergic reactions, sometimes severe (very rare)
• depression, hallucinations, aggressive behavior, disorientation, insomnia
• seizures
• tachycardia (rapid heart rate)
• abnormal liver function
• urticaria
• edema
• weight gain

Very rare side effects(may affect up to 1 in 10,000 people)

• thrombocytopenia (low platelet count)
• tics (involuntary muscle contractions)
• syncope, dyskinesia (involuntary movements), dystonia (abnormal, prolonged muscle contractions), tremor, taste disturbances
• blurred vision, accommodation disorders (vision problems), eye rotation (uncontrolled, circular eye movements)
• angioedema (severe allergic reaction causing swelling of the face or throat), drug rash
• urination disorders (nocturia, pain, and/or difficulty urinating)

Side effects with unknown frequency(frequency cannot be estimated from available data)

• increased appetite
• suicidal attempts (recurring suicidal thoughts or interest in suicide), nightmares
• memory disorders, memory loss
• dizziness (feeling of spinning or loss of balance)
• urinary retention (inability to completely empty the bladder)
• itching (intense itching) and/or urticaria after stopping treatment with the medicine
• arthralgia (joint pain), myalgia (muscle pain)
• acute generalized exanthematous pustulosis (rash with pus-filled blisters)
• hepatitis

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cetoalergedd

The medicine should be stored out of 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 month.
There are no special precautions for storage of the medicine.

6. Contents of the pack and other information

What Cetoalergedd contains

• The active substance of Cetoalergedd is cetirizine dihydrochloride. One coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other ingredients (excipients) are: tablet core: lactose monohydrate, maize starch, maize starch paste, talc, magnesium stearate; coating: hypromellose, titanium dioxide (E 171), talc, and macrogol 6000.

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.

What Cetoalergedd looks like and contents of the pack

• -Cetoalergedd is a white or almost white, capsule-shaped, coated tablet with a dividing line on one side and the imprint "10" on the other.
• -Cetoalergedd is available in blisters in packs of 10 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
tel.: 22 32 16 240

Manufacturer/Importer:

PharmaS d.o.o.
Industrijska cesta 5
44317 Potok, Popovača
Croatia
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
Poland

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Cetirizin Micro Labs 10 mg Filmtabletten
Poland: Cetoalergedd
Portugal: Cetirizina IPCA 10 mg comprimidos revestidos por película
Date of last revision of the leaflet:08.2024