Cetip

Package leaflet: Information for the user

Cetip, 10 mg, coated tablets
Cetirizini dihydrochloridum
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be used according to the instructions provided in this patient leaflet or as directed by a doctor,
pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• Consult your pharmacist if you need advice or further information.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
• If there is no improvement after 2 days, or if the patient feels worse, contact a doctor.

Table of contents

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

1. What Cetip is and what it is used for

The active substance in Cetip is cetirizine dihydrochloride, which belongs to a group of medicines called
antihistamines.
This medicine is used to treat patients with hay fever (seasonal allergic rhinitis), year-round allergies such as allergy to dust or animal hair (perennial allergic rhinitis), as well as swelling, redness, and itching of the skin (urticaria). This medicine also relieves the uncomfortable symptoms and discomfort associated with the above-mentioned conditions, such as sneezing, nasal irritation and runny nose, nasal congestion, itching, redness and watering of the eyes, as well as skin rashes.
If there is no improvement after 2 days, or if the patient feels worse, consult a doctor.

2. Important information before using Cetip

When not to take Cetip:

• if the patient is allergic to cetirizine or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe kidney function disorders,
• if the patient has certain sugar intolerances (hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome),
• if the patient has problems with urinary retention.

Warnings and precautions
Before starting to use Cetip, consult a doctor, pharmacist, or nurse.

• If the patient suffers from epilepsy or is at risk of seizures, medical advice should be sought.
• If the patient has kidney problems.
• If the patient has risk factors for urinary retention (e.g. spinal cord injury, benign prostatic hyperplasia), because cetirizine may increase the risk of urinary retention.

This medicine is not recommended for children under 6 years of age.
No interactions have been reported that could produce any noticeable effects between
alcohol (at a blood concentration of 0.5 per mille, corresponding to the level after
drinking a glass of wine) and cetirizine taken at recommended doses. However, as with
all antihistamines, it is advisable to avoid consuming alcohol concurrently.
Oral hygiene should be maintained, as there is an increased risk of dental or gum infections during prolonged use of this medicine.
Patients scheduled for allergy testing should discontinue use of this medicine three days prior to the test.

Other medicines and Cetip
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used, including herbal preparations and dietary supplements available in pharmacies, supermarkets, or health food stores, as these products may interact with Cetip.

Examples of medicines that may affect cetirizine:

• medicines that depress the central nervous system (antidepressants, anxiolytics, and hypnotics),
• ritonavir (a medicine used in HIV infection).

Cetip with food, drink, and alcohol
Food does not significantly affect the absorption of cetirizine.

• As with all antihistamines, excessive alcohol consumption should be avoided during treatment with this medicine.

Pregnancy, breastfeeding, and fertility
During pregnancy or breastfeeding, or if pregnancy is suspected or planned, consult a doctor or pharmacist before using this medicine.
DO NOT take this medicine during breastfeeding.
Before starting any medication, seek advice from a doctor or pharmacist.

Driving and operating machinery
Cetip contains cetirizine dihydrochloride.
For a complete list of excipients, see section 6.

• This medicine may cause drowsiness; if this occurs, the patient should not drive or operate any tools or machinery.
• If the patient is particularly sensitive to the effects of this medicine, concomitant use of alcohol or other central nervous system depressants may further impair attention and reaction ability.

3. How to use Cetip

This medicine should always be taken according to the instructions in the patient leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse. Do not take more than one tablet per day. If there is no improvement within a few days, consult your doctor.

• Do not exceed the recommended daily dose.
• Swallow the tablets with a glass of water.
• This medicine can be taken regardless of meals.

Recommended dose:
Use in children and adolescents
The tablet may be divided into equal doses.

• Adults and children aged 12 years and older: one tablet once daily.
• Children aged 6 to 12 years: 5 mg (half a tablet) twice daily (half a tablet in the morning and half a tablet in the evening) or 10 mg (one tablet) once daily, as recommended by a doctor.
• Children weighing less than 30 kg: 5 mg (half a tablet) once daily.

This medicine is not recommended for children under 6 years of age.
Patients with impaired liver or kidney function: the usual dose is 5 mg (half a tablet) once daily. Consult your doctor before starting treatment with this medicine.
Taking more Cetip than recommended
If you accidentally take too many Cetip tablets, contact your doctor immediately or go to the nearest hospital emergency department or call emergency services, even if you feel fine. Drowsiness or dizziness may occur; therefore, the patient should not drive or operate machinery.
Bring the medicine in its original packaging so that the doctor can easily identify what the medicine is.
If you miss a dose of Cetip
If you forget to take a tablet, take it as soon as you remember. However, wait at least 24 hours before taking the next tablet.
Do not take a double dose to make up for a missed dose.
Stopping Cetip
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If a patient notices any symptoms of an allergic reaction, they should stop taking
Cetip and contact their doctor immediately. Symptoms of an allergic reaction include:
difficulty breathing, swelling of the face, neck, tongue, and throat. The doctor will assess
the severity of these symptoms and decide on the necessary further actions.
The adverse reactions listed below have been reported during the post-marketing period.
Their frequency is defined as follows:
common (occur in less than 1 in 10 patients but more than 1 in 100 patients),
uncommon (occur in less than 1 in 100 patients but more than 1 in 1,000 patients),
rare (occur in less than 1 in 1,000 patients but more than 1 in 10,000 patients),
very rare (occur in less than 1 in 10,000 patients).

Common adverse reactions

• Fatigue
• Dry mouth
• Nausea
• Diarrhea (in children only)
• Dizziness
• Headache
• Drowsiness
• Sore throat
• Nasal mucosa inflammation and irritation (rhinitis)
• Fatigue and drowsiness
• Abdominal pain
• Cold-like symptoms (in children only)

Uncommon adverse reactions

• Extreme fatigue and weakness (asthenia)
• Feeling of weakness or general malaise
• Unusual skin sensations (paresthesia)
• Psychomotor agitation
• Itching (pruritus)
• Rash
• Diarrhea

Rare adverse reactions

• Increased heart rate (tachycardia)
• Swelling (edema)
• Allergic reactions, sometimes severe (very rare)
• Abnormal liver function test results (consult a doctor)
• Weight gain
• Seizures
• Movement disorders
• Aggression
• Disorientation
• Depression
• Seeing non-existent images or hearing non-existent voices (hallucinations)
• Sleep disturbances (insomnia)
• Abdominal pain
• Skin swelling, redness, and itching (urticaria)
• Insomnia

Very rare adverse reactions

• Low platelet count (thrombocytopenia)
• Visual disturbances (accommodation disorders)
• Blurred vision, difficulty focusing
• Uncontrolled eye movements (ocular rotation)
• Sudden, unusual, and repetitive muscle movements (tics)
• Urinary disorders
• Swelling (edema)
• Drug rash
• Unusual bleeding or bruising
• Taste disturbances
• Tremor, tics
• Involuntary limb movements and/or jerky limb movements
• Fainting (syncope)
• Recurrent rash
• Nocturnal enuresis and/or difficulty urinating

Adverse reactions with unknown frequency

• Increased appetite
• Dizziness
• Urinary retention

Cases of memory loss and/or memory disturbances have also been reported.
In very rare cases, suicidal thoughts have occurred. If a patient observes such an adverse reaction, they should stop taking the tablets and consult a doctor immediately.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Cetip

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

6. Contents of the pack and other information

What Cetip contains

• The active substance is cetirizine dihydrochloride. One coated tablet contains 10 mg of cetirizine 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 a patient has previously been diagnosed with intolerance to certain sugars, the patient should
contact their doctor before taking this medicine.
What Cetip looks like and contents of the pack

• Cetip is in the form of white or almost white, capsule-shaped coated tablets, with a division line on one side and the engraved mark "10" on the other.
• Cetip is available in blisters, with packaging containing 10 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Milapharm Sp. z o.o.
pl. Gen. Józefa Hallera 5/14A
03-464 Warsaw
Phone number: (+48) 699 711 147
Manufacturer:
Medicofarma S.A.
ul. Tarnobrzeska 13
26-613 Radom
PharmaS d.o.o.
Industrijska cesta 5
44317 Potok, Popovača
Croatia
This medicinal product is authorised for sale in the European Economic Area countries under the following names:
DE: Cetirizindihydrochlorid IPCA 10 mg Filmtabletten
PL: Cetip
PT: Zarec 10 mg comprimidos revestidos por película