Cetirizine promedo

Patient Information Leaflet

Cetyryzyna Promedo, 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 so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any 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.

Table of contents:

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

1. What Cetyryzyna Promedo is and what it is used for

The active substance in Cetyryzyna Promedo is cetirizine dihydrochloride.
Cetyryzyna Promedo is an antiallergic medicine.
Cetyryzyna Promedo 10 mg film-coated tablets are indicated for adults, adolescents, and children aged 6 years and older:

• for relief of nasal and ocular symptoms associated with seasonal and perennial allergic rhinitis (i.e. nasal congestion, watery nasal discharge, nasal itching, frequent sneezing, red eyes, tearing, eye itching).
• for relief of symptoms of chronic idiopathic urticaria (long-lasting, intensely itchy rash).

2. Important information before using Cetyryzyna Promedo

When not to use Cetyryzyna Promedo

• if the patient has end-stage renal failure (severe kidney failure requiring dialysis),
• if the patient is allergic to cetyryzine dihydrochloride 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 to take Cetyryzyna Promedo, discuss this with your doctor or pharmacist.
If the patient has kidney impairment, consult a doctor before using the medicine, as a lower dose may be necessary. The doctor will determine the appropriate dose.
If the patient has problems with urination (e.g. due to spinal cord or prostate issues, or bladder problems), consult a doctor.
If the patient has epilepsy or a risk of seizures, consult a doctor.
No clinically significant interactions have been observed between alcohol (at a blood concentration of 0.5 per mille (g/l), equivalent to the concentration after drinking one glass of wine) and cetyryzine administered at recommended doses. However, there are no safety data available regarding the simultaneous use of higher doses of cetyryzine and alcohol. Therefore, as with other antihistamine medicines, it is recommended to avoid taking Cetyryzyna Promedo together with alcohol.
If the patient has planned allergy testing, ask the doctor whether the patient should discontinue taking Cetyryzyna Promedo several days before the test. Cetyryzyna Promedo may affect the results of allergy tests.

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.

Cetyryzyna Promedo and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.

Taking Cetyryzyna Promedo with food and drink
Food does not affect the absorption of Cetyryzyna Promedo.

Pregnancy and breastfeeding
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.
Cetyryzyna Promedo should be avoided during pregnancy. Accidental intake of the medicine by a pregnant woman is not expected to have harmful effects on the fetus. However, the medicine should only be used if necessary and after consultation with a doctor.
Cetyryzine passes into breast milk. Adverse effects in breastfed infants cannot be excluded. Therefore, Cetyryzyna Promedo should not be used during breastfeeding, unless otherwise decided by the doctor.

Driving and operating machinery
Clinical studies have not shown impairment of reaction time, concentration, or ability to drive vehicles after administration of Cetyryzyna Promedo at the recommended dose.
If the patient plans to drive, perform potentially hazardous activities, or operate machinery after taking Cetyryzyna Promedo, the patient should carefully observe how their body reacts to the medicine. Do not take a higher than recommended dose of the medicine.

Cetyryzyna Promedo coated tablets contain lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.

3. How to use Cetyryzyna Promedo

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The tablets should be swallowed with a glass of liquid.
The tablet may be divided into two equal doses.

Adults and adolescents aged over 12 years:
The recommended dose is 10 mg (1 tablet) once daily.

Use in 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 your doctor or pharmacist.

Patients with impaired kidney function
Cetyryzyna Promedo must not be used in patients with end-stage renal disease (severe kidney impairment requiring dialysis).
In patients with moderate renal impairment, a dose of 5 mg once daily is recommended.
If a patient has severe kidney disease, consult a doctor who will adjust the dose accordingly.
If a patient has renal impairment, medical advice should be sought before using this medicine, as a lower dose may be required. The doctor will determine the appropriate dose.
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 Cetyryzyna Promedo 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. Consult your doctor or pharmacist.
When treating with cetirizine, the duration of use should not exceed 10 days without consulting a doctor. If there is no improvement after 3 days, or if the patient feels worse, contact a doctor.

Taking more Cetyryzyna Promedo than recommended
If you have taken more than the recommended dose of Cetyryzyna Promedo, consult a doctor. The doctor will decide whether and what measures should be taken.
After an overdose, the adverse reactions listed below may occur with increased intensity. The following adverse reactions have been reported: disorientation, diarrhoea, dizziness, fatigue, headache, malaise, pupil dilation, itching, motor restlessness, sedation, somnolence, stupor, tachycardia, tremor, and urinary retention (difficulty completely emptying the bladder).

Missed dose of Cetyryzyna Promedo
Do not take a double dose to make up for a missed dose.

Stopping Cetyryzyna Promedo
In rare cases, itching (intense pruritus) and/or urticaria may recur after discontinuation of Cetyryzyna Promedo.

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 they do not occur in everyone.
The following adverse reactions are rare or very rare; however, treatment should be discontinued and a doctor must be contacted immediately 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.

Common adverse reactions (may affect fewer than 1 in 10 people)

• drowsiness
• dizziness, headache
• pharyngitis (sore throat), rhinitis (nasal discharge, nasal congestion) (in children)
• diarrhoea, nausea, dry mouth
• fatigue

Uncommon adverse reactions (may affect fewer than 1 in 100 people)

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

Rare adverse reactions (may affect fewer than 1 in 1,000 people)

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

Very rare adverse reactions (may affect fewer than 1 in 10,000 people)

• thrombocytopenia (low platelet count)
• tics (habitual spasms)
• fainting, dyskinesia (involuntary movements), dystonia (abnormal, prolonged muscle contractions), tremor, taste disturbances
• blurred vision, accommodation disorders (visual focusing disturbances), nystagmus (involuntary, circular eye movements)
• angioedema (severe allergic reaction causing swelling of the face or throat), drug eruption (skin allergic reaction to a medicine)
• urinary disorders (nocturia, pain and/or difficulty urinating)

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

• increased appetite
• suicidal behaviour (recurrent suicidal thoughts or interest in suicide), nightmares
• amnesia (memory loss), memory impairment
• 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
• joint pain, muscle pain
• acute generalized exanthematous pustulosis (rash with pustules containing purulent discharge)
• hepatitis

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 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 provide more information on the safety of the medicine.

5. How to store Cetyryzyna Promedo

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated 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 no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Cetyryzyna Promedo contains

• The active substance is cetirizine dihydrochloride. One coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are: monohydrate lactose, corn starch, pregelatinized corn starch, dried corn starch, talc, magnesium stearate, hypromellose, macrogol, titanium dioxide (E 171).

What Cetyryzyna Promedo looks like and contents of the pack
White or almost white, capsule-shaped coated tablets, with a break line on one side and embossed "10" on the other side.
The pack contains 10 or 20 coated tablets in PVC/Aluminium blisters, packed in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Promedo Pharma Products GmbH
Anklamer Strasse 28
10115 Berlin
Germany
Manufacturer and Importer:
Medezin Sp. z o.o.
ul. Ks. Kazimierza Janika 14
95-050 Konstantynów Łódzki
Poland
For more detailed information, please contact the local representative of the Marketing Authorisation Holder:
Promedo Pharma Products GmbH
Anklamer Strasse 28
10115 Berlin
Germany
Email: [email protected]
Tel. +48 22 329 65 00