Patient Information Leaflet

ALLERTEC WZF, 10 mg, coated tablets
Cetirizini dihydrochloridum
Please read carefully the information in this leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the 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 adverse reactions, 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.

Leaflet Contents

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

1. What Allertec WZF is and what it is used for

Allertec WZF is an antiallergic medicine containing cetirizine, used in adults and children aged 6 years and older:

to relieve nasal and ocular symptoms associated with seasonal and perennial allergic rhinitis (such as nasal congestion, watery nasal discharge, nasal itching, frequent sneezing, red eyes, tearing, eye itching);
to relieve symptoms of chronic idiopathic urticaria (persistent, intensely itchy skin welts).

2. Important information before using Allertec WZF

When not to use Allertec WZF

If the patient is allergic to cetirizine dihydrochloride, hydroxyzine, or piperazine derivatives (substances with a structure similar to cetirizine, contained in other medicines), or to any of the other ingredients of this medicine (listed in section 6).
If the patient has severe kidney disease (severe renal impairment with creatinine clearance less than 10 ml/min).

Warnings and precautions
Before starting treatment with Allertec WZF, discuss this with your doctor or pharmacist.
If the patient has impaired kidney function, a lower dose of the medicine may be required. The doctor will determine the appropriate dose.
If the patient suffers from epilepsy or has had seizures, consult a doctor before taking the medicine.
If the patient has difficulty urinating (in conditions such as spinal cord injury or benign prostatic hyperplasia), consult a doctor before taking the medicine.
No clinically significant interactions between alcohol (at a blood concentration of 0.5 per mille (g/l), corresponding to the level after drinking one glass of wine) and cetirizine administered at recommended doses have been observed. However, there are no data on the safety of concomitant use of higher doses of cetirizine and alcohol. Therefore, during treatment with Allertec WZF, as with other antihistamines, the patient should avoid consuming alcohol.
If the patient has planned allergy testing, ask the doctor whether the patient should discontinue Allertec WZF a few days before the test. Allertec WZF may affect the results of allergy tests.
Children
This medicine should not be given to children under 6 years of age, because the tablet formulation does not allow for appropriate dose adjustment.
Allertec WZF and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No interactions of this medicine with other medicines are expected.
Taking Allertec WZF with food and drink
Food does not noticeably affect the absorption of the medicine.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
The doctor will decide whether Allertec WZF can be used during pregnancy and while breastfeeding.
Driving and operating machinery
Studies have shown that the medicine, when used at the recommended dose, does not affect the ability to drive or operate machinery, the feeling of sleepiness, or psychomotor performance.
However, the patient should pay attention to their individual response to the medicine and, if drowsiness or fatigue occurs, should not drive or operate machinery.
Do not take a higher than recommended dose of the medicine.
Allertec WZF contains lactose and sodium
This medicine contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Allertec WZF

This medicine should always be taken exactly as described in this patient leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine can be taken before, during or after a meal.
Swallow the tablets with a glass of water.
The tablet may be divided into equal doses.
The usual doses are given below.
Children aged 6 to 12 years
5 mg (half a coated tablet) twice daily.
Adults and adolescents over 12 years of age
10 mg (1 coated tablet) once daily.
Patients with impaired renal function
The dose is individually adjusted by the doctor for both children and adults, depending on the degree of renal impairment, age and body weight of the patient.
The usual doses in adults are given below:

Mild renal impairment - 10 mg (1 coated tablet) once daily.
Moderate renal impairment - 5 mg (half a coated tablet) once daily.
Severe renal impairment - 5 mg (half a coated tablet) every other day. Do not use the medicine in cases of severe renal failure with creatinine clearance less than 10 ml/min.

Patients with hepatic impairment
Dose adjustment is not necessary.
Elderly patients
If renal function is normal, dose adjustment is not necessary.
If you feel that the effect of Allertec WZF 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 starting treatment with cetirizine, treatment should not last longer than 10 days without consulting a doctor.
Taking more Allertec WZF than recommended
If you take more than the recommended dose, contact your doctor immediately. The doctor will decide on further management.
After taking a dose higher than the recommended daily dose, the following symptoms may occur: disorientation, diarrhoea, dizziness, fatigue, headache, malaise, dilated pupils, itching, restlessness (especially motor restlessness), sedation, drowsiness, stupor, rapid heartbeat, tremor, urinary retention.
Missing a dose of Allertec WZF
Do not take a double dose to make up for a missed dose.
Stopping Allertec WZF
In rare cases, itching (intense pruritus) and/or urticaria may recur after discontinuation of Allertec WZF.
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 everyone will experience them.
The adverse reactions listed below, together with their frequency of occurrence, are based on
observations from the post-marketing surveillance period of cetirizine.
The following adverse reactions occur rarely or very rarely; however, you should discontinue
taking the medicine and contact your doctor immediately if any of these occur:

allergic reactions, including severe reactions and angioedema (a serious allergic reaction causing swelling of the face and throat). These reactions may occur immediately after the first dose or may appear later.

Common (less than 1 in 10 people):

fatigue,
dry mouth, nausea, diarrhoea,
dizziness, headache,
somnolence (drowsiness),
pharyngitis (sore throat), rhinitis (nasal mucosal inflammation) (in children).

Uncommon (less than 1 in 100 people):

abdominal pain,
asthenia (severe weakness), malaise,
paraesthesia (sensory disturbances),
restlessness,
itching, rash.

Rare (less than 1 in 1,000 people):

tachycardia (rapid heartbeat),
oedema (swelling),
allergic reactions, sometimes severe (very rare),
liver function abnormalities,
weight gain,
convulsions,
aggressive behaviour, disorientation, depression, hallucinations, insomnia,
urticaria (hives).

Very rare (less than 1 in 10,000 people):

thrombocytopenia (reduced platelet count),
accommodation disorders (eye's ability to focus on objects at varying distances), blurred vision, nystagmus (involuntary, rhythmic eye movements),
fainting, tremor, taste disturbances, dystonia (prolonged muscle contractions), dyskinesia (involuntary movements),
tics (habitual muscle spasms),
urinary disorders (nocturnal enuresis, pain and/or difficulty in passing urine),
angioedema (serious allergic reaction causing swelling of the face or throat), drug eruption.

Frequency not known (frequency cannot be estimated from available data):

increased appetite,
suicidal behaviour (recurrent suicidal thoughts or interest in suicide), nightmares,
amnesia (memory loss), memory impairment,
vertigo (sensation of spinning or loss of balance),
urinary retention (inability to completely empty the bladder),
pruritus (intense itching) and/or urticaria after discontinuation of the medicine,
joint pain,
pustular rash,
hepatitis.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 provide more information on the safety of this medicine.

5. How to store Allertec WZF

Keep this medicine out of the sight and reach of children.
Store below 25 °C.
Keep the blister in the outer packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
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 Allertec WZF contains

The active substance is cetirizine dihydrochloride. Each coated tablet contains 10 mg of cetirizine dihydrochloride.
The other ingredients are: monohydrate lactose, microcrystalline cellulose, corn starch, povidone K-25, magnesium stearate, sodium carboxymethyl starch, colloidal anhydrous silica, sodium lauryl sulfate, hypromellose, polyethylene glycol 6000.

What Allertec WZF looks like and contents of the pack
Allertec WZF is in the form of coated tablets. The tablets are white to cream-colored, oblong,
biconvex, with a central break line.
The pack contains 7, 10, 14 or 20 coated tablets in an Aluminium/PVC blister,
packaged in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Site in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba