Allertec Vzf

Leaflet attached to the packaging: patient information

ALLERTEC WZF, 10 mg, coated tablets

Cetirizine dihydrochloride

Read the 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 patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Allertec WZF and what is it used for
• 2. Important information before taking Allertec WZF
• 3. How to take Allertec WZF
• 4. Possible side effects
• 5. How to store Allertec WZF
• 6. Package contents and other information

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

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

• to relieve symptoms of the nose and eyes associated with seasonal and chronic allergic rhinitis (such as a stuffy nose, excessive watery discharge from the nose, itching of the nose, frequent sneezing, redness of the eyes, tearing, itching of the eyes);
• to relieve symptoms of chronic idiopathic urticaria (long-lasting, severely itching hives on the skin).

2. Important information before taking Allertec WZF

When not to take Allertec WZF

• If the patient is allergic to cetirizine dihydrochloride, hydroxyzine, or piperazine derivatives (substances with a similar structure to cetirizine, found in other medicines), or 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 to take Allertec WZF, the patient should discuss it with their doctor or pharmacist.
If the patient has kidney function disorders, a lower dose of the medicine may be necessary. The dose of the medicine will be determined by the doctor.
If the patient has epilepsy or has had seizures, they should consult their doctor before taking the medicine.
If the patient has difficulty urinating (in conditions such as spinal cord injury or prostate enlargement), they should consult their doctor before taking the medicine.
No significant clinical interactions have been observed between alcohol (at a concentration of 0.5 per mille (g/l) in the blood, corresponding to the concentration after drinking one glass of wine) and cetirizine taken at the recommended doses. However, there is no data on the safety of concomitant use of higher doses of cetirizine and alcohol. Therefore, during treatment with Allertec WZF, the patient should avoid consuming alcohol, just like with other antihistamine medicines.
If the patient is scheduled to undergo allergy tests, they should ask their doctor if they should stop taking 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, as the tablet form does not allow for appropriate dose adjustment.

Allertec WZF and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interactions with other medicines are expected.

Taking Allertec WZF with food and drink

Food does not affect the absorption of the medicine in a noticeable way.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The doctor will decide whether Allertec WZF can be taken during pregnancy and breastfeeding.

Driving and operating machinery

Studies have shown that the medicine taken at the recommended dose does not affect the ability to drive vehicles and operate machinery, drowsiness, or psychophysical performance.
However, the patient should pay attention to their individual reaction to the medicine and, in case of drowsiness or fatigue, not drive vehicles or operate machinery.
The patient should not take a higher dose of the medicine than recommended.

Allertec WZF contains lactose and sodium

The medicine contains lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to take Allertec WZF

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The medicine can be taken before, during, or after a meal.
The tablets should be swallowed with a glass of water.
A tablet can be divided into equal doses.
The usual doses of the medicine are listed below.
Children aged 6 to 12 years
5 mg (half a coated tablet) twice a day.
Adults and adolescents over 12 years
10 mg (1 coated tablet) once a day.
Patients with kidney function disorders
The dose of the medicine will be determined by the doctor individually for children and adults, depending on the degree of kidney function disorders, age, and body weight of the patient.
The usual doses of the medicine for adults are listed below:

• mild kidney function disorders - 10 mg (1 coated tablet) once a day.
• moderate kidney function disorders - 5 mg (half a coated tablet) once a day.
• severe kidney function disorders - 5 mg (half a coated tablet) every other day. The medicine should not be taken in case of severe renal impairment with creatinine clearance less than 10 ml/min.

Patients with liver function disorders
Dose adjustment is not necessary.
Elderly patients
If kidney function is normal, dose adjustment is not necessary.
If the patient feels that the effect of Allertec WZF is too strong or too weak, they should consult their doctor.

Duration of treatment

The duration of treatment depends on the type, duration, and course of symptoms. The patient should consult their doctor or pharmacist.
When starting treatment with cetirizine, the duration of treatment should not exceed 10 days without consulting a doctor.

Taking a higher dose of Allertec WZF than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor, who will decide on further action.
After taking a dose higher than the recommended daily dose, the following may occur: disorientation, diarrhea, dizziness, fatigue, headache, malaise, pupil dilation, itching, restlessness, especially motor restlessness, sedation, drowsiness, stupor, accelerated heart rate, tremor, urinary retention.

Missing a dose of Allertec WZF

The patient should not take a double dose of the medicine to make up for a missed dose.

Stopping treatment with Allertec WZF

In rare cases, itching (intensive itching) and/or urticaria may recur after stopping treatment with Allertec WZF.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with a frequency based on observations after the marketing authorization of cetirizine.

The following side effects occur rarely or very rarely, but the patient should stop taking the medicine and immediately inform their doctor if they occur:

• 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 later.

Common (less than 1 in 10 people):

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

Uncommon (less than 1 in 100 people):

• abdominal pain,
• asthenia (very strong weakness), malaise,
• paresthesia (sensory disturbances),
• agitation,
• itching, rash.

Rare (less than 1 in 1000 people):

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

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

• thrombocytopenia (decreased platelet count),
• accommodation disorders (difficulty adjusting the eye to look at different objects at different distances), blurred vision, eye rotation (uncontrolled, circular movements of the eyeballs),
• fainting, tremor, taste disorders, dystonia (long-lasting muscle contractions), dyskinesia (involuntary movements),
• tics (habitual contractions),
• urinary disorders (nocturia, pain and/or difficulty urinating),
• angioedema (a severe allergic reaction that causes swelling of the face or throat), drug rash.

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

• increased appetite,
• suicidal attempts (recurring suicidal thoughts or interest in suicide), nightmares,
• amnesia (memory loss), memory disorders,
• vertigo (feeling of spinning or loss of balance),
• urinary retention (inability to completely empty the bladder),
• itching (intensive itching) and/or urticaria after stopping treatment with the medicine,
• joint pain,
• rash with pus-filled blisters,
• hepatitis.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Allertec WZF

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Store the blister in the outer packaging to protect it 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 month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Allertec WZF contains

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

What Allertec WZF looks like and contents of the pack

Allertec WZF is a white to cream-colored, oblong, biconvex coated tablet with a score line on both sides.
The packaging of the medicine contains 7, 10, 14, or 20 coated tablets in an Aluminium/PVC blister pack, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba
Date of last revision of the leaflet:November 2024