Allertec

Package Leaflet: Information for the Patient

ALLERTEC, 10 mg, film-coated tablets

Cetirizine dihydrochloride

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Allertec and what is it used for

Allertec is an antiallergic medicine that contains cetirizine, used in adults and children over 6 years of age:

• to relieve symptoms of the nose and eyes, associated with seasonal and perennial allergic rhinitis (such as a stuffy nose, runny 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

When not to take Allertec

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

Warnings and precautions

Before taking Allertec, discuss it with your doctor or pharmacist.
If you have kidney problems, you may need to take a lower dose of the medicine. Your doctor will determine the dose of the medicine.
If you have epilepsy or have had seizures, consult your doctor before taking the medicine.
If you have difficulty urinating (in conditions such as spinal cord injury or prostate enlargement), consult your 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 are no data on the safety of concomitant use of higher doses of cetirizine and alcohol. Therefore, during treatment with Allertec, as with other antihistamines, you should avoid consuming alcohol.
If you are scheduled to undergo allergy testing, ask your doctor if you should stop taking Allertec a few days before the test. Allertec may affect the results of allergy tests.

Children

Do not give this medicine to children under 6 years of age, as the tablet form does not allow for appropriate dose adjustment.

Allertec and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
No interactions with other medicines are expected.

Taking Allertec with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will decide whether you can take Allertec during pregnancy and breastfeeding.

Driving and using machines

Studies have shown that the medicine taken at the recommended dose does not affect the ability to drive and use machines, drowsiness, and psychophysical performance.
However, you should pay attention to your individual reaction to the medicine and, in case of drowsiness or fatigue, do not drive or operate machines.
Do not take more than the recommended dose of the medicine.

Allertec contains lactose and sodium

The medicine contains lactose. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means that the medicine is considered "sodium-free".

3. How to take Allertec

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
You can take the medicine before, during, or after a meal.
Swallow the tablets with a glass of water.
The tablet can be divided into equal doses.
Usual doses of the medicine are given below.
Children from 6 to 12 years of age
5 mg (half a film-coated tablet) twice a day.
Adults and adolescents over 12 years of age
10 mg (1 film-coated tablet) once a day.
Patient with renal impairment
The dose of the medicine is determined by the doctor individually for children and adults, depending on the degree of renal impairment, age, and body weight of the patient.
Usual doses of the medicine for adults are given below:

• mild renal impairment - 10 mg (1 film-coated tablet) once a day.
• moderate renal impairment - 5 mg (half a film-coated tablet) once a day.
• severe renal impairment - 5 mg (half a film-coated tablet) every other day. Do not take the medicine in case of severe renal impairment with creatinine clearance less than 10 ml/min.

Patient with hepatic impairment
Dose adjustment is not necessary.
Elderly patients
If kidney function is normal, dose adjustment is not necessary.
If you feel that the effect of Allertec 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 and is determined by the doctor.

Taking a higher dose of Allertec than recommended

If you have taken more than the recommended dose of the medicine, contact your doctor immediately, 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, dilated pupils, itching, restlessness, especially motor, sedation, drowsiness, stupor, increased heart rate, tremor, urinary retention.

Missing a dose of Allertec

Do not take a double dose of the medicine to make up for a missed dose.

Stopping treatment with Allertec

In rare cases, itching (intense itching) and/or urticaria may recur after stopping treatment with Allertec.
If you have any further questions on the use of this medicine, ask your 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 data from post-marketing experience.

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 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 severe weakness), malaise,
• paresthesia (sensory disturbances),
• agitation,
• itching, rash.

Rare (less than 1 in 1000 people):

• increased 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 disturbances, dystonia (prolonged muscle contractions), dyskinesia (involuntary movements),
• tics (habitual contractions),
• urinary disorders (nocturia, pain and/or difficulty urinating),
• angioedema (severe allergic reaction causing 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 disturbances,
• vertigo (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,
• joint pain,
• rash with pus-filled blisters,
• hepatitis.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects 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
You can also report side effects 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 Allertec

Keep the medicine out of the 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.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
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 contains

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

What Allertec looks like and contents of the pack

Allertec is a film-coated tablet. The tablets are white to cream-colored, oblong, biconvex with a dividing line.
The pack contains 20 or 30 film-coated tablets in aluminum/PVC blisters, 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