ALLERTEC

Package leaflet: Information for the patient

ALLERTEC, 10 mg, film-coated tablets
Cetirizini dihydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as 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 a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Allertec is and what it is used for
2. What you need to know 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 Allertec is and what it is used for

Allertec 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, eye redness, tearing, and eye itching);
• to relieve symptoms of chronic idiopathic urticaria (long-lasting, intensely itchy skin rash).

2. Important information before using Allertec

When not to use Allertec

• If the patient is allergic to cetirizine dihydrochloride, hydroxyzine, or piperazine derivatives (substances similar in structure 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, consult a 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 experienced seizures, consult a doctor before using this medicine.
If the patient has difficulty urinating (in conditions such as spinal cord injury or benign prostatic hyperplasia), consult a doctor before using this medicine.
No clinically significant interactions have been observed 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. However, there are no safety data available regarding concomitant use of higher doses of cetirizine and alcohol. Therefore, during treatment with Allertec, as with other antihistamines, the patient should avoid consuming alcohol.
If the patient is scheduled for allergy testing, ask the doctor whether Allertec should be discontinued a few days before the test. Allertec may affect the results of allergy tests.

Children
This medicine should not be given to children under 6 years of age, because the tablet form does not allow for appropriate dose adjustment.

Allertec and other medicines
Tell the doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines the patient plans to use.
No interactions with other medicines are expected.

Taking Allertec 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 might be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The doctor will decide whether Allertec can be used during pregnancy and breastfeeding.

Driving and operating machinery
Studies have shown that the medicine, when used at the recommended dose, does not affect the ability to drive vehicles or operate machinery, perception of drowsiness, or psycho-physical performance.
However, the patient should pay attention to their individual response to the medicine and, if drowsiness or fatigue occurs, should not drive vehicles or operate machinery.
Do not use a higher than recommended dose of the medicine.

Allertec contains lactose and sodium
This medicine contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a 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

This medicine should always be taken as directed by a physician or pharmacist. If in doubt,
consult a doctor or pharmacist.
Allertec may be taken before, during, or after a meal.
Tablets should be swallowed with a glass of water.
The tablet may be divided into equal doses.
The usual recommended 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 renal impairment
The dose must be individually adjusted by a physician for both children and adults, depending on the degree of renal impairment, age, and body weight.
The usual recommended doses for adults are as follows:

• 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 Allertec in patients with 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 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 should be determined by the physician.

Overdose of Allertec
In case of overdose, seek immediate medical advice. The doctor will decide on further management.
After ingestion of a dose higher than the recommended daily dose, the following symptoms may occur:
disorientation, diarrhea, dizziness, fatigue, headache, malaise, pupil dilation, itching, restlessness (especially motor agitation), sedation, drowsiness, stupor, increased heart rate, tremor, and urinary retention.

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

Discontinuation of Allertec
In rare cases, itching (intense pruritus) and/or urticaria may recur after stopping Allertec.

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
covering the period following the introduction of cetirizine into the market.

The following adverse reactions are rare or very rare; 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 severe allergic reaction causing swelling of the face and throat). These reactions may occur immediately after the first dose or may occur later.

Common (less frequent than in 1 out of 10 people):

• fatigue,
• dry mouth, nausea, diarrhoea,
• dizziness, headache,
• somnolence (drowsiness),
• pharyngitis (inflammation of the throat), rhinitis (inflammation of the nasal mucosa) (in children).

Uncommon (less frequent than in 1 out of 100 people):

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

Rare (less frequent than in 1 out of 1,000 people):

• palpitations,
• oedema (swelling),
• allergic reactions, sometimes severe (very rare),
• abnormal liver function,
• weight gain,
• convulsions,
• aggressive behaviour, disorientation, depression, hallucinations, insomnia,
• urticaria (hives).

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

• thrombocytopenia (reduced number of blood platelets),
• accommodation disorders (eye's inability to adjust to viewing objects at different distances), blurred vision, nystagmus (involuntary, rhythmic eye movement),
• 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 (severe allergic reaction causing swelling of the face or throat), drug eruption.

Frequency not known (frequency cannot be estimated from the 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,
• pustular rash (rash with pus-filled blisters),
• hepatitis (liver inflammation).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warszawa
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 to provide more information on the safety of the medicine.

5. How to store Allertec

Keep the 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.
The marking on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
Medicines must 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 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 looks like and contents of the pack
Allertec is in the form of film-coated tablets. The tablets are white to cream-coloured, oblong,
biconvex, with a dividing score line.
The pack contains 20 or 30 film-coated tablets in aluminium/PVC blisters, in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
POLPHARMA S.A. Pharmaceutical Works
Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
POLPHARMA S.A. Pharmaceutical Works
Production Plant in Nowa Dęba
Metalowca 2, 39-460 Nowa Dęba