Allertec kids

Patient Information Leaflet: Instructions for Use

ALLERTEC KIDS, 5 mg/5 ml, syrup
Cetirizini dihydrochloridum
Please read this leaflet carefully 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
a doctor, pharmacist, or nurse.

• Keep this leaflet for future reference.
• 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 or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Table of Contents

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

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

Allertec Kids is an antiallergic medicine containing cetirizine, used in adults, adolescents, and children aged 2 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, and eye itching);
• to relieve symptoms of chronic idiopathic urticaria (long-lasting, intensely itchy skin rash).

If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before using Allertec Kids

When not to use Allertec Kids

• If the patient is allergic to cetirizine dihydrochloride, hydroxyzine, or any piperazine derivatives (substances with a structure similar to cetirizine found 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 Kids, 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 had seizures, medical advice should be sought before using this medicine.
If the patient has difficulty urinating (e.g. due to spinal cord injury or benign prostatic hyperplasia), consult a doctor before using this medicine.
No clinically significant interactions between alcohol (at a blood concentration of 0.5 per mille (g/l), equivalent 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 Kids, as with other antihistamines, the patient should avoid consuming alcohol.
If the patient has planned allergy testing, ask the doctor whether use of Allertec Kids should be discontinued a few days before the test. Allertec Kids may affect the results of allergy tests.

Children and adolescents
Use of this medicine is not recommended in children under 2 years of age.
In children aged 2 to 6 years, Allertec Kids should be used only after a diagnosis of allergy has been confirmed.

Allertec Kids with other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
No interactions with other medicines are expected with this product.

Allertec Kids 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 a doctor before using this medicine.
Use of Allertec Kids in pregnant women should be avoided. A single dose taken during pregnancy is unlikely to have harmful effects on the fetus. However, the medicine should be used only if necessary and after consultation with a doctor.
Cetirizine passes into breast milk. Therefore, Allertec Kids should not be used during breastfeeding unless otherwise directed by a doctor.

Driving and operating machinery
Clinical studies have not shown any impairment of reaction ability, concentration, or ability to drive vehicles after administration of Allertec Kids at the recommended dose.
If the patient intends to drive, perform potentially hazardous activities, or operate machinery after taking Allertec Kids, the patient should carefully observe how their body reacts to the medicine. Do not exceed the recommended dose.

Allertec Kids contains sorbitol (E420), methyl parahydroxybenzoate (E218),
propyl parahydroxybenzoate (E216), propylene glycol, and sodium
The medicine contains 350 mg of sorbitol in each ml of syrup. Sorbitol is a source of fructose. If intolerance to certain sugars has previously been diagnosed in the patient (or their child), or if hereditary fructose intolerance—a rare genetic disorder in which the patient's body cannot metabolize fructose—has been diagnosed, the patient should consult a doctor before taking the medicine or giving it to the child.
In small children (with body weight below 12.5 kg, for whom the sorbitol dose from Allertec Kids exceeds 140 mg/kg body weight per day), sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
The medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed-type reactions).
The medicine contains 50 mg of propylene glycol in 1 ml of syrup.
The medicine contains less than 1 mmol (23 mg) of sodium in 10 ml of syrup, meaning the medicine is considered "sodium-free".

3. How to use Allertec Kids

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.
A measuring cup with a total capacity of 10 ml is provided in the package, marked with graduations allowing measurement of 2.5 ml, 5 ml, and 10 ml of syrup.
The medicine may be taken before, during, or after a meal.
The usual recommended doses are given below.

Children aged 2 to 6 years:
2.5 mg (2.5 ml of syrup) twice daily.
Allertec Kids may be used in children aged 2 to 6 years only after a prior diagnosis of allergy.

Children aged 6 to 12 years:
5 mg (5 ml of syrup) twice daily.

Adults and adolescents over 12 years of age:
10 mg (10 ml of syrup) once daily.

Patients with renal function impairment
The doctor will determine the individual dose for children, adolescents, and adults based on the degree of renal impairment, age, and body weight.
The usual doses for adults are as follows:

• Mild renal impairment – 10 mg (10 ml of syrup) once daily.
• Moderate renal impairment – 5 mg (5 ml of syrup) once daily.
• Severe renal impairment – 5 mg (5 ml of syrup) 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 function impairment
Dose adjustment is not necessary. However, dose adjustment is recommended in patients with hepatic impairment as well as in those with renal impairment.

Elderly patients
If renal function is normal, dose adjustment is not necessary.
If you feel that the effect of Allertec Kids 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.
If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.
Prolonged use of the medicine for longer than 10 days is not recommended without consulting a doctor.

Taking more Allertec Kids 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, pupil dilation, itching, restlessness (especially motor restlessness), sedation, drowsiness, stupor, increased heart rate, tremor, and urinary retention.

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

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

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, 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 must stop taking the
medicine and contact your doctor immediately if any of them 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 develop later.

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

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

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

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

Rare (less frequent than in 1 out of 1000 people):

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

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

• thrombocytopenia (reduced number of blood platelets),
• 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 (bedwetting, pain and/or difficulty passing urine),
• angioedema (severe 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 (recurring 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 not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Allertec Kids medicine

Keep this medicine out of the sight and reach of children.
Protect from light.
Do not use this medicine after the expiry date stated on the carton and label following: EXP.
The expiry date refers to the last day of the stated month.
The shelf life of the medicine after first opening the bottle is 3 months.
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 packaging and other information

What Allertec Kids contains

• The active substance is cetirizine dihydrochloride. 5 ml of syrup contains 5 mg of cetirizine dihydrochloride.
• Other ingredients are: sorbitol (E420), glycerol, propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium saccharin (E954), glacial acetic acid, sodium acetate trihydrate, pomegranate fruit essence, purified water.

What Allertec Kids looks like and contents of the pack
Allertec Kids is a colourless, clear liquid. It is available in brown PET bottles with a polyethylene (HDPE) screw cap and a polypropylene (PP) measuring cup. Each 100 ml bottle is packed in a cardboard box together with the measuring cup. The measuring cup allows measuring of 2.5 ml, 5 ml and 10 ml of syrup.
Marketing Authorisation Holder
POLPHARMA S.A. Pharmaceutical Works
Pelplińska Street 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
POLPHARMA S.A. Pharmaceutical Works
Medana Branch in Sieradz
Władysława Łokietka Street 10, 98-200 Sieradz