Allertec Kids

Package Leaflet: Information for the Patient

ALLERTEC KIDS, 5 mg/5 ml, syrup

Cetirizine dihydrochloride

Read the package 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 package leaflet or as directed by your doctor, pharmacist, or nurse.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet

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

Allertec Kids is an antiallergic medicine that contains cetirizine, used in adults, adolescents, and children aged 2 years and older:

• to relieve symptoms of the nose and eyes associated with seasonal and chronic 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 itchy hives on the skin).

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

2. Important information before taking Allertec Kids

When not to take Allertec Kids

• 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 Kids, you should discuss it with your doctor or pharmacist.
If you have kidney problems, you may need to take a lower dose of the medicine. The dose of the medicine will be determined by your doctor.
If you have epilepsy or have had seizures, you should consult your doctor before taking the medicine.
If you have difficulty urinating (in conditions such as spinal cord injury or prostate enlargement), you should 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 Kids, as with other antihistamines, you should avoid consuming alcohol.
If you are scheduled to undergo allergy tests, you should ask your doctor if you should stop taking Allertec Kids a few days before the test. Allertec Kids may affect the results of allergy tests.

Children and adolescents

This medicine is not recommended for children under 2 years of age.
In children aged 2 to 6 years, Allertec Kids may only be used after a diagnosis of allergy has been made.

Allertec Kids and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
No interactions with other medicines are expected.

Allertec Kids 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 plan to have a child, you should consult your doctor before taking this medicine.
You should avoid taking Allertec Kids if you are pregnant. Single administration of the medicine by a pregnant woman should not have a harmful effect on the fetus. However, the medicine may only be used if necessary and after consulting a doctor.
Cetirizine passes into breast milk. Therefore, you should not take Allertec Kids during breastfeeding, unless your doctor decides otherwise.

Driving and using machines

Clinical studies have not shown a decrease in reaction and concentration abilities, as well as the ability to drive vehicles after taking Allertec Kids at the recommended dose.
If you plan to drive vehicles, perform potentially hazardous activities, or operate machines after taking Allertec Kids, you should carefully observe your body's reaction to the medicine. You should not take a higher dose of the medicine than recommended.

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 you or your child have previously been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which your body does not break down fructose, you should contact your doctor before taking the medicine or giving it to your child.
In small children (with a body weight below 12.5 kg, for whom the dose of sorbitol taken with 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 (possible late 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, which means that the medicine is considered "sodium-free".

3. How to take Allertec Kids

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
A measuring cup with a total capacity of 10 ml and a scale allowing for measuring 2.5 ml, 5 ml, 10 ml of syrup is attached to the packaging.
The medicine can be taken before, during, or after a meal.
Usual doses of the medicine are given below.
Children aged 2 to 6 years:
2.5 mg (2.5 ml syrup) twice a day.
In children aged 2 to 6 years, Allertec Kids may only be used after a diagnosis of allergy has been made.
Children aged 6 to 12 years:
5 mg (5 ml syrup) twice a day.
Adults and adolescents over 12 years of age:
10 mg (10 ml syrup) once a day.
Patients with renal impairment
The dose of the medicine is determined by the doctor individually for children, adolescents, and adults, depending on the degree of renal impairment, age, and body weight of the patient.
Usual doses of the medicine in adults are given below:

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

Patients with hepatic impairment
Dose adjustment is not necessary. In patients with hepatic impairment and renal impairment, dose adjustment is recommended.
Older people
If kidney function is normal, dose adjustment is not necessary.
If you feel that the effect of Allertec Kids is too strong or too weak, you should consult your doctor.

Duration of treatment

The duration of treatment depends on the type, duration, and course of symptoms. You should consult your doctor or pharmacist.
If after 3 days there is no improvement or you feel worse, you should contact your doctor.
It is not recommended to take the medicine for more than 10 days without consulting a doctor.

Overdose of Allertec Kids

In case of taking a higher dose of the medicine than recommended, you should immediately consult a 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, dilation of the pupils, itching, restlessness, especially motor, sedation, drowsiness, stupor, increased heart rate, tremors, urinary retention.

Missed dose of Allertec Kids

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

Stopping treatment with Allertec Kids

In rare cases, itching (intensive itching) and/or hives may reappear after stopping treatment with Allertec Kids.
If you have any further doubts about taking this medicine, you should consult 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 observations that included the period after the introduction of cetirizine to the market.

The following side effects are rare or very rare, but you should stop taking the medicine and immediately inform your doctor 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 administration of the medicine or may occur 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),
• excitement,
• 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 eyes),
• fainting, tremors, taste disorders, dystonia (long-lasting muscle contractions), dyskinesia (involuntary movements),
• tics (habitual contractions),
• urinary disorders (nocturnal enuresis, 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 disorders,
• vertigo (feeling of spinning or loss of balance),
• urinary retention (inability to completely empty the bladder),
• itching (intensive itching) and/or hives after stopping treatment with the medicine,
• joint pain,
• vesicular rash,
• hepatitis.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, you should tell your 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Allertec Kids

Keep the 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 after: EXP.
The expiry date refers to the last day of the month.
The shelf life of the medicine after opening the bottle is 3 months.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Allertec Kids contains

• The active substance of the medicine is cetirizine dihydrochloride. 5 ml of syrup contains 5 mg of cetirizine dihydrochloride.
• The 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 extract, purified water.

What Allertec Kids looks like and contents of the pack

Allertec Kids is a colorless, clear liquid. It is available in brown PET bottles with a polyethylene (HDPE) cap and a polypropylene (PP) measuring cup. Each bottle containing 100 ml of syrup is packaged with a measuring cup in a cardboard box. The measuring cup allows for measuring 2.5 ml, 5 ml, 10 ml of syrup.

Marketing authorization holder

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

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
Władysława Łokietka 10, 98-200 Sieradz

Date of last revision of the package leaflet: