Allertec

Package Leaflet: Information for the Patient

ALLERTEC, 10 mg/ml, Oral Drops, Solution

Cetirizine Dihydrochloride

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the 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 medication containing cetirizine, used in adults and children over 2 years of age:

• 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

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 medications), or any of the other ingredients of this medication (listed in section 6).
• If you have severe kidney disease (severe renal insufficiency 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 function disorders, a lower dose of the medication may be necessary. The dose of the medication will be determined by your doctor.
If you have epilepsy or have had seizures, consult your doctor before taking the medication.
If you have difficulty urinating (in conditions such as spinal cord injury or prostate enlargement), consult your doctor before taking the medication.
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 in 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, 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.

Allertec and Other Medications

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

Taking Allertec with Food and Drink

Food does not affect the absorption of the medication 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 for advice before taking this medication.
Avoid taking Allertec in pregnant women. Single administration of the medication by a pregnant woman should not have a harmful effect on the fetus. However, the medication should only be used if necessary and after consulting a doctor.
Cetirizine passes into breast milk. Therefore, do not take Allertec during breastfeeding, unless your doctor decides otherwise.

Driving and Operating Machines

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

Allertec Contains Methyl Parahydroxybenzoate (E218), Propyl Parahydroxybenzoate (E216), Propylene Glycol, and Sodium

The medication contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possible late reactions).
The medication contains 350 mg of propylene glycol in 1 ml of solution.
The medication contains less than 1 mmol (23 mg) of sodium in 1 ml of solution, which means the medication is considered "sodium-free".

3. How to Take Allertec

Always take this medication exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The medication can be taken before a meal, during a meal, or after a meal.
Drops should be measured with a spoon or diluted in water and taken orally.
When preparing the solution, consider the fact that the volume of water to which the drops are added should be adjusted to the amount that the patient (especially a child) is able to swallow. The solution should be taken immediately after preparation.
Usual doses of the medication are listed below.
One drop contains 0.5 mg of cetirizine dihydrochloride.
Children from 2 to 6 years of age: 2.5 mg (5 drops) twice a day.
Children from 6 to 12 years of age: 5 mg (10 drops) twice a day.
Adults and adolescents over 12 years of age: 10 mg (20 drops) once a day.
Patients with Renal Impairment
The dose of the medication will be determined by your doctor individually for children and adults, depending on the degree of renal impairment, age, and body weight of the patient.
Usual doses of the medication in adults are listed below:

• mild renal impairment - 10 mg (20 drops) once a day.
• moderate renal impairment - 5 mg (10 drops) once a day.
• severe renal impairment - 5 mg (10 drops) every other day. Do not take the medication in case of severe renal insufficiency with creatinine clearance less than 10 ml/min.

Patients 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 your doctor.

Taking a Higher Dose of Allertec than Recommended

In case of taking a higher dose of the medication than recommended, consult 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, pupil dilation, itching, restlessness, especially motor, sedation, sleepiness, stupor, accelerated heart rate, tremor, urinary retention.

Missing a Dose of Allertec

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

Stopping Treatment with Allertec

In rare cases, itching (intensive itching) and/or hives may recur after stopping treatment with Allertec.
If you have any further questions about taking this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Allertec can cause side effects, although not everybody gets them.
The following side effects have been reported based on observations that included the period after cetirizine was introduced to the market.

The Following Side Effects are Rare or Very Rare, but You Should Stop Taking the Medication and Inform Your Doctor Immediately if You Experience:

• allergic reactions, including severe reactions and angioedema (severe allergic reaction that causes swelling of the face and throat). These reactions may occur immediately after the first administration of the medication or later.

Common (less than 1 in 10 people):

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

Uncommon (less than 1 in 100 people):

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

Rare (less than 1 in 1,000 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 disturbances, dystonia (long-lasting muscle contractions), dyskinesia (involuntary movements),
• tics (habitual contractions),
• urination 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,
• memory loss, memory disturbances,
• 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 medication,
• joint pain,
• rash with pus-filled blisters,
• hepatitis.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 to gather more information on the safety of the medication.

5. How to Store Allertec

Keep the medication out of the sight and reach of children.
Store in a temperature below 25°C. Protect from light.
Do not use this medication after the expiry date stated on the carton and bottle after: EXP.
The expiry date stated on the packaging after EXP means the last day of the given month.
The inscription on the packaging after the abbreviation Lot means the batch number.
The shelf life of the medication after opening the bottle is 3 months.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Allertec Contains

• The active substance of the medication is cetirizine dihydrochloride. 1 ml of solution contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are: glycerol, propylene glycol, sodium saccharin (E954), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium acetate trihydrate, glacial acetic acid, purified water.

What Allertec Looks Like and Contents of the Pack

Allertec is a colorless or almost colorless, clear liquid.
The medication packaging contains a glass bottle with a dropper and a tamper-evident cap, containing 10 ml or 20 ml of solution, in a cardboard box.

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.
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz
Date of the Last Update of the Leaflet:November 2024