Allefin Allergi

Package Leaflet: Information for the Patient

Allefin Allergy, 5 mg, Coated Tablets

Levocetirizine Dihydrochloride
For adults, adolescents, and children from 6 years of age.

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 or pharmacist.

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

Table of Contents of the Package Leaflet

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

1. What is Allefin Allergy and what is it used for

The active substance of Allefin Allergy is levocetirizine dihydrochloride.
Allefin Allergy is an antiallergic medicine.
Allefin Allergy is used to treat symptoms associated with:

• allergic rhinitis (including chronic allergic rhinitis);
• urticaria.

Allefin Allergy in the form of coated tablets is indicated for use in adults, adolescents, and children from 6 years of age.
If after 3 days there is no improvement or you feel worse, consult your doctor.

2. Important information before taking Allefin Allergy

When not to take Allefin Allergy

• if you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or any other piperazine derivatives or any of the other ingredients of this medicine (listed in section 6),
• if you have severe kidney problems (severe renal impairment with creatinine clearance less than 10 ml/min).

Warnings and precautions

Before taking Allefin Allergy, discuss it with your doctor or pharmacist.
If you may have difficulty emptying your bladder (in conditions such as spinal cord injury or prostate enlargement), consult your doctor.
Allefin Allergy may increase the risk of seizures, so consult your doctor if you have epilepsy or are at risk of seizures.
If you are scheduled to undergo allergy testing, ask your doctor if you should stop taking Allefin Allergy a few days before the test. Allefin Allergy may affect the results of allergy tests.

Children

It is not recommended to give Allefin Allergy coated tablets to children under 6 years of age, as it is not possible to adjust the dose appropriately for this form of the medicine.

Allefin Allergy with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Allefin Allergy with food, drink, and alcohol

Be cautious when taking Allefin Allergy with alcohol or other substances that affect brain function.
In sensitive patients, taking Allefin Allergy with alcohol or other substances that affect brain function may cause additional drowsiness and impaired reaction.
Allefin Allergy can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Some patients taking Allefin Allergy may experience drowsiness, fatigue, and exhaustion. Be cautious when driving or operating machinery until you know how the medicine affects you.
However, special tests conducted with healthy individuals after taking levocetirizine at the recommended dose did not show an effect on attention, reaction, or driving ability.

Allefin Allergy contains lactose

If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Allefin Allergy

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose of Allefin Allergy for adults, adolescents, and children from 6 years of age is 1 tablet per day.

Dosing in special patient groups:

Kidney and liver problems
Patients with kidney problems may need to reduce the dose of Allefin Allergy depending on the severity of the kidney disease; in children, the dose should also be adjusted according to body weight; the dose will be determined by the doctor.
Patient with severe kidney problems should not take Allefin Allergy.
Patients with liver problems only should take the usual recommended dose of Allefin Allergy.
Patients with both liver and kidney problems may need to take a lower dose depending on the severity of the kidney disease; in children, the dose should also be adjusted according to body weight; the dose will be determined by the doctor.
Patients over 65 years of age
For patients over 65 years of age, there is no need to adjust the dose if kidney function is normal.

Use in children

It is not recommended to give Allefin Allergy tablets to children under 6 years of age.

How and when to take Allefin Allergy

The medicine is for oral use only.
Swallow the tablets whole with water. The medicine can be taken with or without food.

How long to take Allefin Allergy

Do not take the medicine for more than 10 days without consulting your doctor.
If after 3 days there is no improvement or you feel worse, consult your doctor.

Taking more than the recommended dose of Allefin Allergy

In adults, if a higher dose of Allefin Allergy is taken than recommended, drowsiness may occur. In children, initial excitement and restlessness, especially motor, and then drowsiness may occur.
If you suspect that you have taken more than the recommended dose of Allefin Allergy, consult your doctor, who will decide what actions should be taken.

Missing a dose of Allefin Allergy

If you miss a dose of Allefin Allergy or take a lower dose than recommended by your doctor, do not take a double dose to make up for the missed dose. Take the next dose at the usual time.

Stopping Allefin Allergy

Stopping the medicine should not cause any harm. However, in rare cases, itching (intense itching) may occur after stopping Allefin Allergy, even if these symptoms did not occur before starting treatment. These symptoms may resolve on their own. In some cases, these symptoms may be intense and may require restarting treatment. These symptoms should resolve after restarting treatment.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Allefin Allergy can cause side effects, although not everybody gets them.
In case of the first symptoms of hypersensitivity, stop taking Allefin Allergy and inform your doctor. Hypersensitivity symptoms may include: swelling of the lips, tongue, face, and (or) throat, difficulty breathing or swallowing (tightness in the chest or wheezing), urticaria, sudden drop in blood pressure leading to fainting or shock, which can lead to death (frequency not known).
Common (may affect up to 1 in 10 people): Dry mouth, headache, fatigue, and drowsiness/drowsiness.
Uncommon (may affect up to 1 in 100 people): Feeling of exhaustion and abdominal pain.
Frequency not known (cannot be estimated from the available data): Other side effects have also been reported, such as: palpitations, increased heart rate, seizures, tingling, dizziness, fainting, tremors, taste disorders (altered taste), feeling of spinning or swaying, vision disorders, blurred vision, rotational eye movements (uncontrolled circular eye movement), painful or difficult urination, inability to completely empty the bladder, swelling, itching, rash, urticaria (swelling, redness, and itching of the skin), skin eruptions, shortness of breath, weight gain, muscle pain, joint pain, excitement and aggressive behavior, hallucinations, depression, insomnia, recurring suicidal thoughts or interest in suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea.
Itching (intense itching) after stopping Allefin Allergy.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, inform 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
phone: 22 49 21 301, fax: 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 medicine.

5. How to store Allefin Allergy

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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 Allefin Allergy contains

• The active substance is levocetirizine dihydrochloride. Each coated tablet contains 5 mg of levocetirizine dihydrochloride.
• The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, and Opadry II White 85F18422: polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc.

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What Allefin Allergy looks like and contents of the pack

The medicine is in the form of white, round, biconvex coated tablets with a diameter of about 6 mm.
One pack of Allefin Allergy contains 7, 10, or 20 coated tablets in blisters in a cardboard box.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine information
phone: 22 742 00 22
e-mail: [email protected]

Date of last revision of the package leaflet: 10/2024

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