Alergimed

Package Leaflet: Information for the Patient

Alergimed, 5 mg, Film-Coated Tablets

Levocetirizine Dihydrochloride

Read the Package 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 only. 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 any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Alergimed and What is it Used For
• 2. Important Information Before Taking Alergimed
• 3. How to Take Alergimed
• 4. Possible Side Effects
• 5. How to Store Alergimed
• 6. Contents of the Pack and Other Information

1. What is Alergimed and What is it Used For

The active substance of Alergimed is levocetirizine dihydrochloride.
Alergimed is an antiallergic medication.
Alergimed is used to treat symptoms associated with:

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

Alergimed is indicated for adults, adolescents, and children aged 6 years and above.

2. Important Information Before Taking Alergimed

When Not to Take Alergimed:

Warnings and Precautions

Before taking Alergimed, discuss it with your doctor or pharmacist.
If you have problems with emptying your bladder (due to conditions such as spinal cord injury or prostate enlargement), consult your doctor.
If you have epilepsy or are prone to seizures, consult your doctor, as taking Alergimed may increase the frequency of seizures.
If an allergy test is planned, ask your doctor whether you should stop taking Alergimed a few days before the test. This medicine may affect the results of allergy tests.

Children

Alergimed is not recommended for children under 6 years of age, as the film-coated tablets do not allow for appropriate dose adjustment.

Alergimed and Other Medicines

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

Alergimed with Alcohol

Caution is advised when taking Alergimed with alcohol or other substances that affect brain function. In sensitive patients, taking Alergimed with alcohol or other substances that affect brain function may cause additional decreased alertness and reaction ability.

Pregnancy and Breastfeeding

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

Driving and Using Machines

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

Alergimed Contains Lactose

This medicine contains lactose. If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

3. How to Take Alergimed

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
The recommended dose of Alergimed is one tablet per day for adults, adolescents, and children aged 6 years and above.

Recommendations for Special Patient Groups:

Kidney and Liver Impairment
The dose of Alergimed may be reduced in patients with kidney impairment, depending on the severity of the kidney disease, and in children, the dose will be adjusted according to body weight; the dose will be determined by the doctor.
Patients with severe kidney disease requiring dialysis should not take Alergimed.
Patients with liver impairment only should take the usual recommended dose.
In patients with both liver and kidney impairment, a lower dose may be necessary, depending on the severity of the kidney disease. In children, the dose will be adjusted according to body weight; the dose will be determined by the doctor.
Patient Over 65 Years
No dose adjustment is necessary for elderly patients, provided their kidney function is normal.
Use in Children
Alergimed is not recommended for children under 6 years of age.

When and How to Take Alergimed?

This medicine is for oral use only.
Swallow the tablet whole with water. Alergimed can be taken with or without food.

How Long to Take Alergimed?

The duration of treatment depends on the type, duration, and severity of the disease symptoms and is determined by the doctor.

Overdose of Alergimed

In case of overdose, adults may experience drowsiness. In children, initial excitement and restlessness may occur, followed by drowsiness.
If you suspect an overdose of Alergimed, consult your doctor, who will decide what actions should be taken.

Missed Dose of Alergimed

If you miss a dose of Alergimed or take a lower dose than recommended by your doctor, do not take a double dose to make up for the missed dose. Instead, take the next dose at the usual time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Alergimed can cause side effects, although not everybody gets them.
Common(may affect up to 1 in 10 people)
Dry mouth, headache, fatigue, and drowsiness or somnolence.
Uncommon(may affect up to 1 in 100 people)
Feeling of tiredness and abdominal pain.
Frequency Not Known(frequency cannot be estimated from the available data)
Other side effects, such as: palpitations, rapid heartbeat, seizures, paresthesia, dizziness, fainting, tremor, taste disturbances (taste disorders), feeling of spinning or movement, vision disturbances, blurred vision, eye rotation (uncontrolled rotary eye movements), painful or difficult urination, inability to empty the bladder completely, edema, itching (pruritus), rash, urticaria (hives, redness, and itching of the skin), skin eruptions, dyspnea, weight gain, muscle pain, joint pain, aggressive behavior or agitation, hallucinations, depression, insomnia, recurrent suicidal thoughts or interest in suicide, nightmares, hepatitis, liver function disorders, vomiting, increased appetite, nausea, and diarrhea have also been reported.
Itching (intense pruritus) after discontinuation of the medicine.
If you notice the first symptoms of hypersensitivity reaction, stop taking Alergimed and seek medical attention immediately. Symptoms of hypersensitivity reaction may include: swelling of the mouth, tongue, face, and (or) throat, difficulty breathing or swallowing (chest tightness or wheezing), urticaria, sudden decrease in blood pressure leading to fainting or shock, which can be life-threatening.

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 this medicine.

5. How to Store Alergimed

Keep this medicine out of the sight and reach of children.
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 that month.
There are no special storage instructions for this medicine.
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 Alergimed Contains

• The active substance is levocetirizine dihydrochloride. Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride.
• The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, silicon dioxide, magnesium stearate (E 572). Tablet coating: Opadry White YS-1-7003 (titanium dioxide (E 171), hypromellose (E
• 464), macrogol 400, and polysorbate 80).

What Alergimed Looks Like and Contents of the Pack

White, round, biconvex film-coated tablets with a score line, with the marking "161" on one side and "H" on the other side.
The score line is not intended for breaking the tablet.
The tablets are provided in aluminum/OPA/aluminum/PVC blisters in a cardboard box.
Pack sizes: 1, 2, 4, 5, 7, 10, 14, 15, 20, 21, 28, 30, 40, 50, 56, 60, 70, 80, 90, 98, 100, 112, and 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Importer

Marketing Authorization Holder:

Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Importer:

Saneca Pharmaceuticals a. s.
Nitrianska 100
920 27 Hlohovec
Slovakia
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Medis International a.s.
Průmyslová 961/16
747 23 Bolatice
Czech Republic

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Czech Republic:
Alergimed
Poland:
Alergimed
Slovakia:
Alergimed

Date of Last Revision of the Leaflet: 11/2024