Alergimed
Poland
Table of Contents
Package leaflet: Information for the patient
Alergimed, 5 mg, coated tablets
Levocetirizini dihydrochloridum
Please read the entire leaflet carefully before taking 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
your doctor or pharmacist.
- Keep this leaflet, so you can read it again if necessary.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any adverse reactions 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, contact your doctor.
Table of contents
- What Alergimed is and what it is used for
- Important information before taking Alergimed
- How to take Alergimed
- Possible side effects
- How to store Alergimed
- Contents of the pack and other information
1. What Alergimed is and what it is used for
The active substance in Alergimed is levocetirizine dihydrochloride.
Alergimed is an antiallergic medicine.
Alergimed is used to treat symptoms associated with:
- allergic rhinitis (including perennial allergic rhinitis);
- urticaria.
Alergimed is indicated for adults, adolescents, and children aged 6 years and older.
2. Information before using Alergimed
When not to use Alergimed:
- if the patient is allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or other piperazine derivatives, or to any of the other ingredients of this medicine (listed in section 6).
- if the patient has severe kidney disease requiring dialysis.
Warnings and precautions
Before starting Alergimed, discuss it with your doctor or pharmacist.
If the patient has problems with emptying the bladder (due to conditions such as spinal cord injury or benign prostatic hyperplasia), medical advice should be sought.
If the patient suffers from epilepsy or is prone to seizures, consult a doctor, as use of Alergimed may increase the frequency of seizures.
If an allergy test is planned, ask the doctor whether it is necessary to discontinue Alergimed a few days before the scheduled test. This medicine may affect the results of allergy tests.
Children
Alergimed is not recommended for children under 6 years of age, as the coated tablets do not allow for appropriate dose adjustment.
Other medicines and Alergimed
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Alergimed and alcohol
Caution is advised when using Alergimed together with alcohol or other substances affecting brain function. In sensitive patients, concomitant use of Alergimed with alcohol or other substances affecting brain function may additionally reduce alertness and reaction ability.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Some patients taking Alergimed may experience drowsiness, somnolence, fatigue, and exhaustion. Caution should be exercised when driving and operating machinery until the patient knows how this medicine affects him or her. However, specific tests conducted in healthy volunteers after taking levocetirizine at the recommended dose did not show any effect of the drug on attention concentration, reaction ability, or driving ability.
Alergimed contains lactose
This medicine contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before using this medicine.
3. How to use Alergimed
This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The recommended dose of the medicine for adults, adolescents, and children aged 6 years and older is 1 tablet per day.
Dosage recommendations for special patient groups:
Renal and hepatic impairment
In patients with impaired kidney function, the dose may be reduced depending on the severity of kidney disease. In children, the dose will be adjusted according to body weight; the doctor will determine the appropriate dose.
Patients with severe kidney disease requiring dialysis must not take Alergimed.
Patients with liver function impairment alone should usually take the standard recommended dose.
In patients with both hepatic and renal impairment, a lower dose may be necessary depending on the severity of kidney disease. In children, the dose will be adjusted based on body weight; the doctor will determine the appropriate dose.
Patients aged 65 years and older
Dose adjustment in elderly patients is not required, provided that renal function is normal.
Use in children
Alergimed tablets are not recommended for children under 6 years of age.
When and how to take Alergimed
This medicine is for oral use only.
The tablet should be swallowed 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 should be determined by a doctor.
If there is no improvement after 3 days, or if symptoms worsen, consult a doctor. Do not use this medicine for longer than 10 days without consulting a doctor.
Taking more Alergimed than recommended
If an excessive amount of the medicine is taken, adults may experience drowsiness. In children, initial symptoms may include excitation and restlessness, followed by drowsiness.
If an overdose of Alergimed is suspected, consult a doctor, who will decide what actions should be taken.
Missed dose of Alergimed
If a dose of Alergimed is missed or a lower-than-recommended dose is taken, 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 about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Common (may occur in less than 1 in 10 patients):
Dry mouth, headache, fatigue, drowsiness or sedation.
Uncommon (may occur in less than 1 in 100 patients):
Feeling of exhaustion and abdominal pain.
Frequency unknown (frequency cannot be estimated from available data):
Other adverse reactions such as: palpitations, rapid heartbeat, convulsions, tingling sensations, dizziness, fainting, tremor, taste disturbances (disturbances in taste perception), sensation of spinning or movement, visual disturbances, blurred vision, nystagmus (involuntary circular eye movements), painful or difficult urination, inability to completely empty the urinary bladder, swelling, itching (pruritus), rash, urticaria (skin swelling, redness and itching), skin eruptions, shortness of breath, weight gain, muscle pain, joint pain, aggressive behavior or agitation, hallucinations, depression, insomnia, recurrent thoughts of suicide or suicidal ideation, nightmares, hepatitis, liver function disorders, vomiting, increased appetite, nausea and diarrhoea have also been reported.
Itching (intense pruritus) after discontinuation of the medicine.
If the first symptoms of a hypersensitivity reaction occur, treatment with Alergimed should be discontinued immediately and medical advice should be sought without delay. Symptoms of hypersensitivity may include: swelling of the lips, tongue, face and (or) throat, difficulty breathing or swallowing (chest tightness or wheezing), urticaria, sudden drop in blood pressure leading to circulatory collapse or shock, which may result in death.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 pack after: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
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 pack and other information
What Alergimed contains
- The active substance is levocetirizine dihydrochloride. Each coated tablet (tablet) contains 5 mg of levocetirizine dihydrochloride.
- Other ingredients are:
Tablet core: monohydrate lactose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate (E 572).
Tablet coating: Opadry White YS-1-7003 coating (titanium dioxide (E 171), hypromellose (E 464), polyethylene glycol 400 and polysorbate 80).
What Alergimed looks like and contents of the pack
White, round, biconvex coated tablets, smooth on both sides (tablet size is approximately 6.5 mm).
Tablets are supplied in blisters made of Alu-OPA/Alu/PVC foil, or transparent PVC/PVDC-Alu foil, or transparent PVC-Alu foil, packed in a cardboard box.
Pack sizes: 1, 2, 4, 5, 7, 10, 14, 15, 20 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Importer
Marketing Authorisation Holder:
Dr. Max Pharma 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
Medis International a.s.
Prumyslova 961/16
747 23 Bolatice
Czech Republic
This medicinal product is authorised in the European Economic Area under the following names:
Czech Republic: Alergimed
Poland: Alergimed
Slovakia: Alergimed