Loratadine galena

Patient Information Leaflet

LORATADINE GALENA
10 mg, tablets
Loratadine
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of Contents

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

1. What Loratadine Galena is and what it is used for

Loratadine Galena is an antiallergic medicine.
Loratadine Galena is indicated for the relief of symptoms such as sneezing, watery nasal discharge, nasal itching, and itchy, burning eyes caused by seasonal and perennial allergic rhinitis.
Loratadine Galena is also indicated for the relief of symptoms of chronic idiopathic urticaria (itching, skin redness).

2. Information before taking Loratadyna Galena

When not to take Loratadyna Galena

• if the patient is allergic to loratadine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Loratadyna Galena, discuss it with your doctor.
Exercise particular caution in patients with impaired liver function (see section 3. "How to take Loratadyna Galena").
Consult your doctor, even if the above warnings refer to conditions that occurred in the past.
You should stop taking this medicine approximately 48 hours before undergoing skin tests, as loratadine may cause false-negative results in such tests (this medicine may reduce or completely suppress the skin reaction which would normally be positive).

Children
The safety of use has not been established; therefore, Loratadyna Galena should not be used in children under 2 years of age.

Use of Loratadyna Galena in patients with renal and/or hepatic impairment
In patients with severe liver impairment, a lower initial dose should be used (see section 3. "How to take Loratadyna Galena").
Dose adjustment is not required in patients with renal impairment.

Use of Loratadyna Galena in elderly patients
No dose adjustment is necessary in elderly patients.

Loratadyna Galena and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Concomitant use of loratadine with cimetidine, erythromycin, or ketoconazole increases blood concentrations of loratadine; therefore, caution should be exercised when using these medicines together.
Concomitant use of loratadine with certain medicines affecting liver metabolism, such as inhibitors of CYP3A4 or CYP2D6, increases loratadine blood levels, which may lead to an increased risk of adverse effects.

Loratadyna Galena with food, drink, or alcohol
Loratadyna Galena may be taken regardless of meals.
Alcohol does not enhance the effects of loratadine; however, alcohol consumption should be avoided during treatment.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Use of Loratadyna Galena should be avoided during pregnancy.
Since loratadine passes into breast milk, it should not be used in breastfeeding women.
There are no data available on the effect of Loratadyna Galena on fertility.

Driving and operating machinery
In clinical studies, loratadine had no effect or only negligible effect on the ability to drive and operate machinery. However, during treatment, some individuals may experience drowsiness, which could impair the ability to drive and operate machinery.
Therefore, caution should be exercised when using this medicine.

3. How to use Loratadyna Galena

This medicine should always be taken as recommended by the doctor. In case of doubts, consult
your doctor.
The tablet may be divided into halves.
Recommended dose
Children and adolescents
For children aged 2 to 12 years, the dose should be based on body weight:

In children over 12 years of age: 10 mg (1 tablet) once daily.
The safety and efficacy of the medicinal product have not been established in children under 2 years of age.
Adults
10 mg (1 tablet) once daily.
Elderly patients
Dose adjustment is not required in elderly patients.
Patients with renal impairment
Dose adjustment is not required in patients with renal impairment.
Patients with hepatic impairment
Dose reduction may be necessary in patients with severe hepatic impairment. The appropriate dosage should be determined by a physician.
Method of administration
Oral administration.
The product may be taken regardless of meals.
If you feel that the effect of Loratadyna Galena is too strong or too weak, consult your doctor.
Overdose of Loratadyna Galena
Following ingestion of a dose higher than recommended, somnolence, tachycardia, and headache have been reported.
In case of ingestion of a dose higher than recommended, seek immediate medical advice.
There are no data indicating that loratadine poses a risk of abuse or dependence.
Missed dose of Loratadyna Galena
Do not take a double dose to make up for a missed dose.
Discontinuation of Loratadyna Galena
If you have any further questions about the use of this medicinal product, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The frequency of the possible adverse reactions listed below is defined as follows:

• often (occur less frequently than in 1 out of 10 people);
• uncommon (occur less frequently than in 1 out of 100 people);
• very rare (occur less frequently than in 1 out of 10,000 people);
• frequency not known (frequency cannot be estimated from the available data).

Often:

• headache, nervousness and fatigue (in children aged 2 to 12 years),
• drowsiness (in adults and adolescents).

Uncommon:

• headache, increased appetite and sleep disturbances (in adults and adolescents).

Very rare:

• severe allergic reaction (including breathing difficulties, wheezing, itching, hives, swelling). If any of these symptoms occur, immediately discontinue use of the medicine and contact a doctor or go to the nearest hospital.
• dizziness,
• seizures,
• increased heart rate, palpitations,
• nausea, dry mouth, gastric mucosal inflammation,
• liver function abnormalities,
• rash, hair loss,
• fatigue.

Frequency not known:

• weight gain.

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 this medicine.

5. How to store Loratadyna Galena

Keep this medicine out of sight and reach of children.
There are no special requirements for the storage of this medicine.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Loratadyna Galena contains

• The active substance is loratadine. Each tablet contains 10 mg of loratadine.
• Other ingredients are: microcrystalline cellulose, maize starch gelatinised, magnesium stearate.

What Loratadyna Galena looks like and contents of the pack
Loratadyna Galena tablets are white, round, flat, with bevelled edges, a division line and the embossed number "10" on one side.
Packaging: aluminium/PVC/PVDC foil blisters in a cardboard box.
Pack size: 30, 60 or 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Farmaceutyczna Spółdzielnia Pracy "GALENA"
Dożynkowa Street 10
52-311 Wrocław
Poland
Tel.: + 48 71 710 62 01