Loratadina Pilox

Package Leaflet: Information for the Patient

LORATADYNA PYLOX

10 mg, tablets

Loratadine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

Take this medicine always exactly as described in this package leaflet for the patient or as directed by your doctor or pharmacist.

• Keep this 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 leaflet, tell your doctor or pharmacist. See section 4.
• If after 10 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet

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

1. What is Loratadyna Pylox and what is it used for

Loratadyna Pylox is an antihistamine.
Loratadyna Pylox is indicated for the relief of symptoms such as: sneezing, itching,
runny nose, swelling of the mucous membranes, itching and burning of the eyes, caused by
seasonal and perennial allergic rhinitis. Loratadyna Pylox is also indicated for the relief of symptoms of
chronic idiopathic urticaria (itching, skin redness).
Loratadyna Pylox, when taken as directed, does not impair psychomotor performance, does not have a sedative effect, and does not cause drowsiness.

2. Important information before taking Loratadyna Pylox

When not to take Loratadyna Pylox

• if you are allergic to loratadine or any of the other ingredients of this medicine (listed in section 6),
• in children under 2 years of age.

Warnings and precautions

Before taking Loratadyna Pylox, discuss it with your doctor or pharmacist:

• if you have severe liver impairment (see section 3. How to take Loratadyna Pylox).

Treatment should be discontinued about 48 hours before the scheduled skin tests, as loratadine may cause false-negative results of these tests (this medicine may reduce or completely inhibit the skin reaction that would normally be positive).

Children

Loratadine is contraindicated in children under 2 years of age. Administration in children from 2 years of age (see section 3).

Use in patients with liver and/or kidney disorders

In patients with severe liver impairment, a lower initial dose should be used, as the clearance of loratadine may be reduced in these patients. In adult patients and children with a body weight of more than 30 kg with severe liver impairment, it is recommended to start treatment with a dose of 10 mg (1 tablet) every other day, and in children with a body weight of 30 kg or less - 5 mg (in children over 6 years old - half a tablet; in children from 2 to 6 years old - in the form of syrup) every other day.
No dose adjustment is required in patients with renal impairment.

Use in elderly patients

No dose adjustment is required in elderly patients.

Loratadyna Pylox and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
Caution should be exercised when taking loratadine with erythromycin, ketoconazole, and cimetidine, as this may increase the concentration of loratadine in the blood.
Concomitant administration of loratadine with certain medicines that affect liver metabolism, such as CYP3A4 or CYP2D6 inhibitors, increases the concentration of loratadine in the blood, which may cause an increase in side effects.

Loratadyna Pylox with food, drink, and alcohol

The medicine can be taken independently of meals.
Alcohol does not enhance the effect of loratadine; however, during treatment, you should not consume alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Avoid taking Loratadyna Pylox during pregnancy.
Since loratadine passes into breast milk, its use is not recommended in breastfeeding women.
There are no data on the effect of Loratadyna Pylox on fertility.

Driving and using machines

In clinical trials, loratadine had no effect or an insignificant effect on the ability to drive vehicles and operate machinery. During treatment, very rarely, some people may experience drowsiness, which may impair the ability to drive vehicles and operate machinery. Therefore, caution should be exercised during treatment.

3. How to take Loratadyna Pylox

Take this medicine always exactly as described in this package leaflet for the patient or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Recommended dose

Children and adolescents
In children from 2 to 12 years of age, the dose depends on body weight:

In children over 12 years of age: 10 mg (1 tablet) once a day.
The safety and efficacy of the medicine in children under 2 years of age have not been established.
Adults
10 mg (1 tablet) once a day.
Elderly patients
No dose adjustment is required in elderly patients.
Patients with renal impairment
No dose adjustment is required in patients with renal impairment.
Patients with liver impairment
In patients with severe liver impairment, a lower initial dose should be used, as the clearance of loratadine may be reduced in these patients. In adult patients and children with a body weight of more than 30 kg with severe liver impairment, it is recommended to start treatment with a dose of 10 mg (1 tablet) every other day, and in children with a body weight of 30 kg or less - 5 mg (in children over 6 years old - half a tablet; in children from 2 to 6 years old - in the form of syrup) every other day.
If you feel that the effect of Loratadyna Pylox is too strong or too weak, consult your doctor.
If after 10 days there is no improvement or you feel worse, contact your doctor.

Method of administration

Oral administration.
The medicine can be taken independently of meals.
The tablet can be divided into halves.

Taking a higher dose of Loratadyna Pylox than recommended

In case of taking a higher dose than recommended, consult your doctor or pharmacist immediately.
High doses of loratadine may cause drowsiness, tachycardia (increased heart rate), and headaches. Symptomatic and supportive treatment is recommended, e.g., administration of activated charcoal, induction of vomiting, gastric lavage. Hemodialysis does not remove loratadine from the body.
There are no data indicating that loratadine causes a risk of abuse or dependence.

Missing a dose of Loratadyna Pylox

In case of missing a dose, take it as soon as possible. If it is already time for the next dose, do not take the missed dose. Do not take a double dose to make up for the missed dose.

Stopping treatment with Loratadyna Pylox

In case of any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined as follows:

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

Often:

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

Uncommon:

• headache, increased appetite, and sleep disorders in adults and adolescents.

Very rare:

• severe allergic reaction (including difficulty breathing, wheezing, itching, hives, swelling). If you experience any of these symptoms, immediatelystop taking the medicine and contact your doctor or go to the nearest hospital.
• dizziness, seizures,
• increased heart rate, palpitations,
• nausea, dry mouth, gastritis,
• abnormal liver function,
• rash, hair loss,
• fatigue.

Frequency not known:

• weight gain.

If any of the side effects get worse or if you experience any side effects not listed in this leaflet, tell your doctor or pharmacist.

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 Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje 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 medicine.

5. How to store Loratadyna Pylox

There are no special precautions for storage.
Keep the medicine out of the sight and reach of children.
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 Loratadyna Pylox contains

• The active substance is loratadine. One tablet contains 10 mg of loratadine.
• The other ingredients are: microcrystalline cellulose, corn starch, magnesium stearate.

What Loratadyna Pylox looks like and contents of the pack

Loratadyna Pylox is available in the form of white, round, flat tablets with a broken edge, with a dividing line and the number "10" embossed on one side.
Available packaging:
Blister packs of aluminum/PVC/PVDC in a cardboard box.
Pack size: 10 tablets.

Marketing authorization holder and manufacturer

Pharmaceutical Cooperative "GALENA"
Dożynkowa 10 Street
52-311 Wrocław
Poland
Phone: +48 71 710 62 01
Date of last revision of the leaflet:02.06.2023