Patient Information Leaflet

LORATAN, 5 mg/5 ml, syrup
Loratadinum
Please read all of this leaflet carefully before taking this medicine, as it contains important
information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

What Loratan is and what it is used for
Important information before taking Loratan
How to take Loratan
Possible side effects
How to store Loratan
Contents of the pack and other information

1. What Loratan is and what it is used for

Loratan, containing loratadine, is an antihistamine medicine that does not cause drowsiness.
During an allergic reaction, various substances (so-called mediators) are released, causing the development of allergic symptoms. One of the most important mediators is histamine. Loratan, as an antihistamine agent, blocks the activity of histamine, thereby exerting an antiallergic effect. Loratan relieves symptoms caused by histamine during an allergic reaction: itching, redness, swelling, and nasal discharge.
The medicine is indicated for the treatment of symptoms of allergic rhinitis (such as sneezing, watery nasal discharge, nasal itching, itching of the palate, itching and burning sensation, and tearing eyes) and chronic idiopathic urticaria (such as itching and redness of the skin accompanied by typical skin lesions).

2. Important information before using Loratan

When not to use Loratan:

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

Warnings and precautions

In patients with severe hepatic impairment, a lower initial dose should be used (see section 3 "How to take Loratan").
If skin allergy tests are planned, treatment with Loratan should be discontinued approximately 48 hours before the scheduled tests, as it may cause false-negative test results.

Loratan and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Concomitant administration of loratadine with ketoconazole, erythromycin, or cimetidine increases blood concentration of loratadine, but without clinically significant changes (including changes in electrocardiographic recordings).
Clinical studies have not documented significant interactions between loratadine and other concurrently administered drugs.

Loratan with food and drink or alcohol
Taking the medicine with food may slightly delay absorption of loratadine, but does not affect its overall effect. The medicine can be taken regardless of meals.
Loratadine administered together with alcohol does not significantly enhance alcohol's effects, as measured in psychomotor performance tests.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Due to insufficient safety data, Loratan should not be used during pregnancy.
Loratadine passes into breast milk; therefore, the use of Loratan is not recommended during breastfeeding.

Driving and operating machinery
In rare cases, some individuals may experience drowsiness, which may impair the ability to drive or operate machinery.

Loratan contains sucrose
5 ml of syrup contains 3.125 g of sucrose. This should be taken into account in patients with diabetes.
If a patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Loratan contains propylene glycol and sodium benzoate
5 ml of syrup contains 250 mg of propylene glycol and 8.125 mg of sodium benzoate.

3. How to use Loratan

This medicine should always be used according to the doctor's instructions. In case of doubt, consult
your doctor or pharmacist.
The medicine should be taken orally. It can be taken regardless of meals.
A measuring device is attached to the package, enabling accurate measurement of the appropriate amount of syrup.
Adults and children over 12 years of age: 10 mg of loratadine (10 ml of syrup) once daily.
Children aged 2 to 12 years:

children weighing over 30 kg – 10 mg of loratadine (10 ml of syrup) once daily,
children weighing 30 kg or less – 5 mg of loratadine (5 ml of syrup) once daily.

For patients with severe hepatic impairment, the following dosage is recommended:

adults and children weighing over 30 kg – 10 mg of loratadine (10 ml of syrup) every other day,
children weighing below 30 kg – 5 mg of loratadine (5 ml of syrup) every other day.

There is no need to adjust the dose in elderly patients or in patients with renal impairment.
Taking more Loratan than recommended
If you take more medicine than recommended, seek immediate advice from your doctor or
pharmacist.
The main symptoms of overdose are: drowsiness, rapid heartbeat, and headache.
In case of overdose, symptomatic and supportive treatment should be started immediately and continued as long as necessary. Activated charcoal in aqueous suspension may be administered. The doctor may perform gastric lavage. Loratadine cannot be removed from the body by hemodialysis. It is not known whether it can be removed by peritoneal dialysis. After completion of intensive treatment, continued monitoring of the patient is required.
Missing a dose of Loratan
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone experiences them.

Common adverse reactions (occur in 1 to 10 patients in 100):

headache,
nervousness,
drowsiness,
fatigue.

Uncommon adverse reactions (occur in 1 to 10 patients in 1,000):

insomnia,
increased appetite.

Very rare adverse reactions (occur in less than 1 patient in 10,000):

dizziness,
increased heart rate (tachycardia) and palpitations,
nausea,
dry mouth,
gastric mucosal inflammation,
liver function disorders,
rash,
hair loss,
symptoms of severe allergic reaction (facial swelling, swelling of lips, oral cavity, or throat, shortness of breath, itching, urticaria). If any of the above symptoms occur, discontinue use of the medicine immediately and contact your doctor without delay.

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):

weight gain.

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
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported directly to the Marketing Authorisation Holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Loratan

Store in the original packaging, at a temperature not exceeding 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month indicated.
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 packaging and other information

What Loratan contains

The active substance is loratadine. 5 ml of syrup contains 5 mg of loratadine.
The other ingredients (excipients) are: propylene glycol, citric acid monohydrate, glycerol, sucrose, sodium benzoate, peach flavour, purified water.

What Loratan looks like and contents of the pack
The medicinal product is packed in a brown glass bottle with an aluminium cap and tamper-evident ring, containing 125 ml of syrup. The bottle is placed in a cardboard box together with the patient leaflet and a measuring device or dosing spoon.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Product information
tel.: 22 742 00 22
e-mail: [email protected]