Package leaflet: Information for the patient

LORATAN, 10 mg, soft capsules
Loratadinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet for future reference.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual only. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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 antiallergic medicine that does not cause drowsiness.
During an allergic reaction, various substances (so-called mediators) are released, leading to the development of allergic symptoms. One of the most important mediators is histamine. Loratan, as an antihistamine medicine, blocks the effects of histamine, thereby exerting an antiallergic action. 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, eye itching, burning sensation, and tearing) 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 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).
If allergic skin tests are planned, treatment with Loratan should be discontinued approximately 48 hours before the scheduled skin testing, as it may cause false negative results.

Loratan and other medicines
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
Concomitant administration of loratadine with ketoconazole (used for fungal infections), erythromycin (used for bacterial infections), or cimetidine (used for peptic ulcer disease) increases blood concentration of loratadine, but without clinically significant changes (including changes in electrocardiographic recordings - ECG).
No significant interactions of loratadine with other concurrently administered medicines are known.

Loratan with food, drink, or alcohol
Taking the medicine with food may slightly delay absorption of loratadine, but does not affect its efficacy.
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 or 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 data on safety, Loratan should not be used during pregnancy.
Loratadine passes into breast milk; therefore, use of Loratan is not recommended during breastfeeding.

Driving and operating machinery
In some individuals, somnolence may very rarely occur, which may impair the ability to drive or operate machinery.

Loratan contains 70.2 mg of sorbitol per capsule
Loratan contains cochineal red and patent blue
The medicine may cause allergic reactions.

3. How to use Loratan

This medicine should always be used exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The medicine should be taken orally. The capsule should be swallowed whole.
Loratan may be taken regardless of meals.
The usual recommended dose is:
Adults and children over 6 years of age weighing more than 30 kg – 1 capsule (10 mg) once daily.
The use of Loratan in capsule form (10 mg) is not recommended in children weighing less than 30 kg.
In patients with severe hepatic impairment, a reduced initial dose should be used, as loratadine clearance may be reduced in these patients. In such cases, 10 mg of loratadine (1 capsule) should be taken every other day.
Dose adjustment is not necessary 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, tachycardia, and headache.
In case of overdose, symptomatic and supportive treatment should be initiated immediately and continued as long as necessary. Activated charcoal in aqueous suspension may be administered. The physician 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 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine may cause adverse effects, although not everyone will experience them.

Common adverse effects (in 1 to 10 patients out of 100):

headache, nervousness, drowsiness, fatigue.

Uncommon adverse effects (in 1 to 10 patients out of 1,000):

insomnia,
increased appetite.

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

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

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

weight gain.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects may also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Loratan

Keep in the original packaging, at a temperature not exceeding 25°C.
The medicine should be stored out of 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Loratan contains

The active substance is loratadine. One capsule contains 10 mg of loratadine.
The other ingredients (excipients) are: macrogol 400, glycerol, hydrochloric acid, purified water; capsule shell composition: gelatin, partially dehydrated liquid sorbitol, carmine red (E 124), patent blue (E 131), purified water.

What Loratan looks like and contents of the pack
Soft, oval, dark blue capsules with a smooth, glossy surface.
One pack of the medicine contains 15 or 30 capsules.

Marketing Authorisation Holder and Manufacturer
HASCO-LEK S.A. PHARMACEUTICAL PRODUCTION COMPANY
51-131 Wrocław, Żmigrodzka 242 E
Medicine Information
tel.: 22 742 00 22
e-mail: [email protected]