Loratan

Package Leaflet: Information for the Patient

LORATAN, 10 mg, Soft Capsules

Loratadine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Loratan and what is it used for

Loratan contains loratadine, an antiallergic medicine that does not cause drowsiness.
During an allergic reaction, various substances (so-called mediators) are released, causing the development of allergy symptoms. One of the most important mediators is histamine. Loratan, as an antihistamine, inhibits the activity of histamine, thus showing 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, runny nose, nasal itching, palate itching, eye itching and burning, and tearing) and chronic idiopathic urticaria (such as skin itching and redness with typical skin changes).

2. Important information before taking Loratan

When not to take Loratan:

• if you are allergic to loratadine or any of the other ingredients of this medicine (listed in section 6);
• in pregnant women.

Warnings and precautions

• In case of severe liver impairment, a lower initial dose should be used (see section 3).
• In case skin allergy tests are planned, you should stop taking Loratan about 48 hours before the tests, as it may cause false negative results.

Loratan and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
Taking loratadine with ketoconazole (used for fungal infections), erythromycin (used for bacterial infections), or cimetidine (used for stomach ulcers) may increase the level of loratadine in the blood, but without significant clinical changes (including changes in the electrocardiogram - EKG).
No significant interactions between loratadine and other medicines are known.

Loratan with food, drink, or alcohol

Taking the medicine with food may slightly delay the absorption of loratadine, but it does not affect its action.
The medicine can be taken with or without food.
Loratadine taken with alcohol does not enhance its effects to a degree that can be measured in psychomotor tests.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Due to the lack of sufficient data on the safety of use, Loratan should not be used during pregnancy.
Loratadine passes into breast milk, so it is not recommended to take Loratan during breastfeeding.

Driving and using machines

In some people, drowsiness may occur, which may affect the ability to drive and use machines.

Loratan contains 70.2 mg of sorbitol in each capsule

Loratan contains cochineal red and patent blue

The medicine may cause allergic reactions.

3. How to take Loratan

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Take the medicine by mouth. Swallow the capsule whole.
Loratan can be taken with or without food.
The usual dose is:
Adults and children over 6 years of age with a body weight over 30 kg - 1 capsule (10 mg) once daily.
It is not recommended to use Loratan in the form of a capsule (10 mg) in children with a body weight less than 30 kg.
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 such cases, 10 mg of loratadine (1 capsule) should be taken every other day.
No dose adjustment is needed in elderly patients and patients with renal impairment.

Overdose of Loratan

If you take more than the recommended dose, contact your doctor or pharmacist immediately.
The main symptoms of overdose are: drowsiness, rapid heartbeat, and headache.
In case of overdose, symptomatic and supportive treatment should be applied immediately and continued as long as necessary. Activated charcoal can be given as a water suspension. The doctor may perform gastric lavage. Loratadine cannot be eliminated from the body by hemodialysis. It is not known whether it can be eliminated by peritoneal dialysis. After completing intensive treatment, further observation of the patient is necessary.

Missed dose of Loratan

Do not take a double dose to make up for a forgotten dose.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects(affecting 1 to 10 people in 100):

• headache, nervousness, drowsiness, fatigue.

Uncommon side effects(affecting 1 to 10 people in 1000):

• insomnia,
• increased appetite.

Rare side effects(affecting less than 1 person in 10,000):

• dizziness,
• rapid heartbeat (tachycardia) and palpitations,
• nausea,
• dry mouth,
• gastritis,
• liver function disorders,
• rash,
• hair loss,
• severe allergic reaction symptoms (face, lip, mouth, throat, or tongue swelling, difficulty breathing, itching, hives). If you experience any of these symptoms, stop taking the medicine and contact your doctor immediately.

Side effects of unknown frequency(frequency cannot be estimated from available data):

• weight gain.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please 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:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +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 this medicine.

5. How to store Loratan

Store in the original package, at a temperature below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the package. 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 Loratan contains

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

What Loratan looks like and contents of the pack

Soft capsules, oval, dark blue, with a smooth, shiny surface.
One pack of the medicine contains 15 or 30 capsules.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Medicine information

tel.: 22 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of last revision of the leaflet: