Loratan

Package Leaflet: Information for the Patient

LORATAN, 5 mg/5 ml, Syrup

Loratadine

Read the package leaflet carefully before using 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 using Loratan
• 3. How to use Loratan
• 4. Possible side effects
• 5. How to store Loratan
• 6. Package contents 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 accompanying typical skin changes).

2. Important information before using Loratan

When not to use Loratan:

• in pregnant women.

Warnings and precautions

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

Loratan 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.
Concomitant administration of loratadine with ketoconazole, erythromycin, or cimetidine increases the concentration of loratadine in the blood, but without significant clinical changes (including changes in the electrocardiogram).
No significant interactions between loratadine and other concomitantly administered medicines have been documented in clinical studies.

Loratan with food, drink, or alcohol

Concomitant intake of the medicine with food may slightly delay the absorption of loratadine, but it does not affect its action. The medicine can be taken independently of meals.
Loratadine administered concomitantly with alcohol does not enhance its effects to a degree that can be assessed in psychomotor tests.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using 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, therefore, it is not recommended to use Loratan during breastfeeding.

Driving and using machines

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

Loratan contains sucrose

5 ml of syrup contains 3.125 g of sucrose. This should be taken into account in patients with diabetes.
If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the 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 as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
The medicine should be taken orally. It can be taken independently of meals.
A measuring cup is attached to the package to measure the correct amount of syrup.
Adults and children over 12 years: 10 mg of loratadine (10 ml of syrup) once a day.
Children from 2 to 12 years:

• children with a body weight over 30 kg - 10 mg of loratadine (10 ml of syrup) once a day,
• children with a body weight of 30 kg or less - 5 mg of loratadine (5 ml of syrup) once a day.

In patients with severe liver impairment:

• adults and children with a body weight over 30 kg - 10 mg of loratadine (10 ml of syrup) every other day,
• children with a body weight below 30 kg - 5 mg of loratadine (5 ml of syrup) every other day.

No dose adjustment is needed in elderly patients and patients with renal impairment.

Taking a higher dose of Loratan than recommended

If you have taken more than the recommended dose, contact your doctor or pharmacist immediately.
The main symptoms of overdose are: drowsiness, increased heart rate, and headache.
In case of overdose, symptomatic and supportive treatment should be applied immediately and continued as long as necessary. Activated charcoal can be administered 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.

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 using this medicine, ask your doctor.

4. Possible side effects

Like all medicines, Loratan can cause side effects, although not everybody gets them.
Common side effects(in 1 to 10 patients out of 100):

• headache,
• nervousness,
• drowsiness,
• fatigue.

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

• insomnia,
• increased appetite.

Rare side effects(in less than 1 patient out of 10,000):

• dizziness,
• rapid heart rate (tachycardia) and palpitations,
• nausea,
• dry mouth,
• gastritis,
• liver function disorders,
• rash,
• hair loss,
• severe allergic reaction symptoms (face, lip, mouth, throat, and tongue swelling, difficulty breathing, itching, hives). If any of these symptoms occur, stop using 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 Monitoring of Adverse Reactions to Medicinal Products 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 the 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 carton. 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. Package contents 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 flavor, purified water.

What Loratan looks like and contents of the package

The package is a brown glass bottle with an aluminum cap with a ring, containing 125 ml of syrup. The bottle is placed in a cardboard box with a patient leaflet and a measuring cup or spoon for administering the medicine.

Marketing authorization holder and manufacturer

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

Information about the medicine

tel.: 22 742 00 22
e-mail: [email protected]

Date of last revision of the leaflet: