Loratan pro

Package Leaflet: Information for the Patient

LORATAN pro, 10 mg, Soft Capsules

Loratadine

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

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including any 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, consult a doctor.

Table of Contents of the Leaflet

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

1. What is Loratan pro and what is it used for

Loratan pro contains loratadine, an antiallergic medication 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 pro, as an antihistamine, inhibits the activity of histamine, thus exerting an antiallergic effect. Loratan pro 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 nasal discharge, 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 taking Loratan pro

When not to take Loratan pro:

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

Warnings and precautions

Before taking Loratan pro, discuss it with your doctor or pharmacist.

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

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Loratan pro and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Concomitant administration of loratadine with ketoconazole (used in fungal infections), erythromycin (used in bacterial infections), or cimetidine (used in peptic ulcer disease) increases the concentration of loratadine in the blood, but without significant clinical changes (including changes in the electrocardiogram - ECG).
No significant interactions of loratadine with other concomitantly administered medicines are known.

Loratan pro 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 taken 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 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 safety, Loratan pro should not be used during pregnancy.
Loratadine passes into breast milk, so it is not recommended to take Loratan pro 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 pro contains 70.2 mg of sorbitol in each capsule

Loratan pro contains cochineal red and patent blue

The medicine may cause allergic reactions.

3. How to take Loratan pro

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist. If you have any doubts, consult a doctor or pharmacist.
The medicine should be taken orally.
Loratan pro can be taken independently of meals. The capsule should be swallowed whole.
Usually, the recommended dose is:
Adults and children over 12 years - 1 capsule (10 mg) once a day.
Children from 6 to 12 years, with a body weight over 30 kg - 1 capsule (10 mg) once a day.
It is not recommended to use capsules (10 mg) in children with a body weight less than 30 kg.
Treatment with loratadine without a doctor's recommendation should not exceed 10 days.
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 administered every other day. Before taking the medicine, consult a doctor.
No dose adjustment is needed in elderly patients and patients with renal impairment.
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Overdose of Loratan pro

In case of overdose, consult a 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 the end of intensive treatment, further observation of the patient is necessary.

Missed dose of Loratan pro

Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

• headache, nervousness, drowsiness, fatigue.

Uncommon side effects(in 1 to 10 patients out of 1000):

• insomnia,
• increased appetite.

Rare side effects(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,
• symptoms of severe allergic reaction (face, lip, mouth, throat, and tongue swelling, difficulty breathing, itching, hives). If you experience any of these symptoms, stop taking the medicine and consult a 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, 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.
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Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Loratan pro

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 pro 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: gelatin, partially dehydrated liquid sorbitol, cochineal red (E 124), patent blue (E 131), purified water.

What Loratan pro looks like and contents of the pack

Soft capsules, oval, dark blue, with a smooth, shiny surface.
One pack of the medicine contains 2, 7, or 10 capsules.

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: informacjaoleku@hasco-lek.pl

Date of the last update of the leaflet:

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