Patient Information Leaflet

LORATAN pro, 10 mg, soft capsules
Loratadine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 10 days, or if you feel worse, you should contact your doctor.

Leaflet Contents

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

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

Loratan pro, 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 pro, as an antihistamine, blocks the activity of histamine and thus exerts 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, watery nasal discharge, itching of the nose, 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 pro

When not to use Loratan pro:

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

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

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Loratan pro with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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 the blood concentration of loratadine, but without clinically significant changes (including changes in electrocardiographic recording - ECG).
No clinically significant interactions of loratadine with other concurrently administered medicines are known.
Loratan pro with food, drink or alcohol
Taking the medicine with food may slightly delay the absorption of loratadine, but does not affect its efficacy.
The medicine can be taken regardless of meals.
Loratadine administered together with alcohol does not enhance alcohol's effects to a degree detectable in psychomotor tests.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Due to insufficient safety data, Loratan pro should not be used during pregnancy.
Loratadine passes into breast milk; therefore, the use of Loratan pro is not recommended during breastfeeding.
Driving and operating machinery
Very rarely, somnolence may occur in some individuals, which may impair the ability to drive or operate machinery.
Loratan pro contains 70.2 mg of sorbitol in each capsule
Loratan pro contains carmine red and patent blue
The medicine may cause allergic reactions.

3. How to use Loratan pro

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine should be taken orally.
Loratan pro can be taken regardless of meals. The capsule should be swallowed whole.
The usual dose is:
Adults and children over 12 years of age – 1 capsule (10 mg) once daily.
Children aged 6 to 12 years, with body weight above 30 kg – 1 capsule (10 mg) once daily.
The use of capsules (10 mg) is not recommended in children with body weight below 30 kg.
Treatment with loratadine without a doctor's recommendation should not exceed 10 days.
In patients with severe hepatic impairment, a lower 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 administered every other day. Consult a doctor before using the medicine.
There is no need to adjust the dose in elderly patients or in patients with renal impairment.
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Taking more Loratan pro than recommended
If more medicine has been taken than recommended, 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 started immediately and continued as long as necessary. Activated charcoal may be administered as an aqueous suspension. A 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 intensive treatment, continued observation of the patient is necessary.
Missing a dose of Loratan pro
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 reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everybody will experience them.

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

headache, nervousness, drowsiness, fatigue.

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

insomnia,
increased appetite.

Very rare adverse reactions (occurring in less than 1 patient out of 10,000):

dizziness,
increased heart rate (tachycardia) and palpitations,
nausea,
dry mouth,
gastric mucosal inflammation,
liver function disorders,
rash,
alopecia (hair loss),
symptoms of severe allergic reaction (facial swelling, swelling of lips, oral cavity or throat, shortness of breath, itching, urticaria). If any of these symptoms occur, treatment should be discontinued immediately and medical advice should be sought 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.
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Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Loratan pro

Store in the original packaging at a temperature below 25°C.
Keep the medicine 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 must 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 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 composition: gelatin, partially dehydrated liquid sorbitol, carmine red (E 124), patent blue (E 131), purified water.

What Loratan pro looks like and contents of the pack
Soft, oval, dark blue capsules with a smooth, glossy surface.
One pack contains 2, 7 or 10 capsules.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicinal product information
tel.: 22 742 00 22
e-mail: [email protected]
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