Nasometin alergia lora

Package leaflet: Information for the patient

Nasometin Alergia Lora, 10 mg, tablets
Loratadine
Please read all of 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 adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 10 days, you should contact your doctor.

Table of contents

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

1. What Nasometin Alergia Lora is and what it is used for

Nasometin Alergia Lora is an antiallergy medicine that relieves symptoms of allergic reactions.
Nasometin Alergia Lora is used to treat symptoms of allergic rhinitis, such as:
sneezing,
watery or runny nose or nasal itching,
itching of the palate,
itching, redness or watering of the eyes.
Nasometin Alergia Lora is also used to treat symptoms of chronic idiopathic urticaria (i.e. chronic urticaria of unknown cause), such as skin itching and hives.

2. Important information before using Nasometin Alergia Lora

When not to use Nasometin Alergia Lora:
if the patient is allergic to loratadine or to any of the other ingredients of this medicine
(listed in section 6).
Warnings and precautions
You should discuss this with your doctor or pharmacist if:
the medicine is being used for a long time;
after taking Nasometin Alergia Lora, allergy symptoms do not improve or even worsen;
the patient has been diagnosed with severe liver function disorders;
the patient is scheduled to undergo skin allergy tests. It is necessary to discontinue the use of the medicine
at least 2 days before the test in order to obtain reliable results. After the test, the medicine may be taken again as before.
Children
This medicine should not be used in children under 6 years of age or in children weighing less than
30 kg.
Nasometin Alergia Lora and other medicines
If the patient is taking or has recently taken any of the following medicines, they should consult a
doctor before using Nasometin Alergia Lora:
cimetidine (a medicine used to reduce gastric acid secretion);
ketoconazole or fluconazole (medicines used to treat fungal infections);
erythromycin (an antibiotic);
fluoxetine (a medicine used in the treatment of certain psychiatric disorders).
Nasometin Alergia Lora with food, drink and alcohol
This medicine can be taken regardless of meals.
The tablet should be swallowed whole, without chewing, with liquid.
Nasometin Alergia Lora does not intensify the effects of alcohol, but drinking alcohol is not recommended during treatment
with this medicine.
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.
Although no harmful effects of loratadine on the fetus or newborn have been demonstrated, as a precautionary measure,
the use of Nasometin Alergia Lora should be avoided in pregnant women.
Loratadine passes into breast milk; therefore, the use of Nasometin Alergia Lora is not recommended during breastfeeding.
Driving and operating machinery
Studies have shown that the medicine, when used at recommended doses, does not affect or has negligible
effect on the ability to drive or operate machinery. However, very rarely, in some individuals, the medicine may cause drowsiness,
which may impair the ability to perform these activities.
Nasometin Alergia Lora contains lactose
One tablet contains 69.175 mg of monohydrate lactose. If the patient has previously been diagnosed with
intolerance to certain sugars, the patient should contact their doctor before taking the medicine.
One tablet of Nasometin Alergia Lora contains less than 0.01 WW.

3. How to use Nasometin Alergia Lora

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults and children over 12 years of age: 1 tablet (10 mg) once daily.
Children aged 6 to 12 years (with body weight greater than 30 kg): 1 tablet (10 mg) once daily.
Nasometin Alergia Lora should not be used in children with body weight less than 30 kg or in children under 6 years of age.
Use of Nasometin Alergia Lora without medical advice should not exceed 10 days.
Patients with severe hepatic impairment
A dose reduction may be necessary. Consult a doctor before use, who will recommend the appropriate dosage.
Method of administration: see "Nasometin Alergia Lora with food, drink and alcohol" in section 2.
Overdose of Nasometin Alergia Lora
If a patient has taken more than the recommended dose, contact a doctor or pharmacist immediately. Taking more than the recommended dose may cause drowsiness, increased heart rate and headache.
Symptomatic treatment is recommended. Activated charcoal may be given as an aqueous suspension. A doctor may perform gastric lavage. Loratadine cannot be removed from the body by hemodialysis.
There is no data on the effectiveness of peritoneal dialysis.
Missed dose of Nasometin Alergia Lora
If a patient forgets to take the medicine at the usual time, they should take it as soon as possible, then return to the regular dosing schedule. Do not take a double dose to make up for the missed dose.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Common adverse reactions (may occur in less than 1 in 10 people):
headache, nervousness and feeling tired (in children)
drowsiness (in adults and adolescents)
Uncommon adverse reactions (may occur in less than 1 in 100 people):
headache, increased appetite and sleep disturbances (in adults and adolescents)
Very rare adverse reactions (may occur in less than 1 in 10,000 people):
hypersensitivity reactions (including angioedema – swelling of the skin and (or) mucous membranes, e.g. in the face, limbs, joints), severe allergic reactions with sudden breathing difficulties, severe dizziness or collapse, facial or throat swelling (anaphylaxis). If any of the described symptoms occur, seek immediate medical advice or emergency help.
increased heart rate, palpitations, gastric mucosal inflammation, nausea, liver function disorders, dry mouth, dizziness, feeling tired, rash, hair loss, seizures.
Adverse reactions with unknown frequency (frequency cannot be estimated from 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, pharmacist or nurse. Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Nasometin Alergia Lora

Keep this medicine out of sight and reach of children.
Store below 25°C in the original packaging. Protect from moisture.
Do not use this medicine after the expiry date stated on the packaging after EXP.
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. Such measures will help protect the environment.

6. Contents of the pack and other information

What Nasometin Alergia Lora contains

• The active substance is loratadine. One tablet contains 10 mg of loratadine.
• The other ingredients are: monohydrate lactose, magnesium stearate, maize starch, colloidal anhydrous silica.

What Nasometin Alergia Lora looks like and contents of the pack
Nasometin Alergia Lora tablets are white, oval-shaped, with a division line and marked with "LT 10".
The tablets are packed in PVC/Aluminium blisters in a cardboard box.
The packs contain 7, 10 or 20 tablets.
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Manufacturer
Lek S.A.
Domaniewska 50 C
02-672 Warsaw, Poland
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
D-39179 Barleben, Germany

For further information, please contact:
Sandoz Polska Sp. z o.o.
Domaniewska 50 C
02-672 Warsaw, Poland
tel. 22 209 70 00