LORATADINE NORMON 10 MG TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Loratadine Normon 10 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Loratadine Normon is and what it is used for
2. What you need to know before taking Loratadine Normon
3. How to take Loratadine Normon
4. Possible side effects
5. How to store Loratadine Normon
6. Contents of the pack and other information

1. What Loratadine Normon is and what it is used for

Loratadine Normon belongs to a class of medicines known as antihistamines.

Loratadine Normon helps reduce your allergy symptoms by blocking the effects of a substance called "histamine", which is produced by the body when you are allergic to something.

Loratadine Normon relieves symptoms of allergic rhinitis (e.g., hay fever), such as sneezing, runny or itchy nose, and burning or itchy eyes.

It can also be used to help relieve symptoms of urticaria (such as itching, redness, and the number and size of skin rashes).

2. What you need to know before taking Loratadine Normon

Do not take Loratadine Normon

• If you are allergic (hypersensitive) to loratadine or to any of the components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking Loratadine Normon if:

• You have liver disease.
• You are scheduled to undergo any type of skin allergy testing. Do not take Loratadine Normon during the 2 days prior to such tests, as this medicine may interfere with the test results.

If any of the above conditions apply to you (or you are unsure), consult your doctor or pharmacist before taking Loratadine Normon.

Children and adolescents

Do not administer Loratadine Normon tablets to children under 6 years of age or to children weighing less than 30 kg. Other formulations are more suitable for children under 6 years of age or weighing 30 kg or less.

Children under 2 years of age

The safety and efficacy of Loratadine Normon have not been established. No data are available.

Other medicines and Loratadine Normon

The side effects of Loratadine Normon may increase when used concomitantly with medicines that affect the function of certain liver enzymes, or if your liver is not functioning properly. In clinical studies, no increase in loratadine side effects was observed with medications affecting these enzymes.

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines, including non-prescription medicines.

Taking Loratadine Normon with food, drinks, and alcohol

It has not been shown that Loratadine Normon increases the effects of alcoholic beverages.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

As a precautionary measure, it is preferable to avoid taking Loratadine Normon during pregnancy.

Do not take Loratadine Normon if you are breastfeeding. Loratadine is excreted in breast milk.

Driving and using machines

In clinical trials assessing driving ability, no reduction in performance was observed in patients receiving loratadine. At the recommended dose, drowsiness or reduced alertness is not expected with Loratadine Normon. However, very rarely, some individuals may experience drowsiness, which could affect their ability to drive or operate machinery.

Loratadine Normon contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Loratadine Normon

Follow exactly the instructions for use of this medicine provided in this leaflet or those indicated by your doctor or pharmacist.

If in doubt, consult your doctor or pharmacist again.

The score on the tablet is intended solely to divide the tablet if you have difficulty swallowing it whole.

Recommended dose:

Adults and children over 6 years of age weighing more than 30 kg:

Take 1 tablet once daily with a glass of water, with or without food.

Body weight of 30 kg or less:

Do not administer Loratadine Normon 10 mg tablets. Other formulations more suitable for children under 6 years of age weighing 30 kg or less are available.

Children under 2 years of age:

Loratadine Normon is not recommended in children under 2 years of age.

Adults and children with severe liver problems:

Adults and children weighing more than 30 kg:

Take 1 tablet once daily, alternating days, with a glass of water, with or without food.

If you take more Loratadine Normon than you should

Serious problems are not expected; however, you may experience headache, palpitations, or drowsiness.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Loratadine Normon

If you miss a dose, take it as soon as possible, then return to your regular dosing schedule. Do not take a double dose to make up for forgotten doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The most frequently reported adverse effects in adults and adolescents over 12 years of age are:

• Drowsiness.
• Headache.
• Increased appetite.
• Difficulty sleeping.

The most frequently reported adverse effects in children aged 6 to 12 years are:

• Headache.
• Nervousness.
• Fatigue.

During the marketing of loratadine, the following very rare adverse effects have also been reported (may affect up to 1 in 10,000 patients):

• Severe allergic reaction (including swelling).
• Dizziness.
• Seizure.
• Irregular or rapid heartbeat.
• Nausea (feeling sick).
• Dry mouth.
• Stomach discomfort.
• Liver problems.
• Hair loss.
• Skin rash.
• Fatigue.

The frequency of the following adverse effect is unknown:

• Weight gain.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Loratadine Normon

Keep this medicine out of the reach and sight of children.

No special storage conditions are required. Store in the original packaging.

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 month indicated.

Do not use Loratadine Normon if you notice any changes in the appearance of the tablet.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Loratadine Normon

• The active substance is loratadine.
• The other components are: pregelatinized corn starch, monohydrate lactose, and magnesium stearate (E-470b).

Appearance of the product and contents of the pack

• Loratadine Normon is presented in tablet form. Each pack contains 20 tablets. The tablets are white, round, scored on one side and printed on the other.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent review of this leaflet: March 2026

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS):

http://www.aemps.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/63784/P_63784.html