Loratadine Normon 1 mg/ml syrup EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Loratadine Normon 1 mg/ml syrup 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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 relieve your allergy symptoms by blocking the effects of a substance called "histamine", which is released in 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 in adults and children over 2 years of age.

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

The effect of Loratadine Normon lasts for a full day, allowing you to continue your daily routine and sleep normally.

You should consult a doctor if your condition worsens or does not improve after 7 days.

2. What you need to know before starting to take Loratadina Normon

Do not take Loratadina 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 starting to take Loratadina Normon

• If you have liver disease.
• If you are due to undergo any type of skin allergy testing. Do not take Loratadina Normon during the 2 days prior to such tests, as this medicine may alter their results.

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

Children

Do not administer Loratadina Normon to children under 2 years of age.

Other medicines and Loratadina Normon

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

The side effects of Loratadina Normon may increase when used concomitantly with medicines that affect the function of certain liver enzymes responsible for metabolizing the drug. However, in clinical studies, no increase in loratadine side effects was observed with medicines affecting these enzymes.

Loratadina Normon with food, drinks and alcohol

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

Pregnancy and breastfeeding

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

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

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

Driving and use of machines

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

Loratadina Normon contains sucrose, sodium benzoate (E-211), sodium, and propylene glycol (E-1520)

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him/her before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 6 g of sucrose per 10 ml dose.

It may cause dental caries.

This medicine contains 0.56 mg of sodium benzoate (E-211) in each millilitre.

This medicine contains less than 23 mg of sodium (1 mmol) per millilitre; thus, it is essentially “sodium-free”.

This medicine contains 100.03 mg of propylene glycol (E-1520) per millilitre.

3. How to take Loratadina Normon

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

Adults and adolescents over 12 years of age:

Take 10 ml of syrup once daily.

Children aged 2 to 12 years: Dosing by weight:

Body weight above 30 kg:

Take 10 ml of syrup once daily.

Body weight equal to or below 30 kg:

Administer 5 ml of syrup once daily.

Loratadina Normon is not recommended for children under 2 years of age.

Patients with severe liver problems:

Adults and children weighing above 30 kg:

Take 10 ml of syrup once every other day, with or without food.

Children weighing equal to or below 30 kg:

Administer 5 ml of syrup once every other day, with or without food.

However, you should consult your doctor or pharmacist before taking this medicine.

If your symptoms worsen or persist after 7 days of treatment, consult a doctor.

If you take more Loratadina 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 Loratadina 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 a missed dose.

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

4. Possible adverse effects

Like all medicines, Loratadina Normon may 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:

• Somnolence.
• Headache.
• Increased appetite.
• Difficulty sleeping.

The most frequently reported adverse effects in children aged 2 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 of wanting to vomit).
• Dry mouth.
• Stomach discomfort.
• Liver problems.
• Hair loss.
• Skin rash.
• Fatigue.

The frequency of the following adverse effect is unknown (frequency cannot be estimated from the available data):

• 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 through 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 sight and reach 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 this medicine if you notice any changes in the appearance of the syrup.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines 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 sodium benzoate (E-211), sucrose, glycerol (E-422), propylene glycol (E-1520), anhydrous citric acid, peach flavour (contains propylene glycol E-1520), and purified water.

Appearance of the medicinal product and contents of the pack

Loratadine Normon is presented as a syrup. Each container holds 120 ml. The syrup is a slightly viscous, transparent, colourless solution with a peach odour. A dosing device is included.

Marketing Authorisation Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

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

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Health Products (AEMPS) (http://www.aemps.gob.es/)

You can access detailed and up-to-date information about this medicinal product 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/64243/P_64243.html