LORATADINE NORMON 1 mg/ml SYRUP

Introduction

Package Leaflet: Information for the Patient

Loratadina Normon 1 mg/ml Syrup EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet.

Contents of the Package Leaflet

1. What Loratadina Normon 1 mg/ml Syrup EFG is and what it is used for.
2. What you need to know before taking Loratadina Normon 1 mg/ml Syrup EFG.
3. How to take Loratadina Normon 1 mg/ml Syrup EFG.
4. Possible side effects.
5. Storage of Loratadina Normon 1 mg/ml Syrup EFG.

Contents of the packaging and additional information.

1. What Loratadina Normon 1 mg/ml Syrup EFG is and what it is used for

Loratadina Normon belongs to a class of medications known as antihistamines.

Loratadina Normon relieves symptoms associated with allergic rhinitis (such as sneezing, runny or itchy nose, and irritation or itching of the eyes).

Loratadina Normon 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 Loratadina Normon 1 mg/ml Syrup EFG

Do not take Loratadina Normon 1 mg/ml Syrup EFG:

• If you are allergic (hypersensitive) to loratadine or any of the components of Loratadina Normon.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Loratadina Normon 1 mg/ml Syrup EFG.

• If you have severe liver disease (see section 3).
• If you are going to undergo any type of skin allergy test. Do not take Loratadina Normon during the 2 days prior to the test, as this medication may alter the results.

Interaction of Loratadina Normon 1 mg/ml Syrup EFG with other medications:

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

No interactions of Loratadina Normon with other medications are known.

Loratadina Normon 1 mg/ml Syrup EFG with food and beverages:

Loratadina Normon can be taken with or without food.

Pregnancy and Breastfeeding:

Consult your doctor or pharmacist before using any medication.

It is not recommended to take this medication if you are pregnant or breastfeeding.

Driving and Using Machines:

At normal doses, this medication does not affect the ability to drive or use machines. If you notice symptoms of drowsiness, do not drive or use machines; however, try not to perform tasks that require special attention until you know how you tolerate the medication.

This medication contains sucrose, sodium benzoate (E-211), sodium, and propylene glycol (E-1520)

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Patients with diabetes mellitus should note that this medication contains 6 g of sucrose per 10 ml dose.

It may cause cavities.

This medication contains 0.56 mg of sodium benzoate (E-211) per milliliter.

This medication contains less than 23 mg of sodium (1 mmol) per milliliter; it is essentially "sodium-free".

This medication contains 100.03 mg of propylene glycol (E-1520) per milliliter.

3. How to take Loratadina Normon 1 mg/ml Syrup EFG

Follow the administration instructions of this medication exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. Remember to take your medication.

Your doctor will indicate the duration of treatment with Loratadina Normon. Do not stop treatment before.

Adults and children over 12 years of age:

Take 10 ml of Loratadina Normon 1 mg/ml Syrup once a day.

Children from 2 to 12 years of age:

Weight over 30 kg:

Take 10 ml of Loratadina Normon 1 mg/ml Syrup once a day.

Weight equal to or less than 30 kg:

Administer 5 ml of Loratadina Normon 1 mg/ml Syrup once a day.

Patient with severe liver problems:

Adults and children weighing over 30 kg:

Take 10 ml of Loratadina Normon 1 mg/ml Syrup, once a day, every other day.

Children weighing equal to or less than 30 kg:

Administer 5 ml of Loratadina Normon 1 mg/ml Syrup, once a day, every other day.

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

If you take more Loratadina Normon than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Loratadina Normon:

If you forget to take your dose on time, take it as soon as possible, and then return to your usual dosing schedule. Do not take a double dose to make up for missed doses.

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

4. Possible Side Effects

Like all medications, Loratadina Normon 1 mg/ml Syrup EFG can cause side effects, although not everyone will experience them.

The most frequently reported side effects (less than 1 in 10 patients but more than 1 in 100 patients) include drowsiness, headache, nervousness, fatigue, increased appetite, and difficulty sleeping.

Very rarely reported side effects (less than 1 in 10,000 patients) have been cases of severe allergic reaction, dizziness, irregular or rapid heartbeat, nausea (vomiting), dry mouth, upset stomach, liver problems, hair loss, skin rash, and fatigue.

Side effects of unknown frequency: Weight gain. If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet.

5. Storage of Loratadina Normon 1 mg/ml Syrup EFG

Keep out of sight and reach of children.

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

Do not use this medication after the expiration date shown on the packaging after "EXP". The expiration date is the last day of the month indicated.

Do not use this medication if you notice any change in the appearance of the syrup.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the Packaging and Additional Information

Composition of Loratadina Normon

• The active ingredient is loratadine.
• The other components are sodium benzoate (E-211), sucrose, glycerol (E-422), propylene glycol (E-1520), anhydrous citric acid, peach essence (contains propylene glycol E-1520), and purified water.

Appearance of the Product and Contents of the Packaging

Loratadina Normon is presented in the form of a syrup. Each package contains 120 ml. The syrup is a slightly viscous, transparent, colorless solution with a peach odor. A dosing device is included.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Other Presentations

Loratadina Normon 10 mg Tablets EFG

This package leaflet was last revised in: January 2018

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/64243/P_64243.html