LORATADINE NORMON 10 mg TABLETS

Introduction

Prospectus: Information for the user

Loratadine Normon 10 mg Tablets EFG

Read the entire prospectus carefully before starting to take the medication.

• Keep this prospectus as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Contents of the prospectus:

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. Storage of Loratadine Normon
6. Package contents and additional information

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

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

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

Loratadine Normon can also be used to help relieve the 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 any of the components of Loratadine Normon.

• Be careful with Loratadine Normon:

• Use of other medications:

Tell your doctor or pharmacist if you are taking, or have recently taken, any other medication, including those purchased without a prescription.

No interactions of Loratadine Normon with other medications are known. However, inform your doctor or pharmacist if you are using or have recently used other medications.

• Taking Loratadine Normon with food and drinks:

This medication can be taken with or without food.

• Pregnancy and breastfeeding:

Consult your doctor or pharmacist before taking a medication.

It is not recommended to take Loratadine Normon 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, but try not to perform tasks that require special attention until you know how you tolerate the medication.

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

3. How to take Loratadine Normon

Follow these administration instructions for this medication as indicated by your doctor.

Remember to take your medication. Consult your doctor or pharmacist if you have doubts.

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

Adults and children over 2 years of age with a weight over 30 kg

Take one tablet (10 mg) once a day.

Patients with severe liver problems with a weight over 30 kg

Take one tablet (10 mg) once a day, every other day.

Loratadine Normon is not suitable for:

• administration of doses less than 10 mg.
• administration in patients with a weight less than 30 kg.
• patients who have difficulty swallowing.

Use in children

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

• If you take more Loratadine Normon than you should

Consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicology Information Service Telephone: 91 562 04 20.

• If you forget to take Loratadine 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 forgotten doses.

• If you interrupt treatment with Loratadine Normon

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

4. Possible side effects

Like all medications, Loratadine Normon can have side effects, although not everyone experiences 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 rare side effects (less than 1 in 10,000 patients) have been cases of severe allergic reaction, dizziness, irregular or rapid heartbeats, nausea (vomiting), dry mouth, upset stomach, liver problems, hair loss, skin rash, and fatigue.

Side effects of unknown frequency: weight gain.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

5. Storage of Loratadine Normon

Keep out of the reach and sight of children.

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

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

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

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. Package contents and additional information

Composition of Loratadine Normon

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

Appearance of the product and package contents

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

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Other presentations

Loratadine Normon 1 mg/ml syrup EFG.

Date of the last revision of this prospectus: 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.es/

You can access detailed and updated information about this medication by scanning the QR code included in the prospectus 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/63784/P_63784.html