LORATADINE QUALIGEN 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Loratadine Qualigen10 mgfilm-coated tablets

loratadine

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 doubts, 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 it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Loratadine Qualigen and what is it used for
2. What you need to know before taking Loratadine Qualigen
3. How to take Loratadine Qualigen
4. Possible side effects
5. Storage of Loratadine Qualigen

Contents of the pack and further information

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

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

Loratadine Qualigen relieves the symptoms associated with allergic rhinitis (such as sneezing, runny or itchy nose and irritation or itching of the eyes) in adults and children over 2 years of age and weighing more than 30 kg.

Loratadine Qualigen can also be used to help relieve the symptoms of urticaria (such as itching, redness, and the number and size of skin wheals) in adults and children over 2 years of age and weighing more than 30 kg.

2. What you need to know before taking Loratadine Qualigen

Do not take Loratadine Qualigen

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Loratadine Qualigen

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

Other medications and Loratadine Qualigen

No interactions between loratadine and other medications are known. However, inform your doctor or pharmacist if you are using, have recently used, or may need to use other medications, including those obtained without a prescription.

Taking Loratadine Qualigen with food and drinks

Loratadine can be taken with or without food.

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 medication.

Loratadine is not recommended if you are pregnant or breastfeeding.

Driving and using machines

At normal doses, loratadine 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.

Loratadine Qualigen contains lactose

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 Qualigen

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

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

Take one tablet (10 mg) once a day.

Patient with severe liver problems and a weight over 30 kg:

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

Loratadine Qualigen 10 mg film-coated tablets are not suitable for:

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

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

If you take more Loratadine Qualigen 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 Loratadine Qualigen

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

If you stop treatment with Loratadine Qualigen

Remember to take your medication.

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

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

4. Possible side effects

Like all medications, this medication can have 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 rare side effects (less than 1 in 10,000 patients) have been reports of severe allergic reactions, dizziness, irregular or rapid heartbeats, nausea (vomiting), dry mouth, upset stomach, liver problems, hair loss, skin rash, and fatigue. Weight gain with unknown frequency.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Loratadine Qualigen

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

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

Do not use this medication after the expiration date shown on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

• The active ingredient is loratadine. Each tablet contains 10 mg of loratadine.

• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, corn starch, pregelatinized corn starch, colloidal silica, magnesium stearate, hypromellose, macrogol 400, macrogol 6000, carnauba wax, talc.

Appearance of the product and contents of the pack

Loratadine Qualigen is presented in the form of circular, biconvex tablets with a score line on one side and marked LR10 on the other.

Each pack contains 20 tablets in blisters.

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Date of the last revision of this package leaflet: May 2021

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