Loratadine Qualigen 10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Loratadine Qualigen 10 mg film-coated tablets

loratadine

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 you should not give it to others, even if they have the same symptoms, as it may 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.

Leaflet contents

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

Pack size and other information

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

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

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

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

2. What you need to know before taking Loratadina Qualigen

Do not take Loratadine Qualigen

If you are allergic 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 Qualigen:

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

Other medicines and Loratadina Qualigen

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

Taking Loratadina Qualigen with food and drink

Loratadine may be taken with or without food.

Pregnancy and breast-feeding

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

Loratadine is not recommended if you are pregnant or breast-feeding.

Driving and operating machinery

At normal doses, loratadine does not affect the ability to drive or operate machinery. If you experience symptoms of drowsiness, do not drive or operate machinery. Furthermore, avoid performing tasks that may require special attention until you know how you tolerate the medication.

Loratadine Qualigen contains lactose

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

3. How to take Loratadina Qualigen

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and children over 2 years of age weighing more than 30 kg:

Take one tablet (10 mg) once daily.

Patients with severe liver problems weighing more than 30 kg:

Take one tablet (10 mg) once daily on alternate days.

Loratadina Qualigen 10 mg tablets are not suitable for:

• administration of doses lower than 10 mg.
• administration in patients weighing less than 30 kg.
• patients who have difficulty swallowing.

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

If you take more Loratadina Qualigen than you should

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 Qualigen

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 stop taking Loratadina Qualigen

Remember to take your medicine.

Your doctor will indicate how long the treatment with loratadine should last. Do not stop treatment earlier.

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 may cause adverse effects, although not everybody will experience them.

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

Very rare adverse effects reported (less than 1 in 10,000 patients) have included cases of severe allergic reaction, dizziness, irregular or rapid heartbeat, nausea (feeling sick), dry mouth, stomach discomfort, liver problems, hair loss, skin rash, and fatigue. Weight gain has been reported with unknown frequency.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Qualigen

Keep this medicine out of sight and reach of children.

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

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.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you are unsure, 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

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

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

Appearance of the product and contents of the pack

Loratadina Qualigen is presented as circular, biconvex tablets, with a score line on one side and marked "LR10" on the other.

Each pack contains 20 tablets in a blister pack.

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Date of the most recent review of this leaflet: May 2021

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)