LORATADINE VIR 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

LORATADINA VIR 10 mg tablets EFG

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

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

Contents of the Package Leaflet:

1. What is Loratadina VIR and what is it used for
2. What you need to know before taking Loratadina VIR
3. How to take Loratadina VIR
4. Possible side effects
5. Storage of Loratadina VIR
6. Package Contents and Additional Information

1. What is Loratadina VIR and what is it used for

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

Loratadina VIR relieves symptoms associated with allergic rhinitis (such as sneezing, runny or itchy nose, and itchy or red eyes).

Loratadina VIR can also be used to help relieve symptoms of urticaria (such as itching, redness, and the number and size of skin hives).

2. What you need to know before taking Loratadina VIR

Do not take Loratadina VIR

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

Warnings and Precautions

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

Consult your doctor, pharmacist, or nurse before starting to take Loratadina VIR.

Using Loratadina VIR with other medications

No interactions between Loratadina VIR and other medications are known. However, inform your doctor or pharmacist if you are using or have recently used other medications.

Taking Loratadina VIR with food, drinks, and alcohol

Loratadina VIR can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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.

It is not recommended to take Loratadina VIR if you are pregnant or breastfeeding.

Driving and using machines

At normal doses, Loratadina VIR does not affect the ability to drive or use machines. If you experience 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 this medication.

Loratadina VIR 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 Loratadina VIR

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

Your doctor will indicate the duration of your treatment with Loratadina VIR. 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.

Loratadina VIR 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

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

If you take more Loratadina VIR than you should

If you take more Loratadina VIR than you should, consult your doctor or pharmacist immediately.

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

If you forget to take Loratadina VIR

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 missed doses.

4. Possible side effects

Like all medications, Loratadina VIR 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 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.

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet.

5. Storage of Loratadina VIR

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

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging after CAD. 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 tablet.

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

6. Package Contents and Additional Information

Composition of Loratadina Vir

• The active ingredient is loratadine. Each tablet contains 10 mg of loratadine.
• The other components (excipients) are: lactose, cornstarch, povidone, and magnesium stearate.

Appearance of the Product and Package Contents

Loratadina Vir is presented in the form of scored, round, white or almost white tablets. The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Each package contains 20 tablets in a blister pack.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Manufacturer

TOLL MANUFACTURING SERVICES, S.L.

Aragoneses 2

28108 Alcobendas (Madrid)

or

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Date of the last revision of this package leaflet: October 2022

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