Loratadine Vir 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

LORATADINE VIR 10 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet.

Leaflet contents:

1. What Loratadine VIR is and what it is used for
2. What you need to know before taking Loratadine VIR
3. How to take Loratadine VIR
4. Possible side effects
5. How to store Loratadine VIR
6. Contents of the pack and other information

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

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

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

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

2. What you need to know before starting to take Loratadina VIR

Do not take Loratadina VIR

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

Warnings and precautions

• if you have severe liver disease (see section 3. How to take Loratadina VIR).
• if you are due to undergo any type of skin allergy testing. Do not take Loratadina VIR during the 2 days prior to such tests, as this medicine may interfere with the test results.

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

Use of Loratadina VIR with other medicines

No interactions between Loratadina VIR and other medicines are known. However, inform your doctor or pharmacist if you are taking or have recently taken any other medicines.

Taking Loratadina VIR with food, drinks, and alcohol

Loratadina VIR may be taken with or without food.

Pregnancy, breast-feeding, and fertility

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

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 operate machinery. If you experience symptoms of drowsiness, do not drive or operate machinery. Nevertheless, avoid performing tasks that may require special attention until you know how you tolerate this medicine.

Loratadina VIR contains lactose

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

3. How to take Loratadine VIR

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Remember to take your medicine.

Your doctor will advise you on how long to take Loratadine VIR. Do not stop treatment earlier.

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.

Loratadine VIR is not suitable for:

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

Use in children

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

If you take more Loratadine VIR than you should

If you take more Loratadine VIR than you should, contact your doctor or pharmacist immediately.

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

If you forget to take Loratadine VIR

If you miss a dose, take it as soon as possible, and then continue with your usual dosing schedule. Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, Loratadine VIR can cause adverse effects, although not everyone experiences them.

The most frequently reported adverse effects (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.

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

5. Storage of Loratadine VIR

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

No special storage conditions are required.

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.

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

Medicines must not be disposed of via wastewater or household waste. Instead, dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Loratadina Vir

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

Appearance of the product and contents of the pack

Loratadina Vir is presented as white or almost white, round, scored tablets. The score line is intended only to facilitate breaking the tablet for ease of swallowing and not to divide it into equal doses.

Each pack contains 20 tablets in a blister.

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 most recent revision of this leaflet: October 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/