Package Insert: Information for the User

LORATADINE VIR 10 mg Tablets

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

- Keep this package insert. 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 and should not be given to others, even if they have the same symptoms as you, as it may harm them.

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

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 eye itching or burning).

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

Do not take Loratadina VIR

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

Warnings and precautions

• If you have severe liver disease (See section 3. How to take Loratadina VIR).
• If you are to undergo any type of skin test for allergy. Do not take Loratadina VIR during the 2 days prior to the performance of these tests, as this medication may alter the results of the same.

Consult your doctor, pharmacist, or nurse before starting to takeLoratadina VIR

Use of Loratadina VIR with other medications

No interactions of Loratadina VIR with 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, believe you may be pregnant, or intend to become pregnant, consultyour doctor or pharmacist before using this medication.

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

Driving and operating machinery

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

Loratadina VIR contains lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.In case of 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 discontinue treatment before.

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

Take one tablet (10 mg) once a day.

Patients with severe liver problems with a weight of more than 30 kg:

Take one tablet (10 mg), once a day and on alternate days.

Loratadina VIR is not suitable for:

• administration of doses less than 10 mg.
• administration in patients with a weight of 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 Toxicological Information Service; Phone: 91 562 04 20.

If you forgot to take Loratadina VIR

If you forgot 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 compensate for missed doses.

Like all medications, Loratadina VIR may produce adverse effects,although not all people will experience them.

The most frequently reported adverse 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 rarely reported adverse effects (less than 1 in 10,000 patients) have been cases of severe allergic reaction, dizziness, irregular or rapid heartbeats, nausea (urge to vomit), dry mouth, upset stomach, liver problems, hair loss, skin rash, and fatigue.

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus.

Keepthis medicationout of the sight and reach of children.

No special storage conditions are required.

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 this medication if you observe any change in the appearance of the tablet.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications.This will help protect the environment.

Loratadine Vir Composition

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

- The other components (excipients) are: lactose, cornstarch, povidone, and magnesium stearate.

Product appearance and packaging content

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

Each package contains 20 tablets in a blister.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Responsible manufacturer

TOLL MANUFACTURING SERVICES, S.L.

Aragoneses 2

28108 Alcobendas. (Madrid).

or

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Poligono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Last review date of this leaflet: October 2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/