Label: Information for the Patient

Loratadine Viatris 10 mg Tablets EFG

Read this label carefully before taking this medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• 1. If you have any questions, consult yourdoctor or pharmacist.
  2. This medication has been prescribedonlyto you, and you should not give it to others even ifthey havethe same symptomsas you,as it may harm them.

-If you experience any adverse effects,consult your doctor or pharmacist, evenifthey are not listed in this label. See section 4.

Loratadina Viatris contains the active ingredient loratadine, which belongs to a group of medicines known as antihistamines.

This medicine helps to reduce your allergy symptoms by blocking the effects of a substance called “histamine”, which is produced in the body when you are allergic to something.

This medicine relieves symptoms associated with allergic rhinitis (such as hay fever) such as sneezing, runny or itchy nose and eye irritation or itching.

You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Do not takeLoratadina Viatris:

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication.

Be especially careful with loratadine if:

• You have liver disease.
• You are going to undergo any type of skin test for allergy. Do not take this medication during the 2 days prior to the test, as this medication may alter the test results.

Children and adolescents

Do not administer this medication to children under 6 years of age or children weighing less than 30 kg. There are other formulations more suitable for children under 6 years of age or weighing 30 kg or less.

Children under 2 years

The safety and efficacy of this medication have not been established. There are no data available.

Other medications and Loratadina Viatris

The side effects of this medication may increase when used with medications that alter the performance of certain enzymes found in the liver, or if your liver is not functioning properly. In clinical studies, no increase in side effects of loratadine was observed with medications that alter the performance of these enzymes.

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication, including non-prescription medications.

Taking Loratadina Viatris with food and alcohol

No increased effects have been demonstrated with this medication and alcoholic beverages.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

This medication is not recommended for use during pregnancy or breastfeeding.

Driving and operating machinery

In clinical studies evaluating driving ability, no reduced function was observed in patients who received loratadine. At the recommended dose, no somnolence or decreased alertness is expected. However, in very rare cases, some people may experience somnolence, which may affect their ability to drive or operate machinery.

Loratadina Viatris contains lactose

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

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

Your doctor will inform you of the duration of treatment with this medication. Do not discontinue treatment before.

Adults and children over 6 years of age with a weight of more than 30 kg

Take 1 tablet once a daywith a glass of water, with or without food.

Weight of 30 kg or less

Do not give this medication. There are other more suitable presentations for children under 6 years of age who weigh 30 kg or less.

Children under 2 years of age

This medication is not recommended for children under 2 years of age.

Adults and children with severe liver problems

Adults and children who weigh more than 30 kg

Take 1 tablet once a day and on alternate dayswith a glass of water, with or without food.

However, you should consult your doctor, pharmacist, or nurse before taking this medication.

If it worsens, or symptoms persist after 7 days of treatment, you should consult a doctor.

If you take more Loratadina Viatris than you should

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

Somnolence, palpitations, and headache have been reported with overdoses of this medication.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service (Telephone 91 562 04 20), indicating the medication and the amount ingested.

If you forget to take Loratadina Viatris

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 compensate for missed doses.

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

Like all medications, this medication may produce adverse effects, although not everyone may experience them.

The most frequently reported adverse effects in adults and adolescents over 12 years old are:

• Drowsiness.
• Headache.
• Increased appetite.
• Difficulty sleeping.

The most frequently reported adverse effects in children aged 6 to 12 years are:

• Headache.
• Nervousness.
• Fatigue.

During the marketing of loratadine, the following adverse effects have also been reported, which are very rare (may affect up to 1 in 10,000 people):Very Rare(may affect up to 1 in 10,000 people):

• Severe allergic reaction (including swelling).
• Dizziness.
• Seizures.
• Irregular or rapid heartbeats.
• Nausea (urge to vomit).
• Dry mouth.
• Stomach discomfort.
• Liver problems.
• Hair loss.
• Skin rash.
• Fatigue.

Unknown frequencyUnknown(cannot be estimated from available data):

• Weight gain.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD or EXP. 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 medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Loratadina Viatris

• The active ingredient is loratadine. Each tablet contains 10 mg of loratadine.
• The other excipients are: lactose monohydrate, cornstarch, povidone, and magnesium stearate (E-470b).

Appearance of the product and contents of the packaging

Loratadina Viatris is presented in the form of tablets.

White, round tablets with a notch.

Each package contains blisters of 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holderof the marketing authorization

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible for manufacturing

Toll Manufacturing Services, S.L.

C/ Aragoneses, 2

28108 - Alcobendas (Madrid)

Spain

Last review date of this leaflet:April 2022

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