LORATADINE ARISTO 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Loratadina Aristo 10 mg Tablets EFG

Loratadine

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Loratadina Aristo and what is it used for
2. What you need to know before taking Loratadina Aristo
3. How to take Loratadina Aristo
4. Possible side effects
5. Storage of Loratadina Aristo
6. Contents of the pack and further information

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

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

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

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

2. What you need to know before taking Loratadina Aristo

Do not take Loratadina Aristo

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Loratadina Aristo.

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

Use of Loratadina Aristo with other medications:

No interactions of Loratadina Aristo with other medications are known.

Tell your doctor if you are taking, have recently taken, or may need to take another medication.

Taking Loratadina Aristo with food and drinks

Loratadina Aristo 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.

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

Driving and using machines

At normal doses, Loratadina Aristo does not affect the ability to drive or use machines. If you notice symptoms of drowsiness, do not drive or use machines, and avoid performing tasks that require special attention until you know how you tolerate the medication.

Important information about some of the components of Loratadina Aristo

Loratadina Aristo 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 Aristo

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

Remember to take your medication.

The recommended dose is:

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 Aristo 10 mg tablets are 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 and adolescents

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

If you take more Loratadina Aristo than you should

If you take more Loratadina Aristo than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service; Telephone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Loratadina Aristo

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.

If you stop taking Loratadina Aristo

Your doctor will indicate the duration of your treatment with Loratadina Aristo. Do not stop treatment before.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The classification of side effects is based on the following frequencies:

The most frequently reported side effects (may affect more than 1 in 10 patients) include drowsiness, headache, nervousness, fatigue, increased appetite, and difficulty sleeping.

Side effects reported very rarely (may affect up to 1 in 10,000 patients) have been cases of severe allergic reaction, dizziness, irregular or rapid heartbeat, nausea (vomiting), dry mouth, upset stomach, liver problems, hair loss, skin rash, and fatigue.

The side effect with unknown frequency (frequency cannot be estimated from the available data) is weight gain.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the notification system included in the Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.aemps.gob.es/.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Loratadina Aristo

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

No special storage conditions are required.

Do not use Loratadina Aristo after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Do not use Loratadina Aristo 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 medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition

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

Appearance of the product and pack contents

Scored, round, white or almost white tablets.

Supplied in blisters, in packs of 20 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain.

Manufacturer:

TOLL MANUFACTURING SERVICES, S.L.

Aragoneses 2,

28108 Alcobendas (MADRID)

This package leaflet was approved in:December 2017

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