Leaflet: information for the user

Loratadine Aristo 10 mg tablets EFG

Loratadine

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

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed for you only 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 or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to take Loratadine Aristo

3. How to take Loratadine Aristo

4. Possible side effects

5. Storage of Loratadine Aristo

6. Contents of the pack and additional information

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

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

Loratadina Aristo can 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 Aristo

- If you are allergic to the active ingredient 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 to undergo any type of skin test for allergy. Do not take Loratadina Aristo during the 2 days prior to the test, as this medication may alter the test results.

Use of Loratadina Aristo with other medications:

No interactions of Loratadina Aristo with other medications are known.

Inform your doctor if you are taking, have taken recently, 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Do not recommend taking Loratadina Aristo if you are pregnant or breastfeeding.

Driving and operating machinery

At normal doses, Loratadina Aristo does not affect the ability to drive or operate machinery. If you experience drowsiness symptoms, do not drive or operate machinery, however, avoid 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.

Follow exactly the administration instructions for this medication 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 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 Aristo 10 mg tablets are not suitable for:

- administration of doses less than 10 mg.

- administration in patients with a weight of less than30 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 Toxicological Information Service; Telephone 91 562 04 20, indicating the medication and the amount taken.

If you forget to takeLoratadina Aristo

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 make up for the missed doses.

If you interrupt treatment with 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.

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

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

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

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

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

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the notification system included in the Spanish System for Pharmacovigilance of Medicinal Products for Human Use. Website:www.notificaRAM.es.

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

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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use Loratadina Aristo if you observe any change in the appearance of the tablet.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition

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

Appearance of the product and content of the packaging

Scored, round, white or almost white tablets.

Presented in blister packs, in containers with 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain.

Responsible for manufacturing:

TOLL MANUFACTURING SERVICES, S.L.

Aragoneses 2,

28108 Alcobendas (MADRID)

This leaflet has been approved in:December 2017

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/