LORATADINE ARISTO 10 MG TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Loratadina Aristo 10 mg tablets EFG

Loratadine

Read all of 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, ask your doctor or pharmacist.
• 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 may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

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

Loratadina Aristo can 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 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 medicine (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 due to undergo any type of skin allergy testing. Do not take Loratadina Aristo during the 2 days prior to such tests, as this medicine may interfere with the test results.

Taking Loratadina Aristo with other medicines

No interactions between Loratadina Aristo and other medicines are known.

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

Taking Loratadina Aristo with food and drink

Loratadina Aristo may be taken with or without food.

Pregnancy, breastfeeding, 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.

The use of Loratadina Aristo is not recommended during pregnancy or breastfeeding.

Driving and using machines

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

Important information about some of the components of Loratadina Aristo

Loratadina Aristo 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 Aristo

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor again.

Remember to take your medicine.

The recommended dose is:

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 Aristo 10 mg tablets are 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 and adolescents

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

If you take more Loratadine Aristo than you should

If you take more Loratadine Aristo than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service; Telephone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Loratadine Aristo

If you forget to take your dose on time, take it as soon as possible, then return to your usual dosing schedule. Do not take a double dose to make up for forgotten doses.

If you stop taking Loratadine Aristo

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause 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 somnolence, headache, nervousness, fatigue, increased appetite, and difficulty sleeping.

Very rare adverse effects reported (may affect up to 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.

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of 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 leaflet. You may also report them directly via the reporting system included in the Spanish Pharmacovigilance System for Human Medicines. Website: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Loratadine Aristo

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

No special storage conditions are required.

Do not use Loratadine Aristo 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 Loratadine Aristo if you notice any changes in the appearance of the tablet.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you have any doubts, 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

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

Appearance of the product and contents of the pack

Scored, round, white or almost white tablets.

Presented in blisters, packs containing 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 leaflet was approved in: December 2017

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/