LORATADINE ALMUS 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Loratadina Almus 10 mg Tablets EFG

Read the 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 not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Loratadina Almus and what is it used for
2. What you need to know before taking Loratadina Almus
3. How to take Loratadina Almus
4. Possible side effects

5 Storage of Loratadina Almus

1. Contents of the pack and additional information

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

Loratadina belongs to a class of medications known as antihistamines.

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

Loratadina 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 Almus

Do not take Loratadina Almus:

• 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 Almus.

• 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 for 2 days prior to the test, as this medication may alter the results.

Taking Loratadina Almus with other medications:

No interactions between loratadina and other medications are known.

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Taking Loratadina Almus with food and drinks:

Loratadina can be taken with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

It is recommended to avoid using this medication if you are pregnant.

Do not take this medication if you are breastfeeding. Loratadina is excreted in breast milk.

Driving and using machines:

At normal doses, loratadina does not affect the ability to drive or use machines. If you experience symptoms of drowsiness, do not drive or use machines, and try not to perform tasks that require special attention until you know how you tolerate the medication.

Loratadina Almus 10 mg tablets contain 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 Almus

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

Remember to take your medication.

Your doctor will indicate the duration of your treatment with this medication. Do not stop treatment before.

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 Almus 10 mg tablets are not suitable for:

• administering doses lower than 10 mg.
• administering to patients with a weight lower than 30 kg.
• patients who have difficulty swallowing.

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

If you take more Loratadina Almus than you should:

If you take more loratadina than you should, consult your doctor or pharmacist immediately or go to the nearest hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91562 04 20, indicating the medication and the amount ingested.

If you forget to take Loratadina Almus:

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 forgotten doses.

4. Possible side effects

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

The most frequently reported side 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 rare side effects (less than 1 in 10,000 patients) have been reports of severe allergic reactions, dizziness, convulsions, irregular or rapid heartbeats, nausea (vomiting), dry mouth, upset stomach, liver problems, hair loss, skin rash, and fatigue.

Side effects with unknown frequency (cannot be estimated from available data) have been reports of weight gain.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use. Website: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Loratadina Almus

Keep out of sight and reach of children.

Store in the original package.

Do not use this medication after the expiration date indicated on the carton and blister pack. The expiration date is the last day of the month indicated.

Do not use this medication 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 any unused medication in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and additional information

Composition of Loratadina Almus

The active ingredient is loratadina. Each tablet contains 10 mg of loratadina.

The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, cornstarch, and magnesium stearate.

Appearance of the product and contents of the pack

Loratadina Almus 10 mg tablets are presented in the form of white, round, and scored tablets on one side. Each package contains 20 tablets in blister packs.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

Manufacturer:

Teva Pharma, S.L.U.

Polígono Malpica C/ C, 4

50016 Zaragoza.

Date of the last revision of this package leaflet: November 2017

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