LORATADINE STADA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

LORATADINA STADA 10 mg film-coated tablets EFG

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 not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

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

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

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

2. What you need to know before taking Loratadina STADA

Do not take Loratadina STADA:

• If you are allergic to loratadine or 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 STADA.

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

Use of Loratadina STADA with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

No interactions with Loratadina STADA and other medications are known.

Taking Loratadina STADA with food and drinks

Loratadina STADA can be taken with or without food.

Pregnancy and breastfeeding

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 STADA is not recommended if you are pregnant or breastfeeding.

Driving and using machines

At normal doses, Loratadina STADA 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.

Loratadina STADA contains lactose

This medication 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 STADA

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

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Loratadina STADA. 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 STADA 10 mg film-coated 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.

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

If you take more Loratadina STADA than you should

If you have taken more Loratadina STADA than you should, consult your doctor or pharmacist immediately.

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

If you forget to take Loratadina STADA

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.

If you have any further 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 gets 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, irregular or rapid heartbeats, nausea (vomiting), dry mouth, upset stomach, liver problems, hair loss, skin rash, fatigue, and convulsions.

Frequency not known (frequency cannot be estimated from available data):

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 through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Loratadina STADA

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use Loratadina STADA after the expiration date stated on the packaging, after CAD. The expiration date is the last day of the month indicated.

Do not use Loratadina STADA 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 collection 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 further information

Composition of Loratadina STADA

• The active ingredient is loratadine. Each film-coated tablet contains 10 mg of loratadine.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, corn starch, pregelatinized corn starch, colloidal silicon dioxide, magnesium stearate, hypromellose, macrogol 400, macrogol 6000, carnauba wax, and talc.

Appearance of the product and contents of the pack

Loratadina STADA is presented in the form of film-coated tablets, white, round, biconvex, with a score line on one side and the inscription "LR 10" on the other. Each pack contains 20 tablets in blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 San Just Desvern (Barcelona)

[email protected]

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 San Joan Despí

Date of the last revision of this package leaflet:December 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/