LORATADINE CINFA 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

loratadina cinfa 10 mg 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.

Package Leaflet Contents

1. What is loratadina cinfa and what is it used for
2. What you need to know before taking loratadina cinfa
3. How to take loratadina cinfa
4. Possible side effects
5. Storage of loratadina cinfa

Package Contents and Additional Information

1. What is loratadina cinfa and what is it used for

loratadina cinfa belongs to a class of medications known as antihistamines.

Loratadine helps reduce your allergy symptoms by blocking the effects of a substance called "histamine", which is produced in the body when you are allergic to something.

loratadina cinfa relieves symptoms associated with allergic rhinitis (such as hay fever) such as sneezing, runny or itchy nose and irritation or itching of the eyes in adults and children over 6 years old, weighing more than 30 kg.

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

You should consult your doctor if your symptoms worsen or do not improve after 7 days.

2. What you need to know before taking loratadina cinfa

Do not take loratadina cinfa

• 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, pharmacist, or nurse before starting to take loratadina cinfa:

• If you have liver disease.
• If you are going to undergo any type of skin allergy test. Do not take loratadine for 2 days prior to the test, as this medication may alter the results.

If any of the above conditions apply to you (or you are unsure), consult your doctor, pharmacist, or nurse before taking loratadine.

Children and Adolescents

Do not administer loratadine 10 mg to children under 6 years old or children between 6 and 12 years old who weigh less than 30 kg. There are other formulations more suitable for children between 6 and 12 years old who weigh less than 30 kg.

Children under 2 years old

The safety and efficacy of loratadine have not been established. No data are available.

Other Medications and loratadina cinfa

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

The side effects of loratadine may increase when used with medications that alter the performance of certain liver enzymes or if your liver is not functioning properly. In clinical studies, no increase in loratadine side effects was observed with medications that altered the performance of these enzymes. However, it is essential to inform your pharmacist about any other medication you are taking while taking loratadine.

Taking loratadina cinfa with Food, Drinks, and Alcohol

Loratadine can be taken with or without food.

It has not been demonstrated that loratadine increases the effects of alcoholic beverages.

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.

Pregnancy

As a precautionary measure, it is not recommended to take loratadine if you are pregnant.

Breastfeeding

Do not take loratadine if you are breastfeeding, as loratadine is excreted in breast milk.

Driving and Using Machines

In clinical trials that evaluated driving ability, no reduced function was observed in patients who received loratadine.

At the recommended dose, loratadine is not expected to cause drowsiness or decreased alertness. However, in very rare cases, some people may experience drowsiness, which may affect their ability to drive or use machines.

loratadina cinfa 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 cinfa

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

The recommended dose is:

Adults and Children over 12 years old

Take 1 tablet once a day with a glass of water, with or without food.

Children between 6 and 12 years old will be dosed by weight

• Body weight over 30 kg:

Take 1 tablet once a day with a glass of water, with or without food.

• Body weight of 30 kg or less:

Do not give loratadine 10 mg. There are other presentations more suitable for children between 6 and 12 years old who weigh 30 kg or less.

Loratadine is not recommended for children under 6 years old.

Patient with severe liver problems and a weight over 30 kg:

Take 1 tablet (10 mg) once a day, every other day, with a glass of water, with or without food.

Method of Administration

The tablets can be taken independently of meals.

The tablet can be divided into equal doses.

If you take more loratadina cinfa than you should

No serious problems are expected, however, you may experience headache, palpitations, or feel drowsy.

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 cinfa

Do not take a double dose to make up for forgotten doses.

If you forget to take your dose on time, take it as soon as possible, and then return to your regular dosing schedule.

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 most frequently reported side effects (may affect more than 1 in 10 patients) in adults and adolescents over 12 years old include:

• drowsiness,
• headache,
• increased appetite,
• difficulty sleeping.

The most frequently reported side effects (may affect more than 1 in 10 patients) in children between 6 and 12 years old are:

• headache,
• nervousness,
• fatigue.

During the marketing of loratadine, the following very rare side effects (may affect up to 1 in 10,000 patients) have also been reported:

• severe allergic reaction (including swelling),
• dizziness,
• seizures,
• irregular or rapid heartbeats,
• nausea (vomiting),
• dry mouth,
• stomach discomfort,
• liver problems,
• hair loss,
• skin rash,
• fatigue.

Frequency not known (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 directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of loratadina cinfa

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of loratadina cinfa

• The active ingredient is loratadine. Each tablet contains 10 mg of loratadine.
• The other ingredients are: lactose monohydrate, corn starch, povidone, and magnesium stearate.

Appearance of the Product and Package Contents

loratadina cinfa are scored tablets, round, white or almost white, and marked with the code "L" on the other side.

They are presented in PVC/Al blisters. Each package contains 20 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Package Leaflet: September2021

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

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63696/P_63696.html

QR code to: https://cima.aemps.es/cima/dochtml/p/63696/P_63696.html