Package Leaflet: Information for the User

Loratadine Cinfa 10 mg Tablets EFG

Read this leaflet carefully before you start to take 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. Do not give it 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.

Contents of the pack and additional information

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

Loratadine helps to 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.

loratadine cinfa relieves symptoms associated with allergic rhinitis (such as hay fever) such as sneezing, runny or itchy nose and eye itching 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.

Do not take loratadine cinfa

• If you are allergic to loratadine or any of the other ingredients in this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take loratadine cinfa:

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

If any of the above conditions affect 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 or children aged 6 to 12 years weighing less than 30 kg. There are other formulations more suitable for children aged 6 to 12 years weighing less than 30 kg.

Children under 2 years

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

Other medications and loratadine cinfa

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

Taking loratadine 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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

As a precaution, 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 operating machinery

In clinical studies evaluating driving ability, no reduced function was observed in patients receiving 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 operate machinery.

Loratadine cinfa contains lactose

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of 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 aged 6 to 12 years 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 more suitable presentations for children aged 6 to 12 years who weigh 30 kg or less.

Loratadine is not recommended for children under 6 years old.

Patients with severe liver problems with a body weight over 30 kg:

Take 1 tablet (10 mg), once a day and on alternate days with a glass of water, with or without food.

Administration form

Tablets can be taken regardless of meals.

The tablet can be divided into equal doses.

If you take more loratadine cinfa than you should

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

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

If you forgot to take loratadine cinfa

Do not take a double dose to compensate for the missed doses.

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

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 all people will experience them.

The most frequently reported adverse 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 adverse effects (may affect more than 1 in 10 patients) in children aged 6 to 12 years are:

• headache,
• anxiety,
• fatigue.

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

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

Unknown frequency (cannot be estimated from available data):

• Weight gain.

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 Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Loratadine cinfa composition

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

Product appearance and packaging contents

Loratadine cinfa are scored tablets on one side, round, white or almost white, and marked with the code “L” on the other.

It is presented in PVC/Al blisters. Each package contains 20 tablets.

Marketing authorization holder and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: September2021

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your 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