LORATADINE RATIOPHARM 10 mg TABLETS

Introduction

Patient Information Leaflet

Loratadine ratiopharm 10 mg tablets EFG

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this 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 should not be given 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 leaflet. See section 4.

Contents of the leaflet:

1. What is Loratadine ratiopharm and what is it used for
2. What you need to know before taking Loratadine ratiopharm
3. How to take Loratadine ratiopharm
4. Possible side effects
5. Storage of Loratadine ratiopharm
6. Package contents and additional information

1. What is Loratadine ratiopharm and what is it used for

What is loratadine

Loratadine ratiopharm contains the active ingredient loratadine, which belongs to a class of medications called "antihistamines".

How loratadine works

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.

When to use loratadine

Loratadine relieves the symptoms of allergic rhinitis (e.g., hay fever) such as sneezing, runny or itchy nose, and itchy or watery eyes in adults and children over 6 years old who weigh more than 30 kg.

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

Relief from these symptoms lasts a full day and helps you to continue your daily activities and normal sleep periods.

Contact your doctor if you do not notice improvement or if your symptoms worsen.

2. What you need to know before taking Loratadine ratiopharm

Do not take Loratadine ratiopharm

• if you are allergic to loratadine or any of the components of this medication listed in section 6.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Loratadine ratiopharm 10 mg

• if you have liver disease
• if you are going to undergo any type of skin allergy tests. Do not take loratadine during the 2 days prior to the test. This is because 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 ratiopharm.

Children

This medication should not be given to children under 2 years of age or weighing less than 30 kg. There are other formulations more suitable for children under 6 years old or weighing 30 kg or less.

Children under 2 years of age

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

Taking Loratadine ratiopharm with other medications

The side effects of loratadine may increase when used with medications that alter the performance of certain enzymes responsible for metabolism in the liver. However, in clinical studies, no increase in loratadine side effects was observed with medications that altered the performance of these enzymes.

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or may need to take any other medication, including non-prescription medications.

Taking Loratadine ratiopharm with alcohol

It has not been shown 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.

As a precaution, it is recommended to avoid taking loratadine if you are pregnant.

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

Driving and using machines

Loratadine may cause drowsiness or dizziness. If you feel affected, do not drive or use machines.

Loratadine ratiopharm 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 Loratadine ratiopharm

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

The recommended dose is:

Adults and children over 6 years old with a 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 ratiopharm. There are other formulations more suitable for children under 6 years old or weighing 30 kg or less.

Children under 2 years old:

Loratadine is not recommended for children under 2 years old.

Adults and children with severe liver problems:

Adults and children weighing more than 30 kg:

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

However, you should consult your doctor, pharmacist, or nurse before taking this medication.

If you take more Loratadine ratiopharm than you should

If you take more loratadine 10 mg than you should, consult your doctor or pharmacist immediately. No serious problems are expected, but you may experience headache, palpitations, or drowsiness.

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In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone 91 562 04 20.

If you forget to take Loratadine ratiopharm

If you forget to take your dose, take it as soon as you remember, then continue taking it as usual.

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

If you have any other questions about the use of this medication, consult your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following side effects, stop treatment immediatelyand consult your doctor or go to the nearest hospital:

• cases of allergic reaction such as swelling of the lips, tongue, or face (Quincke's edema),
• difficulty breathing and allergic reactions (prickling, burning, itching of the skin with inflammation),
• angioedema (swelling of the skin and mucous membranes).

These are very serious side effects. If you experience them, you may have had a severe allergic reaction. You may need urgent medical attention or hospitalization.

Frequent(may affect up to 1 in 10 people) in adults and children over 12 years old

• drowsiness

Additional side effects in children from 2 to 12 years old

• headache,
• nervousness,
• fatigue.

Uncommon(may affect up to 1 in 100 people) in adults and children over 12 years old

• headache
• increased appetite
• difficulty sleeping

Very rare(may affect up to 1 in 10,000 people)

• 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 leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Loratadine ratiopharm

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

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.

This medication does not require special storage conditions.

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. Package contents and additional information

Composition of Loratadine ratiopharm

• The active ingredient is loratadine. Each tablet contains 10 mg of loratadine.

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

Appearance of the product and package contents

The tablets are white, round, and biconvex with a curved score line on one side. The tablets can be divided into two equal halves.

Each package contains 2, 7, 10, 14, 20, 20x1, 21, 28, 30, 50, 100, or 100x1 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Holder

Teva Pharma, S.L.U. C/Anabel Segura, 11 Edificio Albatros B, 1ª Planta

28108 Alcobendas, Madrid

Spain

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse, 3

89143 Blaubeuren (Germany)

Date of the last revision of this leaflet:September 2023

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/