Loratadine Sun 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

LORATADINE SUN 10 MG TABLETS EFG

loratadine

Read all of this leaflet carefully before you start taking this medicine, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Loratadine SUN 10 mg tablets are and what they are used for
2. What you need to know before taking Loratadine SUN 10 mg tablets
3. How to take Loratadine SUN 10 mg tablets
4. Possible side effects
5. How to store Loratadine SUN 10 mg tablets
6. Contents of the pack and other information

1. What Loratadina SUN 10 mg tablets are and what they are used for

What Loratadina SUN is

Loratadina SUN contains the active substance loratadine, which belongs to a group of medicines called "antihistamines".

How Loratadina SUN works

Loratadina SUN 10 mg tablets help 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.

What Loratadina SUN is used for

Loratadina SUN relieves symptoms associated with seasonal allergic rhinitis (hay fever) and perennial allergic rhinitis (allergy symptoms throughout the year).

These symptoms may include sneezing, runny nose, itchy nose, as well as burning, itching and watering of the eyes.

Loratadina SUN 10 mg tablets are also indicated for the relief of symptoms of chronic idiopathic urticaria (skin rash characterized by hives and wheals).

2. What you need to know before taking Loratadina SUN 10 mg tablets

Do not take Loratadina SUN 10 mg tablets:

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Loratadina SUN tablets if:

• You have severe liver problems.
• You need to undergo skin allergy testing. Do not take Loratadina SUN tablets during the two days prior to these tests, as it could affect the test results.

If you are in any of the situations mentioned above (or are unsure), consult your doctor, pharmacist, or nurse before taking Loratadina SUN tablets.

Children and adolescents

Do not give Loratadina SUN tablets to children under 6 years of age or to children weighing less than 30 kg. Other formulations are more suitable for children under 6 years of age or those weighing 30 kg or less.

Children under 2 years of age

The safety and efficacy of Loratadina SUN tablets have not been established. No data are available.

Taking Loratadina SUN tablets with other medicines

The side effects of Loratadina SUN may increase when used together with medicines that affect the function of certain liver enzymes, or if your liver is not working properly. In clinical studies, no increase in loratadine side effects was observed with medicines affecting these enzymes.

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines, including those not requiring a prescription.

Taking Loratadina SUN with alcohol

It has not been shown that this medicine increases the effects of alcoholic beverages.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

As a precautionary measure, it is preferable to avoid taking loratadine during pregnancy.

Do not take loratadine while breastfeeding, as this medicine passes into breast milk.

Driving and using machines:

In clinical trials assessing driving ability, no impaired function was observed in patients receiving loratadine. At the recommended dose, loratadine is not expected to cause drowsiness or reduced alertness. However, very rarely, some individuals may experience drowsiness, which could affect their ability to drive or operate machinery.

Loratadina SUN 10 mg tablets contain lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Loratadine SUN 10 mg tablets

Follow exactly the administration instructions for this medicine provided in this leaflet, or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.

Recommended dose:

Adults and children over 6 years of age weighing more than 30 kg:

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

Body weight of 30 kg or less:

Do not administer Loratadine SUN 10 mg tablets. There are other formulations more suitable for children under 6 years of age who weigh 30 kg or less.

Children under 2 years of age:

Loratadine SUN 10 mg tablets are not recommended for children under 2 years of age.

Adults and children with severe liver problems:

Adults and children weighing more than 30 kg:

Take 1 tablet once daily on alternate days with a glass of water, with or without food.

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

How to take the medicine

The tablets should be swallowed whole, without chewing, with a little water. They may be taken with or without food.

Try to take your medicine at the same time each day; this will help you remember to take it.

If you take more Loratadine tablets than you should

If you take more Loratadine tablets than prescribed, you may experience drowsiness, rapid heartbeat, and headache. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone (91) 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Loratadine SUN tablets

If you miss a dose, take the medicine as soon as you remember and continue treatment as prescribed. Do not take a double dose to make up for the missed dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The most frequently reported adverse effects in adults and children aged 6 to 12 years are:

• somnolence
• headache
• increased appetite
• difficulty sleeping.

The most frequently reported adverse effects in children aged 6 to 12 years are:

• headache
• nervousness
• fatigue.

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

• severe allergic reaction (including swelling)
• dizziness
• seizures
• increased heart rate, palpitations (sensation of increased heart rate)
• nausea (feeling of needing to vomit)
• dry mouth
• irritation of the stomach lining (gastritis)
• skin rash
• hair loss
• liver disorders
• fatigue.

Frequency not known:

• weight gain

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Loratadine SUN tablets

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

Do not use this medicine after the expiry date stated on the packaging after "exp". The expiry date refers to the last day of the month indicated.

Store in the original packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Loratadine SUN 10 mg tablets

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

• The other components are: monohydrate lactose, corn starch, pregelatinized corn starch and magnesium stearate.

Appearance of the product and contents of the pack

Loratadine SUN 10 mg are round, uncoated tablets, white or almost white, marked with “R” on one side and “10” on the other.

Loratadine SUN 10 mg is available in blisters in pack sizes of 7, 10, 14, 20, 21, 30 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Sun Pharmaceutical Industries B.V.,

Polarisavenue 87,

2132JH Hoofddorp, The Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

The Netherlands

or

Alkaloida Chemical Company Zrt.

4400 Tiszavasvári

Kabay János u. 29

Hungary

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona, Spain

Tel.: +34 93 342 78 90

Date of the most recent revision of this leaflet: January 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/