LORATADINE SUN 10 mg TABLETS

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 loratadina 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 SUN tablets if:

• You have severe liver problems.
• You need to undergo a skin allergy test. Do not take Loratadina SUN tablets for 2 days before the test, as it may affect the results.

If you are in any of the above situations (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 children who weigh less than 30 kg. There are other formulations more suitable for children under 6 years of age or weighing 30 kg or less.

Children under 2 years

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

Taking Loratadina SUN tablets with other medications

The side effects of Loratadina SUN 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 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 take any other medication, including those not requiring a prescription.

Taking Loratadina SUN with alcohol

It has not been shown that this medication 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 loratadina if you are pregnant.

Do not take loratadina if you are breastfeeding, as this treatment passes into breast milk.

Driving and using machines

In clinical trials that evaluated driving ability, no reduced function was observed in patients who received loratadina. At the recommended dose, loratadina is not expected to cause drowsiness or reduced alertness. However, in very rare cases, some people may experience drowsiness, which may affect their ability to drive or use machines.

Loratadina SUN 10 mg tablets contain 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 SUN 10 mg tablets

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

The recommended dose is:

Adults and children over 6 years 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 Loratadina SUN 10 mg tablets. There are other formulations more suitable for children under 6 years of age or weighing 30 kg or less.

Children under 2 years:

Loratadina SUN 10 mg tablets are not recommended for children under 2 years.

Adults and children with severe liver problems:

Adults and children who weigh 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.

Taking the medication

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

Get into the habit of taking your medication at the same time every day, as this will help you remember to take it.

If you take more Loratadina tablets than you should

If you take more Loratadina tablets than you should, you may experience drowsiness, rapid heartbeat, and headache. 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 SUN tablets

If you forget a dose, take the medication as soon as you remember and continue with the treatment as prescribed. Do not take a double dose to make up for the missed 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 have side effects, although not everyone will experience them.

The most frequently reported side effects in adults and children from 6 to 12 years are:

• drowsiness
• headache
• increased appetite
• difficulty sleeping

The most frequently reported side effects in children from 6 to 12 years are:

• headache
• nervousness
• fatigue

During the marketing of loratadina, the following very rare side effects (affecting up to 1 in 10,000 people) have also been observed:

• severe allergic reaction (including swelling)
• dizziness
• seizures
• increased heart rate, palpitations (feeling of increased heart rate)
• nausea (vomiting)
• dry mouth
• stomach irritation (gastritis)
• skin rash
• hair loss
• liver disorders
• fatigue

Frequency not known:

• 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: www.notificaram.es.

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

5. Storage of Loratadina SUN tablets

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 "EXP". The expiration date is the last day of the month indicated.

Store in the original packaging.

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

6. Package contents and additional information

Composition of Loratadina SUN 10 mg tablets

-The active ingredient is loratadina. Each tablet contains 10 mg of loratadina.

-The other ingredients are: lactose monohydrate, corn starch, pregelatinized corn starch, and magnesium stearate.

Appearance of the product and package contents

Loratadina SUN 10 mg are round, uncoated tablets, white or almost white in color, marked with "R" on one side and "10" on the other.

Loratadina SUN 10 mg is available in blister packs in packages 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, Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

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 last revision of this package leaflet:January 2023

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/