Package Insert: Information for the User

LORATADINE SUN 10 MG TABLETS EFG

loratadine

Read this package insert carefully before starting to take this medication, as it contains important information for you

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6.Contents of the Package and Additional Information

What is Loratadina SUN

Loratadina SUN contains the active ingredient loratadine, which belongs to a group of medicines called “antihistamines”.

How Loratadina SUN works

Loratadina SUN 10 mg tablets 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.

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, nasal itching as well as eye itching, burning, and tearing.

Loratadina SUN 10 mg tablets is also indicated for the relief of symptoms of chronic idiopathic urticaria (skin eruption consisting of urticaria and papules).

Do not take Loratadina SUN 10 mg tablets:

- If you are allergic to loratadine or to any of the other ingredients 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 are to undergo any skin tests for allergies. Do not take Loratadina SUN tablets for the two days before these tests, as it may affect the test 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 administer Loratadina SUN tablets to children under 6 years old or children 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

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 enzymes found in the liver, or if your liver is not functioning properly. In clinical studies, no increase in side effects of loratadine was observed with medications that altered the performance of these enzymes.

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

Taking Loratadina SUN with alcohol

No increased effects of alcoholic beverages have been demonstrated with this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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, as this treatment passes through breast milk.

Driving and operating machinery:

In clinical studies evaluating 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 operate machinery.

Loratadina SUN 10 mg tablets contain lactose

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your pharmacist or nurse. In case of doubt, consult your doctor, pharmacist, or nurse again.

The recommended dose is:

Adults and children over 6 years of age with a body weight of more than 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 more suitable presentations for children under 6 years of age who weigh 30 kg or less.

Children under 2 years of age:

Loratadina 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 a day and on alternate days with a glass of water, with or without food.

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

Medication intake

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 every day at the same time, which will help you remember to take the medication.

If you take more Loratadina tablets than you should

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

In case of forgotten dose, take the medication as soon as you remember and continue with the treatment as prescribed. Do not take a double dose to compensate for the missed doses.

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

Like all medications, this medication may have adverse effects, although not all people may experience them.

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

• drowsiness
• 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 (which may affect up to 1 in 10,000 people) have also been observed:

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

Unknown frequency:

• weight gain

Reporting Adverse Effects

If you experience any type ofadverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly to the Spanish System for Pharmacovigilance of Medicines for Human Use: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.

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.

Store in the original packaging.

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 unused packaging and medications. By doing so, you will help protect the environment.

Composition of Loratadine SUN 10 mg tablets

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

-The other components are: lactose monohydrate, cornstarch, pregelatinized cornstarch, and magnesium stearate.

Appearance of the product and content of the packaging

Loratadine SUN 10 mg are round, non-coated tablets, white or almost white in color, marked with “R” on one face and “10” on the other.

Loratadine SUN 10 mg is presented in blister packaging in containers of 7, 10, 14, 20, 21, 30, or 100 tablets.

Not all packaging sizes may be marketed.

Holder of the marketing authorization

Sun Pharmaceutical Industries B.V.,

Polarisavenue 87,

2132JH Hoofddorp, Netherlands

Responsible for manufacturing

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

Last review date of this leaflet:January 2023

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