
Ask a doctor about a prescription for LORATADINE SUN 10 mg TABLETS
Package Leaflet: Information for the User
LORATADINA SUN 10 MG TABLETS EFG
loratadina
Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you
Contents of the package leaflet
What is Loratadina SUN
Loratadina SUN contains the active ingredient loratadina, which belongs to the group of medications 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 the symptoms associated with seasonal allergic rhinitis (hay fever) and perennial (year-round allergy symptoms).
These symptoms may include sneezing, runny nose, nasal itching, as well as itching, redness, and tearing of the eyes.
Loratadina SUN 10 mg tablets are also indicated for the relief of symptoms of chronic idiopathic urticaria (skin rash consisting of hives and papules).
Do not take Loratadina SUN 10 mg tablets:
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to take Loratadina SUN tablets if:
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.
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.
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:
The most frequently reported side effects in children from 6 to 12 years are:
During the marketing of loratadina, the following very rare side effects (affecting up to 1 in 10,000 people) have also been observed:
Frequency not known:
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.
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.
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/
The average price of LORATADINE SUN 10 mg TABLETS in November, 2025 is around 3.11 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
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