LORATADINE FARMALIDER 10 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

Loratadina Farmalider 10 mg Soft Capsules

(Loratadine)

Contents of the Package Leaflet:

1. What is Loratadina Farmalider and what is it used for
2. Before taking Loratadina Farmalider
3. How to take Loratadina Farmalider
4. Possible side effects
5. Storage of Loratadina Farmalider
6. Additional information

1. What is Loratadina Farmalider and what is it used for

Loratadine belongs to the group of medicines called antihistamines, used for the treatment of various allergic processes.

Loratadina Farmalider temporarily relieves the symptoms associated with allergic processes produced by: plant pollen (hay fever), dust, domestic animals, and other allergenic agents.

These symptoms may include sneezing, runny nose, nasal and throat itching, as well as itching, burning, and tearing of the eyes.

2. Before taking Loratadina Farmalider

Do not take Loratadina Farmalider 10 mg soft capsules if:

o You are allergic (hypersensitive) to loratadine or to any of the other components of this medicine.

o You are pregnant or plan to become pregnant.

o You are breastfeeding.

Be careful with Loratadina Farmalider:

o If you have severe liver disease.

Use of other medicines:

Tell your doctor or pharmacist if you are using or have recently used any other medicine, including those obtained without a prescription.

Some medicines, such as those used to treat depression, fungal infections, and some antibiotics like erythromycin, can increase loratadine levels, which can cause an increase in adverse reactions.

Interactions with diagnostic tests:

If you are going to undergo any type of allergy test, do not take Loratadina Farmalider during the 48 hours prior to the test, and inform your doctor because this medicine can alter the test results.

Use with food and drinks

Loratadina Farmalider can be taken with or without food. Avoid consuming alcoholic beverages.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medicine.

It is not recommended to take Loratadina Farmalider if you are pregnant.

Breastfeeding

It is not recommended to take Loratadina Farmalider if you are breastfeeding, as loratadine passes into breast milk.

IMPORTANT FOR WOMEN

If you are pregnant or think you may be pregnant, consult your doctor before taking this medicine. The use of medicines during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.

Use in children:do not administer this medicine to children under 12 years of age.

Driving and using machines:

Very rarely, this medicine can cause drowsiness or reduce reaction time in some people. Therefore, it is recommended not to perform tasks that require special attention (such as driving cars or using machines) until you know how this medicine affects you.

Important information about some of the components of Loratadina Farmalider 10 mg soft capsules

This medicine contains Sorbitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains 0.25% w/w ethanol (alcohol), which corresponds to an amount of 6.25 mg per dose.

3. How to take Loratadina Farmalider

Follow these administration instructions for Loratadina Farmalider exactly, unless your doctor has given you different instructions. Consult your doctor or pharmacist if you have any doubts.

Loratadina Farmalider 10 mg is presented in the form of soft capsules. The capsules should be swallowed whole, without chewing, with the help of a little water, with or without food.

Adults and children over 12 years: one capsule (10 mg) once a day.

Children over 12 years but weighing less than 30 kg should nottake this medicine.

Patient with severe liver problems: one capsule (10 mg) once a day, every other day.

Loratadina Farmalider 10 mg soft capsules are not suitable for:

• administering doses less than 10 mg.
• administering to patients weighing less than 30 kg.
• patients who have swallowing problems.

Loratadina Farmalider 10 mg soft capsules are not recommended for children under 12 years of age.

If symptoms persist after 7 days, consult your doctor.

If you take more Loratadina Farmalider:

If you have taken more Loratadina Farmalider 10 mg soft capsules than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Loratadina Farmalider:

If you forget to take your dose on time, take it as soon as possible and continue with the treatment as indicated. Do not take a double dose to make up for the forgotten dose.

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

4. Possible side effects

Like all medicines, Loratadina Farmalider can have side effects, although not everyone gets them.

The most frequently reported side effects (occurring in 1 to 10 out of 100 patients) include drowsiness, headache, nervousness, fatigue, increased appetite, and difficulty sleeping.

Very rare side effects (occurring in less than 1 in 10,000 patients) have been cases of severe allergic reaction, dizziness, irregular or rapid heartbeat, nausea (vomiting), dry mouth, stomach pain or burning, liver problems, hair loss, skin rash, and fatigue.

Frequency "not known": Weight gain

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Loratadina Farmalider

Keep out of the reach and sight of children.

Storage conditions

Do not store above 30°C.

Expiry date:

Do not use Loratadina Farmalider 10 mg soft capsules after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not use Loratadina Farmalider 10 mg soft capsules if the capsule is damaged (clearly deformed, has lost its contents, or is stuck to the aluminum).

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Additional information

Composition of Loratadina Farmalider:

The active ingredient is: Loratadine. Each soft capsule contains 10 mg of loratadine.

The other ingredients (excipients) are:

• propylene glycol
• glycerol
• Povidone K30
• Macrogol 400
• anhydrous citric acid
• purified water
• gelatin
• glycerol 85%
• partially dehydrated sorbitol liquid 85%
• quinoline yellow 70%
• blue V 85%
• ethanol (less than 0.25% w/w).

Appearance of the product and package size

Loratadina Farmalider 10 mg are green soft capsules.

Loratadina Farmalider 10 mg is presented in blister packs of 7 capsules.

Marketing authorization holder

Farmalider, S.A.

C/ La Granja, 1 - 28108 Alcobendas (Madrid)

Manufacturer

Toll Manufacturing Services, S.L.

C/ Aragoneses, 2 - 28108 Alcobendas (Madrid)

or

Farmalider, S.A.

C/ Aragoneses, 2 - 28108 Alcobendas (Madrid)

This leaflet was approved inAugust 2021