Package Insert: Information for the User

Loratadine Qualigen10 mgCoated Tablets

loratadine

Read this entire 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 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.

Contents of the package and additional information

Loratadina Qualigenbelongs to a class of medications known as antihistamines.

Loratadina Qualigen relieves symptoms associated with allergic rhinitis (such as sneezing, runny or itchy nose and eye burning or itching) in adults and children over 2 years old and weighing more than 30 kg.

Loratadina Qualigen can also be used to help relieve symptoms of urticaria (such as itching, redness and the number and size of skin hives) in adults and children over 2 years old and weighing more than 30 kg.

Do not take Loratadina Qualigen

If you are allergic to loratadine or any of the components of this medication (including those listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Loratadina Qualigen:

-You have severe liver disease (See section 3. How to take Loratadina Qualigen).

-You are scheduled to undergo any type of skin test for allergy. Do not take Loratadina Qualigen during the 2 days prior to the test, as this medication may alter the test results.

Other medications and Loratadina Qualigen

No interactions of loratadine with other medications are known. However, inform your doctor or pharmacist if you are using, have used recently, or may need to use other medications, including those obtained without a prescription.

Taking Loratadina Qualigen with food and drinks

Loratadine can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Loratadine is not recommended for use during pregnancy or breastfeeding.

Driving and operating machinery

At normal doses, loratadine does not affect the ability to drive or operate machinery. If you experience drowsiness, do not drive or operate machinery, but try not to perform tasks that require special attention until you know how you tolerate the medication.

Loratadina Qualigen contains lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and children over 2 years of age with a weight of more than 30 kg:

Take one tablet (10 mg) once a day.

Patients with severe liver problems with a weight of more than 30 kg:

Take one tablet (10 mg) once a day and on alternate days.

Loratadina Qualigen 10 mg tablets are not suitable for:

-administration of doses less than 10 mg.

-administration in patients with a weight of less than30 kg.

-patients who have difficulty swallowing.

Loratadina is not recommended for children under 2 years of age.

If you take more loratadina qualigen than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Telephone 91.562.04.20, indicating the medication and the amount ingested.

If you forget to take Loratadina Qualigen

If you forget to take your dose on time, take it as soon as possible, and then return to your usual dosing schedule. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Loratadina Qualigen

Remember to take your medication.

Your doctor will indicate the duration of treatment with loratadina. Do not discontinue treatment before.

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

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

The most frequently reported adverse effects (less than 1 in 10 patients but more than 1 in 100 patients) include drowsiness, headache, nervousness, fatigue, increased appetite, and difficulty sleeping.

The very rare adverse effects (less than 1 in 10,000 patients) reported have been cases of severe allergic reaction, dizziness, irregular or rapid heartbeats, nausea (urge to vomit), dry mouth, stomach upset, liver problems, hair loss, skin rash, and fatigue. Unknown frequency weight gain.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://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 if you observe any change in the appearance of the tablet.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

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

• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, cornstarch, pregelatinized cornstarch, hydrated colloidal silica, magnesium stearate, hypromellose, macrogol 400, macrogol 6000, carnauba wax, talc.

Appearance of the product and contents of the packaging

Loratadine Qualigen is presented in the form of circular, biconvex tablets with a groove on one face and marked LR10 on the other.

Each package contains 20 tablets in a blister.

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Last review date of this leaflet: May 2021

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