Leaflet:information for the user

Civerán 10 mg film-coated tablets

Loratadine

Read this leaflet carefully before you start to take this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

Civeránbelongs to a class of medications known as antihistamines.

Civeránrelieves symptoms associated with allergic rhinitis (such as sneezing, runny or itchy nose and eye burning or itching).

Civeránmay also be used to help relieve symptoms of urticaria (such as itching, redness and the number and size of skin hives).

Do not take Civerán

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Civerán:

-if you have severe liver disease (See section 3. How to take Civerán).

-You are to undergo any type of skin test for allergy. Do not take Civerán during the 2 days prior to the performance of these tests, because this medication may alter the results of the same.

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

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

The recommended dose is one tablet (10 mg) once a day.

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

The recommended dose is one tablet (10 mg), once a day and on alternate days.

Civerán is not suitable for:

-administration of doses lower than 10 mg.

-administration in patients with a weight of less than 30 kg.

-patients who have difficulty swallowing.

Use in children and adolescents

Civeran is not suitable for children from 2 to 12 years with a body weight of less than 10 kg.

It is not recommended to use Civerán in children under 2 years.

The notch should not be used to break the tablet.

If you take more Civerán than you should

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 Civerán

If you forgot to take a dose at your usual 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 Civerán

Remember to take your medication.

Your doctor will indicate the duration of treatment with Civerán. Do not stop treatment before.

Like all medications,this medicationmay have adverse effects, although not all people will 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) have been reported 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.

Weight gain as unknown frequency.

If you observe these adverse effects or others not described in this leaflet, inform your doctor or pharmacist.

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 leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe blister and on the packagingafter 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 in the 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.

Composition of Civerán

• The active principle is loratadine. Each tablet contains 10 mg of loratadine.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose (E 460i), cornstarch, pregelatinized cornstarch, hydrated colloidal silica (E 551), magnesium stearate (E 470b), hypromellose (E 464), macrogol 400 (E 1521), macrogol 6000 (E 1521), carnauba wax (E 903), talc (E 553b).

Appearance of the product and content of the packaging

Civerán is presented in the form of coated tablets with a film coating, round, biconvex with a score on one face and marked LR10 on the other.

It is presented in a blister pack in containers of 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder

NEURAXPHARM SPAIN, S.L.U

Avda. Barcelona, 69

08970 Sant Joan Despí

(Barcelona) – Spain

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/ )