CIVERÁN 10 mg FILM-COATED TABLETS

Introduction

Leaflet: information for the user

Civerán 10 mg film-coated tablets

Loratadine

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Civerán is and what it is used for
2. What you need to know before taking Civerán
3. How to take Civerán
4. Possible side effects
5. Storage of Civerán
6. Contents of the pack and further information

1. What Civerán is and what it is used for

Civerán belongs to a class of medicines known as antihistamines.

Civerán relieves the symptoms associated with allergic rhinitis (such as sneezing, runny or itchy nose and itchy or burning eyes).

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

2. What you need to know before taking Civerán

Do not take Civerán

• If you are allergic to loratadine or any of the other ingredients of this medicine (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).
• If you are going to have any skin allergy tests. Do not take Civerán for 2 days before these tests, as this medicine may affect the results.

Children and adolescents

U

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

No interactions with other medicines are known for Civerán. However, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

T

Civerán can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Civerán is not recommended if you are pregnant or breastfeeding.

Driving and using machines

At the recommended dose, this medicine is not expected to affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended not to engage in activities that require a state of alertness, such as driving a car or using machines, until you have determined your own response to the medicine.

Civerán contains lactose

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

3. How to take Civerán

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor again.

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

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

Patient with severe liver problems with a weight over 30 kg:

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

Civerán is not suitable for:

• administration of doses below 10 mg.
• administration in patients with a weight below 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 below 10 mg.

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

The score line should not be used to divide 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Civerán

If you forget to take a dose at the usual time, take it as soon as possible, and then return to your regular dosing schedule. Do not take a double dose to make up for forgotten doses.

If you stop taking Civerán

Remember to take your medicine.

Your doctor will tell you how long to take Civerán. Do not stop treatment before then.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Very rare side effects (less than 1 in 10,000 patients) have been reports of severe allergic reactions, dizziness, irregular or rapid heartbeats, nausea (feeling sick), dry mouth, upset stomach, liver problems, hair loss, skin rash, and fatigue.

Weight gain with unknown frequency.

If you notice any of these side effects or others not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Civerán

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and on the carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Civerán

• The active substance is loratadine. Each tablet contains 10 mg of loratadine.
• The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose (E 460i), maize starch, pregelatinized maize starch, colloidal anhydrous 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 and packaging

Civerán is presented as film-coated tablets, round, biconvex with a score line on one side and marked LR10 on the other.

It is available in blister packs of 20 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

NEURAXPHARM SPAIN, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

(Barcelona) – Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona) - Spain

Date of last revision of this leaflet: May 2021

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/)