REVISEA 80 mg SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for the Patient

Revisea 80 mg soft capsules

For Adults

Lavender oil (Lavandula angustifolia Mill., essential oil)

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Follow the administration instructions for this medication contained in this package leaflet or as indicated by your doctor or pharmacist.
• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 1 month of treatment.

Contents of the Package Leaflet

1. What is Revisea and what is it used for
2. What you need to know before taking Revisea
3. How to take Revisea
4. Possible side effects
5. Storage of Revisea
6. Package Contents and Additional Information

1. What is Revisea and what is it used for

Revisea is a traditional herbal medicinal product for the treatment of temporary symptoms of anxiety in adults, based solely on its traditional use.

Additional information for use:

Anxiety can cause one or more temporary symptoms, such as uncontrollable worry, restlessness, tension, or sleep disturbance.

2. What you need to know before taking Revisea

Do not take Revisea

If you are allergic to lavender oil or any of the other components of this medication (listed in section 6), or if you have impaired liver function.

Warnings and precautions

If you suffer from excessive anxiety and/or uncontrollable worries and/or three or more symptoms related to anxiety (e.g., restlessness, fatigue, difficulty concentrating, irritability, muscle tension, sleep disturbances) for a prolonged period, you should consult a doctor because you may be suffering from a mental illness that requires medical supervision.

If you feel that your symptoms persist unchanged after one month of treatment or worsen, consult your doctor.

Lavender oil is not recommended for patients with severe renal impairment requiring dialysis due to the lack of clinical data.

Only limited data are available on the use of lavender oil in patients over 65 years of age.

Children and adolescents

Lavender oil is not recommended for children and adolescents under 18 years of age, as there are no data available on the use of this medication in this age group.

Other medications and Revisea

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

No cases of interaction between lavender oil and other medications have been reported. According to available data, no interaction with other medications is expected.

Available experimental data do not provide any evidence of interactions with other active substances with activity on the central nervous system. As a precautionary measure, lavender oil should not be taken with other anxiolytic, sedative, or alcohol medications due to the lack of clinical data on potential interactions.

Pregnancy and breastfeeding

Pregnancy

Experimental research does not provide any indication that suggests a harmful effect of lavender oil on pregnant women. As there are no clinical data available on the use of lavender oil during pregnancy, this medication is not recommended during pregnancy.

Breastfeeding

It is unknown whether the active components or their metabolites are excreted in breast milk. Consequently, breastfeeding mothers should not take lavender oil.

Driving and using machines

According to the results of a clinical study designed to evaluate the influence of lavender oil on the ability to drive in a small number of healthy individuals, the influence of lavender oil on the ability to drive and use machines is nil or insignificant. However, patients who feel affected, for example by fatigue, should not drive or operate machines. No data are available for patients over 58 years of age.

Revisea contains sorbitol

This medication contains approximately 8.4 mg of sorbitol in each soft capsule.

3. How to take Revisea

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults: Take one soft capsule per day, approximately at the same time.

Do not take lavender oil for more than 3 months. If symptoms persist unchanged after 1 month of treatment or worsen, consult your doctor.

The soft capsules should be taken without chewing, with a sufficient amount of liquid (preferably a glass of water).

Lavender oil should not be taken while lying down.

Children and adolescents

Lavender oil should not be administered to individuals under 18 years of age.

If you take more Revisea than you should

No cases of overdose have been reported.

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 Revisea

Do not take a double dose to make up for forgotten doses; continue treatment as your doctor indicated or as described in this package leaflet.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following list of side effects includes all reactions that occurred during treatment with lavender oil, including those that occurred with higher doses or during prolonged treatment.

Frequency not known (cannot be estimated from available data):

Severe hypersensitivity reactions (allergic reactions) with swelling, circulatory problems, and/or respiratory problems have been reported. In such cases, call a doctor immediately.

If you experience a hypersensitivity reaction (allergic reaction), stop taking this medication.

Frequent (1 to 10 per 100 treated patients):

• Belching.

Frequency not known (cannot be estimated from available data):

• Other gastrointestinal disorders;
• Skin allergic reactions.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Revisea

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

Do not use this medication after the expiration date shown on the box and blister pack after "EXP".

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Revisea

Each soft capsule contains:

Active ingredient: 80 mg of essential oil of Lavandula angustifolia Mill, in the form of Lavender Essential Oil.

The other components (excipients) are:

Contents of the capsule: Refined colza oil.

Capsule shell: Gelatin, non-crystallizable sorbitol liquid (E-420), 85% glycerol, and purified water. Colorants: Carmine acid (E-120); Patent Blue V (E-131).

Appearance of the product and package contents

Purple round capsules containing a clear yellowish oily solution.

They are presented in packages containing 30 soft capsules packaged in PVC/PVDC-Aluminum blisters.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona, Spain

Manufacturer

Laboratorio Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid), Spain

Date of the last revision of this package leaflet: February 2024

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